2216 Amendments of Tudor CIUHODARU
Amendment 256 #
2023/2075(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Acknowledges that tobacco use, physical inactivity, the harmful use of alcohol and drugs, unhealthy diets and environmental factors such as air, food, water and soil pollution and chemical exposure increase the risk of NCDs10 ; _________________ 10 https://www.paho.org/en/topics/noncommu nicable-diseases - :~:text=These%204%20groups%20of%20d iseases,of%20the%20response%20to%20N CDs The Pan American Health Organization, ‘Noncommunicable Diseases’.
Amendment 274 #
2023/2075(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Acknowledges that tobacco use was responsible for 1.6 million deaths in Europe in 2019 and is a high risk factor for developing NCDs such as cancer, cardiovascular diseases and chronic respiratory diseases, and that this figure may be even higher since causes of death are not monitored in all cases;
Amendment 300 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point a
Paragraph 5 – point a
a. implement viable measures to help tobacco users quit;
Amendment 308 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b
Paragraph 5 – point b
b. follow up on the scientific evaluations of the health risks related to electronic cigarettes, heated tobacco products and novel tobacco products, including the assessment of the risks of using these products compared to consuming other tobacco products, especially taking into account the fact that an ever-increasing number of young people are using electronic cigarettes;
Amendment 359 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 – point a
Paragraph 7 – point a
a. Eenact restrictions on alcohol advertising targeting minors and limit such advertising in stadiums or venues for major sports competitions;
Amendment 388 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – introductory part
Paragraph 8 – introductory part
8. Notes that an unhealthy diet, and especially fast food products, whose use has burgeoned in recent years, is one of the major risk factors for NCDs, including cardiovascular diseases, cancer, diabetes and other conditions linked to obesity15; acknowledges that obesity is considered a risk factor for several NCDs; calls on the Commission and the Member States to: _________________ 15 World Health Organization Regional Office for the Eastern Mediterranean, ‘Noncommunicable diseases’.
Amendment 406 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point a
Paragraph 8 – point a
Amendment 424 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b
Paragraph 8 – point b
Amendment 452 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. The increase in drug use has become a public health problem and is a major risk factor for non-communicable diseases, including mental health disorders and hetero-aggression, as well as a major contributory factor in road accidents;
Amendment 465 #
2023/2075(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Stresses the role of health education in the prevention of non- communicable diseases and calls on the Commission and the Member States to promote health education and to introduce health education as a compulsory subject for study in all educational establishments.
Amendment 567 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying as early as possible people with a high risk of developing NCDs and diagnosing people as early as possible to improve disease management, prevent complications and save downstream costs for healthcare systems;
Amendment 588 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing regular targeted health checks for high-risk individuals addressing the main shared metabolic risk factors, ensuring quality care and support NCD patients’ self- management;
Amendment 626 #
2023/2075(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that nurses, doctors, general practitioners and other primary care professionals have a significant role in referring patients for early diagnostic tests and treating NCDs; encourages the Member States to offer training to healthcare professionals to better identify high-risk individuals and treat NCDs;
Amendment 672 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Encourages the Member States to provide regular information to the public on the risk of these diseases and the need for regular checks and examinations to be conducted to detect them as early as possible;
Amendment 709 #
2023/2075(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that patient empowerment and health literacy are crucial for an EU NCD strategy and that early detection, treatment and care should be patient- centred; encourages the promotion of well- informed patients who are actively involved in their own treatment and calls for the therapeutic training of caregivers and patients and their empowerment in the care programmes;
Amendment 773 #
2023/2075(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the Commission to strengthen support and investment in the development of new innovative medical devices and making them available to the public as soon as possible; believes that new technologies can lead to new and better treatments for NCDs;
Amendment 153 #
2023/2074(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that, at any point in their life, any person can become more susceptible to poorer mental health, for various social or personal reasons or causes, and thus become part of a vulnerable group in society; stresses that addressing mental health conditions requires a thorough understanding of the different determinants of mental health and that an intersectional approach is necessary to prevent and mitigate the impacts on individuals, communities and societies;
Amendment 199 #
2023/2074(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Highlights that mental health conditions are the leading cause of years of healthy life loss due to disability in the EU, although many people do not admit they are suffering from such conditions, and that people who are diagnosed with severe mental health conditions are likelier to die prematurely;
Amendment 292 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. invites the EU and the Member States to develop and run awareness- raising campaigns regarding the need for early detection of mental illnesses in different categories of people, especially considering the fact that many people do not admit that they suffer from such conditions;
Amendment 311 #
2023/2074(INI)
8a. is deeply concerned about the low availability of integrated addict support centres in the context of the rising number of such conditions and the huge repercussions for mental health. Considers that sustained measures must be taken by the Commission, possibly a programme to provide diagnosis, support and holistic treatment for people with addictions.
Amendment 355 #
2023/2074(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Underlines the importance of early diagnosis and intervention for mental health conditions, with a focus on teenagers, young people and people from disorganised families at risk of social exclusion once diagnosed with such conditions;
Amendment 458 #
2023/2074(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Invites the Commission and the Member States to invest in further research on mental health, and in the earliest possible implementation of research outcomes, be they medicines or new therapies;
Amendment 473 #
2023/2074(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Member States to develop new social prescribing interventions for people with mental health conditions or who will benefit from such interventions; calls on the Commission to promote discussions with the Member States on best practice in social prescribing and sharing of good practice through specialised platforms;
Amendment 10 #
2023/2010(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
— having regard to the SDG Acceleration Actions platform,
Amendment 12 #
2023/2010(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
— having regard to the UNEA Resolution “5/10. The environmental dimension of a sustainable, resilient and inclusive post-COVID-19 recovery”, adopted by the United Nations Environment Assembly (UNEA) on 2 March 2022,
Amendment 14 #
2023/2010(INI)
Motion for a resolution
Citation 9 b (new)
Citation 9 b (new)
— having regard to the UN High Seas Treaty, the historic agreement to protect the world's oceans reached on 5 March 2023,
Amendment 55 #
2023/2010(INI)
Motion for a resolution
Recital A
Recital A
A. whereas, with less than seven years to go until the deadline for the implementation of the 2030 Agenda, the new geopolitical landscape and the multiple crises in various areas, including the triple planetary crisis of climate change, biodiversity loss and pollution, the Russian war of aggression against Ukraine, energy and food insecurity and soaring prices, fragile supply chains and rapid inflation, have hindered the achievement of the SDGs; whereas the 2030 Agenda and the 17 SDGs are key to addressing the current challenges and reorienting the global compass towards a socially and environmentally just transition that leaves no one and no place behind;
Amendment 149 #
2023/2010(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses its commitment to the 2030 Agenda, especially in light of the new geopolitical landscape and the ongoing climate, biodiversity and health crises; warns against further polarisation in the distribution of wealth and income, which would lead to increased inequality and poverty; highlights, against this backdrop, the importance of the SDGs, which provide a universal compass for people’s prosperity and to protect the planet; recalls that a pledge to leave no one and no place behind lies at the heart of the 2030 Agenda and that the achievement of the SDGs should benefit all countries, people and segments of society;
Amendment 188 #
2023/2010(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Highlights the importance of the 2023 High-Level Political Forum on Sustainable Development and the SDG Summit, which are both due to take place in New York, as opportunities to review progress at the halfway point, which must be the starting point for an intensified effort and accelerated action to achieve the goals by 2030; acknowledges, in this regard, the SDGs being focused on in 2023 (SDGs 6, 7, 9, 11 and 17);
Amendment 217 #
2023/2010(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls urgently on the Commission to develop a comprehensive strategy accompanied by a structured SDGs implementation plan with clear, measurable, accountable and time-bound EU-wide targets; emphasises, in this regard, that successful implementation of the 2030 Agenda is contingent on stronger alignment between the EU’s governance systems in economic, social and environmental matters, such as the European Semester, the European Green Deal and the implementation of the European Pillar of Social Rights;
Amendment 227 #
2023/2010(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to continue integrating the SDGs into the European Semester by better linking it to the monitoring of the NRRPs, and to use the country- specific recommendations to systematically measure Member States’ progress and set out concrete proposals for improvement;
Amendment 241 #
2023/2010(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses Parliament’s important role in promoting the SDGs’ implementation through European policies and heightening the goals’ visibility in public discourse; underlines that coordination and regular structured dialogue within and between the EU institutions is essential in order to ensure the EU’s leadership and increase the effectiveness of its efforts to implement the 2030 Agenda;
Amendment 264 #
2023/2010(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reiterates the call on the Commission to establish a new permanent platform, for a “whole of society” approach as an important innovation , for regular and structured engagement with civil society organisations in order to systematically involve them in a meaningful way in the SDG implementation process;
Amendment 266 #
2023/2010(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Highlights the necessity to develop and promote multiple solutions that any actor in society can implement to reduce the carbon footprint, such as: responsible consumption of resources (from water to food), transition to circular economy, investments in green energy, developing green value chains in the private sector, increasing the percentage of green public procurement, prioritizing and supporting investments in the research sector dedicated to bio-based solutions, increasing the percentage of green credits to support the transition to low-carbon businesses;
Amendment 297 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
Amendment 299 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Further calls on EU Member States and its global partners to share best practices and provide peer-to-peer learning and technical assistance, particularly to developing countries, to support efforts for resource mobilisation and for strengthening and scaling up country-level efforts on sustainable, resilient and inclusive recovery measures which promote a green and digital twin transition whilst considering odemographical issues and mainstreaming gender dimension;
Amendment 305 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Stresses that women's contribution in green economic activities is essential to achieve equitable sustainable development and should be seen and valued; believes that women and girls can also benefit from the opportunities in the field of green entrepreneurship and become green employers rather than employees;
Amendment 306 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Encourages Member States to better engage local and regional authorities (LRAs) in the monitoring and implementation phases of NRRPs to ensure consideration of SGD indicators; recognises the potential of LRAs to drive a green and socially responsible recovery in their localities, to better encourage civic engagement and achieve sustainable growth in local economies;
Amendment 319 #
2023/2010(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. PCalls on the Member States to adopt SGD indicators and monitor their implementation in the NRRPs; points out that, in order to assess the Member States’ progress on the SDGs, the Eurostat sustainable development indicators must be improved by filling the gaps for some SDGs and better measuring policies’ impact on territories and specific vulnerable groups;
Amendment 380 #
2023/2010(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Calls on the Commission to consider extending the SDGs beyond the cohesion policy funds to address the financing gap and explore synergies with Horizon Europe, LIFE+, InvestEU, Digital Europe Programme, as well as the financial support of the European Investment Bank to mainstream sustainable development and scale up policies and projects;
Amendment 384 #
2023/2010(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18 b. Calls on Member States and the EU's global partners to bolster efforts to curb illicit financial flows and cross- border tax evasion, which undermine taxation systems and inhibit domestic resource mobilisation towards the achievement of the 2030 Agenda;
Amendment 413 #
2023/2010(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Encourages the private sector and multilateral financial institutions to continue to support countries whose economies have been affected by the COVID-19 pandemic to achieve a sustainable, resilient and inclusive recovery;
Amendment 4 #
2022/2183(INI)
Draft opinion
Recital A
Recital A
A. whereas nature and biodiversity are the foundations of food and, without strong political action to conserve and restore nature and biodiversity, food securityat both European and international level, food security for all citizens and the right to food will be irreversibly endangered;
Amendment 64 #
2022/2183(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Supports the just transition to agro- ecological and organic farming; reiterates its support for the ambitions, targets and goals of the farm to fork, biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals, including those related to the reduction in the use of pesticides and their associated risks and the setting of EU food waste reduction targets for the entire food chain;
Amendment 98 #
2022/2183(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls for the strict application of the One Health principle in all policies that affect the availability and accessibility of food; stresses that food safety and hence citizens’ health must never be jeopardised;
Amendment 120 #
2022/2183(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Highlights that the availability of plant proteins, if consumed directly, is more than sufficient to meet global protein needs; acknowledges the positive impact that plant-based diets have on humans, animals, the planet and food security; stresses that reducing the number and density of farmed animals can effectively combat the climate and biodiversity crises, decrease the risk of zoonotic diseases and contribute to food security in the short and long terms to the extent that consumers agree to these reductions which affect their diet and dietary habits;
Amendment 123 #
2022/2183(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission and Member States for a European awareness-raising campaign about the possible reduction in the number of farmed animals, and opinion polls on such a reduction, in parallel with public consultations at European level about all of these diet-related issues, which are changes that affect consumers directly;
Amendment 131 #
2022/2183(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the Commission for a strategy comprising measures to be taken in the event of any reduction in the number of farmed animals, to be developed following an assessment of the impact on farmers, the whole of the supply chain that will be affected and, in particular, the local economy horizontally and vertically, with the risk of higher unemployment and increased rural depopulation;
Amendment 179 #
2022/2183(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls for a strategy to regionalise the supply chain of the most important commodities and to ensure the supply of both local and sustainable traditional products, in correlation with the characteristics of each region, and also local and sustainable plant proteins;
Amendment 75 #
2022/2171(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Acknowledges the urgency of ensuring that textile products placed on the EU market coming from any EU or third- country producer are long-lived, reusable and recyclable, and free of hazardous substances; expresses its concern that the measures identified in the EU Strategy might not be sufficient to fulfil the 2030 objective and calls on the Commission to ensure all necessary measures, including additional measures to those identified in the strategy, are taken to achieve the 2030 vision;
Amendment 118 #
2022/2171(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Draws attention to the fact that imports of non-compliant products or products of inferior quality to those initially displayed online sold through online platforms and other digital services are widespread, and calls on those service providers to ensure that the textile products they sell comply with EU law;
Amendment 260 #
2022/2171(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Recalls that separate collection of textiles will be mandatory from 1 January 2025; underlines that the revision of the Waste Framework Directive planned for 2024 should consider specific separate targets for textile waste prevention, textile reuse, preparation for reuse, and recycling; stresses the need to inform the public about these rules in order to prepare the ground for separate collection with a view to the recycling and reuse of clothing products.
Amendment 156 #
2022/2053(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that the agricultural and forestry sectors can play a significant role in this process at European and international level, given that they have the capacity to remove and store carbon through carbon reservoir use and management; underlines that the agricultural and forestry sector contribute to the overall goal to be the first climate- neutral continent;
Amendment 174 #
2022/2053(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Emphasises that sustainable food production and the availability of renewable raw materials remain the primary objective of agriculture and forestry; underlines that bothese sectors and that of European food security are themselves being massively affected by climate change;
Amendment 214 #
2022/2053(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Invites the industry sectors involved in carbon cycling to work with academics and researchers in different domains to identify and come forward with innovative solutions and initiatives aiming to gradually replace fossil carbon with sustainable streams of recycled carbon;
Amendment 224 #
2022/2053(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Expresses support for the Commission initiative to establish a cross- border network for the development of CO2 infrastructure at EU, regional and national level by 2030 and beyond, involving all relevant public and private stakeholders in that endeavour;
Amendment 252 #
2022/2053(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Considers that carbon farming can be a new business model which should be additional and voluntary, and which aims to upscale climate mitigation by paying farmers to implement climate-friendly farm or forest management practices, though without any change in land use, by tapping into the potential of blue carbon ecosystems and by streamlining the industrial use of carbon sequestered for different purposes;
Amendment 315 #
2022/2053(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that carbon farming must be regulated in line with the current CAP and be seen as a complementary and additional topping-up option; underlines, however, that in the longer term carbon farming should be market-based, though without allowing any change in land use, regardless of the motives aduced;
Amendment 34 #
2022/2026(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the Commission has not taken effective steps to ensure legal harmonisation with the CRPD in collaboration with the Member States and other bodies involved in these tasks; whereas there has so far been no review of the existing legislation and policy and no revision of the impact assessment guidelines prior to a proposal for legislation;
Amendment 39 #
2022/2026(INI)
Motion for a resolution
Recital B
Recital B
B. whereas according to the EU Agency for Fundamental Rights, the existing EU legislation relating to the rights of persons with disabilities lacks effective implementation and enforcement; whereas there are still gaps in the monitoring of cases of discrimination, and EU laws do not cover multiple and intersectional forms of discrimination;
Amendment 81 #
2022/2026(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Believes that the right to live independently and to be included in the community can only be guaranteed if alternatives to institutions are developed at EU and national levels; calls on the Commission and the Member States to bring about a shift from institutional and other segregational settings to a system enabling social participation where services are provided in a community according to individual will and preference, while taking into account the possibilities for adaptation and integration of the persons concerned according to the type of disability;
Amendment 82 #
2022/2026(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Believes that the right to live independently and to be included in the community, whatever its size, can only be guaranteed if alternatives to institutions are developed at EU and national levels; calls on the Commission and the Member States to bring about a shift from institutional and other segregational settings to a system enabling social participation where services are provided in a community according to individual will and preference;
Amendment 84 #
2022/2026(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Believes that the right to live independently and to be includtegrated into the community can only be guaranteed if alternatives to institutions are developed at EU and national levels; calls on the Commission and the Member States to bring about a shift from institutional and other segregational settings to a system enabling social participation where services are provided in a community according to individual will and preference;
Amendment 115 #
2022/2026(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to collect disaggregated and reliable data and statistics in order to develop appropriate and effective policies to ensure an accessible society for all persons with disabilities in the EU, and to improve them on an ongoing basis, as necessary;
Amendment 119 #
2022/2026(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Exhorts the Commission and the Member States to raise awareness among the public and among children and young people in particular, and carry out clearly structured consultations with the participation and involvement of the people directly affected in order to acquire a real understanding of disabilities at all levels of society;
Amendment 131 #
2022/2026(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Denounces the fact that some groups of persons with disabilities are at greater risk of being the victim of any kind of violence, such as women and girls, children, elderly people, homeless people, detainees, migrants and refugees, Roma people and LGBTIQ+ people; calls on the Commission and the Member States to address the specific challenges, rights and needs of these people through specialised measures to ensure access to information enabling them to benefit from victim support services and protection and to remove barriers to reporting violence;
Amendment 160 #
2022/2026(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Urges the Commission, particularly with a view to the next European elections in 2024, to work with the Member States to guarantee and create the conditions necessary to implement the rights of persons with disabilities to vote and stand as a candidate, and to ensure that appropriate electoral campaigning can be organised for persons with disabilities;
Amendment 183 #
2022/2026(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Believes that there is a need for exchanges of good practices at European level on successful projects to integrate persons with disabilities in all areas, as well as public information campaigns on how to achieve this integration, not only on basis of the obligation to employ a number of persons with disabilities in a company, but also measures to adapt the working environment to their needs and create the conditions to harness their potential;
Amendment 9 #
2022/2002(INI)
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
— having regard to the Third International Conference on Financing for Development held in Addis Ababa from 13 to 16 July 2015,
Amendment 16 #
2022/2002(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
— having regard to the Sendai Framework for Disaster Risk Reduction 2015-2030, adopted by UN Member States at the Third UN World Conference on Disaster Risk Reduction on 18 March 2015,
Amendment 25 #
2022/2002(INI)
Motion for a resolution
Citation 10 a (new)
Citation 10 a (new)
— having regard to the Council conclusions of 9 April 2019 on “Towards an ever more sustainable Union by 2030”,
Amendment 28 #
2022/2002(INI)
Motion for a resolution
Citation 10 b (new)
Citation 10 b (new)
— having regard to the European Pillar of Social Rights and its Action Plan,
Amendment 43 #
2022/2002(INI)
Motion for a resolution
Citation 19 a (new)
Citation 19 a (new)
— having regard to the UN Decade for Action on Sustainable Development,
Amendment 44 #
2022/2002(INI)
Motion for a resolution
Citation 19 b (new)
Citation 19 b (new)
— having regard to its resolution of 1 March 2022 on the Russian aggression against Ukraine,
Amendment 51 #
2022/2002(INI)
Motion for a resolution
Recital A
Recital A
A. whereas there will be no climate justice without environmentally, socially and economically sustainable development; whereas achieving the SDGs is therefore an essential prerequisite to achieving a just and fair transition under the Paris Agreement and the European Green Deal;
Amendment 52 #
2022/2002(INI)
Motion for a resolution
Recital A
Recital A
A. whereas at European level and internationally there will be no climate justice without environmentally, socially and economically sustainable development; whereas achieving the SDGs is therefore an essential prerequisite to achieving a just transition under the Paris Agreement and the European Green Deal;
Amendment 64 #
2022/2002(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the impact of the COVID- 19 pandemic and the geopolitical and humanitarian crisis is not yet fully known, but has already led to a significant degree of SDG backsliding;
Amendment 66 #
2022/2002(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the long-term impact of the COVID- 19 pandemic is not yet fully known, but has already led to a significant degree of SDG backsliding;
Amendment 69 #
2022/2002(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the impact of Russia’s aggression against Ukraine on the SDGs is disastrous for Ukraine and extremely concerning for the countries in the region as well as at global level, although its consequences cannot yet be fully assessed;
Amendment 121 #
2022/2002(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Reaffirms its commitment to the 2030 Agenda and the 17 SDGs; stresses that, in the light of the pandemic, the SDGs provide a unique pathway to both ensure a recovery that would leave no one and no region behind and build back better a more equitable and resilient world;
Amendment 124 #
2022/2002(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Takes note of the 2021 Eurostat report ‘Sustainable development in the European Union — 2021, Monitoring report on progress towards the SDGs in an EU context’, which shows progress for most SDGs (although many indicators refer only to the period up to 2019), but regrettably shows moderate movement away from SDG 7 ‘Affordable and clean energy’ and SDG 15 ‘Life on land’; looks forward to the 2022 report, scheduled to be published by the end of May 2022;
Amendment 147 #
2022/2002(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the commitment by the President of the Commission to pursue a ‘whole-of-government’ approach towards the EU’s SDG implementation and to mainstream the SDGs across each Commissioner’s portfolio; asserts, however, that such an approach can only be effective with leadership at the highest level; calls for the Commission to further detail how they are implementing the ‘whole of government’ approach to the SDGs, as the SDGs should be better integrated into the EU’s annual programming;
Amendment 176 #
2022/2002(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Regrets the fact that efforts to mainstream the SDGs across EU policies have not matured beyond a mapping exercise; recalls that many EU internal policies not only contribute to the implementation of the SDGs, but also have a very high ecological, social and economic spillover impact on developing countries in the medium and long term;
Amendment 177 #
2022/2002(INI)
4a. Calls for sustainable development to be prioritised at every stage of the policy development process, and for all dimensions of sustainable development to be systematically considered in all impact assessments and evaluations;
Amendment 178 #
2022/2002(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Considers that the communication and peer-learning for capacity building around the SDGs is a crucial element for raising awareness and commitment from all counterparts, which requires a stronger alignment of the EU's governance systems in economic, social and environmental matters, such as the European Semester, the European Green Deal and the implementation of the European Pillar of Social Rights, with the SDGs;
Amendment 196 #
2022/2002(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Is of the view that the adoption of the new comprehensive implementation strategy should be preceded by a broad public participatory consultation process; advocates that future structured dialogues should remain as representative as possible of the wide range of SDGs stakeholders from civil society organisations, the private sector, trade unions, academia, regional and local governments as well as minorities and vulnerable groups; considers that the representation should adequately reflect the four dimensions of sustainable development (society, environment, culture, and economy) and have a proven track record and experience working on SDGs at EU level; considers that stakeholders should further be held accountable by their "constituencies", collecting inputs and reporting back to them;
Amendment 205 #
2022/2002(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Is of the view that the adoption of the new comprehensive implementation strategy should be preceded by a broad public participatory consultation process; in order to obtain the opinions and positions of various social groups, which can then be incorporated into the final text; Is also of the view that an information campaign at European level is needed in order to involve as many European citizens as possible in the consultation;
Amendment 221 #
2022/2002(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls for an annual review of the robust Eurostat SDG indicator set with the systematic participation of civil society organisations, in line with the 2021 review; emphasises that sustainable development is inherently trans-national and trans- sectoral; welcomes the work that Eurostat has initiated to this end and the first attempt to partially quantify such spillover effects, but stresses that this methodology needs to be further developed to sufficiently account for the EU’s global footprint8 ; _________________ 8 Eurostat, European Commission, 'EU SDG Indicator set 2021 – Result of the review in preparation of the 2021 edition of the EU SDG monitoring report', 2021.
Amendment 222 #
2022/2002(INI)
9. Calls for an annual review of the Eurostat SDG indicator set with the systematic participation of academic and civil society organisations, in line with the 2021 review; emphasises that sustainable development is inherently trans-national; welcomes the work that Eurostat has initiated to this end and the first attempt to partially quantify such spillover effects, but stresses that this methodology needs to be further developed to sufficiently account for the EU’s global footprint8; _________________ 8 Eurostat, European Commission, 'EU SDG Indicator set 2021 – Result of the review in preparation of the 2021 edition of the EU SDG monitoring report', 2021.
Amendment 229 #
2022/2002(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that a minimum level of data and statistical disaggregation in relation to the SDGs in the EU should be established, covering, where appropriate, geographic location, sex and gender, income, age, race, ethnicity, migratory status, disability and other characteristics;
Amendment 234 #
2022/2002(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Calls on the Commission to shift to a ‘Wellbeing Economy’ by putting in place ‘Beyond GDP’ indicators, guided by public interests and not merely GDP growth; urges the Commission to come forward with the report and dashboard as soon as possible;
Amendment 242 #
2022/2002(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Recalls that voluntary national reviews are the key accountability tool in the 2030 Agenda; calls foron the EUCommission to present an annual EU voluntary review at eachthe 2023 High-level Political Forum on Sustainable Development (HLPF);
Amendment 246 #
2022/2002(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recognises the importance of voluntary local reviews and voluntary subnational reviews for the implementation of the SDGs; calls on the Commission to present an inclusive EU voluntary regional review ahead of the 2023 SDG Summit, and every four years thereafter; encourages the further development of the UN initiative "Localising the SDGs" to accelerate and scale up efforts to reach the SDGs by 2030; pledges to cooperate with the UN and the EU Institutions to stimulate an increasing mobilisation of cities/localities and regions for the localisation of the SDGs and the drafting of Voluntary Local/Regional/Subnational Reviews which ultimately can contribute to Voluntary National Reviews;
Amendment 277 #
2022/2002(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Welcomes the Commission’s efforts to track EU budget expenditure on climate, biodiversity, clean air, migration and gender equality10 ; regretwelcomes that, in a range of policies, systems are being put in place for SDG reporting, including in development cooperation; stresses, however, that noinsufficient progress has been made to track SGDs-related expenditure in its entirety; _________________ 10 Policy Department for Budgetary Affairs, Directorate-General for Internal Policies, for the Committee on Budgetary Control, 'Budgetary control of the Sustainable Development Goals in the EU budget – What measures are in place to ensure effective implementation?', 2021.
Amendment 285 #
2022/2002(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes efforts made to integrate the SDGs into the European Semester; in a comprehensive way; encourages the Commission to reintegrate SDGs explicitly into a reformed European Semester, leading to a sustainable recovery, which should fully involve local and regional authorities and complement reforms and investments in the Member States, which should be SDG-proofed and of European added value;
Amendment 289 #
2022/2002(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Supports the European Green Deal ; calls for a more synergistic understanding of the SDGs in tackling climate change and highlights, in that context, the utility of the SDGs and in particular SDG 13 and the opportunity to work on trade-offs and policy coherence with the SDGs framework;
Amendment 292 #
2022/2002(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Requests comprehensive mapping of the financial envelopes of EU policies, programmes and funds, which has been reinforced by the additional Next Generation EU funds to create a greener, more digital and more resilient Europe, including of the investments and structural reforms pursued under the Recovery and Resilience Facility and the Just Transition Fund, and the MFF 2021-2027, in order to ensure alignment with the objectives of the 2030 Agenda;
Amendment 294 #
2022/2002(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Stresses that the promotion of the twin transitions (green and digital), as well as considering demographical issues and the implementation of the European Pillar of Social Rights (EPSR) and its Action Plan, in the National Recovery and Resilience Plans (NRRPs) is insufficient to cover the SDGs in a coherent and consistent way to provide a clear path leading to the achievement of milestones and headline targets; considers that the current crisis has shown that the EU needs the SDGs as a broader approach, which also includes, and links up with, other policies such as climate, biodiversity and health to avoid future crises;
Amendment 301 #
2022/2002(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Highlights the urgency of requiring financial institutions to define and adopt medium- and long-term strategies and targets to align financial portfolios with the SDGs and regularly report on progress;
Amendment 342 #
2022/2002(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 353 #
2022/2002(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Reaffirms the need to continue supporting sustainable development globally and the importance for the EU to take the lead in a UN context for the 2030 Agenda and for the Multilateral Environmental Agreements, as a firm supporter of tackling global challenges;
Amendment 357 #
2022/2002(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the EU to present its first official EU voluntary review and voluntary regional review at the 2023 SDG Summit and lay the groundwork for this by presenting an initial reviewCommission, EEAS and Member States, as appropriate, to present the relevant results achieved on the implementation of the five priority SDGs at the upcoming 2022 HLPF, namely, SDGs 4 (quality education), 5 (gender equality), 14 (life below water), 15 (life on land), and 17 (partnerships for the goals);
Amendment 48 #
2022/0417(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Where the applicant or marketing authorisation holder may also benefit from another reduction provided for in Union legislation, only the reduction that is the most favourable to the applicant or marketing authorisation holder shall apply. For all generic and biosimilar medicines, the reduction in fees and charges will be between 30% and 50%.
Amendment 59 #
2022/0417(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. The Commission shall monitor the inflation rate, measured by means of the Harmonised Index of Consumer Prices published by Eurostat pursuant to Regulation (EU) No 2016/792, in relation to the amounts of fees, charges and remuneration set out in the Annexes to this Regulation. The monitoring exercise shall take place no earlier than [OP: please insert date one year after the date of application of this Regulation], and thereafter on an annual basis, based on an external audit submitted to the European Parliament. Any adjustment, in line with inflation, to fees, charges and remuneration established in accordance with this regulation shall become applicable, at the earliest, on 1 January of the calendar year following the calendar year in which the monitoring exercise took place.
Amendment 61 #
2022/0417(COD)
Proposal for a regulation
Article 10 – paragraph 6 – introductory part
Article 10 – paragraph 6 – introductory part
6. At the earliest on [OP: please insert date 3 years after the date of application] and at three-year intervals thereafter, the Executive Director of the Agency may, where considered relevant in view of Article 11(2), and after consultation of the Management Board of the Agency, provide the Commission with a special report outlining, in an objective, fact-based and sufficiently detailed manner, on the basis of an external audit submitted to the Subcommittee on Public Health of the European Parliament, justified recommendations:
Amendment 70 #
2022/0417(COD)
Proposal for a regulation
Article 10 – paragraph 7 – point b
Article 10 – paragraph 7 – point b
(b) objective and verifiable information and quantification, based on an external audit submitted to the European Parliament, that directly supports the relevance of the recommended adjustments.
Amendment 73 #
2022/0417(COD)
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. The Commission may request any clarification or further substantiation, based on an external audit submitted to the European Parliament, of the report and its recommendations, if considered necessary. Following such a request, the Agency shall without undue delay provide the Commission with an updated version of the report which addresses any comments made and questions raised by the Commission.
Amendment 75 #
2022/0417(COD)
Proposal for a regulation
Article 10 – paragraph 9 – point c
Article 10 – paragraph 9 – point c
(c) in the case there is clear and compelling evidence, based on an external audit submitted to the European Parliament, of significant changes in the costs or the cost-revenue balance of the Agency, including costs for cost-based remuneration to competent authorities of the Member States.
Amendment 83 #
2022/0417(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The power to adopt delegated acts referred to in Article 11(1) shall be conferred on the Commission for a period of 2.5 years from [tbc] 20[xx]. The Commission shall draw up a report in respect of the delegation of power not later than 6 months before the end of the 2.5- year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
Amendment 88 #
2022/0417(COD)
Proposal for a regulation
Annex I – point 3 – point 3.4
Annex I – point 3 – point 3.4
3.4. A fee of EUR 575450 000 shall apply to an application for a biological medicinal product which is similar to a reference biological product pursuant to Article 10(4) of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application. The remuneration shall be EUR 236 500 for the rapporteur and EUR 151 700 for the co-rapporteur.
Amendment 90 #
2022/0417(COD)
Proposal for a regulation
Annex I – point 3 – point 3.5
Annex I – point 3 – point 3.5
3.5. A fee of EUR 624 3400 000 shall apply to an application for a marketing authorisation for a medicinal product pursuant to Article 10a of Directive 2001/83/EC. That fee shall cover all strengths, all pharmaceutical forms and all presentations submitted in the same application. The remuneration shall be EUR 160 600 for the rapporteur and EUR 149 400 for the co-rapporteur.
Amendment 94 #
2022/0417(COD)
Proposal for a regulation
Annex I – point 7 – paragraph 2
Annex I – point 7 – paragraph 2
A fee of EUR 29 7014 850 shall apply to a request for scientific advice from the Committee on Herbal Medicinal Products related to traditional herbal medicinal products. The remuneration shall be EUR 4 100 for the rapporteur.
Amendment 101 #
2022/0417(COD)
Proposal for a regulation
Annex I – point 12 – paragraph 2
Annex I – point 12 – paragraph 2
A fee of EUR 16 88 400 shall apply to an application for the designation of an orphan medicinal product pursuant to Regulation (EC) No 141/2000. Such fee shall be waived in full. The remuneration shall be EUR 1 500 for the rapporteur.
Amendment 108 #
2022/0417(COD)
Proposal for a regulation
Annex V – point 8 – paragraph 2 – introductory part
Annex V – point 8 – paragraph 2 – introductory part
A fee reduction of 250% shall apply to the annual pharmacovigilance fee set out in section 3 of Annex III for the following medicinal products:
Amendment 105 #
2022/0400(COD)
Proposal for a directive
Recital 16
Recital 16
(16) Equality bodies can only effectively play their role if they are able to take decisions and act with complete independence without being subject to any external influence, and especially political influence. For that purpose, Member States should take into account a number of criteria that contribute to the independence of equality bodies. Equality bodies should not be set up as part of a ministry or body taking instructions directly from the government. Any staff member or person holding a managerial position – for example as member of a board managing the equality body, head of the equality body, deputy or in case of interim – should be independent, qualified for their position, and selected through a transparent process. Equality bodies should be able to manage their own budget and resources, including by selecting and managing their own staff, and be able to set their own priorities, in accordance with their national priorities in correlation with European priorities.
Amendment 109 #
2022/0400(COD)
Proposal for a directive
Recital 18
Recital 18
(18) The lack of appropriate resources is a key issue hampering the ability of equality bodies to adequately fulfil their tasks. Therefore, Member States should ensure that equality bodies receive sufficient funding, can hire qualified staffstaff appropriately qualified to fulfil the tasks for which they are responsible, and have appropriate premises and infrastructure to carry out each of their tasks effectively, within reasonable time and within the deadlines established by national law. Their budgetary allocation should be stable, except in case ofthe event of an increase in competences and hence in the staff at the organisation, planned on a multi-annual basis, and allow them to cover costs that may be difficult to anticipate such as costs linked to litigation. To ensure that equality bodies are provided with sufficient resources, their budget should for instance not suffer cuts that are significantly higher than the average cuts to other public entities; similarly, their annual growth should at least be pegged to the average growth in funding to other entities. Resources should increase proportionally if equality bodies’ tasks and mandate are expanded.
Amendment 121 #
2022/0400(COD)
Proposal for a directive
Recital 27
Recital 27
(27) To promote their work and equality law and to better publicise their activities, equality bodies should be able to publish a summary of their opinions and decisions without disclosing personal data.
Amendment 123 #
2022/0400(COD)
Proposal for a directive
Recital 29
Recital 29
(29) Legal standing allows equality bodies to act on behalf or in support of victims, allowing them to access justice where procedural and financial barriers or a fear of victimisation often deters them. Legal standing also allows equality bodies to strategically select the cases they decide to pursue in front of national courts, and to contribute to the proper interpretation and application of equal treatment legislation, as well as to the regular supplementing and improvement of existing legislation.
Amendment 146 #
2022/0400(COD)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Member States shall take measures to ensure that equality bodies are independent and free from external influence, and especially political influence, in performing their tasks and exercising their competences, in particular as regards their legal structure, accountability, budget, staffing, and organisational matters.
Amendment 155 #
2022/0400(COD)
Proposal for a directive
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Member States shall provide for transparent rules and safeguards concerning the selection, appointment, promotion, revocation and potential conflict of interest of the staff of equality bodies, in particular persons holding a managerial position, in order to guarantee their competence and independence.
Amendment 170 #
2022/0400(COD)
Proposal for a directive
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) adopt a strategy to regularly inform and raise awareness of the general population, throughout their territory, with particular attention to individuals and groups at risk of discrimination, on the rights under Directives 2006/54/EC and 2010/41/EU and on the existence of equality bodies and their services;
Amendment 219 #
2022/0400(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall guarantee access to equality bodies’ services and publications on an equal basis for all citizens, associations and other interested public or private organisations, and ensure that there are no barriers to submission of complaints.
Amendment 221 #
2022/0400(COD)
Proposal for a directive
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Member States shall ensure accessithat equality bodies have the qualified staff needed to enable access and co-working with persons with disabilityies and provide reasonable accommodation for such persons with disabilities to guarantee their equal access to all services and activities of equality bodies, including assistance to victims, complaint handling, amicable settlement mechanisms, information and publications, and prevention, promotion and awareness- raising activities.
Amendment 228 #
2022/0400(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
They shall ensure that equality bodies have the right to make recommendations on those matters, to publish them and to requireest feedback from the authorities concerned, and to make proposals to improve and update existing equality legislation in line with societal developments.
Amendment 232 #
2022/0400(COD)
Proposal for a directive
Article 14 – paragraph 5
Article 14 – paragraph 5
5. Member States shall ensure that equality bodies may conduct independent surveys concerning discrimination and have the necessary human and financial resources to carry out such studies.
Amendment 236 #
2022/0400(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The Commission shall, by means of an implementing act, establish a list of common indicators at European level to measure the practical effects of this Directive. When preparing the indicators, the Commission may seek advice from the European Union Agency for Fundamental Rights and the European Institute for Gender Equality. Those indicators shall cover the resources, independent functioning, activities, and effectiveness of equality bodies, as well as evolutions in their mandate, powers or structure, ensuring the comparability, objectivity and reliability of the data collected at national level.
Amendment 134 #
2022/0394(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to support operators willing to make additional efforts to increase carbon removals in a sustainable way, the Union certification framework should include a reference framework and reference values, and also take into account the different types of carbon removal activities, their specificities and related environmental impacts. Therefore, this Regulation should provide clear definitions of carbon removal, carbon removal activities, and other elements of the Union certification framework, along with the time periods needed to implement those measures.
Amendment 142 #
2022/0394(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) Permanent cooperation is needed with the world of education and science at European and international level to identify the latest and most up-to-date carbon removal methods and solutions and to apply them as swiftly as possible in order to achieve the Union’s climate and biodiversity objectives.
Amendment 159 #
2022/0394(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) A carbon removal activity should result in a net carbon removal benefit showing that it delivers a positive climate impact. The net carbon removal benefit should be computed following two steps. First, operators should quantify the amount of additional carbon removals that a carbon removal activity has generated in comparison to a baseline and reference values established at European and international level. A standardised baseline reflecting the standard performance of comparable activities in similar social, economic, environmental and technological circumstances and geographical locations should be preferred because it ensures objectivity, minimises compliance and other administrative costs, and positively recognises the action of first movers who have already engaged in carbon removal activities. In the context of carbon farming, the use of available digital technologies, including electronic databases and geographic information systems, remote sensing, artificial intelligence and machine learning, and of electronic maps should be promoted to decrease the costs of establishing baselines and of monitoring carbon removal activities. However, where it is not possible to set such a standardised baseline, a project-specific baseline based on the operator’s individual performance and the field of reference may be used. In order to reflect the social, economic, environmental and technological developments and to encourage ambition over time in line with the Paris Agreement, baselines should be periodically updated.
Amendment 183 #
2022/0394(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Carbon removals should be quantified in a relevant, accurate, complete, consistent and comparable manner. Uncertainties in the quantification should be duly reported and accounted in order to limit the risk of overestimating the quantity of carbon dioxide removed from the atmosphere. Carbon removals generated by carbon farming should be quantified with a high level of accuracy to assure the highest quality and minimise uncertainties. Moreover, in order to incentivise synergies between Union climate and biodiversity objectives, enhanced monitoring of land over a pre-established period needs to be required, thereby helping to protect and enhance the resilience of nature-based carbon removals throughout the Union. The satellite and on-site monitoring and reporting of emissions and removals need to closely reflect those approaches, and make the best use of advanced technologies available under Union programmes, such as Copernicus, making full use of already existing tools, and ensure consistency with the national greenhouse gas inventories.
Amendment 246 #
2022/0394(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) It is appropriate to develop detailed certification methodologies based on common European-level criteria for the different carbon removal activities in order to apply, in a standardised, verifiable and comparable way, the quality criteria laid down in this Regulation. Those methodologies should ensure the robust and transparent certification of the net carbon removal benefit generated by the carbon removal activity, while avoiding disproportionate administrative burden for operators or groups of operators, in particular for small farmers and forest holders, as well as additional costs that would hamper the activity itself. To this end, the Commission should be empowered to supplement this Regulation by adopting delegated acts establishing detailed certification methodologies for the different carbon removal activities. Those methodologies should be developed in close consultation with the Expert Group on Carbon Removals and all other interested actors. They need to be based on the best available scientific evidence, build upon existing public and private schemes and methodologies proven to be effective for carbon removal certification, and take into account any relevant standard and rules adopted at national and Union level.
Amendment 275 #
2022/0394(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) To ensure an accurate, robust and transparent verification, certification bodies responsible for performing the certification of carbon removal activities should have the required competences and skills and should be accredited by national accreditation authorities pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council32 and included in a national and European register. To avoid possible conflicts of interest, the certification bodies should also be completely independent from the operator carrying out the carbon removal activity that is subject to the certification. In addition, Member States should contribute towards ensuring the correct implementation of the certification process by supervising the operation of certification bodies that are accredited by national accreditation authorities, and by informing the certification schemes about relevant non-conformity findings. __________________ 32 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Amendment 282 #
2022/0394(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Certification schemes should be used by operators to demonstrate compliance with this Regulation. Therefore, certification schemes should operate on the basis of reliable and transparent common European-level rules and procedures and should ensure accuracy, reliability, integrity and non- repudiation of origin, and protection against fraud of information and of data submitted by operators. They should also ensure the correct accounting of the verified carbon removal units, notably by avoiding double counting. To this end, the Commission should be empowered to adopt implementing acts, including adequate standards of reliability, transparency, accounting and of independent auditing to be applied by certification schemes, so as to ensure the necessary legal certainty as regards the rules applicable to operators and to certification schemes. To ensure a cost- effective certification process, those technical harmonised rules on certification should also have the objective of reducing unnecessary administrative burden for operators, or group of operators, in particular for Small and Medium Enterprises (SMEs), including small farmers and foresters.
Amendment 284 #
2022/0394(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) In order to ensure a reliable and harmonised control of certification, the Commission should be able to adopt decisions recognising national and European-level certification schemes that meet the requirements set out in this Regulation, including with respect to technical competence, reliability, transparency and independent auditing. Such recognition decisions should be limited in time. To this end, the Commission should be empowered to adopt implementing acts on the content and processes of Union recognition of certification schemes.
Amendment 293 #
2022/0394(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) CNational and European-level certification schemes should establish and maintain interoperable public registries in order to ensure transparency and full traceability of carbon removal certificates, and to avoid the risk of fraud and double counting. Fraud may occur if more than one certificate is issued for the same carbon removal activity because the activity has been registered under two different certification schemes or has been registered twice under the same scheme. Fraud may also occur when the same certificate is used several times to make the same claim based on a carbon removal activity or a carbon removal unit. The registries should store the documents resulting from the certification process of carbon removals, including summaries of certification audits and re-certification audit reports, the certificates and updated certificates, and make them publicly available in electronic form. The registries should also record the certified carbon removal units that meet the Union quality criteria. In order to ensure a level playing field within the single market, the Commission should be empowered to adopt implementing rules setting out common European-level standards and technical rules on the functioning and the inter-operability of those registries.
Amendment 296 #
2022/0394(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Certification schemes play an important role in providing evidence of compliance with the quality criteria for carbon removals. It is therefore appropriate for the Commission to require certification schemes to report regularly on their activity. Such reports should be made public, in full or where appropriate in an aggregated format, in order to increase transparency and to improve supervision by the Commission. Furthermore, such reporting would provide the necessary information for the Commission to report on the operation of the certification schemes with a view to identifying best practices and submitting, if appropriate, a proposal to further promote such best practices, which would then enable certification schemes to be improved. In order to ensure comparable and consistent reporting, the Commission should be empowered to adopt implementing acts setting out the technical details on the content and format of the reports drawn up by the certification schemes.
Amendment 333 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) rules for the functioning and recognition by the Commission of certification schemes at national and European level.
Amendment 440 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point k
Article 2 – paragraph 1 – point k
(k) ‘certification scheme’ means a scheme managed by a private or public organisation that oversees the certification of compliance of operators or group of operators with this Regulation at national or European level;
Amendment 477 #
2022/0394(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) they are independently verified with a view to certification, in accordance with Article 9.
Amendment 605 #
2022/0394(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) they shall monitor, over the course of a pre-established period, and mitigate any risk of release of the stored carbon occurring during the monitoring period;
Amendment 741 #
2022/0394(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. To apply for a certification of compliance with this Regulation, an operator or a group of operators shall submit an application to a certification scheme. Upon acceptance of that application, the operator or a group of operators shall submit to a certification body a comprehensive description of the carbon removal activity, including the certification methodology applied to assess compliance with Articles 4 to 7, the expected total carbon removals and net carbon removal benefit, and the monitoring period for the carbon storage, where applicable. Groups of operators shall also specify how advisory services on carbon removal activities are provided, in particular to small-scale carbon farming operators.
Amendment 789 #
2022/0394(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Certification schemes shall operate on the basis of reliable and transparent common European-level rules and procedures, in particular with regard to internal management and monitoring, handling of complaints and appeals, stakeholder consultation, transparency and publication of information, appointment and training of certification bodies, addressing non- conformity issues, development and management of registries.
Amendment 823 #
2022/0394(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The Commission may adopt implementing acts setting out the structure, format, and technical details of the public registries, and of the recording at national and European level, holding or use of carbon removal units, as referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 210 #
2022/0347(COD)
Proposal for a directive
Recital 5
Recital 5
(5) In taking the relevant measures at Union and national level to achieve the zero pollution objective for air pollution, Member States, the European Parliament, the Council and the Commission should be guided by the ‘precautionary principle’ and the ‘polluter pays principle’ established in the Treaty on the Functioning of the European Union, and the ‘do no harm’ principle of the European Green Deal. They should, inter alia, take into account: the contribution of improved air quality to public health, the quality of the environment, the well-being of citizens, the prosperity of society, employment and the competitiveness of the economy; the energy transition, strengthened energy security and the tackling of energy poverty; food security and affordability; the development of sustainable and smart mobility and transport solutions; the impact of behavioural changes; fairness and solidarity across and within Member States, in light of their economic capability, national circumstances, such as the specificities of islands, and the need for convergence over time; the need to make the transition just and socially fair through appropriate education and training programmes; best available and most recent scientific evidence, in particular the findings reported by the WHO; the need to integrate air pollution related risks into investment and planning decisions; cost- effectiveness and technological neutrality in achieving air pollutant emission reductions; and progression over time in environmental integrity and level of ambition; development of new recovery, storage and recycling processes for a range of polluting products.
Amendment 219 #
2022/0347(COD)
Proposal for a directive
Recital 7
Recital 7
(7) The Commission should regularly review the scientific evidence related to pollutants, their medium- and long-term effects on human health and the environment and technological development. Based on the review, the Commission should assess whether applicable air quality standards are still appropriate to achieve the objectives of this Directive. The first review should be carried out by 31/12/2028 to assess whether air quality standards need to be updated based on the latest scientific information.
Amendment 264 #
2022/0347(COD)
Proposal for a directive
Recital 26
Recital 26
(26) Mercury is a very hazardous substance for human health and the environment, with harmful effects in the medium and long term. It is present throughout the environment and, in the form of methylmercury, has the capacity to accumulate in organisms, and in particular to concentrate in organisms higher up the food chain. Mercury released into the atmosphere is capable of being transported over long distances.
Amendment 328 #
2022/0347(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
6. measures promoting increased cooperation between Member States in reducing air pollution, along with cooperation with third countries sharing borders with the EU in the event of cross- border pollution events.
Amendment 363 #
2022/0347(COD)
Proposal for a directive
Article 3 – paragraph 2 – subparagraph 3 – point c
Article 3 – paragraph 2 – subparagraph 3 – point c
(c) air quality situations and associated impacts on human health and the environment in Member States, as well as cross-border pollution events;
Amendment 407 #
2022/0347(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 37
Article 4 – paragraph 1 – point 37
(37) ‘short-term action plans’ means plans that set out emergency measures to be taken in the short term to reduce the immediate risk or the duration of the exceedance of the alert thresholds, including in the event of cross- border pollution events, where it is recommended that joint teams of experts from the states affected be established;
Amendment 423 #
2022/0347(COD)
Proposal for a directive
Article 5 – paragraph 1 – point g
Article 5 – paragraph 1 – point g
(g) cooperation with the other Member States andStates, including by establishing joint teams of experts from the states affected in the event of cross-border pollution, and with the Commission;
Amendment 426 #
2022/0347(COD)
Proposal for a directive
Article 5 – paragraph 1 – point i
Article 5 – paragraph 1 – point i
(i) establishment of short-term action plans, including at cross-border level when cross-border events occur.
Amendment 501 #
2022/0347(COD)
Proposal for a directive
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Where any alert threshold or any information threshold laid down in Section 4 of Annex I is exceeded, Member States shall take the necessary steps to inform the public at local, national, and also cross- border level where necessary, within a few hours at the latest, making use of different media, timely alert systems and communication channels and ensuring broad public access .
Amendment 505 #
2022/0347(COD)
Proposal for a directive
Article 15 – paragraph 4
Article 15 – paragraph 4
4. Member States shall ensure that information about actual or predicted exceedances of any alert threshold or information threshold is provided to the public at local, national, and also cross- border level where necessary, as soon as possible in accordance with, points 2 and 3 of Annex IX.
Amendment 627 #
2022/0347(COD)
Proposal for a directive
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
Where, in a given zone , there is a risk that the levels of pollutants will exceed one or more of the alert thresholds specified in Section 4 of Annex I, Member States shall draw up short-term action plans indicating the emergency measures to be taken in the short term in order to reduce the risk or duration of such an exceedance, as well as short-term cross-border action plans, where appropriate, including the establishment of joint teams of experts from the states affected.
Amendment 644 #
2022/0347(COD)
Proposal for a directive
Article 21 – paragraph 1 – subparagraph 1 – point a (new)
Article 21 – paragraph 1 – subparagraph 1 – point a (new)
(a) In the event of accidental pollution events with cross-border effects, EU Member States and those sharing a border with the EU shall establish as a matter of urgency short-term joint action plans at local and cross-border level, including the establishment of joint teams of experts from the states affected, and shall notify the Commission as soon as possible of the situation and the measures taken.
Amendment 669 #
2022/0347(COD)
Proposal for a directive
Article 22 – paragraph 3 – point a (new)
Article 22 – paragraph 3 – point a (new)
(a) Member States shall establish timely alert systems for cases in which limit values are exceeded at local, regional, national and cross-border levels, and shall work with the other Member States under joint action plans tailored to the event in question.
Amendment 63 #
2022/0345(COD)
Proposal for a directive
Recital 5
Recital 5
(5) In order to ensure effective treatment of urban wastewater before discharge into the environment, all urban wastewaters from agglomerations of 1 000 p.e. and above should be collected in centralised collecting systems. Where such systems are already in place, Member States should ensure that all sources of urban wastewater are connected to them. Where these systems are not connected to one other, Member States should encourage and support small municipalities to join together to manage wastewaters collectively, with this joint management also enabling a reduction in costs.
Amendment 75 #
2022/0345(COD)
Proposal for a directive
Recital 7
Recital 7
(7) During rainfall, storm water overflows and urban runoff represent a sizeable remaining source of pollution discharged into the environment. Those emissions are expected to increase due to the combined effects of urbanisation and progressive change of the rain regime linked with climate change. Solutions to reduce that source of pollution should be defined at local level taking into account the specific local conditions, while it would also be beneficial to have local and regional action plans covering multiple localities when they are all liable to be impacted by the same watercourses in circumstances of abundant precipitation and, implicitly, by urban runoff. They should be based on an integrated quantitative and qualitative water management in urban areas. Therefore, Member States should ensure that integrated urban wastewater management plans are established at local level for all agglomerations of 100 000 p.e. and above as those agglomerations are responsible for a significant share of the pollution emitted. Furthermore, integrated urban wastewater management plans should also be put in place for agglomeration of between 10 000 p.e. and 100 000 p.e. where storm water overflows or urban runoff poses a risk for the environment or public health.
Amendment 82 #
2022/0345(COD)
Proposal for a directive
Recital 8
Recital 8
(8) In order to ensure that the integrated urban wastewater management plans are cost-effective, it is important that they are based on best practices in advanced urban areas and that they take into account the constant change in the chemical composition of wastewaters resulting from the appearance of new products on the market, which necessitates appropriate measures for the identification and elimination of such products from wastewaters. Therefore, the measures to be considered should be based on a thorough analysis of the local conditions and should favour a preventive approach aiming at limiting the collection of unpolluted rain waters and optimising the use of existing infrastructures. With a preference for ‘green’ developments, new grey infrastructures should only be envisaged where absolutely necessary. In order to protect the environment, in particular the coastal and marine environment, and public health from being adversely affected by the discharge of insufficiently treated urban wastewater, secondary treatment should be applied to all discharges of urban wastewater from agglomerations of 1 000 p.e. and above.
Amendment 99 #
2022/0345(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Recent scientific knowledge underpinning several Commission strategies43highlightsthe need to take action to address the issue of micro- pollutants, which are now detected in all waters in the Union and which are being generated by the appearance on the market of new domestic or industrial products which necessitate new methods of identification and elimination from wastewaters. Some of those micropollutants are hazardous for public health and the environment even in small quantities. An additional treatment, i.e. quaternary treatment, should therefore be introduced in order to ensure that a large spectrum of micro-pollutants is removed from urban wastewater. Quaternary treatment should first focus on organic micro-pollutants, which represent a significant part of the pollution and for which removal technologies are already designed. The treatment should be imposed based on the precautionary approach combined with a risk-based approach. Therefore, all urban wastewater treatment plants of 100 000 p.e. and above should provide quaternary treatment, as those facilities represent a significant share of micro-pollutant discharges in the environment and the removal of micro- pollutants by urban wastewater treatment plants at such scale is cost-effective. For agglomerations of between 10 000 p.e. and 100 000 p.e., Member States should be required to apply quaternary treatment to areas identified as sensitive to pollution with micro-pollutants based on clear criteria, which should be specified. Such areas should include locations where treated urban wastewater discharge to water bodies result in low dilution ratios, or where the receiving water bodies are used for the production of drinking water or as bathing waters. In order to avoid the requirement of quaternary treatment for agglomerations of between 10 000 p.e. and 100 000 p.e., Member States should be required to demonstrate the absence of risks to the environment or to public health on the basis of a standardised risk assessment. In order to give Member States enough time to plan and deliver the necessary infrastructures, the requirement of quaternary treatment should progressively apply until 2040 with clear interim objectives. _________________ 43 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: A European Strategy for Plastics in a Circular Economy (COM/2018/028 final); Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee, European Union Strategic Approach to Pharmaceuticals in the Environment (COM(2019) 128 final); Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (COM(2020) 667 final); Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Pathway to a Healthy Planet for All EU Action Plan: '‘Towards Zero Pollution for Air, Water and Soil' (’, COM/2021/400 final).
Amendment 143 #
2022/0345(COD)
Proposal for a directive
Recital 15
Recital 15
(15) In order to avoid possible internal market distortions, minimum requirements for the implementation of the extended producer responsibility should be established in this Directive, while the practical organisation of the system should be decided at national level. The contributions of the producers should be proportionate to the quantities of the products they place on the market and the hazardouness of their residues. The contributions should cover, but not exceed, the costs for the monitoring activities for micro-pollutants, the collection, analysis, reporting and impartial verification of statistics on the quantities and hazardouness of products placed on the market, and the application of the quaternary treatment to urban wastewater in an efficient manner and in accordance with this Directive. Since urban wastewater is treated collectively, it is appropriate to introduce a requirement for producers to join a centralised organisation which can implement their obligations under the extended producer responsibility on their behalf.
Amendment 156 #
2022/0345(COD)
Proposal for a directive
Recital 17
Recital 17
(17) Since the transboundary nature of water pollution requires cooperation between neighbouring Member States or third countries in addressing such pollution and identifying measures to tackle its source, Member States should be required to inform each other or the third country if significant water pollution originating from urban wastewater discharges in one Member State or third country impacts or is likely to impact the water quality of another Member State or third country. Such information should be immediate in case of incidental pollution significantly affecting downstream water bodies by means of timely alarm systems at local, regional and cross-border level in the event of incidental pollution. The Commission should be informed and, if necessary, participate in meetings at the request of Member States. It is also important to tackle the transboundary pollution from third countries sharing the same water bodies with some of the Member States. For the purpose of dealing with pollution coming or arriving in third countries, the cooperation and coordination with third countries may be carried out in the framework of the United Nations Economic Commission for Europe (UNECE) Water Convention50 or other relevant regional Conventions such as the Regional Seas or Rivers Conventions. _________________ 50 UNECE Convention on the Protection and Use of Transboundary Watercourses and International Lakes as amended, along with decision VI/3 clarifying the accession procedure.
Amendment 158 #
2022/0345(COD)
Proposal for a directive
Recital 18
Recital 18
(18) In order to ensure the protection of the environment and human health, Member States should ensure that the urban wastewater treatment plants built to comply with the requirements of this Directive are designed, constructed, operated, and maintained to ensure sufficient performance under all normal local climatic conditions and should continuously adapt their methods of identifying pollutants in wastewaters in lockstep with the placing on the market of new products which may subsequently be found in wastewaters.
Amendment 170 #
2022/0345(COD)
Proposal for a directive
Recital 21
Recital 21
(21) In order to ensure the protection of the environment, direct discharges of biodegradable non-domestic wastewater into the environment from certain industrial sectors should be subject to prior authorisation on national level and appropriate requirements. Those requirements should ensure that direct discharges from certain industrial sectors are subject to secondary, tertiary and quaternary treatment as necessary for the protection of human health and the environment, and that in the final analysis the parameters set for treated wastewaters are respected.
Amendment 174 #
2022/0345(COD)
Proposal for a directive
Recital 22
Recital 22
(22) According to Article 168(1) TFEU, Union action complements national policies and is to be directed towards improving public health and preventing diseases. In order to ensure optimal use of relevant public health data from urban wastewaters, urban wastewater surveillance should be set up and used for preventive or early warning purposes, for instance in the detection of specific viruses in urban wastewater as a signal of the emergence of epidemics or pandemics, as was the case during the COVID-19 pandemic. Member States should establish a permanent dialogue and coordination between competent authorities responsible for public health and competent authorities responsible for urban wastewater management. In the context of that coordination, a list of parameters relevant for public health to be monitored in urban wastewaters should be established, as well as the frequency and location of the sampling. This approach will take advantage of and complement other Union initiatives in the field of public health protection, such as environmental monitoring that includes wastewater surveillance52. Based on information gathered during the COVID-19 pandemic and experience gained from the implementation of the Commission Recommendation on a common approach to establish a systematic surveillance of SARS-CoV-2 and its variants in wastewaters in the EU53(the ‘recommendation’), Member States should be required to monitor health parameters related to SARS-CoV-2 and its variants on a regular basis. In order to ensure that harmonised methods are used, Member States should, to the extent possible, use sampling and analysis methods set out in the recommendation for the monitoring of SARS-CoV-2 and its variants. _________________ 52 Commission Communication on introducing the European Health Emergency Preparedness and Response Authority, the next step towards completing the European Health Union (COM(2021)576 final). 53 Commission Recommendation (EU) 2021/472 of 17 March 2021 on a common approach to establish a systematic surveillance of SARS-CoV-2 and its variants in wastewaters in the EU (OJ L 98, 19.3.2021, p. 3).
Amendment 195 #
2022/0345(COD)
Proposal for a directive
Recital 28
Recital 28
(28) The evaluation concluded that sludge management could be improved to better align it with the principles of the circular economy and of the waste hierarchy as defined in Article 4 of Directive 2008/98/EC. The actions to better monitor and reduce pollution at source from non-domestic discharges will help improving the quality of the sludge produced and ensure its safe use in agriculture. In order to ensure a proper and safe recovery of nutrients, including the critical substance phosphorus, from the sludge, minimum recovery rates should be defined at Union level, while there is also a need to work more closely with academia and researchers to identify and apply the most appropriate methods of recovering nutrients from sludge for subsequent use in agriculture.
Amendment 203 #
2022/0345(COD)
Proposal for a directive
Recital 30
Recital 30
(30) In order to reduce administrative burden and better use the possibilities offered by digitalisation, the reporting on the implementation of the Directive should be improved and simplified by removing the obligation for Member States to report every two years to the Commission and for the Commission to publish bi-yearly reports. It should be replaced by a requirement for Member States to improve, with the support of the European Environment Agency (EEA), the existing national standardised data sets established under Directive 91/271/EEC, and to regularly update them. Permanent access to the national databases should be provided to the Commission and the EEA. In order to ensure complete information on the application of this Directive, the data sets should include information on compliance of urban wastewater treatment plants with the treatment requirements (pass/fail, loads and concentration of pollutants discharged), on the level of achievement of the objectives of energy neutrality, on GHG emissions of the treatment plants above 10 000 p.e. and on measures taken by the Member States in the context of storm water overflows/ urban runoff, including early warning systems in the event of runoffs, access to sanitation and treatment by individual systems. Moreover, full coherence with Regulation (EC) 166/2006 of the European Parliament and of the Council65 should be ensured to optimise the use of the data, as well as to support full transparency. _________________ 65 Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (Text with EEA relevance) OJ L 33, 4.2.2006, p. 1–17
Amendment 225 #
2022/0345(COD)
Proposal for a directive
Recital 38
Recital 38
(38) Pursuant to the Interinstitutional Agreement on Better Law-Making68, the Commission should carry out an evaluation of this Directive within a certain period of time from the date set for its transposition. That evaluation should be based on experience gained and data collected during the implementation of this Directive, on any available WHO recommendations, and on relevant scientific, analytical, and epidemiological data. In the evaluation, particular attention should be given to the possible necessity to adapt ofthe list of products to be covered by extended producer responsibility according to the evolution of the range of products placed on the market, and to the method of eliminating and denaturing these at the final use stage without major environmental impacts,the improvement of knowledge on the presence of micro- pollutants in the wastewaters and their impacts on public health and the environment, and data from the new monitoring and analysisobligations on micro- pollutants in the inlets and outlets of the urban wastewater treatment plants. _________________ 68 Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1–14).
Amendment 754 #
2022/0345(COD)
Proposal for a directive
Article 9 – paragraph 4 – subparagraph 2 – point a – point i
Article 9 – paragraph 4 – subparagraph 2 – point a – point i
(i) the annual quantities of the products listed in Annex III that they place on the market in the context of their professional activity, to enable the subsequent identification of analytical methods and wastewater treatment processes into which components of these products may permeate;
Amendment 933 #
2022/0345(COD)
Proposal for a directive
Article 12 – paragraph 1 – subparagraph 3
Article 12 – paragraph 1 – subparagraph 3
The Member States concerned shall cooperate in the implementation of a timely alert system in order to identify the discharges in question and the measures to be taken at source to protect the waters that are affected in order to ensure conformity with this Directive.
Amendment 1060 #
2022/0345(COD)
Proposal for a directive
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) identify categories of people without access, or with limited access, to sanitation facilities, including vulnerable and marginalised groups, and provide reasons for such lack of access; , encourage and support the construction of such facilities as a priority in rural areas and more remote areas where access to these facilities is very limited;
Amendment 1117 #
2022/0345(COD)
Proposal for a directive
Article 21 – paragraph 2
Article 21 – paragraph 2
2. For all agglomerations of 10 000 p.e. and above, Member States shall ensure that competent authorities monitor the concentration and loads of pollutants from storm water overflows and urban runoff discharged into water bodies , and that there is a timely alert system at local, regional and cross-border level, where this is necessary.
Amendment 1173 #
2022/0345(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2 – point b
Article 23 – paragraph 1 – subparagraph 2 – point b
(b) the identification and planning of investments required to implement this Directive for each agglomeration, or associations of smaller agglomerations without the wherewithal for their own individual treatment systems, including an indicative financial estimation and a prioritisation of those investments related to the size of the agglomeration and the environmental impact of untreated urban wastewater;
Amendment 1174 #
2022/0345(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2 – point c
Article 23 – paragraph 1 – subparagraph 2 – point c
(c) an estimate of investments needed to renew existing urban wastewater infrastructures, including collecting systems, based on their age and depreciation rates, and to extend wastewater collecting systems in step with the extension of inhabited areas as the population of those areas increases;
Amendment 124 #
2022/0216(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high safety standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients.
Amendment 125 #
2022/0216(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Directives 2002/98/EC16and 2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules, which can create obstacles to cross-border sharing of these substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for these substances, which achieves safety and quality for all parties involved, enhances legal certainty and supports continuous supply, whilst facilitating innovation for the benefit of public health and cross-border cooperation. In order to achieve a coherent application of the legal framework, it is appropriate to repeal Directives 2002/98/EC and 2004/23/EC and to replace them by a Regulation. _________________ 16 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). 17 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
Amendment 128 #
2022/0216(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, taking into consideration the special characteristics of each type of substance.
Amendment 133 #
2022/0216(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. The criteria that define when SoHOs or SOHO preparations become products regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In case of products covered by other legislation of the Union, this Regulation shall only apply to those parts specified on it, without prejudice to other legislation of the Union.Inaddition, this Regulation should apply without prejudice to Union legislation on genetically modified organisms. _________________ 19 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 20 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 21 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 22 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). 23 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
Amendment 134 #
2022/0216(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways in order to preserve all properties that ensure their compatibility with recipients, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. The criteria that define when SoHOs or SOHO preparations become products regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In addition, this Regulation should apply without prejudice to Union legislation on genetically modified organisms. _________________ 19 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 20 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 21 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 22 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). 23 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
Amendment 136 #
2022/0216(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination, or environmental contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy and/or functionality in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply. Furthermore, in case of substances meant for autologous but non-homologous application, this Regulation shall apply without prejudice to Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Or. en (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004)
Amendment 138 #
2022/0216(COD)
Proposal for a regulation
Recital 10
Recital 10
Amendment 142 #
2022/0216(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, issuing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.
Amendment 143 #
2022/0216(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) SoHOs can also be combined with other regulated products before human application. In these circumstances, close interaction between this regulatory framework and other related frameworks is also necessary to ensure a high level of protection when handling these products and hence human health protection for all cases where these substances are used.
Amendment 152 #
2022/0216(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection when handling these products and hence for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. This Regulation should therefore include principles and technical rules to monitor and protect donors from undesirable short-term and long-term side-effects. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a need for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to imply a significant risk.
Amendment 158 #
2022/0216(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue on them as a result of the donation. This Regulation should therefore include principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a needthe possibility for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and frequent donation of plasma should be considered to imply a significant risk.
Amendment 163 #
2022/0216(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures as soon as possible after their introduction so that the other Member States can be informed accordingly. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary.
Amendment 165 #
2022/0216(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and where necessary supported by scientific evidence, and the means of achieving that aim are appropriate and necessary.
Amendment 172 #
2022/0216(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member States, provided that they adhere to the Charter of Fundamental Rights of the European Union. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.
Amendment 173 #
2022/0216(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) This Regulation is not meant to cover research using SoHOs when that research does not involve application to the human body, for example in vitro research or research in animals. However, human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this Regulation, regarding clinical studies with SoHO.
Amendment 175 #
2022/0216(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, prticle 3 of the Charter of Fundamental Rights of the European Union prohibits the human body or parts of it from becoming a source of financial gain. Programmes promoting the donation of SoHOs shouldmust be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a factor which can contributes to high safety standards for SoHOs and therefore to the protection of human health, and increases public trust in donation systems. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessary to ensure that donors are not financially disadvantaged by their donation. Thus, financially neutralcompensation to remove any such risk is acceptable but should never produce a financial gain for the donor orconstitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed,in any way that could posingerisks to their own health and to that of prospective recipients.Compensation and reimbursements should under no circumstances be an incentive or a claim to recruit donors, should not expose vulnerable persons in society to exploitation and should not promote competition among SoHO entities for the recruitment of donors. Such compensation should, therefore, be set by national authorities, at a level justified andappropriate in their Member State to reach such objectives. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 189 #
2022/0216(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to maintain public trust in SoHO donation and use programmes, information that is given to prospective donors, recipients or physicians regarding the likely use and benefits of particular SoHOs or SoHO preparations when applied to recipients should accurately reflect reliable scientific evidence and under no circumstances attribute or imply levels of safety or efficacy not supported by scientific methods. This should ensure that donors, or their families, are not coerced to donate by exaggerated descriptions of benefits and prospective patrecipients are not given false hopes when making decisions on their options for treatment. The verification of compliance with this Regulation through supervisory activities is of fundamental importance to ensure that, across the Union, the objectives of the Regulation are effectively achieved. The responsibility to enforce this Regulation lies with the Member States, whose competent authorities should monitor and verify, through the organisation of supervisory activities, that relevant Union requirements are effectively complied with and enforced.
Amendment 192 #
2022/0216(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from industry interference that might affect their operational impartiality. In order to prevent such interference, it is advisable to make any appointment within these authorities incompatible with decision- making or management positions in the industry.
Amendment 193 #
2022/0216(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from industry or other actors’ interference that might affect their operational impartiality.
Amendment 197 #
2022/0216(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The correct application and enforcement of the rules falling within the scope of this Regulation require an appropriate knowledge of those rules. It is therefore important that the staff performing supervisory activities have an appropriate professional background and are regularly trained, in accordance with their area of competence, on the obligations resulting from this Regulation, in order to make informed decisions and to be able to provide the target public with the correct information.
Amendment 199 #
2022/0216(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult withe Clasification Advisory Council, defined in this Regulation and composed by representatives of the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or fooadvanced therapies, medical devices and the SoHO Coordination Board, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State or the Classification Advisory Council, decide on the regulatory status of a particular substance, product or activity under this Regulation.
Amendment 200 #
2022/0216(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered toinformed sufficiently early to be able to decide, on its own initiative or at the duly substantiated request of a Member State, decide on the regulatory status of a particular substance, product or activity under this Regulation.
Amendment 205 #
2022/0216(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Commission experts should have the necessary medical experience and knowledge to be able to perform controls, including audits, in Member States to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. Commission controls should also serve to investigate and collect information on enforcement practices or problems, emergencies and new developments in Member States. Official controls should be performed by personnel who are independent, free from any conflict of interest and in particular who are not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner.
Amendment 208 #
2022/0216(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release and, distribution and issuing, competent authorities should assess and authorise SoHO preparations to verify that a high level of safety, quality and efficacy is achieved consistently by the application of that specific series of activities, performed in that specific manner. When SoHOs are prepared with newly developed and validated collection, testing or processing methods, consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. The extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that SoHO preparation and use. Where a new or modified SoHO preparation poses negligible risks for recipients (or offspring in the case of medically assisted reproduction), the vigilance reporting requirements provided for in this Regulation should be adequate to demonstrate safety and quality. This should apply for well-established SoHO preparations that are introduced in a new SoHO entity but have been robustly demonstrated as safe and effective by their use in other entities.
Amendment 210 #
2022/0216(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated, following the guidelines specified in this Regulation. The most up- to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end- points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation. (Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 AprilIf a conventional treatment or a control group is based on a medicinal product for human use, these studies shall be considered clinical trials that are covered by Regulation 536/2014. Or. en 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC)
Amendment 212 #
2022/0216(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for medium-term and long- term clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive medium-term and long-term clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with medium-term and long-term monitoring of pre-defined clinical end-points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation.
Amendment 213 #
2022/0216(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
Amendment 214 #
2022/0216(COD)
Proposal for a regulation
Recital 28 b (new)
Recital 28 b (new)
(28 b) The commitment to publish the clinical results obtained should be a mandatory requirement for clinical studies with SoHO. The existence of a registry of SoHO clinical studies at EU level is critical to facilitate patient participation in clinical studies, to boost multi-centre studies and to foster collaboration to generate more robust results and conclusions, and to make the generated knowledge available to other researchers, healthcare professionals, participants themselves and the general public.
Amendment 215 #
2022/0216(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In the interests of efficiency, it should be permitted to conduct clinical outcome studies using the established framework in the pharmaceutical sector for clinical trials, as set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council25, when operators wish to do so. Whilst applicants can choose to record the clinical data generated during the clinical outcome monitoring themselves, they should also be permitted to use existing clinical data registries as a means of such recording when those registries have been verified by the competent authority, or are certified by an external institution, in terms of the reliability of their data management procedures. _________________ 25 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
Amendment 216 #
2022/0216(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation and reduce administrative burden, competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, through the EU SoHO platform, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States and to thus significantly reduce the requirements to generate evidence. Competent authorities should also share with each other information on clinical studies with SoHO, via the EU SoHO Platform.
Amendment 217 #
2022/0216(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation, identify the best solutions and preparations and reduce administrative burden, competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States, to use these solutions and products for the benefit of recipients and to thus significantly reduce the requirements to generate evidence.
Amendment 219 #
2022/0216(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) A broad range of public and private organisations influence the safety, quality and efficacy of SoHOs, even if they do not maintain banks of those SoHOs. Many organisations carry out a single SoHO activity, such as collection or donor testing on behalf of one or many organisations that maintain banks of SoHOs. The SoHO entity concept includes this broad range of organisations, from donor registries to physicians that apply SoHOs to recipients or use SoHO processing devices at the recipient’s bedside. The registration of all such SoHO entities in special directories should ensure that competent authorities have a clear overview of the field and its scale and can take enforcement action when deemed necessary. A SoHO entity registration should refer to the legal entity, regardless of the number of physical sites associated with the entity.
Amendment 220 #
2022/0216(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) Competent authorities should periodically review the SoHO entities registered in their territory and ensure that those entities that carry out both processing and storage of SoHOs are inspected and authorised as SoHO establishments before starting those activities. A SoHO establishment authorisation should refer to the legal entity, even when one SoHO establishment has many physical sites. Competent authorities should consider the impact on safety, quality and efficacy of the SoHO activities carried out at SoHO entities that do not meet the definition of a SoHO establishment and decide whether particular entities should be subject to establishment authorisations due to the risk or scale associated with their activities. Similarly, SoHO entities that have a poor record in terms of compliance with reporting or other obligations might be suitable candidates for authorisation as SoHO establishments.
Amendment 221 #
2022/0216(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States should be involved in both the drafting and voting of these guidelines and should follow a transparent process of consultation with other relevant EU authorities and stakeholders. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines are based on the most up-to-date scientific evidence and achieve the same level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 234 #
2022/0216(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are the member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P- TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection, processing, storage and distribution. It should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this Regulation. The development of the guidelines should include stakeholder consultations to ensure their suitability and transparency.Member States should have an active role in the development of the guidelines, in cooperation with the EDQM. _________________ 26 Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
Amendment 246 #
2022/0216(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States and the Union should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Unionthe autonomy of the Union, based on a wider donor base. Member States and the Union are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 247 #
2022/0216(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary and beneficial to all parties to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Union. Member States are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 257 #
2022/0216(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
Amendment 264 #
2022/0216(COD)
Proposal for a regulation
Recital 37 b (new)
Recital 37 b (new)
(37 b) On the other hand, it is essential to take steps to achieve, as soon as possible, an EU autonomy in the area of SoHO, especially in the case of plasma, which shows an increasing demand due to new therapeutic applications of plasma- derived medicines. Nowadays, the Union suffers from chronic shortages of plasma, resulting in its dependence on imports from third countries. It is necessary to specify the measures to be taken to increase the donor base, always in line with the principles of voluntary and unpaid donation, as well as to improve the infrastructure to enable efficient collection of SoHO, in order to ensure the continued, adequate and safe supply, also in times of crisis.
Amendment 266 #
2022/0216(COD)
Proposal for a regulation
Recital 37 c (new)
Recital 37 c (new)
(37 c) In order to reach an appropriate level of autonomy in the Union, it will be necessary to increase the collection of SoHO, but also to ensure its proper and efficient use. The factors and measures affecting SoHO’s demand play a critical role in ensuring the quality, safety and sustainability of the SoHO system. Suboptimal clinical practices and unnecessary use of SoHO compromises patient safety and limits the availability of SoHO for other patients in need. Member States should take measures to promote the optimal use of SoHO, taking into account alternatives that may reduce the demand, always following the most up-to- date scientific guidelines. The competent authorities should train healthcare professionals to make optimal use of SoHO. Member States should draw up national plans to ensure the supply of SoHO, as well as national emergency plans.
Amendment 267 #
2022/0216(COD)
Proposal for a regulation
Recital 37 d (new)
Recital 37 d (new)
(37 d) In cases where the availability of SoHO preparations or SoHO-derived products depend on profit-making entities, such as some plasma-derived products, there is a risk of altruistic donations turning into disproportionate profits and commercial interests taking precedence over the interests of patients and research. There could even be situations in which some low-profitable products are no longer produced, hampering their accessibility for patients. Similarly, investment in research and innovation for this type of products could be very small or non-existent. Prices of SoHO-derived products, which are obtained from altruistic and unpaid donations, should be fair and transparent. For certain low- profitable products, Member States should encourage research and innovation and should ensure, through negotiations, incentives or public service obligations, that they continue to be manufactured.
Amendment 271 #
2022/0216(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific, experts and donor and patrecipient representative groups at Union level in the field of SoHOs may also be invited.
Amendment 272 #
2022/0216(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coherent and coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in- depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups at Union level in the field of SoHOs.
Amendment 276 #
2022/0216(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. The SCB should receive ongoing and constant relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should monitor these opinions in order to react quickly and in an informed manner to further requests for opinions from other Member States, keep a compendium of the opinions issued by the SCB or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross- sectoral approach and facilitate SoHO innovation.
Amendment 277 #
2022/0216(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB, the Classification Advisory Council or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach and facilitate SoHO innovation.
Amendment 281 #
2022/0216(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. and better communication, collaboration, coordination and exchange of SoHO between Member States. Member States should preferably use this new platform in their exchanges to limit the administrative burden.
Amendment 284 #
2022/0216(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports and the centralisation of this data in order to apply the most viable solutions, as well as improved transparency of national reporting and supervisory activities.
Amendment 287 #
2022/0216(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Pplatform should be limited in time and with regard to the number of persons authorised to access these data and to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 292 #
2022/0216(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the prohibition of making the human body and its parts a source of economic gain, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable and non-discriminatory access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied accordingly.
Amendment 293 #
2022/0216(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence and criteria of compatibility between donors and recipients, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied accordingly.
Amendment 297 #
2022/0216(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures and, where possible, anonymised, to allow aggregation at Union level for more robust evidence gathering on the clinical efficacy of SoHO preparations. For all data processing, such processing should be necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data on donors, recipients and offspring should hence be limited to the minimum necessary and pseudonymised, or anonymised, as appropiate in each case. dDonors, recipients and offspring should be informed of the processing of their personal data in line with the requirements of Regulations (EU) 2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, including the possibility of exceptional cases where circumstances require such processing.
Amendment 300 #
2022/0216(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to enable better access to health data in the interests of public health, Member States should entrust competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of such data, specifying the period for which they are to be retained and how they are to be accessed or the number of persons having access and for how long.
Amendment 303 #
2022/0216(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need. In this context, the objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objectiveThis Regulation will increase coordination between Member States and facilitate the cross-border exchange of SoHO.
Amendment 304 #
2022/0216(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages, using a database to trace the availability thereof in various Member States. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need in the optimal timeframe to achieve the desired results. In this context, the objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 305 #
2022/0216(COD)
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47 a) The objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 307 #
2022/0216(COD)
Proposal for a regulation
Recital 47 b (new)
Recital 47 b (new)
(47 b) In some cases such as bone marrow or haematopoietic stem cell transplants, the level of donor/recipient compatibility has to be extremely high. Therefore, excellent coordination is needed at a global level, beyond the Union level, so that each patient has more options of finding a compatible donor.
Amendment 310 #
2022/0216(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘SoHOs’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction, and for enhanced coordination between Member States to improve the availability and accessibility of SoHO across the Union. This Regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their quality and safety and the safety of SoHO donors, recipients and offspring of medically assisted reproduction.
Amendment 318 #
2022/0216(COD)
(h a) issuing of SoHOs;
Amendment 321 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point m a (new)
Article 2 – paragraph 1 – point m a (new)
(m a) clinical studies with SoHO.
Amendment 323 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. In cases of autologous use of SoHOs, excluding cases where the processing involves a substantial modification or where its application is non-homologous, where:
Amendment 333 #
2022/0216(COD)
(1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body. It consists of a liquid part, plasma, and a solid consisting of red blood cells, leucocytes and platelets;
Amendment 338 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘substance of human origin’ (SoHO) means any substance collected from the human body in whatever manner, whether it contains cells or not and whether those cells are living or not. For the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU, but does include substances which can be extracted from them;
Amendment 339 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘human application’ means inserted, implanted, injected, infused, transfused, transplanted, ingested, transferred (as in transfer to the uterus or fallopian tube of a woman), inseminated or otherwise added to the human body in order to create a biological, mechanical or physiological interaction with that body;
Amendment 340 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘SoHO activity’ means an action, or series of actions, that has a direct impact on the safety, quality or, efficacy or functionality of SoHOs, as listed in Article 2(1);
Amendment 343 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, or a deceased person who has authorised, or on his/her behalf a family member or authorised person, the donation of parts of his/her body after death, whether that donation is successful or not;
Amendment 346 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves voluntarily to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not;
Amendment 349 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘SoHO donation’ means a process by which a person – or on his/her behalf a relative or authorised person – voluntarily and altruistically gives parts of their own body to other people in need, or authorises their use after their death. It includes the necessary medical formalities, examinations and treatments and monitoring of the SoHO donor, whether that donation is successful or not;
Amendment 352 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘living donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not;
Amendment 355 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
(10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm, in vitro fertilisation or any other laboratory or medical intervention that promotes conception and uses SoHOs for the preservation of fertility through collection and storage of SoHO substances for subsequent human application;
Amendment 361 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction;
Amendment 362 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11 a (new)
Article 3 – paragraph 1 – point 11 a (new)
(11 a) ‘unborn offspring from medically assisted reproduction’ means embryos and foetuses conceived by medically assisted reproduction;
Amendment 364 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point b
Article 3 – paragraph 1 – point 12 – point b
(b) meets a pre-defined specification; and
Amendment 366 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c
Article 3 – paragraph 1 – point 12 – point c
(c) is intended for application to a recipient for a specific and homologous clinical indication or is intended for distribution for manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof; and
Amendment 368 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c a (new)
Article 3 – paragraph 1 – point 12 – point c a (new)
(c a) has not been substantially modified, such as to be considered as a medicinal product or advanced therapy, and is not intended to be applied in a non- homologous manner to the recipient.
Amendment 370 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
(12 a) ‘competent authority’ means the body or bodies responsible for SoHO’s activities at national level, designated by each Member State;
Amendment 372 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘donor recruitment’ means any information and communication activity aimed at encouraging persons to become SoHO donors;
Amendment 374 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘donor recruitment’ means any activity aimed at informing and encouraging persons to become SoHO donors;
Amendment 378 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘processing’ means any operation involved in the handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging. It does not include activities involving a substantial modification of SoHOs that would make it a medicinal product or an advanced therapy;
Amendment 382 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 16
Article 3 – paragraph 1 – point 16
(16) ‘quality control’ means several tests or checks, based on common criteria, to confirm that a SoHO activity or SoHO preparation meets pre-defined quality criteria;
Amendment 383 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 16
Article 3 – paragraph 1 – point 16
(16) ‘quality control’ means severaldefined tests or checks to confirm that a SoHO activity or SoHO preparation meets pre- defined quality criteria;
Amendment 386 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
(17) ‘storage’ means the maintenance of SoHOs under appropriate controlled conditions until distribution or issuing;
Amendment 387 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18
Article 3 – paragraph 1 – point 18
(18) ‘release’ means a process through which it is verified that a SoHO or a SoHO preparation meets defined safety and quality criteria and the conditions of any applicable authorisation before distribution, issuing, export or human application;
Amendment 392 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 20
Article 3 – paragraph 1 – point 20
(20) ‘import’ means activities carried out to bring SoHOs or SoHO preparations into the Union from a third country, including the organisation of such activities and physical verification of coherence with associated documentation and of the quality of the preparations, in accordance with EU standards, the appropriateness of transport conditions, the integrity of packaging and the adequacy of labelling before release;
Amendment 393 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21
Article 3 – paragraph 1 – point 21
(21) ‘export’ means distribution of SoHOs or SoHO preparations to third countries outside the Union;
Amendment 394 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 a (new)
Article 3 – paragraph 1 – point 21 a (new)
(21 a) ‘non-homologous use’ means a cell or tissue that, when applied to a recipient, ceases to have the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 395 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 b (new)
Article 3 – paragraph 1 – point 21 b (new)
(21 b) ‘homologous use’ means a cell or tissue that when applied in a recipient mantains the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 396 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 22
Article 3 – paragraph 1 – point 22
(22) ‘clinical outcome monitoring’ means evaluation of the health of a SoHO recipient for the purpose of monitoring the results of a SoHO preparation application, maintaining care and demonstrating safety and efficacy or functionality;
Amendment 397 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 23
Article 3 – paragraph 1 – point 23
(23) ‘autologous use’ means collection of SoHO from one individual for subequent application to the same individual, with or without further SoHO activities between collection and application;
Amendment 399 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 24
Article 3 – paragraph 1 – point 24
(24) ‘SoHO entity’ means an organisation legally established in the Union and accredited that carries out one or more of the SoHO activities set out in Article 2(1);
Amendment 400 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 27
Article 3 – paragraph 1 – point 27
(27) ‘adverse occurrence’ means any incident associated with the donation or human application of SoHO that caused harm to a living SoHO donor, harm to a SoHO recipient or to offspring from medically assisted reproduction or that implied a risk of such harm;
Amendment 405 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point i a (new)
Article 3 – paragraph 1 – point 28 – point i a (new)
(i a) any other adverse ocurrence specified by the EDQM guidelines.
Amendment 407 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 29
Article 3 – paragraph 1 – point 29
(29) ‘SoHO rapid alert’ means a communication regarding a SAO, a communicable disease outbreakn adverse ocurrence or other information that might be of relevance to the safety and quality of SoHOs in more than one Member State and is to be transmitted rapidly between competent authorities and the Commission to facilitate the implementation of preventive or mitigating measures;
Amendment 408 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘EU SoHO Platform’ means the digital platform established and managed by the Commission tofor the exchange of information concerning SoHO activities at Union level, between competent authorities, the Commission, SoHO entities and other relevant entities, and to facilitate coordination and cross-border cooperation, between Member States, on SoHO;
Amendment 411 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘EU SoHO Platform’ means the digital platform established by the Commission to exchange information concerning SoHO activities and which is accessible in all the official EU languages;
Amendment 412 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 33
Article 3 – paragraph 1 – point 33
(33) ‘the compendium of SoHO’ means a list kept up-to-date by the SoHO Coordination Board of decisions, taken at Member State level, and opinions, issued by competent authorities and by the SCB and the Classification Advisory Council, on the regulatory status of specific substances, products or activities and published on the EU SoHO platform;
Amendment 414 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 38
Article 3 – paragraph 1 – point 38
(38) ‘Union training’ means training activities for the personnel of competent authorities and, where appropriate, for personnel of delegated bodies performing SoHO supervisory activities;
Amendment 416 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘critical SoHO’ means a SoHO for which an insufficient supply will result in serious harm or risk of harm to patrecipients;
Amendment 418 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42
Article 3 – paragraph 1 – point 42
(42) ‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHOs and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for patrecipients;
Amendment 420 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42 a (new)
Article 3 – paragraph 1 – point 42 a (new)
(42 a) ‘Classification Advisory Council’ means a body composed of representatives of the SoHO Coordination Board, the European Medicines Agency and the Medical Device Coordination Group with the responsibility of assisting the Member States and the Commission in determining the regulatory status of a substance, product or activity covered by this Regulation;
Amendment 421 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42 b (new)
Article 3 – paragraph 1 – point 42 b (new)
(42 b) ‘SoHO Coordination Board (SCB)’ means a body set up by this Regulation to promote coordination between Member States on SoHO;
Amendment 423 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 45
Article 3 – paragraph 1 – point 45
(45) ‘technical guidelines’ means a description of a series of methodological procedures and parameters, updated in accordance with the latest scientific evidence, that, if followed, achieve a level of quality and safety of a SoHO activity or a SoHO preparation that is considered to be acceptable as a means to comply with regulatory standards;
Amendment 424 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 47 – introductory part
Article 3 – paragraph 1 – point 47 – introductory part
(47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage to, distribution or issuing, to human application or disposal, including the ability to:
Amendment 427 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘imputability’ means the likelihood that a seriousn adverse occurrence, in a SoHO donor, is related to the donacollection process or, in a recipient, to the application of the SoHOs;
Amendment 433 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 61
Article 3 – paragraph 1 – point 61
(61) ‘SoHO for reproductive cellson’ means all cells intended to be used for the purpose of medically assisted reproduction and embryos resulting from fertilisation;
Amendment 434 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 62
Article 3 – paragraph 1 – point 62
(62) ‘third party donation’ means a donation of SoHO for reproductive cellson by a person to a personrecipient or a couple with whom the donor does not have an intimate physical relationship;
Amendment 436 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 63
Article 3 – paragraph 1 – point 63
(63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction frombetween two persons with an intimate physical relationship, where one person supplies their own oocytes and the other person supplies their own sperm. Such gametes shall under no circumstances be applied to third parties;
Amendment 441 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of any quantifiable losses associated with donation, without any net gain or loss;
Amendment 452 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64 a) ‘reimbursement’ means the reimbursement of costs incurred by the donor associated with the donation process;
Amendment 454 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64 b (new)
Article 3 – paragraph 1 – point 64 b (new)
(64 b) ‘financial neutrality’ means a situation in which the donor does not experience net economic gains or losses associated with a donation;
Amendment 461 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70 a) ‘informed consent’ means consent by the donor to make a free and non- coercive donation or consent by the recipient to accept a treatment with a SoHO, after receiving clear, comprehensive and comprehensible information;
Amendment 465 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 b (new)
Article 3 – paragraph 1 – point 70 b (new)
(70 b) ‘European autonomy’ means the situation where the Union has the capacity to self-supply SoHO, being self- sufficient from third countries to cover most of the demand, with the exception of those SoHOs which require global management due to their intrinsic characteristics.
Amendment 468 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 c (new)
Article 3 – paragraph 1 – point 70 c (new)
(70 c) ‘SoHO clinical study’ means an experimental evaluation of a SoHO or a SoHO preparation in humans, with the objective of drawing conclusions regarding its efficacy and safety.
Amendment 470 #
2022/0216(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are compatible with Union law, and are proportionate to the risk to human health. In particular, Member States may introduce requirements for donations, including the prohibition or restriction of imports of SoHO, to ensure a high level of health protection and to achieve the objective defined in Article 54, provided that the conditions of the Treaties are met. Such measures shall not hinder coordination between Member States or European autonomy.
Amendment 478 #
2022/0216(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point c
Article 5 – paragraph 3 – point c
(c) have sufficient resources,human and material resources, as well as operational capacity, and expertise to achieve the aims of, and fulfil their obligations under, this Regulation;
Amendment 489 #
2022/0216(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation of incompatibility that may, directly or indirectly, affect the impartiality of their professional conduct.
Amendment 491 #
2022/0216(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health. They shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.
Amendment 493 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Competent authorities shall be responsible for the SoHO supervisory activities referred to in Chapter III in order to verify the effective compliance of SoHO entities and SoHO preparations authorised in their territory with the requirements set out in this Regulation.
Amendment 495 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) procedures to ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;
Amendment 496 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities efficiently, safely and effectively;
Amendment 499 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with authorities established in other relevant Union legislation referred tothe Classification Advisory Council, defined in Aarticle 2(3), as relevant.67(a) In such cases, competent authorities shall also consult the compendium referred to Article 3 point (33).
Amendment 500 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 1
Article 14 – paragraph 2 – subparagraph 1
Amendment 502 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2
Article 14 – paragraph 2 – subparagraph 2
Amendment 505 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The competent authorities shall inform the SCBClassification Advisory Council of the subsequent decision taken in their Member State, following the consultations referred to in paragraph 1 of this Article, regarding the regulatory status of the substance, product or activity concerned under this Regulation and on any consensus reached as a result of those consultations for publication in the compendium by the SCB. To the extent possible, Member States shall accept the opinion of the Classification Advisory Council. Otherwise, they shall inform the Classification Advisory Council as soon as possible of the decision taken and its justification.
Amendment 509 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State or the Classification Advisory Council, following the consultation referred to in paragraph 1, or on its own initiative, by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b)in the Classification Advisory Council. This decision shall be based on the most up-to- date scientific evidence.
Amendment 510 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
Amendment 513 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40.
Amendment 515 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
Article 14 – paragraph 7 – subparagraph 1
The Commission may, by means of implementing acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3).
Amendment 520 #
2022/0216(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point d
Article 16 – paragraph 2 – point d
(d) participate regularly in training at national or European level in the subject matter and on the obligations of competent authorities resulting from this Regulation, as referred to in paragraph 3 so as to be up to date with any changes or updates to the provisions of the Regulation.
Amendment 521 #
2022/0216(COD)
3. Competent authorities, in cooperation with delegated bodies as necessary, shall develop and implement training programmes at national level for the purpose of ensuring that personnel performing SoHO supervisory activities receive the training referred to in paragraph 2, points (b), (c) and (d). Competent authorities shall maintain records of the training undertaken by their personnel. Competent authorities shall provide opportunities for their personnel to participate in the Union training referred to in Article 69 where such Union training is available and appropriate.
Amendment 524 #
2022/0216(COD)
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. SoHO preparation authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity of the SoHO preparation authorisation of another Member State pending verification that the more stringent measure has been met. This information shall be notified, without undue delay, in the EU SoHO Platform.
Amendment 525 #
2022/0216(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Competent authorities shall have procedures in place to allow that applications for the authorisation of SoHO preparations are submitted in accordance with Article 41. They shall provide guidelines and templates for the submission of applications for SoHO preparation authorisation. When developing these guidelines and templates, competent authorities shall consultfollow the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c). Competent authorities may establish simplified procedures for applications concerning modifications to previously authorised SoHO preparations.
Amendment 531 #
2022/0216(COD)
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21 a Conditional authorisation of SoHO preparations in exceptional situations 1. In exceptional cases, and subject to a medical prescription, the competent authorities may consult the best practices approved and documented by the SCB in accordance with Article 68(1)(c) and authorise the conditional and temporary use of certain SoHOs preparations in cases where: (a) the potential recipient of those SoHO preparations is at vital risk, has no available therapeutic alternatives and their treatment cannot be postponed; (b) available clinical data indicate that the SoHO preparation will be safe and effective. 2. The competent authorities shall, without undue delay, enter information on conditional authorisations of SoHO preparations into the EU SoHO Platform referred to in Chapter XI. 3. After receiving conditional and temporary authorisation for a SoHO preparation, the SoHO entity shall, in parallel, initiate a regular authorisation procedure for that SoHO preparation in accordance with Article 21.
Amendment 532 #
2022/0216(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The assessment of a SoHO preparation, shall include a review of all SoHO activities that are performed for that SoHO preparation and that might influence the safety, quality and efficacy of the SoHO preparation, to make sure it maintains all the properties for being compatible with recipients.
Amendment 533 #
2022/0216(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
5. When assessing the SoHO preparation pursuant to paragraph 4, points (e) and (g), competent authorities shall consider, in the cases where the applicant has proposed to record, and recorded,verify that the clinical studies and their results of the clinical outcome monitoring in an existing clinical registry, that this is an acceptable method, provided that those competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of datahave been correctly recorded in the EU SoHO Platform.
Amendment 534 #
2022/0216(COD)
Proposal for a regulation
Article 24 – paragraph 5
Article 24 – paragraph 5
5. Competent authorities shall ensure that the specific induction training is complemented by regular specialised training for assessment of processing methods and technologies used for specific types of SoHO preparations and by continuous training, as appropriate, throughout the career of the assessors to keep step with technical developments in the field. Competent authorities shall make all reasonable efforts to ensure that assessors that participate in joint assessments have completed the relevant Union training referred to in Article 69(1) and are included in the list referred to in Article 69(5).
Amendment 556 #
2022/0216(COD)
Proposal for a regulation
Article 28 – paragraph 9
Article 28 – paragraph 9
9. By derogation from paragraph 1, in case of emergencythe exceptional situations described in Article 21(a) or in case of emergency, as described in Article 64, competent authorities may authorise imports of SoHOs for immediate application to a specific recipient when justified by the clinical circumstances on a case-by-case basis.
Amendment 565 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 1 – subparagraph 2
Article 32 – paragraph 1 – subparagraph 2
In exceptional cases, competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. They shall also perform their duties impartially, transparently and free from conflicts of interest.
Amendment 567 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. For the specific induction training, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c). The designation criteria shall be clear and transparent.
Amendment 572 #
2022/0216(COD)
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. Competent authorities shall establish procedures for the unique identification of SoHO establishments that are subject to the provisions on the Single European Code in Article 46. Competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. For this purpose, competent authorities may preferably use a SoHO establishment identification code generated by the EU SoHO Platform.
Amendment 573 #
2022/0216(COD)
Proposal for a regulation
Article 34 a (new)
Article 34 a (new)
Article 34 a Monitoring of SoHO availability and continuity of supply 1. As part of the national plans to ensure the continuity of SoHO supply referred to in Article 61(a), the competent authorities shall establish a digital platform through which they can exchange information on the availability of SoHO in the national territory in a fast and efficient manner. Through this system, competent authorities may request national SoHO entities to provide information on the availability of a certain SoHO product in specific situations of need. They shall also take into account alerts sent by national SoHO entities concerning the availability of SoHO and potential shortages. The competent authorities shall ensure that this digital platform is available no later than two years after the entry into force of this Regulation. 2. The competent authorities shall be responsible for monitoring the availability of SoHO at national level. They shall provide guidance to SoHO entities to facilitate the exchange of information on the availability of SoHO referred to in Article 46(a). 3. The competent authorities shall store and analyse information on the availability of SoHO and its fluctuations over time, as well as trends in demand and potential shortages of SoHO and shall draw up reports containing that information which may be made available to other Member States through the EU SoHO Platform as defined in Article 73 (Article 35).
Amendment 576 #
2022/0216(COD)
Proposal for a regulation
Article 36 a (new)
Article 36 a (new)
Amendment 577 #
2022/0216(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. The responsible person for release of SoHOs shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field. The SoHO entity shall ensure that the person responsible for the release of SoHO receives adequate and up-to-date training, appropriate to their job and responsibilities, including specific training on those SoHOs that require it.
Amendment 579 #
2022/0216(COD)
Proposal for a regulation
Article 40 – paragraph 3
Article 40 – paragraph 3
3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 21(a) 64.
Amendment 580 #
2022/0216(COD)
Proposal for a regulation
Article 41 – paragraph 2 – point a – point ii
Article 41 – paragraph 2 – point a – point ii
(ii) any specific SoHO collection procedures with a view to maintaining all the properties to be compatible with recipients;
Amendment 582 #
2022/0216(COD)
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results to their competent authorities. In conducting the clinical investigation study as referred to in paragraph 3, points (b) and (c), for the SoHO preparation concerned, the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of datashall register that study and the results obtained in the SoHO EU Platform in accordance with Article 36 (a).
Amendment 585 #
2022/0216(COD)
Proposal for a regulation
Article 41 a (new)
Article 41 a (new)
Article 41 a Clinical studies with SoHO 1. SoHO entities may conduct clinical studies with SoHO, in the context of the monitoring plans defined in Article 41 or beyong it, with the aim of comparing or improving treatments. 2. Clinical studies shall always have the safety and well-being of the participants in the study as a priority and they shall respect the provisions of Articles 53, 54, 55, 56, 58 and 59 of this Regulation, concerning the protection of donors and recipients. SoHO entities intending to start a clinical study shall seek to obtain more robust and reliable data, through collaboration with other SoHO entities, if necessary. 3. SoHO entities must apply for a favorable opinion from the Research Ethics Committee before starting any clinical study. The Committee shall assess the ethical, legal and methodological aspects of the study, to determine the capacity of the study design to draw robust conclusions, as well as well-being and safety-related aspects of the participants, before issuing a favorable opinion for the study. 4. The person responsible for the clinical study shall be adequately trained. 5. Before starting the clinical study, SoHO entities shall register it on the EU SoHO Platform, where they shall also record the results after the end of the study, in accordance with Article 36 (a). 6. SoHO entities shall request approval of the clinical study to competent authorities before starting a clinical study with SoHO, in accordance with Article 36(a). SoHO entities may request assistance regarding administrative, technical and ethical aspects of the clinical study to the competent authorities, in accordance with Article 36(a).
Amendment 591 #
2022/0216(COD)
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Amendment 592 #
2022/0216(COD)
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse occurrences, including adverse occurrences detected during clinical outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 41 or as part of a clinical study with SoHO, as referred to in Article 41(a).
Amendment 595 #
2022/0216(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. SoHO establishments shall not carry out any SoHO activities without prior SoHO establishment authorisation. This shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another SoHO entity.
Amendment 603 #
2022/0216(COD)
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
2. SoHO entities shall protect the physical and mental health of living donors before, during and after the donation.
Amendment 604 #
2022/0216(COD)
Proposal for a regulation
Article 52 – paragraph 2 a (new)
Article 52 – paragraph 2 a (new)
2 a. SoHOs from living donors shall be obtained from individuals whose state of health is such that no adverse effects on their health are expected/likely as a result of donation.
Amendment 607 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point a a (new)
Article 53 – paragraph 1 – point a a (new)
(a a) ensure that donors are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence, and intended to avoid potential risks to the health of SoHO recipients or donors;
Amendment 608 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that is adequate in view of their capacity to understand it, so that they can give free and informed consent;
Amendment 609 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point f
Article 53 – paragraph 1 – point f
(f) verify the eligibility of the donor on the basis of a donor health evaluation, including mental health-related aspects that could be altered by the donation process, that aims to minimise any risk that the donation might pose to the donor’s health;
Amendment 626 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. In the course of the donor health evaluations referred to in paragraph 1, point (f), SoHO entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical and mental health and their health histories to assure the safety of the donation process for those donors. SoHO entities may perform laboratory tests as part of the donor health evaluations. They shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. The physician, as referred to in Article 51, shall approve the procedure and criteria for donor health evaluations.
Amendment 627 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHO that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross- entity registry that allows interconnection with other such registries at Union level, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 643 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to living donors for losses related to their participation in donations through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit that ensures that allowances are transparent, financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.
Amendment 648 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. SoHO entities may compensate or reimburse living donors as provided for by their competent authorities pursuant to paragraph 2. SoHO entities shall report transparently to the competent authorities on the compensation used, and on any changes made in this respect.
Amendment 651 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3 a. Compensation may under no circumstances be used for promotion or as a claim for recruitment, shall not be an incentive to donate and shall not lead to exploitation of the most vulnerable persons in society or to situations of inappropriate competition for the recruitment of donors.
Amendment 653 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3 b (new)
Article 54 – paragraph 3 b (new)
3 b. The Commission shall assess the ethical aspects of voluntary and unpaid donation and verify that Member States’ compensation and reimbursement systems follow the guidelines specified in this Regulation. This assessment shall determine, inter alia, that such compensations and reimbursements under no circumstances constitute an incentive or a claim to recruit donors, that they do not expose vulnerable people in society to exploitation activities, that they do not undermine public confidence in the donation system or that they do not promote competition between SoHO entities for the recruitment of donors. Member States shall provide the Commission with the information requested to perform this assessment. By [one year after the entry into force of this Regulation], and every three years, the Commission shall submit a report to the Council and the European Parliament assessing the compensation and reimbursement systems in the Member States and, where appropriate, making recommendations to the Member States on how they can be improved. These reports shall be made available to the public.
Amendment 658 #
2022/0216(COD)
Proposal for a regulation
Article 55 – paragraph 3 – point d
Article 55 – paragraph 3 – point d
(d) the intended use of the donated SoHO, in particular covering proven benefits for the future recipients and any possible research or commercial uses to which the donor should give an informed consent;
Amendment 671 #
2022/0216(COD)
Proposal for a regulation
Article 56 – paragraph 6
Article 56 – paragraph 6
Amendment 676 #
2022/0216(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 679 #
2022/0216(COD)
Proposal for a regulation
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
SoHO entities shall ensure that recipients are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence and intended to avoid potential risks to the health of donors or recipients;
Amendment 688 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – introductory part
Article 58 – paragraph 2 – introductory part
2. In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of communicable disease transmission from SoHO donors to recipients by combining, at least,follow the scientific and technical specifications defined in Article 59 to mitigate the following measurerisks:
Amendment 690 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point a
Article 58 – paragraph 2 – point a
Amendment 692 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
Amendment 695 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point c
Article 58 – paragraph 2 – point c
Amendment 699 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 a (new)
Article 58 – paragraph 2 a (new)
2 a. of communicable disease transmission from SoHO donors to recipients by combining, at least, the following measures: (i) reviewing and evaluating the donors’ current and past health, travel and relevant behavioural histories to allow the application of temporary or permanent deferrals when risks cannot be fully eliminated by donor testing; (ii) testing of donors for communicable diseases using certified and validated testing methods, or other methods considered appropriate in accordance with the guidelines defined in Article 59; (iii) when feasible and suitable according to the guidelines defined in Article 59, using processing technologies that reduce, inactivate or eliminate any potential communicable pathogens.
Amendment 701 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 b (new)
Article 58 – paragraph 2 b (new)
2 b. of non-communicable disease transmission, including genetic conditions and cancer, from donors to the recipients or to offspring from medically assisted reproduction by combining, at least, the following measures: (i) reviewing the donors’ current and past health to allow temporary or permanent deferral of donors that carry a risk of transmitting cancerous cells or other non- communicable diseases that might be passed to a recipient by SoHO application; (ii) where the transmission of genetic conditions is an identified risk, and in particular in the case of medically assisted reproduction with third party donation: - testing donors for those conditions, as indicated by prevalence or severity as presenting the highest risk;or - testing prospective recipients to identify any relevant genetic risk, combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring.
Amendment 702 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 c (new)
Article 58 – paragraph 2 c (new)
2 c. of communicable or non- communicable disease transmission to the recipients through cross-contamination of donations during collection, processing, storage and distribution by measures that ensure that physical contact between SoHOs from different donors is avoided or, in cases where combining donations is necessary for efficacy of the SoHO preparation, is minimised.
Amendment 703 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 d (new)
Article 58 – paragraph 2 d (new)
Amendment 704 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 e (new)
Article 58 – paragraph 2 e (new)
2 e. that any reagents and solutions added to SoHOs or coming in contact with SoHOs during collection, processing, storage and distribution might be transmitted to recipients and have a toxic, or other, detrimental effect on their health by combining, at least, the following measures: (i) specifying such reagents and solutions prior to their purchase; (ii) verifying any required certifications of such reagents and solutions; (iii) demonstrating the removal of such reagents and solutions, when necessary, prior to distribution.
Amendment 705 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 f (new)
Article 58 – paragraph 2 f (new)
Amendment 706 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 g (new)
Article 58 – paragraph 2 g (new)
2 g. that SoHOs cause an immune reaction in recipients by combining, at least, the following measures: (i) accurately typing and matching of patients to donors, when such matching is necessary; (ii) correctly distributing SoHOs to the correct recipients pursuant to Article 45.
Amendment 707 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 h (new)
Article 58 – paragraph 2 h (new)
Amendment 708 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
Amendment 713 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
Amendment 714 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 5
Article 58 – paragraph 5
Amendment 717 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 6
Article 58 – paragraph 6
Amendment 719 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 7
Article 58 – paragraph 7
Amendment 721 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 8
Article 58 – paragraph 8
Amendment 723 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 9
Article 58 – paragraph 9
Amendment 726 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 10 – point a
Article 58 – paragraph 10 – point a
(a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by their competent authority pursuant to Article 41(4), or a clinical study referred to in Article 41(a);
Amendment 727 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 10 – point b
Article 58 – paragraph 10 – point b
(b) apply SoHO preparations to recipients unnecessarily. SoHO entities shall make an optimal use of SoHO, taking into account therapeutic alternatives, and following the most up-to- date scientific guides specified in Article 59 ;
Amendment 728 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 10 – point c a (new)
Article 58 – paragraph 10 – point c a (new)
(c a) prioritise cosmetic uses over clinical uses, especially in the event of a possible shortage of SoHO.
Amendment 730 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 1
Article 58 – paragraph 11 – subparagraph 1
Amendment 732 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 2
Article 58 – paragraph 11 – subparagraph 2
For donors that donate repeatedly, the interviews referred to in the first subparagraph may be limited to aspects that might have changed and may be replaced with questionnaires.
Amendment 741 #
2022/0216(COD)
Amendment 742 #
2022/0216(COD)
Proposal for a regulation
Article -62 (new)
Article -62 (new)
Amendment 747 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
Amendment 773 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point f a (new)
Article 62 – paragraph 3 – point f a (new)
(f a) communication strategy for the general public.
Amendment 776 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 6
Article 62 – paragraph 6
6. Member States shall review regularly their national SoHO emergency plans at least every 3 years and whenever necessary to take into account changes in the organisation of competent authorities and, experience gained from implementing the plans and simulation exercises and the recommendations issued by the Commission, as referred to in Article 62(a).
Amendment 786 #
2022/0216(COD)
Proposal for a regulation
Article 62 b (new)
Article 62 b (new)
Article 62 b European SoHO autonomy 1. By two years after the entry into force of this Regulation, the Commission shall submit a report to the Council and the European Parliament assessing the different measures applicable to secure the SoHO supply at national level, in the Member States, and at Union level. This report shall include measures to promote donation, in a manner compatible with the principles of voluntary and unpaid donation defined in paragraph 54 – such as informative and awareness-raising campaigns for citizens on the benefits of donation, as well as measures for the efficient use of SoHO. Based on the results of this report, the Commission shall develop a plan to promote European SoHO autonomy and give recommendations to Member States to implement measures in this regard in their national plans, described in Article 61 (a). 2. The plan for a European autonomy proposed by the Commission shall be reviewed every 5 years. 3. The Commission shall work with Member States to promote public participation in SoHO donation activities, in particular with regard to critical SoHO, with a view of ensuring resilient supply and a significant increase in donation rates where risks of shortages are identified. In doing so, it shall encourage the collection of SoHO through strong public and non-profit sector participation.
Amendment 787 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
1. Critical SoHO entities shall without undue delay launch a SoHO supply alert to their competent authorities in case of a significant interruption, indicating the underlying reason, the expected impact on patients and any mitigating actions taken including possible alternative supply channels if appropriate. Interruptions shall be considered significant when the application of critical SoHO is cancelled or postponed due to unavailability and this poses a serious risk to human health.
Amendment 788 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 1 a (new)
Article 63 – paragraph 1 a (new)
Amendment 790 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The SoHO National Authorities mayshall submit to the EU SoHO Platform the SoHO supply alert received, especially in cases where the supply interruption might affect other Member States or where such interruption might be addressed through cooperation between Member States pursuant to Article 62(3), point (d).
Amendment 791 #
2022/0216(COD)
Proposal for a regulation
Article 64 – title
Article 64 – title
Derogation from the obligations to authorise SoHO preparations in public health emergency situations
Amendment 794 #
2022/0216(COD)
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
Member States may take additional measures to the ones set out in their national SoHO emergency plans to ensure critical SoHOs suppontinuity of SoHO supply, as well as in the national SoHO emergency plans to secure SoHO supply, especially in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States and the Commission without undue delay and give reasons for the measures taken.
Amendment 797 #
2022/0216(COD)
Proposal for a regulation
Article 65 a (new)
Article 65 a (new)
Article 65 a Plans to ensure continuity of supply to SOHO entities SoHO entities carrying out SoHO activities related to critical SoHOs shall have in place a plan to ensure continuity of supply of its own entity that supports the implementation of the national SoHO continuity of supply plan referred to in Article 61 (a).
Amendment 806 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate, in order to ensure a multidisciplinary and diverse representation of stakeholders in the SoHO sector. Other Union institutions, bodies, offices and agencies shall have an observer role.
Amendment 812 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. The Commission shall chair the meetings ofBoard shall be co-chaired by a representative of the Commission and by one rotating representative of the Member States, who shall be elected by and from among the representatives of the Member States in the SCB. The chair shall not take part in votes of the SCB.
Amendment 814 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 6 – point k a (new)
Article 67 – paragraph 6 – point k a (new)
(k a) make available to the public a summary of the topics discussed at the meetings.
Amendment 819 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point a
Article 68 – paragraph 1 – point a
(a) in collaboration with other authorities designated in other relevant Union legislation, preparing opinions at the request of competent authorities in accordance with Article 14(2) first sub-paragraph1), on the regulatory status under this Regulation of a substance, product or activity and transmitting its opinions to the compendium;
Amendment 820 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point b
Article 68 – paragraph 1 – point b
(b) when preparing the opinions referred to in point (a) of this paragraph, initiating, at Union level, a consultation with equivalent advisory bodies establishedparticipate in other relevant Union legislation in accordance with Article 14(2) second sub-paragraph, and including in the compendium the opinions concerning the Union legislation to be applied in cases where there is agreement with the equivalent advisory bodies Classification Advisory Council as defined in Article 68 (a);
Amendment 822 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point d
Article 68 – paragraph 1 – point d
(d) recording information notified in accordance with Article 14(32), and including such information in the compendium;
Amendment 825 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point g a (new)
Article 68 – paragraph 1 – point g a (new)
Amendment 826 #
2022/0216(COD)
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)
Amendment 828 #
2022/0216(COD)
Proposal for a regulation
Article 69 – paragraph 1 – subparagraph 1
Article 69 – paragraph 1 – subparagraph 1
The Commission shall organise Union training in cooperation with the Member States concerned.
Amendment 832 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation shall be based on the highest scientific standards, be proactive in identifying future needs and be transparent, involving the relevant stakeholders in consultations related to the development of the technical guidelines.
Amendment 837 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1 a (new)
Article 71 – paragraph 1 a (new)
The Commission shall evaluate the transparency in the procedures and development of the technical guidelines by the EDQM and their suitability to the needs and interests of the Member States.
Amendment 838 #
2022/0216(COD)
Proposal for a regulation
Article 72 – paragraph 1 – point a
Article 72 – paragraph 1 – point a
(a) providing secretariat and technical, scientific and logistic support to the SCB and its working groups and to the Classification Advisory Council;
Amendment 839 #
2022/0216(COD)
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
2. With regard to the support referred to in paragraph 1, point (a), the Commission shall, in particular, organise the meetings of the SCB and its working groups, the travel of members of the SCB, and of the Classification Advisory Council, the travel of members of the SCB and the Classification Advisory Council reimbursement and special allowances for scientific experts that participate in those meetings, and ensure the appropriate follow-up.
Amendment 840 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange, registration and storage of information concerning SoHO activities in the Union, as provided for in this Regulation. To ensure optimal use of the EU SoHO Platform, the Commission shall:
Amendment 842 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point a (new)
Article 73 – paragraph 1 – point a (new)
(a) develop the technical and functional specifications of the EU SoHO Platform, including the data exchange mechanism for the exchange with existing national systems and the format for electronic submission;
Amendment 843 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point b (new)
Article 73 – paragraph 1 – point b (new)
Amendment 844 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point c (new)
Article 73 – paragraph 1 – point c (new)
(c) develop relevant guidance for reporting through the EU SoHO Platform;
Amendment 845 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point d (new)
Article 73 – paragraph 1 – point d (new)
(d) ensure data interoperability between the EU SoHO Platform, Member States’ IT systems and other relevant IT systems and databases, such as the EMA’s European Shortages Monitoring Platform or systems defined in the European Health Data Space, without duplication of reporting;
Amendment 846 #
2022/0216(COD)
(e) ensure that the Commission, national authorities and competent authorities, SoHO entities, SCB, ECDC, EMA, EDQM and other relevant bodies have adequate levels of access to the information contained in the EU SoHO Platform to carry out their tasks;
Amendment 847 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point f (new)
Article 73 – paragraph 1 – point f (new)
(f) ensure that confidential information sent to the system is protected from unjustified disclosure;
Amendment 848 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point g (new)
Article 73 – paragraph 1 – point g (new)
(g) ensure that the EU SoHO Platform is fully operational at the latest 2 years after the entry into force of this Regulation, and develop an implementation plan for the Platform.
Amendment 849 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 a (new)
Article 73 – paragraph 1 a (new)
1 a. Information collected through the EU SoHO Platform on SoHO shortage alerts, SoHO shortages and demand trends, cross-border SoHO requests and resolutions, or import and export of SoHO to third countries outside the EU will be used for the monitoring, prevention and management of SoHO shortages in the EU, as well as to enhance the EU SoHO autonomy, as part of the plan defined in Article 62 (a).
Amendment 851 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The EU SoHO platform shall also provide a secure environment for the exchange of information between competent authorities and, the Commission and the EMA, the ECDC, the SCB and EDQM, in particular in relation to SAO and rapid alerts. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 852 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 a (new)
Article 74 – paragraph 2 a (new)
2 a. The EU SoHO Platform shall also be the main intermediary for reporting SoHO shortages and for cross-border requests of SoHO. National authorities shall issue and receive shortage alerts that cannot be resolved at Member State level, as well as SoHO cross-border requests and shall be able to respond to them. National authorities, aware of the national availability of SoHO, as referred to in Article 34(a), shall use the EU SoHO Platform to report any SoHO shortages that may lead to a public health emergency or severe ocurrence.
Amendment 853 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 b (new)
Article 74 – paragraph 2 b (new)
2 b. In the event of a SoHO-related health emergency or for the purpose of preventing potential threats, alerts issued through the EU SoHO Platform shall allow for rapid situational awareness by the Commission, competent authorities and other relevant bodies so that action can be taken as soon as possible as set out in Regulation (EU) 2022/2371 on serious cross-border threats to health.
Amendment 854 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 c (new)
Article 74 – paragraph 2 c (new)
2 c. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 855 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 d (new)
Article 74 – paragraph 2 d (new)
2 d. The EU SoHO Platform shall contain a record of clinical studies with SoHO and their results, as referred to in Article 36 (a).
Amendment 340 #
2022/0196(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Two European citizens’ initiatives address the use of pesticides and call for ambitious medium- and long-term reduction targets. The initiative ‘Ban glyphosate and protect people and the environment from toxic pesticides’ submitted to the Commission on 6 October 2017 called on the Commission, under its third aim, ‘to set EU-wide mandatory reduction targets for pesticide use, with a view to achieving a pesticide-free future’. In its reply adopted on 12 December 2017, the Commission stated that it would re- evaluate the need for EU-wide mandatory targets for pesticides. More recently, the initiative ‘Save bees and farmers! Towards a bee-friendly agriculture for a healthy environment’ calls on the Commission ‘to propose legal acts to phase out synthetic pesticides in EU agriculture by 80% by 2030, starting with the most hazardous, and to become free of synthetic by 2035.’ The initiative has collected over 1 million statements of support by 30 September 2021 which are currently being verified by Member States authorities.
Amendment 347 #
2022/0196(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In the final report of the Conference on the Future of Europe, published on 9 May 2022, when it comes to the proposals on agriculture, food production, biodiversity and ecosystems, pollution, citizens ask the Union in particular to significantly reduce the use of chemical pesticides and fertilizers, in line with the existing targets, while still ensuring food security, and support for research to develop as swiftly as possible more sustainable and natural- based alternatives. Citizens ask for more research and innovations, including in technological solutions for sustainable production, plant resistance, and precision farming, and more communication, advisory systems, and training for and from farmers as well as asking the Union to protect insects, in particular indigenous and pollinating insects.55 __________________ 55 Conference on the Future of Europe – Report on the Final Outcome, May 2022, Proposals 1 and 2, pp. 43-44.
Amendment 415 #
2022/0196(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Member States should draft and publish national medium- and long-term action plans. In order for the Member State national action plans to be effective, they should contain quantitative objectives, references to binding national 2030 reduction targets as set out in national law, together with related indicative targets set out in the national action plans, joint measures, timetables and indicators to reduce risks and impacts of pesticide use on human health and the environment. This will allow for a structured approach to the setting of quantitative objectives and targets, with a clear link to the national 2030 reduction targets. In order to monitor compliance with the provisions of this Regulation, Member States should also be required to report annually on targets and precise quantitative data relating to compliance with provisions on use, training, application equipment and integrated pest management.
Amendment 454 #
2022/0196(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Economic instruments, including those under the CAP that provide support to farmers, can play a crucial role in the achievement of objectives relating to the sustainable use of plant protection products and, in particular, reducing the use of chemical plant protection products. Member States have to show in their national CAP Strategic Plans, by means of rigorous monitoring and regular reporting, that their implementation of the CAP contributes to and supports other relevant Union legislation and their objectives, including objectives under this Regulation.
Amendment 471 #
2022/0196(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) An approach to pest control that follows integrated pest management in ensuring careful consideration of all available means that discourage the development of populations of harmful organisms, while keeping the use of chemical plant protection products to levels that are economically and ecologically justified and minimising risks to human health and the environment is necessary for the protection of human health and the environment, and to help stem the process of the disappearance of species of insects and other creatures in farming areas. ‘Integrated pest management’ emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems, encourages natural pest control mechanisms and uses chemical control only when all other control means are exhausted. To ensure that integrated pest management is implemented consistently on the ground, it is necessary to lay down clear rules in this Regulation. In order to comply with the obligation to follow integrated pest management, a professional user should consider and implement all methods and practices that avoid the use of plant protection products. Chemical plant protection products should only be used when all other control means have been exhausted. In order to ensure and monitor compliance with this requirement, it is important that professional users keep a record of the reasons why they apply plant protection products or the reasons for any other action taken in line with integrated pest management and of advice received in support of their implementation of integrated pest management from independent advisors. These records are also required for aerial applications.
Amendment 480 #
2022/0196(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) To avoid unnecessary duplication, the Commission should establish a standard template for Member States to integrate records kept by professional users of actions taken in line with integrated pest management with those kept under Article 67 of Regulation (EC) No 1107/2009, along with statistics on the plant protection products placed and sold on the market, to avoid the use of unsuitable products.
Amendment 494 #
2022/0196(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to verify compliance by professional users with integrated pest management, an electronic integrated pest management and plant protection product use register should be maintained, especially for products imported from countries outside the EU, which are liable not to conform to EU standards on chemical pest management substances, with the aim of verifying compliance with the rules on integrated pest management set out in this Regulation and supporting the development of Union policy. Access to the register should also be granted to national statistical authorities for the development, production and dissemination of official statistics in accordance with Chapter V of Regulation (EC) No 223/2009 of the European Parliament and of the Council66. This register should record any preventative measure or intervention and the reasons for that preventative measure or intervention. This will provide the competent authorities with the information necessary to verify whether a professional user has carried out a decision-making process, in accordance with integrated pest management, before determining the specific preventative measure or intervention. The register should also contain details in relation to advice required annually in support of integrated pest management in order to verify that such strategic longer term planning in relation to integrated pest management is taking place. __________________ 66 Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).
Amendment 498 #
2022/0196(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) In order to ensure that plant protection products and related application equipment are used in a manner that protects human health and the environment, it is necessary to provide for general requirements on professional users in relation to the regular training required to use certain plant protection products, in close connection with the appearance of new plant protection products or application equipment, the use of more hazardous plant protection products and the need to comply with inspection requirements for application equipment in professional use.
Amendment 513 #
2022/0196(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Use of plant protection products may have particularly negative impacts in certain areas that are frequently used by the general public or by vulnerable groups, communities in which people live and work and ecologically sensitive areas, such as Natura 2000 sites protected in accordance with Directive 2009/147/EC of the European Parliament and of the Council67 and Council Directive 92/43/EEC68. If plant protection products are used in areas used by the general public, it is necessary to inform the public on the possibility of exposure of humans to such plant protection products is high. In order to protect human health and the environment, the use of plant protection products in sensitive areas and within 3 metres of such areas, should therefore be prohibited. Derogations from the prohibition should only be allowed under certain conditions and on a case-by-case basis. __________________ 67 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). 68 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
Amendment 523 #
2022/0196(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) The aquatic environment and drinking water supplies are especially sensitive to plant protection products, which have long-term harmful effects. In order to protect the aquatic environment, the use of plant protection products in and around surface waters areas should therefore be prohibited. Member States should have in place appropriate measures to avoid deterioration of surface and groundwater as well as coastal and marine waters and allow achievement of good surface and groundwater status, to protect the aquatic environment and drinking water supplies from the impact of plant protection products. In addition, it is important that professional users are trained in how to minimise or eliminate applications of certain plant protection products classified as “harmful to aquatic life with long lasting effects”, “very toxic to aquatic life with long lasting effects” or “toxic to aquatic life with long lasting effects”. It is also important that professional users are trained on the importance of giving preference to low risk plant protection products or non-chemical alternatives, use of drift reducing technology and risk mitigation measures.
Amendment 530 #
2022/0196(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Precision farming refers to agricultural management systems carefully tailoring crop management to fit localised conditions such as those found within land parcels. The application of existing technology, including the use of Union space data and services (Galileo and Copernicus), has the potential to significantly reduce pesticide usage. It is therefore necessary to provide for a legislative framework that incentivises the development of precision farming and to grant the appropriate financial support for the purchasing of the requisite IT equipment. Application of plant protection products from an aircraft, including application by planes, helicopters and drones, is usually less precise than other means of application and may therefore potentially cause adverse impacts on human health and the environment. Aerial application should therefore be prohibited, with limited derogations on a case-by-case basis where it has a less negative impact on human health and the environment than any alternative application method or there is no viable alternative application method. It is also necessary to record the numbers of aerial applications carried out on the basis of permits granted for aerial application in order to have clear data on how many aerial applications for which permits were granted actually took place.
Amendment 539 #
2022/0196(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) Handling of plant protection products, including storage, dilution and mixing of such products, cleaning of application equipment after use, recovery and disposal of tank mixtures and disposal of empty packaging and remnants of plant protection products pose particular risks of exposure to humans and to the environment. Therefore it is appropriate to provide for specific measures addressing these activities. T, and especially the collection, destruction and recycling, where this is possible, of the remains of products and their packaging, to the extent that the use, storage and disposal of plant protection products require compliance with minimum health and safety requirements at the workplace, those requirements are laid down by, inter alia, Council Directive 89/391/EEC69, Council Directive 89/656/EEC70, Council Directive 98/24/EC71, Directive 2004/37/EC of the European Parliament and of the Council72 and Directive 2009/104/EC of the European Parliament and of the Council73. __________________ 69 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1). 70 Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (third individual directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (OJ L 393, 30.12.1989, p. 18). 71 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11). 72 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50). 73 Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 260, 3.10.2009, p. 5).
Amendment 541 #
2022/0196(COD)
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29a) Article 29a – The Member States and the Commission shall support cooperation between the academic world and users of pest treatments of all kinds with a view to the development of new less-polluting plant protection products and methods and the handing-on of best practices to other potential beneficiaries of such treatments less damaging to the environment and to humans.
Amendment 543 #
2022/0196(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) Given the importance of advice on the use of plant protection products as a means to support their use in a manner that protects human health and the environment in accordance with integrated pest management, it is important that advisors are adequately trained in the medium and long term, while also taking technological developments into account.
Amendment 549 #
2022/0196(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) Sale of a plant protection product is an important element in the distribution chain because it allows distributors to provide the necessary information to support its proper use, especially in the case of new products and products from outside the EU. Specific advice on safety instructions for human health and the environment should be available to the purchaser or end user at the time of sale in order to allow questions to be answered that will facilitate the correct use of the relevant plant protection product. For non- professional users, general information should be available at point of sale on safe use, handling and storage of plant protection products, especially in the case of new products and products from outside the EU, and on disposal of the packaging of such products, since those users do not generally have the same practical knowledge as professional users.
Amendment 552 #
2022/0196(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) It is essential that Member States establish and maintain systems of both initial and regular follow-up training, in coordination with the appearance of new products or products from outside the EU, for distributors, advisors and professional users of plant protection products and certification systems to record such training, in order to ensure that those operators are fully aware of the potential risks to human health and the environment and of the appropriate measures to reduce those risks as much as possible. The training for advisors should be more extensive than that of distributors and professional users since they need to be able to support the proper implementation of integrated pest management and crop- specific rules. The use or purchase of a plant protection product authorised for professional use must be limited to persons in possession of a training certificate. In addition, in order to ensure safe use of plant protection products for human health and the environment, distributors should be required to provide both professional and non-professional purchasers of plant protection products with product specific information at point of sale.
Amendment 564 #
2022/0196(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) Considering the possible risks to human health and the environment from the use of plant protection products, the public should have access to better information on the overall impacts of the use of such products through awareness- raising programmes for a range of target groups, information passed on through distributors and other appropriate measures.
Amendment 566 #
2022/0196(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) In order to better understand the trends regarding acute poisoning incidents and chronic poisoning, and regarding the ways to treat cases of poisoning, arising from exposure of persons to plant protection products, information on such trends should be compiled by each Member State. The Commission should also monitor the overall trends at Union level.
Amendment 617 #
2022/0196(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The EU Biodiversity Strategy for 2030 recognises the need for urgent action to protect biodiversity. There is evidence of a widespread reduction of species, in particular insects and pollinators, in the Union. Biodiversity loss is, amongst other factors, driven by the use of plant protection products, especially when it comes to the marketing of new products whose effects are not well known, or of products originating from outside the EU and which may not conform to the relevant EU standards, while Member States actions under current Union policy instruments have not yet been able to stop this trend of biodiversity loss. It is therefore essential to ensure that plant protection products are used in such a way as to mitigate the risk of harmful effects of such products on wildlife, through a number of measures including training, inspection of application equipment in professional use and protection of the aquatic environment and sensitive areas.
Amendment 642 #
2022/0196(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level the Commission should carry out an regular evaluation of this Regulation.
Amendment 2146 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 3 – introductory part
Article 18 – paragraph 3 – introductory part
3. By way of derogation from paragraph 1, a competent authority designated by a Member State may permit a professional user to use a plant protection product in a sensitive area for a limited period with a precisely defined start and end date that is the shortest possible but does not exceed 60 days, and which are strictly monitored and recorded, provided that all of the following conditions are met:
Amendment 2179 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 6 a (new)
Article 18 – paragraph 6 a (new)
6a. entry in the pest control product register
Amendment 2297 #
2022/0196(COD)
Proposal for a regulation
Article 22 – paragraph 2 – point d
Article 22 – paragraph 2 – point d
(d) disposal of obsolete plant protection products and remnants and their packaging and identification of potential measures for their recycling.
Amendment 2371 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
1a. regular training closely correlated to the emergence of new plant protection products on the market, and especially the marketing of products originating outside the EU and liable not to comply with the relevant EU requirements.
Amendment 2453 #
2022/0196(COD)
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
4a. emergence and marketing of new pest control products.
Amendment 2465 #
2022/0196(COD)
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. The competent authority referred to in paragraph 1 shall establish a website or websites dedicated to providing regular information on risks associated with the use of plant protection products. That information may be provided directly or by providing links to relevant websites of other national or international bodies.
Amendment 220 #
2022/0195(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In its resolution of 9 June 202149 , the European Parliament strongly welcomed the commitment to draw up a legislative proposal with binding short-, medium- and long-term nature restoration targets, and furthermore considered that in addition to an overall restoration target, ecosystem-, habitat- and species-specific restoration targets should be included, covering forests, grasslands, wetlands, peatlands, pollinators, free- flowing rivers, coastal areas and marine ecosystems and taking account of the regional and local characteristics of all of these habitats and ecosystems. _________________ 49 European Parliament resolution of 9 June 2021 on the EU Biodiversity Strategy for 2030: Bringing nature back into our lives (2020/2273(INI)).
Amendment 226 #
2022/0195(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The EU Biodiversity Strategy for 2030 sets out a commitment to legally protect a minimum of 30 % of the land, including inland waters, and 30 % of the sea in the Union, of which at least one third should be under strict protection, including all remainexisting primary and old-growth forests. The criteria and guidance for the designation of additional protected areas by Member States51 (the ‘Criteria and guidance’), developed by the Commission in cooperation with Member States and stakeholders, highlight that if the restored areas comply or are expected to comply, once restoration produces its full effect, with the criteria for protected areas, those restored areas should also contribute towards the Union targets on protected areas and become a model for the restoration of other similar areas. The Criteria and guidance also highlight that protected areas can provide an important contribution to the restoration targets in the EU Biodiversity Strategy for 2030, by creating the conditions for restoration efforts to be successful. This is particularly the case for areas which can recover naturally by stopping or limiting some of the pressures from human activities. Placing such areas, including in the marine environment, under strict protection, including cross-border cooperation where appropriate, will, in some cases, be sufficient to lead to the recovery of the natural values they host. Moreover, it is emphasised in the Criteria and guidance that all Member States are expected to contribute towards reaching the Union targets on protected areas set out in the EU Biodiversity Strategy for 2030, to an extent that is proportionate to the natural values they host and to the potential they have for nature restoration. _________________ 51 Commission Staff Working Document Criteria and guidance for protected areas designations (SWD(2022) 23 final).
Amendment 232 #
2022/0195(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The EU Biodiversity Strategy for 2030 sets out a target to ensure that there is no deterioration or reduction in conservation trends or in the status of protected habitats and species and that at least 30 % of species and habitats not currently in favourable status will fall into that category or show a strong positive trend towards falling into that category by 2030. The guidance52 developed by the Commission in cooperation with Member States and stakeholders to support the achievement of these targets highlights that maintenance and restoration efforts are likely to be required for most of those habitats and species, either by halting their current negative trends by 2030 or by maintaining current stable or improving trends, or by preventing the decline of habitats and species with a favourable conservation status. The guidance further emphasises that those restoration efforts primarily need to be planned, implemented and coordinated at national or, regional levelsand cross-border levels, where appropriate, and that, in selecting and prioritising the species and habitats to be improved by 2030, synergies with other Union and international targets, in particular environmental or climate policy targets, are to be sought. _________________ 52 Available at Circabc (europa.eu) [Reference to be completed]
Amendment 234 #
2022/0195(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Commission’s State of Nature Report from 202053 noted that the Union has not yet managed to stem the decline of protected habitat types and species whose conservation is of concern to the Union. That decline is caused mostly by abandonment of extensive agriculture, intensifying management practices, the modification of hydrological regimes, urbanisation and pollution as well as unsustainable forestry activities and species exploitation. Furthermore, invasive alien species, which sometimes become very aggressive in order to survive, and climate change represent major and growing threats to native Union flora and fauna. _________________ 53 Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee “The state of nature in the European Union Report on the status and trends in 2013 - 2018 of species and habitat types protected by the Birds and Habitats Directives”, COM/2020/635 final.
Amendment 244 #
2022/0195(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) It is appropriate to set an common Europe-wide overarching objective for ecosystem restoration to foster economic and societal transformation, the creation of high-quality jobs and sustainable growth. Biodiverse ecosystems such as wetland, freshwater, forest as well as agricultural, sparsely vegetated, marine, coastal and urban ecosystems deliver, if in good condition, a range of essential ecosystem services, and the benefits of restoring degraded ecosystems to good condition in all land and sea areas far outweigh the costs of restoration. Those services contribute to a broad range of socio- economic benefits, depending on the economic, social, cultural, regional and local characteristics.
Amendment 255 #
2022/0195(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) SThe securing and long-term maintenance of biodiverse ecosystems and tackling climate change are intrinsically linked. Nature and nature-based solutions, including natural carbon stocks and sinks, are fundamental for fighting the climate crisis. At the same time, the climate crisis is already a driver of terrestrial and marine ecosystem change, and the Union must prepare for the increasing intensity, frequency and pervasiveness of its effects. The Special Report of the Intergovernmental Panel on Climate Change (IPCC)55 on the impacts of global warming of 1.5°C pointed out that some impacts may be long-lasting or irreversible. The Sixth IPCC Assessment Report56 states that restoring ecosystems will be fundamental in helping to combat climate change and also in reducing risks to food security. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) in its 2019 Global Assessment Report on Biodiversity and Ecosystem Services57 considered climate change a key driver of change in nature, and it expected its impacts to increase over the coming decades, in some cases surpassing the impact of other drivers of ecosystem change such as changed land and sea use. _________________ 55 Intergovernmental Panel on Climate Change (IPCC): Special Report on the impacts of global warming of 1.5°C and related global greenhouse gas emission pathways, in the context of strengthening the global response to the threat of climate change, sustainable development, and efforts to eradicate poverty [Masson- Delmotte, V., P. Zhai, H.-O. Pörtner, D. Roberts, J. Skea, P.R. Shukla, A. Pirani, W. Moufouma-Okia, C. Péan, R. Pidcock, S. Connors, J.B.R. Matthews, Y. Chen, X. Zhou, M.I. Gomis, E. Lonnoy, T. Maycock, M. Tignor, and T. Waterfield (eds.)] https://www.ipcc.ch/sr15/ 56 Climate Change 2022: Impacts, Adaptation and Vulnerability | Climate Change 2022: Impacts, Adaptation and Vulnerability (ipcc.ch). 57 IPBES (2019): Global assessment report on biodiversity and ecosystem services of the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services. E. S. Brondizio, J. Settele, S. Díaz, and H. T. Ngo (editors). IPBES secretariat, Bonn, Germany. 1148 pages. https://doi.org/10.5281/zenodo.3831673.
Amendment 258 #
2022/0195(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Regulation (EU) 2021/1119 of the European Parliament and of the Council58 sets out a binding objective of climate neutrality in the Union by 2050 and negative emissions thereafter, and to prioritise swift and predictable emission reductions and, at the same time, enhance removals by natural sinks. The restoration and long-term maintenance of all components of ecosystems can make an important contribution to maintaining, managing and enhancing natural sinks and to increasing biodiversity while fighting climate change. Regulation (EU) 2021/1119 also requires relevant Union institutions and the Member States to ensure continuous progress in enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate change. It also requires that Member States integrate adaptation in all policy areas and promote nature-based solutions59 and ecosystem-based adaptation. _________________ 58 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). 59 Nature-based solutions are solutions that are inspired and supported by nature, that are cost-effective, and that simultaneously provide environmental, social and economic benefits and help build resilience. Such solutions bring more, and more diverse, nature and natural features and processes into cities, landscapes and seascapes, through locally adapted, resource-efficient and systemic interventions. Nature-based solutions must therefore benefit biodiversity and support the delivery of a range of ecosystem services.
Amendment 286 #
2022/0195(COD)
Proposal for a regulation
Recital 24
Recital 24
Amendment 299 #
2022/0195(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Deadlines should therefore be established for putting in place restoration measures within and beyond Natura 2000 sites, in order to gradually improve the condition of protected habitat types across the Union as well as to re-establish them until the favourable reference area needed to achieve favourable conservation status of those habitat types in the Union in the medium and long term is reached. In order to give the necessary flexibility to Member States to put in place large scale restoration efforts, it is appropriate to group habitat types according to the ecosystem to which they belong and set the time-bound and quantified area-based targets for groups of habitat types. This will allow Member States to prioritise and choose which habitats to restore first within the group.
Amendment 311 #
2022/0195(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure that the restoration measures are efficient and that their results can be measured over time, it is essential that the areas that are subject to such restoration measures, with a view to improving the condition of habitats that fall within the scope of Annex I to Directive 92/43/EEC, to re-establish those habitats and to improve their connectivity, show a continuous improvement until good condition is reached within the prescribed period and as per the targets set.
Amendment 315 #
2022/0195(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) It is also essential that the areas that are subject to restoration measures with a view to improving the quality and quantity of the habitats of species that fall within the scope of Directive 92/43/EEC, as well as habitats of wild birds falling within the scope of Directive 2009/147/EC, show a continuous improvement to contribute to the achievement of a sufficient quantity and quality of the habitats of such species within the prescribed period and as per the targets set.
Amendment 334 #
2022/0195(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The EU Biodiversity Strategy for 2030 emphasises the need for stronger action to restore degraded marine ecosystems, including carbon-rich ecosystems and important fish spawning and nursery areas. The Strategy also announces that the Commission is to propose a new action plan to conserve fisheries resources and protect marine ecosystems over the medium and long term and as per the targets set.
Amendment 360 #
2022/0195(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Actions to ensure that urban green spaces will no longer be at risk of being degraded need to be strongly enhanced. In order to ensure that urban green spaces continue to provide the necessary ecosystem services, their loss should be stopped as soon as possible and they should be restored and increased, inter alia by better integrating green infrastructure and nature-based solutions into urban planning at both public and private level, and by integrating green infrastructure, such as green roofs and green walls, in the design of buildings.
Amendment 400 #
2022/0195(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) Restoration measures need to be put in place to enhance the biodiversity of agricultural ecosystems across the Union, including in the areas not covered by habitat types that fall within the scope of Directive 92/43/EEC. In the absence of a common method for periodically assessing the condition of agricultural ecosystems that would allow setting common European-level and specific restoration targets for agricultural ecosystems, it is appropriate to set a general obligation to improve biodiversity in agricultural ecosystems in the medium and long term and measure the fulfilment of that obligation on the basis of existing indicators.
Amendment 406 #
2022/0195(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) Since farmland birds are well- known and widely recognised key indicators of the health of agricultural ecosystems, it is appropriate to set targets for their recoveryperiodic monitoring and recovery of their populations. The obligation to achieve such targets would apply to Member States, not to individual farmers. Member States should achieve those targets by putting in place effective restoration measures on farmland, working with and supporting farmers and other stakeholders for their design and implementation on the ground.
Amendment 412 #
2022/0195(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) High-diversity landscape features on agricultural land, including buffer strips, rotational or non-rotational fallow land, hedgerows, individual or groups of trees, tree rows, field margins, patches, ditches, streams, small wetlands, terraces, cairns, stonewalls, small ponds and cultural features, provide space for wild plants and animals, including pollinators, prevent soil erosion and depletion, filter air and water, support climate change mitigation and adaptation and agricultural productivity of pollination-dependent crops. Productive trees that are part of arable land agroforestry systems and productive elements in non-productive hedges can also be considerd as high biodiversity landscape features provided that they do not receive fertilizers or pesticide treatment and if harvest takes place only at moments where it would not compromise high biodiversity levels. Therefore, a requirement to ensure an increasing trend for the share of agricultural land with high-diversity landscape features, by planting varieties resistant to new climate conditions in the relevant areas or acclimatising varieties originating from warm areas which, once planted, can give the desired yields, should be set out. Such a requirement would enable the Union to achieve one of the other key commitments of the EU Biodiversity Strategy for 2030, namely, to cover at least 10 % of agricultural area with high-diversity landscape features. Increasing trends should also be achieved for other existing indicators, such as the grassland butterfly index and the stock of organic carbon in cropland mineral soils.
Amendment 430 #
2022/0195(COD)
Proposal for a regulation
Recital 56
Recital 56
(56) The new EU Forest Strategy for 203081 outlined the need to restore forest biodiversity. Forests and other wooded land cover over 43,5 % of the EU’s land space. Forest ecosystems that host rich biodiversity are vulnerable to climate change but are also a natural ally in adapting to and fighting climate change and climate-related risks, including through their carbon-stock and carbon-sink functions, and provide many other vital ecosystem services and benefits, such as the provision of timber and wood, food and other non-wood products, climate regulation, soil stabilisation and erosion control and the purification of air and water. For effective erosion control, it is necessary to identify varieties that can adapt quickly to new climatic conditions, are relatively fast-growing and can be grown on smaller or larger areas, as necessary. _________________ 81 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. New EU Forest Strategy for 2030 (COM/2021/572 final).
Amendment 443 #
2022/0195(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) Restoration measures need to be put in place in the medium and long term to enhance the biodiversity of forest ecosystems across the Union, including in the areas not covered by habitat types falling within the scope of Directive 92/43/EEC. In the absence of a common method for assessing the condition of forest ecosystems that would allow for the setting of specific restoration targets for forest ecosystems in the medium and long term, it is appropriate to set a general obligation to improve biodiversity in forest ecosystems and measure the fulfilment of that obligation on the basis of existing indicators, such as standing and lying deadwood, the share of forests with uneven-aged structure, forest connectivity, the common forest bird index82, and the stock of organic carbon. _________________ 82 Common bird index (EU aggregate) - Products Datasets - Eurostat (europa.eu).
Amendment 449 #
2022/0195(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) Restoration targets and obligations for habitats and species protected under Directives 92/43/EEC and 2009/147/EC, for pollinators and for freshwater, urban, agricultural and forest ecosystems should be complementary and be analysed periodically so that they can work in synergy, with a view to achieving the overarching objective of restoring ecosystems across the Union’s land and sea areas. The restoration measures required to achieve one specific target will in many cases contribute to the achievement of other targets or obligations. Member States should therefore plan restoration measures strategically with a view to maximising their effectiveness in contributing to the recovery of nature across the Union in the medium and long term. Restoration measures should also be planned in such manner that they address climate change mitigation and climate change adaptation and the prevention and control of the impact of natural disasters. They should aim at optimising the ecological, economic and social functions of ecosystems, including their productivity potential, taking into account their contribution to the sustainable development of the relevant regions and communities. It is important that Member States prepare detailed national restoration plans based on the best available scientific evidence, and that the public is given early and effective opportunities to participate in the preparation of the plans. Member States should take account of the specific conditions, features and needs in their territory, in order for the plans to respond to the relevant pressures, threats and drivers of biodiversity loss, and should cooperate to ensure restoration and connectivity across borders.
Amendment 464 #
2022/0195(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) Considering the importance of addressing consistently the dual challenges of biodiversity loss and climate change, the restoration of biodiversity should take into account the deployment of renewable energy and vice versa. The Communication on REPowerEU: Joint European Action for more affordable, secure and sustainable energy87 states that Member States should swiftly map, assess and ensure suitable land and sea areas that are available for renewable energy projects, commensurate with their national energy and climate plans, the contributions towards the revised 2030 renewable energy target and other factors such as the availability of resources, grid infrastructure and the targets of the EU Biodiversity Strategy. The Commission proposal for a Directive of the European Parliament and of the Council amending Directive (EU) 2018/2001 on the promotion of the use of energy from renewable sources, Directive 2010/31/EU on the energy performance of buildings and Directive 2012/27/EU on energy efficiency88 and the Commission recommendation on accelerating permitting for renewable energy projects and facilitating Power Purchase Agreements89, both adopted on 18 May 2022, also provide for the identification of renewables go-to areas. Those are specific locations, whether on land or sea, particularly suitable for the installation of plants for the production of energy from renewable sources, other than biomass combustion plants, where the deployment of a specific type of renewable energy is not expected to have significant environmental impacts, in view of the particularities of the selected territory. Member States should give priority to artificial and built surfaces, such as rooftops, transport infrastructure areas, parking areas, waste sites, industrial sites, mines, artificial inland water bodies, lakes or reservoirs, and, where appropriate, urban waste water treatment sites, as well as degraded land not usable for agriculture. In the designation of renewables go-to areas, Member States shouldmust avoid protected areas and consider their national nature restoration plans. Member States should coordinate the development of national restoration plans with the designation of the renewables go-to areas in close liaison with local and regional authorities and also private individuals who can participate in such projects and make the necessary land available on the agreed basis. During the preparation of the nature restoration plans, Member States should ensure synergies with the already designated renewables go-to areas and ensure that the functioning of the renewables go-to areas, including the permitting procedures applicable in the renewables go-to areas foreseen by Directive (EU) 2018/2001, remain unchanged. _________________ 87 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions REPowerEU: Joint European Action for more affordable, secure and sustainable energy (COM/2022/108 final). 88 Proposal for a Directive of the European Parliament and of the Council amending Directive (EU) 2018/2001 on the promotion of the use of energy from renewable sources, Directive 2010/31/EU on the energy performance of buildings and Directive 2012/27/EU on energy efficiency, COM/2022/222 final. 89 Commission recommendation on speeding up permit-granting procedures for renewable energy projects and facilitating Power Purchase Agreements, C(2022) 3219 final.
Amendment 481 #
2022/0195(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) The European Environment Agency (the ‘EEA’) should support Member States in preparing the national restoration plans, as well as in periodically monitoring progress towards meeting the restoration targets and obligations. The Commission should assess whether the national restoration plans are adequate for achieving those targets and obligations.
Amendment 486 #
2022/0195(COD)
Proposal for a regulation
Recital 67
Recital 67
(67) In order to monitor the progress in implementing the national restoration plans, the restoration measures put in place, the areas subject to restoration measures, and the data on the inventory of barriers to river continuity, a system should be introduced requiringcommon system of indicators should be introduced at European level to enable Member States to set up, keep up-to-date and make accessible relevant data on results from such monitoring. The electronic reporting of data to the Commission should make use of EEA’s Reportnet system and should aim to keep the administrative burden on all entities as limited as possible. To ensure an appropriate infrastructure for public access, reporting and data-sharing between public authorities, Member States should, where relevant, base the data specifications on those referred to in Directive 2003/4/EC of the European Parliament and of the Council92, Directive 2007/2/EC of the European Parliament and of the Council93 and Directive (EU) 2019/1024 of the European Parliament and of the Council94. _________________ 92 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). 93 Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1). 94 Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).
Amendment 500 #
2022/0195(COD)
Proposal for a regulation
Recital 70
Recital 70
(70) To ensure the achievement of the targets and obligations set out in this Regulation, it is of utmost importance that adequate private and public investments are made in restoration, Member States should integrate expenditure forincluding through public-private partnerships, and Member States should integrate multiannual expenditure necessary to fulfil biodiversity objectives, including in relation to opportunity and transition costs resulting from the implementation of the national restoration plans, in their national budgets and reflect how Union funding is used. Regarding the Union funding, expenditure under the Union budget and Union financing programmes, such as the Programme for the Environment and Climate Action (LIFE)96, the European Maritime Fisheries and Aquaculture Fund (EMFAF)97, the European Agricultural Fund for Rural Development (EAFRD)98, the European Agricultural Guarantee Fund (EAGF), the European Regional Development Fund (ERDF), the Cohesion Fund99 and the Just Transition Fund100, as well as the Union framework programme for research and innovation, Horizon Europe101, contributes to biodiversity objectives with the ambition to dedicate 7,5 % in 2024, and 10 % in 2026 and in 2027 of annual spending under the 2021-2027 Multiannual Financial Framework102 to biodiversity objectives. The Recovery and Resilience Facility (RRF)103 is a further source of funding for the protection and restoration of biodiversity and ecosystems. With reference to the LIFE Programme, special attention should be given to the appropriate use of the Strategic Nature Projects (SNaPs) as a specific tool that could support the implementation of this Regulation, by way of mainstreaming available financial resources in an effective and efficient way. _________________ 100 Regulation (EU) 2021/1056 of the European Parliament and of the Council of 24 June 2021 establishing the Just Transition Fund (OJ L 231 30.06.2021, p. 1). 101 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013(OJ L 170, 12.5.2021, p. 1). 102 Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027 (OJ L 433I, 22.12.2020, p. 11). 103 Regulation (EU) 2021/241 of the European Parliament and of the Council of 12 February 2021 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17). 96 Regulation (EU) 2021/783 of the European Parliament and of the Council of 29 April 2021 establishing a Programme for the Environment and Climate Action (LIFE), and repealing Regulation (EU) No 1293/2013 (OJ L 172, 17.5.2021, p. 53). 97 Regulation (EU) 2021/1139 of the European Parliament and of the Council of 7 July 2021 establishing the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/1004 (OJ L 247, 13.7.2021, p. 1). 98 Regulation (EU) 2020/2220 of the European Parliament and of the Council of 23 December 2020 laying down certain transitional provisions for support from the European Agricultural Fund for Rural Development (EAFRD) and from the European Agricultural Guarantee Fund (EAGF) in the years 2021 and 2022 and amending Regulations (EU) No 1305/2013, (EU) No 1306/2013 and (EU) No 1307/2013 as regards resources and application in the years 2021 and 2022 and Regulation (EU) No 1308/2013 as regards resources and the distribution of such support in respect of the years 2021 and 2022 (OJ L 437, 28.12.2020, p. 1). 99 Regulation (EU) 2021/1058 of the European Parliament and of the Council of 24 June 2021 on the European Regional Development Fund and on the Cohesion Fund (OJ L 231, 30.6.2021, p. 60).
Amendment 509 #
2022/0195(COD)
Proposal for a regulation
Recital 72
Recital 72
(72) Member States should promote a fair and cross-society approach in the preparation and implementation of their national restoration plans, by including processes for participation of the public and by considering the needs of local communities and stakeholders, and also local and regional circumstances.
Amendment 529 #
2022/0195(COD)
Proposal for a regulation
Recital 77
Recital 77
(77) The Commission should carry out an evaluation of this Regulation periodically. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making, that evaluation should be based on the criteria of efficiency, effectiveness, relevance, coherence and EU value added and should provide the basis for impact assessments of possible further measures. In addition, the Commission should assess the need to establish additional restoration targets, based on common methods for assessing the condition of ecosystems not covered by Articles 4 and 5, taking into account the most recent scientific evidence.
Amendment 1591 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall prepare medium-term and long-term national restoration plans and, carry out periodic monitoring and conduct the preparatory monitoring and research needed to identify the restoration measures that are necessary to meet the targets and obligations set out in Articles 4 to 10, taking into account the latest scientific evidence.
Amendment 1690 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 6
Article 11 – paragraph 6
6. Member States shall coordinate the development of national restoration plans with the designation of the renewables go- to areas in collaboration with local and regional authorities and private individuals who own land suitable for such projects. During the preparation of the nature restoration plans, Member States shall ensure synergies with the already designated renewables go-to areas and ensure that the functioning of the renewables go-to areas, including the permitting procedures applicable in the renewables go-to areas foreseen by Directive (EU) 2018/2001 remain unchanged.
Amendment 1818 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point f
Article 12 – paragraph 2 – point f
(f) the timing for putting in place the restoration measures in accordance with Articles 4 to 10; including periodic monitoring of the measures and outcomes achieved,
Amendment 1952 #
2022/0195(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Member States shall review their national restoration plan at least once every 10 years, in accordance with Articles 11 and 12, taking into account periodic monitoring and progress made in the implementation of the plans, the best available scientific evidence as well as available knowledge of changes or expected changes in environmental conditions due to climate change.
Amendment 159 #
2022/0140(COD)
Draft legislative resolution
Citation 2
Citation 2
— having regard to Article 294(2) and Articles 16, 114 and 11468 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9- 0167/2022),
Amendment 168 #
2022/0140(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16, 114 and 11468 thereof,
Amendment 171 #
2022/0140(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improvegrant access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for the improvement for other purposes that would benefit the society such as research, innovation, policy- making, health threats preparedness and control, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal and technical framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.
Amendment 173 #
2022/0140(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes that would benefit the society such as research, innovation, policy- making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’), as well as the clarification of access to those data, in conformity with Union values.
Amendment 176 #
2022/0140(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) The EHDS constitutes a key component for the creation of a strong and resilient European Health Union to better protect the health of European citizens, prevent and address future pandemics and improve resilience of Europe’s health systems.
Amendment 177 #
2022/0140(COD)
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1 b) This Regulation should work horizontally with other European programs such as the Digital Europe Programme, Connecting Europe Facility and Horizon Europe. The European Commission should ensure that other European programs complement and facilitate the implementation of the European Health Data Space.
Amendment 179 #
2022/0140(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The COVID-19 pandemic has highlighted the imperative of having timely access to quality electronic health data for health threats preparedness and response, as well as for prevention, diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, to reduced costs and an improved response to health threats and ultimately would have helped to save more lives. In 2020, the Commission urgently adapted its Clinical Patient Management System, established by Commission Implementing Decision (EU) 2019/126941, to allow Member States to share electronic health data of COVID-19 patients moving between healthcare providers and Member States during the peak of the pandemic, but this was only an emergency solution, showing the need for a structural and systemicapproach at Member States and Union level. _________________ 41 Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 200, 29.7.2019, p. 35).
Amendment 180 #
2022/0140(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The COVID-19 pandemic has highlighted the imperative of having timely access to electronic health data for health threats preparedness and response, as well as for diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, and ultimately would have helped to save lives. In 2020, the Commission urgently adapted its Clinical Patient Management System, established by Commission Implementing Decision (EU) 2019/126941, to allow Member States to share electronic health data of COVID-19 patients moving between healthcare providers and Member States during the peak of the pandemic, but this was only an emergency solution, showing the need for a structural approach at Member States and Union level, including appropriate measures on access to, and protection of, patients' personal data. _________________ 41 Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 200, 29.7.2019, p. 35).
Amendment 184 #
2022/0140(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The COVID-19 crisis strongly anchored the work of the eHealth Network, a voluntary network of digital health authorities, as the main pillar for the development of mobile contact tracing and warning applications and the technical aspects of the EU Digital COVID Certificates. It also highlighted the value of access to real time data to steer effective policy responses and the need for sharing electronic health data that are findable, accessible, interoperable and reusable (‘FAIR principles’), and ensuring that electronic health data are as open as possible and as closed as necessary. Synergies between the EHDS, the European Open Science Cloud42and the European Research Infrastructures should be ensured, as well as lessons learned from data sharing solutions developed under the European COVID-19 Data Platform. _________________ 42 EOSC Portal (eosc-portal.eu).
Amendment 185 #
2022/0140(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The COVID-19 crisis strongly anchored the work of the eHealth Network, a voluntary network of digital health authorities, as the main pillar for the development of mobile contact tracing and warning applications and the technical aspects of the EU Digital COVID Certificates. It also highlighted the need for sharing electronic health data that are findable, accessible, interoperable and reusable (‘FAIR principles’), and ensuring that electronic health data are as open as possible and as closed as necessary so as to protect patients' personal data and information. Synergies between the EHDS, the European Open Science Cloud42and the European Research Infrastructures should be ensured, as well as lessons learned from data sharing solutions developed under the European COVID-19 Data Platform. _________________ 42 EOSC Portal (eosc-portal.eu).
Amendment 188 #
2022/0140(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant. In addition, the Regulation should comply with Cyber Resilience Act. _________________ 43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 194 #
2022/0140(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an appropriate and secure electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, includingthe necessary treatment, especially when this is long-term, and which also relates to the provision of associated health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.
Amendment 196 #
2022/0140(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, threat assessment, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.
Amendment 200 #
2022/0140(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, and other complementary exams of diagnosis and therapeutics, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). To this end, Member States should ensure a common standard for health care data exchange to ensure and facilitate the data exchange and translation to the Union official languages. However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it. In this respect, appropriate funding and appropriate support at EU level should be considered as a means to reduce fragmentation, heterogeneity, and division and to achieve a system that is user-friendly and intuitive in all countries.
Amendment 204 #
2022/0140(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided secure health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved access to their own personal electronic health data and are empowered to share it. Those data also need to be properly secured and protected against cyberattacks.
Amendment 209 #
2022/0140(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. While patient portals, mobile applications and other personal health data access services exist in many places, including national solutions in some Member States, the right of access to health data is still commonly implemented in many places through the provision of the requested health data in paper format or as scanned documents, which is time- consuming. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition. Appropriate Union funding should be granted to Member States transpose the information on Article 5(1) to electronic format. All health data prior to the implementation of this Regulation shall be inserted in electronic health records with the support of Member States and without additional burden to healthcare professionals.
Amendment 211 #
2022/0140(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector, in parallel with the measures on access to, and protection, of those data. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. While patient portals, mobile applications and other personal health data access services exist in many places, including national solutions in some Member States, the right of access to health data is still commonly implemented in many places through the provision of the requested health data in paper format or as scanned documents, which is time- consuming. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition.
Amendment 214 #
2022/0140(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period. Where health data is only available on paper, if the effort to make data available electronically is disproportionate, there should be no obligation that such health data is converted until the moment of contact between the patient and the health professional. The availability of health data prior to the implementation of this regulation should happen in a timely manner into electronic format through a process facilitated by Member States. Any digital transformation in the healthcare sector should aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons should be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.
Amendment 221 #
2022/0140(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data and does not have the same clinical or legal value as information provided by a healthcare professional. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.
Amendment 222 #
2022/0140(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Natural persons should be further empowered to exchange and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible and if the appropriate protection measures and complied with. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high- quality, safe and efficient healthcare services to the natural person.
Amendment 225 #
2022/0140(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. Healthcare providers must follow data minimization principles when requesting personal health data, limiting it to the strictly necessary and justified data for a given service. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data.
Amendment 235 #
2022/0140(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person dependent on that information. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.
Amendment 237 #
2022/0140(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Article 9(2), point (h), of Regulation (EU) 2016/679 provides for exceptions where the processing of senstitive data is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health care or treatment or the management of health care systems and services on the basis of Union or Member State law. This Regulation should provide conditions and safeguards for the processing of electronic health data by healthcare providers and health professionals in line with Article 9(2), point (h), of Regulation (EU) 2016/679 with the purpose of accessing personal electronic health data provided by the natural person or transmitted from other healthcare providers. However, this Regulation should be without prejudice to the national laws concerning the processing of health data, including the legislation establishing categories of health professionals that can process different categories of electronic health data.
Amendment 238 #
2022/0140(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and, avoiding duplications and errors and reducing costs. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as appropriate electronic and digital devices and health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format. None of the provisions in this Regulation should be interpreted as limiting the obligation of healthcare professionals to conduct themselves in accordance with the applicable codes of conduct, deontological guidelines or other provisions governing ethical conduct with respect to sharing or accessing information, particularly in life- threatening or extreme situations.
Amendment 242 #
2022/0140(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers, provided that access to that data is properly secured, can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.
Amendment 245 #
2022/0140(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission, especially in the case of cross-border patients or of people who find themselves in another Member State for a limited period of time and may need healthcare assistance for a variety of reasons. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general, for cross-border patients or people who find themselves in another Member State for a limited period of time and may need healthcare assistance for a variety of reasons.
Amendment 247 #
2022/0140(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospitalealth units discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.
Amendment 253 #
2022/0140(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data. _________________ 45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18). 46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 255 #
2022/0140(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19 a) The interoperability of the EHDS should contribute to high quality of European health data sets.
Amendment 257 #
2022/0140(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) While EHR systems are widely spread, the level of digitalisation of health data varies in Member States depending on data categories and on the coverage of healthcare providers that register health data in electronic format. In order to support the implementation of data subjects’ rights of access to and exchange of electronic health data, Union action is needed to avoid further fragmentation. In order to contribute to a high quality and continuity of healthcare, certain categories of health data should be registered in electronic format systematically and according to specific data quality requirements, including measures on access to, and the protection of, those data. The European electronic health record exchange format should form the basis for specifications related to the registration and exchange of electronic health data. The Commission should be empowered to adopt implementing acts for determining additional aspects related to the registration of electronic health data, such as categories of healthcare providers that are to register health data electronically, categories of data to be registered electronically, or data quality and data security requirements.
Amendment 259 #
2022/0140(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20 a) In order to support the successful implementation of the EHDS and the execution of an effective landscape of European health data cooperation, the European Commission and Member States should agree on time-based targets to implement improved health data interoperability across the European Union with a range of targets and milestones to be reviewed and assessed in an annual report.
Amendment 261 #
2022/0140(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) thatthat they provide and reimburse. Telemedicine and online pharmacy services have they provide and reimburseotential to reduce health inequalities and reinforce the free movement of european citizens across borders. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine, including and online pharmacy services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.
Amendment 265 #
2022/0140(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) Telemedicine is becoming an increasingly important tool that can provide patients access to care and tackle inequities. Digital and other technological tools can minimize the circumstance of remote care, however, telemedicine should not be viewed as a replacement for in-person medicine, as there are certain conditions and procedures that require physical examination and intervention.
Amendment 271 #
2022/0140(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. Digital health authorities should ensure that appropriate training initiatives are undertaken at the local level. In particular, health professionals should be informed and trained with respect to their rights and obligations under the present Regulation. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, healthcare professionals, manufacturers of EHR systems and wellness applications, as well as other stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.
Amendment 277 #
2022/0140(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data, and funding as well as other means of European level support should be considered.
Amendment 278 #
2022/0140(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence, or when they work in a Member State other than the one in which they live. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.
Amendment 285 #
2022/0140(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities with time- based targets among the Member States, as joint controllers, and prescribe its own obligations, as processor.
Amendment 291 #
2022/0140(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme, as well as to instill the trust of citizens. To that end, a mandatory conformity assessment by notified bodies for EHR systems processing one or more priority categories of electronic health data should be establishconducted to overcome market fragmentation while ensuring a proportionate approach. Through this self- certification,compliance with robust security and data protection requirements. Through this conformity assessment, notified bodies should ascertain that EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48. _________________ 48 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
Amendment 299 #
2022/0140(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to a mandatory self-certificationconformity assessment by a notified body, software for general purposes should not be considered as EHR systems, even when used in a healthcare setting, and should therefore not be required to comply with the provisions of Chapter III.
Amendment 302 #
2022/0140(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) To further support interoperability and security, Member States may maintain or define specific rules for the procurement, reimbursement, financing or use of EHR systems at national level in the context of the organisation, delivery or financing of health services. Such specific rules should not impede the free movement of EHR systems in the Union. Some Member States have introduced mandatory certification of EHR systems or mandatory interoperability testing for their connection to national digital health services. Such requirements are commonly reflected in procurements organised by healthcare providers, national or regional authorities. Mandatory certification of EHR systems at Union level via a conformity assessment procedure should establish a baseline that can be used in procurements at national level.
Amendment 303 #
2022/0140(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) Compliance with essential requirements on interoperability and security should be demonstrated by the manufacturers of EHR systems through the implementation of common specifications. To that end, implementing powers should be conferred on the Commission to determine such common specifications regarding datasets, coding systems, technical specifications, including standards, specifications and profiles for data exchange, as well as requirements and principles related to security, confidentiality, integrity, patient safety and protection of personal data as well as specifications and requirements related to identification management and the use of electronic identification. Digital health authorities should contribute to the development of such common specifications and base their discussion on previous debates.
Amendment 304 #
2022/0140(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In order to ensure an appropriate and effective enforcement of the requirements and obligations laid down in Chapter III of this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II, notified bodies for EHR systems or a separate market surveillance authority responsible for EHR systems. While designating digital health authorities or national notified bodies as market surveillance authorities could have important practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks.
Amendment 311 #
2022/0140(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A voluntamandatory labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. Such labelling schemes should also include information for users on data protection rights and an indication of whether the provider of the app or the browser operator has access to data generated by the app in any way. The Commission mayshould set out in implementing acts the details regarding the format and content of such label.
Amendment 324 #
2022/0140(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguardsthe necessary safeguards must be determined in accordance to this Regulation. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.
Amendment 329 #
2022/0140(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, health surveillance, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health- related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators, policy- makers, regulators and doctors to use those data for different purposes, including research, innovation, policy-making, regulatory purposes, patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use insofar as such effort is always conducted through effective and secured processes, such as aggregation and randomisations and with due respect to professional duties, including but not limited to, confidentiality duties.
Amendment 330 #
2022/0140(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, files on the COVID pandemic and other events with a major impact on public health, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health-related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators, policy- makers, regulators and doctors to use those data for different purposes, including research, innovation, policy-making, regulatory purposes, patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use.
Amendment 339 #
2022/0140(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person- generated data, such as data from medical devices, wellness applications or other wearables and digital health applications, which must comply with the data security measures. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 340 #
2022/0140(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person- generated data, such as data from medical devices, wellness applications or other wearables and digital health applications. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset for research and innovation activities. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 345 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. Health professionals contribute to the EHDS by registering the required categories of patient data in the EHR. Health professionals who are required to register data in an EHR system for primary use purposes should be exempt from providing the data again for secondary use purposes. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented ofr difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding, should be made available by data holders to health data access bodies, in order to maximise the impact of the public investment and support research, innovation, patient safety or policy making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associations, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sector.
Amendment 348 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS, but they must comply with the measures on appropriate access and security in respect of such personal data. The public or private entities often receive public funding, from national or Union funds to collect, store and process electronic health data for research, statistics (official or not) or other similar purposes, including in areas where the collection of such data is fragmented ofr difficult, such as rare diseases, cancer etc. Such data, collected, stored and processed by data holders with the support of Union or national public funding, should be made available by data holders to health data access bodies, in order to maximise the impact of the public investment and support research, innovation, adaptation to the evolution of new healthcare technologies, patient safety orand policy- making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associations, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sector.
Amendment 356 #
2022/0140(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society. Particularly, the secondary use of health data for research and development purposes should contribute to a return to society in the form of new medicines, medical devices, health care products and services at affordable and fair prices for European citizens, as well as enhancing access and availability of such in all Member States. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public health bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agenciesNational public health authorities and European Union agencies related to health may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. POther public sector bodies from Member States and European Union institutions, bodies, offices and agencies may carry out such research activities by using third parties, including sub- contractors, as long as the public sector body remain at all time the supervisor of these activities. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be prohibited.
Amendment 359 #
2022/0140(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities and information campaigns on a range of health matters, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agencies may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. Public sector bodies may carry out such research activities by using third parties, including sub-contractors, as long as the public sector body remain at all time the supervisor of these activities and the measures on access to, and the security of, personal data are strictly complied with. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access, be this limited or not, depending on the situation, to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be prohibited.
Amendment 362 #
2022/0140(COD)
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41 a) Natural persons should be empowered to and have a right to control their electronic health data under this Regulation. Therefore the possibility for data subjects to decline the processing of all or parts of their health data for secondary use for some or all purposes should be provided. An easily understandable and accessible opt-out mechanism in a user-friendly format should be provided in this regard. Natural persons who opt-out of the processing of some or all of their health data for secondary use should not preclude their possibility to reconsider and provide some or all of their health data for secondary use at a later point.
Amendment 365 #
2022/0140(COD)
Proposal for a regulation
Recital 41 b (new)
Recital 41 b (new)
(41 b) Due to the highly sensitive nature of certain types of electronic health data, where full anonymisation is not possible and therefore the risk of re-identification of the data subject is high, additional safeguards should be provided for. An opt-in mechanism whereby data subjects explicitly consent or give their permission to the processing of part or all of such data for some or all secondary use purposes should be envisaged. This is particularly relevant for human genetic, genomic and proteomic data, as well as data from biobanks. Where data subjects explicitly consent to the use of parts or all of this data for some or all secondary use purposes, they should be made aware of the sensitive nature of the data they are sharing.
Amendment 366 #
2022/0140(COD)
Proposal for a regulation
Recital 41 c (new)
Recital 41 c (new)
(41 c) Different demographics have varying degrees of digital literacy which may hamper their ability to enact their rights to control their electronic health data. In addition to the right for natural persons to authorise another natural person of their choice to access or control their electronic health data on their behalf, Member States should charge digital health authorities with the creation of targeted national digital literacy programmes to maximise social inclusion and to ensure all natural persons can effectively exercise their rights under this Regulation.
Amendment 370 #
2022/0140(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) The establishment of one or more health data access bodies, supporting access to electronic health data in Member States, is an essential component for promoting the secondary use of health- related data. Member States should therefore establish one or more health data access body, for instance to reflect their constitutional, organisational and administrative structure. However, one of these health data access bodies should be designated as a coordinator in case there are more than one data access body. Where a Member State establishes several bodies, it should lay down rules at national level to ensure the coordinated participation of those bodies in the EHDS Board. That Member State should in particular designate one health data access body to function as a single contact point for the effective participation of those bodies, and ensure swift and smooth cooperation with other health data access bodies, the EHDS Board and the Commission. Health data access bodies may vary in terms of organisation and size (spanning from a dedicated full-fledged organization to a unit or department in an existing organization) but should have the same functions, responsibilities and capabilities, and comply with all the measures on access to, and the security of, personal medical data. Health data access bodies should not be influenced in their decisions on access to electronic data for secondary use. However, their independence should not mean that the health data access body cannot be subject to control or monitoring mechanisms regarding its financial expenditure or to judicial review. Each health data access body should be provided with the financial and human resources, premises and infrastructure necessary for the effective performance of its tasks, including those related to cooperation with other health data access bodies throughout the Union. Each health data access body should have a separate, public annual budget, which may be part of the overall state or national budget. In order to enable better access to health data and complementing Article 7(3) of Regulation […] of the European Parliament and of the Council [Data Governance Act COM/2020/767 final], Member States should entrust health data access bodies with powers to take decisions on access to and secondary use of health data. This could consist in allocating new tasks to the competent bodies designated by Member States under Article 7(1) of Regulation […] [Data Governance Act COM/2020/767 final] or in designating existing or new sectoral bodies responsible for such tasks in relation to access to health data.
Amendment 376 #
2022/0140(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Considering the administrative burden for health data access bodies to inform the natural persons whose data are used in data projects within a secure processing environment, the exceptions provided for in Article 14(5) of Regulation (EU) 2016/679 should apply. Therefore, health data access bodies should provide general information concerning the conditions for the secondary use of their health data containing the information items listed in Article 14(1) and, where necessary to ensure fair and transparent processing, Article 14(2) of Regulation (EU) 2016/679, e.g. information on the purpose and the data categories processed. Exceptions from this rule should be made when the results of the research could assist in the treatment of the natural person concerned. In this case, the data user should inform the health data access body, which should inform the data subject or his health professional, with due regard for the stated wish of the data subject not to be contacted. Natural persons should be able to access the results of different research projects on the website of the health data access body, ideally in an easily searchable manner. The list of the data permits should also be made public. In order to promote transparency in their operation, each health data access body should publish an annual activity report providing an overview of its activities.
Amendment 380 #
2022/0140(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to support the secondary use of electronic health data, the data holders should refrain from withholding the data, requesting unjustified fees that are not transparent nor proportionate with the costs for making data available (and, where relevant, with marginal costs for data collection), requesting the data users to co- publish the research or other practices that could dissuade the data users from requesting the data. Where ethical approval is necessary for providing a data permit, its evaluation should be based on its own merits. On the other hand, Union institutions, bodies, offices andnational public health authorities, European Union agencies, including EMA, ECDC and the Commission,EMCDDA have very important and insightful data. Access to data of such institutions, bodies, offices and agencies should be granted through the health data access body where the controller is located.
Amendment 387 #
2022/0140(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) In order to strengthen the enforcement of the rules on the secondary use of electronic health data, appropriate measures that can lead to penalties or temporary or definitive exclusions from the EHDS framework ofr even fines directed to the data users or data holders that do not comply with their obligations. The health data access body should be empowered to verify compliance and give data users and holders the opportunity to reply to any findings and to remedy any infringement. The imposition of penalties should be subject to appropriate procedural safeguards in accordance with the general principles of law of the relevant Member State, including effective judicial protection and due process.
Amendment 389 #
2022/0140(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, common standards for data anonymisation shall be further developed and the use of anonymised electronic health data which is devoid of any personal data should be made available, when possible and if the data user asks it, with data that cannot be anonymised or pseudonymized being excluded of reuse possibilities. Requests of pseudonymised data should be duly justified. When providing access to a pseudonymised or anonymised dataset, a Data Access Body should follow state-of- the-art anonymisation/pseudonymisation technology. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the concerned natural person(s)'s professional, with due regard for the stated wish of the data subject not to be contacted. Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 397 #
2022/0140(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, the use of anonymised electronic health data which is devoid of any personal data should be made available when possible and if the data user asks it. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity and must ensure the total protection of that data. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the concerned natural person(s). Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 409 #
2022/0140(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) As the COVID-19 crisis has shown, the Union institutions, bodies, offices and agencies, especially the Commission, need access to health data for a longer period and on a recurring basis. This is may be the case not only in specific circumstances in times of crisis but also to provide scientific evidence and technical support for Union policies on a regular basis. Access to such data may be required in specific Member States or throughout the whole territory of the Union, and the conditions and period of access must be set out very clearly, while the security of the data must also be respected.
Amendment 411 #
2022/0140(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) As the COVID-19 crisis has shown, the Union institutions, bodies, offices and agencies, especially the Commission, need access to health data for a longer period and on a recurring basis. This is may be the case not only in specific circumstances in times of crisis but also to provide scientific evidence and technical support for Union policies on a regular basis. Access to such data may be required in specific Member States or throughout the whole territory of the Union.
Amendment 418 #
2022/0140(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) For requests to access electronic health data from a single data holder in a single Member State and in order to alieviate the administrative burden for heath data access bodies of managing such request, the data user should be able to request this data directly from the data holder and the data holder should be able to issue a data permit while complying with all the requirements and safeguards linked to such request and permit. Multi- country requests and requests requiring combination of datasets from several data holders should always be channelled through health data access bodies. The data holder should report to the health data access bodies about any data permits or data requests they provide.
Amendment 420 #
2022/0140(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) Given the sensitivity of electronic health data, data users should not have an unrestricted access to such data. All secondary use access to the requested electronic health data should be done through a secure processing environment. In order to ensure strong technical and security safeguards for the electronic health data, the health data access body or, where relevant, single data holder should provide access to such data in a secure processing environment, complying with the high technical and security standards set out pursuant to this Regulation. Some Member States took measures to locate such secure environments in Europe. The processing of personal data in such a secure environment should comply with Regulation (EU) 2016/679, including, where the secure environment is managed by a third party, the requirements of Article 28 and, where applicable, Chapter V. Such secure processing environment should reduce the privacy risks related to such processing activities and prevent the electronic health data from being transmitted directly to the data users. The health data access body or the data holder providing this service should remain at all time in control of the access to the electronic health data with access granted to the data users determined by the conditions of the issued data permit. Only non-personal electronic health data which do not contain any electronic health data should be extracted by the data users from such secure processing environment. Thus, it is an essential safeguard to preserve the rights and freedoms of natural persons in relation to the processing of their electronic health data for secondary use. The Commission should assist the Member State in developing high common security standards in order to promote the security and interoperability of the various secure environments as well as the regular updating of these security measures to keep pace with IT developments and to counter attacks on databases.
Amendment 431 #
2022/0140(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) The authorisation process to gain access to personal health data in different Member States can be repetitive and cumbersome for data users. Whenever possible, synergies should be established to reduce the burden and barriers for data users. One way to achieve this aim is to adhere to the “single application” principle whereby, with one application, the data user obtains authorisation from multiple health data access bodies in different Member States.
Amendment 434 #
2022/0140(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) Cooperation and work is ongoing between different professional organisations, the Commission and other institutions to set up minimum data fields and other characteristics of different datasets (registries for instance). This work is more advanced in areas such as cancer, rare diseases, cardiovascular and metabolic diseases, risk factors assessment and statistics and shall be taken into account when defining new standards and disease-specific harmonised templates for structured data elements.. However, many datasets are not harmonised, raising comparability issues and making cross- border research difficult. Therefore, more detailed rules should be set out in implementing acts to ensure a harmonised provision, coding and registration of electronic health data. Member States should work towards delivering sustainable economic and social benefits of European electronic health systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of healthcare and ensuring access to safe and high-quality healthcare. Existing health data infrastructures and registries put in place by institutions and stakeholders can contribute to defining and implementing data standards, to ensuring interoperability and must be leveraged to allow continuity and build on existing expertise.
Amendment 441 #
2022/0140(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) The use of funds should also contribute to attaining the objectives of the EHDS. Public procurers, national competent authorities in the Member States, including digital health authorities and health data access bodies, as well as the Commission should make references to applicable technical specifications, standards and profiles on interoperability, access to and security and data quality of data, as well as other requirements developed under this Regulation when defining the conditions for public procurement, calls for proposals and allocation of Union funds, including structural and cohesion funds.
Amendment 450 #
2022/0140(COD)
Proposal for a regulation
Recital 64 a (new)
Recital 64 a (new)
(64 a) Member States should consider criminalising unauthorised re- identification and disclosure of de- identified personal data to serve as a deterrent measure.
Amendment 457 #
2022/0140(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) In order to promote the consistent application of this Regulation, a European Health Data Space Board (EHDS Board) should be set up. The Commission should participate in its activities and chair it. It should contribute to the consistent application of this Regulation throughout the Union, including by helping Member State to coordinate the use of electronic health data for healthcare, certification, but also concerning the secondary use of electronic health data. Given that, at national level, digital health authorities dealing with the primary use of electronic health data may be different to the health data access bodies dealing with the secondary use of electronic health data, the functions are different and there is a need for distinct cooperation in each of these areas, the EHDS Board should be able to set up subgroups dealing with these two functions, as well as other subgroups, as needed, which can be granted limited or permanent access to data provided that they respect the security of that data. For an efficient working method, the digital health authorities and health data access bodies should create networks and links at national level with different other bodies and authorities, but also at Union level. Such bodies could comprise data protection authorities, cybersecurity, eID and standardisation bodies, as well as bodies and expert groups under Regulations […], […], […] and […] [Data Governance Act, Data Act, AI Act and Cybersecurity Act].
Amendment 459 #
2022/0140(COD)
Proposal for a regulation
Recital 65 a (new)
Recital 65 a (new)
(65 a) The EHDS Board should operate transparently with open publication of meeting dates and minutes of the discussion as well as an annual report elaborated together with the European Commission.
Amendment 462 #
2022/0140(COD)
Proposal for a regulation
Recital 70
Recital 70
(70) Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties and fines for their infringement. For certain specific infringements, Member States should take into account the margins and criteria set out in this Regulation.
Amendment 464 #
2022/0140(COD)
Proposal for a regulation
Recital 71
Recital 71
(71) In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level the Commission should carry out an evaluation of this Regulation. The Commission should carry out a partial evaluation of this Regulation 53 years after its entry into force, on the self-certification of EHR systems, and an overall evaluation 75 years after the entry into force of this Regulation. The Commission should submit reports on its main findings following each evaluation to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions.
Amendment 471 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthens the rights of natural persons in relation to the availability and, control and security of their electronic health data;
Amendment 474 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthenoutlines the rights of natural persons in relation to the availability and control of their electronic health data;
Amendment 476 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union, with the appropriate security measures;
Amendment 515 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic formatrelevant for health research in electronic format that have been irreversibly anonymised and data that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 516 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concerning mental and physical health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 534 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content or quality of the data between these organisations, software applications or devices, through the processes they support, enabling data portability across data holders and health care providers for data recipients and data users;
Amendment 538 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different organisations, software applications, devices and healthcare providers;
Amendment 541 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point j
Article 2 – paragraph 2 – point j
(j) ‘health professional access service’ means a service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatmentcare and with authorised permission to do so;
Amendment 548 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point l
Article 2 – paragraph 2 – point l
(l) ‘telemedicine’ means the provision of healthcare services, including remote care and online pharmacies, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;
Amendment 549 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point m
Article 2 – paragraph 2 – point m
(m) ‘EHR’ (electronic health record) means any collection of electronicthe past or present electronic mental and physical health data related to a natural person and collected in the health system, processed for healthcarethe purpose of the provision of healthcare services or research purposes;
Amendment 555 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or softwarother article whose primary purpose intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records or that can be reasonably expected by the manufacturer to be used for these purposes;
Amendment 564 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
(o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for other purposes than healthcare, such as well-being and pursuing healthy life- styla healthy lifestyle, well-being purposes or that can be reasonably expected by the manufacturer for these purposes;
Amendment 572 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point y
Article 2 – paragraph 2 – point y
(y) ‘data holder’ means any natural or legal person, which is an entity or a body controller as set out in Regulation (EU) 2016/679 in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies whoich are a controller as set out in Regulation (EU) 2018/1725 which hasve the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, to process personal electronic health data or in the case of non-personal health data, through control of the technical design of athe product and related services, the ability to make and as allowed by contract with natural or legal person owning, renting or leasing the product or related service, the ability to make the relevant and appropriate data pursuant to the relevant requirements laid down in this Regulation available, including to register, provide, restrict access or exchange certain data;
Amendment 594 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ac
Article 2 – paragraph 2 – point ac
(ac) ‘dataset catalogue’ means a collection of datasets descriptions, which is arranged in a systematic manner and consists of a user-oriented public part, where information concerning individual dataset parameters is accessible by electronic means through an online portal;
Amendment 603 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) "notified body’ means a conformity assessment body notified in accordance with Article 27f of this Regulation;
Amendment 607 #
2022/0140(COD)
(ae b) ‘conformity assessment’ means the process demonstrating whether the essential requirements of this Regulation relating to EHR systems have been fulfilled;
Amendment 612 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae c (new)
Article 2 – paragraph 2 – point ae c (new)
(ae c) ‘conformity assessment body’ means a body that performs conformity assessment activities, including testing, certification and inspection;
Amendment 615 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae d (new)
Article 2 – paragraph 2 – point ae d (new)
(ae d) ‘data sharing’ means the provision defined in Article 2 (10) of the Regulation (EU) 2022/868;
Amendment 633 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of thisese rights whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.
Amendment 638 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Where the personal health data have not been registered electronically prior to the application of this Regulation, Member States mayshall require that such data is made available in electronic format pursuant to this Article. This shall not affect the obligation to make personal electronic health data registered after the application of this Regulation available in electronic format pursuant to this Article.
Amendment 644 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point b
Article 3 – paragraph 5 – subparagraph 1 – point b
(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf or to enable legal guardians to act on behalf of their dependents in accordance with the national law of the Member State.
Amendment 654 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Natural persons may insert, access and export their electronic health data in and from their own EHR or in that of natural persons whose health information they can access, through electronic health data access services orand applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative as non-validated, and information shall only be considered as a clinical fact if validated by an identified, registered health professional with the relevant competence. Natural persons shall not have the possibility to directly change data inserted by healthcare professionals. The process must be secure.
Amendment 662 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 7
Article 3 – paragraph 7
7. Member States shall ensure that, when exercising the right to rectification under Article 16 of Regulation (EU) 2016/679, natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5, point (a), of this Article. The rectification of a clinical fact in the EHR must be validated by an identified, registered health professional with the appropriate competence. The process must be secure.
Amendment 668 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 1
Article 3 – paragraph 8 – subparagraph 1
Natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit partially or totally, their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.
Amendment 673 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 3
Article 3 – paragraph 8 – subparagraph 3
By way of derogation from Article 9 of Regulation […] [Data Act COM/2022/68 final], the data recipient shall not be required to compensate the data holder for making electronic health data available.
Amendment 674 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 4
Article 3 – paragraph 8 – subparagraph 4
Natural persons shall have the right that, where priority categories of personal electronic health data referred to in Article 5 are transmitted or made available by the natural person according to the European electronic health record exchange format referred to in Article 6, such data shall be read and accepterecognised as valid by other healthcare providers.
Amendment 680 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. Member StatesFor judicial reasons strictly related to medical liability of health professionals, the date and time of omitted information must be recorded and only visible to the health data access bodies under these circumstances. The European Commission shall establish the rules and specific safeguards regarding such restriction mechanisms through a delegated act.
Amendment 691 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. In order to demonstrate compliance with this right, all relevant entities shall maintain a system of automated recording showing unequivocally who, when and where had access to data, accessible to the patient. The information shall be provided immediately and free of charge through electronic health data access services in a commonly accepted, interoperable format.
Amendment 714 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) have access to the electronic health data of natural persons under their treatmentcare and restrict to their functions of action, irrespective of the Member State of affiliation and the Member State of treatment;
Amendment 718 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) ensure that the personal electronic health data of the natural persons they treatcare are updated with information related to the health services provided and, if not, update data concerning the health services provided by them.
Amendment 731 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals lawfully exercising their activities through health professional access services and that health professionals can easily select specific relevant information in the EHR. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge. To this end, they may cooperate, where appropriate, with professional associations under the terms provided for by national rules.
Amendment 763 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point f
Article 5 – paragraph 1 – subparagraph 1 – point f
(f) discharge reports.;
Amendment 765 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point f a (new)
Article 5 – paragraph 1 – subparagraph 1 – point f a (new)
(f a) medical directives.
Amendment 785 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) harmonised datasets containing electronic health data and defining structures, such minimum as data fields and data groups for the content representation of clinical content and other parts of the electronic health data, that can be enlarged to include disease-specific data;
Amendment 790 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are issued in the format referred to in paragraph 1 and such data shall be read and accepted by therecognised as valid by the data recipient including measures aimed at ensuring priority categories of personal electronic health data arecipient translated as necessary for the provision of healthcare to the language of the patient or the healthcare professional.
Amendment 796 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States shall ensure that, wWhere data is processed in electronic format, Member States shall facilitate health professionals to systematically register the relevant health data falling under at least the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.
Amendment 806 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 1 – introductory part
Article 7 – paragraph 3 – subparagraph 1 – introductory part
The Commission shall, by means of implementingdelegated acts, determine the requirements for the registration of electronic health data by healthcare providers and natural persons, as relevant. Those implementingdelegated acts shall establish the following:
Amendment 816 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3 a. For the purpose of transparency and accountability, natural persons or their legal representatives must be able to see which healthcare professional accessed their electronic health record separately in each specific category and when.
Amendment 817 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 b (new)
Article 7 – paragraph 3 b (new)
3 b. When health data is registered or updated, electronic health records must identify the time, person and location of the registry.
Amendment 826 #
2022/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Where a Member State accepts the provision of telemedicine services, it shall, under the same conditions, accept the provision of the services of the same type by healthcare providers located in other Member States with the same rights and obligations to access and register electronic health data. Telemedicine services shall respect the national law of the Member State in which is being provided.
Amendment 835 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission shall, by means of implementingdelegated acts, determine the requirements for the interoperable, cross- border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 836 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The Member States and the Commission shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).
Amendment 839 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Each Member State shall designate a digital health authority responsible for the implementation and enforcement of this Chapter at national level. Implementation shall be harmonised at national level and across Member States with the EHDS Board conducting an oversight and leadership role in achieving this. The Member State shall communicate the identity of the digital health authority to the Commission by the date of application of this Regulation. Where a designated digital health authority is an entity consisting of multiple organisations, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The Commission shall make this information publicly available.
Amendment 843 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
(b) ensure that complete and up to date information about the implementation of rights and obligations provided for in in Chapters II and III is made readily available to natural persons, health professionals and healthcare providers and that appropriate training initiatives are undertaken at the local level;
Amendment 848 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point h
Article 10 – paragraph 2 – point h
(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, the access period and the access process per se, and security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;
Amendment 853 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k
Article 10 – paragraph 2 – point k
(k) offer, in compliance with national legislation, telemedicine services and ensure that such services are easy to use, accessible and equitable to different groups of natural persons and health professionals, including natural persons with disabilities, do not discriminate and offer the possibility of choosing between in person and digital services;
Amendment 855 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k a (new)
Article 10 – paragraph 2 – point k a (new)
(k a) ensure a communication plan to the natural person, health professional and stakeholders to inform the rights and obligations of which element of the EHDS and inform the natural person the advantages and potential gains to science and society of the primary and secondary use of electronic health data;
Amendment 856 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k b (new)
Article 10 – paragraph 2 – point k b (new)
(k b) offer, free of charge, accessible online training, to natural persons and health professionals on how to use electronic health data access service and health professional access service, respectively;
Amendment 882 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ and healthcare professionals’ representatives. Members of the digital health authority shall avoid any conflicts of interest. The Commission shall be empowered to adopt delegated acts setting out what is likely to constitute a conflict of interest together with the procedure to be followed in such cases.
Amendment 903 #
2022/0140(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken and inform the legal authorities if applicable.
Amendment 918 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The implementing act shall include the agreement of target implementation dates, including for improved cross-border health data interoperability, in consultation with the EHDS board.
Amendment 936 #
2022/0140(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The Commission and Member States may facilitate the exchange of electronic health data with other infrastructures, such as the Clinical Patient Management System or other services or infrastructures in the health, care or social security fields which may become authorised participants to MyHealth@EU. The Commission shall, by means of implementing acts, set out the technical aspects of such exchanges, with a focus on the mode and period of access, in compliance with patient data security measures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The connection of another infrastructure to the central platform for digital health shall be subject to a decision of the joint controllership group for MyHealth@EU referred to in Article 66.
Amendment 953 #
2022/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. EHR systems may be placed on the market or put into service only if theyafter a notified body has assessed and verified that the EHR system complyies with the provisions laid down in this Chapter.
Amendment 962 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) draw up the technical documentation of their EHR systems in accordance with Article 24 before placing their system on the market;
Amendment 965 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point d
Article 17 – paragraph 1 – point d
(d) draw up an EU declaration of conformitycarry out the relevant conformity assessment procedures as referred to in Article 267a;
Amendment 966 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point d a (new)
Article 17 – paragraph 1 – point d a (new)
Amendment 967 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point e
Article 17 – paragraph 1 – point e
Amendment 969 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point g
Article 17 – paragraph 1 – point g
(g) take without undue delay any necessary corrective action in respect of their EHR systems which are not or are no longer in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;
Amendment 971 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point i
Article 17 – paragraph 1 – point i
(i) inform the market surveillance authorities and notified bodies of the Member States in which they made their EHR systems available or put them into service of the non- conformity and of any corrective action taken;
Amendment 975 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point j
Article 17 – paragraph 1 – point j
(j) upon request of a market surveillance authority or a notified body, provide it with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.
Amendment 976 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point k
Article 17 – paragraph 1 – point k
(k) cooperate with market surveillance authorities and notified bodies, at their request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 979 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of an EHR system continues to comply with the essential requirements laid down in Annex II and the common specifications referred to in Article 23. Changes in EHR system design or characteristics shall be adequately taken into account and reflected in the technical documentationfor EHR systems to remain in conformity with this Regulation. Changes in EHR system design or characteristics and changes in the harmonised standards or the technical specifications referred to in Annex II and III by reference to which the conformity of the EHR system is declared or by application of which its conformity is verified shall be adequately taken into account and reflected in the technical documentation. When deemed appropriate with regard to the risks presented by EHR systems, manufacturers shall, to protect the rights of natural persons, carry out sample testing or put into service, investigate, and, if necessary, keep a register of complaints, of non-conforming EHR systems and EHR systems recalls, and shall keep distributors informed of any such monitoring.
Amendment 980 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity for 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market, where relevant, at the disposal of the market surveillance authorities for 10 years after the last EHR system conformity assessment. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from the competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 982 #
2022/0140(COD)
3 a. Manufacturers who consider or have reason to believe that an EHR system, which they have placed on the market or put into service is not in conformity with the essential requirements set out in Annex II shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the EHR system presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the EHR system available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
Amendment 984 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 b (new)
Article 17 – paragraph 3 b (new)
3 b. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements set out in Annex II, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the risks posed by the EHR system, which they have placed on the market or put into service.
Amendment 990 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for the period referred to in Article 17(3);
Amendment 994 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point c
Article 18 – paragraph 2 – point c
(c) cooperate with the market surveillancecompetent national authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate.
Amendment 999 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity;
Amendment 1000 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a a (new)
Article 19 – paragraph 2 – point a a (new)
(a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer
Amendment 1002 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point b
Article 19 – paragraph 2 – point b
(b) the EHR system bears the CE marking of conformity referred to in Article 27 ;
Amendment 1005 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. Where an importer considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The importer shall inform without undue delay the manufacturer of such EHR system and the market surveillancenational competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 1007 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 6
Article 19 – paragraph 6
6. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for the period referred to in Article 17(3) and ensure that the technical documentation can be made available to those authorities, upon request. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 1010 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7
Article 19 – paragraph 7
7. Importers shall, further to a reasoned request from a market surveillancecompetent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the market surveillancecompetent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1015 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
Amendment 1016 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point a a (new)
Article 20 – paragraph 1 – point a a (new)
(a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer;
Amendment 1018 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
1 a. When making an EHR system available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
Amendment 1021 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Distributors shall, further to a reasoned request from a market surveillancecompetent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1022 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
4 a. Where a distributor considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The distributor shall inform without undue delay the manufacturer of such EHR system and the national competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
Amendment 1024 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4 b (new)
Article 20 – paragraph 4 b (new)
4 b. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the competent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1044 #
2022/0140(COD)
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
Article 25 a Presumption of conformity of EHR systems 1. An EHR system which is in conformity with harmonised standards as referred to in Article 23 shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards. 2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential requirements set out in Annex II. 3. The Commission is empowered to adopt implementing acts establishing technical specifications for the essential requirements set out in Annex II where the following conditions have been fulfilled: (a) no reference to harmonised standards covering the relevant essential health and safety requirements is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; (b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements and there are undue delays in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2). 4. An EHR system which is in conformity with the technical specifications shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those technical specifications.
Amendment 1046 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.
Amendment 1049 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. By drawing upissuing the EU declaration of conformity, to the manufacturerhealth data access body, the notified body shall assume responsibility for the conformity of the EHR system.
Amendment 1057 #
2022/0140(COD)
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27 a Conformity assessment procedures for EHR systems 1. In order to certify the conformity of an EHR system with this Regulation, the manufacturer or its authorised representative, shall apply for EU type- examination procedure provided for in Annex IVa; 2. Notified bodies shall take into account the specific interests and needs of small and medium sized enterprises when setting the fees for conformity assessment and reduce those fees proportionately to their specific interests and needs.
Amendment 1058 #
2022/0140(COD)
Proposal for a regulation
Article 27 b (new)
Article 27 b (new)
Article 27 b Notification Member States shall notify the Commission and the other Member States of conformity assessment bodies authorised to carry out conformity assessments in accordance with this Regulation.
Amendment 1059 #
2022/0140(COD)
Proposal for a regulation
Article 27 c (new)
Article 27 c (new)
Article 27 c Notifying authorities 1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 27j. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 27d. In addition, that body shall have arrangements to cover liabilities arising out of its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Amendment 1060 #
2022/0140(COD)
Proposal for a regulation
Article 27 d (new)
Article 27 d (new)
Article 27 d Requirements relating to notifying authorities 1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment of the EHR system. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. 6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Amendment 1061 #
2022/0140(COD)
Proposal for a regulation
Article 27 e (new)
Article 27 e (new)
Article 27 e Information obligation on notifying authorities Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Amendment 1062 #
2022/0140(COD)
Proposal for a regulation
Article 27 f (new)
Article 27 f (new)
Amendment 1063 #
2022/0140(COD)
Proposal for a regulation
Article 27 g (new)
Article 27 g (new)
Article 27 g Presumption of conformity of notified bodies Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 27f in so far as the applicable harmonised standards cover those requirements.
Amendment 1064 #
2022/0140(COD)
Proposal for a regulation
Article 27 h (new)
Article 27 h (new)
Article 27 h Subsidiaries of and subcontracting by notified bodies 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 27f and shall inform the notifying authority accordingly. 2. A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 4. A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IVa.
Amendment 1065 #
2022/0140(COD)
Proposal for a regulation
Article 27 i (new)
Article 27 i (new)
Article 27 i Notification procedure 1. A notifying authority shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 27f. 2. The notifying authority shall send a notification to the Commission and the other Member States of each conformity assessment body referred to in paragraph 1, using the electronic notification tool developed and managed by the Commission. 3. The notification referred to in paragraph 2 shall include the following: (a) full details of the conformity assessment activities to be performed; (b) the relevant attestation of competence. 4. Where a notification is not based on an accreditation certificate referred to in Article 27i(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 27f. 5. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 27i(2), or within two months of the notification where it includes documentary evidence referred to in Article 27i(3). Only such a body shall be considered a notified body for the purposes of this Regulation. 6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification referred to in paragraph 2.
Amendment 1066 #
2022/0140(COD)
Proposal for a regulation
Article 27 i (new)
Article 27 i (new)
Article 27 i Application for notification 1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment procedures set out in Annex IVa as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 27f. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 27f.
Amendment 1067 #
2022/0140(COD)
Proposal for a regulation
Article 27 k (new)
Article 27 k (new)
Article 27 k Identification numbers and lists of notified bodies 1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts. 2. The Commission shall make publicly available the list of notified bodies including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Amendment 1068 #
2022/0140(COD)
Proposal for a regulation
Article 27 l (new)
Article 27 l (new)
Article 27 l Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 27f, or that it is failing to fulfil its obligations as set out in Article 27m the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
Amendment 1069 #
2022/0140(COD)
Proposal for a regulation
Article 27 m (new)
Article 27 m (new)
Article 27 m Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1070 #
2022/0140(COD)
Proposal for a regulation
Article 27 n (new)
Article 27 n (new)
Amendment 1071 #
2022/0140(COD)
Proposal for a regulation
Article 27 o (new)
Article 27 o (new)
Article 27 o Appeals against decisions of notified bodies A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Amendment 1072 #
2022/0140(COD)
Proposal for a regulation
Article 27 p (new)
Article 27 p (new)
Article 27 p Information obligation on notified bodies 1. A notified body shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval decision; (b) any circumstances affecting the scope of, or the conditions for, its notification; (c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities; (d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting. 2. A notified body shall provide other notified bodies carrying out similar conformity assessment activities covering the same kinds of machinery product with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Amendment 1073 #
2022/0140(COD)
Proposal for a regulation
Article 27 q (new)
Article 27 q (new)
Article 27 q Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place and properly operated in the form of a sectoral group of notified bodies. A notified body shall participate in the work of that group, directly or by means of designated representatives.
Amendment 1074 #
2022/0140(COD)
Proposal for a regulation
Article 27 q (new)
Article 27 q (new)
Article 27 q Exchange of experience The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Amendment 1075 #
2022/0140(COD)
Proposal for a regulation
Chapter III – Section 3 a (new)
Chapter III – Section 3 a (new)
3a Section 3a Conformity assessment
Amendment 1079 #
2022/0140(COD)
Proposal for a regulation
Article 28 – paragraph 4 a (new)
Article 28 – paragraph 4 a (new)
4 a. Market surveillance authorities shall immediately inform Notified Bodies about manufacturers of EHR systems that no longer comply with the requirements on the declaration of conformity.
Amendment 1080 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Where a market surveillance authority findsof one Member State have sufficient reason to believe that an EHR system presents a risk to the health or, safety or rights of natural persons or to other aspects of public interest protection, ithey shall require the manufacturer of the EHR system concerned, icarry out an evaluation in relation to the EHR system concerned covering all relevant requirements laid down in this Regulation. Its authorised representatives and all other relevant economic operators toshall cooperate as necessary with the market surveillance authorities for that purpose and take all appropriate measures to ensure that the EHR system concerned no longer presents that risk when placed on the market to withdraw the EHR system from the market or to recall it within a reasonable period. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the EHR system does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the EHR system into compliance with those requirements, to withdraw the machinery product from the market, or to recall it within a reasonable period which is commensurate with the nature of the risk referred to in the first subparagraph. The market surveillance authorities shall inform the relevant notified body accordingly.
Amendment 1083 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1 a. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
Amendment 1096 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
1 a. Where the relevant economic operator does not take adequate corrective action within the period referred to in Article 29, paragraph 1, second subparagraph, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system being made available on their national market, to withdraw the machinery product from that market or to recall it. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
Amendment 1097 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 b (new)
Article 30 – paragraph 1 b (new)
1 b. The information referred to in paragraph 1.a, second subparagraph, shall include all available details, in particular the data necessary for the identification of the noncompliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.In particular, the market surveillance authorities shall indicate whether the noncompliance is due to any of the following: (a) failure of the EHR system to meet the requirements relating to the essential requirements set out in Annex II; (b) shortcomings in the harmonised standards referred to in Article 25a(1); (c) shortcomings in the technical specifications referred to in Article 25a(4).
Amendment 1098 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 c (new)
Article 30 – paragraph 1 c (new)
1 c. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the EHR system concerned, and, in the event of disagreement with the adopted national measure, of their objections.
Amendment 1099 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 d (new)
Article 30 – paragraph 1 d (new)
1 d. Where, within three months of receipt of the information referred to in paragraph 1a, second subparagraph, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
Amendment 1100 #
2022/0140(COD)
Proposal for a regulation
Article 30 a (new)
Article 30 a (new)
Article 30 a Union safeguard procedure 1. Where, on completion of the procedure set out in Article 29(2) and Article 30(1a), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall without delay communicate it to them and to the relevant economic operator or operators. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 68(2a). 2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. Where the national measure is considered justified and the non-compliance of the EHR system is attributed to shortcomings in the harmonised standards or technical specifications referred to in Article 30(1b), points (b) and (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Amendment 1106 #
2022/0140(COD)
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Where a manufacturer of a wellness application claims interoperability with an EHR system and therefore compliance with the essential requirements laid down in Annex II and common specifications in Article 23, such wellness application mayshall be accompanied by a label, clearly indicating its compliance with those requirements. The label shall be issued by the manufacturer of the wellness application and the health data access body shall be informed.
Amendment 1107 #
2022/0140(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The Commission mayshall, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1132 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. Data holders shall, through a secure system ensuring protection of the patients’ data, make the following categories of electronic data available for secondary use, in accordance with the provisions of this Chapter:
Amendment 1142 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
(a) electronic health data from EHRs;
Amendment 1151 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point b
Article 33 – paragraph 1 – point b
(b) data on factors impacting on health, including social, environmental behavioural determinants of health;
Amendment 1156 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point d
Article 33 – paragraph 1 – point d
(d) healthcare-related administrative data, including claims and reimbursement data;
Amendment 1166 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
(e) extracts from human genetic, genomic and proteomic data, such as genetic markers;
Amendment 1220 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro and small enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59in the context of healthcare provision. _________________ 59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 1222 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 2 a (new)
Article 33 – paragraph 2 a (new)
2 a. The Commission, together with the Member States, will define measures to protect the personal data of healthcare professionals involved in the treatment of a natural person, in order to prevent the possibility of identifying which prescriptions doctors administer to their patients.
Amendment 1229 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3 a. The natural person shall receive information about the benefits of providing access to their health data for secondary use.
Amendment 1251 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
Amendment 1265 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5 a (new)
Article 33 – paragraph 5 a (new)
5 a. Natural persons shall have the right to decline the processing of parts or all of their electronic health data for secondary use. In this regard, health data access bodies shall provide an easily understandable and accessible opt-out mechanism in a user-friendly format whereby natural persons have the option to explicitly remove parts or all of their electronic health data to be processed for some or all secondary use purposes.
Amendment 1268 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5 b (new)
Article 33 – paragraph 5 b (new)
5 b. For the categories of electronic health data referred to in (e) and (m) of the first paragraph, health data access bodies shall only provide this health data for secondary use processing after natural persons have explicitly consented to its use. Such an opt-in mechanism shall be easily understandable and accessible and provided for in a user-friendly format whereby data subjects are made aware of the sensitive nature of the data.
Amendment 1274 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 7
Article 33 – paragraph 7
Amendment 1295 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point a
Article 34 – paragraph 1 – point a
(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance, monitoring and evaluating health programmes or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;
Amendment 1300 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, as well as, where national laws apply, professional associations, in the health or care sector to carry out their tasks defined in their mandates;
Amendment 1311 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) education oruniversity and post-university teaching activities in health or care sectors;
Amendment 1314 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point e
Article 34 – paragraph 1 – point e
(e) scientific research related to health or care sectors for prevention, early detection, diagnosis, treatment, rehabilitation or healthcare management, including fundamental, exploratory or applied healthcare research;
Amendment 1325 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services contributing to public health or social security and intended for healthcare or long-term care purposes, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
Amendment 1339 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security and intended for healthcare or long-term care purposes, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
Amendment 1372 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point a
Article 35 – paragraph 1 – point a
(a) taking decisions detrimental to a natural person or a group of natural persons based on their electronic health data; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;
Amendment 1377 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point b
Article 35 – paragraph 1 – point b
(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance or credit contract or to modify their contributions and insurance premiums or conditions of loans or exclude them from the benefit of participating in clinical trials;
Amendment 1388 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
Amendment 1393 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e
Article 35 – paragraph 1 – point e
(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco and nicotine products, weaponries or products, or goods or services which are designed or modified in such a way that they incite chemical, behavioural or any other type of addiction or that they contravene public order or morality.
Amendment 1404 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) automated individual decision- making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679.
Amendment 1412 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e b (new)
Article 35 – paragraph 1 – point e b (new)
(e b) data of pharmaceutical prescriptions or medical devices by commercial name, with the exception of usage by public authorities.
Amendment 1415 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e c (new)
Article 35 – paragraph 1 – point e c (new)
(e c) national defense and security.
Amendment 1417 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e d (new)
Article 35 – paragraph 1 – point e d (new)
(e d) confidential data used by public bodies which are market regulators.
Amendment 1436 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Member States shall ensure that each health data access body is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers in a timely manner.
Amendment 1468 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point d
Article 37 – paragraph 1 – point d
(d) process electronic health data for the purposes set out in Article 34, including the collection, combination, preparation and disclosure of those data for secondary use on the basis of a data permit, while also ensuring proper security of that data;
Amendment 1490 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point j
Article 37 – paragraph 1 – point j
(j) cooperate with and supervise data holders to enable them to enact their rights to opt-out of data processing for secondary use as referred to in Article 33(5a) and to opt-in for data processing for the specific categories of data referred to in Article 33(5b) ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;
Amendment 1532 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 2 – point d a (new)
Article 37 – paragraph 2 – point d a (new)
(d a) cooperate with European institutions and agencies, where applicable in accordance with Union law.
Amendment 1543 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
(c) the applicable rights of natural persons in relation to secondary use of electronic health data, including the right to opt-out referred to in Article 33(5a) and the right to opt-in for the categories of data referred to in Article 33(5b);
Amendment 1550 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – point d a (new)
Article 38 – paragraph 1 – point d a (new)
(d a) the record on who has been granted access to the data, the legal basis and the purpose, in accordance with Union and national law;
Amendment 1558 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. HAt the request of a natural person or a group representing natural persons, health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.
Amendment 1566 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Where a health data access body isData users shall inform the health data access bodies of conclusive findings that arise from the secondary use of natural persons’ health data. Health data access bodies shall provide an accessible and easily understandable mechanism for natural persons to express their explicit will to be informed by a data user of a finding that may impact on the health of athat natural person, the health data access body may inform the natural person and his or her treating health professional about. Electronic health records shall notify the health professionals with the appropriate competence to communicate to the natural person about that finding to better evaluate thate finding and its consequences.
Amendment 1571 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this Regulation.
Amendment 1574 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this Regulation.
Amendment 1627 #
2022/0140(COD)
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. The data holder shall put the electronic health data at the disposal of the health data access body within 23 months from receiving the request from the health data access body. In exceptional cases, that period may be extended by the health data access body for an additional period of 2 months.
Amendment 1632 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to set up, data enrichment, maintainance or updating of the dataset and conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]. No fees should be charged to public health authorities, at local, regional or national level or to address public health research, including but not limited to, epidemiological surveillance or monitoring of health projects and programmes.
Amendment 1646 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting, set up, data enrichment, maintainance or updating of the dataset and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update that dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
Amendment 1657 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 6
Article 42 – paragraph 6
6. The Commission mayshall, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1665 #
2022/0140(COD)
4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non- compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years, and fines shall be imposed in accordance with Article 83 of the Regulation (EU) 2016/679.
Amendment 1671 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance with Article 49.
Amendment 1677 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 5 a (new)
Article 43 – paragraph 5 a (new)
5 a. Any natural person affected by a breach of the data permit issued pursuant to Articles 35 and 46 should have the right to an effective judicial remedy before a tribunal in accordance with Article 47 of the Charter of Fundamental Rights of the European Union.
Amendment 1685 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission mayshall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1715 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access bodyholder. Data users shall not re- identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.
Amendment 1721 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3 a. In providing anonymised and pseudonymised datasets, health data access bodies shall follow the state-of-the- art in anonymisation and pseudonymisation technologies. The European Health Data Space Board, together with the digital health authorities, shall discuss and create norms and standards for data holders to apply.
Amendment 1752 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point g
Article 45 – paragraph 2 – point g
(g) an justified estimation of the period during which the electronic health data is needed for processing;
Amendment 1756 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h a (new)
Article 45 – paragraph 2 – point h a (new)
(h a) a communication plan defining audiences and tools to publicly inform on the results or outcomes of the access to the data in accordance with Article 46(11);
Amendment 1760 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h b (new)
Article 45 – paragraph 2 – point h b (new)
(h b) provide the specified information under Article 14 of Regulation (EU) 2016/679 and facilitate the exercise of the rights of natural persons with Chapter III of Regulation (EU) 2016/67.
Amendment 1761 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h c (new)
Article 45 – paragraph 2 – point h c (new)
(h c) information, such as but not limited to professional qualifications, which justify the data applicant's suitability to use the requested data for the intended purpose.
Amendment 1767 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 4 – introductory part
Article 45 – paragraph 4 – introductory part
4. Where the applicant intends to access the personal electronic health data in a pseudonymised format or non- personal data, the following additional information shall be provided together with the data access application:
Amendment 1813 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 26 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
Amendment 1843 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 9
Article 46 – paragraph 9
9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted within 6 months followingimmediately after the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.
Amendment 1851 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 182 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public in lay summaries on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 1877 #
2022/0140(COD)
Proposal for a regulation
Article 48 – title
Article 48 – title
Making data available for public sector bodies and Union institutions, bodies, offices andnational public health authorities and European Union public health agencies without a data permit
Amendment 1885 #
2022/0140(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodnational public health authorities and the European Union health agencies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.
Amendment 1890 #
2022/0140(COD)
Proposal for a regulation
Article 49
Article 49
Access to electronic health data from a 1. access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shall be addressed to health data access bodies. 2. issue a data permit in accordance with Article 46 or provide an answer to a data request in accordance with Article 47. The data holder shall then provide access to the electronic health data in a secure processing environment in compliance with Article 50 and may charge fees in accordance with Article 42. 3. 51, the single data provider and the data user shall be deemed joint controllers. 4. shall inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this Article in order to enable the health data access body to fulfil its obligations under Article 37(1) and Article 39.rticle 49 deleted single data holder Where an applicant requests In such case, the data holder may By way of derogation from Article Within 3 months the data holder
Amendment 1900 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Article 50 – paragraph 1 – introductory part
1. TSubject to the issuance of a data permit, the health data access bodies shall provide access to electronic health data only through a secure processing environment, with technical and organisational measures and security and interoperability requirements. In particular, they shall take the following security measures:
Amendment 1910 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 3
Article 50 – paragraph 3
3. The health data access bodies shall ensure regular audits of the secure processing environments. and take immediate corrective action of any shortcomings, risks or vulnerabilities identified in the secure processing environments
Amendment 1917 #
Amendment 1921 #
2022/0140(COD)
Proposal for a regulation
Article 51 – paragraph 1
Article 51 – paragraph 1
1. The health data access bodies and the data users, including Union institutions, bodies, offices and agencies,In addition to data holders, the health data access bodies shall be deemed a controller for the processing of personal electronic health data in accordance with Article 37(1)(d). The data users shall be deemed joint controllers of electronic health data processed in accordance with data permi for the processing of personal electronic health data in pseudonymised form in the secure processing environment pursuant to the data permit. The health data access body shall act as a processor for the health data user´s processing pursuant to a data permit in the secure processing environment.
Amendment 1925 #
2022/0140(COD)
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
2. The Commission shall, by means of implementing acts, establish a template for the joint controllers’ arrangement. Those implementing acts shall be adopted in accordance with the advisory procedure set out in Article 68(2).
Amendment 1929 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. Union institutions, bodies, offices and agencies involved in health research, health policy or analysis, shall be authorised participants of HealthData@EU.
Amendment 1934 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 5
Article 52 – paragraph 5
5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation and whereby the transfer of electronic health data is compliant with the provisions laid down in Chapter V of Regulation (EU) 2016/679 and provide access to data users located in the Union, on equivalent terms and conditions, to the electronic health data available to their health data access bodies. The Commission may adopt implementing acts establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of HealthData@EU for the purposes of secondary use of health data, is compliant with the Chapter IV of this Regulation and Chapter V of Regulation 2016/679 and provides access to data users located in the Union to the electronic health data it has access to on equivalent terms and conditions. The compliance with these legal, organisational, technical and security requirements, including with the standards for secure processing environments pursuant to Article 50 shall be checked under the control of the Commission. These implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.
Amendment 1945 #
2022/0140(COD)
The Commission mayshall, by means of implementing acts, set out:
Amendment 1947 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point a
Article 52 – paragraph 13 – subparagraph 1 – point a
(a) requirements, technical specifications, the IT architecture of HealthData@EU, conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU which shall ensure state- of-the-art data security, confidentiality, and protection of electronic health data in the cross border infrastructure;
Amendment 1952 #
2022/0140(COD)
(aa) conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU;
Amendment 1961 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 2
Article 52 – paragraph 13 – subparagraph 2
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The Commission shall consult with and involve the European Union Agency for Cyber Security (ENISA) in the aforementioned process.
Amendment 1975 #
2022/0140(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. AThe same data permit issued by one concerned health data access body mayshall benefit from mutual recognition by the other concerned health data access bodies.
Amendment 1976 #
2022/0140(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. AThe same data permit issued by one concerned health data access body mayshall benefit from mutual recognition by the other concerned health data access bodies.
Amendment 1981 #
2022/0140(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The Commission shall establish an EU Datasets Catalogue connecting the national catalogues of datasets established by the health data access bodies and other authorised participants in HealthData@EU. taking into consideration the health interoperability resources already developed across the Union.
Amendment 2006 #
2022/0140(COD)
Proposal for a regulation
Article 61 – paragraph 2
Article 61 – paragraph 2
2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization and pseudonymisation techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
Amendment 2017 #
2022/0140(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
Amendment 2023 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor mayshall be invited to the meetings, where the issues discussed are of relevance for them. The Board shall also consult on a regular basis European level patient organisations and European level healthcare professional organisations and may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.
Amendment 2036 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. Stakeholders and relevant third partieRelevant stakeholders, including patients’ ' and healthcare presentativesofessional's organisations and academia, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 2039 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 5
Article 64 – paragraph 5
5. The EHDS Board shall cooperate with other relevant bodies, entities and experts, such as the European Data Innovation Board referred to in Article 26 of Regulation […] [Data Governance Act COM/2020/767 final], competent bodies set up under Article 7 of Regulation […] [Data Act COM/2022/68 final], supervisory bodies set up under Article 17 of Regulation […] [eID Regulation], European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679 and cybersecurity bodies, in particular the European Agency for Cybersecurity (ENISA).
Amendment 2040 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 5 a (new)
Article 64 – paragraph 5 a (new)
5a. The EHDS Board, in conjunction with the European Commission, shall publish an annual report covering the implementation status of the European Health Data Space and other relevant points of development, including with respect to cross-border health data interoperability, and implementation challenges.
Amendment 2066 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point f
Article 65 – paragraph 2 – point f
(f) to facilitate the exchange of views on the secondary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, regulators and policy makers in the health sector to support the design of aligned implementation strategies, guidance and standards and to assess the needs for further improvement.
Amendment 2076 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 5(2), 107(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 2081 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. The power to adopt delegated acts referred to in Articles 5(2), 107(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 2083 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State and targeted stakeholders, including health professionals and patients’ organisations, in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 2086 #
2022/0140(COD)
Proposal for a regulation
Article 68 – paragraph 2 a (new)
Article 68 – paragraph 2 a (new)
2a. In accordance with the Inter- Institutional Agreement of 13 April 2016 on Better Law-Making, the Commission shall make use of expert groups, consult targeted stakeholders and carry out public consultations to gather broader expertise in the early preparation of draft implementing acts.
Amendment 2091 #
2022/0140(COD)
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate and, dissuasive and encouraging corrective action to the infringements. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.
Amendment 2100 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. After 53 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies.
Amendment 2120 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 3 – point b
Article 72 – paragraph 3 – point b
(b) from 32 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;
Amendment 2122 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 32 years after date of entry into application.
Amendment 2129 #
2022/0140(COD)
Proposal for a regulation
Annex II – point 2 – point 2.5
Annex II – point 2 – point 2.5
2.5. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised exporting of personal electronic health data for the reasons of replacing the EHR system by another product. Authorised exporting of personal electronic health data shall be free of charge, without undue delay, or in in any event within one month from the request and in a structured, commonly used and machine-readable format, in line with the interoperability and security requirements to be developed according to Articles 23 and 50.
Amendment 2131 #
2022/0140(COD)
Proposal for a regulation
Annex II – point 3 – point 3.1
Annex II – point 3 – point 3.1
3.1. An EHR system shall be designed and developed in such a way that it ensures highly safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.
Amendment 2133 #
2022/0140(COD)
Proposal for a regulation
Annex IV a (new)
Annex IV a (new)
Amendment 22 #
2022/0105(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Aarhus Convention, ratified by the European Community on 17 February 2005 by Council Decision 2005/370/EC , recognises that increased and ongoing public access to environmental information and the dissemination of such information to different categories of recipient contribute to a greater awareness of environmental matters, a free exchange of views, more effective participation by the public in environmental decision-making and, eventually, to a better environment.
Amendment 25 #
2022/0105(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The Portal should provide the public with free-of-charge and online access to a further integrated and coherent dataset in all official EU languages on key environmental pressures generated by industrial installations since such data constitute a cost-effective tool for drawing comparisons and taking decisions in environmental matters, encouraging better environmental performance, tracking trends, ongoing information demonstrating progress in pollution reduction, benchmarking installations, monitoring compliance with relevant international agreements, monitoring any incidents or accidents with cross-border implications and measures taken to contain the impact thereof, setting priorities and evaluating progress achieved through Union and national environmental policies and programmes.
Amendment 32 #
2022/0105(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to monitor the environmental performance of industrial installations, the data to be included in the Portal should cover, above quantitative thresholds, releases to the environment of certain pollutants, off-site transfers of waste water containing these pollutants and off-site transfers of waste in order to neutralise them.
Amendment 38 #
2022/0105(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The Portal should also include data on the use of water, energy and raw materials by the concerned installations and waste generated by the technological process to allow monitoring of progress towards a circular, highly resource- efficient economy.
Amendment 44 #
2022/0105(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Operators of installations should also report information concerning the production volume, number of employees and operating hours of the concerned installation as well as information on accidents that have led to releases, especially those with cross-border implications, in order to enable the contextualisation of reported data on pollutant releases and off-site transfers of waste and waste water.
Amendment 48 #
2022/0105(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The overall benefit of the Portal for access to environmental information concerning industrial installations should be maximised by including links to other information flows that stem from Union environmental legislation on climate change, air, water and land protection and on waste management, including reporting under Directive 2012/18/EU of the European Parliament and of the Council41, Directive 2008/98/EC of the European Parliament and of the Council42and Directive 2010/75/EU. Moreover, in order to maximise the Portal’s value to users, it should be designed to facilitate future integration with other relevant environmental data flows, including examples of best practices and projects that have environmental benefits once implemented. _________________ 41 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1). 42 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
Amendment 53 #
2022/0105(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) As the operators of livestock production and aquaculture installations, especially smaller ones, may lack the necessary resources to accurately quantify their deliberate releases of pollutants, Member States should be entitled to quantify them on their behalf with the same methods and indicators being used at European level to avoid discrimination.
Amendment 64 #
2022/0105(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) PReal-time public participation should be ensured in further development of the Portal by providing early and effective opportunities to submit comments, information, analysis and opinions for the decision-making process in order to identify the most sustainable and relevant solutions.
Amendment 67 #
2022/0105(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) It should be possible for the Commission to periodically update the list of industrial or agricultural activities in relation to which reporting requirements apply. The Commission should therefore be empowered to adopt delegated acts in accordance with Article 290 of the Treaty amending Annex I to this Regulation to add activities that have, or are expected to have, an impact on health or the environment and to align the Annex with amendments to the Protocol, as well as unveiling activities that involve the adoption of measures ensuring compliance with the provisions in force, reducing their impact on health or the environment and setting a good example to other operators or businesses.
Amendment 73 #
2022/0105(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) When adopting delegated acts, it is of particular importance that the Commission carry out regular, timely and appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making58. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 58 OJ L 123, 12.5.2016, p. 1.
Amendment 110 #
2022/0105(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e
Article 4 – paragraph 1 – point e
(e) the environmental medium (air, water, land) or combination of two or three of them, into which the pollutant is released;
Amendment 136 #
2022/0105(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) use of water, energy and raw materials, as well as the quantities of waste resulting from the technological process;
Amendment 141 #
2022/0105(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e
Article 5 – paragraph 1 – point e
(e) information allowing contextualisation of the data reported under points (a) to (d), including production volume, number of employees, number of operating hours, and information on accidents that have led to releases, particularly those with cross-border implications;
Amendment 148 #
2022/0105(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Operators shall obtain the data referred to in paragraph 1 by means of measurement. Where measurement is not practicable, operators shall use calculation. Where neither measurement nor calculation is practicable, operators may obtain the data by estimation, provided they specify each time the situation and the conditions for which one or other method is used.
Amendment 151 #
2022/0105(COD)
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The data referred to in paragraph 1 shall include releases and transfers reported as totals of all deliberate, accidental, routine and non-routine activities. In providing this data, operators shall specify, where available, any data that relate to accidental releases, especially those with cross-border implications.
Amendment 173 #
2022/0105(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The public shall have the opportunity to submit comments, information, analyses and opinions within a reasonable timeframe. The information, comments, analyses and opinions submitted must be translated into at least two other official languages of the Union, including Romanian, ensuring that all EU citizens have access thereto and the most suitable proposals for improving the portal can be adopted.
Amendment 178 #
2022/0105(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) reporting procedures, which should be the same at European level;
Amendment 180 #
2022/0105(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) the data to be reported and the deadlines for doing so;
Amendment 182 #
2022/0105(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
Member States and the Commission shall promote public awareness of the Portal by means of information campaigns directed at various categories of recipient and understanding and use of the data contained in it.
Amendment 194 #
2022/0105(COD)
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The power to adopt delegated acts referred to in Article 7(3) and Article 14 shall be conferred on the Commission for a period of five years from … [Office of Publication: please insert the date = the date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period and regularly report to the Parliament and Council regarding the situation in the Member States. Where appropriate, these reports may also provide a basis for periodically updating the Regulation. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 12 #
2022/0100(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In order to increase awareness on the global warming potential of ozone depleting substances, in addition to the ozone depleting potential of the substances, their respective global warming potential should also be listed in this Regulation. In order to reduce the risk of pyro- cumulonimbus formation from forest fires and the negative impact on the stratosphere and the ozone layer, Member States should establish binding action plans based on guidelines established by the Commission to reduce deliberate fires and tree burning in forests as much as possible.
Amendment 14 #
2022/0100(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In order to increase people’s awareness on the global warming potential of ozone depleting substances, in addition to the ozone depleting potential of the substances, their respective global warming potential should also be listed in this Regulation.
Amendment 16 #
2022/0100(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Regulation (EC) No 1005/2009 and previous Union legislation, established more stringent control measures than required under the Protocol, requiring more restrictive rules on import and export. Air pollution in the form of nitrogen oxides (NOx) can harm the ozone layer and therefore more ambition is required at Union and Member State level to reduce the use of nitrogen fertilisers.
Amendment 19 #
2022/0100(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Halons Technical Options Committee (HTOC) established under the Protocol indicated that non-virgin halon stocks for critical uses might not be sufficient to meet the needs from 2030 onwards at global level. To avoid that new production of halons become necessary to meet future needs, it is important to take measures to increase the availability and adequate monitoring of stocks of halon recovered from equipment.
Amendment 23 #
2022/0100(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Restrictions set out in this Regulation regarding products and equipment containing ozone depleting substances should also cover products and equipment relying on or containing those substances in order to prevent circumventions of those restrictions.
Amendment 24 #
2022/0100(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) It is important to ensure that ozone depleting substances are allowed to be placed on the market for the purpose of reclamation in the Union, provided that appropriate storage and transport conditions are in place. Ozone depleting substances and the products and equipment containing those substances or whose functioning relies upon those substances should also be allowed to be placed on the market for the purpose of destruction by technologies approved by the Parties or by technologies not yet approved but that are environmentally equivalent.
Amendment 27 #
2022/0100(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The export of products and equipment containing hydrochlorofluorocarbons may be exceptionally permitted in cases where it may be more beneficial to allow these products and equipment to end their natural life cycle in a third country than to be decommissioned and disposed of in the Union, provided that the required appropriate facilities, as well as the specialist staff to carry out such operations, are in place, so as to avoid any further environmental pollution.
Amendment 29 #
2022/0100(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Given that the production process for some ozone depleting substances can result in emissions of the fluorinated greenhouse gas produced trifluoromethane as a by-product, such by-product emissions should be rigorously monitored, destroyed or recovered for subsequent use as a condition for the placing the ozone depleting substance on the market. Producers and importers should also be required to document measures adopted to prevent emissions of trifluoromethane during the production process.
Amendment 30 #
2022/0100(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) To avoid illegal trade of prohibited substances and products covered under this Regulation, the prohibitions established therein as well as the licensing requirements for trade should not only cover the entry of goods into the customs territory for release for free circulation in the Union, but also temporary storage and all other customs procedures established under Union customs law. LProvided that the required appropriate storage facilities are in place, licensing facilitations should be allowed for goods under temporary storage, in order to avoid unnecessary burden on operators and customs authorities.
Amendment 33 #
2022/0100(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The intentional release of ozone depleting substances into the atmosphere, where such release is unlawful, is a serious infringement of this Regulation and should be explicitly prohibited. All feasible measures should be taken by undertakings to reduce the unintentional release of ozone depleting substances into the atmosphere also considering their global warming potential. Thus, it is necessary to lay down provisions on the recovery of used ozone depleting substances from products and equipment and the prevention of leakages of such substances, provided that the required appropriate storage facilities are in place. Recovery obligations should also be extended to building owners and contractors when removing certain foams from buildings to maximise emissions reductions.
Amendment 39 #
2022/0100(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards to the establishment of a list of undertakings that may use ozone depleting substances as process agents as well as the maximum quantities to be used for make- up or for consumption, and maximum emission levels for each undertaking; the determination of essential and analytical uses for which production and import is permitted within a certain period and the specification of authorised users, the granting of derogations from the end-dates and cut-off dates established in relation to critical uses of halons; the authorisation of the temporary production, placing on the market, further supply and use of methyl bromide in emergency cases; the authorisation of the export of products and equipment containing hydrochlorofluorocarbons; the detailed arrangements for the declaration of conformity for pre-charged equipment and verification; the evidence to be provided on the destruction or recovery of trifluoromethane by production during the manufacturing of ozone depleting substances; the form and content of labelling requirements; the authorisation of trade with entities not covered by the Protocol; and the format for the submission of information by Member States on critical uses of halons and illegal trade, as well as the format and means of the information to be reported by undertakings in particular on production, import, export, storage, feedstock uses and destruction. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council28. __________________ 28 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 40 #
2022/0100(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards to the establishment of a list of prohibited uses of ozone depleting substances as feedstock and maximum emission levels for each use.
Amendment 42 #
2022/0100(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to amend certain non- essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (‘TFEU’) should be delegated to the Commission as regards the processes for which ozone depleting substances may be used as process agents, and the maximum amount permitted for such uses including their emissions in the Union, the conditions for the placing on the market and further distribution of ozone depleting substances for essential laboratory and analytical uses, the timeframes established in Annex V for critical uses of halons, the functioning of the licensing system for ozone depleting substances, additional measures for the monitoring of substances and of products and equipment placed under temporary storage and customs procedures, the rules applicable to the release for free circulation of products and equipment imported from or exported to any entity not covered by the Protocol; the establishment of a list of products and equipment for which the recovery of ozone depleting substances and their destruction is technically and economically feasible, and the specification of the technologies to be applied; amendments of Annexes I and II listing ozone depleting substances; the update of global warming and ozone depleting potentials of listed substances; the reporting requirements for Member States on critical uses of halons and illegal trade and the reporting requirements by undertakings in particular on production, import, export, storage, feedstock uses and destruction. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 44 #
2022/0100(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down rules on the production, import, export, placing on the market, storage and further supply as well as use, recovery, recycling, reclamation and destruction of ozone depleting substances, on the reporting of information related to those substances and on the import, export, placing on the market, further supply and use of products and equipment containing ozone depleting substances or whose functioning relies upon on those substances.
Amendment 49 #
2022/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)
Article 3 – paragraph 1 – point 6 a (new)
(6a) 'producers' - means any natural or legal person producing controlled substances or new substances within the Union or who exploits heating or cooling systems, or fire defence system;
Amendment 50 #
2022/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
(9) ‘reclamation’ means the reprocessing of an ozone depleting substance in order to match the performance that is equivalent to that of a virgin substance, taking into account its original intended use;
Amendment 53 #
2022/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘virgin substances’ means substances which are the result of a technological process and which have not previously been used;
Amendment 55 #
2022/0100(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. Pyro-cumulonimbus formation from forest fires and burning trees and the negative impact on the stratosphere and the ozone layer shall be limited by binding national action plans based on guidelines established by the Commission.
Amendment 56 #
2022/0100(COD)
Proposal for a regulation
Article 4 – paragraph 2 b (new)
Article 4 – paragraph 2 b (new)
2b. Member States shall ensure ambition in reducing nitrogen fertilisers based on guidelines established by the Commission.
Amendment 57 #
2022/0100(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
By way of derogation from Article 4(1), ozone depleting substances listed in Annex I may be produced, placed on the market, and subsequently supplied or made available to another person within the Union for payment or free of charge to be used as feedstock. shall be subject to quantitative limits and included in Annexes II and IV, based on a list established by the Commission. The Commission shall conduct an impact assessment study in order to establish the list, by 31 March 2025.
Amendment 61 #
2022/0100(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
The Commission shall, by means of implementing acts, establish a list and determine those quantitative limits and allocate quotas to undertakings for the period from 1 January to 31 December 2026 and for each 12-month period thereafter. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 28(2).
Amendment 63 #
2022/0100(COD)
Proposal for a regulation
Article 6 – paragraph 1 b (new)
Article 6 – paragraph 1 b (new)
Amendment 66 #
2022/0100(COD)
Proposal for a regulation
Article 6 – paragraph 1 c (new)
Article 6 – paragraph 1 c (new)
The Commission is empowered to adopt delegated acts in accordance with Article 29 to supplement this Regulation by establishing additional measures to those set out in this Regulation to set out quantitative limits of ozone depleting substances listed in Annex I used as feedstock within the Union.
Amendment 68 #
2022/0100(COD)
Proposal for a regulation
Article 6 – paragraph 1 d (new)
Article 6 – paragraph 1 d (new)
The Commission may, if appropriate, by means of implementing acts, establish a list of processes for which the use of ozone depleting substances listed in Annex I as feedstocks is prohibited and a maximum emission level for undertakings using ozone depleting substances listed in Annex I as feedstock. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 28(2).
Amendment 70 #
2022/0100(COD)
Proposal for a regulation
Article 6 – paragraph 1 e (new)
Article 6 – paragraph 1 e (new)
Controlled substances produced or placed on the market as feedstock may only be used for that purpose. As of 1 January 2026, containers of such substances shall be labelled with a clear indication that the substance may only be used as feedstock. Where such substances are required to be labelled in accordance with , or Regulation (EC) No 1272/2008, such indication shall be included in the label referred to in those Directives or in the supplemental information part of the label as referred to in Article 25(3) of that Regulation.
Amendment 75 #
2022/0100(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
(1) By way of derogation from Article 4(1), halons may be placed on the market and used for critical uses in accordance with Annex V. Halons may only be placed on the market and subsequently supplied or made available to another person within the Union for payment or free of charge by undertakings authorised by the competent authority of the Member State concerned to store halons for critical uses, provided that it can be demonstrated that appropriate containers and packaging are used for storage and transport purposes.
Amendment 79 #
2022/0100(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
(1) In case of an emergency, where unexpected outbreaks of particular pests or diseases so require, the Commission may, at the request of the competent authority of a Member State, by means of implementing acts, authorise the temporary production, placing on the market, and use of methyl bromide, provided that the placing on the market and use of methyl bromide are allowed respectively under Regulation (EC) No 1107/2009 and Regulation (EU) No 528/2012 and provided that it can be demonstrated that appropriate containers and packaging are used for storage and transport purposes. Any unused quantities of methyl bromide shall be destroyed.
Amendment 83 #
2022/0100(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
(1) By way of derogation from Article 5(1), products and equipment for which the use of the respective ozone depleting substance is authorised in accordance with Article 8 or Article 9 may be placed on the market, subsequently supplied or made available to another person within the Union for payment or free of charge, provided that it can be demonstrated that appropriate containers and packaging are used for storage and transport purposes.
Amendment 91 #
2022/0100(COD)
Proposal for a regulation
Article 15 – paragraph 1 – subparagraph 3 a (new)
Article 15 – paragraph 1 – subparagraph 3 a (new)
The Commission is empowered to adopt implementing acts to set out the evidentiary requirements to satisfy the requirements of this paragraph.
Amendment 109 #
2022/0100(COD)
Proposal for a regulation
Article 17 – paragraph 12 – subparagraph 1
Article 17 – paragraph 12 – subparagraph 1
Member States customs authorities shall designate or approve customs offices or other places and shall specify the route to those offices and places, in accordance with Articles 135 and 267 of Regulation (EU) No 952/2013, for the presentation to customs of ozone depleting substances listed in Annex I and of products and equipment containing those substances or whose functioning relies upon those substances at their entry into or at their exit from the customs territory of the Union. Those customs offices or places shall be sufficiently equipped with the storage and assessment facilities to carry out the relevant physical controls based on risk analysis, and shall be knowledgeable on matters related to the prevention of illegal activities under this Regulation.
Amendment 113 #
2022/0100(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Ozone depleting substances listed in Annex I contained in refrigeration, air- conditioning and heat pump equipment, equipment containing solvents or fire protection systems and fire extinguishers shall, during the maintenance or servicing of equipment or before the dismantling or disposal of equipment, be recovered for destruction, recycling or reclamation, provided that the required appropriate containers and packaging are used, and the specialist staff to carry out the destruction, recycling or reclamation operations are in place.
Amendment 115 #
2022/0100(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Ozone depleting substances listed in Annex es I and II contained in refrigeration, air- conditioning and heat pump equipment, equipment containing solvents or fire protection systems and fire extinguishers shall, during the maintenance or servicing of equipment or before the dismantling or disposal of equipment, be recovered for destruction, recycling or reclamation.
Amendment 117 #
2022/0100(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Building owners and contractors shall ensure that during renovation, refurbishing or demolition activities implying the removal of metal-faced panels that contain foams with ozone depleting substances listed in Annex I are avoided to the extent possible by recovery for reuse or destruction of the foams and the substances contained therein. Member States shall ensure in this regard the appropriate upskilling for construction workers on sustainable working techniques to strengthen recovery, recycling and reclaim.
Amendment 124 #
2022/0100(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Where recovery of the foams referred to in the first subparagraph is not technically feasible, the building owner or contractor shall draw up documentation providing evidence for the infeasibility of the recovery in the specific case, as well as for appropriate storage. Such documentation shall be retained for five years and shall be made available, upon request, to the competent authorities and the Commission.
Amendment 129 #
2022/0100(COD)
Proposal for a regulation
Article 20 – paragraph 9
Article 20 – paragraph 9
9. Member States shall promote the recovery, recycling, reclamation and destruction of ozone depleting substances listed in Annex I and shall establish the minimum qualification requirements for the personnel involved in all these operations.
Amendment 136 #
2022/0100(COD)
Proposal for a regulation
Article 21 – paragraph 3 b (new)
Article 21 – paragraph 3 b (new)
3b.. Undertakings operating refrigeration, air conditioning or heat pump equipment, or fire protection systems, including their circuits, which contain controlled substances shall ensure that the stationary equipment or systems with a fluid charge of: (a) 3 kg or more of controlled substances are checked for leakage at least once every 12 months; this shall not apply to equipment with hermetically sealed systems, which are labelled as such and contain less than 6 kg of controlled substances; (b) 30 kg or more of controlled substances are checked for leakage at least once every 6 months; (c) 300 kg or more of controlled substances are checked for leakage at least once every 3 months; and that any detected leakage is repaired as soon as possible and in any event within 14 days. The equipment or system shall be checked for leakage within 1 month after a leak has been repaired to ensure that the repair has been effective.
Amendment 138 #
2022/0100(COD)
Proposal for a regulation
Article 21 – paragraph 5
Article 21 – paragraph 5
5. Member StatesThe Commission shall establish theUnion minimum qualification requirements for the personnel carrying out activities referred to in paragraph 3in form of intensive/short term trainings for existing skilled personnel within installing companies, followed by certification of both companies and their personnel issued by national certification bodies, according to Commission Implementing Regulation (EU) 2015/20671a for the personnel carrying out activities referred to in paragraph 3. _________________________ 1a Commission Implementing Regulation (EU) 2015/2067 of 17 November 2015 establishing, pursuant to Regulation (EU) No 517/2014 of the European Parliament and of the Council, minimum requirements and the conditions for mutual recognition for the certification of natural persons as regards stationary refrigeration, air conditioning and heat pump equipment, and refrigeration units of refrigerated trucks and trailers, containing fluorinated greenhouse gases and for the certification of companies as regards stationary refrigeration, air conditioning and heat pump equipment, containing fluorinated greenhouse gases (OJ L 301, 18.11.2015, p. 28).
Amendment 140 #
2022/0100(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The Commission is empowered to adopt delegated acts in accordance with Article 29 to amend Annex II with a view to updating it to include in that Annex any substances that are not covered by this Regulation but have been found by the Scientific Assessment Panel (‘SAP’), established under the Protocol, or by another recognised authority of equivalent stature to have a significant ozone- depleting potential.
Amendment 144 #
2022/0100(COD)
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 3 a (new)
Article 24 – paragraph 1 – subparagraph 3 a (new)
Each year by 31 March [OP: Please insert the year of application of this Regulation], and every year thereafter, each undertaking that placed on the market ozone depleting substances shall submit to the Commission a report demonstrating compliance with Article 15(2).
Amendment 145 #
2022/0100(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
(2) The Commission and the competent authorities of the Member States shall take appropriate measures to protect the confidentiality of the information submitted to it in accordance with this Article and the conditions under which access to these data is granted.
Amendment 148 #
2022/0100(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The competent authorities of Member States shall carry out regular checks to establish whether undertakings comply with their obligations under this Regulation.
Amendment 150 #
2022/0100(COD)
Proposal for a regulation
Article 26 – paragraph 3 – subparagraph 1
Article 26 – paragraph 3 – subparagraph 1
Checks referred to in paragraphs 1 and 2 shall include on-site visits of establishments with the appropriate frequency by maintaining the benchmarks set in Regulation (EC) No 1005/2009 and verification of relevant documentation and equipment.
Amendment 152 #
2022/0100(COD)
Proposal for a regulation
Article 27 – paragraph 3 – point d
Article 27 – paragraph 3 – point d
(d) the financial and social situation of the undertaking held responsible; , including the working conditions criteria according with the provisions of Directive 2009/104/EC of the European Parliament and of the Council1a; _______________ 1a Directive 2009/104/EC of the European Parliament and of the Council of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC (OJ L 260, 3.10.2009, p. 5).
Amendment 160 #
2022/0100(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. The power to adopt delegated acts referred to in Article 6(4), Article 7(4), Article 8(7), Article 9(3), Article 16(13), Article 18, Article 19(2), Article 20(8), Article 22, Article 23(3) and Article 24(4) shall be conferred on the Commission for an indeterminate period of time [from the date of application of the Regulation]
Amendment 162 #
2022/0100(COD)
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – paragraph 3
3. The delegation of power referred to in Article 6(4), Article 7(4), Article 8(7), Article 9(3), Article 16(13), Article 18, Article 19(2), Article 20(8), Article 22, Article 23(3) and Article 24(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 164 #
2022/0100(COD)
Proposal for a regulation
Article 29 – paragraph 6
Article 29 – paragraph 6
6. A delegated act adopted pursuant to Article 6(4), Article 7(4), Article 8(7), Article 9(3), Article 16(13), Article 18, Article 19(2), Article 20(8), Article 22, Article 23(3) and Article 24(4) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 224 #
2022/0066(COD)
Proposal for a directive
Recital 4
Recital 4
(4) This Directive should apply to criminal conduct which amounts to violence against women or domestic violence, as criminalised under Union or national law. This includes the criminal offences defined in this Directive, namely rape, female genital mutilation, the non- consensual sharing of intimate or manipulated material, cyber stalking, cyber harassment, cyber incitement to violence or hatred and criminal conduct covered by other Union instruments, in particular Directives 2011/36/EU36 and 2011/93/EU37 of the European Parliament and of the Council, which define criminal offences concerning the sexual exploitation of children and trafficking of human beings for the purpose of sexual exploitation. Lastly, certain criminal offences under national law fall under the definition of violence against women. This includes crimes such as femicide, sexual harassment, sexual abuse, stalking, early and forced marriage, forced abortion, forced sterilisation and different forms of cyber violence, such as online sexual harassment, cyber bullying or the unsolicited receipt of sexually explicit material. Domestic violence is a form of violence which has been reaching significant levels in the last few years in all EU countries, and may be specifically criminalised under national law or covered by criminal offences which are committed within the family or domestic unit or between former or current spouses. _________________ 36 Directive 2011/36/EU of the European Parliament and of the Council of 5 April 2011 on preventing and combating trafficking in human beings and protecting its victims, OJ L 101, 15.4.2011, p. 1–11. 37 Directive 2011/93/EU of the European Parliament and of the Council of 13 December 2011 on combating the sexual abuse and sexual exploitation of children and child pornography, and replacing Council Framework Decision 2004/68/JHA, OJ L 335, 17.12.2011, p. 1– 14.
Amendment 267 #
2022/0066(COD)
Proposal for a directive
Recital 8
Recital 8
(8) Domestic violence is a serious social problem which often remains hidden, in the absence of reporting by victims and adequate information about reporting to the relevant authorities. It can lead to serious psychological and physical trauma with severe consequences because the offender typically is a person known to the victims, whom they would expect to be able to trust. Such violence can take on various forms, including physical, sexual, psychological and economic. Domestic violence may occur whether or not the offender shares or has shared a household with the victim. Victims usually hesitate to complain about such acts of violence because they do not have any way of leaving home, especially where there are children involved.
Amendment 277 #
2022/0066(COD)
Proposal for a directive
Recital 9
Recital 9
(9) In light of the specificities related to these types of crime it is necessary to lay down a comprehensive set of rules, which addresses the persisting problem of violence against women and domestic violence in a targeted manner and caters to the specific needs of victims of such violence, in order to remove them from the conflict zone and protect them. The existing provisions at Union and national levels have proven to be insufficient to effectively combat and prevent violence against women and domestic violence. In particular, Directives 2011/36/EU and 2011/93/EU concentrate on specific forms of such violence, while Directive 2012/29/EU of the European Parliament and of the Council38 lays down the general framework for victims of crime. While providing some safeguards for victims of violence against women and domestic violence, it is not set out to address their specific needs, and numerous offences, including criminal acts against women, are still being recorded. _________________ 38 Directive 2012/29/EU of the European Parliament and of the Council of 25 October 2012 establishing minimum standards on the rights, support and protection of victims of crime, and replacing Council Framework Decision 2001/220/JHA (OJ L 315, 14.11.2012, p. 57).
Amendment 303 #
2022/0066(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Victims of violence against women and domestic violence are at an increased risk of intimidation, retaliation, secondary and repeat victimisation, and murder. Particular attention should thus be paid to these risks and to the need to protect the dignity and physical integrity of such victims, as well as their lives and children, where necessary.
Amendment 310 #
2022/0066(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Rape is one of the most serious offences breaching a person’s sexual integrity and is a crime that disproportionately affects women. It entails a power imbalance between the offender and the victim, which allows the offender to sexually exploit the victim for purposes such as personal gratification, asserting domination, gaining social recognition, advancement or possibly financial gain. Many Member States still require the use of force, threats or coercion for the crime of rape. Other Member States solely rely on the condition that the victim has not consented to the sexual act, which is often difficult to prove in court. Only the latter approach achieves the full protection of the sexual integrity of victims. Therefore, it is necessary to ensure equal protection throughout the Union by providing the constitutive elements of the crime of rape of women. .
Amendment 323 #
2022/0066(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Rape should explicitly include all types of sexual penetration, with any bodily part or object. The lack of consent should be a central and constitutive element of the definition of rape, given that frequently no physical violence or use of force is involved in its perpetration. Initial consent should be withdrawable at any given time during the act, in line with the sexual autonomy of the victim, should be sustainable and acceptable in court and should not automatically imply consent for future acts. Non-consensual sexual penetration should constitute rape even where committed against a spouse or intimate partner.
Amendment 333 #
2022/0066(COD)
Proposal for a directive
Recital 15
Recital 15
(15) With regard to offences amounting to rape, offenders who have been previously convicted of offences of the same nature should be obliged to wear an electronic tag and participate in intervention programmes to mitigate the risk of recidivism.
Amendment 365 #
2022/0066(COD)
Proposal for a directive
Recital 17
Recital 17
(17) It is necessary to provide for harmonised definitions at European and international level of offences and penalties regarding certainall forms of cyber violence. Cyber violence particularly targets and impacts women politicians, journalists and human rights defenders. It can have the effect of silencing women and hindering their societal participation on an equal footing with men. Cyber violence also disproportionately affects women and girls in educational settings, and vulnerable adolescents in general, such as schools and universities, with detrimental consequences to their further education and to their mental health, which may, in extreme cases, lead to suicide.
Amendment 371 #
2022/0066(COD)
(18) The use of information and communication technologies, which is growing rapidly at European and global level, bears the risk of easy, fast and wide- spread amplification of certain forms of cyber violence with the effect of creating or enhancing profound and long-lasting harm for the victim. The potential for such amplification, which is a pre-requisite for the perpetration of several offences of cyber violence defined under this Directive, should be reflected by the element of making certain material accessible, through information and communication technologies, to a ‘multitude’ of end-users. The term ‘multitude’ should be understood as referring to reaching a significant number of end-users of the technologies in question, thus allowing for significant access to, and potential further distribution of that material. That term should be interpreted and applied having regard to the relevant circumstances, including the technologies used to make that material accessible and the means these technologies offer for amplification.
Amendment 374 #
2022/0066(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Especially due to its tendency for easy, swift and broad distribution and perpetration, as well as its intimate nature, the non-consensual making accessible of intimate images or videos and material that depict sexual activities, to a multitude of end-users, by means of information and communication technologies, can be very harmful for the victims. The offence provided for in this Directive should cover all types of such material, such as images, photographs and videos, including sexualized images, audio clips and video clips. It should relate to situations where the making accessible of the material to a multitude of end-users, through information and communication technologies, occurs without the victim’s consent, irrespective of whether the victim consented to the generation of such material or may have transmitted it to a particular person. The offence should also include the non-consensual production or manipulation, for instance by image editing, of material that makes it appear as though another person is engaged in sexual activities, insofar as the material is subsequently made accessible to a multitude of end-users, through information and communication technologies, without the consent of that person. Such production or manipulation should include the fabrication of ‘deepfakes’, where the material appreciably resembles an existing person, objects, places or other entities or events, depicting sexual activities of another person, and would falsely appear to others to be authentic or truthful. In the interest of effectively protecting victims of such conduct, threatening to engage in such conduct should be covered as well. There needs to be cooperation with all telephony operators and social network owners and then they need to be involved in the processes of detecting such behaviours and stopping them.
Amendment 382 #
2022/0066(COD)
Proposal for a directive
Recital 20
Recital 20
(20) Cyber stalking is a modern form of violence which is often perpetrated against family members or persons living in the same household, but also perpetrated by ex-partners or acquaintances, and it is becoming increasingly common amid the rapid development of new technologies and applications. Typically, technology is misused by the offender to proceed to intensify coercive and controlling behaviour, manipulation and surveillance, thereby increasing the victim’s fear, anxiety and gradual isolation from friends and family. Therefore, minimum rules on cyber stalking shouldmust be established as soon as possible. The offence of cyber stalking should cover the continuous surveillance of the victim without their consent or legal authorisation by means of information and communication technologies. This might be enabled by processing the victim’s personal data, such as through identity theft or the spying out of such data on their various social media or messaging platforms, their emails and phone, stealing passwords or hacking their devices to access their private spaces, via the installation of geo-localisation apps, including stalkerware, or via stealing their devices. Furthermore, stalking should cover the monitoring of victims, without that person’s consent or authorisation, via technology devices connected through the Internet of Things, such as smart home appliances.
Amendment 422 #
2022/0066(COD)
Proposal for a directive
Recital 28
Recital 28
(28) Victims of domestic violence and violence against women are typically in need of immediate protection or specific support, for example in the case of intimate partner violence, where the rate of recidivism tends to be high. Therefore, an individual assessment to identify the victim’s protection needs should be conducted upon the very first contact of competent authorities with the victim or as soon as suspicion arises that the person is a victim of violence against women or domestic violence, so that the victim can be removed from the persecutor’s influence. This can be done before a victim has formally reported an offence or proactively if a third party reports the offence.
Amendment 428 #
2022/0066(COD)
Proposal for a directive
Recital 29
Recital 29
(29) When assessing the victim’s protection and support needs, the primary concern should lie in safeguarding the victim’s safety and providing tailored support, taking into account, among other matters, the individual circumstances of the victim. Such circumstances requiring special attention could include the victim’s pregnancy or the victim’s dependence on or relationship to the offender, or children who are at risk of becoming victims of the violence.
Amendment 442 #
2022/0066(COD)
Proposal for a directive
Recital 31
Recital 31
(31) Due to their vulnerability to secondary and repeat victimisation, to intimidation and to retaliation, and the fact that they suffer emotional harm that prejudices their development, the victim’s children should receive the same protection measures as those accorded to the victim. Other persons dependant on the victim, such as adults with disabilities or older dependant adults for whom the victim provides care, may experience similar emotional harm and should thus be accorded the same protection measures, either those granted by public authorities or with the support of non-governmental organisations working in the field.
Amendment 446 #
2022/0066(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Victims of violence against women and domestic violence are often in need of specific support. To ensure they effectively receive offers of support, the competent authorities should refer victims to appropriate support services. This should in particular be the case where an individual assessment has found particular support needs of the victim. In that case, support services should be able to reach out to the victim even without the victim’s consent. For the processing of related personal data by competent authorities, Member States should ensure that it is based on law, in accordance with Article 6(1)(c) read in conjunction with Article (6)(2) and (3) of Regulation (EU) 2016/679 of the European Parliament and of the Council41. Such laws should include appropriate personal data safeguards that respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the individuals. Where competent authorities transfer victims’ personal data to support services for victims’ referral, they should ensure that the data transferred is limited to what is necessary to inform the services of the circumstances of the case, and that the persons who have access to the information and the period are established very clearly, so that victims receive appropriate support and protection. _________________ 41 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance), (OJ L 119, 4.5.2016, p. 1–88).
Amendment 452 #
2022/0066(COD)
Proposal for a directive
Recital 33
Recital 33
(33) Member States should take the necessary measures to ensure the availability of emergency barring, restraining and protection orders to ensure effective protection of victims and their dependants, including the introduction of an obligation to wear an electronic ankle tag in the event of reoffending.
Amendment 458 #
2022/0066(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Protection orders may include prohibiting the offender or suspect to access certain localities; to and wearing an electronic tag in the event of reoffending, particularly to prevent them approaching the victim or dependant closer than a prescribed distance or to contact them, including through the use of online interfaces and to possess firearms or deadly weapons, where necessary.
Amendment 471 #
2022/0066(COD)
Proposal for a directive
Recital 38
Recital 38
(38) Given the complexities and gravity of offences of violence against women and domestic violence and specific support needs of victims, Member States should ensure additional support and prevention of such offences is provided by designated bodies. Given their expertise in matters of discrimination on grounds of sex, national equality bodies, set up in accordance with Directives 2004/113/EC42, 2006/54/EC43 and 2010/41/EU44 of the European Parliament and of the Council, are well placed to fulfil these tasks. Such bodies should in addition have legal standing to act on behalf or in support of victims of all forms of violence against women or domestic violence in judicial proceedings, including for the application for compensation and removal of online illegal content, with the victims’ approval. This should include the possibility of acting on behalf or in support of several victims together. To enable these bodies to effectively carry out their tasks, Member States should ensure that they are provided with sufficient human and financial resources. and provide periodic training to specialised personnel in order to keep pace with the development of new technologies used in connection with the aforementioned offences. _________________ 42 Council Directive 2004/113/EC of 13 December 2004 implementing the principle of equal treatment between men and women in the access to and supply of goods and services, (OJ L 373, 21.12.2004, p. 37). 43 Directive 2006/54/EC of the European Parliament and of the Council of 5 July 2006 on the implementation of the principle of equal opportunities and equal treatment of men and women in matters of employment and occupation (recast), (OJ L204, 26.7.2006, p. 23). 44 Directive 2010/41/EU of the European Parliament and of the Council of 7 July 2010 on the applicationof the principle of equal treatment between men and women engaged in an activity in a self-employed capacity and repealing Council Directive 86/613/EEC, (OJ L 180, 15.7.2010, p. 1).
Amendment 480 #
2022/0066(COD)
Proposal for a directive
Recital 39
Recital 39
(39) Certain offences covered by this Directive involve the increased risk of repeated, prolonged or even continuous victimisation. That risk occurs especially in relation to offences involving the making accessible to a multitude of end-users, through information and communication technologies, of material, resulting from certain offences of cyber violence, considering the ease and speed with which such material can be distributed on a large scale and the difficulties that often exist when it comes to removing such material. That risk typically remains even after a conviction. Therefore, in order to effectively safeguard the rights of the victims of those offences, Member States should be required to take suitable measures aimed at the removal of the material in question and to request assistance from telephone operators and social network owners to this end. Considering that removal at the source may not always be feasible, for instance because of legal or practical difficulties relating to the execution or enforcement of an order to remove, Member States should also be allowed to provide for measures to disable access to such material.
Amendment 492 #
2022/0066(COD)
Proposal for a directive
Recital 44
Recital 44
(44) In order to avoid secondary victimisation, victims should be able to obtain compensation in the course of criminal proceedings. Compensation from the offender should be full and should not be restricted by a fixed upper limit. It should cover all harm and trauma experienced by victims and costs incurred to manage the damages, including among other things therapy costs, impact on the victim’s employment situation, loss of earnings, psychological damages, and moral prejudice due to the violation of dignity. The amount of compensation should reflect that victims of domestic violence may have to uproot their lives in order to seek safety, entailing a possible change of address or employment or finding new schools for children or even creating a new identity.
Amendment 520 #
2022/0066(COD)
Proposal for a directive
Recital 48
Recital 48
(48) Victims of domestic violence and violence against women typically have multiple protection and support needs. In order to address these effectively, Member States should provide such services at the same premises, or have such services coordinated through a central contact point. To ensure also victims in remote areas or unable to physically reach such centres are reached, Member States should provide for online access to such services. This should entail setting up a single and updated website where all relevant information on and access to available support and protection services is provided (one-stop online access). The website should follow accessibility requirements for persons with disabilities and ensure greater protection of victims’ personal data.
Amendment 563 #
2022/0066(COD)
Proposal for a directive
Recital 53
Recital 53
(53) Shelters play a vital role in protecting victims from acts of violence. Beyond providing a safe place to stay, shelters should provide the necessary support concerning interlocking problems related to victims’ health, financial situation and the well-being of their children and uninterrupted access to school, ultimately preparing victims for an autonomous life.
Amendment 605 #
2022/0066(COD)
Proposal for a directive
Recital 58
Recital 58
(58) Member States should ensure that preventive measures, such as awareness- raising campaigns targeted at different segments of the public, are taken to counter violence against women and domestic violence. Prevention should also take place in formal education from an early age, in particular, through strengthening sexuality education and socio-emotional competencies, empathy and developing healthy and respectful relationships.
Amendment 727 #
2022/0066(COD)
Proposal for a directive
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) “victim” means any person, regardless of sex or gender, unless specified otherwise, who has suffered harm, which was directly caused by one- off or repeated acts of violence covered under this Directive, including child witnesses of such violence;
Amendment 771 #
2022/0066(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Member States shall ensure that a non-consensual act is understood as an act which is performed without the woman’s consent given voluntarily or where the woman is unable to form a free will due to her physical or mental condition, thereby exploiting her incapacity to form a free will, such as in a state of unconsciousness, intoxication, sleep, illness, bodily injury or disability, a non-consensual act which can be accepted and taken into account by courts.
Amendment 851 #
2022/0066(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) placing another person under continuous surveillance, without that person’s consent or legal authorisation to do so, by means of information and communication technologies, to track or monitor that person’s movements and activities; and later use the recordings made to intimidate and manipulate them;
Amendment 856 #
2022/0066(COD)
Proposal for a directive
Article 8 – paragraph 1 – point c
Article 8 – paragraph 1 – point c
(c) making material containing the personal data of another person, without that person’s consent, accessible to a multitude of end-users, by means of information and communication technologies, for the purpose of inciting those end-users to cause physical or significant psychological harm to the person, with a view to intimidating and manipulating them.
Amendment 870 #
2022/0066(COD)
Proposal for a directive
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) initiating an attack with third parties directed at another person, by making threatening or insulting material accessible to a multitude of end-users, by means of information and communication technologies, with the effect of intimidating and manipulating the victim/s; and also causing significant psychological harm to the attacked person;
Amendment 954 #
2022/0066(COD)
(o a) (p) a repeat offence is committed by the offender in any one of the above cases.
Amendment 990 #
2022/0066(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. In addition to the rights of victims when making a complaint under Article 5 of Directive 2012/29/EU, Member States shall ensure that victims are informed that they can report criminal offences of violence against women or domestic violence to the competent authorities in an easy and accessible manner. This shall include the possibility of reporting criminal offences online or through other information and communication technologies, including the possibility to submit evidence, in particular concerning reporting of criminal offences of cyber violence.
Amendment 1120 #
2022/0066(COD)
Proposal for a directive
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Member States shall ensure the transmission of relevant personal data concerning the victim and their situation to the relevant support services, where this is necessary to ensure that the victim receives appropriate support and protection and shall ensure the protection of this data and access to data. Such transmission shall be confidential.
Amendment 1127 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Member States shall ensure that, in situations of immediate danger for the victim’s or their dependant’s health or safety, the competent authorities issue orders addressed at an offender or suspect of violence covered by this Directive to vacate the residence of the victim or their dependants for a sufficient period of time and to prohibit the offender or suspect from entering the residence or to enter the victim’s workplace, coming within a certain distance of the victim or contacting the victim or their dependants in any way. Such orders shall have immediate effect and not be dependent on a victim reporting the criminal offence.
Amendment 1146 #
2022/0066(COD)
Proposal for a directive
Article 21 – paragraph 4
Article 21 – paragraph 4
4. Any breaches of emergency barring or restraining and protection orders shall be subject to effective, immediately enforceable, proportionate and dissuasive criminal or other legal penalties.
Amendment 1255 #
2022/0066(COD)
Proposal for a directive
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) advice and information on any relevant legal or practical matters arising as a result of the crime, including on access to housing, education, training and assistance to move house or remain in or find employment;
Amendment 1463 #
2022/0066(COD)
Proposal for a directive
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Preventive measures shall include awareness-raising campaigns, research and education programmes, where appropriate developed in cooperation with relevant civil society organisations, social partners, impacted communities and other stakeholders, aimed at different audience categories.
Amendment 1471 #
2022/0066(COD)
Proposal for a directive
Article 36 – paragraph 3
Article 36 – paragraph 3
3. Member States shall make information on preventive measures, the rights of victims, access to justice and to a lawyer, and the available protection and support measures available to the general public and ensure that this information is updated periodically.
Amendment 1549 #
2022/0066(COD)
Proposal for a directive
Article 37 – paragraph 7 a (new)
Article 37 – paragraph 7 a (new)
7a. Member States shall periodically adapt these general or specialised training courses to the development of new technologies, to enable the aforementioned specialists to keep abreast of new methods developed by criminals in the area of cyber violence.
Amendment 108 #
2022/0047(COD)
(5) This Regulation ensures that users of a product or related service in the Union can access, in a timely manner, the data generated by the use of that product or related service and that those users can use the data, including by sharing them with third parties of their choice. It imposes the obligation on the data holder to make data available to users and third parties nominated by the users in certain circumstances and ensure the protection of that data. It also ensures that data holders make data available to data recipients in the Union under fair, reasonable and non-discriminatory terms and in a transparent manner. Private law rules are key in the overall framework of data sharing. Therefore, this Regulation adapts rules of contract law and prevents the exploitation of contractual imbalances that hinder fair data access and use for micro, small or medium-sized enterprises within the meaning of Recommendation 2003/361/EC. This Regulation also ensures that data holders make available to public sector bodies of the Member States and to Union institutions, agencies or bodies, where there is an exceptional need, the data that are necessary for the performance of tasks carried out in the public interest. In addition, this Regulation seeks to facilitate switching between data processing services and to enhance the interoperability of data and data sharing mechanisms and services in the Union. This Regulation should not be interpreted as recognising or creating any legal basis for the data holder to hold, have access to or process data, or as conferring any new right on the data holder to use data generated by the use of a product or related service. Instead, it takes as its starting point the control that the data holder effectively enjoys, de facto or de jure, over data generated by products or related services.
Amendment 124 #
2022/0047(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Physical products that obtain, generate or collect, by means of their components, data concerning their performance, use or environment and that are able to communicate that data via a publicly available electronic communications service (often referred to as the Internet of Things) should be covered by this Regulation. Electronic communications services include land- based telephone networks, television cable networks, satellite-based networks and near-field communication networks. Such products may include vehicles, home equipment and consumer goods, medical and health devices or agricultural and industrial machinery. The data represent the digitalisation of user actions and events and should accordingly be accessible to the user, while information derived or inferred from this data, where lawfully held, should not be considered within scope of this Regulation. Such data are potentially valuable to the user and support innovation and the development of digital and other services protecting the environment, health and the circular economy, in particular though facilitating the maintenance and repair of the products in question, in order to prolong their life and avoid the need to use raw materials for the manufacture of new products.
Amendment 131 #
2022/0047(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The user of a product should be understood as the legal or natural person, such as a business or consumer, which has purchased, rented or leased the product. Depending on the legal title under which he uses it, such a user bears the risks and enjoys the benefits of using the connected product and should enjoy also the access to the data it generates. The user should therefore be entitled to derive benefit from data generated by that product and any related service, subject to protection of that data.
Amendment 133 #
2022/0047(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) In case several persons or entities own a product or are party to a lease or rent agreement and benefit from access to a related service, reasonable efforts should be made in the design of the product or related service or the relevant interface so that all persons can have access to data they generate. Users of products that generate data typically require a user account to be set up. This allows for identification of the user by the manufacturer as well as a means to communicate to exercise and process data access requests. Manufacturers or designers of a product that is typically used by several persons should put in place the necessary mechanism that allow separate user accounts for individual persons, where relevant, or the possibility for several persons to use the same user account and ensure appropriate safeguards when accessing that account during its existence. Access should be granted to the user upon simple request mechanisms granting automatic execution, not requiring examination or clearance by the manufacturer or data holder. This means that data should only be made available when the user actually wants this. Where automated execution of the data access request is not possible, for instance, via a user account or accompanying mobile application provided with the product or service, the manufacturer should inform the user how the data may be accessed.
Amendment 138 #
2022/0047(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In sectors characterised by the concentration of a small number of manufacturers supplying end users, there are only limited options available to users with regard to sharing data with those manufacturers. In such circumstances, contractual agreements may be insufficient to achieve the objective of user empowerment. The data tends to remain under the control of the manufacturers, making it difficult for users to obtain value from the data generated by the equipment they purchase or lease. Consequently, there is limited potential for innovative smaller businesses to offer data-based solutions in a competitive manner and for a diverse data economy in Europe. This Regulation should therefore build on recent developments in specific sectors, such as the Code of Conduct on agricultural data sharing by contractual agreement. Sectoral legislation may be brought forward to address sector-specific needs and objectives and develop new applications and services. Furthermore, the data holder should not use any data generated by the use of the product or related service in order to derive insights about the economic situation of the user or its assets or production methods or the use in any other way that could undermine the commercial position of the user on the markets it is active on. This would, for instance, involve using knowledge about the overall performance of a business or a farm in contractual negotiations with the user on potential acquisition of the user’s products or agricultural produce to the user’s detriment, or for instance, using such information to feed in larger databases on certain markets in the aggregate (,e.g. databases on crop yields for the upcoming harvesting season) as such use could affect the user negatively in an indirect manner. The user should be given the necessary technical interface to manage permissions, preferably with granular permission options (such as “allow once” or “allow while using this app or service”), including the option to withdraw permission.
Amendment 141 #
2022/0047(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The user should be free to use the data for any lawful purpose. This includes providing the data the user has received exercising the right under this Regulation to a third party offering an aftermarket service that may be in competition with a service provided by the data holder, or to instruct the data holder to do so. The data holder should ensure that the data made available to the third party is as accurate, complete, reliable, relevant and up-to-date as the data the data holder itself may be able or entitled to access from the use of the product or related service. Any trade secrets or intellectual property rights should be respected in handling the data. It is important to preserve incentives to invest in products with functionalities based on the use of data from sensors built into that product. The aim of this Regulation should accordingly be understood as to foster the development of new, innovative products or related services tailored to the development of society and user needs, stimulate innovation on aftermarkets, but also stimulate the development of entirely novel services making use of the data, including based on data from a variety of products or related services. At the same time, it aims to avoid undermining the investment incentives for the type of product from which the data are obtained, for instance, by the use of data to develop a competing product.
Amendment 147 #
2022/0047(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) In order to prevent the exploitation of users, third parties to whom data has been made available upon request of the user should only process the data for the purposes agreed with the user and share it with another third party only if this is necessary to provide the service requested by the user, subject to the protection of that data .
Amendment 153 #
2022/0047(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) In order to ensure that the conditions for mandatory data access are fair for both parties, the general rules on data access rights should refer to the rule on avoiding unfair contract terms, so as to avoid possible prejudice to one party in favour of the other.
Amendment 156 #
2022/0047(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) To protect micro, small or medium- sized enterprises from excessive economic burdens which would make it commercially too difficult for them to develop and run innovative business models, the compensation for making data available to be paid by them should not exceed the direct cost of making the data available and be non-discriminatory. A possible means of supporting these businesses in such situations would be to offer affordable subscriptions.
Amendment 160 #
2022/0047(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) Ensuring access to alternative ways of resolving domestic and cross-border disputes that arise in connection with making data available should benefit data holders and data recipients and therefore strengthen trust in data sharing. In cases where parties cannot agree on fair, reasonable and non-discriminatory terms of making data available, dispute settlement bodies should offer a simple, fast and low- cost solution to the parties within a reasonable period.
Amendment 161 #
2022/0047(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) To avoid that two or more dispute settlement bodies are seized for the same dispute, particularly in a cross-border setting, and prevent excessively lengthy proceedings, a dispute settlement body should be able to reject a request to resolve a dispute that has already been brought before another dispute settlement body or before a court or a tribunal of a Member State.
Amendment 168 #
2022/0047(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) In case of public emergencies, such as public health emergencies, emergencies resulting from environmental degradation and major natural disasters including those aggravated by climate change, as well as human-induced major disasters, such as major cybersecurity incidents, the public interest resulting from the use of the data will outweigh the interests of the data holders to dispose freely of the data they hold, especially if such an emergency also has cross-border implications. In such a case, data holders should be placed under an obligation to make the data available to public sector bodies or to Union institutions, agencies or bodies upon their request and for a fixed period, so as to identify the best solutions to resolve the emergency in question. The existence of a public emergency is determined according to the respective procedures in the Member States or of relevant international organisations.
Amendment 175 #
2022/0047(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) An exceptional need may also arise when a public sector body can demonstrate that the data are necessary either to prevent a public emergency, or to assist recovery from a public emergency, in circumstances that are reasonably proximate to the public emergency in question. Where the exceptional need is not justified by the need to respond to, prevent or assist recovery from a public emergency, the public sector body or the Union institution, agency or body should demonstrate that the lack of timely access to and the use of the data requested for a specified period prevents it from effectively fulfilling a specific task in the public interest that has been explicitly provided in law. Such exceptional need may also occur in other situations, for example in relation to the timely compilation of official statistics when data is not otherwise available or when the burden on statistical respondents will be considerably reduced. At the same time, the public sector body or the Union institution, agency or body should, outside the case of responding to, preventing or assisting recovery from a public emergency, demonstrate that no alternative means for obtaining the data requested exists and that the data cannot be obtained in a timely manner through the laying down of the necessary data provision obligations in new legislation.
Amendment 179 #
2022/0047(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) A proportionate, limited and predictable framework at Union level is necessary for the making available of data by data holders, in cases of exceptional needs, to public sector bodies and to Union institution, agencies or bodies both to ensure legal certainty and to minimise the administrative burdens placed on businesses. To this end, data requests by public sector bodies and by Union institution, agencies and bodies to data holders should be transparent and proportionate in terms of their scope of content and their granularity. The purpose of the request and the intended use of the data requested for a clearly specified period should be specific and clearly explained, while allowing appropriate flexibility for the requesting entity to perform its tasks in the public interest. The request should also respect the legitimate interests of the businesses to whom the request is made. The burden on data holders should be minimised by obliging requesting entities to respect the once-only principle, which prevents the same data from being requested more than once by more than one public sector body or Union institution, agency or body where those data are needed to respond to a public emergency. To ensure transparency, data requests made by public sector bodies and by Union institutions, agencies or bodies should be made public without undue delay by the entity requesting the data and online public availability of all requests justified by a public emergency should be ensured.
Amendment 181 #
2022/0047(COD)
Proposal for a regulation
Recital 62
Recital 62
(62) The objective of the obligation to provide the data is to ensure that public sector bodies and Union institutions, agencies or bodies have the necessary knowledge and information to respond to, prevent or recover from public emergencies or to maintain the capacity to fulfil specific tasks explicitly provided by law. The data obtained by those entities may be commercially sensitive. Therefore, Directive (EU) 2019/1024 of the European Parliament and of the Council65 should not apply to data made available under this Regulation and should not be considered as open data available for reuse by third parties. This however should not affect the applicability of Directive (EU) 2019/1024 to the reuse of official statistics for the production of which data obtained pursuant to this Regulation was used, provided the reuse does not include the underlying data. In addition, it should not affect the possibility of sharing the data for conducting research or for the compilation of official statistics, provided the conditions laid down in this Regulation are met. Public sector bodies should also be allowed to exchange data obtained pursuant to this Regulation with other public sector bodies to address the exceptional needs for which the data has been requested, subject to adequate protection of that data. _________________ 65 Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).
Amendment 194 #
2022/0047(COD)
Proposal for a regulation
Recital 74
Recital 74
(74) Data processing service providers should be required to offer all assistance and support that is required to make the switching process successful and effective without requiring those data processing service providers to develop new categories of services within or on the basis of the IT-infrastructure of different data processing service providers to guarantee functional equivalence in an environment other than their own systems. Nevertheless, service providers are required to offer all assistance and support that is required to make the switching process effective at no extra cost to the recipient. Existing rights relating to the termination of contracts, including those introduced by Regulation (EU) 2016/679 and Directive (EU) 2019/770 of the European Parliament and of the Council67 should not be affected. _________________ 67 Directive (EU) 2019/770 of the European Parliament and of the Council of 20 May 2019 on certain aspects concerning contracts for the supply of digital content and digital services (OJ L 136, 22.5.2019, p. 1)’.
Amendment 198 #
2022/0047(COD)
Proposal for a regulation
Recital 85
Recital 85
(85) In order to take account of the rapid development of new technologies in this area and the technical aspects of data processing services, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of supplementing this Regulation to introduce a monitoring mechanism on switching charges imposed by data processing service providers on the market, to further specify the essential requirements for operators of data spaces and data processing service providers on interoperability and to publish the reference of open interoperability specifications and European standards for the interoperability of data processing services. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making of 13 April 201670. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 70 OJ L 123, 12.5.2016, p. 1.
Amendment 199 #
2022/0047(COD)
Proposal for a regulation
Recital 86
Recital 86
(86) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in respect of supplementing this Regulation to adopt common specifications to ensure the periodic updating and interoperability of common European data spaces and data sharing, the switching between data processing services, the interoperability of smart contracts as well as for technical means, such as application programming interfaces, for enabling transmission of data between parties including continuous or real-time and for core vocabularies of semantic interoperability, and to adopt common specifications for smart contracts. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council71 . _________________ 71 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13).
Amendment 276 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point d
Article 3 – paragraph 2 – point d
(d) whether the manufacturer supplying the product or the service provider providing the related service intends to use the data itself or allow a third party to use the data and, if so, the purposes for which those data will be used and the period for which they can be accessed;
Amendment 279 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point g
Article 3 – paragraph 2 – point g
(g) how the user may request that the data are shared with a third-party, the period during which the third party has access to this data and the necessary safeguards after the data access has ended;
Amendment 303 #
2022/0047(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. The user or third party shall not be required to provide any information beyond what is necessary to verify the quality as user or as third party pursuant to paragraph 1. The data holder shall not keep any information on the third party’s access to the data requested beyond the period for which it has been granted and beyond what is necessary for the sound execution of the third party’s access request and for the security and the maintenance of the data infrastructure.
Amendment 317 #
2022/0047(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. A third party shall process the data made available to it pursuant to Article 5 only for the purposes and under the conditions agreed with the user, including the period of access, and subject to the rights of the data subject insofar as personal data are concerned, and shall delete the data when they are no longer necessary for the agreed purpose.
Amendment 348 #
2022/0047(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Data holders and data recipients shall have access to cross-border and other dispute settlement bodies, certified in accordance with paragraph 2 of this Article, to settle disputes in relation to the determination of fair, reasonable and non- discriminatory terms for and the transparent manner of making data available in accordance with Articles 8 and 9.
Amendment 354 #
2022/0047(COD)
Proposal for a regulation
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) destroy the data made available by the data holder and any copies thereof after expiry of the period for which access has been granted;
Amendment 389 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) specify what data are required and the period of access thereto;
Amendment 391 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
(c) explain the purpose of the request, the intended use of the data requested, and the duration of that use as well as the procedure to be followed after expiry of the access period;
Amendment 405 #
2022/0047(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. A data holder receiving a request for access to data under this Chapter shall make the data available to the requesting public sector body or a Union institution, agency or body without undue delay during the agreed period of access.
Amendment 414 #
2022/0047(COD)
Proposal for a regulation
Article 19 – paragraph 1 – point a
Article 19 – paragraph 1 – point a
(a) not use the data in a manner incompatible with the purpose for which they were requested and beyond the agreed period of access;
Amendment 474 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 2 – point c
Article 31 – paragraph 2 – point c
(c) the national competent authority responsible for the application and enforcement of Chapter VI of this Regulation shall have the necessary expertise and experience in the field of data and electronic communications services.
Amendment 476 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point a
Article 31 – paragraph 3 – point a
(a) promoting information and awareness among users and entities falling within scope of this Regulation of the rights and obligations under this Regulation;
Amendment 477 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point f
Article 31 – paragraph 3 – point f
(f) cooperating with competent authorities of other Member States to ensure the consistent application of this Regulation, particularly regarding issues with cross-border implications, including the exchange of all relevant information by electronic means, without undue delay;
Amendment 12 #
2022/0031(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) According to Regulation (EU) 2021/953, test certificates are to be issued based on two types of tests for SARS-CoV- 2 infection, namely molecular nucleic acid amplification tests (‘NAAT’), including those using reverse transcription polymerase chain reaction (‘RT-PCR’), and rapid antigen tests, which rely on detection of viral proteins (antigens) using a lateral flow immunoassay that gives results in less than 30 minutes, provided they are carried out by health professionals or by skilled testing personnel. However, Regulation (EU) 2021/953 does not cover antigenic assays, such as enzyme-linked immunosorbent assays or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests2, responsible for preparing updates to the common list of COVID-19 rapid antigen tests3 agreed by the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council4, also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory- based antigenic assays. Those proposals are assessed against the same criteria as those used for rapid antigen tests, and the Health Security Committee has established a list of the laboratory-based antigenic assays that meet those criteria. As a result, and in an effort to enlarge the scope of the different types of diagnostic tests that may be used as the basis for the issuance of an EU Digital COVID Certificate, the definition for rapid antigen tests should be adapted to include laboratory-based antigenic assayand antibody detection tests, including serological tests for SARS-CoV-2 antibodies, should be adapted to include laboratory-based antigenic assays and antibody detection tests, including serological tests for SARS-CoV-2 antibodies. It should thus be possible for Member States to issue test certificates on the basis of the antigen tests or the antibody tests, including serological tests for SARS-CoV-2 antibodies, included in the EU common list agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria. _________________ 2 https://ec.europa.eu/health/health- security-and-infectious-diseases/crisis- management/covid-19-diagnostic-tests_en 3 https://ec.europa.eu/health/system/files/202 2-01/covid-19_rat_common-list_en.pdf 4 Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 33 #
2022/0031(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) As a result, it cannot be excluded that Member States continue to require Union citizens exercising their right to free movement to present proof of COVID-19 vaccination, test or recovery beyond 30 June 2022, the date when Regulation (EU) 2021/953 is set to expire. It is thus important to avoid that, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022, Union citizens and their family members are deprived of the possibility to make use of their EU Digital COVID Certificates, which are an effective, secure and privacy-preserving way of proving one’s COVID-19 status. At the same time, given that any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV- 2, including the requirement to present EU Digital COVID Certificates, should be lifted as soon as the epidemiological situation allows, the extension of the application of Regulation (EU) 2021/953 should be limited to 12 monthsuntil 30 June 2022. In addition, the extension of that Regulation should not be understood as requiring Member States, in particular those that lift domestic public health measures, to maintain or impose free movement restrictions. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union delegated to the Commission pursuant to Regulation (EU) 2021/953 should be equally extended. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to scientific progress in containing the COVID-19 pandemic.
Amendment 41 #
2022/0031(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Similarly, Regulation (EU) 2022/XXXX of the European Parliament and of the Council8 does not prolongs the period of application of Regulation (EU) 2021/954 of the European Parliament and of the Council9, which extends the EU Digital COVID Certificate framework to third-country nationals who are legally staying or residing in the Schengen area without controls at internal borders and applies as a matter of Schengen acquis, without prejudice to the specific rules on the crossing of internal borders set out in Regulation (EU) 2016/399 of the European Parliament and of the Council10. _________________ 8 Reference to be added. 9 Regulation (EU) 2021/954 of the European Parliament and of the Council of 14 June 2021 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) with regard to third- country nationals legally staying or residing in the territories of Member States during the COVID-19 pandemic (OJ L 211, 15.6.2021, p. 24). 10 Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (OJ L 77, 23.3.2016, p. 1).
Amendment 45 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 2021/953
Article 2 – paragraph 5 – point b a (new)
Article 2 – paragraph 5 – point b a (new)
(ba) antibody detection tests, including serological tests for SARS-CoV-2 antibodies, carried out by authorised personnel,
Amendment 46 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a – point i
Article 1 – paragraph 1 – point 2 – point a – point i
Regulation (EU) 2021/953
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) a certificate confirming that the holder has been subject to a NAAT test, or an antigen test listed in the EU common list of COVID-19 antigen testsan antigen test, an antibody test, or a serological test for antibodies against SARS-CoV-2, listed in the EU common list of COVID-19 antigen tests or antibody tests, including serological tests for antibodies against SARS-CoV-2, agreed by the Health Security Committee, carried out by health professionals or by skilled testing personnel in the Member State issuing the certificate and indicating the type of test, the date on which it was carried out and the result of the test (test certificate);
Amendment 48 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a a (new)
Article 1 – paragraph 1 – point 2 – point a a (new)
Regulation (EU) 2021/953
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) In paragraph 1, point (ba) is added: “(ba) antibody tests, including serological tests for antibodies against SARS-CoV-2, conducted by authorised personnel;”
Amendment 50 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a – point ii
Article 1 – paragraph 1 – point 2 – point a – point ii
Regulation (EU) 2021/953
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
The Commission shall publish the EU common list of COVID-19 antigen tests and antibody tests, including serological tests for antibodies against SARS-CoV-2, agreed by the Health Security Committee, including any updates.;
Amendment 56 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EU) 2021/953
Article 5 – paragraph 5 – subparagraph 3 a (new)
Article 5 – paragraph 5 – subparagraph 3 a (new)
Member States may also issue vaccination certificates referred to in point (a) of Article 3(1) to persons participating in clinical trials that concern a COVID-19 vaccine and that have been approved by Member States’ ethical committees and competent authorities, regardless whether they have been administered the vaccine candidate or the dose administered to the control group. The information about the COVID-19 vaccine to be included in the vaccination certificate in accordance with the specific data fields set out in point 1 of the Annex shall not undermine the integrity of the clinical trial. Member States may accept vaccination certificates or antibody tests, including serological tests for antibodies against SARS-CoV-2, issued by other Member States in accordance with this paragraph in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2.;
Amendment 59 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 – point a (new)
Article 1 – paragraph 1 – point 4 – point a (new)
Regulation (EU) 2021/953
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(a) in Article 6(2), the following point (ba) is added: “(ba) antibody tests, including serological tests for antibodies against SARS-CoV-2, carried out by authorised personnel”;
Amendment 62 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EU) 2021/953
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 71 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2021/953
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 83 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2021/953
Article 17 – paragraph 2
Article 17 – paragraph 2
It shall apply from 1 July 2021 to 30 June 20232.
Amendment 84 #
2022/0031(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2021/953
Annex – point 2 – point i
Annex – point 2 – point i
(i) testing centre or facility (optional for antigen tests or antibody tests, including serological tests for antibodies against SARS-CoV-2, carried out by authorised personnel);.
Amendment 103 #
2021/2186(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Considers that too much parliamentary time is taken up with targeting conservative Member States, such as Hungary or Poland, but that not enough is done to eliminate corruption and breaches of the rule of law and media freedom in other Member States, and hence considers it necessary to monitor respect for the rule of law and freedom of the press throughout Europe;
Amendment 172 #
2021/2186(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Condemns attempts by governments to silence and intimidate media outlets that criticise them and to eliminate media freedom and pluralism; also condemns social media platforms that censor, deplatform or intimidate independent journalists and free citizens who express a narrative differing from that of mainstream media;
Amendment 199 #
2021/2186(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Condemns governmental politicisation of the media, wherebyich is prejudicing the provision of proper information to EU citizens and respect for the principle of access to information, and through which governments use ithe media as a tool for their own propaganda; urges the Member States to decouple nominations to broadcasting councils from political parties, ensuring independence of financing, editorial freedom and journalistic integrity; notes that the German broadcasters ARD and ZDF are firmly in the hands of politicians, despite decades of appeals by the German Constitutional Court to try and change this;
Amendment 263 #
2021/2186(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Condemns the violence of Antifa rioting in the midst of peaceful vaccine passport protests across Europe and the lack of any measures to counter these groups; notes the allegations that they are working in cooperation with police authorities to create headlines and discredit the protests;
Amendment 308 #
2021/2186(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Is concerned about the use of the vague notion of ‘hate speech’ and stresses the need to clarify this concept in European legislation; calls on the Commission and the Member States to work, in cooperation with internet companies, to provide adequate safeguards, in particular to ensure that any interference is limited to what is necessary and proportionate, and to include the possibility of judicial redress;
Amendment 335 #
2021/2186(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Strongly condemns NGOs masquerading as aid agencies while facilitating the smuggling of unqualified migrants into the EU; urges the Commission to cease funding such entities and regularly to publish a list with the names of such organisations to stop them receiving fresh funding from other sources;
Amendment 364 #
2021/2186(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Expresses grave concern about the excessive lockdown measures, including the ending of flights and cross-border transport connections, which have put businesses into debt and closure, seen people separated from their loved ones and families (often during their final hours), increased mental illness through isolation, and the number of suicides, and led to rises in domestic violence, as people are imprisoned in their homes and prevented from having external contact, and seen children unnecessarily masked and vaccinated; urges the Member States to encourage early treatment of the SARS- CoV-2 infection9; __________________ 9 Alexander, P.E. et al. ‘Early multidrug treatment of SARS-CoV-2 infection (COVID-19) and reduced mortality among nursing home (or outpatient/ambulatory) residents’, PMC, 5 June 2021, https://www.ncbi.nlm.nih.gov/pmc/articles/ PMC8178530/
Amendment 375 #
2021/2186(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to present to the European Parliament full details of contracts concluded for the purchase of COVID-19 vaccines, without redactions, along with a status report on vaccine stocks and the measures to be taken if those doses are not used, and calls for full transparency of health data associated with the vaccines’ efficacy and side effects; notes that manufacturers of harmful vaccines are liable under Directive 85/374/EEC;
Amendment 21 #
2021/2011(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Recalls its demand in its resolution of 10 February 2021 on the New Circular Economy Action Plan1 for binding EU reduction targets for primary raw materials use and an increase in the recovery and recycling of materials in production processes, where possible; requests that the Commission include all possible options to minimise resource consumption in its demand scenarios for critical raw materials (CRM); __________________ 1 Texts adopted, P9_TA(2021)0040.
Amendment 68 #
2021/2011(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Asks the Commission to set ambitious product design requirements for easy removal of CRMs, focusing on raw materials with a risk of supply shortages and, consequently, a risk of excessive price increases; calls for ambitious minimum recycled CRM content targets; requests that the Commission propose new collection schemes and regular updates of the lists of recyclable products to increase collection rates of waste products containing CRMs; asks the Commission to propose dedicated recycling targets for CRMs, by extending the approach suggested in the proposal for a regulation on batteries and waste batteries (COM(2020)0798) to other product groups;
Amendment 151 #
2021/2011(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Believes that additional research and innovation projects need to be developed to reduce the environmental impact of extracting and processing raw materials, particularly in the case of those that require costly and polluting extraction and processing;
Amendment 163 #
2021/2011(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Believes that mining and any raw material search and exploitation activity should be forbidden in nature conservation areas; calls on the Commission to evaluate legislative options to ensure that local communities are fully involved, alongside interregional and cross-border cooperation, in the permit procedures for new industrial and new mining projects.
Amendment 131 #
2021/0422(COD)
Proposal for a directive
Recital 2
Recital 2
(2) The Union continues to be concerned with the significant and continuous rise in environmental criminal offences and their effects, in recent years, offences which undermine the effectiveness of Union environmental legislation. These offences are moreover increasingly extending beyond the borders of the Member States in which the offences are committed. Such offences, especially those that cross borders, pose a threat to the environment and therefore call for an appropriate and effective response.
Amendment 136 #
2021/0422(COD)
Proposal for a directive
Recital 3
Recital 3
(3) The existing systems of penalties under Directive 2008/99/EC of the European Parliament and of the Council20 and environmental sectoral law have not been sufficient in all environmental policy area to achieve compliance with Union law for the protection of the environment. Compliance should be strengthened by the availability of common criminal penalties, which demonstrate social disapproval of a qualitatively different nature compared to administrative penalties. _________________ 20 Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28).
Amendment 147 #
2021/0422(COD)
Proposal for a directive
Recital 7
Recital 7
(7) In order to constitute an environmental offence under this Directive, conduct should be unlawful under Union law protecting the environment or national laws, administrative regulations or decisions giving effect to that Union law. The conduct which constitutes each category of criminal offence should be defined and, where appropriate, a threshold which needs to be met for the conduct to be criminalised should be set. Such conduct should be considered a criminal offence when committed intentionally and, in certain cases, also when committed with serious negligence. Illegal conduct that causes death or serious injury of persons, substantial damage to flora and fauna or a considerable risk of substantial damage for the environment or is considered otherwise as particularly harmful to the environment constitutes a criminal offence when committed with serious negligence. Member States remain free to adopt or maintain more stringent criminal law rules in that area.
Amendment 154 #
2021/0422(COD)
Proposal for a directive
Recital 3
Recital 3
(3) The existing systems of penalties under Directive 2008/99/EC of the European Parliament and of the Council20 and environmental sectoral law have not been sufficient in all environmental policy area to achieve compliance with Union law for the protection of the environment. Compliance should be strengthened by the availability of promptly enforceable criminal penalties, which demonstrate social disapproval of a qualitatively different nature compared to administrative penalties. _________________ 20 Directive 2008/99/EC of the European Parliament and of the Council of 19 November 2008 on the protection of the environment through criminal law (OJ L 328, 6.12.2008, p. 28).
Amendment 156 #
2021/0422(COD)
Proposal for a directive
Recital 4
Recital 4
(4) The effective investigation, prosecution and adjudication of environmental criminal offences should be improved, for example by setting short deadlines in order to make such action more effective. The list of environmental criminal offences which were set out in Directive 2008/99/EC should be revised and additional categories of offences based on the most serious breaches of Union environmental law, such as acts of arson in forests or wildlife parks, should be added. Provisions on sanctions should be strengthened in order to enhance their deterrent effect as well as the enforcement chain in charge of detecting, investigating, prosecuting and adjudicating environmental criminal offences.
Amendment 161 #
2021/0422(COD)
Proposal for a directive
Recital 10
Recital 10
(10) The acceleration of climate change, biodiversity loss and environmental degradation, paired with tangible examples of their devastating effects, have led to the recognition of the green transition as the defining objective of our time and a matter of intergenerational equity. Therefore, when Union legislation covered by this Directive evolves, this Directive should also cover any updated or amended Union legislation falling within the scope of criminal offences defined under this Directive, when the obligations under Union law remain unchanged in substance. However, when new legal instruments prohibit new conduct harmful to the environment, this Directive should be reviewed and updated as society evolves, and then amended in order to add to the categories of criminal offences also the new serious breaches of Union environmental law.
Amendment 162 #
2021/0422(COD)
Proposal for a directive
Recital 7
Recital 7
(7) In order to constitute an environmental offence under this Directive, conduct should be unlawful under Union law protecting the environment or national laws, administrative regulations or decisions giving effect to that Union law. The conduct which constitutes each category of criminal offence should be defined and, where appropriate, a threshold which needs to be met for the conduct to be criminalised should be set. Such conduct should be considered a criminal offence when committed intentionally and, in certain cases, also when committed with serious negligence. Illegal conduct that causes death or serious injury of persons, substantial damagematerial damage to the environment, persons or administrative premises or a considerable risk of substantial damage for the environment or is considered otherwise as particularly harmful to the environment constitutes a criminal offence when committed with serious negligence. Member States remain free to adopt or maintain more stringent criminal law rules in that area.
Amendment 167 #
2021/0422(COD)
Proposal for a directive
Recital 9
Recital 9
(9) The environment shouldmust be protected in a wide sense, as set out under Article 3 (3) TEU and Article 191 TFEU, covering all natural resources - air, water, soil, wild fauna and flora including habitats - as well as services provided by natural resources.
Amendment 169 #
2021/0422(COD)
(10.) The acceleration of climate change, biodiversity loss and environmental degradation, paired with tangible examples of their devastating effects, have led to the recognition of the green transition as the defining objective of our time and a matter of intergenerational equity. Therefore, when Union legislation covered by this Directive evolves, this Directive should also cover any updated or amended Union legislation falling within the scope of criminal offences defined under this Directive, when the obligations under Union law remain unchanged in substance. However, when new legal instruments prohibit new conduct harmful to the environment, this Directive should be amended in order to add to the categories of criminal offences also the new serious breaches of Union environmental law., in order to take account of social developments and any legislative modifications.
Amendment 170 #
2021/0422(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Inciting, and aiding and abetting the criminal offences committed intentionally should also be punishable. An attempt to commit a criminal offence that causes death or serious injury of a person, substantial damage to the environment or is likely to cause substantial damage to the environment or is otherwise considered particularly harmful to flora and fauna in general should also constitute a criminal offence when committed intentionally.
Amendment 173 #
2021/0422(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Sanctions for the offences should be effective, dissuasive and proportionate, and also harmonised in the case of cross- border offences. To this end, minimum levels for the maximum term of imprisonment should be set for natural persons. Accessory sanctions are often seen as being more effective than financial sanctions especially for legal persons. Additional sanctions or measures should be therefore available in criminal proceedings. These should include the obligation to reinstate the environment, exclusion from access to public funding, including tender procedures, grants and concessions and withdrawal of permits and authorisations. This is without prejudice to the discretion of judges or courts in criminal proceedings to impose appropriate sanctions in the individual cases.
Amendment 173 #
2021/0422(COD)
Proposal for a directive
Recital 12
Recital 12
(12) In criminal proceedings and trials, due account should be taken of the involvement of organised criminal groups operating in ways that negatively impact the environment within a Member State or at cross-border and European level. Criminal proceedings should address corruption, money laundering, cyber-crime and document fraud and – in relation to business activities – the intention of the offender to maximise profits or save expenses, where these occur in the context of environmental crime. These crime forms are often interconnected with serious environmental crime forms and should therefore not be dealt with in isolation. In this respect, it is of particular concern that some environmental crimes are committed with the tolerance or active support of the competent administrations or officials performing his/her public duty. In certain cases this can even take the form of corruption. Examples of such behaviours are turning a blind eye or remaining silent on the infringement of laws protecting the environment following inspections, deliberately omitting inspections or controls for example with regard to whether the conditions of a permit are being respected by the permit-holder, resolutions or votes in favour of granting illegal licences or issuing falsified or untrue favourable reports.
Amendment 174 #
2021/0422(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Inciting, and aiding and abetting the criminal offences committed intentionally should also be punishable. An attempt to commit a criminal offence that causes death or serious injury of a person, substantial damage to the environment or is likely to cause substantial damage to the environment within a Member State or at cross-border level or is otherwise considered particularly harmful should also constitute a criminal offence when committed intentionally.
Amendment 175 #
2021/0422(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Sanctions for the offences should be effective, dissuasive and proportionate, and enforced as rapidly as possible in order to be effective. To this end, minimum levels for the maximum term of imprisonment should be set for natural persons. Accessory sanctions are often seen as being more effective than financial sanctions especially for legal persons. Additional sanctions or measures should be therefore available in criminal proceedings. These should include the obligation to reinstate the environment within a clearly specified deadline, exclusion from access to public funding, including tender procedures, grants and concessions and withdrawal of permits and authorisations for a clearly specified period. This is without prejudice to the discretion of judges or courts in criminal proceedings to impose appropriate sanctions in the individual cases.
Amendment 188 #
2021/0422(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Member States should lay down clear rules concerning limitation periods necessary in order to enable them to counter environmental criminal offences effectively, without prejudice to national rules that do not set limitation periods for investigation, prosecution and enforcement.
Amendment 189 #
2021/0422(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Given, in particular, the mobility of perpetrators of illegal conduct covered by this Directive, together with the cross- border nature of offences and the possibility of cross-border investigations,. Member States should establish jurisdiction in order to counter such conduct effectively and cooperate with local and regional authorities in order to identify the precise location and scale of offences and act as effectively as possible.
Amendment 193 #
2021/0422(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Furthermore, judicial and administrative authorities in the Member States should have at their disposal a range of criminal sanctions and other measures to address different types of criminal behaviour in a tailored and effective manner, with an emphasis on cross-border and cross-regional crime.
Amendment 196 #
2021/0422(COD)
Proposal for a directive
Recital 24
Recital 24
(24) Environmental criminal offences harm nature and society. By reporting breaches of Union environmental law, people perform a service of public interest and play a key role in exposing and preventing and ultimately penalising such breaches, and thus safeguarding the welfare of society. Individuals in contact with an organisation in the context of their work-related activities are often the first to know about threats or harm to the public interest and the environment. Persons who report irregularities are known as whistleblowers. Potential whistleblowers are often discouraged from reporting their concerns or suspicions for fear of retaliation. Such persons should benefit from balanced and effective whistleblowers protection set out under Directive (EU) 2019/1937of the European Parliament and of the Council25 . _________________ 25 Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305/17).
Amendment 197 #
2021/0422(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Given, in particular, the mobility of perpetrators of illegal conduct covered by this Directive, together with the cross- border nature of offences and the possibility of cross-border investigations, Member States should establish jurisdiction in order to counter such conduct effectively, with the option to set up joint teams for monitoring and investigating these offences.
Amendment 203 #
2021/0422(COD)
Proposal for a directive
Recital 28
Recital 28
(28) The effective functioning of the enforcement chain depends on a range of specialist skills. As the complexity of the challenges posed by environmental offences and the technical nature of such crime require a multidisciplinary approach, a high level of legal knowledge, technical expertise as well as a high level of training and specialisation within all relevant competent authorities are necessary. Member States should provide training appropriate to the function of those who detect, investigate, prosecute or adjudicate environmental crime. To maximise the professionalism and effectiveness of enforcement chain, Member States should also consider assigning specialised investigation units, prosecutors and criminal judges to deal with environmental criminal cases. General criminal courts could provide for specialised chambers of judges. Technical expertise in a Member State should be made available to all relevant enforcement authorities for use in cross-border investigations where needed.
Amendment 209 #
2021/0422(COD)
Proposal for a directive
Recital 30
Recital 30
(30) To ensure an effective, integrated and coherent enforcement system that includes administrative, civil and criminal law measures at national and cross-border level, Member States should organise internal cooperation, exchanges of good practice and communication between all actors along the administrative and criminal enforcement chains and between punitive and remedial sanctioning actors. Following the applicable rules, Member States should also cooperate through EU agencies, in particular Eurojust and Europol, as well as with EU bodies, including the European Public Prosecutor’s Office (EPPO) and the European Anti- Fraud Office (OLAF), in their respective areas of competence.
Amendment 223 #
2021/0422(COD)
Proposal for a directive
Recital 32
Recital 32
(32) To effectively tackle the criminal offences referred to in this Directive, it is necessary that competent authorities in the Member States collect accurate, consistent and comparable data on the scale of and trends in environmental offences and the efforts to combat them and their results. These data should be used for regular monitoring for the purpose of producing statistics, preparing statistics to serve the operational and strategic planning of enforcement activities as well as for providing information to citizens. Member States should collect and report to the Commission relevant statistical data on environmental offences. The Commission should regularly assess and publish the results based on the data transmitted by the Member States.
Amendment 228 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) the discharge, emission or introduction of a quantity of materials or substances or ionising radiation into air, soil or water which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to animals or plants within a Member State or at cross-border level;
Amendment 230 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) the placing on the market of a product which, in breach of a prohibition or another requirement, causes or is likely to cause death or serious injury to any person or substantial damage to air, water or soil quality, or to animals or plants as a result of the product's use on a larger scale within a Member State or at cross-border level;
Amendment 233 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c – paragraph 1
Article 3 – paragraph 1 – point c – paragraph 1
and it causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to animals or plants within a Member State or at cross- border level;
Amendment 236 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – introductory part
Article 3 – paragraph 1 – point e – introductory part
(e) the collection, transport, recovery or disposal of waste, within a Member State or at cross-border level, followed by the supervision of such operations and the after-care of disposal sites, including action taken as a dealer or a broker (waste management), when an unlawful conduct:
Amendment 241 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point e – point ii
Article 3 – paragraph 1 – point e – point ii
(ii) concerns other waste than referred to in point (i) and causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to animals or plants within a Member State or at cross-border level;
Amendment 247 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) the installation, operation or dismantling of an installation in which a dangerous activity is carried out or in which dangerous substances, preparations or pollutants are stored or used falling within the scope of Directive 2012/18/EU of the European Parliament and of the Council43, Directive 2010/75/EU of the European Parliament and of the Council44 or Directive 2013/30/EU of the European Parliament and of the Council45 and which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to animals or plants; within a Member State or at cross-border level; _________________ 43 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC Text with EEA relevance (OJ L 197, 24.7.2012, p. 1– 37). 44 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17– -119). 45 Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013 on safety of offshore oil and gas operations and amending Directive 2004/35/EC (OJ L 178, 28.6.2013, p. 66– 106).
Amendment 249 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point j
Article 3 – paragraph 1 – point j
(j) the manufacture, production, processing, handling, use, holding, storage, transport, import, export or disposal of radioactive material falling within the scope of Council Directive 2013/59/Euratom46, Council Directive 2014/87/Euratom47 or Council Directive 2013/51/Euratom48, which causes or is likely to cause death or serious injury to any person or substantial damage to the quality of air, the quality of soil or the quality of water, or to animals or plants within a Member State or at cross-border level; _________________ 46 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1–-73). 47 Council Directive 2014/87/Euratom of 8 July 2014 amending Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations (OJ L 219, 25.7.2014, p. 42–-52). 48 Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12–- 21).
Amendment 252 #
2021/0422(COD)
Proposal for a directive
Article 3 – paragraph 1 – point k
Article 3 – paragraph 1 – point k
(k) the abstraction of surface water or groundwater which causes or is likely to cause substantial damage to the ecological status or potential of surface water bodies or to the quantitative status of groundwater bodies and especially environmental damage to surface water bodies covering several Member States;
Amendment 300 #
2021/0422(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall take the necessary measures to ensure that the offences referred to in Articles 3 and 4 are punishable by effective, proportionate and dissuasive criminal penalties within specified time limits in order to make such measures effective.
Amendment 362 #
2021/0422(COD)
Proposal for a directive
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) the offence caused destruction or irreversible or long-lasting substantial damage to an ecosystem within a Member State or at cross-border level;
Amendment 413 #
2021/0422(COD)
Proposal for a directive
Article 12 – paragraph 2 – subparagraph 1
Article 12 – paragraph 2 – subparagraph 1
Where an offence referred to in Articles 3 and 4 falls within the jurisdiction of more than one Member State, theose Member States shall cooperate with the other parties, and joint investigation and territorial delineation teams may also be set up, to determine which Member State shall conduct criminal proceedings. The matter shall, where appropriate and in accordance with Article 12 of Council Framework Decision 2009/948/JHA59, be referred to Eurojust. _________________ 59 Council Framework Decision 2009/948/JHA of 30 November 2009 on prevention and settlement of conflicts of exercise of jurisdiction in criminal proceedings (OJ L 328, 15.12.2009, p. 42).
Amendment 91 #
2021/0381(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The supply of and demand for political advertising are growing and increasingly cross-border in nature. A large, diversified and increasing number of services are associated with that activity, such as political consultancies, advertising agencies, “ad-tech” platforms, public relations firms, influencers and various data analytics and brokerage operators. Political advertising can take many forms including paid content, sponsored search results, paid targeted messages, promotion in rankings, promotion of something or someone integrated into content such as product placement, the production of studies and summaries, estimates and forecasts, and the use of influencers and other endorsements. Related activities can involve for instance the dissemination of political advertising upon request of a sponsor or the publication of content against payment.
Amendment 93 #
2021/0381(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Political advertising can be disseminated or published through various means and media across borders. It can be disseminated or published via traditional offline media such as newspapers, television and radio, and also increasingly via online platforms, websites, mobile applications, computer games and other digital interfaces. The latter are not only particularly prone to be offered cross- border, but also raise novel and difficult regulatory and enforcement challenges. The use of online political advertising is strongly increasing, and certain linear offline forms of political advertising, such as radio and television, are also offered online as on-demand services. Political advertising campaigns tend to be organised to make use of a range of media and forms, both around and during electoral campaigns for local, regional, national or other elections, and also in between electoral campaigns, to attract new followers and supporters or to promote various political platforms and programmes.
Amendment 94 #
2021/0381(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Political advertising can be disseminated or published through various means and media across borders. It can be disseminated or published via traditional offline media such as printed and online newspapers, television and radio, and also increasingly via online platforms, websites, mobile applications, computer games and other digital interfaces. The latter are not only particularly prone to be offered cross- border, but also raise novel and difficult regulatory and enforcement challenges. The use of online political advertising is strongly increasing, and certain linear offline forms of political advertising, such as radio and television, are also offered online as on-demand services. Political advertising campaigns tend to be organised to make use of a range of media and forms.
Amendment 96 #
2021/0381(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Given that it is normally provided against remuneration, advertising, including political advertising, constitutes a service activity under Article 57 of the Treaty on the Functioning of the European Union (‘TFEU’). In Declaration No 22, regarding persons with a disability, annexed to the Treaty of Amsterdam, the Conference of the Representatives of the Governments of the Member States agreed that, in drawing up measures under Article 114 of the TFEU, the institutions of the Union are to take account of the needs of persons with disabilities, and as such there is a need for political advertising messages targeting and tailored to specific types of disability - for example at people with hearing difficulties or visual impairments.
Amendment 103 #
2021/0381(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In the context of political advertising, targeting techniques are frequently used. Targeting or amplification techniques should be understood as techniques that are used either to address a tailored political advertisement only to a specific person or group of persons or to increase the circulation, reach or visibility of a political advertisement, which may also be transmitted by accessing personal data - mobile phone or land-line number, email addresses - without the consent of the persons being targeted. Given the power and the potential for the misuse of this personal data ofor targeting, including through microtargeting and other advanced techniques, such techniques may present particular threats to legitimate public interests, such as fairness, equal opportunities and transparency in the electoral process and the fundamental right to be informed in an objective, transparent and pluralistic way.
Amendment 108 #
2021/0381(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In this context, providers of political advertising services are likely to be discouraged from providing their political advertising services in cross- border situations. This is particularly true for microenterprises and SMEs, which often do not have the resources to absorb or pass on the high compliance costs connected to the preparation, placement, publication or dissemination of political advertising in more than one Member State, especially in situations where citizens originating from Member States other than that in which they live want to vote for candidates in their home country. This limits the availability of services and negatively impacts the possibility for service providers to innovate and offer multi-medium and multi-national campaigns within the internal market.
Amendment 115 #
2021/0381(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The definition of political advertising should include advertising published or disseminated directly or indirectly by, or published or disseminated directly or indirectly for or on behalf of a political actor, as well as the obligation to use decent language without attacks of any kind on political opponents or opposing candidates. Since advertisements by, for or on behalf of a political actor cannot be detached from their activity in their role as political actor, they can be presumed to be liable to influence the political debate, except for messages of purely private or purely commercial nature.
Amendment 122 #
2021/0381(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) It is necessary to define political advertisement as an instance of political advertising. Advertisements include the means by which the advertising message is communicated, including in print, by broadcast media or via an online platforms service and social networks.
Amendment 126 #
2021/0381(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The transparency requirements should also not apply to the sharing of information through electronic communication services such as electronic message services or telephone calls, as long as no political advertising service is involved, although such exchanges of information should respect personal data protection rules.
Amendment 130 #
2021/0381(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) As regards online intermediaries, Regulation (EU) 2021/XX [Digital Services Act] applies to political advertisements published or disseminated by online intermediaries through horizontal rules applicable to all types of online advertising, including commercial and political advertisements. Based on the definition of political advertising established in this Regulation, it is appropriate to provide additional granularity of the transparency requirements laid out for advertising publishers falling under the scope of Regulation (EU) 2021/XX [Digital Services Act], notably very large platforms. This concerns in particular information related to the amount of funding of political advertisements and the sources of that funding. The requirements of this Regulation leave unaffected the provisions of the Digital Services Act, including as regards risk assessment and mitigation obligations for very large online platforms as regards their advertising systems.
Amendment 133 #
2021/0381(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) Transparency of political advertising should enable citizens to understand that they are confronted with a political advertisement. Political advertising publishers should ensure the publication in connection to each political advertisement of a clear statement to the effect that it is a political advertisement and of the identity of its sponsor, as well as the amounts paid for the material disseminated, which must conform to the provisions on the funding of electoral campaigns in the Member States. Where appropriate, the name of the sponsor could include a political logo. Political advertising publishers should make use of labelling which is effective, taking into account developments in relevant scientific research and best practice on the provision of transparency through the labelling of advertising. They should also ensure the publication in connection to each political advertisement of information to enable the wider context of the political advertisement and its aims to be understood, which can either be included in the advertisement itself, or be provided by the publisher on its website, accessible through a link or equivalent clear and user-friendly direction included in the advertisement.
Amendment 134 #
2021/0381(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) This information should be provided in a transparency notice which should also include the identity of the sponsor and the sums outlaid for the dissemination of the materials, in order to support accountability in the political process in the event of non-compliance with the provisions in force. The place of establishment of the sponsor and whether the sponsor is a natural or legal person should be clearly indicated. Personal data concerning individuals involved in political advertising, unrelated to the sponsor or other involved political actor should not be provided in the transparency notice. The transparency notice should also contain information on the dissemination period, any linked election, the amount spent for and the value of other benefits received in part or full exchange for the specific advertisement as well for the entire advertising campaign, the source of the funds used and other information to ensure the fairness of the dissemination of the political advertisement and compliance with the legal provisions on the funding of electoral campaigns of all types in force in the Member States. Information on the source of the funds used concerns for instance its public or private origin, the fact that it originates from inside or outside the European Union. Information concerning linked elections or referendums should include, when possible, a link to information from official sources regarding the organisation and modalities for participation or for promoting participation in those elections or referendums. The transparency notice should further include information on how to flag political advertisements in accordance with the procedure established in this Regulation. This requirement should be without prejudice to provisions on notification according to Article 14, 15 and 19 of Regulation (EU) 2021/XXX [Digital Services Act].
Amendment 135 #
2021/0381(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Since political advertising publishers make political advertisements available to the public, they should publish or disseminate that information to the public together with the publication or dissemination of the political advertisement. Political advertising publishers should not make available to the public those political advertisements not fulfilling the transparency requirements under this Regulation. In addition, political advertising publishers which are very large online platforms within the meaning of Regulation (EU) 2021/XXX [Digital Services Act] should make the information contained in the transparency notice available through the repositories of advertisements published pursuant to Article 30 Regulation [Digital Services Act] . This will facilitate the work of interested actors including researchers, and especially researchers and campaign monitoring and assessment establishments, in their specific role to support free and fair elections or referendums and fair electoral campaigns including by scrutinising the sponsors of political advertisement and amounts allocated in accordance with Member State legislation and by analysing the political advertisement landscape.
Amendment 136 #
2021/0381(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to allow specific entities to play their role in democracies, it is appropriate to lay down rules on the transmission of information published with the political advertisement or contained in the transparency notice to interested actors such as vetted researchers, journalists, civil society organisations, campaign monitoring and election opinion poll establishments and accredited election observers, in order to support the performance of their respective roles in the democratic process and accredited election observers, in order to support the performance of their respective roles in the democratic process. Providers of political advertising services should not be required to respond to requests which are manifestly unfounded or excessive. Further, the relevant service provider should be allowed to charge a reasonable fee in case of repetitive and costly requests, taking into account the administrative costs of providing the information.
Amendment 151 #
2021/0381(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) In order to ensure enhanced transparency and accountability, when making use of targeting and amplification techniques in the context of political advertising involving the processing of personal data, controllers should implement additional safeguards. They should adopt and implement a policy describing the use of such techniques to target individuals or amplify their content and keep record of their relevant activities, to avoid influencing the persons targeted to vote one way or another. When publishing, promoting or disseminating a political advertisement making use of targeting and amplification techniques, controllers should provide, together with the political advertisement, meaningful information to allow the concerned individual to understand the logic involved and main parameters of the targeting used, and the use of third-party data and additional analytical techniques, including whether the targeting of the advertisement was further optimised during delivery.
Amendment 160 #
2021/0381(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) The Commission should encourage the drawing up of codes of conduct, based on criteria agreed at European level with the Member States, as referred to in Article 40 of Regulation (EU) 2016/679 to support the exercise of data subjects’ rights in this context.
Amendment 162 #
2021/0381(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) Information to be provided in accordance with all requirements applicable to the use of targeting and amplification techniques under this Regulation should be presented in a format which is easily accessible, clearly visible and user-friendly, including through the use of plain language, and suitable for persons with hearing difficulties and visual impairments.
Amendment 170 #
2021/0381(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) Member States should publish the exact duration of their legally-recognised electoral periods, established according to their electoral traditions, sufficiently in advance of the beginning of the electoral calendar.
Amendment 179 #
2021/0381(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation shall apply to political advertising aimed at local, regional, national and referendum campaigns prepared, placed, promoted, published or disseminated in the Union, or directed to individuals in one or several Member States, irrespective of the place of establishment of the advertising services provider, and irrespective of the means used.
Amendment 193 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
1. ‘service’ means any self-employed economic activity, normally provided for remuneration, as referred to in Article 57 TFEU, based on a written contract or agreement signed by all the parties involved, as referred to in Article 57 TFEU;
Amendment 208 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
6. ‘political advertising campaign’ means the preparation, placement, promotion, publication or dissemination of a series of linked advertisements in the course of a contract for political advertising, on the basis of common preparation, sponsorship or funding, with a view to elections;
Amendment 210 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
7. ‘sponsor’ means the natural or legal person on whose behalf a political advertisement is prepared, placed, published or disseminated based on a written contract or agreement signed by all the parties involved;
Amendment 213 #
2021/0381(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
8. ‘targeting or amplification techniques’ means techniques that are used either to address a tailored political advertisement only to a specific person or group of persons or to increase the circulation, reach or visibility of a political advertisement, but which must respect personal data rules and not influence voter choices;
Amendment 238 #
2021/0381(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The information referred to in paragraph 1 shall be in writing and may be in electronic form. Such information shall be retained for a period of five years from the date of the last preparation, placement, publication or dissemination, as the case may be, and may be made available at any time to the competent authorities upon written request and within the time limit laid down by national law or that specified by the applicant.
Amendment 272 #
2021/0381(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) based among others on things on the information received in line with Article 6(3), information on the aggregated amounts spent or other benefits received in part or full exchange, based on a written contract or agreement signed by all the parties involved, for the preparation, placement, promotion, publication and dissemination of the relevant advertisement, and of the political advertising campaign where relevant, and their sources;
Amendment 276 #
2021/0381(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d
Article 7 – paragraph 2 – point d
(d) where applicable, an indication of elections or referendums with which the advertisement is linked; and of the dissemination period in conformity with the law in force;
Amendment 286 #
2021/0381(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Political advertising publishers shall retain their transparency notices together with any modifications for a period of five years after the end of the period referred to in paragraph 4 and may make them available to the competent authorities at any time upon written request and within the time limit laid down by national law or that specified by the applicant.
Amendment 297 #
2021/0381(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Where they provide political advertising services, advertising publishers shall include information on the amounts or the value of other benefits received in part or full exchange for those services, based on a written contract or agreement signed by all the parties involved, including on the use of targeting and amplification techniques, aggregated by campaign, as part of their management report within the meaning of Article 19 of Directive 2013/34/EU in their annual financial statements.
Amendment 341 #
2021/0381(COD)
Proposal for a regulation
Article 12 – paragraph 3 – point a
Article 12 – paragraph 3 – point a
(a) adopt and implement an internal policy describing clearly and in plain language, in particular, the use of such techniques to target individuals or amplify the content, but without influencing voter choice, and retain such a policy for a period of five years;
Amendment 389 #
2021/0381(COD)
Proposal for a regulation
Article 15 – paragraph 9 a (new)
Article 15 – paragraph 9 a (new)
9a. The competent authorities of the Member States shall draw up, at the end of each campaign, election or referendum, reports on the conformity with existing legislation and with this Regulation of service providers providing political advertising services in the Union, as well as with the protection of personal data, when using techniques to target a specific audience or to amplify the impact of political advertising material. Those reports shall be forwarded to the Commission and, in the case of elections to the European Parliament, to the European Parliament.
Amendment 393 #
2021/0381(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
(a) the nature, gravity and duration of the infringement, with a focus on respect for personal data when using techniques to target a specific audience or to amplify the impact of political advertising material which may influence voter choice;
Amendment 407 #
2021/0381(COD)
Proposal for a regulation
Annex I – point e
Annex I – point e
(e) the provisional aggregated amount spent on, and the value of other benefits received in part or full exchange for the specific advertisement, and on the specific advertising campaign where relevant, including on the preparation, placement, promotion, publication and dissemination of the political advertisements, as well as the aggregated actual amount spent and the value of other benefits received once known, based on a written contract or agreement signed by all the parties involved.
Amendment 412 #
2021/0381(COD)
Proposal for a regulation
Annex I – point f
Annex I – point f
(f) the sources of the funds being used for the specific advertising campaign including for the preparation, placement, promotion, publication and dissemination of the political advertisements, based on a written contract or agreement signed by all the parties involved.
Amendment 57 #
2021/0218(COD)
Proposal for a directive
Recital 3
Recital 3
(3) Directive (EU) 2018/2001 of the European Parliament and of the Council9 sets a binding Union target to reach a share of at least 32 % of energy from renewable sources in the Union's gross final consumption of energy by 2030. Under the Climate Target Plan, the share of renewable energy in gross final energy consumption would need to increase to 405% by 2030 in order to achieve the Union’s greenhouse gas emissions reduction target10 . Therefore, the target set out in Article 3 of that Directive needs to be increased. _________________ 9Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources, OJ L 328, 21.12.2018, p. 82–209 10Point 3 of the Communication from the Commission COM(2020) 562 final of 17.9.2020, Stepping up Europe’s 2030 climate ambition Investing in a climate- neutral future for the benefit of our people
Amendment 63 #
2021/0218(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) At COP26, the Commission together with global leaders elevated the global ambition level for the preservation and recovery of global forests, and for an accelerated transition to zero emissions transportation.
Amendment 68 #
2021/0218(COD)
Proposal for a directive
Recital 4
Recital 4
(4) There is a growing recognition of the need for alignment of bioenergy policies with the cascading principle ofin particular with respect to forest and agricultural biomass use11 , with a view to ensuring fair access to the biomass raw material market for the development of innovative, high value-added bio-based solutions and a sustainable circular bioeconomy. WThe cascading principle should be applied by putting the use of raw materials, for example wood, into an order of value to create resource effectiveness and promoting using biomass according to its highest economic and environmental added value for maximising the positive climate impact of bioenergy and to minimise harmful impacts on the biodiversity. Policies should therefore take into account these principles and further promote the re- introduction of secondary raw materials in the economy over recovery for energy purposes, as required by the waste hierarchy established in Directive 2008/98/EC. In particular, when developing support schemes for bioenergy, Member States should therefore take into consideration the available sustainable supply of biomass for energy and non- energy uses and the maintenance of the national forest carbon sinks and ecosystems as well as the principles of the circular economy and the biomass cascading use, and the waste hierarchy established in Directive 2008/98/EC of the European Parliament and of the Council12 . For this, they should grant no support to the production of energy from saw logs, veener logs, stumps and roots and avoid promoting the use of quality roundwood for energy except in well-defined circumstanceprimary woody biomass. In line with the cascading principle, woody biomass should be used according to its highest economic and environmental added value in the following order of priorities: 1) wood-based products, 2) extending their service life, 3) re-use, 4) recycling, 5) bio-energy and 6) disposal. WOnly where no other use for woody biomass is economically viable or environmentally appropriate, energy recovery from secondary woody biomass helps to reduce energy generation from non- renewable sources. Member States’ support schemes for bioenergy should therefore be directed to such feedstocks for which little market competition exists with the material sectors, and whose sourcing is considered positive for both climate, environment and biodiversity, in order to avoid negative incentives for unsustainable bioenergy pathways, as identified in the JRC report ‘The use of woody biomass for energy production in the EU’13 . On the other hand, in defining the further implications of the cascading principle, it is necessary to recognise the national specificities which guide Member States in the design of their support schemes. Waste prevention, reuse and recycling of waste should be the priority option. Member States should avoid creating support schemes which would be counter to targets on treatment of waste and which would lead to the inefficient use of recyclable waste. Moreover, in order to ensure a more efficient use of bioenergy, from 2026 on Member States should not give support anymore to electricity-only plants , unless the installations are in regions with a specific use status as regards their transition away from fossil fuels or if the installations use carbon capture and storage. _________________ 11The cascading principle aims to achieve resource efficiency of biomass use through prioritising biomass material use to energy use wherever possible, increasing thus the amount of biomass available within the system. In line with the cascading principle, woody biomass should be used according to its highest economic and environmental added value in the following order of priorities: 1) wood-based products, 2) extending their service life, 3) re-use, 4) recycling, 5) bio-energy and 6) disposal. 12 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). 13 https://publications.jrc.ec.europa.eu/reposit ory/handle/JRC122719, in particular as regards the available volumes of feedstock and share of pre-existing competing industrial uses other than energy recovery. Moreover, waste prevention, reuse and recycling of waste should be the priority option. Member States should not create support schemes which would be counter to targets on treatment of waste and which would lead to the inefficient use of recyclable waste.
Amendment 110 #
2021/0218(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Renewable fuels of non-biological origin can be used for energy purposes, but also for non-energy purposes as feedstock or raw material in industries such as steel or chemicals, where they often are the only option to decarbonise and where they reduce more greenhouse gases per unit of hydrogen than in transport or heating. The use of renewable fuels of non- biological origin for both purposes exploits their full potential to replace fossil fuels used as feedstock and to reduce greenhouse gas emissions in industry and should therefore be included in a target for the use of renewable fuels of non- biological origin. National measures to support the uptake of renewable fuels of non-biological origin in industry should not result in net pollution increases due to an increased demand for electricity generation that is satisfied by the most polluting fossil fuels, such as coal, diesel, lignite, oil peat and oil shale.
Amendment 121 #
2021/0218(COD)
Proposal for a directive
Recital 29
Recital 29
(29) The use of renewable fuels and renewable electricity in transport can contribute to the decarbonisation of the Union transport sector in a cost-effective manner, and improve, amongst other, energy diversification in that sector while promoting innovation, growth and jobs in the Union economy and reducing reliance on energy imports. With a view to achieving the increased target for greenhouse gas emission savings defined by the Union, the level of renewable energy supplied to all transport modes in the Union should be increased. Expressing the transport target as a greenhouse gas intensity reduction target would stimulate an increasing use of the most cost-effective and performing fuels, in terms of greenhouse gas savings, in transport. In addition, a greenhouse gas intensity reduction target would stimulate innovation and set out a clear benchmark to compare across fuel types and renewable electricity depending on their greenhouse gas intensity. Complementary to this, increasing the level of the energy-based target on advanced biofuels and biogas and introducing a target for renewable fuels of non-biological origin would ensure an increased use of the renewable fuels with smallest environmental impact in transport modes that are difficult to electrify. The achievement of those targets should be ensured by obligations on fuel suppliers as well as by other measures included in [Regulation (EU) 2021/XXX on the use of renewable and low-carbon fuels in maritime transport - FuelEU Maritime and Regulation (EU) 2021/XXX on ensuring a level playing field for sustainable air transport], and complemented by additional incentives set by this Directive. Dedicated obligations on aviation fuel suppliers should be set only pursuant to [Regulation (EU) 2021/XXX on ensuring a level playing field for sustainable air transport].
Amendment 124 #
2021/0218(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Electromobility will play an essential role in decarbonising the transport sector. To foster the further development of electromobility, Member States should establish a credit mechanism enabling operators of charging points accessible to the public, as well as private charging points to contribute, by supplying renewable electricity, towards the fulfilment of the obligation set up by Member States on fuel suppliers. While supporting electricity in transport through such a mechanism, it is important that Member States continue setting a high level of ambition for the decarbonisation of their liquid fuel mix in transportmaritime transport and aviation.
Amendment 128 #
2021/0218(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The Union’s renewable energy policy aims to contribute to achieving the climate change mitigation objectives of the European Union in terms of the reduction of greenhouse gas emissions. In the pursuit of this goal, it is essential to also contribute to wider environmental objectives, and in particular the prevention of biodiversity loss, which is negatively impacted by the indirect land use change associated to the production of certain biofuels, bioliquids and biomass fuels. Contributing to these climate and environmental objectives constitutes a deep and longstanding intergenerational concern for Union citizens and the Union legislator. As a consequence, the changes in the way the transport target is calculated should not affect the limits established on how to account toward that target certain fuels produced from food and feed crops on the one hand and high indirect land-use change-risk fuels on the other handThe European Union should reduce first generation biofuels, bioliquids and biomass fuels produced from crops by 2030. Since first being promoted in 2003, an abundance of scientific evidence has demonstrated that first generation biofuels, bioliquids and biomass fuels offer few if any carbon savings and are not appropriate for use in the energy sector. The European Union should instead promote fuels in quantities which balance the necessary ambition with the need to avoid contributing to direct and indirect land-use changes. Therefore it is necessary to put an end to the use of high indirect land-use change-risk fuels, such as palm oil and soy and lower the maximum share of fuels produced from crops. In addition, in order not to create an incentive to use biofuels and biogas produced from food and feed crops in transport, Member States should continue to be able to choose whether count them or not towards the transport target. If they do not count them, they may reduce the greenhouse gas intensity reduction target accordingly, assuming that food and feed crop-based biofuels save 50% greenhouse gas emissions, which corresponds to the typical values set out in an annex to this Directive for the greenhouse gas emission savings of the most relevant production pathways of food and feed crop-based biofuels as well as the minimum savings threshold applying to most installations producing such biofuels.
Amendment 132 #
2021/0218(COD)
Proposal for a directive
Recital 31 a (new)
Recital 31 a (new)
(31a) The current criteria for low ILUC biofuels stipulate that feedstock from which the biofuels, bioliquids and biomass fuels were produced should avoid displacement of food and feed crops through improved agricultural practices or through cultivation of areas not previously used for crop production. As the latest scientific evidence show, these criteria do not necessarily reduce displacement and ILUC impacts of biofuel feedstock and a simple interpretation of the low ILUC criteria in the RED II could allow a doubling of the amount of palm oil used in EU biofuels compared to current consumption levels without reducing ILUC impacts. Estimates show that large quantities of palm oil will be produced in the next years on low carbon stock land in that was not previously used for agriculture to meet baseline demand for food, feed, and oleochemicals. This amount could qualify as low ILUC based on the RED II definition, but diverting it from other uses will still indirectly cause further palm expansion onto high carbon stock land. It is therefore appropriate to put an end to the exemption granted for low indirect land-use change-risk biofuels, bioliquids and biomass fuels;
Amendment 133 #
2021/0218(COD)
Proposal for a directive
Recital 31 b (new)
Recital 31 b (new)
(31b) Over the past 15 years, biofuel policy in Europe has created an additional source of soy oil demand, with significant volumes of material imported either in raw form or processed into biodiesel. Through this biofuel demand, as well as through imports of soy meal as livestock feed, the EU has contributed to an export business that, in South America in particular, has long been identified as a major driver of deforestation. While palm oil has been clearly labelled as high ILUC-risk and soy oil was identified as the biofuel feedstock second most strongly associated with conversion of high carbon stock areas, the initial EU assessment found that it was below the threshold for action. Now that the use of palm oil biodiesel in Europe is expected to decline due to the latest policy measures, there is a risk that the gap left by the phase-out of palm oil biodiesel in the EU biofuels market will be filled up with soy. An analysis of recent data suggests that there may be a higher expansion of soy into high carbon-stock areas compared to what was previously estimated, meaning soy oil would meet the EU threshold to be considered a high-ILUC risk feedstock. In the context of the EU Green Deal, the commitments to become carbon neutral, reduce deforestation and protect and restore global biodiversity, the use of soy oil for biodiesel production should be phased out as soon as possible in line with the policy approach on palm oil.
Amendment 134 #
2021/0218(COD)
Proposal for a directive
Recital 31 c (new)
Recital 31 c (new)
(31c) Current rules and regulations lead to a non-transparent certification process of the sustainability of Used Cooking Oil (UCO). Together with the difficulty to detect adulteration of UCO with virgin oil, risks of fraud exist. Moreover, the lack of traceability of the origin of UCO and the risks of fraud create risks of displacement effects - if virgin oil is mixed with UCO and more UCO is produced artificially, it leads to increased virgin oil production, which may cause adverse environmental impacts such as indirect land use change. Weaknesses in the certification process are also applicable to other biofuel feedstocks, but due to the higher economic value of UCO fraud risks are more linked to UCO than to other feedstocks. Therefore measures to improve the monitoring and verification of the sustainability of UCO, strengthened certification process, as well as a system for detecting adulterated UCO, are urgently needed in order to maintain UCO on the list of eligible feedstocks in Annex IX.
Amendment 135 #
2021/0218(COD)
Proposal for a directive
Recital 31 d (new)
Recital 31 d (new)
(31d) The current Directive promotes certain types of advanced biofuels produced from a list of materials defined in its Annex IX. This list is the basis for Member States to define the different levels of support to different types of biofuels under their national framework. Whereas the list was intended to include only sustainable waste and residues for biofuels production, it actually includes some unsustainable feedstocks as certain feedstocks have significant displacement or land use change emissions. Applying the waste hierarchy and cascading use principles to the feedstocks listed would also ensure that the competing uses of the raw materials are considered, to avoid diverting a raw material, be it a product, by-product, waste or residue, from a higher value use. The existing Annex IX list includes raw materials that without any doubt have a higher value potential use within the waste hierarchy. It is therefore appropriate to remove certain problematic feedstocks from the Annex IX list;
Amendment 137 #
2021/0218(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Expressing the transport target as a greenhouse gas intensity reduction target makes it unnecessary to use multipliers to promote certain renewable energy sources. This is because different renewable energy sources save different amounts of greenhouse gas emissions and, therefore, contribute differently to a target. Renewable electricity should be considered to have zero emissions, meaning it saves 100% emissions compared to electricity produced from fossil fuels. This will create an incentive for the use of renewable electricity since renewable fuels and recycled carbon fuels are unlikely to achieve such a high percentage of savings. Electrification relying on renewable energy sources would therefore become the most efficient way to decarbonise road transport. In addition, in order to promote the use of advanced biofuels and biogas and renewable fuels of non-biological origin in the aviation and maritime modes, which are difficult to electrify, it is appropriate to keepincrease the multiplier for those fuels supplied in those modes when counted towards the specific targets set for those fuels.
Amendment 138 #
2021/0218(COD)
Proposal for a directive
Recital 33
Recital 33
(33) Direct electrification of end-use sectors, including the transport sector, contributes to the efficiency and facilitates the transition to an energy system based on renewable energy. It is therefore in itself an effective means to reduce greenhouse gas emissions. However, the current provisions allow crediting of renewable electricity beyond the grid average only where electricity is obtained from a direct connection to an installation generating renewable electricity, which is not always practically feasible or even desirable from a grid management perspective. The creation of a framework on additionality applying specifically to renewable electricity supplied to electric vehicles in the transport is therefore not required. ecessary.
Amendment 147 #
2021/0218(COD)
Proposal for a directive
Recital 35
Recital 35
(35) To ensure higher environmental effectiveness of the Union sustainability and greenhouse emissions saving criteria for solid biomass fuels in installations producing heating, electricity and cooling, the minimum threshold for the applicability of such criteria should be lowered from the current 20 MW to 52 MW.
Amendment 155 #
2021/0218(COD)
Proposal for a directive
Recital 36
Recital 36
(36) Directive (EU) 2018/2001 strengthened the bioenergy sustainability and greenhouse gas savings framework by setting criteria for all end-use sectors. It set out specific rules for biofuels, bioliquids and biomass fuels produced from forest biomass, requiring the sustainability of harvesting operations and the accounting of land-use change emissions. To achieve an enhanced protection of especially biodiverse and carbon-rich habitats, such as primary forests, semi-natural forests, highly biodiverse forests, grasslands and p,peat lands and heat hlands, exclusions and limitations to source forest biomass from those areas should be introduced, in line with the approach for biofuels, bioliquids and biomass fuels produced from agricultural biomass. In addition, the greenhouse gas emission saving criteria should also apply to existing biomass- based installations to ensure that bioenergy production in all such installations leads to greenhouse gas emission reductions compared to energy produced from fossil fuels.
Amendment 156 #
2021/0218(COD)
Proposal for a directive
Recital 36 a (new)
Recital 36 a (new)
(36a) Special attention should be given towards forest science to address open questions and provide data, as they are key for understanding better the role of our trees for climate, environment, economy and society
Amendment 172 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point -a (new)
Article 1 – paragraph 1 – point 1 – point -a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 23
Article 2 – paragraph 2 – point 23
Amendment 175 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point - a (new)
Article 1 – paragraph 1 – point 1 – point - a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 24
Article 2 – paragraph 2 – point 24
Amendment 183 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point - a (new)
Article 1 – paragraph 1 – point 1 – point - a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 34
Article 2 – paragraph 2 – point 34
(-a) point 34 is replaced by the following: “(34) ‘advanced biofuels’ means biofuels that are produced from thwaste and residue feedstock listed in Part A of Annex IX;” that do not have significant displacement effects based on a regional displacement analysis;" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 185 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point -a (new)
Article 1 – paragraph 1 – point 1 – point -a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 35
Article 2 – paragraph 2 – point 35
(-a) point 35 is replaced by the following: “(35) ‘recycled carbon fuels’ means liquid and gaseous fuels that are produced from liquid or solid waste streams of non- renewable origin which are not suitable for material recovery in accordance with Article 4 of Directive 2008/98/EC, or from waste processing gas and exhaust gas of non-renewable origin which are produced as an unavoidable and unintentional consequence of the production process in industrial installations;” and direct air captured carbon;” Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 191 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point a a (new)
Article 1 – paragraph 1 – point 1 – point a a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 37
Article 2 – paragraph 2 – point 37
(aa) point 37 is deleted
Amendment 193 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point a a (new)
Article 1 – paragraph 1 – point 1 – point a a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 40
Article 2 – paragraph 2 – point 40
(aa) point 40 is replaced by the following: "(40) ‘food and feed crops’ means starch-rich crops, sugar crops or oil crops produced on agricultural land as a main crop excluding residues, waste or ligno-cellulosic material and intermediate crops, such as catch crops and cover crops, provided that the use of such intermediate crops does not trigger demand for additional land; nd other crops grown primarily for energy purposes excluding residues and waste;" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 200 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 1a
Article 2 – paragraph 2 – point 1a
(1a) ‘quality roundwoodprimary woody biomass’ means roundall wood felled or otherwise harvested and removed, whose characteristics, such as species, dimensions, rectitude, and node density, make it suitable for industrial use, as defined and duly justified by Member States according to the relevant forest conditions. This does not include pre-commercial thinning operations or trees extracted from forests affected by fires, pests, diseases or damage due to abiotic factors from forests and other tree areas;
Amendment 224 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 26 a (new)
Article 2 – paragraph 2 – point 26 a (new)
“(26a) ‘secondary woody biomass’ means woody biomass resulting from a previous processing in at least one industry, e.g. black liquor, sawdust and postconsumer wood; it excludes primary woody biomass, including when it is processed into chips, briquettes or pellets;”
Amendment 233 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 36 a (new)
Article 2 – paragraph 2 – point 36 a (new)
“(36a) 'direct air carbon capture' means the process by which carbon is captured from the ambient air for the production of renewable fuels of non-biological origin;”
Amendment 240 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 44 c (new)
Article 2 – paragraph 2 – point 44 c (new)
“(44c) ‘semi-natural forest’ means a forest or other wooded land that is neither primary forest nor plantation forest and is composed predominantly of native trees and shrub species which have not been planted;”
Amendment 254 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Directive (EU) 2018/2001
Article 3 – paragraph 1
Article 3 – paragraph 1
“1. Member States shall collectively ensure that the share of energy from renewable sources in the Union’s gross final consumption of energy in 2030 is at least 405%.;”
Amendment 270 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 1
Article 3 – paragraph 3 – subparagraph 1
3. Member States shall take measures to ensure that energy from biomass is produced in a way that minimises undue distortive effects on the biomass raw material market and harmful impacts on biodiversity and the environment. To that end , they shall take into accountapply the waste hierarchy as set out in Article 4 of Directive 2008/98/EC and the cascading principle referred to in the third subparagraph.
Amendment 292 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 2 – point a – point i
Article 3 – paragraph 3 – subparagraph 2 – point a – point i
(i) the use of saw logs, veneer logs, stumps and rootprimary woody biomass to produce energy.
Amendment 305 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 2 – point b
Article 3 – paragraph 3 – subparagraph 2 – point b
Amendment 621 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Directive (EU) 2018/2001
Article 27 – paragraph 1 – subparagraph 1 – point c – point iii
Article 27 – paragraph 1 – subparagraph 1 – point c – point iii
(iii) the amount of renewable electricity supplied to the transport sector is determined by multiplying the amount of electricity supplied to that sector by the average share of renewable electricity supplied in the territory of the Member State in the two previous years. By way of exception, where electricity is obtained from a direct connection to an installation generating renewable electricity and supplied to the transport sector, that electricity shall be fully counted as renewable; By 31 December 2023, the Commission shall adopt a delegated act in accordance with Article 35 on additionality for renewable electricity supplied to the transport sector, to enable the use of up to 100% of renewable electricity, i.e. beyond the average share of renewable electricity supplied in the territory of the Member State in the two previous years;
Amendment 630 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point c
Article 1 – paragraph 1 – point 16 – point c
Directive (EU) 2018/2001
Article 27 – paragraph 1a – point c
Article 27 – paragraph 1a – point c
(c) the shares of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX and of renewable fuels of non-biological origin supplied in the aviation and maritime modes, including for voyages to or from third countries, shall be considered to be 1,2 times their energy content.’;
Amendment 636 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point e – point ii
Article 1 – paragraph 1 – point 16 – point e – point ii
Directive (EU) 2018/2001
Article 27 – paragraph 3 – subparagraph 4
Article 27 – paragraph 3 – subparagraph 4
Where electricity is used for the production of renewable fuels of non-biological origin, either directly or for the production of intermediate products, the average share of electricity from renewable sources in the country of production, as measured two years before the year in question, in the relevant hour as made available by transmission system operators in accordance with Article 20a(1) shall be used to determine the share of renewable energy.;
Amendment 643 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 17 – point b a (new)
Article 1 – paragraph 1 – point 17 – point b a (new)
Directive (EU) 2018/2001
Article 28 – paragraph 6
Article 28 – paragraph 6
(ba) paragraph 6 is replaced by the following: "By 25 June 2019 and every two years thereafter, the Commission shall review the list of feedstock set out in Parts A and B of Annex IX with a view to adding and removing feedstock in accordance with the principles set out in the third subparagraph. The Commission is empowered to adopt delegated acts in accordance with Article 35 to amend the list of feedstock set out in Parts A and B of Annex IX by adding, but not or removing, feedstock. Feedstock that can be processed only with advanced technologies shall be added to Part A of Annex IX. Feedstock that canbe processed into biofuels, or biogas for transport, with mature technologies shall be added to Part B of Annex IX. Such delegated acts shall be based on an analysis of the potential of the raw material as feedstock for the production of biofuels and biogas for transport, taking into account all of the following: (a) the principles of the circular economy and of the waste hierarchy established in Directive 2008/98/EC, as well as the cascading use principle referred to in Articles 3 and 29 ; (b) the Union sustainability criteria laid down in Article 29(2) to (7); (c) the need to avoid significant distortive effects on markets for (by-)products, wastes or residues; (d) the potential for delivering substantial greenhouse gas emissions savings compared to fossil fuels based on a life- cycle assessment of emissions including emissions from the land sector and possible displacement effects, taking into account available volumes of feedstock and share of pre-existing competing industrial uses other than energy recovery with due regard to national specificities; (e) the need to avoid negative impacts on the environment and biodiversity; (f) the need to avoid creating an additional demand for land. " Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 652 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a – point i a (new)
Article 1 – paragraph 1 – point 18 – point a – point i a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 1 – subparagraph 1
Article 29 – paragraph 1 – subparagraph 1
(ia) – in paragraph 1, the first subparagraph is replaced by the following: "Energy from biofuels, bioliquids and biomass fuels shall be taken into account for the purposes referred to in points (a), (b) and (c) of this subparagraph only if they fulfil the sustainability and the greenhouse gas emissions saving criteria laid down in paragraphs 2 to 7 and 10: , and if they fully respect the waste hierarchy as set out in Article 4 of Directive 2008/98/EC and the cascading principle referred to in Article 3" ; Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 655 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a – point i b (new)
Article 1 – paragraph 1 – point 18 – point a – point i b (new)
Directive (EU) 2018/2001
Article 29 – paragraph 1 – subparagraph 2
Article 29 – paragraph 1 – subparagraph 2
(ib) subparagraph 2 is replaced by the following: "However, biofuels, bioliquids and biomass fuels produced from waste and residues, other than agricultural, aquaculture, fisheries and forestry residues, are required to fulfil only the greenhouse gas emissions saving criteria laid down in paragraph 10 in order to be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph. This subparagraph shall also apply to waste and residues that are first processed into a product before being further processed into biofuels, bioliquids and biomass fuels. In the case of the use of mixed wastes, however, the operators are required to apply mixed waste sorting systems of defined quality aimed at removing fossil materials (such as plastics and synthetic textiles) to ensure only non- recyclable biogenic waste is used as feedstock. This subparagraph shall also apply to waste and residues that are first processed into a product before being further processed into biofuels, bioliquids and biomass fuels. Energy from solid biomass fuels shall not be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph if it is produced from primary woody biomass."; Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 672 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a – point ii - point a
Article 1 – paragraph 1 – point 18 – point a – point ii - point a
Directive (EU) 2018/2001
Article 29 – paragraph 1 – subparagraph 4 – point a
Article 29 – paragraph 1 – subparagraph 4 – point a
— (a) in the case of solid biomass fuels, in installations producing electricity, heating and cooling with a total rated thermal input equal to or exceeding 52 MW,
Amendment 681 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a a (new)
Article 1 – paragraph 1 – point 18 – point a a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 2
Article 29 – paragraph 2
(aa) paragraph 2 is replaced by the following: "Biofuels, bioliquids and biomass fuels produced from waste and residues derived not from forestry but from agricultural land shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 only where operators or national authorities have monitoring or management plans in place in order to address the impacts on soil quality and soil carbon, and where the land has not been converted from forests. Information about how those impacts are monitored and managed shall be reported pursuant to Article 30(3). " Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 693 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point a b (new)
Article 1 – paragraph 1 – point 18 – point a b (new)
Directive (EU) 2018/2001
Article 29 – paragraph 3 – subparagraph 1
Article 29 – paragraph 3 – subparagraph 1
"Biofuels, bioliquids and biomass fuels produced from agricultural and forest biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land with a high biodiversity value, namely land that had one of the following statuses in or after January 2008, whether or not the land continues to have that status: (a) primary forest and other wooded land, namely forest and other wooded land of native species including semi-natural forests, where there is no clearly visible indication of human activity and the ecological processes are not significantly disturbed; (b) highly biodiverse forest and other wooded land which is species-rich and not degraded, or has been identified as being highly biodiverse by the relevant competent authority, unless evidence is provided that the production of that raw material did not interfere with those nature protection purposes; (c) areas designated: (i) by law or by the relevant competent authority for nature protection purposes; or (ii) for the protection of rare, threatened or endangered ecosystems or species recognised by international agreements or included in lists drawn up by intergovernmental organisations or the International Union for the Conservation of Nature, subject to their recognition in accordance with the first subparagraph of Article 30(4), unless evidence is provided that the production of that raw material did not interfere with those nature protection purposes; (d) highly biodiverse grassland spanning more than one hectare that is: (i) natural, namely grassland that would remain grassland in the absence of human intervention and that maintains the natural species composition and ecological characteristics and processes; or (ii) non-natural, namely grassland that would cease to be grassland in the absence of human interventionand that is species-rich and not degraded and has been identified as being highly biodiverse by the relevant competent authority, unless evidence is provided that the harvesting of the raw material is n. (iii) heathland that maintains the natural speciessary to preserve its status as highly biodiverse grassland. composition and ecological characteristics and processes" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 703 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point b
Article 1 – paragraph 1 – point 18 – point b
Directive (EU) 2018/2001
Article 29 – paragraph 3 – subparagraph 1 a
Article 29 – paragraph 3 – subparagraph 1 a
This paragraph, with the exception of the first subparagraph, point (c), also applies to biofuels, bioliquids and biomass fuels produced from forestprimary woody biomass.;
Amendment 715 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point c
Article 1 – paragraph 1 – point 18 – point c
Directive (EU) 2018/2001
Article 29 – paragraph 4 – subparagraph 2 a
Article 29 – paragraph 4 – subparagraph 2 a
The first subparagraph, with the exception of points (b) and (c), and the second subparagraph also apply to biofuels, bioliquids and biomass fuels produced from forest biomass.;
Amendment 720 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point c a (new)
Article 1 – paragraph 1 – point 18 – point c a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 4 – subparagraph 1 and 2
Article 29 – paragraph 4 – subparagraph 1 and 2
(ca) – in paragraph 4, subparagraph 1 and 2 are replaced by the following "Biofuels, bioliquids and biomass fuels produced from agricultural biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be made from raw material obtained from land with high-carbon stock, namely land that had one of the following statuses in January 2008 and no longer has that status: (a) wetlands, namely land that is covered with or saturated by water permanently or for a significant part of the year; (b) continuously forested areas, namely land spanning more than one hectare with trees higher than five metres and a canopy cover of more than 30 %, or trees able to reach those thresholds in situ; (c) land spanning more than one hectare with trees higher than five metres and a canopy cover of between 10 % and 30 %, or trees able to reach those thresholds in situ, unless evidence is provided that the carbon stock of the area before and after conversion is such that, when the methodology laid down in Part C of Annex V is applied, the conditions laid down in paragraph 10 of this Article would be fulfilled. This paragraph shall not apply if, at the time the raw material was obtained, the land had the same status as it had in January 2008. (d) heathland that maintains the natural species composition and ecological characteristics and processes" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 726 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point d
Article 1 – paragraph 1 – point 18 – point d
Directive (EU) 2018/2001
Article 29 – paragraph 5
Article 29 – paragraph 5
5. Biofuels, bioliquids and biomass fuels produced from agricultural or forest biomass taken into account for the purposes referred to in paragraph 1, first subparagraph, points (a), (b) and (c), shall not be made from raw material obtained from land that was peatland in January 2008, unless evidence is provided that the cultivation and harvesting of that raw material does not involve drainage of previously undrained soil.;.
Amendment 738 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point e b (new)
Article 1 – paragraph 1 – point 18 – point e b (new)
DIRECTIVE (EU) 2018/2001
Article 29 – paragraph 6 – subparagraph 1 – point a – point iii
Article 29 – paragraph 6 – subparagraph 1 – point a – point iii
Amendment 739 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point d a (new)
Article 1 – paragraph 1 – point 18 – point d a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 6 – subparagraph 1
Article 29 – paragraph 6 – subparagraph 1
(da) in in paragraph 6, subparagraph 1, the introductory part is replaced by the following: "Biofuels, bioliquids and biomass fuels produced from forest biomass taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 shall not be derived from primary woody biomass, shall fully respect the waste hierarchy as set out in Article 4 of Directive 2008/98/EC and the cascading principle referred to in Article 3, and shall meet the following criteria to minimise the risk of using forest biomass derived from unsustainable production: " Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 755 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point f
Article 1 – paragraph 1 – point 18 – point f
Directive (EU) 2018/2001
Article 29 – paragraph 6 – subparagraph 1 – point b – point iv
Article 29 – paragraph 6 – subparagraph 1 – point b – point iv
Amendment 759 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point f
Article 1 – paragraph 1 – point 18 – point f
Directive (EU) 2018/2001
Article 29 – paragraph 6 – subparagraph 1 – point b – point iv
Article 29 – paragraph 6 – subparagraph 1 – point b – point iv
(iv) that harvesting is carried out consideensuring maintenance of soil quality and biodiversity with the aim of minimispreventing negative impacts, in a way that avoidprevents harvesting of stumps and roots not suitable for material use, degradation of primary forests or seminatural forests or their conversion into plantation forests, and harvesting on vulnerable soils; minimises large clear-cuts and ensures locally appropriate thresholds for deadwood extraction andprevents clear-cuts, unless they are necessary for the health of the forest, applies deadwood extraction only when it is beneficial for climate and biodiversity, and ensures requirements to use logging systems that minimise impacts on soil quality, including soil compaction, and on biodiversity features and habitats:;
Amendment 767 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point f a (new)
Article 1 – paragraph 1 – point 18 – point f a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 7
Article 29 – paragraph 7
Amendment 770 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point f b (new)
Article 1 – paragraph 1 – point 18 – point f b (new)
Directive (EU) 2018/2001
Article 29 – paragraph 7 a (new)
Article 29 – paragraph 7 a (new)
(fb) the following paragraph 7a is inserted: “Biofuels, bioliquids and biomass fuels produced from agricultural and forest biomass and Renewable Fuels of Non- Biological Origin taken into account for the purposes referred to in points (a), (b) and (c) of the first sub-paragraph of paragraph 1 shall meet the following requirements: (a) raw material is obtained from lands or forests for which third parties’ rights concerning use and tenure of the land or forest are respected by obtaining free, prior and informed consent of these third parties, with the participation by representative institutions and organisations; (b) human and labour rights of third parties are respected; and (c) the availability of food and feed for third parties is not at risk. For purposes of this paragraph, “third parties” refers to local and indigenous communities or any other persons involved in the production or harvesting of raw materials or affected by the operations to produce or extract raw material.”;
Amendment 771 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point f a (new)
Article 1 – paragraph 1 – point 18 – point f a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 6 – subparagraph 1 – point b
Article 29 – paragraph 6 – subparagraph 1 – point b
(b) when evidence referred to in point (a) of this paragraph is not available, the biofuels, bioliquids and biomass fuels produced from forest biomass shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 if management systems are in place at forest sourcing area level ensuring: (i) the legality of harvesting operations; (ii) forest regeneration of harvested areas; (iii) that areas designated by international or national law or by the relevant competent authority for nature protection purposes, including in wetlands and peatlands, are protected unless evidence is provided that the harvesting of that raw material does not interfere with those nature protection purposes; fa) paragraph 6, - subparagraph 1, - point (b) is deleted; Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 776 #
2021/0218(COD)
Amendment 777 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point f c (new)
Article 1 – paragraph 1 – point 18 – point f c (new)
Directive (EU) 2018/2001
Article 29 – paragraph 9
Article 29 – paragraph 9
(fc) paragraph 9 is replaced by the following: "By 31 December 2026, the Commission shall assess whether the criteria laid down in paragraphs 6 and 7 effectively minimise the risk of using forest biomass derived from unsustainable production and address LULUCF criteria, on the basis of the available data. The Commission shall, if appropriate, submit a legislative proposal to amend the criteria laid down in paragraphs 6 and 7 for the period after 2030. " Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 794 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point – g a (new)
Article 1 – paragraph 1 – point 18 – point – g a (new)
Directive (EU) 2018/2001
Article 29 – paragraph 10 –subparagraph 1 – point a
Article 29 – paragraph 10 –subparagraph 1 – point a
(ga) in paragraph 10, subparagraph 1, point a,is replaced by the following: "(a) at least 570 % for biofuels, biogas consumed in the transport sector, and bioliquids produced in installations in operation on or before 5 October 2015; ;" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 795 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point - g b (new)
Article 1 – paragraph 1 – point 18 – point - g b (new)
Directive (EU) 2018/2001
Article 29 – paragraph 10 – subparagraph 1 – points b and c
Article 29 – paragraph 10 – subparagraph 1 – points b and c
Amendment 800 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point g b (new)
Article 1 – paragraph 1 – point 18 – point g b (new)
Directive (EU) 2018/2001
Article 29 – paragraph 11 – subparagraph 1 – introductory part
Article 29 – paragraph 11 – subparagraph 1 – introductory part
(gb) paragraph 11, subparagraph 1 is replaced by the following : "Electricity from biomass fuels shall be taken into account for the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1 only if the fuels in use do not include primary woody biomass and it meets one or more of the following requirements: Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 803 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point g c (new)
Article 1 – paragraph 1 – point 18 – point g c (new)
Directive (EU) 2018/2001
Article 29 – paragraph 12
Article 29 – paragraph 12
Amendment 807 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 18 – point g d (new)
Article 1 – paragraph 1 – point 18 – point g d (new)
Directive (EU) 2018/2001
Article 29 – paragraph 14
Article 29 – paragraph 14
(gd) paragraph 14 is replaced by the following: "14. For the purposes referred to in points (a), (b) and (c) of the first subparagraph of paragraph 1, Member States may establish additional sustainability criteria for biomass fuels fuels, bioliquids and biomass fuels" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 815 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19
Article 1 – paragraph 1 – point 19
Directive (EU) 2018/2001
Article 29a – paragraph 3
Article 29a – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 35 to supplement this Directive by specifying the methodology for assessing greenhouse gas emissions savings from renewable fuels of non-biological origin and from recycled carbon fuels. The methodology for calculating emission savings from renewable fuels of non- biological origin shall ensure, as appropriate, that hydrogen production does occur in hours with maximum renewable energies in the electricity mix. The methodology shall ensure that credit for avoided emissions is not given for CO2 the capture of which has already received an emission credit under other provisions of law. The carbon content of the wastes and their release to the atmosphere shall be included in the methodology.;
Amendment 839 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 20 – point c a (new)
Article 1 – paragraph 1 – point 20 – point c a (new)
Directive (EU) 2018/2001
Article 30 – paragraph 4 – subparagraph 2
Article 30 – paragraph 4 – subparagraph 2
(ca) in paragraph 4, subparagraph 2 is replaced by the following: "The Commission may decide that those schemes contain accurate information on measures taken for soil, water and air protection, for the restoration of degraded land, and for the avoidance of excessive water consumption in areas where water is scarce, and for certification of biofuels, bioliquids and biomass fuels with low indirect land-use change-risk. ." Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 868 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21 a (new)
Article 1 – paragraph 1 – point 21 a (new)
Directive (EU) 2018/2001
Article 31 – paragraph 1 – subparagraph 1 – point a
Article 31 – paragraph 1 – subparagraph 1 – point a
(21a) in paragraph 1, subparagraph 1, point (a) is replaced by the following: "(a) where a default value for greenhouse gas emissions saving for the production pathway is laid down in Part Aor B of Annex V for biofuels and bioliquids and in Part A of Annex VI for biomass fuels where the el value for those biofuels or bioliquids calculated in accordance with point 7 of Part C of Annex V andis equal to or less than zero and estimated indirect land- use change emissions are zero in accordance with part B of Annex VIII, and where the evalue for those biomass fuels calculated in accordance with point 7 of Part B of Annex VI is equal to or less than zero, by using that default value ;" Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 880 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point - 1 (new)
Article 1 – paragraph 1 – point - 1 (new)
Directive (EU) 2018/2001
Article 1
Article 1
(-1) Article 1 is replaced by the following: "This Directive establishes a common framework for the promotion of energy from renewable sources. It sets a binding Union target for the overall share of energy from renewable sources in the Union's gross final consumption of energy in 2030. It also lays down rules on financial support for electricity from renewable sources, on self-consumption of such electricity, on the use of energy from renewable sources in the heating and cooling sector and in the transport sector, on regional cooperation between Member States, and between Member States and third countries, on guarantees of origin, on administrative procedures and on information and training. It also establishes sustainability and greenhouse gas emissions saving criteria in accordance with principle of cascade use for biofuels, bioliquids and biomass fuels. " Or. en (DIRECTIVE (EU) 2018/2001)
Amendment 913 #
2021/0218(COD)
Proposal for a directive
Annex I – paragraph 1 – point 5 – point c a (new)
Annex I – paragraph 1 – point 5 – point c a (new)
Directive (EU) 2018/2001
Annex V – Part C – points 19 a (new) and 19 b (new)
Annex V – Part C – points 19 a (new) and 19 b (new)
ca) The following points 19 a and 19 b are added: “19a. Emissions from indirect land-use change, eiluc, shall be calculated in accordance with Annex VIII. 19b. Emissions from extraction or cultivation (eec), direct land-use change (el) and indirect land-use change (eiluc), shall be apportioned to co-products on the basis of their energy content. Emissions apportioned to co-products shall be additional to the emissions apportioned to the principal product.”;
Amendment 294 #
2021/0211(COD)
Proposal for a directive
Recital 30
Recital 30
(30) The Carbon Border Adjustment Mechanism (CBAM), established under Regulation (EU) […./..] of the European Parliament and of the Council51 , is an alternative to complements free allocation to address the risk of carbon leakage. To the extent that sectors and subsectors are covered by that measure, they should not receive free allocation. However, a transitional phasing-out of free allowances is needed to allow producers, importers and traders to adjust to the new regime. and once the CBAM has fully demonstrated its effectiveness in equalising CO2 costs between imported and domestic products and in protecting the competitiveness of European exports, the free allocation received by these sectors should be gradually phased out. Once the CBAM has fully demonstrated its effectiveness in equalising CO2 costs between imported and domestic products and in protecting the competitiveness of European exports, and not earlier than 2030, a gradual phasing-out of free allowances is needed to allow producers, importers and traders to adjust to the new regime. The procedure to define the date at which the gradual phase-out should start is defined in Article XXX of [CBAM Regulation].The reduction of free allocation should be implemented by applying a factor to free allocation for CBAM sectors, while the CBAM is phased in. This percentage (CBAM factor) should be equal to 100 % during the transitional period between the entry into force of [CBAM Regulation] and 2025, 90 % in 2026[XXX– date at which the CBAM fully equalises CO2 costs], 90 % the following year and should be reduced by 10 percentage points each year to reach 0 % and there by eliminate free allocation by the tenth year. The relevant delegated acts on free allocation should be adjusted accordingly for the sectors and subsectors covered by the CBAM. The free allocation no longer provided to the CBAM sectors based on this calculation (CBAM demand) must be auctioned and the revenues will accrue to the Innovation Fund, so as to support innovation in low carbon technologies, carbon capture and utilisation (‘CCU’), carbon capture and geological storage (‘CCS’), renewable energy and energy storage, in a way that contributes to mitigating climate change. Special attention should be given to projects in CBAM sectors. To respect the proportion of the free allocation available for the non- CBAM sectors, the final amount to deduct from the free allocation and to be auctioned should be calculated based on the proportion that the CBAM demand represents in respect of the free allocation needs of all sectors receiving free allocation. _________________ 51[please insert full OJ reference]
Amendment 328 #
2021/0211(COD)
Proposal for a directive
Recital 31 a (new)
Recital 31 a (new)
(31a) While the surrendering of CBAM certificates for EU imports addresses the risk of carbon leakage on the EU market, it is essential to also avoid the risk that EU exports on global markets are replaced by more carbon intensive goods or by goods that are not subject to equivalent carbon costs. For this purpose, a CBAM factor equal to 100 % should apply to exports outside the EU of the products covered by the CBAM Regulation, as long as no WTO- compatible export solution measure to equalise CO2 costs has been implemented based on proposal of the Commission. Existing carbon pricing mechanisms in third countries should lead to an adjustment of the CBAM factor.
Amendment 399 #
2021/0211(COD)
Proposal for a directive
Recital 40
Recital 40
(40) Renewable liquid and gaseous fuels of non-biological origin and recycled carbon fuels can be important to reduce greenhouse gas emissions in sectors that are hard to decarbonise. Where recycled carbon fuels and renewable liquid and gaseous fuels of non-biological origin are produced from captured carbon dioxide under an activity covered by this Directive, the emissions should be accounted under that activityfor at the point of release. To ensure that renewable fuels of non-biological origin and recycled carbon fuels contribute to greenhouse gas emission reductions and to avoid double counting for fuels that do so, it is appropriate to explicitly extend the empowerment in Article 14(1) to the adoption by the Commission of implementing acts laying down the necessary adjustments for how to account for the eventual release of carbon dioxide and how to avoid double counting to ensure appropriate incentives are in place, taking also into account the treatment of these fuels under Directive (EU) 2018/2001.
Amendment 419 #
2021/0211(COD)
Proposal for a directive
Recital 43
Recital 43
Amendment 440 #
2021/0211(COD)
Proposal for a directive
Recital 44
Recital 44
Amendment 455 #
2021/0211(COD)
Proposal for a directive
Recital 45
Recital 45
Amendment 458 #
2021/0211(COD)
Proposal for a directive
Recital 46
Recital 46
Amendment 472 #
2021/0211(COD)
Proposal for a directive
Recital 47
Recital 47
Amendment 479 #
2021/0211(COD)
Proposal for a directive
Recital 48
Recital 48
Amendment 488 #
2021/0211(COD)
Proposal for a directive
Recital 49
Recital 49
Amendment 500 #
2021/0211(COD)
Proposal for a directive
Recital 50
Recital 50
Amendment 511 #
2021/0211(COD)
Proposal for a directive
Recital 51
Recital 51
Amendment 519 #
2021/0211(COD)
Proposal for a directive
Recital 52
Recital 52
Amendment 656 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Directive 2003/87/EC
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) ‘emissions’ means the release of greenhouse gases into the atmosphere from sources in an installation or the release from an aircraft performing an aviation activity listed in Annex I or from ships performing a maritime transport activity listed in Annex I of the gases specified in respect of that activity, or the release of greenhouse gases corresponding to the activity referred to in Annex III;;
Amendment 968 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a – point i
Article 1 – paragraph 1 – point 12 – point a – point i
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 2b
Article 10a – paragraph 1 – subparagraph 2b
Amendment 1006 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2003/87/EC
Article 10a –paragraph 1a – subparagraph 1
Article 10a –paragraph 1a – subparagraph 1
Amendment 1028 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2003/87/EC
Article 10a – paragraph 1a – subparagraph 2
Article 10a – paragraph 1a – subparagraph 2
Amendment 1343 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point e
Article 1 – paragraph 1 – point 15 – point e
Directive 2003/87/EC
Article 12 – paragraph 3 b – subparagraph 1
Article 12 – paragraph 3 b – subparagraph 1
An obligation to surrender allowances shall not arise in respect of emissions of greenhouse gases which are considered to have been captured and utilised to become permanently chemically bound in a productor transferred for further use so that they doid not enter the atmosphere under normal use.
Amendment 1348 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point e
Article 1 – paragraph 1 – point 15 – point e
Directive 2003/87/EC
Article 12 – paragraph 3 b – subparagraph 2
Article 12 – paragraph 3 b – subparagraph 2
The Commission shall adopt implementing acts concerning the requirements to consider that greenhouse gases have become permanently chemically bound in a product so that they do not enter the atmosphere under normal useon how to account at the point of release into the atmosphere, for the greenhouse gases transferred from a capturing installation.
Amendment 1383 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19 a (new)
Article 1 – paragraph 1 – point 19 a (new)
Directive 2003/87/EC
Article 29
Article 29
(19a) Article 29 is replaced by the following: Article 29 “Article 29 Report to ensure the better functioning of the carbon market the carbon market If, on the basis of the regular reports on the carbon market referred to in Article 10(5), the Commission has evidence that the carbon market is not functioning properly, for instance due to the role of noncompliance operators such as financial investors, it shall submit a report to the European Parliament and to the Council. The report may be accompanied, if appropriate, by proposals aiming at increasing transparency of the carbon market and addressing measures to improve its functioning. and to tackle the role and impact of financial speculation.”
Amendment 1408 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2003/87/EC
Chapter IV a
Chapter IV a
Amendment 78 #
2021/0205(COD)
(4) The air transport market is subject to increasingly strong competition between economic actors across the Union, whether public or private, for which a level playing field is indispensable. The stability and prosperity of the air transport market and its economic actors relies on a clear and harmonised policy framework where aircraft operators, airports and other aviation actors can operate on the basis of equal opportunities. Where market distortions occur, they risk putting aircraft operators or airports at a disadvantage with internal or external competitors. In turn, this can result in a loss of competitiveness of the air transport industry, and a loss of air connectivity for citizens and businesses.
Amendment 83 #
2021/0205(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) A key objective of the common transport policy is sustainable development. This requires an integrated approach aimed at ensuring both the effective functioning of Union transport systems and protection of the environment. Sustainable development of air transport requires the introduction of joint measures, decided by mutual agreement at European and international levels, aimed at reducing the carbon emissions from aircraft flying from Union airports. Such measures should contribute to meeting the Union’s climate objectives by 2030 and 2050.
Amendment 94 #
2021/0205(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Communication on a Sustainable and Smart Mobility Strategy10 adopted by the Commission in December 2020 sets a course of action for the EU transport system to achieve its green and digital transformation and become more resilient. The decarbonisation of the air transport sector is a necessary and challenging process, especially in the short term. Technological advancements, pursued in European and national research and innovation aviation programmes have contributed to important emission reductions in the past decades. However, the constant, global growth of air traffic hasand the increase in the number of airports and destinations have outpaced the sector’s emissions reductions. Whereas new technologies are expected to help reducing short-haul aviation’s reliance on fossil energy in the next decades, sustainable aviation fuels offer the only solution for significant decarbonisation of all flight ranges, already in the short term. However, this potential is currently largely untapped. _________________ 10Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Sustainable and Smart Mobility Strategy – putting European transport on track for the future (COM/2020/789 final), 9.12.2020.
Amendment 102 #
2021/0205(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The gradual introduction of sustainable aviation fuels on the air transport market will represent an additional fuel cost for airlines, as such fuel technologies are currently more expensive to produce than conventional aviation fuel. This is expected to exacerbate the pre-existing issues of level playing field on the air transport market as regards aviation fuel, and to cause further distortions among aircraft operators and airports, because there is a danger that new sustainable aviation fuel production technologies will not be accessible to all. This regulation should take measures to prevent that the introduction of sustainable aviation fuels affects negatively the competitiveness of the aviation sector by defining harmonised requirements across the Union.
Amendment 113 #
2021/0205(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) At EU level, general rules on renewable energy for the transport sector are set out in Directive (EU) 2018/2001 of the European Parliament and of the Council11. In the past, such horizontal cross-sectoral regulatory frameworks have not proven effective to operate a transition from fossil fuels to sustainable aviation fuel in air transport, with important repercussions for air transport beneficiaries. Directive (EU) 2018/2001 and its predecessor set out overarching targets across all transport modes to be supplied with renewable fuels. As aviation is a small fuels market for which renewable fuels are more costly to produce while a fully integrated European transport market, in comparison to other transport modes, such regulatory frameworks should be complemented with aviation-specific measures to effectively boost the deployment of sustainable aviation fuels. Further, national transpositions of Directive (EU) 2018/2001 risks creating significant fragmentation in the air transport market, where national rules on sustainable aviation fuels would set out widely differing targets. This would be expected to further exacerbate the issues of level playing field in air transport. _________________ 11Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82).
Amendment 114 #
2021/0205(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Therefore, uniform rules need to be laid down for the aviation internal market to complement Directive (EU) 2018/2001 and to deliver on its overall objectives by addressing the specific needs and requirements arising from the EU aviation internal market. In particular, the present Regulation aims to avoid a fragmentation of the aviation market, prevent possible competitive distortions between economic actors, or unfair practices of cost avoidance as regards the refuelling of aircraft operators, with significant effects on the prices paid by air transport beneficiaries.
Amendment 116 #
2021/0205(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) This regulation aims in the first instance to set out a framework restoring and preserving a level playing field on the air transport market as regards the use of aviation fuels. Such a framework should prevent divergent requirements across the Union that would exacerbate refuelling practices distorting competition between aircraft operators or putting some airports at competitive disadvantage with others. In a second instance, it aims to gear the EU aviation market with robust rules to ensure that gradually increasing shares of sustainable aviation fuels can be introduced at EU airports without detrimental effects on the final prices charged to beneficiaries or the competitiveness of the EU aviation internal market.
Amendment 120 #
2021/0205(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The present Regulation should apply to aircraft engaged in civil aviation, carrying out commercial air transport flights. It should not apply to aircraft such as military aircraft and aircraft engaged in operations for humanitarian, search, rescue, disaster relief or medical purposes, as well as customs, police and fire-fighting operations. Indeed, flights operated in such circumstances are of exceptional nature and as such cannot always be planned in the same way as regular flights. Due to the nature of their operations, they may not always be in a position to fulfil obligations under this Regulation, as it may represent unnecessary burden. In order to cater for a level playing field across the EU aviation single market, this regulation should cover the largest possible share of commercial air traffic operated from airports located on EU territory. At the same time, in order to safeguard air connectivity for the benefits of EU citizens, businesses and regions, it is important to avoid imposing undue burden on air transport operations at small airports. A threshold of yearly passenger air traffic and freight traffic should be defined, below which airports would not be covered by this Regulation; however, the scope of the Regulation should cover at least 95% of total traffic departing from airports in the Union. For the same reasons, a threshold should be defined to exempt aircraft operators accountable for a very low number of departures from airports located on EU territory, especially those airports that have only recently begun operating and have not had time to consolidate their business.
Amendment 139 #
2021/0205(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The present Regulation should aim to ensure that aircraft operators can compete on the basis of equal opportunities as regards the access to sustainable aviation fuels. To avoid any distortions on the air services market, all Union airports covered by this Regulation should be supplied with uniform minimum shares of sustainable aviation fuels, in strict proportion to the traffic at the airport concerned. Whereas the market is free to supply and use larger quantities of sustainable fuel, this Regulation should ensure that the mandatory minimum shares of sustainable aviation fuels are the same across all the covered airports and take into account the traffic at the airports concerned. It supersedes any requirements established directly or indirectly at national or regional level requiring aircraft operators or aviation fuel suppliers to uptake or supply sustainable aviation fuels with different targets than the ones prescribed under this Regulation. In order to create a clear and predictable legal framework and in doing so encourage the market development and deployment of the most sustainable and innovative with growth potential to meet future needs fuel technologies, this Regulation should set out gradually increasing minimum shares of synthetic aviation fuels over time. Setting out a dedicated sub-obligation on synthetic aviation fuels is necessary in view of the significant decarbonisation potential of such fuels, and in view of their current estimated production costs. When produced from renewable electricity and carbon captured directly from the air, synthetic aviation fuels can achieve as high as 100% emissions savings compared to conventional aviation fuel. They also have notable advantages compared to other types of sustainable aviation fuels with regards to resource efficiency (in particular for water needs) of the production process. However, synthetic aviation fuels’ production costs are currently estimated at 3 to 6 times higher than the market price of conventional aviation fuel. Therefore, this Regulation should establish a dedicated sub-obligation for this technology. Other types of synthetic fuels, such as low carbon synthetic fuels achieving high greenhouse gas reductions, could be considered for inclusion in the scope of this Regulation in the course of future revisions, where such fuels become defined under the Renewable Energy Directive.
Amendment 143 #
2021/0205(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) It is essential to ensure that the minimum shares of sustainable aviation fuels can be successfully supplied to the aviation market without supply shortages. For this purpose, sufficient lead-time should be planned to allow the renewable fuels industry to develop production capacity accordingly, and also the storage capacity in order to meet demand. The supply of sustainable aviation fuels should become mandatory starting in 2025. Similarly, in order to provide legal certainty and predictability to the market and drive investments durably towards sustainable aviation fuels production capacity, the terms of this Regulation should be stable over a long period of time.
Amendment 148 #
2021/0205(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) With the introduction and ramp-up of sustainable aviation fuels at Union airports, practices of fuel tankering may be exacerbated as a consequence of aviation fuel costs increases. Tankering practices are unstainable and should be avoided as they undermine the Union’s efforts to reduce environmental impacts from transport. Those would be contrary to the aviation decarbonisation objectives as increased aircraft weight would increase fuel consumption and related emissions on a given flight, and may also have undesirable effects on flight safety in the case of a heavier aircraft. Tankering practices also put at risk the level playing field in the Union between aircraft operators, and also between airports. This Regulation should therefore require aircraft operators to refuel prior to departure from a given Union airport. The amount of fuel uplifted prior to departures from a given Union airport should be commensurate with the amount of fuel necessary to operate the flights departing from that airport, taking into account the necessary compliance with fuel safety rules. The requirement ensures that equal conditions for operations in the Union applying equally to Union and foreign operators, while ensuring high level of environmental protection. As the Regulation does not define a maximum share of sustainable aviation fuels in all aviation fuels, airlines and fuel suppliers may pursue more ambitious environmental policies with higher sustainable aviation fuels uptake and supply in their overall network of operations, while avoiding fuel tankering.
Amendment 287 #
2021/0205(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
(2) Member States shall ensure that any aircraft operator failing to comply with the obligations laid down in Article 5 is liable to an administrative fine. That fine shall be at least twice as high as the multiplication of the yearly average price of aviation fuel per tonne and of the total yearly non- tanked quantity, and may be increased for repeat violations;
Amendment 294 #
2021/0205(COD)
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
(3) Member States shall ensure that any aviation fuel supplier failing to comply with the obligations laid down in Article 4 relative to the minimum share of sustainable aviation fuels is liable to an administrative fine. That fine shall be at least twice as high as the multiplication of the difference between the yearly average price of conventional aviation fuel and sustainable aviation fuel per tonne and of the quantity of aviation fuels not complying with the minimum share referred to in Article 4 and Annex I, and may be increased for repeat violations;
Amendment 308 #
2021/0205(COD)
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
(7) Member States shallould prepare themselves in good time to have the necessary legal and administrative framework in place at national level to ensure the fulfilment of the obligations and the collection of the administrative fines. Member States shall transfer the amount collected through those administrative fines as contribution to the InvestEU Green Transition Investment Facility, as a top-up to the EU guarantee.
Amendment 22 #
2020/2273(INI)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. Whereas the degradation of habitats and disruption of migration corridors by, for example, river modifications and dams, overexploitation for their caviar and meat, as well as pollution have driven sturgeons to the brink of extinction; whereas the drastic decrease of the number of spawners, associated with the population decline, trigger the failure of the natural reproduction, reducing the chance of the few remaining males and females to meet and spawn;
Amendment 24 #
2020/2273(INI)
Draft opinion
Recital C b (new)
Recital C b (new)
Cb. Whereas the data held by the research institutes indicate that the populations of sturgeon species are fragmented, missing certain generations, and the species of sturgeon natural reproduction is deficient, the number of adults migrating to the Danube for reproduction is extremely low and the species sturgeon is on the verge of extinction;
Amendment 34 #
2020/2273(INI)
Draft opinion
Recital D a (new)
Recital D a (new)
Amendment 85 #
2020/2273(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Calls on the Commission to urgently and temporarily transfer the sturgeons from Annex V to Annex II or even Annex I to Habitats Directive 92/43 / EEC, until scientifically determined that wild stock of sturgeons are no longer red listed under the IUCN list;
Amendment 88 #
2020/2273(INI)
Draft opinion
Subheading 2 a (new)
Subheading 2 a (new)
Stresses the emergency to establish “fish stock recovery areas” (or “no take zones”) in the Black Sea, to allow the recovery of the wild populations of sturgeons, as such areas were proven beneficial both for biodiversity conservation and for fishery management;
Amendment 114 #
2020/2273(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
Amendment 180 #
2020/2273(INI)
Draft opinion
Paragraph 20
Paragraph 20
20. Welcomes the high level of ambition when setting targets; strongly recommends, however, that such targets should not be legally binding, and that they should be set on a case-by-case basis, adapted to local specificities and to the level required to protect nature; recommends that such targets should also take into account socio-economic considerations, should be backed by reconversion programs and alternative livelihood to fishing communities and the need to ensure a long-term resilience of the fisheries and aquaculture value chain, be proportionate with the objective pursued and have a solid scientific basis;
Amendment 208 #
2020/2273(INI)
Draft opinion
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Welcomes the restoration of free flowing of rivers in a sustainable way, taking into account the environmental, social and economic aspects, investing in technology and innovation for the creation of fishing migrating routes, without hindering the right of Member States to decide on their energy mix, the economic activity of hydropower plants, the energy security and the environmental benefits of hydropower;
Amendment 284 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Considers that it is necessary to organise a Europe-wide awareness campaign on protecting biodiversity and extending protected areas, targeting different age categories, and young people in particular;
Amendment 341 #
2020/2273(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Welcomes the upcoming legislative proposal on the EU Nature Restoration Plan and reiterates its call for a restoration target of at least 30 % of the EU’s land and seas, which should be implemented by each Member State consistently throughout their territory, and through transnational cooperation where protected areas straddle the territories of several countries; considers that in addition to an overall restoration target, ecosystem- specific targets should be set, with a particular emphasis on ecosystems for the dual purposes of biodiversity restoration and climate change mitigation and adaptation; stresses that after restoration, no ecosystem degradation should be allowed;
Amendment 470 #
2020/2273(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Recalls that the EU has committed to achieving land degradation neutrality by 2030, but that this target is unlikely to be achieved; calls on the Commission, therefore, to present at the earliest opportunity an EU-level strategy on desertification and land degradation;
Amendment 487 #
2020/2273(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission to set specific ambitious targets on urban biodiversity, as well as short timeframes for the implementation of these nature- based solutions and green infrastructure, and to develop a Trans-European Network for Green Infrastructure (TEN-G) linked to the Trans- European Nature Network (TEN-N);
Amendment 563 #
2020/2273(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses that all fishing activities must be subject to maximum sustainable yield levels, with zero tolerance of illegal fishing practices and the elimination of by- catches of sensitive species, including, where applicable, severe penalties for those found in breach of the relevant bans;
Amendment 612 #
2020/2273(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that priority for protected areas must be environmental conservation and restoration, establishing highly- protected zones aimed at restoring habitats and fish stocks, and that no activity in these areas should undermine this goal; calls on the Commission to avoid future marine renewable energy developments and bottom-trawling fishing within Marine Protected Areas;
Amendment 649 #
2020/2273(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Underlines that the new EU Forest Strategy must be fully aligned with the Climate Law and the Biodiversity Strategy; calls for the inclusion in the Nature Restoration Plan of specific binding targets for the protection and restoration of forest ecosystems, which should alscoupled with short timeframes for their implementation, and for these targets to be incorporated into the Forest Strategy, too;
Amendment 746 #
2020/2273(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to prepare, as soon as possible, a long-term EU action plan on climate and biodiversity that has a clearly defined step-by-step process, that improves coherence and interconnections for future actions, and integrates commitments under the post- 2020 Global Biodiversity Framework and the Paris Agreement;
Amendment 1018 #
2020/2273(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls on the Commission to reinforce biodiversity within Union youth programmes such as the European Voluntary Service, and to launch a Green Erasmus programme focused on restoration and conservation aimed at generating more engagement with these programmes among young people; reiterates its calls for a specific mission and funding dedicated to biodiversity within future research programmes;
Amendment 1096 #
2020/2273(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Reiterates its call for a full ban on the trade in both raw and worked ivory to, from and within the EU, including ‘pre- convention’ ivory and rhino horns, and asks for similar restrictions for other endangered species, such as tigers; calls for measures to increase protection of these animals by cooperating with international institutions and the relevant countries in order to prevent the killing of animals for ivory harvesting;
Amendment 15 #
2020/2260(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
- having regards to its resolution of 18 December 2019 on the EU Pollinators Initiative1a, __________________ 1a P9_TA(2019)0104
Amendment 75 #
2020/2260(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
- having regard to Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy; Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration and Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources,
Amendment 113 #
2020/2260(INI)
Motion for a resolution
Citation 23 a (new)
Citation 23 a (new)
- having regard to its resolution of 11 February 2015 on country of origin labelling for meat in processed food1a, __________________ 1a OJ C 310, 25.8.2016, p. 15–18.
Amendment 114 #
2020/2260(INI)
Motion for a resolution
Citation 23 b (new)
Citation 23 b (new)
- having regard to its resolution of 12 May 2016 on mandatory indication of the country of origin or place of provenance for certain food1a, __________________ 1a OJC 76, 28.2.2018, p. 49–53.
Amendment 118 #
2020/2260(INI)
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to its resolution of 13 March 2019 on a Europe that protects: Clean air for all1a, __________________ 1a P8_TA(2019)0186
Amendment 128 #
2020/2260(INI)
Motion for a resolution
Citation 25 a (new)
Citation 25 a (new)
- having regards to Special Eurobarometer 505:"Making our food fit for the future – Citizens’ expectations" from October 2020,
Amendment 148 #
2020/2260(INI)
Motion for a resolution
Citation 37 a (new)
Citation 37 a (new)
- having regard to Council Presidency Conclusions of 15 December 2020 on front-of-pack nutrition labelling, nutrient profiles and origin labelling,
Amendment 151 #
2020/2260(INI)
Motion for a resolution
Citation 37 a (new)
Citation 37 a (new)
- having regards to the European Committee of the Regions' opinion on the Farm to Fork Strategy "From Farm to Fork – the local and regional dimension"1a, __________________ 1a NAT-VII/005
Amendment 224 #
2020/2260(INI)
Motion for a resolution
Recital B
Recital B
B. whereas Europe’s food system should deliver food and nutrition security in a way that contributes to social well- being and maintains and, restores ecosystem health and ensures animal health and welfare; whereas currently, the food system is responsible for a range of impacts on human and animal health and on the environment, the climate and biodiversity; whereas the way in which we produce and consume food needs to significantly transform in order to ensure coherence with the SDGs, the Paris Agreement, the Convention on Biological Diversity and EU policies, particularly in the areas of sustainability, the environment, climate, public health, animal welfare, food and economic sustainability for farmers;
Amendment 227 #
2020/2260(INI)
Motion for a resolution
Recital B
Recital B
B. whereas Europe’s food system should deliver food and nutrition security to all European citizens in a way that contributes to social well- being and maintains and restores ecosystem health; whereas currently, the food system is responsible for a range of impacts on human and animal health and on the environment, the climate and biodiversity; whereas the way in which we produce and consume food needs to transform in order to ensure coherence with the SDGs, the Paris Agreement, the Convention on Biological Diversity and EU policies, particularly in the areas of sustainability, the environment, climate, public health, animal welfare, food and economic sustainability for farmers;
Amendment 307 #
2020/2260(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the European model of a multifunctional agricultural sector, driven by family farms, continues to ensurprovide an important part of the quality food production, local supply chains, good agriculture practices, high environmental standards and vibrant rural areas throughout the EU;
Amendment 361 #
2020/2260(INI)
Motion for a resolution
Recital D
Recital D
Amendment 396 #
2020/2260(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas it is estimated that in the EU in 2017 over 950,000 deaths (one out of five) and over 16 million lost healthy life years were attributable to unhealthy diets, mainly cardiovascular diseases and cancers1a; __________________ 1aEU Science Hub : https://ec.europa.eu/jrc/en/health- knowledge-gateway/societal- impacts/burden
Amendment 404 #
2020/2260(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the European food system has played a crucial role during the COVID-19 pandemic, demonstrating its resilience with farmers, processors and retailers working together under difficult conditions, including lockdowns, to ensure that European consumers continue to have access to safe, affordable, and high quality products without impediment; whereas the COVID-19 crisis, nevertheless, has highlighted the limits and weaknesses of globalised and intricate food supply chains, and has shown that over- specialisation of agricultural production leaves countries more vulnerable to trade restrictions and sudden shifts in consumer demand;
Amendment 418 #
2020/2260(INI)
Motion for a resolution
Recital E
Recital E
whereas the European food system has played a crucial role during the COVID-19 pandemic, demonstrating its resilience with farmers, processors and retailers working together under difficult conditions, without disruptions to the food chain, including lockdowns, to ensure that European consumers continue to have access to safe, affordable, and high quality products without impediment;
Amendment 467 #
2020/2260(INI)
Motion for a resolution
Recital E c (new)
Recital E c (new)
Ec. whereas emissions of ammonia (NH3) rose for the fourth year running, increasing by 0.4% across the EU, from 2016 to 20171a with the overall increase over the 2014-2017 period of about 2.5%; whereas these increases are because of the lack of emission reductions in the agricultural sector; whereas ammonia emissions can lead to increased acid depositions and excessive levels of nutrients in soil, rivers or lakes, which can have negative impacts on aquatic ecosystems and cause damage to forests, crops and other vegetation; whereas eutrophication can lead to severe reductions in water quality with subsequent impacts including decreased biodiversity, and toxicity effects; __________________ 1aAnnual EEA briefing ‘National Emission Ceilings (NEC) Directive reporting status 2019’ https://www.eea.europa.eu/themes/air/air- pollution-sources-1/national-emission- ceilings/nec-directive-reporting-status- 2019
Amendment 472 #
2020/2260(INI)
Motion for a resolution
Recital E d (new)
Recital E d (new)
Ed. whereas agriculture is the third biggest source of primary PM10 emissions in the EU, as stressed by the European Environment Agency; whereas ammonia (NH3) emissions from agriculture contribute to episodes of high PM concentrations experienced across Europe each spring, as well as to both short- and long-term negative health impacts;
Amendment 476 #
2020/2260(INI)
Motion for a resolution
Recital E e (new)
Recital E e (new)
Ee. whereas methane emissions from agriculture are an important precursor to ground-level ozone, which has adverse effects on human health; whereas 98 % of the EU’s urban population is exposed to ozone levels exceeding WHO guidelines;
Amendment 477 #
2020/2260(INI)
Motion for a resolution
Recital E f (new)
Recital E f (new)
Ef. whereas agro-ecology is an integrated approach that simultaneously applies ecological and social concepts and principles to the design and management of food and agricultural systems; whereas it seeks to optimise the interactions between plants, animals, humans and the environment while taking into consideration the social aspects that need to be addressed for a sustainable and fair food system;
Amendment 479 #
2020/2260(INI)
Motion for a resolution
Recital E g (new)
Recital E g (new)
Eg. whereas agro-ecology can support food production and security and nutrition while restoring the ecosystem services and biodiversity that are essential for sustainable agriculture and plays an important role in building resilience and adapting to climate change; whereas the UN Food and Agriculture Organisation (FAO)recognises it as a solution to tackle the multi-facetted social and environmental challenges facing the global food system;
Amendment 480 #
2020/2260(INI)
Motion for a resolution
Recital E h (new)
Recital E h (new)
Amendment 515 #
2020/2260(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the ambitions and goals of the farm to fork strategy as an important steps in ensuring a sustainable, fair, healthy and resilient food system, which is central to achieving the goals set out in the European Green Deal and in the SDGs; emphasises the inextricable links between healthy people, healthy societies and a healthy planet, encourages the Commission to translate the strategy into concrete legislative and non-legislative action as soon as possible;
Amendment 520 #
2020/2260(INI)
1. Welcomes the farm to fork strategy as an important step in ensuring a sustainable, fair and resilient quality food system, which is central to achieving the goals set out in the European Green Deal and in the SDGs; emphasises the inextricable links between healthy people, healthy societies and a healthy planet, encourages the Commission to translate the strategy into concrete legislative and non- legislative action as soon as possible;
Amendment 576 #
2020/2260(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the announcement of an impact-assessed proposal for a legislative framework for sustainable food systems; invites the Commission to use this proposal to set out a holistic common food policy aimed at reducing the environmental and climate footprint of the EU food system in order to make Europe the first climate- neutral continent by 2050 and strengthen its resilience to ensure food security in the face of climate change and biodiversity loss, leading a global transition towards sustainability from farm to fork, based on the principle of a multifunctional agricultural sector while ensuring consistency between policies by taking into account the existing legislation in order to enable all actors in the European food system to stay interconnected and to develop long-term plans based on realistic and transparent objectives to provide consumers with quality products; suggests that the respective base lines and progress achieved in each Member State be taken into account, while promoting the exchange of know-how and best practices between Member States; stresses the need to include the entire food and beverage chains, with emphasis on keeping alive, producing and marketing traditional products from rural and remote areas to encourage small producers, including processing, marketing, distribution and retail;
Amendment 593 #
2020/2260(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the announcement of an impact-assessed proposal for a legislative framework for sustainable food systems; invites the Commission to use this proposal to set out a holistic, integrated common food policy aimed at reducing the environmental and climate footprint of the EU food system in order to make Europe the first climate- neutral continent by 2050 and strengthen its resilience to ensure food security in the face of climate change and biodiversity loss, leading a global transition towards sustainability from farm to fork, based on the principle of a multifunctional agricultural sector while ensuring consistency between policies by taking into account the existing legislation in order to enable all actors in the European food system to develop long- term plans based on realistic and transparent objectives; suggests that the respective base lines and progress achieved in each Member State be taken into account, while promoting the exchange of know-how and best practices between Member States; stresses the need to include the entire food and beverage chains including production, processing, marketing, transport, distribution and retail and to cover the environmental, social(including health) and economic dimensions of sustainability;
Amendment 664 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Calls on the Commission to use the farm to fork strategy to build a truly long-term vision for Europe’s sustainable and competitive food system, able to guarantee access to healthy and quality products through binding targets for agriculture on biodiversity, climate, air pollution, water pollution, pesticides use and land degradation, while addressing sustainability issues around consumption, health and trade and safeguarding a high level of animal health and welfare, and at the same time promoting reciprocity of EU production standards with all commercial partners;
Amendment 676 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Calls on the farm to fork strategy to deliver together with the Biodiversity Strategy on the EU’s climate and environmental objectives through protection and restoration of ecosystems currently used for food production with a particular focus on the restoration of grasslands and drained peatlands, two major carbon sinks, as well as through protection of remaining natural ecosystems from further agricultural expansion such as peatlands, wetlands and old-growth forests;
Amendment 680 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Stresses that the Common Agricultural Policy and the farm to fork strategy must be determined together at European level, in order to complement each other and protect a fair balance between production, consumer health and environment, and must be attributed adequate resources to strengthen farmers’ position in the agri-food supply chain;
Amendment 682 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 e (new)
Paragraph 2 e (new)
2e. Reiterates that to ensure a proportionate contribution from the sector, agriculture should be target-driven in the EU’s ambition to move towards net- zero emissions by mid-century or before; stresses that inclusion of farmers in climate action is crucial in order to achieve global mitigation targets without compromising global food and nutrition security and the Sustainable Development Goals;
Amendment 683 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 f (new)
Paragraph 2 f (new)
2f. Calls for a sustainable and efficient CAP which actively encourages farmers to deliver more environmental and climate benefits, including through strengthened common standards and mandatory requirements, especially for eco-schemes, providing a wide range of tools for farmers adapted to specific natural conditions to more efficiently use essential resources and inputs in food production, to improve biodiversity and soils, increase carbon sequestration, preserve sensitive habitats, contribute to the circular economy, reduce waste in the production cycle and phase-out subsidies which damage the climate;
Amendment 719 #
2020/2260(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
Amendment 782 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Points out that, in addition to revising the directive on the sustainable use of pesticides to reduce the use and risks of pesticides, the Commission should improve the environmental risk assessment for plant protection products in order to take into account the effects of pesticides on water quality and drinking water sources, including cumulative and combination effects; emphasises that pesticides that have a strong negative impact on groundwater and surface water quality, or to the production of drinking water, should be phased out as a priority, and that the substitution of harmful pesticides by low-risk substances should be promoted; stresses the need to improve policy coordination between agricultural, pesticide-, biocide- and fertiliser-related legislation and, inter alia, water legislation in order to ensure the protection of our water resources, and in particular of those used for drinking water production, from overexploitation and agricultural pollution;
Amendment 818 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes that several CAP measures can contribute to the implementation of the Sustainable Use of Pesticides Directive, for example by promoting IPM and organic farming; reminds that CAP rules also require Member States to establish farm advisory systems and provide advice on IPM to all farmers; regrets however that, while the IPM principles are mandatory for farmers, they are not included as a condition for CAP payments and despite encouragement for more sustainable farming practices, there are few measures deterring farmers from using ‘standard’ PPPs rather than turning to non-chemical or alternative methods1e; calls on the Member States to convert the general IPM principles into practical and measurable criteria and verify these criteria at farm level; calls on the Commission to incorporate these measurable IPM criteria into ‘conditionality’ in the post-2020 CAP and ensure they are enforced; _________________ 1eSpecial Report of the Court of Auditors 05/2019 "Sustainable use of plant protection products: limited progress in measuring and reducing risks"
Amendment 842 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Notes with interest the Commission's estimation of the EU-wide risks and impacts related to PPP use, published in November 2019, based on calculations of the two recently adopted harmonised risk indicators (one indicator based on PPP sales statistics and the other based on the number of emergency authorisations); regrets however that neither of the indicators show the extent to which the SUP Directive has been successful in achieving the EU objective of sustainable use of PPPs and that several concerns have been raised regarding the scientific rationale for the weightings used;1f calls on the Commission, in order to adequately assess the progress made towards policy objectives, to improve the harmonised risk indicators, or develop new ones that take into account, for Harmonised Risk Indicator II, agricultural areas or volumes of active substance, for Harmonised Risk Indicator I, the way PPPs are used; _________________ 1fEuropean Court of Auditors' Special Report 05/2019 "Sustainable use of plant protection products: limited progress in measuring and reducing risks"
Amendment 936 #
2020/2260(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Emphasises the importance of recognising the significant impact of agriculture and especially animal production on greenhouse gas (GHG) emissions and land use; stresses the need to enhance natural carbon sinks and reduce agricultural emissions of carbon dioxide, methane and nitrous oxide, in particular in the feed and livestock sectors; emphasises the importance of setting strict limits for greenhouse gas emissions in the animal feed sector, calls for regulatory measures and targets to ensure progressive reductions in all GHG emissions in these sectors;
Amendment 1150 #
2020/2260(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
Amendment 1165 #
2020/2260(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Underlines the importance of seed security and diversity, and of taking action to avoid a monopoly by the largest seed companies, notably of promoting EU- grown plant proteins to deliver locally sourced food and feed stuffs with high nutritional value while granting farmers access to quality seeds for plant varieties adapted to the pressures of climate change, including traditional and locally-adapted varieties, while ensuring access to innovative plant breeding in order to contribute to healthy seeds and protect plants against harmful pests and diseases; raises awareness of the potential negative effects of concentration and monopolisation in the seed sector through appropriate information campaigns;
Amendment 1182 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Underlines that inconsistencies between different EU policies affecting our food system have hindered progress towards EU’s international commitments on the SDGs and a truly sustainable European food system; stresses that the farm to fork strategy and the European Green Deal must ensure full policy coherence between agriculture, environment, trade and climate policies; calls on the CAP National Strategic Plans to fully support the implementation of existing EU environmental law and to contribute to the objectives of the Green Deal in order to ensure coherence with EU’s climate and environmental targets;
Amendment 1199 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission and on Member States to promote the agro- ecological farming practices in EU agriculture based on the set of principles as defined by FAO1g, in particular through the CAP Strategic Plans, in order to transform the EU’s food and agricultural system, to mainstream sustainable agriculture and to achieve Zero Hunger and multiple other SDGs; _________________ 1gThe 10 Elements of Agroecology Guiding the Transition to Sustainable Food and Agricultural Systems http://www.fao.org/3/I9037EN/i9037en.pd f
Amendment 1217 #
2020/2260(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls for CAP National Strategic Plans to ensure adequate financial support and incentives to promote new ecological ‘green’ business models for agriculture and artisanal food production, notably through fostering short supply chains and quality food production; to achieve these objectives, stresses that it is essential that European regions should be able to continue to perform their role as managing authorities in order to support the transitions as locally as possible and to ensure that the future strategic plans meet local needs;
Amendment 1297 #
2020/2260(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that the European food system delivers a sufficient and varied supply of safe, nutritious, affordable and sustainable food to people at all times and underlines that increasing the economic, environmental and social sustainability of food producers will ultimately increase their resilience; encourages the Commission to consider the food supply chain and its workers as a strategic asset for the safety and well-being of all Europeans and to encourage small producers to keep alive traditional recipes and market those products, with a view of avoiding the overuse of heavily processed food;
Amendment 1317 #
2020/2260(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that the European food system generally delivers a sufficient and varied supply of safe, and nutritious, affordable and sustainable food to people at all times and underlines that increasing the economic, environmental and social sustainability of food producers will ultimately increase their resilience; encourages the Commission to consider the food supply cha food to people at all times; points out, however, that an estimated 11% of the population (49 million people, EU-27) are unable to afford a quality meal every second day and that COVID-19 is likely to exacerbate fin and itcial difficulties wforkers as a strategic asset for the safety and well-being of all Europea many European households; stresses that food poverty requires appropriate policy response;
Amendment 1325 #
2020/2260(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Underlines that increasing the economic, environmental and social sustainability of food producers will ultimately increase their resilience; encourages the Commission to consider the food supply chain and its workers as a strategic asset for the safety and well- being of all Europeans;
Amendment 1371 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by anthropogenic climate change, the destruction of biodiversity, environmental degradation and our current food production systems; recommends a closer cooperation between academia and the authorities responsible for finding solutions to fight these diseases;
Amendment 1390 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the increasingly frequent emergence of zoonotic diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by anthropogenic climate change, the destruction of biodiversity, environmental degradation and our current food production and consumption systems;
Amendment 1403 #
2020/2260(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Welcomes the emphasis placed on the need to reduce antibiotics use in animal agriculture and stresses that EU initiatives in this area should adopt a One Health approach that recognises the interdependence between the health and well-being of humans, animals and the planet; calls to ensure equivalent standards for products of animal origin imported into the EU as those adopted under the Veterinary Medicines Regulation; notes the need, as part of the revision of the feed additives Regulation, to address substances currently not classified as antibiotics, such as coccidiostats, that may be used in animal agriculture in high quantities for preventative use and thereby compensate for poor animal husbandry practices;
Amendment 1476 #
2020/2260(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Commission to follow up on Directive (EU) 2019/633 on unfair trading practices22 and the EU code of conduct on responsible business and marketing practices by producing a monitoring framework for the food and retail sectors and providing for legal action if progress in integrating economic, environmental and social sustainability into corporate strategies is insufficient, and in so doing promoting and rewarding the efforts of sustainable agricultural producers while increasing the availability and affordability of healthy, sustainable food options and reducing the overall environmental footprint of the food system; insists on the need for the EU code of conduct for food and retail businesses to focus on commitments which are relevant to shaping healthy and sustainable food environments, and which are specific, measurable and time bound, and centred on key operations of the entities involved; stresses the importance of halting and addressing consolidation and concentration in the grocery retail sector in order to ensure fair prices for farmers; _________________ 22 OJ L 111, 25.4.2019, p. 59.
Amendment 1539 #
2020/2260(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Urges the review of the EU promotion programme for agricultural and food products, including the EU school scheme, with a view to bringing it into coherence with the objectives of the Green Deal and farm to fork strategy and enhancing its contribution to sustainable production and consumption, notably by focusing on educational messages about the importance of healthy nutrition, short local and regional supply chains and promoting greater consumption of fruit and vegetables with the aim of reducing obesity rates;
Amendment 1551 #
2020/2260(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Urges the review of the EU promotion programme for agricultural and food products, including the EU school scheme, with a view to enhancing its contribution to sustainable production and consumption, notably by focusing on educational messages about the importance of healthy nutrition and promoting greater consumption of fruit and vegetables produced locally and regionally as opposed to imported with the aim of reducing obesity rates;
Amendment 1606 #
2020/2260(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Recalls the need to promote effective Agricultural Knowledge and Innovation Systems (AKIS), enabling all food chain actors to become sustainable by speeding up innovation and accelerating knowledge transfer; but also the possibility of perfecting and accumulating new knowledge through lifelong learning; recalls, in addition, the need for a farm sustainability data network to set benchmarks for farm performance and document the uptake of sustainable farming practices, while allowing for the precise and tailored application of new production approaches at farm level by providing farmers with access to fast broadband connections and the possibility of exchanging good practices;
Amendment 1651 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for a comprehensive and complementary range of measures to reduce the burden that highly processed foods with high salt, sugar and fat content place on public health; regrets that the introduction of nutrient profiles is greatly delayed andcalls that nutrient profiles, which are long overdue, remain pertinent and necessary to meet the objectives of Regulation (EC) No 1924/2006 on Nutrition and Health Claims; welcomes the announcement of a legislative proposal to establish nutrient profiles; points out that many food products, including some marketed towards children, continue to use health and nutrition claims despite them having high levels of nutrients of concern; stresses that a robust set of nutrient profiles must be developed to restrict or prohibit the use of false nutritional claims on foods high in fats, sugars and/or salt; calls for a mandatory EU-wide front-of-pack nutrition labelling system based on independent science;
Amendment 1688 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights that 1 in 2 adults is overweight or obese in the EU, demonstrating the need for stronger action to help stem this public health crisis; recognises that front-of-pack nutritional labels have been identified by international public health bodies such as the World Health Organisation as a key tool to help consumers make more informed and healthier food choices; calls on the Commission to ensure that the EU mandatory front-of-pack nutritional label is developed based on robust, independent scientific evidence and demonstrated consumer understanding; stresses furthermore that to facilitate comparison across products, it should include an interpretive element and be based on uniform reference amounts such as per 100g/100ml;
Amendment 1734 #
2020/2260(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Welcomes the Commission’s commitment to revise the EU legislation on food contact materials (FCM); reiterates its call to revise the legislation on FCM in line with the regulation on the registration, evaluation, authorisation and restriction of chemicals (REACH), as well as classification, labelling and packaging regulations, and to insert, without further delay, specific provisions to substitute endocrine disrupting chemicals; stresses that equal safety requirements should be applied to virgin and recycled materials;
Amendment 1742 #
2020/2260(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Insists further on the need for comprehensive, harmonised regulation of all FCMs, which should be based on the precautionary principle, the principle of ‘no data, no market’, comprehensive safety assessments that address all the relevant safety and health endpoints and are based on the latest scientific data for all chemicals used in FCMs, effective enforcement and improved information to consumers;
Amendment 1745 #
2020/2260(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Notes that vast majority of chemicals in the EU is currently regulated on a case-by-case basis and for each specific use while ample evidence justifies that for the most harmful chemicals the generic approach to risk management becomes the default option, in particular as regards their use in consumer products; calls, therefore, on the Commission to extend the generic approach to risk management across legislation to ensure that substances used in agriculture, food production and processing do not contain chemicals that cause cancers, gene mutations, affect the reproductive or the endocrine system, or are persistent and bio-accumulative;
Amendment 1753 #
2020/2260(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Welcomes the fact that the strategy rightly recognises the role and influence of the food environment in shaping consumption patterns and the need to make it easier for consumers to choose healthy and sustainable diets; reiterates the importance of promoting sustainable diets by raising consumer awareness of the impacts of consumption patterns and providing information on diets that are better for human health and have a lower environmental footprint, such as products from short local and regional supply chains; underlines the important role which consumer organisations can play in this regard; underlines that food prices must send the right signal to consumers; welcomstresses, therefore, the strategy’s objective that the healthy and sustainable choice should become the most affordable one; at the shift to a more sustainable food system cannot rely solely on individual choices by consumers and that a range of actions, including regulation, is needed to make food production more sustainable by default;
Amendment 1796 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
Amendment 1801 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Underlines that the affordability of healthy and sustainable food choices is the main obstacle to the adoption by consumers of healthy and sustainable diets and that food prices must send the right signal to consumers; welcomes, therefore, the strategy’s objective that the healthy and sustainable choice should become the most affordable one; invites the Commission to launch a study to quantify in economic terms the environmental and societal (including health-related) costs associated with the production and consumption of the most consumed food products on the EU market, as a first step towards moving towards true cost accounting for food;1a _________________ 1aSpecial Eurobarometer 505. Making our food fit for the future – Citizens’ expectations. October 2020. ‘Healthy, sustainable food choices are affordable’ was the answer most frequently given by consumers when asked about what would help them to adopt a healthy and sustainable diet.
Amendment 1804 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
18c. Welcomes the future legislative proposals to improve consumer information on food origin; highlights that origin is the most important factor for Europeans when buying food; reminds the Commission of the Parliament’s resolutions of 11 February 2015 and 12 May 2016, where Parliament called for mandatory origin labelling of drinking milk, dairy products and meat used as an ingredient in processed foods; adds furthermore that mandatory labelling of origin should also be extended to seafood products, not least those that are preserved or processed;
Amendment 1808 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 d (new)
Paragraph 18 d (new)
Amendment 1813 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 f (new)
Paragraph 18 f (new)
18f. Stresses that Regulation (EU) No 1169/2011 requires that where the origin of a food is given and is different from the one of its primary ingredient, the origin of the primary ingredient shall be given or at least indicated as being different to the origin of the food; points out that in practice that means that products whose primary ingredients are not locally or regionally sourced can be marketed as such if the origin of said non-local primary ingredients is indicated in small print; underlines that there is an imbalance between the visibility of marketing practices that use national, regional and local names and symbols for products whose primary ingredients are not nationally, regionally or locally sourced and EU labelling requirements; considers this to be detrimental to the consumers' right to be properly informed and potentially misleading; calls on the Commission to rectify that imbalance;
Amendment 1816 #
2020/2260(INI)
Motion for a resolution
Paragraph 18 g (new)
Paragraph 18 g (new)
18g. Points out that Directive 2001/110 regulates that honey sold on European markets is either labelled as coming from a specific country, as ‘EU’ or as ‘non- EU’, or as both ‘EU and non-EU’ honey blends. In both non-EU cases, blended or not, the consumer is not aware whether the product is actually genuine EU standard quality honey, meaning without added sugar syrup, for example; calls on the Commission and Member States to support the EU beekeeping sector by reinforcing import inspections in order to prevent imports of adulterated honey; considers that the current rules are not fit for purpose as they provide ambiguous information to consumers and facilitate the import and sale of low quality or adulterated honey in the EU; calls on the Commission to propose legislative changes for honey labelling rules that will result in better consumer information and support the EU beekeeping sector;
Amendment 1839 #
2020/2260(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Reaffirms its beliefUnderlines that policy measures that are dependent solely on consumer choice lack efficacy and unduly shift the responsibility to purchase sustainable products to consumers; notes that third- party certification and labelling alone are not effective in ensuring sustainable production and consumption;
Amendment 1949 #
2020/2260(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Considers that the further development of sustainable plant protein production and alternative sources of protein in the EU is a way of effectively addressing many of the environmental and climate challenges that EU agriculture is facing, as well as preventing deforestation in countries outside the EU;
Amendment 1953 #
2020/2260(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Recalls its resolution of 15 January 2020 on the European Green Deal and its resolution of 22 October 2020 on an EU legal framework to halt and reverse EU-driven global deforestation and its repeated demand to the Commission to present, without delay, a proposal for an EU legal framework based on mandatory due diligence to ensure sustainable and deforestation-free supply chains for products placed on the Union market, with a particular focus on tackling the main drivers of imported deforestation and instead encouraging imports that do not create deforestation and ecosystem degradation abroad;
Amendment 2013 #
2020/2260(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 2017 #
2020/2260(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Reiterates its call to take the measures required to achieve a Union food waste reduction target of 30 % by 2025 and 50 % by 2030 compared to the 2014 baseline; underlines that binding targets are needed to achieve this, but also broader information campaigns on food production aimed at the younger generations precisely in order to avoid waste, as well as encouraging smaller or larger retailers not to waste food reaching its use by date;
Amendment 2073 #
2020/2260(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Highlights with concern the downward trend across the EU in both the number of official food controls undertaken and the resources allocated to them; supports the Commission in its efforts to combat food fraud; considers that the punishment should fit the crime in cases of intentional food fraud and calls on Member States to adequately reflect that principle in national legislation, in line with the Official Controls Regulation 2017/625;
Amendment 2243 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Underlines that approximately 80% of global deforestation is caused by the expansion of land used for agriculture1a; stresses in this context that the Commission Communication on Stepping up EU Action to Protect and Restore the World’s Forests of July 2019 recognises that Union demand for products such as palm oil, meat, soy, cocoa, maize, timber, rubber, including in the form of processed products or services, is a large driver of deforestation, forest degradation, ecosystem destruction and associated human rights violations across the globe and represents around 10 % of the global share of deforestation embodied in total final consumption1b; in addition notes that EU consumption of other commodities, such as cotton, coffee, sugar cane, rapeseed and mangrove- farmed shrimps also contributes to global deforestation; _________________ 1aFAO. 2016. State of the World’s Forests 2016. Forests and agriculture: land-use challenges and opportunities. Rome. http://www.fao.org/3/a-i5588e.pdf 1bEuropean Commission, 2013. The impact of EU consumption on deforestation: Comprehensive analysis of the impact of EU consumption on deforestation. Final report. Study funded by the European Commission and undertaken by VITO, the International Institute for Applied Systems Analysis, HIVA-Onderzoeksinstituut voor Arbeid en Samenleving and International Union for the Conservation of Nature NL.
Amendment 2272 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26b. Considers that trade and international cooperation are important tools for consolidating higher standards of sustainability, especially with regard to sectors that are linked to agriculture, forests and their derived value chains; stresses that Union trade and investment agreements should include binding and enforceable sustainable development chapters that fully respect international commitments, in particular the Paris Agreement and the 2030 Agenda for Sustainable Development;
Amendment 2284 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 c (new)
Paragraph 26 c (new)
26c. Recommends, in the context of the ‘do no harm’ principle as highlighted in the communication on the European Green Deal, that the Commission better and regularly assess the impact of existing trade and investment agreements on deforestation, forest and ecosystem degradation, land grabbing and human rights and ensure that more ambitious binding and enforceable provisions on forest and ecosystem protection, biodiversity, on ending land grabbing and sustainable forestry are included in the trade and sustainable development chapters of all free trade and investment agreements;
Amendment 2288 #
2020/2260(INI)
Motion for a resolution
Paragraph 26 d (new)
Paragraph 26 d (new)
26d. Notes with concern that despite being banned in the EU, European companies continue to produce and sell pesticides to third countries with lower human health and environmental protection laws; calls on the Commission to halt the production and export of banned pesticides to third countries, some of which can be detected in food sold back to the EU market and to ensure that imported and exported chemicals and products containing thereof abide by the same standards as those governing chemicals and products produced and used in the Union in order to ensure a level playing field between EU and non- EU manufacturers;
Amendment 9 #
2020/2209(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that persons with disabilities are entitled to enjoy their fundamental rights on an equal basis; calls on the Member States to take appropriate measures to provide effective access to justice for persons with disabilities; emphasises that facilities and services must be accessible, developed and adapted to ensure equal access to justice;
Amendment 14 #
2020/2209(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls for policies to promote digital public services that are accessible for persons with disabilities in line with the rapid advances in information technologies; recalls that information should be accessible, in particular by using simple and understandable language and illustrations for persons with learning impairments1; _________________ 1 Petition No 1305/2015.
Amendment 42 #
2020/2209(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Considers it necessary to encourage the use of new technologies, including information and communications technologies, mobility support devices and ancillary devices and technologies that are suitable for people with disabilities;
Amendment 48 #
2020/2209(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Stresses the importance of teaching staff regarding the education of children with disabilities and special needs; urges, therefore, that training, further training and specialist training in this field be made available to them;
Amendment 71 #
2020/2091(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that AAQ Directives are based on air quality standards and indicators that are now 15 to 20 years old and fail to factor in developments regarding the nature and composition of pollutants from new products and technologies , and that some of them are much weaker than current World Health Organization (WHO) guidelines and the levels suggested by the latest scientific evidence on human health impacts; welcomes the commitment made in the European Green Deal to revise and correlate air quality standards and indicators and align them more closely with WHO standards;
Amendment 88 #
2020/2091(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Recommends that revised air quality standards should also cover other non-regulated pollutants withand their relevant health impacts in the EU; highlights the EU’s ambition to lead the transition to a healthy planet, and recalls that in order to become a global leader it should lead by example by adopting, inter alia, ambitious quality standards for all air pollutants and, above all, regularly updating them;
Amendment 97 #
2020/2091(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 99 #
2020/2091(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses the need to provide ongoing training for experts, including retraining for those with experience in other fields who are seeking to enter his area of activity, and for young unemployed people;
Amendment 132 #
2020/2091(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that confinement measures to control the spread of pandemic led to a drastic decrease in emissions and air pollution, primarily attributable to lower road, air and international transport volumes and reductions in certain economic and industrial activities, thus clearly showing the impact of human activities on the environment; notes with regret that continuous exposure to air pollution may worsen the impact of respiratory viruses such as COVID-19; underlines that fighting air pollution must be at the core of the EU recovery plan, and that mandatory and effectively enforced air quality requirements are key to guaranteeing citizens’ health and improving their resilience against future health threats;
Amendment 150 #
2020/2091(INI)
9. Welcomes the announcement of the Commission’s Zero Pollution Action Plan; emphasises that air pollution is a burdenproblem that requires a holistic approachnd cross-border approach, in view of the damage to health and the environment caused by certain pollutant emissions, either alone or through chemical reactions; alerts that any new measures will be worthless if air quality is not properly prioritised and mainstreamed in all EU policies, including EU emission source legislation, such as on climate, energy, transport, industry, agriculture and waste, while ensuring better synergies between all policy areas; calls on the Commission and the Member States to cooperate more closely in all areas and at all levels in order to help local authorities achieve cleaner air;
Amendment 167 #
2020/2091(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Urges the Commission and the Member States to strengthen all emissions legislation and to use their legal powers to ensure compliance; underlines that reducing emissions at source is the only effective way to guarantee clean air; alerts that most Member States will not comply with their 2020 and 2030 emissions reduction commitments established under the NEC directive; stresses the need for stringent measures to reduce transport emissions, particularly road and maritime transport, aviation, industrial installations, agriculture and energy production;
Amendment 195 #
2020/2091(INI)
11. Notes that Air Quality Plans (AQPs), a key requirement of the AAQ Directives in cases when Member States do not comply with air quality standards, are often ineffective in terms of delivering their expected results; calls on the Commission to establish a set of minimum requirements and share best practices for both the drafting and implementation of AQPs and to impose penalties on polluters who fail to comply with European requirements;
Amendment 214 #
2020/2091(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Considers that public information and awareness have a critical role in facilitating direct individual involvement in measures to to improve air quality and in addressing air pollution; draws attention to the fact that Member States, regions and cities define air quality indices differently, and urges the Commission and Member States to establish a standardised air quality classification system applicable across the EU;
Amendment 222 #
2020/2091(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses that information on the possible health effects of air pollution provided by Member States is scarce, unclear and not easily accessible for the public; calls on the Commission and Member States to launch updated public information campaigns on topics such as different types of air pollutants and their impact on human health or current local levels of air pollution, and to publish rankings of the best and least progress made by air quality zones;
Amendment 224 #
2020/2091(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Urges the Commission to introduce an annual award for cities or regions that have taken the most effective measures to reduce air pollution, producing visible and tangible results, in order to encourage a more more active and efficient approach by local and national authorities and to popularise these measures at European level;
Amendment 225 #
2020/2091(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Calls on the Commission and the Member States to continue to support the forums and encourage consultations with other countries in a bid to identify effective solutions and facilitate the implementation of European, national and local policies seeking to achieve acceptable air quality standards;
Amendment 108 #
2020/2085(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes the Council’s efforts to promote the development of an EU animal welfare label based on harmonised and technically substantiated criteria and the immediate implementation of this animal welfare provision;
Amendment 146 #
2020/2085(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the need for better monitoring of maritime livestock transport, especially following the accidental blockage of the Suez Canal, which resulted in the deaths of thousands of animals on transport vessels;
Amendment 204 #
2020/2085(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses the importance of regular exchanges with representatives of national authorities, agricultural stakeholder organisations and experts concerning examples of good practice and possible improvements in the area of animal welfare; points out that, despite its low cost, knowledge transfer in this area is highly efficient and should therefore be put into practice more quickly; stresses the importance of holding such regular exchanges also with the representatives of third countries importing animals from Europe.
Amendment 10 #
2020/2076(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas industry is essential for Europe’s progress and future prosperity; it represents over 20% of the EU economy and provides jobs for around 35 million people;
Amendment 17 #
2020/2076(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas European industry has a competitive advantage globally, setting an example in meeting the highest social, labour and environmental standards, allowing Europe to promote its values;
Amendment 43 #
2020/2076(INI)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. whereas digital technologies change the image of industry, creating new business models, allow it to be more productive, offer workers new skills and support the decarbonisation of the economy;
Amendment 94 #
2020/2076(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Underlines that EU institutions, Member States, regions, industry and all the other relevant players should work together to create lead markets in clean technologies and ensure that European industry is a global frontrunner;
Amendment 149 #
2020/2076(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Welcomes the Commission’s initiative of expanding the Digital Innovation Hubs to all European regions to allow SMEs to integrate digital innovations, thus creating volunteering and training opportunities in the field of digital technologies;
Amendment 161 #
2020/2076(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Underlines that it is essential that there is a better balance of men and women in industrial sectors, more specifically by encouraging women to study science, technology, engineering and mathematics, consider a career in technology and invest in digital skills, thus improving the gender balance with respect to setting up and managing enterprises;
Amendment 112 #
2020/2071(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression, is the concentration of supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise, such as the current COVID-19 crisis and the closure of EU borders;
Amendment 127 #
2020/2071(INI)
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicines are inadequate at European level, with chemicals that are cheap and easy to produce and mature medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 132 #
2020/2071(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas the lack of essential medicines is becoming increasingly common at national and global level, increasing the burden on health services, incurring additional costs and jeopardising patients unable to obtain the medicines they need;
Amendment 196 #
2020/2071(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines, vaccines, and medical equipment; proposes obligations for the Union’s pharmaceutical industry to have a diversified supply chain and a medicine shortage risk mitigation plan for managing any vulnerabilities and risks to their supply chain; stresses the importance of ensuring that all Member States especially those which are vulnerable from a public health and economic perspective due to their location or size have fair and affordable access to the supply chain;
Amendment 199 #
2020/2071(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment to meet the needs of European citizens;
Amendment 255 #
2020/2071(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the need for each health system to have assured access to a continuous supply of high-quality and affordable essential medicines;
Amendment 314 #
2020/2071(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; calls on the Commission to pay special attention to the possibility of a no- deal Brexit and the ramifications it can cause in medical trade and supply; calls on the Commission to propose ambitious and concrete actions to address these issues in its planned pharmaceutical strategy;
Amendment 323 #
2020/2071(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers it essential to ensure universal access to health insurance, first-rate essential services and safe, effective, good quality and affordable medicines and vaccines;
Amendment 386 #
2020/2071(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that security of supply is an essential factor in combating shortages and must be used as a qualitative criterion in connection with the award of public pharmacy contracts and calls for tenderEuropean joint procurement for the supply of medicines, as recommended in Article 67 of Directive 2014/24/EU; proposes that investments in the manufacture of active ingredients and medicinal end products in the EU should also be a key criterion;
Amendment 407 #
2020/2071(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission to expand its joint European response to include joint procurement actions and procedures for all developed vaccines, medication, medical equipment and medical technology; insists that this joint response be a priority post-pandemic, and be easily accessible for citizens in every Member State especially those that are particularly vulnerable from a public health and economic perspective due to their remote location or small size;
Amendment 430 #
2020/2071(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care in all Union countries irrespective of economic or spatial differences; stresses the key contribution that can be made by new technologies and artificial intelligence with proper data protection safeguards in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 452 #
2020/2071(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research; calls on the Commission to provide increased financial resources under Horizon Europe and other EU programmes to strengthen support for rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that best practices, clinical trials, and medication pertaining to rare diseases be available to all citizens regardless of their Member State;
Amendment 540 #
2020/2071(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the Commission to develop a European system for monitoring the need for medicines to prevent cancer and infections, accompanied by an early warning system in case of malfunctions at European level;
Amendment 549 #
2020/2071(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; insists that the use of such a reserve be transparent, accountable, and fair for all Member States;
Amendment 552 #
2020/2071(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to create a European contingency reserve of medicines of strategic importance for health care, supplies of which are critical, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages and unjustified price hikes in such cases and outside crisis periods;
Amendment 592 #
2020/2071(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to ensure the setting up of common, European medical stocks; calls on the Commission and the Member States to develop innovative and coordinated joint strategies and to step up exchanges of good practice in the area of stock management; stresses that ensuring all Member States have fair and transparent access to these stocks through joint European coordination is crucial to managing vulnerabilities and risks to the supply chain; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff;
Amendment 651 #
2020/2071(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; insists that such a digital platform be in strict compliance with the most recent data protection legislation; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 653 #
2020/2071(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling and unjustified price hikes in times of crisis;
Amendment 687 #
2020/2071(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Considers it essential to examine the nature of medicine shortages and recommend alternative treatments to patients and health professionals;
Amendment 738 #
2020/2071(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls for transparency regarding European medicine stock levels; points out that the introduction of a European medicine stocktaking system could facilitate transparency in the supply chain by updating manufacturers regarding market reserves, making it possible to improve supply management;
Amendment 10 #
2020/2070(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the announcement of a renovation wave as part of the European Green Deal in a bid to significantly step up energy efficiency in the EU; urges the Commission to present it as planned, given that it is a key element of the post-COVID- 19 recovery plan; calls on the Member States to step up large-scale renovation plans under the national energy and climate plans (NCEPs);
Amendment 42 #
2020/2070(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses the importance of formulating a building and demolition waste management protocol encouraging ecological disposal and more waste recycling;
Amendment 77 #
2020/2070(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
2a. Stresses that digital technologies can make the construction and operation of buildings more efficient, thereby helping to achieve energy saving targets; urges the Commission to support the introduction of common public procurement principles and rules for the digitisation of building specifications, including energy performance;
Amendment 104 #
2020/2070(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
2a. Supports the development of flexible national and regional platforms for the funding of energy efficiency and renewables; these platforms can provide a comprehensive solution facilitating joint investment by local banks, financial intermediaries and energy service companies designed to offer attractive sustainable energy funding products;
Amendment 122 #
2020/2070(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Considers that Union financial instruments should be deployed in an effective and innovative manner with a view to leveraging investment in energy efficiency measures;
Amendment 6 #
2020/2042(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas according to the IPCC, climate change poses disproportionate and asymmetric risks to human and natural systems due to differences in vulnerability and exposure;
Amendment 8 #
2020/2042(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Amendment 11 #
2020/2042(INI)
Draft opinion
Recital A c (new)
Recital A c (new)
Ac. whereas according to the World Health Organization, as of the year 2030, climate change is expected to contribute to approximately 250 000 additional deaths per year, from malnutrition, malaria, diarrhoea and heat stress;
Amendment 12 #
2020/2042(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas climate change is particularly affecting developing countries dependent on agriculture and forestry;
Amendment 13 #
2020/2042(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas developing countries are disproportionately affected by meteorological changes, in many cases lacking sufficient capacity to respond to more frequent and intense natural disasters such as droughts, floods and heatwaves;
Amendment 14 #
2020/2042(INI)
Draft opinion
Recital A d (new)
Recital A d (new)
Ad. whereas according to the OECD, development co-operation has a critical role to play in supporting developing countries as they shift to low-emissions and climate-resilient development pathways;
Amendment 15 #
2020/2042(INI)
Draft opinion
Recital A e (new)
Recital A e (new)
Ae. whereas the European Parliament in its resolution of 16 January 2018 on women, gender equality and climate justice (2017/2086(INI)) acknowledges that women are particularly vulnerable to climate change and experience its effects disproportionately because of their social roles;
Amendment 26 #
2020/2042(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas the impact on health caused by climate change will be felt most by the poor who frequently have low resistance to diseases such as cholera, diarrhoea or malaria and enjoy limited access to the necessary healthcare and medicines;
Amendment 30 #
2020/2042(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas climate change is affecting enjoyment of basic human rights;
Amendment 31 #
2020/2042(INI)
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas adaptation to climate change places major stress on those suffering from heart problems, neurological disorders or obesity, as well vulnerable individuals among the very young and the old, that is to say children less than five years old and adults over 65;
Amendment 39 #
2020/2042(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on all EU Member States to rapidly scale up climate finance, prioritising grants-based finance, in particular for LDCs and SIDS, and to consider an increased financial support during the 2020- 2025 period that is commensurate with the socio-economic challenges posed by the COVID-19 pandemic;
Amendment 45 #
2020/2042(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that many people from developing countries are unable to adapt to climate change, partly due to lack of education and access to information; points out that, in many cases adaptation requires the use of new technologies such as flood control systems, new farming techniques or early-warning systems;
Amendment 64 #
2020/2042(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Believes that the EU should promote and support adaptation and mitigation measures in developing countries as they are most vulnerable to climate change and are in urgent need of assistance; adaptation should be an extension of sustainable development and as such should focus on: economic growth and diversification, better health and education and more effective disaster preparation mechanisms;
Amendment 66 #
2020/2042(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Expresses concern at how international climatearbon market mechanisms can have negative implications; calls on the EU and Member States to advocate a ‘do no harm’ principle for all such mechanisms;
Amendment 76 #
2020/2042(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Stresses that insufficient adaptation capacities leadcould result inter alia in armed conflicts, food shortages, and natural catastrophes, and consequently lead also to climate-induced displacement; calls for the WIM Taskforce on Displacement to step up its activities;
Amendment 101 #
2020/2042(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls for greater international support for indigenous land rights, which would contribute to limiting global warming. while at the same time ensuring their livelihoods;
Amendment 102 #
2020/2042(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stresses the need for the EU to promote research collaboration between European and developing countries so as to facilitate knowledge transfer and ensure that developing countries focus more closely on research into climate change;
Amendment 108 #
2020/2042(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Reiterates the acknowledgment of different impacts of climate change for women and men and therefore the promotion of measures improving the position of women in combating climate change at societal and governmental (decision-making) level;
Amendment 112 #
2020/2042(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Underlines the ruling of the UN Human Rights Committee of 20 January 2020, which statesing that countries may not deport individuals facingwho face climate change- induced conditions that violate the right to life, thus evoking non-refoulement obligations and declaring that inaction in the face of global warming can lead to violations of human rights; calls on the Member States to consider the risk of violations of the right to life due to climate change as part of their return decisions, notably triggering non- refoulement obligations;
Amendment 113 #
2020/2042(INI)
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Reiterates the necessity of strengthening the incorporation of climate mitigation and adaptation approaches and mainstream those into wider official development assistance policies and programs;
Amendment 115 #
2020/2042(INI)
Draft opinion
Paragraph 9 c (new)
Paragraph 9 c (new)
Amendment 126 #
2020/2042(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights that women and minors are most vulnerable populations in the face of disasters and climate change;
Amendment 128 #
2020/2042(INI)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Urges the Commission to mainstream gender equality and climate justice in the elaboration and implementation of all policies that have impact on the situation of women and girls;
Amendment 129 #
2020/2042(INI)
Draft opinion
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Reminds the Commission to ensure coherent implementation of international existing and future instruments, in particular the Paris Agreement and Agenda 2030 for Sustainable Development to take into account the internal and external impact of the EU;
Amendment 130 #
2020/2042(INI)
Draft opinion
Paragraph 7 d (new)
Paragraph 7 d (new)
7d. Underlines that the European Union´s global engagement - both in terms of climate policy and migration displacement policy - has significantly expanded and is set to become yet more important in the context of geopolitical shifts;
Amendment 131 #
2020/2042(INI)
Draft opinion
Paragraph 7 e (new)
Paragraph 7 e (new)
7e. Highlights that environmental change and migration is addressed in its civil protection, humanitarian aid and development policies; stresses, however, that in the context of policies on international protection, no concrete initiatives to date have addressed the protection needs of people affected by environmental change, and specifically environmental - and other - disasters, as according to the prevailing interpretation of the 1951 Refugee Convention, displacement based on environmental reasons alone does not meet the requirement for refugee protection; notes that, within the EU, complementary forms of protection deriving from the Qualification Directive and the Temporary Protection Directive, as well as protection from non-refoulement under the Return Directive, could provide protection alternatives; deplores, however, that all of those instruments reveal deficiencies in the protection of environmentally displaced persons.
Amendment 14 #
2020/2029(INI)
Motion for a resolution
Citation 15 a (new)
Citation 15 a (new)
- having regard to Directive 2011/93/EU of the European Parliament and of the Council of13 December 2011 on combating the sexual abuse and sexual exploitation of children and child pornography, and replacing Council Framework Decision2004/68/JHA,
Amendment 55 #
2020/2029(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas there are many forms of trafficking, but they are all based on the abuse of the inherent vulnerability of the victims and aimed at the exploitation of human beings;
Amendment 56 #
2020/2029(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas online and social media platforms are among the most frequent methods used to recruit victims;
Amendment 65 #
2020/2029(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. Whereas trafficking is a highly gendered phenomenon and sexual exploitation remains the most prevalent form of trafficking in the EU since 2008;
Amendment 70 #
2020/2029(INI)
Motion for a resolution
Recital A c (new)
Recital A c (new)
Ac. whereas societal tolerance of gender inequality and violence against women and girls and the lack of public awareness of the issues surrounding THB perpetuate a permissive environment for THB and a culture of impunity;
Amendment 80 #
2020/2029(INI)
Motion for a resolution
Recital A d (new)
Recital A d (new)
Ad. whereas trafficking in human beings is a complex transnational phenomenon that can be tackled effectively only if the EU institutions, Member States and international organisations work together in a coordinated manner;
Amendment 85 #
2020/2029(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. whereas THB is a crime driven by high demand and profits, estimated at of EUR 29,4 billion a year, according to Europol; whereas differences between legislation in Member States greatly facilitate the activities of organised crime, there is still too low risk of prosecution and a high level of impunity and the sanctions applied to deter this crime are inadequate in comparison with the high profits;
Amendment 87 #
2020/2029(INI)
Motion for a resolution
Paragraph -1 a (new)
Paragraph -1 a (new)
-1a. Whereas law enforcement authorities in the EU have witnessed a considerable increase in intra-EU trafficking and that nearly half (49%) of all victims of trafficking in the EU are EU citizens and more than one third (27%) of all EU victims are trafficked internally within one’s own country;
Amendment 91 #
2020/2029(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Points out the need for a coordinated and coherent framework at EU level based on more efficient monitoring that guarantees the protection of victims of THB, including through coordinated implementation with the rights conferred by the Victims’ Rights Directive, the Residence Permit Directive and the Compensation Directive15; _________________ 15 Council Directive 2004/80/EC of 29 April 2004 relating to compensation to crime victims, OJ L 261, 6.8.2004, p. 15.
Amendment 104 #
2020/2029(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the importance of the funding of the Asylum, Migration and Integration Fund (AMIF), the Daphne Program and Internal Security Fund (ISF) programmes to continue to be used for projects tackling THB, as well as using other available instruments, such as the Rights, Equality and Citizenship Programme, EMPACT actions, EU-UN Spotlight Initiative, the EU Trust Fund for Africa, Glo.Act Initiative, the Development Cooperation Instrument and the European Development Fund;
Amendment 113 #
2020/2029(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the importance of measures aimed at responding to the special needs of victims in vulnerable situations, many of whom are victims of THB and sexual exploitation, and other measures designed to tackle all forms of violence against women and children, especially in emergency situations;
Amendment 141 #
2020/2029(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission and the Member States to monitor the use of digital technologies, internet and social media for THB as the predominant tools used to recruit trafficking victims and to regulate third party responsibility for technology companies hosting exploitative materials;
Amendment 163 #
2020/2029(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on all Member States to ensure that early expert legal intervention and advice is provided to potential victims of THB at the earliest possible moment, including accessible information about their legal rights and options;
Amendment 191 #
2020/2029(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights that while the full impact of the COVID-19 pandemic is not yet measureable, it is nevertheless clear that the crisis disproportionately affects the most vulnerable victims of THB, especially women and children; calls on Member states to ensure effective functioning of NRMs and equivalent systems and that they should be updated to respond to emerging THB trends during the COVID- 19 pandemic;
Amendment 220 #
2020/2029(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Urges the Member States to ensure gender-specific provision of services and supports to victims of THB that is appropriate to their needs, recognizing any needs that may be specific to the form of trafficking to which they have been subjected; Calls on the Member States to address the needs of LGBTI people, as they are highly vulnerable to THB due to the cumulative effect of different types of discrimination on the grounds of sexual orientation and gender identity;
Amendment 246 #
2020/2029(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Urges the Member States to adopt specific measures to monitor cases more closely, and to address violence against women and gender inequalities as the root causes of trafficking; recommends that the Commission strengthen and develop the gender dimension in the monitoring of the implementation of EU anti-trafficking legislation;
Amendment 277 #
2020/2029(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on the Commission and the Member States to work with website owners and IT firms to develop mechanisms to monitor and block porn sites or sites with pornographic content and their owners, as well as users who target minors;
Amendment 279 #
2020/2029(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission and the Member States to run regular awareness and education campaigns for young people on the safe use of online technologies and how to spot the methods used to recruit sexual exploitation victims online;
Amendment 293 #
2020/2029(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Urges the Member States to adopt comprehensive sexuality education as a key form of prevention of all forms of violence against women and girls including trafficking and sexual exploitation, to include consent and relationships education promoting healthy attitudes of respect and equality in all interactions and the reality of prostitution and THB for sexual exploitation;
Amendment 352 #
2020/2029(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Points to the need to set up national mechanisms for data collection on THB victims in international protection procedures to be able to ensure follow up on identified cases;
Amendment 353 #
2020/2029(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls on the Member States to take action to ensure that all victims, including migrant victims, have access to justice irrespective of their residence status;
Amendment 355 #
2020/2029(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Calls on Member states to extend the International Protection granted to victims of human trafficking to their family members after having assessed the potential involvement of these relatives in the trafficking process;
Amendment 356 #
2020/2029(INI)
Motion for a resolution
Paragraph 23 c (new)
Paragraph 23 c (new)
23c. Calls on Member states to swift procedures of family reunification of those family members of the victims at risk in the country of origin;
Amendment 357 #
2020/2029(INI)
Motion for a resolution
Paragraph 23 d (new)
Paragraph 23 d (new)
23d. Is concerned that the recovery and reflection period is linked to cooperation by the victim during the investigation and is granted by law enforcement agencies; deplores that the period does not apply to EU/EEA nationals nor to asylum seekers; calls on the Commission to monitor the implementation of available legal solutions at Member states level, in particular the granting of a recovery and reflection period;
Amendment 371 #
2020/2029(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls on Member states to provide more safe and legal routes for migration in order to prevent the exploitation of vulnerable individuals;
Amendment 376 #
2020/2029(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Member states to ensure strong child protection measures, presumption of childhood and child age assessment, the protection before and during criminal proceedings, access to unconditional assistance, compensation, non-punishment, assistance and support to the family member of a child victim as well as prevention;
Amendment 377 #
2020/2029(INI)
26. Calls on the Member States to focus on identifying child victims and helping them to avail themselves of their rights; recalls the obligation of Member States to pay special attention to child victims of trafficking and to provide special protection to children in criminal procedures, with the best interests of the child being considered paramount at all times; emphasises the need for guardians, including temporary guardians as an emergency measure, to be appointed immediately for child victims;
Amendment 385 #
2020/2029(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls on the Commission and the Member States to put more emphasis on training and upskilling the support workers in local, regional and national organisations who work with victims, and educating them on the new methods used by human traffickers;
Amendment 391 #
2020/2029(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Notes with high concern the prevalence of child sexual abuse and normalisation of trafficking and sexual exploitation of children, and calls for the regulation of pornographic sites and hosting platforms to ensure full prevention of the risk of such materials becoming available and normalized;
Amendment 437 #
2020/2029(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Stresses the importance of financial investigation and ‘following the money’ as a key strategy for investigating and prosecuting the organised crime networks that profit from THB; calls on the Commission to assess and promote the use of existing judicial and police cooperation, and the available toolsMember States to launch financial investigations and work with money laundering specialists when starting a new trafficking investigation; calls on Member States to strengthen cooperation in freezing and confiscating the assets of individuals involved in trafficking and providing compensation to victims; calls on the Commission to assess and promote the use of existing judicial and police cooperation, and the available tools, such as mutual recognition of court judgments, joint investigation teams and the European investigation order;
Amendment 453 #
2020/2029(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Recalls the role of EU agencies in the early identification of victims and the fight against THB; calls for more resources for the Justice and Home Affairs (JHA) Agencies to enable their staff to be trained and capacity-building instruments to be developed in the area of detecting victims, including the appointment of gender- trained agency officers, especially in the Member States faced with increased mixed migratory flows; calls on the Commission to develop guidelines to mainstream gender expertise in the activities of law enforcement authorities across the EU, including by developing sustained programs of improving gender balance in decision-making processes and in the staff of the JHA agencies relevant to trafficking;
Amendment 461 #
2020/2029(INI)
Motion for a resolution
Paragraph 33 a (new)
Paragraph 33 a (new)
33a. Encourages Member States to increase exchange of data and information by using Europol’s resources and databases such AP Phoenix, AP Migrant Smuggling and AP Twins;
Amendment 476 #
2020/2029(INI)
Motion for a resolution
Paragraph 34 a (new)
Paragraph 34 a (new)
34a. Calls on the Commission to review implementation of the Anti-Trafficking Directive by Member States and introduce infringement procedures where there has been a lack of effective implementation;
Amendment 487 #
2020/2029(INI)
Motion for a resolution
Paragraph 35 a (new)
Paragraph 35 a (new)
35a. Calls on the Commission to review the application of Directive 2004/81/EC on granting residence permits to victims of trafficking who are third country nationals ensuring that victims are not returned upon expiry of reflection period, calls on the Member States to grant that the unconditional access to assistance and support mandated by Directive2011/36/EU is reconciled with Directive 2004/81/EC and its application; calls on the Commission to review Directive 2004/81/EC to ensure that residence permits for trafficked persons are not made conditional to the participation or willingness to participate of the trafficked person in the investigation or criminal proceedings of the case;
Amendment 1 #
2020/2022(INI)
Motion for a resolution
Citation 3
Citation 3
— having regard to the Charter of Fundamental Rights of the European Union, in particular Article 6, Article 7, Article 8, Article 11, Article 13, Article 221, Article 22, Article 23, Article 24, Article 25 and Article 246 thereof,
Amendment 4 #
2020/2022(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive)3a, _________________ 3a OJ L 95, 15.4.2010, p. 1–24
Amendment 12 #
2020/2022(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
— having regard to the judgement of the Court of Justice of 24 November 2011 in case C-70/105a, _________________ 5aJudgement of the Court of Justice of 24 November 2011, Scarlet Extended SA v Société belge des auteurs, compositeurs et éditeurs SCRL (SABAM)
Amendment 16 #
2020/2022(INI)
Motion for a resolution
Recital -A (new)
Recital -A (new)
-A. whereas fundamental rights, such as protection of privacy and personal data, the principle of non-discrimination, as well as freedom of expression and information, need to be ingrained at the core of a successful and durable European policy on digital services; whereas these rights need to be seen both in the letter of the law, as well as the spirit of their implementation;
Amendment 17 #
2020/2022(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. recital -Aa whereas the trust of users can only be gained by digital services that respect their fundamental rights, thus ensuring both uptake of services, as well as a competitive advantage and stable business models for companies;
Amendment 20 #
2020/2022(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the privacy rules in the electronic communication sector, as set out in the Directive concerning the processing of personal data and the protection of privacy in the electronic communications sector, are currently under revision;
Amendment 25 #
2020/2022(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the amount of all types of user- generated content, including harmful and illegal content, shared via cloud services or online platforms has increased exponentially;
Amendment 27 #
2020/2022(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the use of personal data for the purposes of individual profiling, and its subsequent repurposing, even when seemingly innocuous data is collected from the digital traces of individuals, can be mined in a way that can generate insights that can enable very intimate personal information to be inferred at a very high level of accuracy, especially when these data are merged with other data sets;
Amendment 28 #
2020/2022(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas social media and other content distribution platforms utilise profiling techniques to target and distribute their content, as well as advertisements; whereas the automated algorithms decide how to handle, prioritise, distribute and delete third-party content on online platforms, including during political and electoral campaigns;
Amendment 29 #
2020/2022(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Cc. whereas the proliferation of disinformation, even propaganda online, has been aided by platforms whose very business model is based on profiting from collection and analysis of user data; whereas consequently promoting spreadable, sensationalist content forms part of their business logic, and pushes them to generate more traffic and ‘clicks’, and, in turn, generate more profiling data and thus more profit;
Amendment 30 #
2020/2022(INI)
Motion for a resolution
Recital C d (new)
Recital C d (new)
Cd. whereas the Cambridge Analytica and Facebook scandals revealed how user data had been used to micro-target certain voters with political advertising, and at times, even with targeted disinformation, therefore showing the danger of opaque data processing operations of online platforms;
Amendment 31 #
2020/2022(INI)
Ce. whereas the widespread use of algorithms for content filtering and content removal processes also raises rule of law concerns, questions of legality, legitimacy and proportionality;
Amendment 39 #
2020/2022(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the political approach to tackle harmful and illegal content online in the EU has mainly focused on voluntary cooperation thus faris based on court order mandated takedowns, but a growing number of Member States are adopting further national legislation to address illegal content;
Amendment 45 #
2020/2022(INI)
Motion for a resolution
Recital F
Recital F
F. whereas some forms of harmful content may be legal, yet detrimental to society or democracy, yet be legal, with examples such as opaque political advertising and disinformation on COVID-19 causes and remedies;
Amendment 47 #
2020/2022(INI)
Motion for a resolution
Recital G
Recital G
G. whereas a pure self-regulatory approach of platforms does not provide legitimacy or adequate transparency and proper information to public authorities, civil society and users on how platforms address illegal and harmful contentcontent and content that is deleted against violations of terms and conditions; whereas such an approach does not guarantee compliance with fundamental rights; and creates a risk of excessive interference with the right of freedom of expression and creates a problematic situation where law enforcement responsibilities are handed over to private parties;
Amendment 52 #
2020/2022(INI)
Motion for a resolution
Recital H
Recital H
H. whereas regulatory oversight and supervision of platforms lacks horizontalis sector-specific in the EU; whereas further and more comprehensive coordination between the different oversight bodies across the EU would be beneficial;
Amendment 54 #
2020/2022(INI)
Motion for a resolution
Recital I
Recital I
Amendment 58 #
2020/2022(INI)
Motion for a resolution
Recital J
Recital J
J. whereas the lack of comparable, robust public data on the prevalence and both court mandated and self-regulatory removal of illegal and harmful content online creates a deficit of transparency and accountability;
Amendment 66 #
2020/2022(INI)
Motion for a resolution
Recital K
Recital K
K. whereas child sexual exploitation online is one of the forms of illegal content shaped by technological developments; whereas the vast amount of child sexual abuse material circulating online poses serious challenges for detection, investigation and, most of all, victim identification efforts;
Amendment 68 #
2020/2022(INI)
Motion for a resolution
Recital L
Recital L
L. whereas according to the Court of Justice of the European Union (CJEU), jurisprudence host providers may have recourse to automated search tools and technologies to assess if content is equivalent to content previously declared unlawful, and should thuss long as it does not result in monitoring generally the information which it stores, or in actively seeking facts or circumstances indicating illegal activity, as provided for in Article 15(1) of Directive 2000/31; whereas such content should be removed following an court order from a Member State;
Amendment 71 #
2020/2022(INI)
Motion for a resolution
Recital L a (new)
Recital L a (new)
La. whereas a trusted electronic identification is elementary to ensure secure access to digital services and to carry out electronic transactions in a safer way; whereas currently only 15 Member States have notified an electronic identity scheme for cross-border recognition in the framework of the Regulation (EU) 910/2014;
Amendment 81 #
2020/2022(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses that illegal content online should be tackled with the same rigour as illegal content offlineis the same as illegal content offline; takes therefore the position that any legally mandated content moderation measure in the Digital Services Act should concern only illegal content, as it is defined in European or national law, and the legislative text should not include any legally vague and undefined terms, such as “harmful content”, as targeting such content would put fundamental rights and freedom of speech at serious risk and put the service providers in a legally unclear position;
Amendment 85 #
2020/2022(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Paragraph -1. Underlines that the modernisation of current e-Commerce rules can inevitably affect fundamental rights, including the protection of privacy and personal data, the freedom of expression and information, equality and non-discrimination, freedom of thought, conscience and religion, freedom of assembly and association, freedom of the arts and sciences, and the right to an effective remedy; therefore urges the Commission to be extremely vigilant in its approach and also integrate international human rights standards into its revision;
Amendment 87 #
2020/2022(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Paragraph -1a. Notes how the current digital ecosystem encourages also problematic behaviour, such as hate speech and disinformation; is concerned how promoting controversial content has become the key to the targeted advertisement-based business models, where sensational and polarising content maximises the screen time of users, generating more profiling data, more advertising hours, and therefore more profits; underlines how this type of a business model can have very intrusive and negative effects, not only on individuals and their fundamental rights, but societies as a whole;
Amendment 95 #
2020/2022(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Believes in the clear economic benefits of a functioning digital single market for the EU and its Member States; stresses the important obligation to ensure a fair digital ecosystem in which fundamental rights and, especially data protection are respected; calls for a minimum level of intervention based on the principles of necessity and proportionality, privacy and non- discrimination are at its core;
Amendment 104 #
2020/2022(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Deems it necessary that illegal content is removed swiftly and consistently in order to address crimes and fundamental rights violation, through a clear and harmonised notice-and-action procedure with the necessary safeguards in place, such as transparency of the process, the right to appeal and access to effective judicial redress; considers that voluntary codes of conduct only partially address the issue;
Amendment 114 #
2020/2022(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Recalls that illegal content online should not only bebe just removed by online platforms, but should be followed up by law enforcement and, where needed, the judiciary; finds, in this regard, that a key issue in some Member States is not that they just have unresolved cases but rather unopened ones; calls for barriers to filing complaints with competent authorities to be removed; is convinced that, given the borderless nature of the internet and the fast dissemination of illegal content online, cooperation between service providers and national competent authorities should be improvedalso unopened ones;
Amendment 117 #
2020/2022(INI)
Motion for a resolution
Paragraph 4 – subparagraph 1 (new)
Paragraph 4 – subparagraph 1 (new)
Is convinced that, given the borderless nature of the internet and the fast dissemination of illegal content online, cooperation between service providers and national competent authorities should be improved;
Amendment 122 #
2020/2022(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Acknowledges the fact that, while the illegal nature of certain types of content can be easily established, the decision is more difficult for other types of content as it requires contextualisation; warns that some automated tools are not sophisticated enough to take contextualisation into account, which could lead to unnecessary restrictions being placed on the freedom of expressionreminds in this regard of the incapacity of current automated tools in grasping the importance of context for specific pieces of content, underlines that algorithms are not currently capable of critical analysis, and takes therefore the view that the Digital Services Act should not contain any obligation for compulsory use of automated tools in content moderation; believes that any voluntary automated measures put in place by the content hosting platforms should be subject to extensive human oversight and to full transparency of design and performance;
Amendment 134 #
2020/2022(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Strongly believes that the current EU legal framework governing digital services should be updated with a view to addressing the challenges posed by new technologies such as the prevalence of all- encompassing profiling and algorithmic decision-making that permeates all areas of life, and ensuring legal clarity and respect for fundamental rights; considers that the reform should build on the solid foundation of and full compliance with existing EU law, especially the General Data Protection Regulation and the Directive on privacy and electronic communications;
Amendment 139 #
2020/2022(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights that the practical capacity of individuals to understand and navigate the complexity of the data ecosystems in which they are embedded is extremely limited, as is their ability to identify whether the information they receive and services they use are made available to them on the same terms as to other users; Calls on the Commission therefore to place transparency and non- discrimination at the heart of the Digital Services Act;
Amendment 143 #
2020/2022(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Deems it indispensable to have the widest-possiblefull harmonisation of rules on liability exemptions and content moderation at EU level to guarantee the respect of fundamental rights and the freedoms of users across the EU; expresses its concern that recent national laws to tackle hate speech and disinformation lead to a fragmentation of rules;
Amendment 148 #
2020/2022(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls, to this end, for legislative proposals that keepthat the digital single market is kept open and competitive by requiring digital service providers to apply effective, coherent, transparent and fair procedures andwith robust procedural safeguards to remove illegal content in line with European values; firmly believes that this should be harmonised within the digital single marketvia a harmonised notice-and-action procedure in line with European legislation;
Amendment 155 #
2020/2022(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Believes, in this regard, that online platforms that are actively hosting or moderating content should bear more, yet proportionate, responsibility for the infrastructure they provide and the content on it; emphasises that this should be achieved without resorting toit is crucial for online platforms to have clarity provided for by setting clear rules, requirements and safeguards for a harmonised notice-and-action procedure; emphasises that any measure put in place for the removal of illegal content cannot constitute or imply a general monitoring requirements;
Amendment 158 #
2020/2022(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Highlights that this should include rules on the notice-and-action mechanisms and requirements for platforms to take proactive measures that are proportionate to their scale of reach and operational capacities in order to address the appearance of illegal content on their services; supports a balanced duty-of-care approach andSupports a clear chain of responsibility to avoid unnecessary regulatory burdens for the platforms and unnecessary and disproportionate restrictions on fundamental rights, including the freedom of expression;
Amendment 167 #
2020/2022(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses the need for appropriate safeguards and due process obligations, including human oversight and verification, in addition to counter notice procedures, to ensure that removal or blocking decisions are accuratelegal, well- founded and respect fundamental rights; recalls that the possibility of judicial rwhile counter-notice proceduress should be mad, complaint mechanisms and out-of-court dispute settlements can be availuable to satisfy the right to effectiveols in protecting fundamental rights of the users of digital services, they cannot preclude access to effective judicial redress and remedy;
Amendment 178 #
2020/2022(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Supports limited liability for contentexemption for all types of intermediaries and the country of origin principle, butand considers improved coordination for removal requests between national competent authorities to be essential; emphasises that such orders should be subject to legal safeguards in order to prevent abuse and ensure full respect of fundamental rights; stresses that sanctions should apply only to those service providers that fail to comply with legitimate orders;
Amendment 192 #
2020/2022(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Believes that the terms of services of digital service providers should be clear, transparent and fair; deplores the fact that some terms of servrecalls that any take- down-notices from content platforms do not allow law enforcement to use non-personal accounts, which poses a threat both to possible investigations and to personal safetyan authority has to always be based on law, not on the terms of service of the service providers;
Amendment 195 #
2020/2022(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines that certain types of legal, yet harmful, content should also be addressed to ensure a fair digital ecosystem; expects guidelines to include increased transparency rules on content moderation or political advertising policy to ensure that removals and the blocking of harmful content are limited to the absolute necessarye need to regulate content curation and tracking-based targeted advertisement through giving more choice and control to users; emphasises that users should be able to choose to opt out completely of any content curation, decide whether to opt in to tracking, and have more options on the way content is ranked to them, including a ranking outside their ordinary content consumption habits; strongly believes that the design and performance of such recommendation systems should be subject to full transparency, presented in a user-friendly manner;
Amendment 205 #
2020/2022(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Highlights how the personalisation of informational environments that data- driven profiling makes possible brings with it new capacities to manipulate individuals in subtle, yet highly effective ways; underlines that when the profiling is deployed at scale for political micro targeting to manipulate voting behaviour, it can seriously undermine the foundations of democracy; therefore expects the Commission to provide guidelines on the use of such persuasive digital technologies in electoral campaigns and political advertising policy;
Amendment 208 #
2020/2022(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Is concerned of platforms and services that deliberately lock in their users onto that specific platform, thus amplifying their dominant market power and their ability to profile their users even more thoroughly, creating extremely invasive and revealing profiles of their users; calls therefore on the Commission to guarantee the interoperability of digital services; considers in this regard the application programming interfaces (APIs), enabling a user to interconnect between platforms and to import content moderation rules on the content they view on a platform, to be useful tools in bringing true interoperability to users and thus increasing their options to choose between different kinds of recommendation systems and services;
Amendment 210 #
2020/2022(INI)
Motion for a resolution
Paragraph 15 c (new)
Paragraph 15 c (new)
15c. Notes that policies for monetisation of content affect what kind of content is seen by users and therefore finally also what kind of content will be uploaded by users; calls therefore for online content hosting platforms to be required to have transparent, non- discriminatory content demonetisation policies in order to guarantee fully the right to freedom of expression online;
Amendment 211 #
2020/2022(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Deems that accountability- andUnderlines the wedge between the speed and capacity of machines relative to the capacity of humans to monitor these machines; therefore deems that accountability always lies with the human overseers - and calls for evidence-based policy making, requiresing robust data on the prevalence and removal of illegal content online, in order to ensure a transparent system that can be trusted by all;
Amendment 220 #
2020/2022(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls, in this regard, for a regular public reporting for large commercial obnligation for platforms, proportionate to their scale of reach and operational capacitiesne platforms to make their procedures and decisions to remove content publicly available;
Amendment 224 #
2020/2022(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls, moreover, for a regular public reporting obligation for national authorities on their requests for deletion of illegal content from digital platforms;
Amendment 226 #
2020/2022(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Expresses its concern regarding the fragmentation of public oversight and supervision of platforms and the frequentdocumented lack of financial and human resources for the supervision and oversight bodies needed to properly fulfil their tasks; calls for increased cooperation with regard to regulatory oversight of digital services;
Amendment 228 #
2020/2022(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Considers that in order to guarantee proper enforcement of the Digital Services Act, the oversight of compliance with this Act should be entrusted in an independent authority, while any decisions relating to content should always remain with the judiciary; emphasises in this regard that sanctioning for non-compliance with the Digital Services Act should be based on an assessment of a clearly defined set of factors, such as proportionality, technical and organisational measures and negligence, and the resulting sanctions should be based on a percentage of the annual global turnover of a company;
Amendment 230 #
2020/2022(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
Amendment 236 #
2020/2022(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
Amendment 243 #
2020/2022(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
Amendment 257 #
2020/2022(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Emphasises the indispensability of agreed standards of essential security in cyberspace in order for digital services to provide their full benefits to citizens; notes therefore the urgent need for Member States to take coordinated action to ensure basic cyber hygiene and to prevent avoidable dangers in cyberspace, including through legislative measures;
Amendment 261 #
2020/2022(INI)
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23b. Stresses that the only way for digital services to achieve their full potential is to enable users to be identified unambiguously in an equivalent manner to offline services; notes that online identification can be improved by enforcing eIDAS Regulation’s cross- border interoperability of electronic identifications across the European Union; reminds that Member States and European institutions have to guarantee that the electronic identifications are secure, enable data minimisation and comply with all other aspects of GDPR;
Amendment 3 #
2020/2021(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Calls on the Commission to include, in its economic recovery roadmap and financial support schemes,Stresses that the EU’s new recovery plan should ensure that EU funds for recovery are only used in a manner consistent with the Union’s climate and environmental objectives; calls on the Commission to also set out EU guidelines for the Member States on how to design their national investment plans so that they are consistent with the European Green Deal and, the Paris Agreement; stresses that and UN Sustainable Development Goals; stresses that the new recovery plan and such guidelines wshould enable the EU to save and transform its economy (i.e. take the EU out of the crisis and accelerate the transition towards climate neutrality) and circular economy), while leaving no one behind;
Amendment 8 #
2020/2021(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Calls on the Commission to carry on with the initiatives of the European Green Deal, including the actions identified in the Circular Economy Action Plan, in order to continue the fight against climate change, biodiversity loss and degradation of the environment; stresses the importance of opposing any proposals to postpone the introduction of stricter standards or compliance with already set obligations; considers that any such proposal should be critically examined, taking into account not only the commercial interests of companies concerned, but the wider social interests, pursuing objectives of full employment and social progress;
Amendment 12 #
2020/2021(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Emphasises that the transition to climate neutrality by 2050 at the latest and the transition to a truly circular economy and sustainable single market create new business opportunities and jobs and can therefore significantly contribute to a sustainable economic recovery;
Amendment 13 #
2020/2021(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. In the transition to a circular economy and climate neutrality by 2050 at the latest, stresses that it is crucial that the Commission and Member States adequately assess employment needs, including education and training requirements, promote the development of the economy and do their utmost to achieve a fair and just transition;
Amendment 14 #
2020/2021(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Calls on the Commission and the Member States to engage with all parts of the society and stakeholders, including citizens/consumers, consumer and non- governmental organisations, business, trade unions and workers’ representatives to enable and empower them to take action towards a sustainable single market;
Amendment 19 #
2020/2021(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Points out that both sustainable production and consumption should be promoted; considers in this regard that resource efficiency should be improved by increasing the circularity of value chains, reducing the consumption of resources, increasing uptake of secondary raw materials and cutting down on waste generation; stresses that a new economy comprising circular services should be developed;
Amendment 26 #
2020/2021(INI)
Draft opinion
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Calls on all companies and organisations to register to the EMAS system in order to improve their environmental performance; looks forward to the upcoming review of the Non-financial reporting directive that should lead to a substantial improvement on the availability of information on the environmental performance of companies;
Amendment 28 #
2020/2021(INI)
Draft opinion
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Stresses that stringent requirements should be established on the basis of due diligence to ensure no products are placed on the Union market that lead to degradation of the environment or violations of human rights;
Amendment 29 #
2020/2021(INI)
Draft opinion
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Acknowledges it essential that the narrative in our industries changes “from cradle to grave” to “ cradle to cradle”, and that sustainability is strengthened in all steps of the supply chains, ensuing environmental and social sustainability in the end-product as well as in the manufacturing of all its components and the extraction of raw materials;
Amendment 30 #
2020/2021(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers that it is crucial to ensure that the ‘sustainable choice’ will be the default choice – which is attractive, affordable, accessible and sustainable – for all consumers in the EU as soon as possible; calls on the Commission to encouragstrongly welcomes in this regard the intention of the Commission to develop a sustainable product policy framework that will among other measures strengthen and extend eco- design in order to improve the sustainability of products through requirements before their placing on the market; calls on the Commission to promote the development, production and marketing of sustainable and safe products that are suitable for multiple use, technically durable and easily repairable, do not contain hazardous substances, and, after having become waste and having been prepared for reuse or recycling, suitable to be made available or placed on the market in order to facilitate the proper implementation of the waste hierarchy; calls on the Commission to also support and develop economic tools that give an economic advantage to the ‘sustainable choice’;
Amendment 41 #
2020/2021(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Emphasises that consumers should be able to fully participate in the ecological transition; calls on the Commission to develop legislative proposals on the tools needed to achieve this goal, including improved product information through labelling, green claims, extended legal guarantees and definitions, as well as stringent measures against planned obsolescence and greenwashing; calls on the Commission to guarantee the right to repair for people in the EU to have their goods repairedwithout delay; highlights that all such tools must be based on the provision of simple and clear information and processes to consumers, as well as on sound environmental criteria, which enable consumers to assess accurately the climate and environmental impact of products on the basis of their life cycle, their environmental footprint, their lifespan and their quality; emphasises however that encouraging sustainable consumption is only one aspect of the coin and that the transition to circularity should start from production and eco- design;
Amendment 48 #
2020/2021(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to also adequately address the dual quality of products and ensure that people in all Member States have access to the same quality of foodstuffs and other products, and that they enjoy equal consumer rights, such as right to repair, no matter in which Member State they reside.
Amendment 53 #
2020/2021(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Proposes the development of clear guidelines and standards for green claims and commitments that translate into ecolabels; looks forward to the planned legislative proposal on substantiating green claims; considers that by providing the consumers with transparency and guidance through accurate and accountable information and ecolabelling, consumers will have increased trust in products and markets, which will ultimately lead to sustainable consumption;
Amendment 62 #
2020/2021(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Stresses the role of Green Public Procurement (GPP) to accelerate the shift towards a more sustainable and circular economy, and the importance of promoting the uptake of GPP during the EU’s economic recovery; recalls the commitments of the Commission to propose further legislation on GPP. and calls on the Commission to make an ambitious proposal that would significantly increase the use of Green Public Procurement;
Amendment 67 #
2020/2021(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Indicates that the global value chains need to be diversified, through the new rules for e-commerce, the conclusion of the Environmental Goods Agreement which has the potential to stimulate the use of environmental goods and the reform at international level of the Intellectual property rights aimed at improving competitiveness and more effective protection and reward of the creative work and innovation, towards a deep sustainable single market;
Amendment 68 #
2020/2021(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Highlights that all consumers should have the right to safe products that do not harm the environment or human health; calls for a rapid and effective phase out and ban of hazardous substances used in the single market; emphasises this to be particularly important when it comes to substances with endocrine disrupting properties; stresses that the development of a sustainable single market must be based on creating a non-toxic circular economy and environment whereby hazardous substances are not used or recycled;
Amendment 69 #
2020/2021(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5c. Considers it important to raise the public awareness on the rights of consumers and importance of sustainable product and service consumption; calls on the Commission and Member States to facilitate this through a platform for exchange of best practices that includes citizens, and representatives of the public and private sector, local authorities, academia, non-governmental and civil society organisations and consumer organisations, ensuring all citizens have access to easily understandable and comprehensive information.
Amendment 24 #
2020/2017(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Points out that digital technologies and their use can help to bridge the gap between pupils from privileged and disadvantaged social and economic backgrounds by providing access to adequate learning opportunities;
Amendment 28 #
2020/2017(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes that, while AI has created new career opportunities, significant skills shortages still exist; welcomes, therefore, the moves by the Commission to involve everyone in the development of AI, including as many women as possible and those with disabilities, and to arouse interest among young people and encourage them to study AI-related subjects in addition to those relating to their career aspirations;
Amendment 46 #
2020/2017(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Underlines the clear risks of daily exposure to digital data largely generated by impenetrable algorithms, leaving both adults and young people vulnerable to harmful online content; notes that critical thinking and the ability to interact with skill and confidence in the online environment are needed more than ever;
Amendment 63 #
2020/2017(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Stresses the importance of promoting a better grasp of the fundamentals of digitalisation and AI by imparting the necessary skills at every level of education, focusing in particular on AI and robotics, on the availability of more high-quality ICT programmes for further education and on software reliability and security;
Amendment 66 #
2020/2017(INI)
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Notes that AI will have a major impact in cyberspace and play a very useful part in combating cybercrime; stresses the importance of monitoring the safe use of AI and the need for close collaboration between the public and private sectors to counter user vulnerabilities and the dangers arising in this connection;
Amendment 10 #
2020/2016(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
- having regard to the Council of Europe’s European Ethical Charter on the Use of Artificial Intelligence in Judicial Systems and their Environment, adopted on 4 December 2018,
Amendment 21 #
2020/2016(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas AI can be seen as the ability of a system to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation; Whereas the key components of development in AI are the availability of vast quantities of: data, computing power, and human capital and talent;
Amendment 24 #
2020/2016(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
A b. whereas, despite continuing advances in computer processing speed and memory capacity, there are as yet no programs that can match human flexibility over wider domains or in tasks requiring understanding of context or critical analysis; whereas, some AI applications have attained the performance levels of human experts and professionals in performing certain specific tasks, and can provide results in a completely different speed and scale;
Amendment 26 #
2020/2016(INI)
Motion for a resolution
Recital A c (new)
Recital A c (new)
A c. whereas several Member States use the application of embedded artificial intelligence (AI) systems in the field of law enforcement;
Amendment 31 #
2020/2016(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the use of AI technology should be developed in such a way as to put people at its center and therefore to be worth of public trust;
Amendment 36 #
2020/2016(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas AI systems always have to be in the service of humans and have the ultimate safety valve of being designed so that they can always be shut down by a human operator;
Amendment 47 #
2020/2016(INI)
E a. whereas the development and operation of AI systems for police and judicial authorities involves the contribution of multiple individuals, organisations, machine components, software algorithms, and human users in often complex and challenging environments;
Amendment 51 #
2020/2016(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas allocating and distributing responsibility between humans and machines is increasingly difficult; whereas ultimately it is the responsibility of the Member States to guarantee the full respect of fundamental rights when AI systems are used in the field of law enforcement;
Amendment 52 #
2020/2016(INI)
Motion for a resolution
Recital F b (new)
Recital F b (new)
F b. whereas the relationship between protecting fundamental rights and effective policing must always be an essential element in the discussions on whether and how AI should be used by law enforcement sector, where decisions may have long lasting consequences on the life and freedom of individuals;
Amendment 65 #
2020/2016(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
H a. whereas AI has the potential to be a permanent part of our criminal justice ecosystem by providing investigative analysis and assistance;
Amendment 85 #
2020/2016(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. recalls that the EU has already established data protection standards for law enforcement, which form the foundation for any future regulation in AI; recalls that processing of personal data must be lawful and fair; the purposes of processing must be specified, explicit and legitimate; must be adequate, relevant and not excessive in relation to the purpose for which is it processed; be accurate and kept up to date (inaccurate data should, subject to the purpose for which it would otherwise be retained, be correcte dor erased); should be kept for no longer than is necessary and processed in a secure manner;
Amendment 87 #
2020/2016(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Reaffirms that all AI solutions for law enforcement and the judiciary also need to fully respect the principles of non- discrimination, human dignity, prevention of damage, transparency, impartiality and accuracy, fairness and explainability of the use of biometric recognition technologies, guarantee of the human control by the user, freedom of movement, the presumption of innocence and right of defence, freedom of expression and information, freedom of assembly and of association, equality before the law, and the right to an effective remedy and a fair trial;
Amendment 94 #
2020/2016(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. notes that the use of biometric data, such as for facial recognition technologies, relates more broadly to the principle of the right to human dignity; human dignity is the basis of all fundamental rights guaranteed by the Charter of Fundamental Rights; The Court of Justice of the EU (CJEU) has confirmed in its case law that the fundamental right to dignity is part of EU law, therefore biometric data, including facial images, must be processed in a way that respects human dignity;
Amendment 106 #
2020/2016(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Underlines the right of the parties to access the data collection process and that relating to prognostic assessments useful for crime prevention police, to the cataloguing and evaluation of criminal evidence and to preventive assessments of whether a suspect might be a danger to society, to the risk of recidivism and the output produced or obtained through AI for notification procedures, as well as the role of AI and related technologies in criminal law enforcement and crime prevention;
Amendment 138 #
2020/2016(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Highlights the power asymmetry between those who develop and employ AI technologies and those who interact and are subject to them; it is, therefore, essential also to provide for a rule that ensures the transparency of the corporate structures of companies that produce and manage AI systems and institutionalise the principle of independence of the programmers, since it is they who prepare not only the selection of data and information to be processed at the basis of the algorithms, but also the assessment criteria that inform and produce a decision;
Amendment 143 #
2020/2016(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. stresses that only a robust European AI governance enable the necessary operationalisation of fundamental rights principles;
Amendment 145 #
2020/2016(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Considers it necessary to create a clear and fair regime for assigning legal responsibility for the potential adverse consequences produced by these advanced digital technologies; Recognises the challenges to correctly locate the responsibility for potential harm, given the complexity of development and operation of AI systems;
Amendment 149 #
2020/2016(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Highlights how individuals have become overly trusting in the seemingly objective and scientific nature of AI tools and thus fail to consider the possibility of their results being incorrect, incomplete or irrelevant, with potentially grave adverse consequences specifically in the area of law enforcement and justice; Emphasises the over-reliance on the results provided for by AI systems, and notes with concern the lack of confidence and knowledge, by authorities, to question or override an algorithmic recommendation;
Amendment 156 #
2020/2016(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Underlines that in judicial and law enforcement contexts, the final decision always needs to be taken by a human, who can be held accountable for the decisions made, and include the possibility of a recourse for a remedy; it is necessary to prevent the use of algorithms – so-called automated decision systems – can replace human minds in final decisions, in order to avoid deterministic approaches and ensure the formation of the free judgment of judicial authorities, and whose decisions must always be justifiable, responsible and free of prejudices;
Amendment 160 #
2020/2016(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls for algorithmic explainability and transparency in order to ensure that the development, deployment and use of AI systems for judiciary and law enforcement comply with fundamental rights, and are trusted by citizens, as well as in order to ensure that results generated by AI algorithms can be rendered intelligible to users and to those subject to these systems, and that there is transparency on the source data and how the system arrived at a certain conclusion; on that note, it is necessary to develop specific mandatory rules of conduct for public and private entities responsible for the design and use of AI, to ensure that they adhere to the principles of transparency and clarity relating to the processes for developing mathematical models and predictive algorithms, while complying with the requirement for independent verification of the quality and reliability of the results achieved, in terms of acquiring and assessing evidence - especially circumstantial evidence - beyond all reasonable doubt;
Amendment 164 #
2020/2016(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls for, in order to guarantee the algorithmic explainability and transparency of law enforcement AI systems, only such tools to be allowed to be purchased by the law enforcement in the Union, which algorithms and logic are open, to at least the police forces themselves, that can be audited, evaluated and vetted by them, and not closed and labelled proprietary by the vendors;
Amendment 166 #
2020/2016(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11 b. considers that the use and collection of any biometric data for remote identification purposes, for example by conducting facial recognition in public places, as well as at automatic border control gates used for border checks at airports, may pose specific risks to fundamental rights; the implications of which could vary considerably depending on the purpose, context and scope of use;
Amendment 171 #
2020/2016(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls for a compulsory fundamental rights impact assessment to be conducted prior to the implementation or deployment of any AI systems for law enforcement or judiciary, in order to assess any potential risks to fundamental rights; Underlines that this could oftentimes be built upon the mandatory Data Protection Impact Assessments;
Amendment 198 #
2020/2016(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16 a. Calls for the Fundamental Rights Agency, in collaboration with the European Data Protection Board and the European Data Protection Supervisor to draft comprehensive guidelines for the development, use and deployment of AI applications and solutions for the use by law enforcement and judicial authorities;
Amendment 1 #
2020/2012(INL)
Draft opinion
Recital A
Recital A
A. Whereas the Union is founded on the ethical values stated in Article 2 of the Treaty on European Union;
Amendment 3 #
2020/2012(INL)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. Whereas rapid advances in contemporary scientific research and innovation in the fields of environment, health and food safety have raised a number of important ethical, legal and social issues that affect the relationship between science and society;
Amendment 4 #
2020/2012(INL)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. Whereas environment, health and food safety research and innovation activities carried out in Europe must comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols1a; _________________ 1aArticle 19 of Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC Text with EEA relevance
Amendment 5 #
2020/2012(INL)
Draft opinion
Recital A c (new)
Recital A c (new)
Ac. Whereas Article 16 TFEU states that everyone has the right to the protection of their personal data; whereas Article 22 of the General Data Protection Regulation refers to the situation where data are only used by automated processing, and recognises the right of the data subject not to be subject to a decision based solely on automated processing;
Amendment 8 #
2020/2012(INL)
Draft opinion
Recital B
Recital B
B. Whereas the artificial intelligence (AI) global leadership race, which will determine the source of ethical values and standards shaping the sector worldwide, is picking up the pace and the Union should set an example for the rest of the world;
Amendment 11 #
2020/2012(INL)
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 17 #
2020/2012(INL)
Draft opinion
Recital C
Recital C
C. Whereas AI solutions may benefit society in the areas of green transition, environment protection,and biodiversity protection, circular economy and waste management, climate change, energy management and efficiency, water and air quality, e.g. smart grids and electro-mobilityarth observation and risk management, among others;
Amendment 20 #
2020/2012(INL)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. Whereas in its digital package published on 19 February 2020 the Commission states that ICT today accounts for between 5% and 9% of global electricity consumption and 2% of CO2 emissions and that the volume of data transferred and stored will continue to grow exponentially in the years to come; whereas the 2018 Joint Research Centre study “Artificial Intelligence/A European Perspective” estimates that data centres and data transmission could account for 3-4% of all power consumption of the Union;
Amendment 23 #
2020/2012(INL)
Draft opinion
Recital C b (new)
Recital C b (new)
Amendment 24 #
2020/2012(INL)
Draft opinion
Paragraph 1
Paragraph 1
1. Believes that any ethical framework shouldthere is a difference between ethics and law and the role they play in our societies; any framework of ethical principles for the development, deployment and use of Artificial Intelligence (AI), robotics and related technologies should complement the EU Charter of Fundamental Rights and thereby seek to respect human dignity and autonomy, prevent harm, promote fairness, and transparency, respect the principle of explicability of technologies; and guarantee that the technologies are there to serve people, with the ultimate aim of increasing human well-being for everybody;
Amendment 26 #
2020/2012(INL)
Draft opinion
Recital C c (new)
Recital C c (new)
Cc. Whereas properly regulated AI would help guide efforts to achieve the UN SDGs and help reach the climate objectives of the Paris Agreement;
Amendment 29 #
2020/2012(INL)
Draft opinion
Recital D
Recital D
D. Whereas AI can be applied to almost any field in medicine: biomedical research, exemplified by the AI-discovered antibiotic Halicin or AI contributions to new cancer prevention, more precise diagnosis and new therapies, medical education, clinical decision-making, personalized medicine, psychiatric diagnosis and treatment, in revolutionizing robotic prostheses and support systems, telemedicine, telesurgery and the overall efficiency of the health systems;
Amendment 34 #
2020/2012(INL)
Draft opinion
Recital D a (new)
Recital D a (new)
Da. whereas AI technology will accelerate the digital transformation of industry and play an essential part in the success of the digital economy in an increasingly connected world;
Amendment 39 #
2020/2012(INL)
Draft opinion
Paragraph 2
Paragraph 2
2. SHighlights the power asymmetry between those who employ AI technologies and those who interact and are subject to them; in this context stresses the importance of developing an “ethics-by-default and by design” framework which fully respect the Charter of Fundamental Rights of the European Union, Union law and the Treaties;
Amendment 40 #
2020/2012(INL)
Draft opinion
Recital E
Recital E
E. Whereas current policy and ethical guidelines for AI are lagging behind ethical challenges that must be identified and mitigated, since AI has tremendous capability to threaten patient preference, safety, and privacy; whereas the boundaries between the roles of physicianmedical professionals and carers and machines in patient care need to be outlined;
Amendment 44 #
2020/2012(INL)
Draft opinion
Paragraph 3
Paragraph 3
3. Considers that the current Union legalislative framework will need to be updaon protection of privacy and personal data fully applies to AI, robotics and related technologies, however could benefit from being supplemented with guidingrobust ethical principlguidelines; points out that, where it would be premature to adopt legal acts, a soft law framework should be used;
Amendment 48 #
2020/2012(INL)
Draft opinion
Recital F
Recital F
F. Whereas AI solutions may benefit society in the area of food safety and Farming 2.0, where the Union holds leadership in AI applications, especially in areas where water resources are scarce and climate change has severe impacts;
Amendment 51 #
2020/2012(INL)
Draft opinion
Recital F a (new)
Recital F a (new)
Fa. Whereas it is essential to identify an effective means of ensuring trustworthy digital technologies, making it possible to reap their benefits while protecting fundamental rights and encouraging the development of informal, open, tolerant and just societies; this is particularly important in the case of hybrid human/artificial intelligence systems;
Amendment 63 #
2020/2012(INL)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Underlines the importance of the “right to explanation” of any decision taken by automated processing, this is the right to obtain human intervention on the part of the controller, to express his or her point of view and to contest the decision taken by an automated system4a; states, therefore, that ultimately, humans should keep the responsibility for decision making, especially in sectors where there are high stakes and risks such as health; _________________ 4a Article 22 GDPR Regulation
Amendment 65 #
2020/2012(INL)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses the need for a regulatory framework stipulating the ethical principles to be applied to the design, development, implementation and functioning of this technology - from data access to strict outcome monitoring;
Amendment 66 #
2020/2012(INL)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Promotes a European Agency for Artificial Intelligence, which ensures a European coordination of AI standards and regulations; this centralized agency develops common criteria for a European certificate of ethical compliance, which also takes the data used for algorithmic processes into account;
Amendment 68 #
2020/2012(INL)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Promotes Corporate Digital Responsibility on a voluntary basis; the EU should support corporations, who by choice use digital technologies and AI ethically within their companies; the EU should encourage corporations to become proactive by establishing a platform for companies to share their experiences with ethical digitalization, as well as coordinating the actions and strategies of participating companies;
Amendment 69 #
2020/2012(INL)
Draft opinion
Paragraph 2
Paragraph 2
2. Underlines that overregulation may hamper AI sector innovation, especially for SMEs and Start-ups; considers that hindering the Union AI sector in delivering benefits of AI applications in e.g. healthcare, environment protection and food quality to the citizens, may also bear ethical weight, especially in the context of global competition, where securing full respect of Union ethical values may pose a challengereminds that beyond Union action, many third countries are working on their ethical frameworks and that there are multiple proposals at a global level; is aware that the main difficulty for ethical principles may lie in the application of such principles rather than in their existence especially in the context of global competition and of high risk sectors as healthcare; recalls, in this regard, that Parliament’s resolution of 16 February 2017 on Civil Law Rules on Robotics asked the Commission to consider the designation of a European Agency for Artificial Intelligence that ensures a harmonised approach across the Union, develops common criteria and an application process relating to the granting of a European certificate of ethical compliance, and that addresses the new opportunities and challenges, in particular those of a cross-border nature, arising from ongoing technological developments;
Amendment 75 #
2020/2012(INL)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights that many of the proposals by countries which are not members of the Union and by international organizations revolve around common principles or concepts for AI, those being: human-centricness, trustworthiness, respect for human autonomy, harm prevention, equity and "no one left behind" and explicability; is of the opinion that an international ethical framework around these principles would be highly desirable; is concerned about AI progress and innovations leading to social inequality if no action is taken; calls therefore on the Commission and Member States to take the necessary measures to leave no one behind in the transition to a digital Europe, and to guarantee a fair, affordable and equal access to these innovations especially in areas such as healthcare;
Amendment 76 #
2020/2012(INL)
Draft opinion
Paragraph 6
Paragraph 6
6. Stresses that the protection of networks of interconnected AI and robotics mustis important, and strong measures must be taken to prevent security breaches, cyber- attacks and the misuse of personal data;
Amendment 78 #
2020/2012(INL)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls for a comprehensive risk assessment of AI, robotics and related technologies in addition to the impact assessment provided by Article 35 GDPR (Article 27 of Directive (EU) 2016/680 and Article 39 of Regulation (EU) 2018/1725); the more impact an algorithm has, the more transparency, auditability, accountability and regulation is needed; where an algorithmic decision leads to a limitation of fundamental rights, there needs to be a very robust assessment in place; in highly critical fields - when health, freedom or human autonomy are directly endangered - the implementation of AI should be prohibited;
Amendment 91 #
2020/2012(INL)
Draft opinion
Paragraph 7
Paragraph 7
7. Notes that AI and robotic technology are used more and more in the area of law enforcement and border control could enhance public safety and security; stresses that its use must respect the principles of proportionality and necessity; , often with adverse effects on individuals when it comes to their rights to privacy, data protection and non- discrimination; stresses that the deployment and use of these technologies must respect the principles of proportionality and necessity, the Charter of Fundamental Rights, in particular the rights to data protection, privacy and non- discrimination, as well as the relevant secondary Union law such as EU data protection rules;
Amendment 98 #
2020/2012(INL)
Draft opinion
Paragraph 8
Paragraph 8
8. Stresses that AI and robotics are not immune from making mistakes and can easily have inherent bias; notes that biases can be inherent in the underlying datasets, especially when historical data is being used, introduced by the developers of the algorithms, or generated when the systems are implemented in the real world setting; considers the need for legislators to reflect upon the complex issue of liability in the context of criminal justice.
Amendment 98 #
2020/2012(INL)
Draft opinion
Paragraph 4
Paragraph 4
4. Notes that, with the rapid development of AI and the uncertainty that lies ahead, a common Union AI ethical framework will expand an ecosystem of trust as defined in the Commission White Paper, whether in environment protection, healthcare or food safety applications, thus supporting the ecosystem of excellence in legal certainty and providing effective response to the challenges yet not defined in courtrooms, management meetings or scientific laboratories; points out that ethics is not made up of permanent principles, but has been changing over the course of various cultures and times; supports in this regard that the framework should be periodically reviewed to guarantee its applicability through time and new developments;
Amendment 102 #
2020/2012(INL)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Recommends measures to encourage the involvement of all AI ethics stakeholders from the private sector, consumer groups and academia for the formulation of an ethical code tailored to technological, social and political developments;
Amendment 110 #
2020/2012(INL)
Draft opinion
Paragraph 5
Paragraph 5
5. Strongly supports the Commission in establishing a common Union AI ethical framework to counter the shortcomings caused by AI internal market fragmentation, including environmental, healthcare, and food safety applications, and to prevent AI double standards across Member States for AI developed in Union and beyond, inter alia in areas such as consumer data management, protection and privacy in smart grids, waste management, equal access to services and technologies, patient-doctor relationship standards, data protection and privacy, civil liability in AI- assisted public healthcare, civil liability regarding autonomous vehicles or machinery;
Amendment 115 #
2020/2012(INL)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers that in areas such as health, liability must ultimately lie with a natural or legal person; emphasizes the need for traceable and publicly available training data for algorithms;
Amendment 118 #
2020/2012(INL)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Emphasises that patients should know when and how they are interacting with a human professional and when they are not; insists that patients should have the freedom to decide about this interaction and should be offered an alternative of equal standard;
Amendment 123 #
2020/2012(INL)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls for citizen and patient empowerment regarding their personal data and for securing the full enforcement of Union legal framework on data protection and privacy, relevant notably in the healthcare AI applications and related sensitive data, to strengthen the “Right to an explanation” foreseen in Article 22 of Regulation (EU) 2016/679 of the European Parliament and of the Council (General Data Protection Regulation, (GDPR))2 and higher interpretability requirements for high-risk AI; _________________ 2Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 128 #
2020/2012(INL)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights, in the healthcare sector, that data originated from patients using AI technologies should fulfil all the privacy requirements as stipulated in the GDPR, and that by no means, the data generated should contribute to any kind of discrimination (known or novel); calls on the Commission and Member States to guarantee that data accessibility to private companies, such as health or life insurance companies, is prevented and that the “right to be forgotten” of patients is fully respected;
Amendment 132 #
2020/2012(INL)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
Amendment 153 #
2020/2012(INL)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Points out that the use of tracking and contact tracing technologies by public authorities during the COVID 19 crisis and other potential health emergencies might conflict with data protection; recalls in this regard the Commission Guidance on applications supporting the fight against the COVID 19 pandemic in relation to data protection and the need for proportionality, limitation in time, alignment with European values and respect of human dignity and fundamental rights;
Amendment 156 #
2020/2012(INL)
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Highlights that AI and robotics can bring numerous benefits to our environment, health and food safety as the dematerialisation of the economy makes the Union less dependent on raw materials or on the increased use of personalised medicine; underlines however, that their carbon footprint remains still high; calls on the Commission to carry out a study on the impact of AI technology’s carbon footprint and the positive and negative impacts of the transition to the use of AI technology by consumers; further calls on the Commission to include the footprint information in the common European Dataspace for Smart Circular Applications foreseen in the EU Action Plan on Circular Economy and to deal specifically with these technologies within the ICT key value chain of the above- mentioned plan;
Amendment 163 #
2020/2012(INL)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls for securing sufficient financing for the Union AI transformation; supports the ambitions laid out in the Commission White Paper to attract €200 billion of AI public and private investment in the next 10 years in the Union; welcomes the attention granted to deficits of AI ecosystems in less-developed regions and to the needs of SMEs and start-ups; calls on the Commission to facilitate geographically balanced access to allidentify public infrastructure and promote the prioritization of AI funding, in cluding for SMEs and start- upsimate change mitigation and adaptation, renewable energies and health; stresses that the new Union objectives must not diminish Union engagement in its long standing priorities, like the CAP or, Cohesion Policy., the Green Deal and the COVID19 Recovery Plan;
Amendment 12 #
2020/2009(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to the Commission Communication of 20 June 2020 entitled "Tackling COVID-19 disinformation - Getting the facts right";
Amendment 38 #
2020/2009(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the crisis has highlighted the essential role played by journalists in providing citizens with reliable and verified information, thereby helping to save lives; more effort must therefore be made to ensure safe and suitable working conditions for journalists;
Amendment 49 #
2020/2009(INI)
Motion for a resolution
Recital C
Recital C
C. whereas according to the 2020 World Press Freedom Index, the COVID- 19 pandemic has highlighted and amplified many other crises that threaten the right to freely reported, independent, diversereveals a wide range of discrepancy between the individual Member States varying from second place in the world ranking given to Finland up to one hundred and reliable informationeventh place given to Bulgaria;
Amendment 52 #
2020/2009(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas according to the 2020 World Press Freedom Index the COVID- 19 pandemic has highlighted and amplified many other crises that threaten the right to freely reported, independent, diverse and reliable information;
Amendment 54 #
2020/2009(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas recent years show a growing pattern of intimidation to silence journalists that requires urgent actions to uphold the essential role of the independent media in ensuring the principles of rule of law;
Amendment 55 #
2020/2009(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Cc. whereas the transparency of the media ownership is an absolute precondition for ensuring media pluralism and independent journalism;
Amendment 69 #
2020/2009(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas strengthening media freedom requires credible and detailed information on the scope and the nature of the challenges within the Member States and the EU as a whole, including on individual cases of violation of the principles of the independent media or infringements of fundamental rights of journalist;
Amendment 73 #
2020/2009(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas the rights of the journalists to report and investigate needs to be further enhanced and effectively protected;
Amendment 107 #
2020/2009(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Aa. whereas disinformation regarding the COVID-19 pandemic could have serious consequences, possibly leading to disregard for official health advice and risk taking or having an adverse impact on our institutions and societies and in economic and financial terms;
Amendment 113 #
2020/2009(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that freedom of the press is extremely important and must not be affected by any measures or by any authority, even if the information provided does not always reflect the official version of the truth, and that no decision can therefore be taken to close down a publication or website;
Amendment 122 #
2020/2009(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Strongly reiterates its call on the Commission to treat attempts by Member State governments to damage media freedom and pluralism as constituting a serious and systematic abuse of powers and as going against the fundamental values of the EU as enshrined in Article 2 TEU; welcomes, therefore, the Commission’s intention to include a specific chapter on monitoring media freedom and pluralism in its Annual Report on the Situation of the Rule of Law within the EU; urges the Commission to take into account the impact of the emergency measures taken in 2020 in the context of COVID-19 on press freedom, media pluralism and safety of journalists; in this context, recalls Parliament’s repeated call for a permanent, independent and comprehensive mechanism covering democracy, the rule of law and fundamental rights in the EU; urges the Commission and Member States to develop and maintain credible framework of protections of media freedom and media pluralism; highlights the need of a fully-fledged EU mechanism on media freedom, beyond the framework of the new Rule of Law mechanism, which should introduce clear standards and benchmarks at EU level as well as incentives for higher convergence between the individual Member States, including through legislation, if necessary.
Amendment 148 #
2020/2009(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that public authorities must ensure transparency regarding their activities, thereby helping to bolster public confidence, bearing in mind that, the free flow of information helps to protect life and health and facilitates and promotes social, economic and political debate and decision making;
Amendment 149 #
2020/2009(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to monitor and collect information and statistics on media freedom and pluralism within all Member States, and to analyse closely cases of the infringement of the fundamental rights of journalists;
Amendment 155 #
2020/2009(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reiterates its concern that few specific legal or policy frameworks protecting journalists and media workers from violence, threats and intimidation can be identified at national level within the EU; calls on public figures and representatives of the authorities to refrain from denigrating journalists as this undermines trust in the media across society; underlines the important role of journalists in reporting on protests and demonstrations and calls for their protection from both the protesters and law enforcement in order that they can carry out their role without fear; asks Member `states to provide specific training programmes for law enforcement who are responsible for fulfilling state obligations of the protection of journalists, calls on the Member States and the Commission to ensure the effective protection and safety of journalists and other media actors as well as of their sources, including in a cross-border context; strongly reiterates its call on the Commission to present proposals to prevent so-called ‘Strategic Lawsuits Against Public Participation’ (SLAPP); highlights that women journalists are especially vulnerable to harassment and intimidation and therefore should be subject to additional safeguards;
Amendment 167 #
2020/2009(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Reaffirms that anonymity and encryption are essential tools for the exercise of democratic rights and freedoms, and for protecting the confidentiality of sources in journalism
Amendment 168 #
2020/2009(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
Amendment 174 #
2020/2009(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that excessive concentration of the content-producing and content-distributing sectors may threaten citizens’ access to a range of content; underlines that media pluralism, which depends on the existence of a diversity of media ownership and of content as well as independent journalism, is key to challenging the spread of disinformation and ensuring that EU citizens are well- informed; condemns any attempt to monopolize the media ownership in the Member States as well as to exert political interference in media management; urges the Commission and the Member States to act quickly and resolutely to increase the transparency of the media ownership and the financial sources used by media owners as well as to fight more efficiently irregular or covert funding practices which threaten per se the independence, credibility and sustainability of the media sector and affects the freedom of expression;
Amendment 194 #
2020/2009(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Commission and the Member States to urgently introduce EU and national emergency recovery packages to protect the jobs and livelihoods of media workers, support companies and fund public service media through the COVID- 19 crisis; stresses that in the face of the pandemic European citizens need professional, economically secure and independent journalists; reiterates in this context its call for the creation of a permanent European fund for journalists in the framework of the next MFF (2021- 2027), as redrafted following the COVID- 19 crisis, offering direct financial support for independent journalists and media outlets, freelancers and self-employed media workers; highlights that investigative journalism as key for the critical thinking and for ensuring transparency and checks on the work of politicians and invites the Commission to propose a dedicated financial instrument providing financial support explicitly for investigative journalism
Amendment 223 #
2020/2009(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Takes note of the Code of Conduct on Countering Illegal Hate Speech Online, promoted by the Commission, and of its fourifth evaluation round, from which it emerges that IT companies are remov71% of the content deemed to be illegal hate speech was removed; highlights the wide marging on average 72 % of the illegal hate speech notified to themf discretion left to private companies to determine what is illegal; Stresses the necessity to have all companies that run platforms to be part of the code of conduct;;
Amendment 243 #
2020/2009(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
Amendment 271 #
2020/2009(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Welcomes the launch of the European Digital Media Observatory - EDMO project, which will increase the level of available scientific knowledge regarding online disinformation, promote the development of an EU information verification services market and support the creation of a cross-border and multidisciplinary community composed of fact checkers and academic researchers cooperating with stakeholders to identify, analyse and expose potential disinformation threats, with regard to COVID for example;
Amendment 272 #
2020/2009(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on Member States to increase their efforts to strengthen media literacy across education to help citizens identify disinformation;
Amendment 286 #
2020/2009(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls on social media companies and online platforms to make available tools to enable users to report and flag potential disinformation in order to facilitate prompt rectification and to allow for review by independent and impartial third party fact checking organisations;
Amendment 287 #
2020/2009(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
Amendment 17 #
2020/2006(INL)
Motion for a resolution
Recital A
Recital A
A. Whereas biologically diverse forests being natural carbon sinks are indispensable in the fight against climate change in line with the Paris Agreement’s goals to hold the increase in the global average temperature to well below 2°C above pre-industrial levels and pursue efforts to limit the temperature increase to 1, 5°C above pre-industrial levels, and that the best available science indicates that limiting the increase to 1.5 degrees would substantially reduce harm to people and natural ecosystems in relation to the 2 degrees scenario, as well as for climate change adaptation and biodiversity conservation;
Amendment 24 #
2020/2006(INL)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas forests provide important ecosystem services to society, such as clean air, water flow regulation, carbon reduction, protection against water and wind erosion, habitats for animals and plants, restoration of degraded land, resilience to climate change;
Amendment 29 #
2020/2006(INL)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. Whereas the UN IPCC Special Report on Global Warming of 1.5˚C evidences clear benefits to people and natural ecosystems of limiting global warming to 1.5°C compared to 2°C;
Amendment 35 #
2020/2006(INL)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. Whereas emissions from land-use change, mostly due to deforestation, account for approximately 12% of global GHG emissions and are the second biggest cause of climate change after burning coal, oil and gas;
Amendment 38 #
2020/2006(INL)
Motion for a resolution
Recital A c (new)
Recital A c (new)
Ac. Whereas forests provide subsistence and income for 25% of the world’s population;
Amendment 40 #
2020/2006(INL)
Motion for a resolution
Recital A d (new)
Recital A d (new)
Ad. Whereas forests have cultural, social and spiritual value for many people and peoples;
Amendment 41 #
2020/2006(INL)
Motion for a resolution
Recital A e (new)
Recital A e (new)
Ae. Whereas global tree cover loss has been rising steadily over the past 18 years and in 2019 alone 3.8 million hectares of primary rainforests were destroyed;
Amendment 42 #
2020/2006(INL)
Motion for a resolution
Recital A f (new)
Recital A f (new)
Af. Whereas approximately 80% of global deforestation is caused by the expansion of land used for agriculture;
Amendment 43 #
2020/2006(INL)
Motion for a resolution
Recital A g (new)
Recital A g (new)
Ag. Whereas the livelihoods and food security of many of the world’s rural poor depend on vibrant forests and trees and evidence shows that around 40% of the extreme rural poor – around 250 million people – live in forest and savannah areas;
Amendment 44 #
2020/2006(INL)
Motion for a resolution
Recital A h (new)
Recital A h (new)
Ah. Whereas more than three land and environmental defenders were murdered each week in 2018;
Amendment 45 #
2020/2006(INL)
Motion for a resolution
Recital A i (new)
Recital A i (new)
Ai. Whereas more than 300 people were killed in resource and land-use conflicts in the Amazon region in the last decade;
Amendment 56 #
2020/2006(INL)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas deforestation and forest degradation are responsible for approximately 20% of the global carbon dioxide (CO2) emissions and also represent a major threat in the context of climate change; whereas deforestation occurs at an alarming rate of 13 million hectares per year, most of it in tropical regions in developing countries;
Amendment 58 #
2020/2006(INL)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. Whereas 87% of Europeans agree that new laws are needed to ensure the products sold in the Member States do not contribute to global deforestation according to a YouGov poll;
Amendment 61 #
2020/2006(INL)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas the recent COVID-19 pandemic also shows that the risk of infectious diseases emerging and spreading increases with the destruction of nature; whereas protecting and restoring biodiversity and well- functioning ecosystems is therefore key to boost our resilience and prevent the emergence and spread of future diseases;
Amendment 65 #
2020/2006(INL)
Motion for a resolution
Recital B c (new)
Recital B c (new)
Bc. whereas afforestation and restoration of degraded forest land can contribute to reducing the pressure on ancient forests and can be an additional method of efficient defence in the fight against climate change;
Amendment 68 #
2020/2006(INL)
Motion for a resolution
Recital B d (new)
Recital B d (new)
Bd. whereas deforestation can have a devastating impact on the livelihoods of the most vulnerable populations, including indigenous populations, which depend to a great extent on forest ecosystems;
Amendment 78 #
2020/2006(INL)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Underlines that approximately 80% of global deforestation is caused by the expansion of land used for agriculture; stresses in this context that the Commission Communication on Stepping up EU Action to Protect and Restore the World’s Forests of July 2019 recognises that Union demand for products such as palm oil, meat, soy, cocoa, maize, timber, rubber, including in the form of processed products or services, is a large driver of deforestation, forest degradation, ecosystem destruction and human rights violations across the globe;
Amendment 85 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Notes with the highest concern that in the period from 2014 to 2018, the rate of tree cover loss has increased by 43% to an average loss of 26,1 million hectares per year, as compared to 18,3 million hectares per year in the period from 2002 to 2013; is particularly worried about the loss of primary forests as the three most recent years with available data (2016, 2017 and 2018) have registered the highest loss rates this century with deforestation rates in the Brazilian Amazon alone having increased 88% in June 2019 compared to June 2018;
Amendment 89 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Points out that protecting existing forests and sustainably increasing forest cover can provide livelihoods, increase income for local communities and allow for sustainable bioeconomies to be developed;
Amendment 94 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Points out that reforestation, restoration of existing degraded forests and increasing tree cover on agricultural landscapes via agroforestry represent the only available sources of negative emissions with significant potential to contribute to the achievement of the Paris Agreement goals;
Amendment 96 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights that destruction and degradation of natural forests is not only happening in tropical areas, but all over the world, including inside the Union and in its direct neighbourhood;
Amendment 98 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Believes that any EU legal framework to halt and reverse EU-driven global deforestation (referred to as the EU legal framework hereafter) must also cover the halt and reversal of destruction and degradation of high-carbon stock and biodiversity-rich ecosystems, as otherwise pressure could be shifted to these areas;
Amendment 99 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Notes, that so far, with the exception for timber and certain wood products, there are no rules in place that prohibit placing on the European market products that contributed to the destruction of forests ; notes that, therefore, consumers of many forest and ecosystem-risk commodities in the Union have no guarantee that these products did not contribute to deforestation and that consequently consumers unblameably, unwillingly and unknowingly drive deforestation;
Amendment 100 #
2020/2006(INL)
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Is convinced that mandatory sustainability rules enacted in a large market, like within the European Union, have the potential of steering global production practices towards more sustainable ones;
Amendment 111 #
2020/2006(INL)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes business’ growing awareness of the problem of global deforestation and ecosystem destruction, the need for corporate action and corresponding commitments; emphasises, however, that companies’ voluntary anti- deforestation commitments often only cover parts of their supply chains and were, as of yet, not sufficient to halt global deforestation;
Amendment 124 #
2020/2006(INL)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Points out that third-party certification schemes have played an important role in bringing together business and civil society to develop a common understanding of the problem of deforestation; observes, however, that voluntary third-party certification schemes alone, to date, are not effective in halting and reversing global deforestation and need to be complemented by mandatory measures; notes that voluntary third-party certification can be an auxiliary tool to assess and mitigate deforestation risks when designed and implemented well with regard to the sustainability criteria it is based on, the robustness of the certification and accreditation process, independent monitoring, possibilities to monitor the supply chain, and sound requirements to protect primary forests and promote sustainable forest managementother natural forests;
Amendment 132 #
2020/2006(INL)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Criticises that third-party certification and labels alone unduly shift the responsibility to decide whether to purchase deforestation-free products to the consumers; which will be insufficient in its effectiveness to mainstream more sustainable production; therefore emphasises that third- party certification can only be complementary to, but cannot replace, thorough operators’ due diligence processes of companies and impair the operators’ liability;
Amendment 143 #
2020/2006(INL)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Is concerned that the multitude of existing certification schemes and labels leads to consumers’ confusion and impairs their chances to make an informed choice;
Amendment 145 #
2020/2006(INL)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Notes that the criteria for what constitutes a “deforestation-free” commodity or products underpinning certification schemes have not always been comprehensive enough, as they sometimes only cover some of a product's relevant ingredients, only parts of a product’s life-cycle, or use an insufficient definition of “deforestation-free”, which can lead to label-shopping by companies and water down ambition of certification in general;
Amendment 168 #
2020/2006(INL)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Welcomes the intention of the Commission to tackle global deforestation and forest degradation but asks for a more ambitious policy approach; calls on the Commission to present a proposal for an EU legal framework based on mandatory due diligence, reporting, disclosure and third- party participation requirements, as well as liability and penalties in case of breaches of obligations for all companies placing for the first time on the Union market commodities with the highestentailing forest and ecosystem risks and products derived from these commodities, and access to justice and remedy for victims of breaches of these obligations; traceability obligations should be placed on traders on the Union market, to ensure sustainable and deforestation-free value chains, as laid down in the Annex to this resolution; emphasises that the same legal framework should apply to Union-basedall financial institutions authorised to operate in the Union and that are providing money to companies that harvest, extract, produce or process forest and ecosystem-risk commodities and derived products;
Amendment 174 #
2020/2006(INL)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. emphasises that halting deforestation and forest degradation, combined with sustainable restoration, afforestation and reforestation activities, provides economic development opportunities; stresses to this end that it is necessary to pay special attention to the production and sustainable consumption of agricultural and forestry products and to take action at global, national, regional and local levels, as well as to make significant investments;
Amendment 179 #
2020/2006(INL)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Emphasises that granting effective access to justice and remedies for victims of corporate human rights and environmental harms must be part of such a legal framework;
Amendment 191 #
2020/2006(INL)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Points out that forest and ecosystem-risk commodities covered by this EU legal framework should be determined on the basis of objective and science-based considerations that such commodities pose high risks forare associated with the destruction and degradation of forests and high-carbon stock and biodiversity-rich ecosystems, as well as for the rights of indigenous people and human rights in general;
Amendment 207 #
2020/2006(INL)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Stresses that weak land tenure and land rights are an important driver of deforestation and degradation of forests and ecosystems;
Amendment 217 #
2020/2006(INL)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses that local communities, indigenous peoples, land and environmental defenders often are on the frontline of the fights to preserve ecosystems; is concerned that the degradation and destruction of forests and other valuable ecosystems frequently goes along with human rights violations or follows from it; urges, therefore, to include the protection of human rights, in particular land tenure, land and labour rights, with a special view to the rights of indigenous peoples and local communities, within the future EU legal framework;
Amendment 220 #
2020/2006(INL)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. emphasises that it is important to encourage the consumption of products from deforestation-free supply chains in the EU, and to improve the assessments of the impact of consumption in the EU and other markets on the world’s forests;
Amendment 226 #
2020/2006(INL)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Notes that such an EU legal framework should also be extended to high-carbon stock and biodiversity-rich ecosystems other than forests, such as river basins or delta areas on entering a sea or an ocean, with important vegetation and fauna, so as to avoid pressure being shifted to these landscapes;
Amendment 231 #
2020/2006(INL)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Believes that these obligations should apply to all companies placing forest and ecosystem-risk commodities (FERC) on the Union market, irrespective of their size or place of registration; while recognising that requirements following the operator’s risk assessment must be proportionate to the level of risks associated with the given commodities; believes that in a fragmented end-market, the inclusion of smaller and larger companies is key to ensure both large-scale impact and consumer trust; emphasises that the regulatory framework must not give rise to undue burdens on small and medium-sized producers, including smallholders, or prevent their access to markets and international trade; recognises, due to a lack of capacity; recommends therefore, that due diligence, rethey be supportinged and disclosure requirements must be proportionate to the level of risks associated with the given commoditiebe provided with the necessary tools to be able to produce in compliance with environmental and human rights requirements;
Amendment 241 #
2020/2006(INL)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses that digitalisation and new technology tools hold the potential to provide unprecedented solutions for companies to identify, prevent, mitigate and account for human rights and environmental impacts;
Amendment 242 #
2020/2006(INL)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Recalls the findings of the study on due diligence requirements through the supply chain, commissioned by the European Commission’s Directorate- General for Justice and Consumers, that finds that a majority of business respondents agree that mandatory due diligence would have a positive impact on human rights and the environment;
Amendment 243 #
2020/2006(INL)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Notes that initial findings of the same study indicate that extra costs occurring to companies to set up and run due diligence systems are only small;
Amendment 244 #
2020/2006(INL)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Believes that EU-wide mandatory due diligence requirements would provide benefits to business through levelling the playing field by holding competitors to the same standards and would provide legal certainty as opposed to a mosaic of different measures at national level;
Amendment 247 #
2020/2006(INL)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Is convinced that the EU Timber Regulation, especially its due diligence requirements, represents a good model to build upon for a future EU legal framework to halt and reverse EU-driven global deforestation, but that a lack of implementation and enforcement of the EU Timber Regulation, and the non-coverage of certain timber products, means that it does not live up to its spirit and intent; is of the opinion, therefore, that lessons can be learnt from the EU Timber Regulation for improved implementation and enforcement rules for a future EU legal framework to halt and reverse EU-driven global deforestation;
Amendment 250 #
2020/2006(INL)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Understands that consumers and producers should be better informed especially when it comes to the link between the consumption of basic products and deforestation; furthermore, citizens should be encouraged by regulatory incentives to adopt better balanced, healthier and more nutritious diets and to reduce food waste;
Amendment 253 #
2020/2006(INL)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Calls for the EU to develop a green timber procurement policy to support the protection and restoration of forest ecosystems around the world;
Amendment 263 #
2020/2006(INL)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines that the impact of the Union’s consumption of forest and ecosystem-risk commodities, and in particular the consumption of meat and dairy products, needs to be adequately addressed in any follow-up, regulatory or non-regulatory, actions and measures to the EU Biodiversity Strategy for 2030 and Farm to Fork Strategy, as well as in the post-2020 Common Agricultural Policy;
Amendment 293 #
2020/2006(INL)
Motion for a resolution
Annex I – point 1 – paragraph 2 – point b
Annex I – point 1 – paragraph 2 – point b
b. the supply practices and financing of all economic operators active on the Union internal market,
Amendment 297 #
2020/2006(INL)
Motion for a resolution
Annex I – point 1 – paragraph 2 – point c
Annex I – point 1 – paragraph 2 – point c
c. production practices of economic operators harvesting, extracting, supplying, and processing forest and ecosystem-risk commodities (FERCs) or producing FERC- derived products in the Union internal market, as well as the practices of their financiers;
Amendment 313 #
2020/2006(INL)
Motion for a resolution
Annex I – point 2 – paragraph 1
Annex I – point 2 – paragraph 1
The proposal should apply to all economic operators, irrespective of their legal form, size or complexity of their value chains, i.e. any natural or legal person (excluding non-commercial consumers) that places commodities that are covered by the proposal and their derived products on the Union internal market for the first time, or that provides financing to operators undertaking these activities. This should apply to both Union and non- Union-based operators. Operators that are not based in the Union should mandate an authorised representative to perform the tasks (in accordance with Regulation (EU) 2019/1020 of the European Parliament and of the Council1 ). _________________ 1Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).
Amendment 344 #
2020/2006(INL)
Motion for a resolution
Annex I – point 2 – paragraph 4
Annex I – point 2 – paragraph 4
The proposal should cover all commodities that are most frequently associated with deforestation, natural forest degradation, and natural ecosystem conversion and degradation. These commodities should be listed in an annex to the proposal and comprise at least palm oil, soy, meat, leather, cocoa, coffee, rubber, and maize and all intermediate or final products that are derived from these commodities, and products that contain these commodities. In the event that the derived products contain input from more than one commodity covered by the proposal, due diligence should be performed with respect to each of these commodities. Commodities covered by Regulation (EU) No 995/2010 of the European Parliament and of the Council2 (‘the EU Timber Regulation’) should be integrated into the scope of the proposal within three years from the date of entry into force of the proposal. To this end, the Commission should first conduct an assessment of the feasibility and the modalities of integrating these commodities, taking into account the upcoming fitness check of the EU Timber Regulation, and ensure that the objectives of the FLEGT Action Plan are not jeopardised and considering the legal and political implications on current Voluntary Partnership Agreements (VPAs) and legally-binding trade agreements between the European Union and a timber-producing country outside the EU. The partner timber-producing countries of the EU should be closely associated with the integration of the Timber commodities covered by the Timber Regulation into the new proposal. _________________ 2Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market Text with EEA relevance (OJ L 295, 12.11.2010, p. 23).
Amendment 356 #
2020/2006(INL)
Motion for a resolution
Annex I – point 2 – paragraph 5
Annex I – point 2 – paragraph 5
The Commission should adopt delegated acts to amend the list of commodities and their derived products that are covered by the proposal if evidence emerges concerning the detrimental impact of their harvesting, extraction or production on natural forests, natural ecosystems or human rights. The Commission should have a vigilant, proactive role in identifying emerging risks, and actively consult a diversity of stakeholders with relevant experience to maintain a list of commodities that reflects the state of knowledge about human rights and environment risks in relevant sectors.
Amendment 365 #
2020/2006(INL)
Motion for a resolution
Annex I – point 2 – paragraph 6
Annex I – point 2 – paragraph 6
The proposal should equally apply to Union-basedall financial institutions providing moneyauthorised to operate in the Union and who are providing finance, investment, insurance or other services to economic operators that harvest, extract, produce, process or sell forest and ecosystem-risk commodities and their derived products to ensure that these financial institutions themselves and their supply chain companies are respecting the responsibilities on the environment and human rights as set out in the proposal.
Amendment 445 #
2020/2006(INL)
Motion for a resolution
Annex I – point 3 – point 3.4 – paragraph 1
Annex I – point 3 – point 3.4 – paragraph 1
FERCs placed on the Union market, in raw form or as products derived from or containing such commodities, should not be harvested, extracted or produced from land obtained or used in violation of human rights embedded into national laws, nor those rights expressed, as a minimum, in international agreements, such as thenure rights, rights of indigenous people,s and local communities, including tenure rights and the procedural right to give or withhold their free prior and informed consent as set out for example by the UN Permanent Forum on Indigenous Issues, the right to water and UN and regional treaty bodies, the right to water, the right to defend human rights, labour rights as enshrined in ILO fundamental conventions and other internationally recognised human rights related to land use, access or ownership, and the human right to a healthy environment, as defined in the Framework Principles on Human Rights and the Environment and the standards and good practices identified by the UN Special Rapporteur on human rights and the environment.
Amendment 452 #
2020/2006(INL)
Motion for a resolution
Annex I – point 3 – point 3.4 – paragraph 2
Annex I – point 3 – point 3.4 – paragraph 2
At all stages, harvesting, extracting or producing covered commodities should respect local communities’ and indigenous peoples’ community and land tenure rights in all forms, whether they are public, private, communal, collective, indigenous, women’s or customary rights. Indigenous peoples’ and local communities’ formal and customary rights to lands, territories and resources should be identified and respected, as should their ability to defend their rights without reprisals. Those rights include the rights to own, occupy, use and administer these lands, territories and resources.
Amendment 455 #
2020/2006(INL)
Motion for a resolution
Annex I – point 3 – point 3.4 – paragraph 3
Annex I – point 3 – point 3.4 – paragraph 3
Commodities covered by the proposal should not be obtained from land whose acquisition and use affects community and land tenure rights. In particular, commodities placed on the Union market should not be harvested, extracted or produced from areas under local communities’ andthe lands of indigenous peoples’ l and and tenure rights in all forms and that have lost that status, unless this occurred in the presence of free, prior and informed consent of the local communities and indigenous peoples concernedlocal communities, both those lands formally titled and those under customary ownership, without their free, prior and informed consent.
Amendment 472 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1
Economic operators should have a complete overview of all actors at all levels of their value chains, be it suppliers, franchisees, licensees, joint ventuall determine whether the commodities and products in their entire value chains comply with the sustainability and human rights criteria of the proposal, by accessing and evaluating information on the precise land area(s) from where these goods originate. In addition to the environmental criteria, access to information must allow the operator to conclude that those using the land to produce FERCs are entitled to do so and have obtained Frese, investors, clients, contractors, customers, consultants, financial, and legal and other advisers.Prior and Informed Consent (FPIC) from those holding rights on those land areas and that they are not violating, or have violated, any human rights referred to in this proposal. In particular, operators are required to have, and make available, information on:
Amendment 476 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point i (new)
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point i (new)
(i) The precise area or areas of harvest or extraction or production of the commodities. Concerning cattle, beef and leather, economic operators must be able to obtain information about the various areas of pasture where cattle has been fed or, where cattle is raised using feed, about the origin of feed used;
Amendment 477 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point ii (new)
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point ii (new)
(ii) The present ecological status of the area of harvest, extraction or production;
Amendment 478 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point iii (new)
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point iii (new)
(iii) The ecological status of the area at the indicated cut-off date of this proposal.
Amendment 479 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point iv (new)
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point iv (new)
(iv) Legal status of land (ownership/title including both formal and customary rights of indigenous peoples and local communities to lands, territories and resources) and evidence of Free, Prior and Informed Consent (FPIC).
Amendment 480 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point v (new)
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point v (new)
(v) The elements of the supply chain of the commodity in question, with the aim of having information about the likelihood of contamination risks 1) with products of unknown origin or 2) originating from deforested areas, or 3) from areas in which natural forest, forest and ecosystem conversion and degradation occurred.
Amendment 481 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point vi (new)
Annex I – point 4 – point 4.1 – paragraph 3 – point a – paragraph 1 – point vi (new)
(vi) Where, by whom and under which conditions the commodities are harvested, transformed or processed with a view to determine compliance with the human rights obligations of this proposal.
Amendment 487 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point b – paragraph 1
Annex I – point 4 – point 4.1 – paragraph 3 – point b – paragraph 1
Where an economic operator sets up new operations or engages new business partners, it should identify the actors involved in the new supply chain and investments, and assess their policies and practices, as well as their harvesting, production, extraction and processing sites. For existing operations, ongoing adverse impacts and harms as well as potential risks should be identified and assessed. Risks analysis should be done with regard to the risks occurring from the economic operator’s activities to, or impact on, the environment, individuals or communitiegenous peoples, local communities and individuals affected, rather than material risk to corporate shareholders.
Amendment 494 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point c – paragraph 1
Annex I – point 4 – point 4.1 – paragraph 3 – point c – paragraph 1
Amendment 501 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point d – paragraph 1
Annex I – point 4 – point 4.1 – paragraph 3 – point d – paragraph 1
Amendment 528 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.1 – paragraph 3 – point g – paragraph 1
Annex I – point 4 – point 4.1 – paragraph 3 – point g – paragraph 1
The Union may negotiate Voluntary FERC Partnership Agreements with FERC- producing countries (partner countries), which create a legally binding obligation for the parties to implement a licensing scheme and to regulate trade in FERCs in accordance with the national law of the FERC-producing country and the environmental and human rights criteria laid out in the proposal. FERCs which originate in partner countries with Voluntary FERC Partnership Agreements should be considered to be of negligible risk for the purpose of the proposal.
Amendment 541 #
2020/2006(INL)
Motion for a resolution
Annex I – point 4 – point 4.3 – paragraph 3
Annex I – point 4 – point 4.3 – paragraph 3
The Commission should adopt delegated acts to set out the format, the frequency and the elements of the reports. In particular, economic operators should, inter alia, report on the system they use and how they apply it to the commodities in question, identified risks and impacts; the actions taken to cease and remedy existing abuses and to prevent and mitigate risks of abuse, as well as their outcomes; the measures and results of monitoring the implementation and effectiveness of such actions, warnings received through the early-warning mechanism and how the economic operator took them into account in their due diligence processes, and a list of all subsidiaries, subcontractors and suppliers, products and their quantity and origin. A failure to publish complete and timely reports should be penalised.
Amendment 561 #
2020/2006(INL)
Motion for a resolution
Annex I – point 5 – point 5.1 – paragraph 1 – point a – introductory part
Annex I – point 5 – point 5.1 – paragraph 1 – point a – introductory part
a. Providing for proportionate, effective and dissuasive penalties and sanctions for non-compliance with any of the above-mentioned obligations and where non-compliance with any of the above-mentioned obligations causes, contributes to, is linked to, or aggravates, abuses or the risk of environmental damage or human rights abuses or the risks thereof. These cshould include:
Amendment 569 #
2020/2006(INL)
b. Designating competent national investigating and enforcement authorities (‘competent authorities’). The competent authorities should monitor that economic operators effectively fulfil the obligations laid down in the proposal. For that purpose, the competent authorities should carry out official checks, in accordance with a plan as appropriate, which may include checks on the premises of economic operators and field audits, and should be able to adopt provisional orders and, in addition and without prejudice to the application of sanctions, they should have the power to require economic operators to take remedial actions where necessary. The competent authorities should endeavcarry ourt to carry outimely and thorough checks when in possession of relevant information, including substantiated concerns from third parties. They should treat information related to their activity in accordance with Directive 2003/4 on public access to environmental information.
Amendment 578 #
2020/2006(INL)
Motion for a resolution
Annex I – point 5 – point 5.1 – paragraph 2 – indent 4
Annex I – point 5 – point 5.1 – paragraph 2 – indent 4
- guidance on third-party concerns to establish Union-wide criteria to assess whether a concern is substantial and reliable enough to be acceptprocessed, and develop clear timelines forprocedural standards for the timely, impartial, effective and transparent responses by the national competent authorities towards third-party concerns;
Amendment 593 #
2020/2006(INL)
Motion for a resolution
Annex I – point 5 – point 5.2 – point c – paragraph 1
Annex I – point 5 – point 5.2 – point c – paragraph 1
Amendment 279 #
2020/0360(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Security of supply, as one main driver behind Regulation (EU) No 347/2013, has been significantly improved through projects of common interest. Moreover, the Commission’s climate target impact assessment27 expects the consumption of natural gas to be reduced significantly because its non-abated use is not compatible with carbon-neutrality. On the other hand, the consumption of biogas, renewable and low-carbon hydrogen and synthetic gaseous fuels will increase significantly towards 2050. Therefore, the natural gas infrastructure no longer needs support through the TEN-E policy. The planning of energy infrastructure should reflect this changing gas landscape. To reflect this change also in the governance dimension of this regulation, the newly created European Scientific Advisory Board on Climate Change, shall deliver binding advice on the overall climate compatibility of the projects of common and mutual interest, that ensures the consistency with the 1.5°C goal of the Paris Agreement. _________________ 27 SWD(2020) 176 final
Amendment 305 #
2020/0360(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Moreover, a new infrastructure category should be created for smart gas grids to support investments which integrate renewable and low carbon gases such as biogas, biomethane, andhydrogen in the hydrogen, in the network and help manage a resulting more complexthis system, building on innovative digital technologies. Blending of hydrogen into the existing gas network would lead to minimal greenhouse gas reductions, as it is only possible to a very small degree and is inefficient.
Amendment 312 #
2020/0360(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Regulation (EU) No 347/2013 requires a candidate project of common interest to prove a significant contribution to at least one criterion from a set of criteria in the process for the elaboration of the Union list, which may, but does not need to, include sustainability. That requirement, in line with the specific needs of the internal energy market at the time, enabled development of projects of common interest which addressed only security of supply risks even if they did not demonstrate benefits in terms of sustainability. However, given the evolution of the Union infrastructure needs and the decarbonisation goals, the Conclusions of the 2020 July European Council, according to which “Union expenditure should be consistent with Paris Agreement objectives and the "do no harm" principle of the European Green Deal, sustainability in terms of the integration of renewable energy sources into the grid or the reduction of greenhouse gas emissions, as relevant, should be assessed in order to ensure that TEN-E policy is coherent with energy and climate policy objectives of the Union. The sustainability of CO2 transport networks is addressed by their purpose to transport carbon dioxideCarbon storage capacities are not yet developed and in any case limited, while CO2 transport networks are generally not necessary for decarbonising the energy system, as this can be done without any carbon emissions. While Carbon Capture and Storage may be needed for unabatable process emissions from heavy industry, this is out of scope of the TEN-E policy and should be addressed separately.
Amendment 325 #
2020/0360(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The Union should facilitate infrastructure projects linking the Union’s energy networks with third-country networks that are mutually beneficial and necessary for the energy transition and the achievement of the climate targets, and which also meet the specific criteria of the relevant infrastructure categories pursuant to this Regulation, in particular with neighbouring countries and with countries with which the Union has established specific energy cooperation. Therefore, this Regulation should include in its scope projects of mutual interest where they are sustainable and able to demonstrate significant net socio-economic benefits for at least two Member States and at least one third country. Such projects would be eligible for inclusion in the Union list upon conditions of regulatory approximation with the Union and upon demonstrating a contribution to the Union’s overall energy and climate objectives in terms of security of supply and decarbonisation. Such regulatory alignment or convergence should be presumed for the European Economic Area or Energy Community Contracting Parties. In addition, the third country with which the Union cooperates in the development of projects of mutual interest should facilitate a similar timeline for accelerated implementation and other policy support measures, as stipulated in this Regulation. It has to be provided that the strategies are aligned with the partnering countries’ economic, social and environmental interests and concerns as well as decarbonization objectives, are non-detrimental to the energy security of the partnering countries and the Union, human rights or sustainable community livelihoods, and contribute to sharing know-how. Therefore, in this Regulation, projects of mutual interest should be considered in the same manner as projects of common interest with all provisions relative to projects of common interest applying also to projects of mutual interest, unless otherwise specified.
Amendment 352 #
2020/0360(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Following close consultations with all Member States and stakeholders, the Commission has identified 13 strategic trans-European energy infrastructure priorities, the implementation of which is essential for the achievement of the Union’s 2030 and 2050 energy and climate policy targets. Those priorities cover different geographic regions or thematic areas in the field of electricity transmission and storage, offshore grids for renewable energy, hydrogen transmission and storage, electrolysers, smart gas grids, and smart electricity grids, and carbon dioxide transport.
Amendment 407 #
2020/0360(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) addresses the identification of projects of common interest necessary to implement priority corridors and areas falling under the energy infrastructure categories in electricity, smart gas grids, hydrogen, and electrolysers, and carbon dioxide set out in Annex II (‘energy infrastructure categories’);
Amendment 424 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘smart gas grid’ means a gas network that makes use of innovative digital solutions to integrate in a cost efficient manner a plurality of low-carbon and renewable gas sources in accordance wrenewable hydrogen in the hydrogen network and help manage this system and contribute to iths consumers’ needs and gas quality requirements in order to reduce the carbon footprint of the related gas consumption, enable an increased share of renewable and low-carbon gases, and create links with other energy carriers and sectors;mplete decarbonisation, without blending of hydrogen into the existing gas network, which is only possible to a very small degree and leads to further losses of efficiency.
Amendment 448 #
2020/0360(COD)
(16a) ‘energy efficiency first’ as defined in Article 2(18) of Regulation (EU) 2018/1999 means: “taking utmost account in energy planning, and in policy and investment decisions, of alternative cost- efficient energy efficiency measures to make energy demand and energy supply more efficient, in particular by means of cost-effective end-use energy savings, demand response initiatives and more efficient conversion, transmission and distribution of energy, whilst still achieving the objectives of those decisions”
Amendment 469 #
2020/0360(COD)
Proposal for a regulation
Article 3 – paragraph 4 – introductory part
Article 3 – paragraph 4 – introductory part
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 of this Regulation amending annexes to this Regulation in order to establish the Union list of projects of common interest (‘Union list’), subject to the second paragraph of Article 172 of the Treaty on the Functioning of the European Union. The Commission shall establish the Union list by adopting separate delegated acts, one per each of the infrastructure categories outlined in Annex II.
Amendment 486 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) the project is in line with the “energy efficiency first” principle.
Amendment 490 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point a
Article 4 – paragraph 2 – point a
(a) the project contributes significantly to the decarbonisation objectives of the Union and those of the third country and to sustainability, including through the integration of renewable energy into the grid and the transmission of renewable generation to major consumption centres and storage sites, and;
Amendment 531 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point c
Article 4 – paragraph 3 – point c
Amendment 533 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point c – point ii
Article 4 – paragraph 3 – point c – point ii
Amendment 535 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point c – point iii
Article 4 – paragraph 3 – point c – point iii
Amendment 541 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point d – introductory part
Article 4 – paragraph 3 – point d – introductory part
(d) for hydrogen projects falling under the energy infrastructure categories set out in point (3) of Annex II the project is to contribute significantly to sustainability, including by reducing greenhouse gas emissions, by enhancing the deployment of renewable hydrogen and supporting variable renewable power generation by offering flexibility and/or storage solutions, while not inhibiting decarbonisation of the power system in the Union or third countries. Furthermore, the project is to contribute significantly to at least one of the following specific criteria:
Amendment 553 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point e – point i
Article 4 – paragraph 3 – point e – point i
(i) sustainability, including by reducing greenhouse gas emissdecarbonisations and enhancing the deployment of renewable hydrogen.
Amendment 561 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point f – introductory part
Article 4 – paragraph 3 – point f – introductory part
(f) for smart gas grid projects falling under the energy infrastructure category set out in point (2) of Annex II, the project is to contribute significantly to sustainability by enabling and facilitating the integration of renewable and low-carbon gases, such as biomethane, or renewable hydrogen, into the gas distribution and transmission networks in order to reduce greenhouse gas emisscontribute to its complete decarbonisations. Furthermore, the project is to contribute significantly to at least one of the following specific criteria:
Amendment 593 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1 – point c a (new)
Article 4 – paragraph 5 – subparagraph 1 – point c a (new)
(ca) The Energy Efficiency First principle, as defined in Article 2.
Amendment 636 #
2020/0360(COD)
Proposal for a regulation
Article 11 – title
Article 11 – title
11 Energy system wide cost-benefit and climate compatibility analysis
Amendment 638 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. By [16 November 2022], the Agency in collaboration with the European Network of Transmission System Operators (ENTSO) for Electricity and, the ENTSO for Gas and the European Scientific Advisory Board on Climate Change, shall publish and submit to Member States, and the Commission and the Agency their respectivethe integrated methodologies, including the network and market modelling, for a harmonised energy system-wide cost- benefit analysisd climate compatibility analysis, that ensures the consistency with the 1.5°C goal of the Paris Agreement, at Union level for projects of common and mutual interest falling under the categories set out in points (1)(a), (b), (c) and (e) and point (3) of Annex II.
Amendment 647 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Prior to submitting their respective integrated, science- reviewed methodologiesy, the ENTSO for Electricity and the ENTSO for Gas shall conduct an extensive consultation process involving at least the organisations representing all relevant stakeholders, including the entity of distribution system operators in the Union (‘EU DSO entity’), all relevant hydrogen stakeholders, civil society and, where it is deemed appropriate the national regulatory authorities and other national authorities.
Amendment 649 #
2020/0360(COD)
Amendment 656 #
2020/0360(COD)
Amendment 659 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 4
Article 11 – paragraph 4
Amendment 666 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. No later than three months of the day of receipt of the Commission’s opinion, as referred to in paragraph 4, the ENTSO for Electricity and the ENTSO for Gasagency shall adapt their respective methodologiesy taking due account of the Commission’s opinion, and submit them to the Commission for approval.
Amendment 672 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 6
Article 11 – paragraph 6
Amendment 678 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
Amendment 685 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 8
Article 11 – paragraph 8
8. Within two weeks of the approval by the Agency or the Commission in accordance with paragraphs 5 and 6, the ENTSO for Electricity and the ENTSO for Gasagency shall publish their respective methodologiesy on theirits websites. The agency shall publish the corresponding input data and other relevant network, load flow and market data in a sufficiently accurate form in accordance with national law and relevant confidentiality agreements.
Amendment 696 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 10
Article 11 – paragraph 10
10. Every three years, the Agency shall establish and make publicly available a set of indicators and corresponding reference values for the comparison of unit investment costs for comparable projects of the infrastructure categories included in points (1) and (3) of Annex II. Those reference values may be used by the ENTSO for Electricity and the ENTSO for Gas for the cost-benefit analyses carried out for subsequent Union-wide ten-year network development plans. The first of such indicators shall be published by [1 November 2022].
Amendment 704 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 11
Article 11 – paragraph 11
11. By [31 December 2023], the ENTSO for Electricity and the ENTSO for Gasagency shall jointly submit to the Commission and the AgencyESABCC a consistent and interlinked energy market and network model including electricity, gas and hydrogen transmission infrastructure as well as storage, LNG and electrolysers, covering the energy infrastructure priority corridors and the areas drawn up in line with the principles laid down in Annex V.
Amendment 720 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
1. By [31 July 2022], the Agency, after having conducted an extensive consultation process involving the ESABCC and the Commission and at least the organisations representing all relevant stakeholders, including the ENTSO for Electricity, the ENTSO for Gas, Union DSO entity, and relevant hydrogen sector stakeholders, shall publish the framework guidelines for the joint scenarios to be developed by ENTSO for Electricity and ENTSO for Gasthe Agency and the ESABCC. Those guidelines shall be regularly updated as found necessary.
Amendment 726 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
The guidelines shall includoperationalise the energy efficiency first principle and ensure that the underlying ENTSO for Electricity and ENTSO for Gas scenarios are is fully in line with the latest medium and long-term European Union decarbonisation targets and the latest available Commission scenarios.
Amendment 732 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 740 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. The ENTSO for Electricity and ENTSO for Gas shall invite the organisations representing all relevant stakeholders, including the Union DSO entity and all relevant hydrogen stakeholders, to participate in the scenarios development process. In order to deliver an integrated energy system, a balanced depth of expertise across all climate neutral energy solutions, from demand through delivery to supply side, is required in the Agency’s scenarios building process. The Agency shall invite relevant technical expertise, including the ENTSO for Electricity and ENTSO for Gas, the Union DSO entity and all relevant representatives from the renewable hydrogen sector, renewable electricity industry, flexibility providers and civil society to participate in the scenarios development process. The agency shall report on how the assumptions are adding up to a consistent pathway to climate neutrality, while consulting the ESABCC which is to give a binding opinion on the outcome.
Amendment 742 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. The ENTSO for Electricity and the ENTSO for Gasagency shall publish and submit the draft joint scenarios report to the Agency and the Commission for theirits opinion.
Amendment 748 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 5
Article 12 – paragraph 5
Amendment 755 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. The Commission, giving due consideration to the Agency opinion defined under paragraph 5, shall submit its opinion to the ENTSO for Electricity and the ENTSO for Gas shall submit its opinion to the agency.
Amendment 761 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 7
Article 12 – paragraph 7
7. The ENTSO for Electricity and the ENTSO for Gasagency shall adapt their jointits scenarios report, taking due account of the Agency’s opinion, in line with the Commission’s and the ESABCC’s opinion and submit the updated report to the Commission for its approval.
Amendment 767 #
2020/0360(COD)
Proposal for a regulation
Article 12 – paragraph 8
Article 12 – paragraph 8
8. Within two weeks of the approval of the joint scenarios report by the Commission in accordance with paragraph 7, the ENTSO for Electricity and the ENTSO for Gasagency shall publish their joint scenarios report on theirits websites. TheyIt shall publish the corresponding input and output data in a sufficiently accurate form, taking due account of the national law and relevant confidentiality agreements.
Amendment 774 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 1 – introductory part
Article 13 – paragraph 1 – introductory part
1. Every two years the ENTSO for Electricity and the ENTSO for Gasagency shall publish and submit to the Commission and the Agency the infrastructure gaps reports developed within the framework of the Union-wide ten-year network development plans.
Amendment 778 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
When assessing the infrastructure gaps the ENTSO for Electricity and the ENTSO for Gas shallagency shall implement the energy efficiency first principle and consider with priority all relevant non-infrastructure related solutions to address the identified gaps. To ensure implementation of the energy efficiency first principle and consider wi, the ENTSOs shall a) ensure transparency on the energy demand assumptions used for all fuels available, which underpin the priority all relevantoject b) provide an overview of all non- infrastructure related solutions considered to address the identified gaps. and why they where not implemented.
Amendment 788 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2
Article 13 – paragraph 1 – subparagraph 2
Amendment 792 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. The ENTSO for Electricity and the ENTSO for Gas shall submit their respective draft infrastructure gaps report to the Agency and the Commissionagency shall submit its draft infrastructure gaps report to the Commission, the ENTSO for Electricity and the ENTSO for Gas and the ESABCC for their opinion.
Amendment 797 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
Amendment 802 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The Commission, considering the Agency’s opinion referred to in paragraph 3the ENTSO for Electricity and the ENTSO for Gas, and the ESABCC, shall draft and submit itsrespective opinions to the ENTSO for Electricity or the ENTSO for Gasagency.
Amendment 807 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 5
Article 13 – paragraph 5
5. The ENTSO for Electricity and the ENTSO for Gasagency shall adapt their infrastructure gaps reports taking due account of the Agency’sENTSO for Electricity and the ENTSO for Gas' opinion and in line with the Commission’s and the ESABCC's opinion before the publication of the final infrastructure gaps reports.
Amendment 900 #
2020/0360(COD)
(ba) all relevant information about the public consultations carried out about the project
Amendment 903 #
2020/0360(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point c
Article 23 – paragraph 1 – point c
(c) the main expected benefits and the costs of the projects, as well as the expected climate benefits, except for any commercially sensitive information;
Amendment 974 #
2020/0360(COD)
Proposal for a regulation
Annex I – Part 4 – point 12
Annex I – Part 4 – point 12
Amendment 978 #
2020/0360(COD)
Proposal for a regulation
Annex I – Part 4 – point 13 – introductory part
Annex I – Part 4 – point 13 – introductory part
(13) Smart gas grids: Adoption of smart gas grid technologies across the Union to efficiently integrate a plurality of renewable and low-carbon gas sourcesrenewable hydrogen into the gashydrogen network, support the uptake of innovative solutions for network management and facilitating smart energy sector integration and demand response.
Amendment 1003 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point a
Annex II – paragraph 1 – point 2 – point a
(a) any of the following equipment or installation aiming at enabling and facilitating the integration of renewable and low-carbon gases (including biomethane or hydrogen) into thehydrogen into the hydrogen network: digital systems and components integrating ICT, control systems and sensor technologies to enable the interactive and intelligent monitoring, metering, quality control and management of gas production, transmission, distribution and consumption within a gasthe network. Furthermore, such projects may also include equipment to enable reverse flows from the distribution to the transmission level and related necessary upgrades to the existing network.
Amendment 1011 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – introductory part
Annex II – paragraph 1 – point 3 – introductory part
(3) concerning renewables-based hydrogen:
Amendment 1046 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 4 – point a
Annex II – paragraph 1 – point 4 – point a
(a) electrolysers that: (i) have at least 100 MW capacity, (ii) the production complies with the life cycle greenhouse gas emissions savings requirement of 780 % relative to a fossil fuel comparator of 94g CO2e/MJ as set out in Article 25(2) and Annex V of Directive (EU) 2018/2001 of the European Parliament and of the Council.60 Life cycle greenhouse gas emissions savings are calculated using the methodology referred to in Article 28(5) of Directive (EU) 2018/2001 or, alternatively, using ISO 14067 or ISO 14064-1. Quantified life-cycle GHG emission savings are verified in line with Article 30 of Directive (EU) 2018/2001 where applicable, or by an independent third party, and (iii) have also a network-related function; _________________ 60 OJ L 328, 21.12.2018, p. 82.
Amendment 1052 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5
Annex II – paragraph 1 – point 5
Amendment 1057 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point a
Annex II – paragraph 1 – point 5 – point a
Amendment 1061 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point b
Annex II – paragraph 1 – point 5 – point b
Amendment 1077 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 1 – point 5
Annex III – Part 1 – point 5
(5) each Group shall invite, as appropriate, the organisations representing relevant stakeholders — and, where deemed appropriate, directly the stakeholders— including producers, distribution system operators, suppliers, consumers and organisations for environmental protection. The Group may organise hearings or consultations, where relevant for the accomplishments of its tasks. shall also organise a public consultation and report on how the opinions expressed where taken into account by modifying proposed projects, or justifying why such opinions were not taken into account, and on which measures were taken to ensure local actors were made aware of and enabled to participate in the public consultation.
Amendment 1082 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 1 – point 6
Annex III – Part 1 – point 6
(6) as regards the meetings of the Groups, the Commission shall publish, on a platform accessible to stakeholders, the internal rules, an updated list of member organisations, regularly updated information on the progress of work, meeting agendas, as well as meeting minutes, where available. Participants lists, meeting agendas and minutes shall be produced and published for each meeting. The deliberations of the decision-making bodies of the Groups and the project ranking in accordance with Article 4(5) ashall be re confidentialrded in meeting minutes and published.
Amendment 1091 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 2 – point 4
Annex III – Part 2 – point 4
(4) as of 1 January 2024, the proposed hydrogen projects of common interest falling under the categories set out in point (3) of Annex II are projects that are part of the latest available Union-wide ten-year network development plan for gas, developed by the ENTSO for GasAgency pursuant Article 812 of this Regulation (EC) No 715/2009.
Amendment 1095 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 2 – point 5 – introductory part
Annex III – Part 2 – point 5 – introductory part
(5) by 30 June 2022 and, subsequently, for every Union-wide ten-year network development plans, the ENTSO for Electricity and ENTSO for Gasagency shall issue updated guidelines for inclusion of projects in their respective Union-wide ten-year network development plans, referred to in points (3) and (4), in order to ensure equal treatment and transparency of the process. For all the projects included in the Union list of projects of common interest in force at the time, the guidelines shall define a simplified process of inclusion in the Union-wide ten-year network development plans by automatic inclusion taking into account the documentation and data already submitted during the previous Union-wide ten-year network development plan processes as long as the information therein remains valid.
Amendment 1097 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 2 – point 5 – paragraph 1
Annex III – Part 2 – point 5 – paragraph 1
The ENTSO for Electricity and ENTSO for GasAgency shall consult with the Commission and the AgencyESABCC about their respective draft guidelines for inclusion of projects in the Union-wide ten-year network development plans and take due account of the Commission’s and the Agency’s recommendations before the publication of the final guidelines.
Amendment 1099 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 2 – point 6
Annex III – Part 2 – point 6
Amendment 1128 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 2 – point a
Annex IV – point 2 – point a
(a) for projects of mutual interest in the category set out in point (1)(a) and (e) of Annex II, the project increases the grid transfer capacity, or the capacity available for commercial flows, at the border of that Member State with one or more third countries and brings significant benefits, under the specific criteria listed in in Article 4(3), to at least two Member States and the third countries. The calculation of the benefits for the Member States shall be performed and published by the ENTSO for ElectricitAgency in the frame of Union-wide ten-year network development plan;
Amendment 1130 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 2 – point b
Annex IV – point 2 – point b
(b) for projects of mutual interest in the category set out in point (3) of Annex II, the hydrogen project enables the transmission of renewables-based hydrogen across at the border of a Member State with one or more third countries and proves bringing significant benefits, under the specific criteria listed in in Article 4(3), to at least two Member States and the third countries, while not inhibiting their decarbonisation. The calculation of the benefits for the Member States shall be performed and published by the ENTSO for Gasagency in the frame of Union-wide ten- year network development plan;
Amendment 1133 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 2 – point c
Annex IV – point 2 – point c
Amendment 1144 #
2020/0360(COD)
(5) concerning renewables-based hydrogen falling under the category set out in point (3) of Annex II, the criteria listed in Article 4 shall be evaluated as follows:
Amendment 1162 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 6 – point a
Annex IV – point 6 – point a
(a) level of sustainability measured by assessing the share of renewable and low- carbon gases integrated into the gas network, the related greenhouse gas emission savings towards total system decarbonisation and the adequate detection of leakage.
Amendment 1166 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 6 – point b
Annex IV – point 6 – point b
(b) quality and security of supply measured by assessing the ratio of reliably available gas supply and peak demand, the share of imports replaced by local renewable and low-carbon gaseshydrogen, the stability of system operation, the duration and frequency of interruptions per customer.
Amendment 118 #
2020/0321(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health, but it has also demonstrated the need for closer cooperation and faster exchanges of information between Members States and the European institutions on the measures implemented. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 146 #
2020/0321(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The rapid evolution of COVID-19 and the spread of the virus led to a sharp increase in demand for medical devices such as ventilators, surgical masks, and COVID-19 test kits while disruption of production or limited capacity to rapidly increase production and the complexity and global nature of the supply chain for medical devices, led to a negative impact on supply. Those issues resulted in new entities being involved in the production of those products, which subsequently resulted in bottlenecks in conformity assessment, as well as the prevalence of non-compliant, unsafe, and in some cases counterfeit products. It is therefore appropriate to establish long-term structures within an appropriate Union body tohat will ensure monitoring of shortages of medical devices resulting from a public health emergency and to propose measures that can be agreed and implemented jointly across Europe.
Amendment 156 #
2020/0321(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Safe and efficacious medicinal products that treat, prevent or diagnose diseases which cause public health emergencies, should be developed, if necessary through joint undertakings by public authorities, the private sector and academia, and made available within the Union as soon as possible during such emergencies. The COVID-19 pandemic has also highlighted sub-optimal coordination and decision- making as regards multinational clinical trials, and Union-level advice on the use of medicinal products in national compassionate use programmes or outside of their authorised indications in the Union, causing delays in the adoption of research outcomes and in the development and availability of new or repurposed medicines.
Amendment 164 #
2020/0321(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) During the COVID-19 pandemic ad hoc solutions, including contingent arrangements between the Commission, the European Medicines Agency (‘the Agency’), marketing authorisation holders, manufacturers and Member States, had to be found to achieve the objective of making available to the Member States safe and efficacious medicinal products to treat COVID-19 or prevent its spread, and to facilitate and speed up the development and marketing authorisation of treatments and vaccines.
Amendment 199 #
2020/0321(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure that safe, high quality, and efficacious medicinal products, which have the potential to address public health emergencies, can be developed and made available within the Union as soon as possible during public health emergencies, an emergency task force should be established within the Agency to provide advice on such medicinal products. The Emergency Task Force should provide advice free of charge on scientific questions related to the development of treatments and vaccines and on clinical trial protocols, as well as existing minimum stock levels needed to manage the crisis adequately, to those organisations involved in their development, such as marketing authorisation holders, clinical trial sponsors, public health bodies, and academia, irrespective of their exact role in the development of such medicinal products.
Amendment 208 #
2020/0321(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) With respect to medical devices, an executive steering group on medical devices should be established to coordinate urgent actions within the Union in relation to the management of supply and demand issues of medical devices, and to establish a list of critical devices and minimum stock levels required in the case of a public health emergency.
Amendment 212 #
2020/0321(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices, alongside enhanced protection of data infrastructure and dissemination from possible cyberattacks. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data.
Amendment 215 #
2020/0321(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, but with clear rules on controlling access to the data (users with access, data retention period) and ensuring adequate protection of the data.
Amendment 309 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Steering Group’) is hereby established as part of the Agency. It shall meet as often as needed, either in person or remotely, in preparation for or during a public health emergency or following a request for assistance referred to in Article 4(3). The Agency shall provide its secretariat.
Amendment 316 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Medicines Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State, as well as one alternate for unforeseen circumstances. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.
Amendment 447 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures for establishing the critical medicines lists and the minimum stock levels required to ensure continuity of medical care;
Amendment 562 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The Emergency Task Force is hereby established as part of the Agency. It shall be convened as often as needed during public health emergencies, either in person or remotely. The Agency shall provide its secretariat.
Amendment 587 #
2020/0321(COD)
9a. The Agency shall use traditional and social media to issue periodic communications, agreed by all Member States, to keep the general public informed, using accessible language and providing explanations that can be understood by all;
Amendment 607 #
2020/0321(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Emergency Task Force, as well as its decisions, proposals and recommendations to the national and European authorities.
Amendment 626 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
ensure enhanced protection of electronic tools and disseminated data against cyberattacks, deciding in conjunction with the Member States how the data in question can be accessed (users with access, data access period, data retention period);
Amendment 629 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The Executive Steering Group on Medical Devices (‘the Medical Devices Steering Group’) is hereby established as part of the Agency. It shall meet as often as needed, either in person or remotely, in preparation for or during a public health emergency. The Agency shall provide its secretariat.
Amendment 634 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. The Medical Devices Steering Group shall be composed of a representative of the Agency, a representative of the Commission and one senior representative per Member State, including one alternate in case of unforeseen circumstances. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields.
Amendment 651 #
2020/0321(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Immediately following the recognition of a public health emergency and after consultation of its working party, the Medical Devices Steering Group shall adopt a list of medical devices which it considers as critical during the public health emergency (‘the public health emergency critical devices list’) as well as minimum necessary stock levels. The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 673 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) develop streamlined electronic monitoring and reporting systems, including for existing or potential stock levels;
Amendment 685 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 3 – point f
Article 23 – paragraph 3 – point f
(f) mitigation plans including production and supply capacity, so as to ensure the minimum stock levels required;
Amendment 709 #
2020/0321(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
The Agency shall, via its web-portal and other appropriate means and, in conjunction with national competent authorities, inform the public and relevant interest groups with regard to the work of the Medical Devices Steering Group and its proposals and recommendations.
Amendment 87 #
2020/0320(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) In this respect, the Centre should be tasked with providing epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between human and animal health and the environment. It should monitor the capacity of the national health systems to respond to communicable disease threats and other cross-border threats to health, in particular given the importance of this information in the preparation of the national preparedness and response plans. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, provide guidelines for surveillance, monitoring, screening, diagnosis, treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response, and provide timely objective, reliable and easily accessible information on communicable diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity.
Amendment 102 #
2020/0320(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission and, Member States and the Health Security Committee through dedicated networks with competent coordinating bodies, including newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,.
Amendment 120 #
2020/0320(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform timely and accurate risk assessment and response, the Centre should in particular monitor and report on trends in communicable diseases, support and facilitate evidence-based response action, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor and assess the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.
Amendment 136 #
2020/0320(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change. This framework should be aligned with the best evidence available and WHO guidelines, when available.
Amendment 144 #
2020/0320(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The Centre should enhance preparedness and response capabilities at national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States and the Commission, should carry out various actions, including the development of Union andpreparedness and response plans and support the development of national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with agencies, competent bodies and organisations operating in the field of data collection.
Amendment 189 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and those related special health issues set out in Article 2 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], the mission of the Centre shall be to identify, assess and report on current and emerging threats to human health from communicable diseases and other cross- border threats to health, and provide recommendations for response at Union and national levels, as well as at regional level, if necessary.
Amendment 224 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point g
Article 3 – paragraph 2 – point g
(g) provide, upon request of the Commission or the HSC, or its own initiative, guidelines for surveillance, monitoring, screening, diagnosis, treatment and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant societies;
Amendment 232 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j
Article 3 – paragraph 2 – point j
(j) provide, upon request of the Commission or the Health Security Committee (‘HSC’), or on its own initiative, evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.
Amendment 257 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point c a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) promote the automatisation of the data communication process between the national and the Union surveillance systems;
Amendment 273 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point a
Article 5 – paragraph 2 – subparagraph 2 – point a
(a) ensure the further development of the digital platforms and applications supporting epidemiological surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services, with the aim to simplify the data exchange process and reduce the administrative burden at Union and Member State levels;
Amendment 312 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point f
Article 5 – paragraph 4 – point f
(f) contribute to the assessment of the burden of communicable diseases on the population using data, such as disease prevalence, complications, hospitalisation, morbidity and mortality, and ensure that this data is disaggregated on age, gender and disability;
Amendment 322 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 5 –- subparagraph 3 a (new)
Article 5 – paragraph 5 –- subparagraph 3 a (new)
National focal points shall, to the greatest extent possible, be the same as the National IHR Focal Points, to minimise the duplication of resources and efforts.
Amendment 334 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 1
Article 5a – paragraph 1
1. The Centre shall support Member States to strengthen their communicable disease prevention and control systems, improving and facilitating the data collection process with real-time and interoperability sharing of data, as well as capacitating TESSy and other platforms to better address the monitoring and surveillance needs.
Amendment 352 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 3 a (new)
Article 5a – paragraph 3 a (new)
3a. The Centre shall develop a platform to monitor the vaccination coverage by Member States, taking into account Member States and regional specificities of the vaccination schemes.
Amendment 367 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 2 – point h
Article 5b – paragraph 1 – subparagraph 2 – point h
(h) support the Member States to develop targeted activities addressing at- risk groups and community preparedness;
Amendment 378 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 2 – point j
Article 5b – paragraph 1 – subparagraph 2 – point j
(j) bolster modelling, anticipation and forecast capacity of the Centre; and of the Member States; and
Amendment 380 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point a
Article 1 – paragraph 1 – point 7 – point a
Regulation (EC) No 851/2004
Article 6 – paragraph 1a
Article 6 – paragraph 1a
1a. The Centre shall provide concrete analyses and recommendations for actions to prevent and control communicable disease threatss and other cross-border threats to health upon request of the Commission.;
Amendment 388 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point b
Article 1 – paragraph 1 – point 7 – point b
Regulation (EC) No 851/2004
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules at Union and Member States level, allowing for the health data to be used for healthcare, research, policy making and regulatory purposes. For the purposes of studies under the first paragraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors.;
Amendment 394 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 1– point c a (new)
Article 7 – paragraph 1– point c a (new)
(ca) at the request of the Health Security Committee
Amendment 405 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) ensure that the EWRS is efficiently and effectively linked with other Union alert systemnd international alert systems and databases.
Amendment 410 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Centre shall work with the Commission and the HSC on the EWRS continuous updates, including for the use of modern technologies, such as digital mobile applications, artificial intelligence models, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States and on defining the functional requirements of the EWRS.
Amendment 422 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 4 a (new)
Article 8a – paragraph 4 a (new)
4a. The Centre shall work together with the Member States to improve the risk assessment capacity of the Member States and shall provide training in this area if necessary.
Amendment 425 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 851/2004
Article 8b – paragraph 1 – point a a (new)
Article 8b – paragraph 1 – point a a (new)
(aa) Union responses to the serious cross-border threat to health
Amendment 429 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Regulation (EC) No 851/2004
Article 9 – paragraph 6
Article 9 – paragraph 6
6. The Centre shall, as appropriate, support and coordinate training programmes, in particular in epidemiological surveillance, field investigations, preparedness and prevention, and public health research. and risk communication. Those programmes shall take into consideration the need for updating training and shall respect the principle of proportionality and the training needs of Member States;
Amendment 439 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point e a (new)
Article 11 – paragraph 1a – point e a (new)
(ea) implementation of the Centre’s recommendations on countermeasures by Member States and the outcomes thereof.
Amendment 465 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point a
Article 1 – paragraph 1 – point 15 – point a
Regulation (EC) No 851/2004
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
The Centre shall communicate on its own initiative within the scope of its mission, after having given prior information to the Member States and, to the Commission and to the Health Security Committee.
Amendment 468 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point a
Article 1 – paragraph 1 – point 15 – point a
Regulation (EC) No 851/2004
Article 12 – paragraph 1 – subparagraph 2
Article 12 – paragraph 1 – subparagraph 2
The Centre shall ensure that the public or any interested party is rapidly given objective, reliable, evidence-based and easily accessible information with regard to the results of its work. The Centre shall make available information for the general public, including through a dedicated website It shall also publish its opinions produced in accordance with Article 6.; the information communications shall be aligned with the HSC communications.
Amendment 472 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point b
Article 1 – paragraph 1 – point 15 – point b
Regulation (EC) No 851/2004
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 486 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 5 a (new)
Article 21 – paragraph 5 a (new)
5a. The Centre shall ensure the confidentiality of health data under the data protection legislation of Member States and the Union.
Amendment 251 #
2020/0300(COD)
Proposal for a decision
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This decisions sets out a general action programme in the field of the environment for the period up to 31 December 2030 (‘8th EAP’). It lays down its priority objectives, identifies enabling conditions for their achievement and sets a framework to measure and establish whether the Union and its Member States are on track to meet those priority objectives.
Amendment 286 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 1
Article 2 – paragraph 1
1. The 8th EAP has the long-term priority objective for 2050 that citizens live well, within the planetary boundaries in a regenerative economy where nothing is wasted, no net emissions of greenhouse gases are produced and economic growth is decoupled from resource use and environmental degradation. A healthy environment underpins the well-being of citizens, biodiversity thrives and natural capital is protected, restored and valued in ways that enhance resilience to climate change and other environmental risks. The Union proposes and sets the pace for ensuring the prosperity of present and future generations globally.
Amendment 314 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) continuous progress in enhancing adaptive capacity, strengthening resilience and reducing the vulnerability of all EU citizens to climate change;
Amendment 369 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ensuring effective and efficient implementation of Union legislation on environment and climate and striving for excellence in environmental performance at Union, national, regional and local levels including through providing appropriate administrative and compliance assurance capacity, as laid out in the regular Environmental Implementation Review, as well as stepping up action against environmental crime, and continually pinpointing new means of maximising the impact of existing solutions,
Amendment 575 #
2020/0300(COD)
Proposal for a decision
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. The European Environment Agency and the European Chemicals Agency shall support the Commission in improving the availability and relevance of data and knowledge, in particular by carrying out the following, in a continuous manner:
Amendment 4 #
2020/0108(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Covid-19 pandemic is a major shock to the global and Union economy. Due to the necessary containment measures, economic activity in the EU dropped significantly. The contraction in EU GDP in 2020 is expected to be around 7.5%, far deeper than during the financial crisis in 2009. The outbreak of the pandemic has shown the interconnectivity of global supply chains and exposed some vulnerabilities such as the over-reliance of strategic industries on non-diversified external supply sources. Such vulnerabilities need to be addressed, to improve the Union’s emergency response as well as the resilience of the entire economy, while maintaining its openness to competition and trade in line with its rules. Investment activity is expected to have dropped significantly. Even before the pandemic, while a recovery in investment-to-GDP ratios in the Union could be observed, it remained below what might be expected in a strong recovery and was insufficient to compensate for years of underinvestment following the 2009 crisis. More importantly, the current investment levels and forecasts do not cover the Union’s needs for structural investment to restart and sustain long-term growth in the face of technological change and global competitiveness, including for innovation, skills, infrastructure, small and medium- sized enterprises (SMEs) and the need to address key societal and environmental challenges such as sustainability, the impacts of climate change or population ageing. Consequently, in order to achieve the Union's policy objectives and to support a swift, just, inclusive, sustainable and healthy economic recovery, support is necessary to address market failures and sub-optimal investment situations and to reduce the investment gap in targeted sectors.
Amendment 8 #
2020/0108(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) The disruptive economic and social effect of the COVID-19 crisis weakens public and private investment capacity thus limiting the financial resources essential for the transition to a climate neutral and resource efficient Union. In this regard, in the framework of Next Generation EU, InvestEU should contribute to reducing this gap.
Amendment 9 #
2020/0108(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) In the last years, the Union has adopted ambitious strategies to complete the Single Market and to stimulate sustainable and inclusive growth and jobs, such as 'Europe 2020 - A strategy for smart, sustainable and inclusive growth' of 3 March 2010, 'Action Plan on Building a Capital Markets Union' of 30 September 2015, 'A new European Agenda for Culture' of 22 May 2018, 'Clean Energy for all Europeans' of 30 November 2016, 'Closing the loop - An EU action plan for the Circular Economy' of 2 December 2015, 'A European Strategy for Low- Emission Mobility' of 20 July 2016, ‘European Defence Action Plan’ of 30 November 2016, 'Launching the European Defence Fund' of 7 June 2017, 'Space Strategy for Europe' of 26 October 2016, the Interinstitutional Proclamation on the European Pillar of Social Rights of 13 December 2017, the ‘European Green Deal’ of 11 December 2019, the ‘European Green Deal Investment Plan’ of 14 January 2020, the ‘Strong Social Europe for Just Transitions’ of 14 January 2020, the ‘ Strategy for shaping Europe’s digital future’, the ‘Data Strategy’ and the ‘Artificial Intelligence Communication’ of 19 February 2020, ‘A New Industrial Strategy for Europe’ of 10 March 2020 and, ‘SME Strategy for a sustainable and digital Europe’ of 10 March 2020, 'A new Circular Economy Action Plan For a cleaner and more competitive Europe' of 11 March 2020, 'An EU Biodiversity Strategy for 2030' of 20 May 2020 and 'A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system' of 20 May 2020. The InvestEU Fund should exploit and reinforce synergies between those mutually reinforcing strategies through providing support to investment and access to financing.
Amendment 24 #
2020/0108(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement on Climate Change and the SDGs, the InvestEU Programme will contribute to mainstream climate and environmental actions and to the achievement of an overall target of 25 % of the Union budget expenditures supporting climate objectives and an annual target of 30 % as soon as possible and at the latest by 2027. Actions under the InvestEU Programme are expected to contribute 3at least 40 % of the overall financial envelope of the InvestEU Programme to climate and environmental objectives. Relevant actions will be identified during the InvestEU Programme's preparation and implementation and reassessed in the context of the relevant evaluations and review processes.
Amendment 45 #
2020/0108(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Low infrastructure investment rates in the Union during the financial crisis and again during the Covid-19 crisis undermined the Union's ability to boost sustainable growth, job creations, competitiveness and convergence. It also creates risk of consolidating imbalances and impacts regions’ development long- term. Sizeable investments in Union infrastructure, in particular with regard to interconnection and energy efficiency and to creating a Single European Transport Area, are essential to meeting the Union's sustainability targets as defined in the European Green Deal, including the Union’s commitments towards the SDGs, and the Paris Agreement, the 2030 energy and climate targets and the Union commitment to a climate neutral economy by the 2050 at the latest. Accordingly, support from the InvestEU Fund should target investments into transport, energy, including energy efficiency and renewable energy sources and other safe and sustainable low- emission energy sources, environmental infrastructure, infrastructure related to climate actioncluding biodiversity conservation and restoration, natural-based solutions and green infrastructure, infrastructure related to climate mitigation and adaptation, waste prevention and circular economy infrastructure, maritime infrastructure and digital infrastructure. The InvestEU Programme should prioritise areas that are under-invested, and in which additional investment is required. To maximise the impact and added value of Union financing support, it is appropriate to promote a streamlined investment process that enables visibility of the project pipeline and maximises synergies across relevant Union programmes in areas such as transport, energy and digitisation. Bearing in mind threats to safety and security, investment projects receiving Union support should include measures for infrastructure resilience, including infrastructure maintenance and safety, and should take into account principles for the protection of citizens in public spaces. This should be complementary to the efforts made by other Union funds that provide support for security components of investments in public spaces, transport, energy and other critical infrastructure, such as the European Regional Development Fund.
Amendment 50 #
2020/0108(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15 a) The InvestEU Programme should contribute to the Union's climate objectives laid down in [Regulation (EU) 2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU) 2018/1999 ("European Climate Law")] and should not finance projets that are inconsistent with the achievement of the Union's climate objectives.
Amendment 54 #
2020/0108(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) In the economic crisis caused by the Covid-19 pandemic, market allocation of resources is not fully efficient and perceived risk impairs private investment flow significantly. Under such circumstances, the key feature of the InvestEU Fund of de-risking economically viable projects to crowd in private finance is particularly valuable and should be reinforced , inter alia in order to counteract the risk of an asymmetric recovery. The InvestEU Programme should be able to provide crucial support to companies in the recovery phase and at the same time ensure a strong focus of investors on the Union’s medium- and long-term policy priorities such as the European Green Deal, the European Green Deal Investment Plan, the Strategy on shaping Europe’s digital future and the Strong Social Europe for Just Transitions. These operations should support the creation or preservation of quality and sustainable jobs within the Union as well as contribute to the transition towards a climate neutral European economy and its digital transition. It should significantly increase the risk-taking capacity of the European Investment Bank (EIB) Group and national promotional banks and institutions and other implementing partners in support of economic recovery.
Amendment 60 #
2020/0108(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The primary focus of the strategic European investment window should be on support to those final recipients established in a Member State and operating in the Union whose activities are of strategic importance to the Union in particular in view of the green andtransition towards a climate neutral European economy and its digital transitions and of enhanced resilience in areas of (i) critical healthcare provision, manufacturing and stockpiling of pharmaceuticals, medical devices and, medical supplies and vaccines , strengthening of health crisis response capacity and of the civil protection system,the resilience of healthcare and health systems in preparation for future crisis response capacity and of the civil protection system, (ia) critical sustainable infrastructure to move to a de-carbonised, circular and environmentally sustainable sound European economy in line with the Union´s climate objective (ii) critical infrastructure, whether physical or virtual; (iii) provision of goods and services instrumental to the operation and maintenance of such infrastructure, (iv) key enabling, transformative, greesustainable, circular, low carbon and digital technologies and game-changing innovations where the investment is strategically important for the Union’s sustainable industrial future, including artificial intelligence, blockchain, software, robotics, semiconductors, microprocessors, edge cloud technologies, high-performance computing, cybersecurity, quantum technologies, photonics, industrial biotechnology, digital technologies for tracking, tracing and mapping of resources, renewable energy technologies, energy storage technologies including batteries, sustainable transport technologies, cleagreen hydrogen and fuel cell applications, decarbonisation technologies for industry, carbon capture and storage, waste prevention, circular economy and bioeconomy technologies, biomedicine, nanotechnologies, pharmaceuticals and renewable, circular and advanced materials; (v) manufacturing facilities for mass production of Information Communication and Technology components and devices in the EU; (vi) supply and stockpiling of critical inputs to public actors, businesses or consumers in the Union; (vii) critical technologies and inputs for the security of the Union and its Member States, such as defence and space sectors and cybersecurity, and dual use items as defined in point 1 of Article 2 of Council Regulation (EC) No 428/2009. The final recipients should have their registered office in a Member State and they should be active in the Union in the sense that they have substantial activities in terms of staff, manufacturing, research and development or other business activities in the Union. Projects which contribute to diversification of strategic supply chains in the Single Market through operations in multiple locations across the EU should be able to benefit.
Amendment 64 #
2020/0108(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) The InvestEU Fund provided under the strategic European investment window should support infrastructure with a view to strengthening the resilience of healthcare and health systems in preparation for future pandemics, including the performance of stress tests of national and regional healthcare systems, improve the health status in societies, have healthier people therefore less susceptible to health threats and boost the creation of the European health Union.
Amendment 65 #
2020/0108(COD)
Proposal for a regulation
Recital 28 b (new)
Recital 28 b (new)
(28 b) The European Council, in its Conclusions of 12 December 2019 , has agreed on the objective of achieving a climate-neutral Union by 2050, in line with the objectives of the Paris Agreement, while also recognising that it is necessary to put in place an enabling framework and that the transition will require significant public and private investment. The InvestEU fund provided under the strategic European investment window should support critical sustainable infrastructure in the sectors which has submitted a roadmap to the Commission setting out how and by which date the sector can reduce its emissions to close to zero, and identifying obstacles and opportunities as well as the technological solutions that would need to be developed and investments that would need to be made within the sector.
Amendment 67 #
2020/0108(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The strategic European investment window should also target suppliers established and operating in the Union whose activities are of strategic importance to the Union and that would need long term investment or are covered by the Foreign Direct Investment Screening mechanism. In addition, important projects of common European interest should in particular be able to benefit from the strategic European investment window. However, financial support should not be provided when a project is inconsistent with the achievement of the European Green Deal, the Union's climate objectives and the Paris agreement objectives.
Amendment 70 #
2020/0108(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The InvestEU should also provide support to financing to generate investment to the benefit of just transition regions, in line with the objectives identified in their just transition plans, and should be consistent with Article 5 of Regulation (EU) …/… (JTF Regulation).
Amendment 109 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – introductory part
Article 7 – paragraph 1 – point e – introductory part
(e) a strategic European investment policy window which comprises strategic investment to support final recipients that are established in a Member State and that operate in the Union, and whose activities are of strategic importance to the Union, in particular in view of the green andtransition towards a sustainable and climate neutral European economy and its digital transitions and of enhanced resilience , complying with the “do no significant harm” principle and the EU taxonomy established by Regulation (EU) 2020/852, in one of the following areas:
Amendment 113 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point i
Article 7 – paragraph 1 – point e – point i
i) critical healthcare provision, manufacturing and stockpiling of pharmaceuticals, medical devices and, medical supplies and vaccines , strengthening of health crisis response capacitythe resilience of healthcare and health systems in preparation for future crisis response capacity, including the performance of stress tests of national and regional healthcare systems, and of the civil protection system;
Amendment 117 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point i a (new)
Article 7 – paragraph 1 – point e – point i a (new)
i a) critical sustainable infrastructure to move to a de-carbonised, circular and environmentally sustainable European economy and society in line with the Union's climate objectives laid down in [Regulation (EU) 2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU)2018/1999 ("European Climate Law");
Amendment 119 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point ii
Article 7 – paragraph 1 – point e – point ii
ii) critical infrastructure, whether physical or virtual, including infrastructure elements identified as critical in the fields of energy, transport, environment, health, food safety, secure digital communication, 5G, internet of things, online service platforms, secure cloud computing, data processing or storage, payments and financial infrastructure, aerospace, defence, communications, media, education and training, electoral infrastructure and sensitive facilities, as well as land and real estate crucial for the use of such critical infrastructure;
Amendment 124 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point iv – introductory part
Article 7 – paragraph 1 – point e – point iv – introductory part
iv) key enabling, transformative, greesustainable, circular, low carbon and digital technologies and game- changing innovations where the investment is strategically important for the Union’s sustainable industrial future, including
Amendment 126 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point iv – point a
Article 7 – paragraph 1 – point e – point iv – point a
(a) artificial intelligence, blockchain, software, robotics, semiconductors, microprocessors, edge cloud technologies, high-performance computing, cybersecurity, quantum technologies, photonics, industrial biotechnology, digital technologies for tracking, tracing and mapping of resources,
Amendment 130 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point iv – point b
Article 7 – paragraph 1 – point e – point iv – point b
(b) renewable energy technologies, energy storage technologies including batteries, sustainable transport technologies, cleagreen hydrogen and fuel cell applications, decarbonisation technologies for industry, carbon capture and storage, circular waste prevention, circular economy and bioeconomy technologies,
Amendment 137 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point iv – point c
Article 7 – paragraph 1 – point e – point iv – point c
(c) biomedicine, nanotechnologies, pharmaceuticals and advanced, renewable and circular materials;
Amendment 142 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point vi
Article 7 – paragraph 1 – point e – point vi
vi) supply and stockpiling of critical inputs to public actors, businesses or consumers in the EU, including energy or raw materials or food security or pharmaceuticals, having regard to resource efficiency, waste prevention and circularity in strategic value chains;
Amendment 145 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point vii – paragraph 1 a (new)
Article 7 – paragraph 1 – point e – point vii – paragraph 1 a (new)
Access to the finacing made available under the strategic European investment policy window shall be conditional on the endorsement and demonstration of Member States commitment to the Union objective of climate neutrality and individual Member States climate neutrality objective by 2050 at the latest, as well as on the adoption of a long-term strategy as referred to in Article 15 of Regulation(EU) 2018/1999.
Amendment 221 #
2020/0108(COD)
Proposal for a regulation
Annex III – point 8 – point 8.2 a (new)
Annex III – point 8 – point 8.2 a (new)
Amendment 3 #
2020/0104(COD)
(3) At Union level, the European Semester of economic policy coordination (‘European Semester’), including the principles of the European Pillar of Social Rights, is the framework to identify national reform priorities and monitor their implementation. In order to provide guidance to Member States on where structural reforms and investments to support the transition towards an European climate neutral economy are most needed, the European Semester requires to be progressively updated through the used of harmonised indicators, in order to include all the United Nations Sustainable Development Goals and the objectives of the European Green Deal in its evaluation. Member States develop their own national multiannual investment strategies in support of those reforms. Those strategies should be presented alongside the yearly National Reform Programmes as a way to outline and coordinate priority investment projects to be supported by national and/or Union funding.
Amendment 12 #
2020/0104(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Past experiences have shown that investment is often drastically cut during crises. HoweverTherefore, it is essential to support investment in this particular situation to speed up the recovery and strengthen long- term sustainable growth potential. Investing in greensustainable, circular, climate- neutral and digital technologies, capacities and processes aimed at achieving the Union net-zero greenhouse gas emissions objectives by 2050 assisting clean energy transition, boosting energy efficiency in housing, the development of circular economy models and other key sectors of the economic are important to achieve sustainable growth and help create jobs. It will also help make the Union more resilient and less dependent by diversifying key supply chains.
Amendment 17 #
2020/0104(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) Investing in strengthening the resilience of healthcare and health systems in preparation for future pandemics, including the performance of stress tests of national and regional healthcare systems, improve the health status in societies, have healthier people therefore less susceptible to health threats and boost the creation of the European health Union, are important to achieve sustainable growth and to promote an economic, social and territorial cohesion.
Amendment 21 #
2020/0104(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Currently, no instrument foresees direct financial support linked to the achievement of results and to implementation of reforms and public investments of the Member States lin response to challenges identified in the European Semesterked with the priorities and objectives of Union funds and programmes, and with a view to having a lasting impact on the productivity and resilience of the economy of the Member States.
Amendment 26 #
2020/0104(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Against this background, it is necessary to strengthen the current framework for the provision of support to Member States and provide direct financial support to Member States through an innovative tool. To that end, a Recovery and Resilience Facility (the ‘Facility’) should be established under this Regulation to provide effective financial and significant support to step up the implementation of reforms and related public investments in the Member Stateboost public strategic investment in the Member States and step up the implementation of relevant reforms. The Facility should be comprehensive and should also benefit from the experience gained by the Commission and the Member States from the use of the other instruments and programmes.
Amendment 29 #
2020/0104(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10 a) The disruptive economic and social effect of the COVID-19 crisis weakens public and private investment capacity thus limiting the financial resources essential for the transition to a climate neutral and resource efficient Union. In this regard, in the framework of Next Generation EU, the Recovery and Resilience Facility should contribute to reducing this gap as highlighted in the report of the “EU Technical Expert Group on Sustainable Finance (TEG)” entitled “5 high level principles for recovery and resilience” of 15 July 2020.
Amendment 35 #
2020/0104(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Reflecting the European Green Deal as Europe’s sustainable growth strategy and the translation of the Union's commitments to implement the Paris Agreement and the United Nations’ Sustainable Development Goals, the Facility established by this Regulation will contribute to mainstreaming climate actions and environmental sustainability and to the achievement of an overall target of 25 % of the EU budget expenditures supporting climate objectives and an annual target of 30% as soon as possible and at the latest by 2027. Actions under the Facility are expected to contribute at least 40% of the overall financial envelope of the Recovery and Resilience Facility to climate and environmental objectives.
Amendment 44 #
2020/0104(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to implement these overall objectives, relevant actions will be identified during the Facility’s preparation and implementation, and reassessed in the context of the relevant evaluations and review processes. Also, due attention should be paid to the impact of the national plans submitted under this Regulation on fostering not only the green transition towards a sustainable and climate neutral economy, but also the digital transformation. They will both play a priority role in relaunching, decarbonising and modernising our economy.
Amendment 46 #
2020/0104(COD)
Proposal for a regulation
Recital 13
Recital 13
Amendment 56 #
2020/0104(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The Facility’s general objective should be the promotion of economic, social and territorial cohesion. For that purpose, it should contribute to improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis, and supporting the green and digital transitions aimed at achieving a climate neutral Europe by 2050transition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transition, thereby restoring the growth potential of the economies of the Union in the aftermath of the crisis, fostering employment creation and to promoting sustainable growth.
Amendment 61 #
2020/0104(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) To ensure its contribution to the objectives of the Facility, the recovery and resilience plan should comprise measures for the implementation of reforms and public investment projects through a coherent recovery and resilience plan. The recovery and resilience plan should be consistherent with the relevant country- specific challenges and priorities identified in the context of the European Semester, with the national reform programmes, the national energy and climate plans, the just transition plans, and the partnership agreements and operational programmes adopted under the Union funds. To boost actions that fall within the priorities of the European Green Deal and the Digital Agenda, the plan should also set out measures that are relevant for the green and digital transitions. The measures should enable a swift deliver of targets, objectives and contributions set out in national energy and climate plans and updates thereof. All supported activities should be pursued in full respect of the climate and environmental priorities of the UnionUnion priorities and support the transition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transition. The recovery and resilience plans should design their investments in line with the European Green Deal (EGD) as the Union’s new growth strategy, the European Pillar of Social Rights, the United Nations Sustainable Development Goals (UNSDGs) and the Digital Agenda. The measures should enable a swift deliver of targets, objectives and contributions set out in national energy and climate plans and updates thereof. All supported activities should be pursued in full respect of the climate and environmental priorities of the Union and respect the “do not significant harm” principle referred to in Regulation 2020/852. The recovery and resilience plan should be consistent with the relevant country-specific challenges and priorities identified in the context of an updated European Semester, which should include the tracking of the objectives of the European Green Deal, the NECPs and the UNSDGs, with the national reform programmes, the national energy and climate plans, the just transition plans, and the partnership agreements and operational programmes adopted under the Union funds.
Amendment 71 #
2020/0104(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) To inform the preparation and the implementation of the recovery and resilience plans by Member States, the Council, in close cooperation with the European Parliament, should be able to discuss, within the European Semester, the state of recovery, resilience and adjustment capacity in the Union. To ensure appropriate evidence, this discussion should be based on the Commission’s strategic and analytical information available in the context of the European Semester and, if available, on the basis of the information on the implementation of the plans in the preceding years.
Amendment 81 #
2020/0104(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. The recovery and resilience plan should set out the detailed set of measures for its implementation, including targets and milestones, and the expected impact of the recovery and resilience plan on growth potential, job creation and economic and, social resilience; it should also include measures that are relevant for the green and the support to the transition towards a sustainable and climate neutral European economy by 2050 at the latest and theits digital transitions; it should also include an explanation of the consistency of the proposed recovery and resilience plan with the relevant country-specific challenges and priorities identified in the context of the updated European Semester. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process.
Amendment 86 #
2020/0104(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Commission should assess the recovery and resilience plan proposed by the Member States and should act in close cooperation with the Member State concerned. The Commission will fully respect the national ownership of the process and will therefore take into account the justification and elements provided by the Member State concerned and assess whether the recovery and resilience plan proposed by the Member State is expected to contribute to effectively address challenges identified in the relevant country-specific recommendation addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester; whether the pleffectively to strengthen the sustainable growth potential, job creation and economic and social resilience of the Member State, mitigate the economic and social impact of the crisis and contribute to enhancing economic, social and territorial cohesion and support the transition towards a sustainable and contains measures that effectively contribute to the greenlimate neutral European economy by 2050 at the latest and theits digital transitions and, to addressing the challenges resulting from them; whether the plan is expected to have a lasting impact in the Member State concerned; whether the planrecovery and resilience plan proposed by the Member State is expected to effectively contribute to strengthen the growth potential, job creation and economic and social resilience of the Member State, mitigate the economic and social impact of the crisis and contribueffectively address challenges identified in the relevant country-specific recommendation addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the updated European Semester; whether the plan is expected to enhancing economic, social and territorial cohesionhave a lasting impact in the Member State concerned;; whether the justification provided by the Member State of the estimated total costs of the recovery and resilience plan submitted is reasonable and plausible and is commensurate to the expected impact on the economy and employment; whether the proposed recovery and resilience plan contains measures for the implementation of reforms and public investment projects that represent coherent actions; and whether the arrangement proposed by the Member State concerned are expected to ensure effective implementation of the recovery and resilience plan, including the proposed milestones and targets, and the related indicators.
Amendment 96 #
2020/0104(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The request for a loan should be justified by the financial needs linked to additional reforms and investments included in the recovery and resilience plan, notably relevant for the green andtransition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transitions, and by therefore, by a higher cost of the plan than the maximum financial contribution (to be) allocated via the non-repayable contribution. It should be possible to submit the request for a loan together with the submission of the plan. In case the request for loan is made at a different moment in time, it should be accompanied by a revised plan with additional milestones and targets. To ensure frontloading of resources, Member States should request a loan support at the latest by 31 August 2024. For the purposes of sound financial management, the total amount of all the loans granted under this Regulation should be capped. In addition, the maximum volume of the loan for each Member State should not exceed 4.7% of its Gross National Income. An increase of the capped amount should be possible in exceptional circumstances subject to available resources. For the same reasons of sound financial management, it should be possible to pay the loan in instalments against the fulfilment of results.
Amendment 107 #
2020/0104(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is opportune that the Commission provides an annual report to the European Parliament and the Council on the implementation of the Facility set out in this Regulation. This report should include information on the progress made by Member States under the recovery and resilience plans approved; it should also include information on the volume of the proceeds assigned to the Facility under the European Union Recovery Instrument in the previous year, broken down by budget line, and the contribution of the amounts raised through the European Union Recovery Instrument to the achievements of the objectives of the Facility. It should also include the contribution of the Facility to meeting the Union climate and sustainability policy objectives, in particular the Union's climate objectives laid down in [Regulation (EU)2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU) 2018/1999 (“European Climate law)] and the priorities set out in the National Climate and Energy Plans.
Amendment 120 #
2020/0104(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
The scope of application of the Recovery and Resilience Facility established by this Regulation shall refer to policy areas related to economic, social and territorial cohesion, the green andtransition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transitions, health, competitiveness, resilience, productivity, education and skills, research and innovation, smart, sustainable and inclusive growth, jobs and investment, and the stability of the financial systems.
Amendment 132 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The general objective of the Recovery and Resilience Facility shall be to promote the Union’s economic, social and territorial cohesion by improving the resilience and adjustment capacity of the Member States, mitigating the social and economic impact of the crisis, and supporting the green andthe transition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transitions, thereby contributing to restoring the growth potential of the economies of the Union, fostering employment creation in the aftermath of the COVID-19 crisis, and promoting sustainable growth.
Amendment 137 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1 a. The Recovery and Resilience Facility shall ensure that at least 40% of its overall financial envelope contributes to objective of the transition towards a sustainable and climate neutral European economy by 2050 at the latest . Member States shall identify and track climate and environment spending by using the EU taxonomy established by Regulation (EU) 2020/852.
Amendment 152 #
2020/0104(COD)
Proposal for a regulation
Article 9
Article 9
Amendment 174 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The recovery and resilience plans shall be consistent with the general and specific objectives of the Facility as defined in Article 4 of this Regulation and in line with the relevant country-specific challenges and priorities identified in the context of the European Semester, in particular those relevant for or resulting from the green and digital transition. The recovery and resilience plans shall also be consistent with the information included by the Member States in the national reform programmes under the European Semester, in their national energy and climate plans and updates thereof under the Regulation (EU)2018/199921 , ,in the territorial just transition plans under the Just Transition Fund22 , ,and in the partnership agreements and operational programmes under the Union funds. _________________ 21Regulation (EU)2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action. 22 […]The Recovery and resilience facility shall apply to investments respecting the “do not significant harm” principle referred to in Regulation (EU) 2020/852.
Amendment 182 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 2 a (new)
Article 14 – paragraph 2 a (new)
2 a. The recovery and resilience plans shall not include measures causing significant harm to any of the environmental objectives listed in Regulation (EU) 2020/852 in accordance with Article 17 of the same Regulation.
Amendment 190 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point a
Article 15 – paragraph 3 – point a
(a) an explanation of the way the relevant country-specific challenges and priorities identified in the context of the European Semester are expected to be addressed; letter (a) should be replaced with letter (c)
Amendment 193 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point b
Article 15 – paragraph 3 – point b
(b) an explanation of how the plan strengthens the growth potential, job creation and economic and social resilience of the Member State concerned, mitigates the economic and social impact of the crisis, promote sustainable growth and its contribution to enhance economic, social and territorial cohesion and convergence; Letter (b) should be replaced by letter (a)
Amendment 198 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c
Article 15 – paragraph 3 – point c
(c) an explanation of how the measures in the plan are expected to contribute to the green and the digital transitions or to thetransition towards a sustainable and climate neutral European economy by 2050 at the latest in particular their contribution to meeting the Union climate and sustainability policy objectives taking into account the objectives set out in the National Climate and Energy Plans (NECPs) and the Union's climate objectives laid down in[Regulation (EU) 2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU) 2018/1999 ("European Climate Law")] and their contribution in addressing social, economic or environmental challenges resultderiving from them; is transition.
Amendment 203 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c a (new)
Article 15 – paragraph 3 – point c a (new)
(c a) an explanation of how the measures in the plan are expected to contribute to strengthening the resilience of healthcare and health systems in preparation for future pandemics, improve the health status in societies, have healthier people therefore less susceptible to health threats;
Amendment 210 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c b (new)
Article 15 – paragraph 3 – point c b (new)
(c b) an explanation of how the measures in the plan are expected to contribute to the digital transitions or and the challenges resulting from them;
Amendment 232 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – introductory part
Article 16 – paragraph 3 – introductory part
3. The Commission shall assess the importance and coherence of the recovery and resilience plan and its contribution to the green andtransition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transitions, and for that purpose, shall take into account the following criteria:
Amendment 238 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
(a) whether the recovery and resilience plan is expected to contribute to effectively address challenges identified in the relevant country-specific recommendations addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester; letter a is replaced with letter (d)
Amendment 242 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b
Article 16 – paragraph 3 – point b
(b) whether the plan contains measures that effectively contribute to the green and the digital transitions or to addressing the challenges resulting from themtransition towards a sustainable and climate neutral European economy by 2050 at the latest in particular their contribution to meeting the Union sustainability policy objectives taking into account the objectives set out in the National Climate and Energy Plans (NECPs) and the Union's climate objectives laid down in [Regulation (EU) 2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU) 2018/1999 ("European Climate Law")] and their contribution in addressing social, economic or environmental challenges deriving from this transition;
Amendment 249 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b a (new)
Article 16 – paragraph 3 – point b a (new)
(b a) whether the plan contains measures that effectively contribute to strengthening the resilience of healthcare and health systems in preparation for future pandemics, improve the health status in societies, have healthier people therefore less susceptible to health threats;
Amendment 254 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point b b (new)
Article 16 – paragraph 3 – point b b (new)
(b b) whether the plan contains measures that effectively contribute to the digital transitions or to addressing the challenges resulting from them;
Amendment 255 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point d
Article 16 – paragraph 3 – point d
(d) whether the recovery and resilience plan is expected to effectively contribute to strengthen the growth potential, job creation, and economic and social resilience of the Member State, mitigate the economic and social impact of the crisis, promote sustainable growth and contribute to enhance economic, social and territorial cohesion; letter (d) should be replaced with letter (a)
Amendment 309 #
2020/0104(COD)
Proposal for a regulation
Article 24 – paragraph 3 – point b a (new)
Article 24 – paragraph 3 – point b a (new)
(b a) the contribution to meeting the Union climate and sustainability policy objectives, in particular the Union's climate objectives laid down in [Regulation (EU) 2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU) 2018/1999 ("European Climate Law")] and the priorities set out in the National Climate and Energy Plans
Amendment 323 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – introductory part
Annex II – point 2 – paragraph 1 – introductory part
In accordance with Article 16(3), the Commission shall assess the importance and coherence of the recovery and resilience plans, and its contribution to the green andtransition towards a sustainable and climate neutral European economy by 2050 at the latest and its digital transitions, and for that purpose, it shall take into account the following criteria:
Amendment 327 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point a
Annex II – point 2 – paragraph 1 – point a
(a) whether the recovery and resilience plan is expected to contribute to effectively address challenges identified in the relevant country-specific recommendations addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester; letter (a) is replaced with letter (d)
Amendment 329 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point b
Annex II – point 2 – paragraph 1 – point b
(b) whether the plan contains measures that effectively contribute to the green and the digital transitions or to addressing the challenges resulting from them; transition towards a sustainable and climate neutral European economy by 2050 at the latest in particular their contribution to meeting the Union sustainability policy objectives taking into account the objectives set out in the National Climate and Energy Plans (NECPs) and the Union's climate objectives laid down in [Regulation (EU) 2020/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU)2018/1999 ("European Climate Law")] and their contribution in addressing social, economic or environmental challenges deriving from this transition.
Amendment 332 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point b a (new)
Annex II – point 2 – paragraph 1 – point b a (new)
(b a) whether the plan contains measures that effectively contribute to strengthening the resilience of healthcare and health systems in preparation for future pandemics, improve the health status in societies, have healthier people therefore less susceptible to health threats;
Amendment 335 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point b b (new)
Annex II – point 2 – paragraph 1 – point b b (new)
(b b) whether the plan contains measures that effectively contribute to the digital transitions or to addressing the challenges resulting from them;
Amendment 336 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 1 – point d
Annex II – point 2 – paragraph 1 – point d
(d) whether the recovery and resilience plan is expected to effectively contribute to strengthen the growth potential, job creation, and economic and social resilience of the Member State, mitigate the economic and social impact of the crisis, promote sustainable growth and contribute to enhance economic, social and territorial cohesion; letter (d) should be replaced with letter (a)
Amendment 345 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.1 – introductory part
Annex II – point 2 – paragraph 3 – point 2.1 – introductory part
2.1 The recovery and resilience plan is expected to contribute to effectively address challenges identified in the relevant country-specific recommendations addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester. 2.1 should be replaced with 2.4
Amendment 353 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2 – introductory part
Annex II – point 2 – paragraph 3 – point 2.2 – introductory part
2.2 The plan contains measures that effectively contribute to the green and the digital transitionstransition towards a sustainable and climate neutral European economy by 2050 at the latest or to addressing the challenges resulting from them.
Amendment 357 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 1 – indent 1
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 1 – indent 1
— the implementation of the envisaged measures is expected to significantly contribute to establishmeeting the Union climate- and environmental-friendly systems and to the greening of economic or social sectors with a view to contribute to the overall objective of asustainability policy objectives taking into account the objectives set out in the National Climate and Energy Plans (NECPs) and the Union's climate objectives laid down in [Regulation (EU) 2020/XXX establishing the framework for achieving climate- neutral Europe by 2050;ity and amending Regulation (EU) 2018/1999 ("European Climate Law")]
Amendment 362 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 2
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 2
Amendment 368 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 3 – introductory part
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 3 – introductory part
Amendment 371 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 3 – indent 1
Annex II – point 2 – paragraph 3 – point 2.2 – paragraph 1 – subparagraph 3 – indent 1
— the implementation of the envisaged measures is expected to significantly contribute to address the challenges resulting from the green and/or digital transitionssocial, economic and environmental challenges resulting from the transition towards a sustainable climate neutral European economy
Amendment 376 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.2 a (new)
Annex II – point 2 – paragraph 3 – point 2.2 a (new)
2.2 a The plan contains measures that effectively contribute to the digital transitions or to addressing the challenges resulting from them. - the implementation of the envisaged measures is expected to significantly contribute to establish climate- and environmental-friendly systems and to the greening of economic or social sectors with a view to contribute to the overall objective of a climate-neutral Europe by 2050 at the latest; or - the implementation of the envisaged measures is expected to significantly contribute to the digital transformation of economic or social sectors; or - the implementation of the envisaged measures is expected to significantly contribute to address the challenges resulting from the green and/or digital transitions and -the implementation of the envisaged measures is expected to have a lasting impact.
Amendment 377 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.4 – introductory part
Annex II – point 2 – paragraph 3 – point 2.4 – introductory part
2.4 The recovery and resilience plan is expected to effectively contribute to strengthen the growth potential, job creation, and economic and social resilience of the Member State, mitigate the economic and social impact of the crisis, promote sustainable growth and contribute to enhance economic, social and territorial cohesion; 2.4 should be preplaced with 2.1
Amendment 382 #
2020/0104(COD)
Proposal for a regulation
Annex II – point 2 – paragraph 3 – point 2.4 – paragraph 1 – subparagraph 1 – indent 1
Annex II – point 2 – paragraph 3 – point 2.4 – paragraph 1 – subparagraph 1 – indent 1
— the recovery and resilience plan contains measures that aim at addressing weaknesses of the economy of the Member States and at boosting the growth potential of the economy of the Member State concerned, stimulating job creation and mitigating the adverse effects of the crisis, promote sustainable growth while avoiding adverse impacts of those measures on climate and environment.
Amendment 121 #
2020/0102(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) Article 191 TFEU provides that the Union should contribute to protecting human health through a Union policy on the environment.
Amendment 122 #
2020/0102(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared, due to an exponential increase of cases, declared COVID-19 (the disease resulting from the novel coronavirus (COVID-19SARS-CoV-2) outbreak a global pandemic. That pandemic hase COVID-19 pandemic and more specifically the moderate to severe cases of the disease that need intermediate and intensive medical care pushed several health systems to breaking point within and outside Union, caused an unprecedented worldwide health crisis with severe socio- economic consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, women, carers and the elderly the hardest. The world continues the fight against this unprecedented health crisis, which has led to lock downs and restrictions on the circulation of people, animals, food, medicines and others.
Amendment 135 #
2020/0102(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States in order to improve the prevention andto support rights- and evidence-based approaches that have a high impact in order to improve preparedness for, prevention and a timely and effective control of the spread of severe human infections and diseases across borders, to develop and guarantee the availability and accessibility of products for the prevention and treatment of diseases, to combat other serious cross- border threats to health and to safeguard and improve the health and well-being of people in the Union. __________________ 8 Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220.
Amendment 152 #
2020/0102(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The pandemic has revealed the importance of public health policies, and their benefits for citizens, communities and the economy. Such policies are cost- saving and offer returns in the long term of 14:1, meaning that for each euro invested in public health policies, we have economic return of 14 euros.
Amendment 153 #
2020/0102(COD)
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6b) While the Union´s action in the field of health is limited, the Union should follow a coherent public health strategy in order to flexibly respond to existing epidemics taking into consideration local specificities and having the capacity to face future worrying realities and health threats, such as pandemics and cross- border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, of disease prevention, in promoting a healthy lifestyle and preparing their health systems for emerging technologies.
Amendment 155 #
2020/0102(COD)
Proposal for a regulation
Recital 6 c (new)
Recital 6 c (new)
Amendment 156 #
2020/0102(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) It is therefore appropriate to establish a new Programme for the Union's action in the field of health, called EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the goals of the Union action and its competences in the area of public health the Programme should place emphasis on actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level and actions with an impact on the internal market. The EU regulates products relevant to health and health outcomes including, amongst others, pharmaceuticals, medical devices, tobacco, alcohol, food and chemicals, therefore the Programme should take into consideration regulation in such areas to improve the health outcomes in the EU. A holistic approach is needed to improve health outcomes, and EU policy-makers should ensure that the principle of 'health in all policies' is applied in all policy- making.
Amendment 159 #
2020/0102(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument] and ensure that resilient healthcare and health systems are in place in preparation for future pandemics, improve the health status in societies and to ensure that people are healthier and therefore less susceptible to health threats. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument]. Preparedness is the key to improving resilience to future threats, and Member States, given their responsibility for the provision of healthcare, should carry out stress tests on their healthcare systems to identify weaknesses and verify that they are prepared for a possible future health crisis, through the support of the Commission and its coordination action to establish common acceptable parameters.
Amendment 166 #
2020/0102(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) COVID-19 has demonstrated the inter-dependencies between human health and the health of our planet and our vulnerabilities. The emergence of zoonotic diseases which are transmitted from animals to humans is exacerbated by anthropogenic climate change, the destruction of biodiversity and environmental degradation. Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 186 #
2020/0102(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. such as the elderly, children, Roma, migrants, and people living in a socioeconomically precarious situation, amongst others, including those suffering from non-communicable diseases, such as cardiovascular diseases, cancer, respiratory diseases, diabetes and mental illnesses amongst others, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. The crisis has revealed that e-health and telemedicine have room to increase and improve the healthcare services and health coverage in a more efficient way. The programme should increase the e-skills of patients and health professionals, improve e-health infrastructures and services, allowing for more competences to be given to patients for the management of their own health and disease treatment, lightening the burden on the healthcare services and increasing their efficiency and availability in responding to demands.
Amendment 195 #
2020/0102(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The right to physical and mental health is a fundamental human right. Every person, without discrimination, has the right to access modern and comprehensive healthcare. The EU4Health programme should guarantee that universal health coverage is provided, in line with the international commitments made through SDGs and with WHO policies, and ensure that everyone can use the health services they need without experiencing financial hardship. To continue being a global leader in health and to provide a high standard healthcare across the Union, the Commission should propose a Directive on minimum standards for quality healthcare with a set of criteria that should be reported by Member States, such as hospital beds per capita, critical care capacities, numbers of doctors and nurses per capita, rate of health expenditure and access and affordability of healthcare for all, including for vulnerable people. This would improve patient safety and result in better conditions in healthcare for patients and professionals.
Amendment 203 #
2020/0102(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions, which foster the production, procurement and management of crisismedical and care relevant products to mitigate the risk of shortages, especially in times of health crises, ensuring complementarity with other Union instruments.
Amendment 205 #
2020/0102(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to minimise the public health consequences of serious cross- border threats to health it should be possible for actions supported under the Programme to cover coordination of the activities which strengthen the interoperability and coherence of Member States’ health-systems through benchmarking, cooperation and exchange of best practices and ensure their capability to respond to health emergencies, that includes contingency planning, preparedness exercises and the upskilling of health care and public health staff and the establishment of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in time of crisis. The benchmarking, cooperation and exchange of best practices should be equally promoted in periods where there are no crises.
Amendment 219 #
2020/0102(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility, sustainability and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster (primordial, primary, secondary, tertiary and quaternary) disease prevention and health promotion, to provide new outcome -based care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs enhancing citizens’ levels of health literacy and digital health literacy and ensure an efficient public health workforce equipped with the right skills, including digital skills, regularly updated in the light of scientific and technological progress, as provided for by Directive 2005/36 on the recognition of professional qualifications . This synergy between European Health Programme and Digital Europe Programme should contribute to the implementation and expansion of e-health, as telemedicine, reducing unnecessary travel and unmet healthcare needs. The development of a European health data space and of a European Electronic Health Record would provide health care systems, researchers and public authorities with means to improve the accessibility, affordability, availability and quality of healthcare, increasing the amount of data available to patients and health workers therefore improving the quality of healthcare and the patient´s freedom of movement around the Union. . Given the fundamental right to access to preventive healthcare and medical treatment enshrined in Article 35 of the Charter of Fundamental Rights of the European Union and in view to the common values and principles in European Union Health Systems as set out in the Council Conclusions of 2 June 200612 the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no- one is barred access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected. The programme needs to guarantee access to and sharing of personal health data while applying the GDPR rules meticulously and increase the digital skills of patients. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 228 #
2020/0102(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The value of health data is essential for having more reliable information to improve healthcare services, health policy-making and to evaluate the implementation of actions and policies in our society. The European Health Data Space will represent a strong pillar of health in the Union and should be constructed involving all sectors and stakeholders, taking into account the needs of health professionals and patient. The Programme should capacitate and enlarge the competence of the ECDC to improve the capacity of surveillance of NCDs. The European Health Data should collect data on healthcare use, health behaviour and health problems, including information on rare diseases, vaccination, allergies and others.
Amendment 238 #
2020/0102(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Health is an investment and the Programme should have this concept at its core. Keeping people healthy and active longer and empowering them to take an active role in managing their health through health literacy in order to take well informed decisions, will have positive effects on health, health inequalities, health iniquities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national health systems and budgets. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages"13. The Programme therefore should contribute to the actions taken towards reaching the SDGse goals, consequently will improve the social determinants of health and enhance the health of the Union. __________________ 13 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Next steps for a sustainable European future. European action for sustainability COM (2016) 739 final of 22.11.2016.
Amendment 242 #
2020/0102(COD)
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The Programme should provide for equal and fair access to healthcare. “Health inequalities” cover situations ranging from unequal access to treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities and inequities are avoidable by reasonable means, and thus preventable, and the Programme should improve the knowledge on health inequalities and inequities to tackle them.
Amendment 247 #
2020/0102(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of commercial determinants of health a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes and mental health illnes,s represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, with non- communicable diseases (NCDs) were responsible for 87% of Disability-Adjusted Life Years (DALYs) in the EU in 2017, resulting in considerable social and economic impacts. To decrease the impact of non-communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, particularly but not exclusively Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors, specialities and policy -fields, taking into account the interrelated nature of most non- communicable diseases, combined with efforts to strengthen health systems and societies.
Amendment 264 #
2020/0102(COD)
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) Mental and psychological well- being is crucial for good mental health. The Programme should be aimed at improving the mental health of individuals and society, including the promotion of mental well-being, the prevention of mental disorders, the protection of human rights and the care of people affected by mental disorders and neurological diseases.
Amendment 267 #
2020/0102(COD)
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) Early detection and screening plays a crucial role in prevention strategies and in timely treatment and health outcomes. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status, well-being, and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, local authorities and citizens should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services.
Amendment 271 #
2020/0102(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme therefore should contribute tohave a holistic approach to individual health and the link with all the health determinants: socio-economic, environmental, health system, commercial and individual determinants of health. To achieve the best health status possible, the Programme should tackle all the determinants. Health promotion, health protection and disease prevention throughout the lifetime of an individual and to healshould be at the core of the promotiongramme by addressing health and mental risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugharmful drugs and other addictive behaviours. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and, lack of physical inactivity that can lead to a person becoming overweight and suffering from obesity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme therefore should contribute to a high level of human health promotion and protection, throughout the entire lifetime of an individual, including through the promotion of physical activity, nutritional care and promotion of health education and health literacy. The Programme should also strengthen and support Health in All Policies and support the implementation of health assessment of EU policies. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy and these policies should take into account the Programme objectives.
Amendment 288 #
2020/0102(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) Given that health needs differ during a person's lifetime, the Programme should also support Member States to create and implement health programmes that are aligned with the needs of population, and should work to achieve a minimum standard in health programmes that tackle specific populations, such as children's health, maternal health and ageing-related health, as programmes that are horizontal to the lifetime as mental health and reproductive and sexual health.
Amendment 293 #
2020/0102(COD)
Proposal for a regulation
Recital 18 b (new)
Recital 18 b (new)
(18b) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases, cancer and type 2 diabetes, could be prevented through access to prevention services, affordability of healthy nutrition and healthy lifestyle, while other illnesses, for instance neurological diseases, can be managed to slow their onset if detected early, or helping patients feel their best and remain active for longer. The Union and Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the area of both communicable and non- communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.
Amendment 295 #
2020/0102(COD)
Proposal for a regulation
Recital 18 c (new)
Recital 18 c (new)
(18c) The International Agency for Research on Cancer (IARC) considered classified diesel engine exhaust as carcinogenic to humans. The Programme should make sure that the health impacts and costs of air pollution are integrated into the Union action against cancer, while ensuring full coherence with the European zero emission strategy.
Amendment 300 #
2020/0102(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of several non-communicable diseases that share common risk factors. Addressing the prevention of cancer along with other NCDs in a coordinated fashion and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors also improving palliative care and pain management. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer and should endeavour to include cancer action into a broader NCD framework to move away from a disease-centred approach and towards a patient-focused approach.
Amendment 307 #
2020/0102(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Under Article 153 TFEU, the Union is to support and complement the activities of Member States concerning improvement of the working environment, and protection of workers' health, safety and working conditions. Considering the large amount of time that the workers spend in their workplaces and the possible risk they could have, such as exposure to health hazard substances and carcinogens and to repeated movements, leading to a high burden of incapacity and number of work days lost, which in turn has consequences for the individual, family and society. The Programme should also reflect the importance of occupational health and its impact on health workers and societies. The Commission should work with Member States to create new legislation to improve workers health conditions, improve their working conditions, the balance between work and life, promote wellbeing and better mental health, prevent early-retirement due to ill health and poor health management.
Amendment 320 #
2020/0102(COD)
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme should ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner.
Amendment 322 #
2020/0102(COD)
Proposal for a regulation
Recital 19 c (new)
Recital 19 c (new)
(19c) A crucial part of treatment of diseases is rehabilitation, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job market and reduce the burden on health services by reducing hospital readmissions. Although there are considerable benefits for patients, as well as the wider society, the access to and uptake of quality rehabilitation is patchy in most of the Member States and is considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention reducing the burden of diseases.
Amendment 329 #
2020/0102(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The programme should support vulnerable population groups that have more difficulty in accessing healthcare, due to their socio-economic or geographic characteristics. Synergies between the Programme and ESF+ and ERDF are crucial, and the Commission should take into account the particularity of remotes areas and more concretely, the outermost regions based on Article 349 TFEU.
Amendment 334 #
2020/0102(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a considerable body of Union acquis was developed which guarantees the high standards of quality and safety for medicinal products and medical devices. Given the rising healthcare demand, Member States’ healthcare systems face challenges in the availability and affordability of medicines and medical devices. To ensure a better public health protection as well as the safety and empowerment of patients in the Union, it is essential that patients and health systems have access to sustainable, efficient, equitable and high quality healthcare products and can fully benefit from them.
Amendment 341 #
2020/0102(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such and medical devices, promote research and the development of new medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicin, with particular attention to antimicrobials and vaccines to tackle AMR and vaccine-preventable diseases, boost the production of essential medicines and the active pharmaceutical ingredient (API), develop such medicinal products as transformation of healthcare products and platforms for monitoring and collecting information on patients health, increasing self-management of their health, and information about the use of healthcare services, medicines and medical devices.
Amendment 363 #
2020/0102(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. The Programme should support the ECDC monitoring and surveillance programmes concerning usage of antimicrobials and AMR, and the support to the implementation of local, regional and national plans to fight against AMR, supported by evidence-based strategies and the sharing of good practices within the Union. __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 369 #
2020/0102(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) HAI are infections that patients get while receiving healthcare for another condition or infections suffered by inhabitants of long-term residences. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of the Council's Recommendation of 9 June 2009 on patient safety, including the prevention and control of HAI 1a.
Amendment 373 #
2020/0102(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Since environmental pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem that can impact on public health, the Programme should foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment15 . The Programme will reinforce the need to have health impact assessments in the EU policies and should promote health promotion and protection in all EU policies, taking into account the European Green Deal, The Farm to Fork Strategy, The Biodiversity Strategy and the Pharmaceutical Strategy for Europe and others. __________________ 15Communication of the Commission to the European Parliament, the Council and the European economic and Social Committee ‘European Union Strategic Approach to Pharmaceuticals in the Environment’, COM(2019)128 final of 11.03.2019.
Amendment 375 #
2020/0102(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for the recognition of professional qualifications, medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross- border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and provide high quality, unbiased, comparable and reliable data to underpin policymaking and monitoring. Union health legislation needs to be based on current scientific evidence-based data, that should be collected locally across Europe, through a well-defined homogeneous methodology. The legislation and its implementation and consequences should be evaluated and reported, resulting in a cycle of quality improvement of health in the Union.
Amendment 386 #
2020/0102(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Solidarity and unity are principles of the Union and the programme should ensure that the Union has a coherent approach to combating cross-border health-threats. Under Article 168 TFEU, the Programme should support the creation of a European Health Response Mechanism, ready to respond to public health threats, coordinated by the ECDC and led by the Commissioner for Health and the Commissioner for Crisis Management, fully articulated with the other EU health agencies. This Mechanism with its own medical resources under a strengthened Union Civil Protection Mechanism will be prepared with a pandemic emergency plan, in order to have a coordinated response and the capacity to rapidly scale up the response to future health crises, based on standardised information.
Amendment 389 #
2020/0102(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as cardiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities, and their increasing prevalencer. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 412 #
2020/0102(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed with the Member States and with relevant international organisations such as the United Nations and its specialised agencies, in particular the WHO, the World Bank, as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD) to implement the Programme. Pursuant to Article 94 of Council Decision 2013/755/EU20 , persons and entities established in Overseas Countries and Territories (OCTs) are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant OCTs are linked. __________________ 20Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union ( ‘Overseas Association Decision’ ) (OJ L 344, 19.12.2013, p. 1).
Amendment 420 #
2020/0102(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) Given the nature and potential scale of cross-border threats to human health, the objective of protecting people in the Union from such threats and to increase crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union, action at Union level can also be taken to support Member States’ efforts in the pursuit of a high level of protection of public health, to improve the availability, sustainability, acceptability, accessibility and affordability in the Union of medicines, medical devices and other crisishealth relevant products, to support innovation and to support integrated and coordinated work and implementation of best practices among Member States, and to address inequalities and inequities in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Amendment 424 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food or environment, chemical, biological, environmental, nuclear or unknown origin, having a health dimension and which requires urgent action by authorities;
Amendment 426 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘crisis relevant products’ means products and; substances and tools necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences, includedto the monitoring and the epidemiological surveillance of the diseases and infections, including but not limited to: medicinal products - including vaccines - and their intermediates, active pharmaceutical ingredients and raw materials; medical devices; hospital and medical equipment (such as ventilators, protective clothing and equipment, diagnostic materials and tools); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production); training; infrastructure and technology to increase the availability of data;
Amendment 429 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
(5) ‘One Health approach’ means an approach which recognises thate interconnection between the human and, animal health are interconnectedand environmental spheres, that diseases may be transmitted from humans to animals and vice versaone pillar to another and must therefore be tackled in both, and that the environment links humans and animalsa holistic approach;
Amendment 433 #
2020/0102(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘serious cross-border threat to health’ means a life- threatening or otherwise serious hazard to health of biological, chemical, radiological, nuclear, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 453 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) protect people in the Union from serious cross-border threats to health; implement better preparedness and coordination within and between Member States as regards health emergencies;
Amendment 460 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) support existing and future Union health legislation, improve the availability in the Union of medicines, vaccines, medical devices and other crisismedical relevant products, contribute to their affordability, and support innovation and e-health solutions, contribute to their accessibility, sustainability and affordability, and support research, innovation and development in health and healthcare;
Amendment 476 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) strengthen health systems and the healthcare workforce, including by digital and green transformation, and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable data sharing, to increase the general level of public health and health literacy of the population.
Amendment 486 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support systematic health impact assessment of other EU policies ensuring a comprehensive, Health in All Policies approach;
Amendment 492 #
2020/0102(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3 b (new)
Article 3 – paragraph 1 – point 3 b (new)
(3b) support health promotion, health protection and disease prevention, reduce health inequalities and inequities, improve physical and mental health, addressing in particular the key lifestyle related risk factors with a focus on the Union added value and scale up to healthier and more resilient societies;
Amendment 502 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Article 4 – paragraph 1 – point 1
(1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and, surveillance and health risk assessment;
Amendment 515 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
(2) ensure the availability in the Union of reserves or stockpiles of crisismedical relevant products, and a reserve of medical, healthcare and support staff to be mobilised in case of a crisis, improving the training of health professionals and updating their knowledge;
Amendment 520 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) support actions to ensure appropriate availability, accessibility, sustainability and affordability of crisis relevant productmedicines, vaccines, medical devices and other necessary health supplies, stimulate the development of the health production industry within the Union;
Amendment 528 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) support the research and development of new medicines, medical devices and health products, enhance clinical trials and research based on real world data;
Amendment 530 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
(4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting green and digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models leading to person-centred systems and universal health coverage, and address inequalities in healthand inequities in health and promote a set of minimal health services standards and ensure that the right to affordable preventive and curative health and care as set out in the European Pillar of Social Rights is respected;
Amendment 536 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4a) support the digitalization of health, increasing the skills of citizens and health workers and services, the interoperability of systems and availability of data, ensuring data comparability, to improve the knowledge and evidence on health, support the creation and implementation of a European Health Data Space while respecting citizens´ data protection rights and the Union data protection framework;
Amendment 545 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5
Article 4 – paragraph 1 – point 5
(5) support actions aimed at addressing health inequalities and strengthening health system’s ability to foster protection, disease prevention and health promotion, early diagnosis and screening, and implement health promotion inclusive of mental health, patient rights and safety and cross-border healthcare, and promote the excellence of medical and healthcare professionals as well as their education, enhance their fixation and mitigate the consequences of the 'brain drain' phenomenon, scale up the occupational health of all workers and address the protection and safety of healthcare professionals;
Amendment 556 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancerincluding cardiovascular diseases, cancer, chronic respiratory disease, diabetes and mental health conditions, with the aim of reducing the prevalence and improving the quality of life of patients, by providing a European strategic chronic disease framework to support Member States' action addressing the commercial determinants of health;
Amendment 574 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 6 a (new)
Article 4 – paragraph 1 – point 6 a (new)
(6a) strengthen the programmes to fight against communicable diseases and health threats, as AMR, HIV/AIDS, tuberculosis, hepatitis, influenza, sexually transmitted infections among others, promoting healthy lifestyles, premature detection, access to treatment and long- life care;
Amendment 578 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 7
Article 4 – paragraph 1 – point 7
(7) foster and support the informed, prudent and efficient use of medicines, and in particular of antimicrobials, and more environmentally friendly production and disposal of medicines and medical devicesinvest in the protection of the environment and sustainability in the whole value chain of all medicines, vaccines, medical devices and other medical products, from the production to the disposal, guaranteeing that an environmental risk assessment for such products is carried out;
Amendment 590 #
2020/0102(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 9
Article 4 – paragraph 1 – point 9
(9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, the identification of health technologies meant to benefit from a European assessment, and scaling up networking through the European Reference Networks and other transnational networks aiming to increase the coverage of patients and the response to more diseases and health problems;
Amendment 652 #
2020/0102(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The interim evaluation of the Programme shall be performed once there is sufficient information available about their implementation, but not later than four years after the start of the implementation and before any decision is taken on future work programmes. The results of the interim evaluation shall be made public.
Amendment 659 #
2020/0102(COD)
Proposal for a regulation
Annex I – point a – point ii
Annex I – point a – point ii
(ii) Critical health infrastructure relevant in the context of health crises, tools, structures, processes, production and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks and relevant medical products.
Amendment 680 #
2020/0102(COD)
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels providing advice, data and information to support health policy development and implementation, including the follow-up evaluation of the implementation of health policies;
Amendment 699 #
2020/0102(COD)
Proposal for a regulation
Annex I – point c – point iv a (new)
Annex I – point c – point iv a (new)
(iva) Development and operation of databases and digital tools and their interoperability of health data, including where appropriate with other sensing technologies, such as space-based technology and to support access to and analysis of data from real world healthcare settings; support the implementation of artificial intelligence and other tools in order to improve the quality of health data;
Amendment 711 #
2020/0102(COD)
Proposal for a regulation
Annex I – point d – point i
Annex I – point d – point i
(i) Implementation, enforcement, monitoring of Union health legislation and action for the protection and promotion of health; and technical support to the implementation of legal requirements;
Amendment 736 #
2020/0102(COD)
Proposal for a regulation
Annex I – point d – point xi a (new)
Annex I – point d – point xi a (new)
(xia) Systematic health impact assessment of other Union policy actions;
Amendment 745 #
2020/0102(COD)
Proposal for a regulation
Annex I – point e – point ii
Annex I – point e – point ii
(ii) Establishment and management of EU reserves and stockpiles of crisisof medically relevant products in complementarity with other Union instruments;
Amendment 753 #
2020/0102(COD)
Proposal for a regulation
Annex I – point e – point v
Annex I – point e – point v
(v) Establishment and operation of a Union health response mechanism coordinated by the ECDC and with the assistance of other health-related agencies (EMA, EFSA, ECHA, EEA) of a Union reserve of medical and healthcare staff and experts and of a mechanism to deploy such staff and experts as necessary to prevent or respond to a health crisis throughout the Union; establishment and operation of a Union Health Emergency team to provide expert advice and technical assistance on request by the Commission in the case of a potential health crisis or health threat;
Amendment 755 #
2020/0102(COD)
Proposal for a regulation
Annex I – point e – point v a (new)
Annex I – point e – point v a (new)
(va) Strengthening mechanisms that ensure the availability of blood components, organs, tissues and cells at European level;
Amendment 762 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point iv
Annex I – point f – point iv
(iv) Preventive actions to protect all citizens, taking into consideration and paying special attention to vulnerable and risk groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups; the health crisis in view of the ensuing needs, and ensure that those vulnerable groups receive uninterrupted basic care and avoid their health status being degraded;
Amendment 767 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point v
Annex I – point f – point v
(v) Actions to address and manage the collateral health consequences of a health crisis, in particular those on mental health, on patients suffering from chronic diseases and other vulnerable groups, such as people living with addiction, with HIV/AIDS, tuberculosis or in socially vulnerable situations;
Amendment 771 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(v a) Actions to support e-health, the transition to telemedicine, the use of digital health tools, enabling patients to use e-health solutions and implement self- care plans, empowering citizens and patients to self-manage as regards their health;
Amendment 776 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point vi
Annex I – point f – point vi
(vi) Actions to strengthen surge capacity, research, development, laboratory capacity, production and deployment of crisis-relevant niche products;
Amendment 778 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point vii a (new)
Annex I – point f – point vii a (new)
(viia) Establishment and operation of a mechanism responsible for procurement and development of countermeasures against biological threats, including bioterrorism, and chemical, nuclear and radiological threats;
Amendment 784 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point viii a (new)
Annex I – point f – point viii a (new)
(viii a) Support action regarding epidemiological surveillance, focusing on national health entities, thus contributing to assessment of factors that affect or determine the health of citizens;
Amendment 789 #
2020/0102(COD)
Proposal for a regulation
Annex I – point f – point viii b (new)
Annex I – point f – point viii b (new)
(viiib) Support actions aimed at preventing the risks for individual and collective health that are associated with human organ trafficking and human trafficking for the purpose of organ procurement;
Amendment 792 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – introductory part
Annex I – point g – introductory part
(g) Strengthen national health systems, promote and protect health and prevent diseases:
Amendment 793 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point i
Annex I – point g – point i
(i) Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience, in particular to address the challenges identified by the European Semester and to strengthen primary care, reinforce the integration of care and aim at universal health coverage and equal access to healthcare, regarding citizens' biopsychosocial needs, and harmonise minimum standards for quality healthcare;
Amendment 801 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point iii
Annex I – point g – point iii
(iii) Support toactions to address the decision of qualified health workers to leave their Member State of origin to work elsewhere, improve the geographical distribution of healthcare workforce, and avoidance of ‘medical deserts’void ‘medical deserts’ and the phenomenon of ‘brain drain’, and promote and implement retention policies in the healthcare sector as well in the health investigation and development sector;
Amendment 805 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point iv
Annex I – point g – point iv
(iv) Support the establishment and coordination and deployment of Union Reference Laboratories and Centres, and of Centres of excellence of excellence, improve the access of and the coverage to all citizens that need it , and support the establishment of Union disease-specific platforms for the exchange, comparison and benchmarking of best practices between Member States;
Amendment 806 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point v
Annex I – point g – point v
(v) Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination), and implementation of health programmes that address health promotion and disease prevention and tackle communicable and non-communicable diseases;
Amendment 817 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) and mitigate the main risk factors of chronic diseases;
Amendment 820 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point ix a (new)
Annex I – point g – point ix a (new)
(ixa) Support the development and the implementation of European disease management guidelines in the area of both communicable and non- communicable diseases, such as cancer, paediatric cancer, cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes, among others;
Amendment 822 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point x
Annex I – point g – point x
(x) Support Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices and promote the regular practice of physical activity and healthy diets taking into account the needs of vulnerable groups;
Amendment 825 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xi a (new)
Annex I – point g – point xi a (new)
(xia) Advance the integration of ERNs into national health systems, by supporting the organisation of national multi-stakeholder workshops on integration to stimulate local discussions, as well as the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level;
Amendment 833 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii a (new)
Annex I – point g – point xiii a (new)
(xiiia) Support actions to combat all types of discrimination concerning patients and to ensure that there is equal access for all to health;
Amendment 836 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii b (new)
Annex I – point g – point xiii b (new)
(xiiib) Support actions to adopt a common set of health determinants and methodologies, and support Member States to collect, analyse and report these data and improve the knowledge, and support Union actions to mitigate health inequalities and iniquities;
Amendment 838 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii c (new)
Annex I – point g – point xiii c (new)
(xiiic) Improve the current monitoring system of the Union to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 839 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii d (new)
Annex I – point g – point xiii d (new)
(xiiid) Support Member States’ actions to boost health education and health literacy, creating well-informed societies, enhancing healthier lifestyles;
Amendment 840 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii e (new)
Annex I – point g – point xiii e (new)
(xiiie) Support the creation and promotion of a Union platform for reliable and updated health information, available in all official languages of the Union, with food, medicines, health, sports and data on other issues;
Amendment 841 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii f (new)
Annex I – point g – point xiii f (new)
(xiiif) Support the development and implementation of guidelines on health promotion and disease prevention in different stages of a person's lifetime and needs; creating quality standards to focus on, inter alia, child health, maternal health, aging health, mental health and reproductive and sexual health;
Amendment 842 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii g (new)
Annex I – point g – point xiii g (new)
(xiiig) Support action to reduce health inequalities and inequities and reduce the unmet needs of vulnerable people, people living with chronic diseases, disabilities or incapacities;
Amendment 843 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii h (new)
Annex I – point g – point xiii h (new)
(xiiih) Support collaboration between different sectors to improve health determinants and enhance the benefits in health outcomes;
Amendment 844 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii i (new)
Annex I – point g – point xiii i (new)
(xiiii) Support the establishment of quality assurance schemes for disease- specific centres;
Amendment 845 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii j (new)
Annex I – point g – point xiii j (new)
(xiiij) Actions supporting the quality of life of chronic disease patients, care givers and informal carers;
Amendment 846 #
2020/0102(COD)
Proposal for a regulation
Annex I – point g – point xiii k (new)
Annex I – point g – point xiii k (new)
(xiiik) Actions supporting continuity of care (integrated care approaches for prevention, diagnosis, treatment and follow-up care);
Amendment 885 #
2020/0102(COD)
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Support equal and timely access to truly innovative medicines and therapies;
Amendment 888 #
2020/0102(COD)
Proposal for a regulation
Annex I – point h – point v b (new)
Annex I – point h – point v b (new)
(vb) Support implementing policies, national programmes and guidelines regarding reducing inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe, including availability and affordability of such health care and services;
Amendment 929 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point ii a (new)
Annex I – point i – point ii a (new)
(iia) Support tools and platforms to collect real-world data to produce real- world evidence, promote research and evidence on the safety, effectiveness and impact of vaccines, while guaranteeing robust evidence generation in the pre- approval phase;
Amendment 933 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials, including those involving increased coordination at Union level and with EMA, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; support publication of all clinical reports (including CSRs) on the day marketing authorisation is granted for such medicines and vaccines;
Amendment 941 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point iv
Annex I – point i – point iv
(iv) Support action to ensure greater availability and affordability in the Union of medicines, vaccines, and medical devices and contribute to their affordability for patients and health systems, using the Union mechanism as joint procurement at the same time enhance the transparency of the process;
Amendment 949 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point v
Annex I – point i – point v
(v) Support action to encourage the development of innovative products andion of less commercially interesting products such as antimicrobial; encourage the development of medicines for rare diseases and making access to them affordable, and investment in the research and development of new antimicrobials and other medicines to fight against communicable diseases;
Amendment 951 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to implement models of R&D and IP ownership and management which prioritise the public interest and ensure that there are societal benefits, for example by including binding safeguards to ensure availability, accessibility and affordability of medical products developed with public funds;
Amendment 970 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point viii
Annex I – point i – point viii
(viii) Action to strengthen the environmental risk assessment of pharmaceuticals and medical devices;
Amendment 974 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to promote the prudent use and disposal of antimicrobials, surveillance of antimicrobial use, antimicrobial resistance and support action to fight against AMR;
Amendment 979 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international regulatory convergence on medicines and, vaccines, medical devices. and products and e-health solutions;
Amendment 982 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x a (new)
Annex I – point i – point x a (new)
(xa) Support the creation of national tools to implement the health technology assessments (HTA);
Amendment 983 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x b (new)
Annex I – point i – point x b (new)
(xb) action to promote data transparency in the entire value chain of medicines;
Amendment 984 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x c (new)
Annex I – point i – point x c (new)
(xc) action to create scientific advisory systems at national and Union level that support SMEs, Start-ups and others in the health sector;
Amendment 985 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x d (new)
Annex I – point i – point x d (new)
(xd) Support actions aimed at strengthening the fight against counterfeiting and piracy of medicines and medical devices;
Amendment 986 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x e (new)
Annex I – point i – point x e (new)
(xe) Support actions to promote the reinforcement of investment in a joint R&D policy;
Amendment 987 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x f (new)
Annex I – point i – point x f (new)
(xf) Support the strengthening of investment in instruments for monitoring the commerce and availability of medicines for human use and medical devices, at national and Union level;
Amendment 988 #
2020/0102(COD)
Proposal for a regulation
Annex I – point i – point x g (new)
Annex I – point i – point x g (new)
(xg) Support research into possible repurposing of existing drugs, exploring new uses and indications of therapies for existing drugs;
Amendment 989 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point i
Annex I – point j – point i
(i) Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data security and quality assurance processes for data exchange, access, use and reuse; support for cross border networking, including through theimprovement and better use of electronic health records, registries and other databases;
Amendment 997 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point ii
Annex I – point j – point ii
(ii) Support toinvestments for the digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies; digital upskilling of health care professsionals and citizens;
Amendment 998 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point iii
Annex I – point j – point iii
(iii) Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions, Agencies and bodies; including support for the implementation of an Electronic European Health Record; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and strengthen citizens’ access to and control over theirwith a view to the safe and efficient deployment of AI in healthcare; strengthen and facilitate citizens’ access to and control over their health data; support uptake and broader implementation of current successful initiatives and projects on person-centred digital health and health data;
Amendment 1002 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point iii a (new)
Annex I – point j – point iii a (new)
(iiia) Support actions to promote a European cohesion and coherence policy for digital health in order to harmonize the legal, organizational, semantic and technical components necessary for a functional and efficient cross-border ecosystem;
Amendment 1003 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point iii b (new)
Annex I – point j – point iii b (new)
(iiib) Support the development of digital tools and digital solutions to increase the use of e-health and improve the sustainability and resilience of healthcare systems;
Amendment 1004 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point iii c (new)
Annex I – point j – point iii c (new)
(iiic) Support action to scale up cross- border information exchange services and commence the implementation of projects such as Patient Summary and ePrescription;
Amendment 1005 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point iv
Annex I – point j – point iv
(iv) Support access to and optimal use of telemedicine/telehealth, including through and other e- health tools, including through boosting the coverage of internet and satellite communications for remote areas, foster digitally-driven organisational innovation in healthcare facilities and promote digital tools supporting citizen empowerment, and person-centred care. and self-management of health; promote the involvement of patients in the co-design and co- development of user-friendly tele- medicine and tele-health solutions;
Amendment 1009 #
2020/0102(COD)
Proposal for a regulation
Annex I – point j – point iv a (new)
Annex I – point j – point iv a (new)
(iva) Actions to support the involvement of patients and healthcare professionals in the development, design and deployment of user-centred accessible, secure and efficient digital health innovation;
Amendment 1012 #
2020/0102(COD)
Proposal for a regulation
Annex I – point k – point iii
Annex I – point k – point iii
(iii) Communication to promote disease prevention andand protect health, prevent disease and promote healthy lifestyles, in cooperation with all concerned actors at international, Union and nat, national and regional level.;
Amendment 1013 #
2020/0102(COD)
Proposal for a regulation
Annex I – point k – point iii a (new)
Annex I – point k – point iii a (new)
(iiia) Communication, information and awareness campaigns on blood, organs, tissues and cells donation, that alert the public to the importance of such donation, in terms of solidarity, health policy and therapeutical benefits;
Amendment 1014 #
2020/0102(COD)
Proposal for a regulation
Annex I – point k – point iii b (new)
Annex I – point k – point iii b (new)
(iiib) Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatments of diseases;
Amendment 1015 #
2020/0102(COD)
Proposal for a regulation
Annex I – point k – point iii c (new)
Annex I – point k – point iii c (new)
(iiic) Communication addressed to citizens on health risks from environmental and food issues;
Amendment 1018 #
2020/0102(COD)
Proposal for a regulation
Annex II – part A – point II a (new)
Annex II – part A – point II a (new)
IIa. Review existing fast-track flexibilities in the Union approval framework and support pragmatic clinical trials
Amendment 1019 #
2020/0102(COD)
Proposal for a regulation
Annex II – part A – point III
Annex II – part A – point III
III. Number of actions and best practices directly contributing to the SDG 3.4/Member StateUniversal Health Care (UHC) service coverage index
Amendment 1021 #
2020/0102(COD)
Proposal for a regulation
Annex II – part A – point IV
Annex II – part A – point IV
IV. Implementation of best practichealth programmes by EU Member States that promote health and prevent diseases
Amendment 1023 #
2020/0102(COD)
Proposal for a regulation
Annex II – part A – point IV a (new)
Annex II – part A – point IV a (new)
IVa. Unmet needs in terms of the access to centrally authorised medicines, vaccines or medical devices, due to the lack of affordability, availability and time
Amendment 1024 #
2020/0102(COD)
Proposal for a regulation
Annex II – part A – point IV b (new)
Annex II – part A – point IV b (new)
IVb. Universal Health Care (UHC) service coverage index
Amendment 1026 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 a (new)
Annex II – part B – point 1 a (new)
1a. Number of strategic reserves of medicines, vaccines, medical devices and other medical products
Amendment 1027 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 b (new)
Annex II – part B – point 1 b (new)
1b. Number of strategic reserves of health professionals with training and preparedness to respond to health threats and health crises
Amendment 1028 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 c (new)
Annex II – part B – point 1 c (new)
1c. Unmet needs in terms of medicines, vaccines, medical devices, due to the lack of availability, affordability or time
Amendment 1029 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 d (new)
Annex II – part B – point 1 d (new)
1d. The ratio of new medicines or vaccines in the market compared to the number of clinical trials in the Union and per Member State
Amendment 1030 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 e (new)
Annex II – part B – point 1 e (new)
1e. Universal Health Care (UHC) service coverage index
Amendment 1031 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 f (new)
Annex II – part B – point 1 f (new)
1f. Creation of the European Health Data Space (EHDS)
Amendment 1032 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 g (new)
Annex II – part B – point 1 g (new)
1g. Coverage of citizens with access to their data on the EHDS, per Member State
Amendment 1033 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 h (new)
Annex II – part B – point 1 h (new)
1h. Number of breaches of security of the EHDS
Amendment 1034 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 i (new)
Annex II – part B – point 1 i (new)
1i. Coverage of health professionals with digital skills, per Member State
Amendment 1035 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 j (new)
Annex II – part B – point 1 j (new)
1j. Coverage of citizens having the digital skills necessary to use e-health technology, per Member State
Amendment 1036 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 k (new)
Annex II – part B – point 1 k (new)
1k. Number of health promotion programmes implemented per Member State, based on health issues covered, using the WHO International Classification of diseases (ICD10)
Amendment 1037 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 l (new)
Annex II – part B – point 1 l (new)
1l. Coverage of workers with access to occupational healthcare services, per Member State
Amendment 1038 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 m (new)
Annex II – part B – point 1 m (new)
1m. Ratio of environmental health assessments compared to the number of medicines, vaccines and medical devices that entered into the market
Amendment 1039 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 n (new)
Annex II – part B – point 1 n (new)
1n. Vaccination coverage, by vaccine- preventable-disease, age and sex
Amendment 1040 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 o (new)
Annex II – part B – point 1 o (new)
1o. Number of Member States that implemented the European Electronic Health Record while providing stronger guarantees for personal data protection
Amendment 1041 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 p (new)
Annex II – part B – point 1 p (new)
1 p. Age-standardised five-year net survival of cancer, in total, by type of cancer, gender and age
Amendment 1042 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 q (new)
Annex II – part B – point 1 q (new)
1q. Ratio of Cancer Registries (CRs) to number of Member States (MSs) reporting information of the cancer stage at diagnosis
Amendment 1043 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 r (new)
Annex II – part B – point 1 r (new)
1r. Age-standardized DALYs attributable to the NCDs (per 100 000 people), by disease, gender and age
Amendment 1044 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 s (new)
Annex II – part B – point 1 s (new)
1s. Age-standardized NCD mortality rate (per 100 000 people), by disease, by gender and age
Amendment 1045 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 t (new)
Annex II – part B – point 1 t (new)
1t. Age-standardized deaths attributable to the environment (per 100 000 people) by gender and age
Amendment 1046 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 u (new)
Annex II – part B – point 1 u (new)
1u. Number of medical doctors (per 10 000 people), by Member State and region
Amendment 1047 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 v (new)
Annex II – part B – point 1 v (new)
1v. Number of nurses (per 10 000 people), by Member State and region
Amendment 1048 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 w (new)
Annex II – part B – point 1 w (new)
1w. Number of healthcare professionals (per 10 000 people), by Member State and region
Amendment 1049 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 x (new)
Annex II – part B – point 1 x (new)
1x. Age-standardised obesity prevalence, by gender and age
Amendment 1050 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 y (new)
Annex II – part B – point 1 y (new)
1 y. Age-standardised prevalence of people who are overweight, by gender and age
Amendment 1051 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 z (new)
Annex II – part B – point 1 z (new)
1z. Age-standardised harmful use of alcohol prevalence, by gender and age
Amendment 1052 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 aa (new)
Annex II – part B – point 1 aa (new)
1aa. Age-standardised gambling prevalence, by gender and age
Amendment 1053 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 ab (new)
Annex II – part B – point 1 ab (new)
1ab. Age-standardised proportion of citizens who do not exercise, by gender and age
Amendment 1054 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 ac (new)
Annex II – part B – point 1 ac (new)
1ac. Proportion of HIV/AIDS patients with access to adequate treatment, by gender and age
Amendment 1055 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 ad (new)
Annex II – part B – point 1 ad (new)
1ad. Proportion of Tuberculosis patients with access to adequate treatment, by gender and age
Amendment 1056 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 ae (new)
Annex II – part B – point 1 ae (new)
1ae. Proportion of viral hepatitis patients with access to adequate treatment, by gender and age
Amendment 1057 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 af (new)
Annex II – part B – point 1 af (new)
1af. Maternal mortality ratio (per 100 000 live births)
Amendment 1058 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 1 ag (new)
Annex II – part B – point 1 ag (new)
1ag. Infant mortality rate (per 100 000 live births);
Amendment 1071 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 8
Annex II – part B – point 8
8. Smoking prevalencAge-standardised smoking prevalence, by gender and age
Amendment 1091 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B – point 14 a (new)
Annex II – part B – point 14 a (new)
14a. Number of health impact assessments of Union policies
Amendment 1095 #
2020/0102(COD)
Proposal for a regulation
Annex II – part B a (new)
Annex II – part B a (new)
Ba. Age-standardized QALYs attributable to the NCDs (per 100 000 people), by disease, gender and age
Amendment 135 #
2020/0036(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Achieving climate neutrality should require a contribution from all economic sectors, including aviation and maritime transport, to reduce their emissions to close to zero. In light of the importance of energy production and consumption on greenhouse gas emissions, the transition to a sustainable, affordable and secure energy system relying on a well-functioning internal energy market is essential. The digital transformation, technological innovation, and research and development are also important drivers for achieving the climate-neutrality objective.
Amendment 170 #
2020/0036(COD)
(10) The Union is a global leader in the transition towards climate neutrality, and is determined to achieve it in a just, socially fair and inclusive way as well as help raise global ambition and to strengthen the global response to climate change, using all tools at its disposal, including climate diplomacy.
Amendment 184 #
2020/0036(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The European Parliament called for the necessary transition to a climate-neutral society by 2050 at the latest and for this to be made into a European success story33 and has declared a climate and environment emergency34 . The European Council, in its Conclusions of 12 December 201935 , has agreed on the objective of collectively achieving a climate-neutral Union by 2050, in line with the objectives of the Paris Agreement, while also recognising that it is necessary to put in place an enabling framework and that the transition will require significant public and private investment. The European Council also invited the Commission to prepare a proposal for the Union’s long- term strategy as early as possible in 2020 with a view to its adoption by the Council and its submission to the United Nations Framework Convention on Climate Change. _________________ 33European Parliament resolution of 15 January 2020 on the European Green Deal (2019/2956(RSP)). 34European Parliament resolution of 28 November 2019 on the climate and environment emergency (2019/2930(RSP)). 35 Conclusions adopted by the European Council at its meeting on 12 December 2019, EUCO 29/19, CO EUR 31, CONCL 9.
Amendment 306 #
2020/0036(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) To ensure the Union and the Member States remain on track to achieve the climate-neutrality objective and progress on adaptation, the Commission should regularly assess progress. Should the collective progress made by Member States towards the achievement of the climate-neutrality objective or on adaptation be insufficient or any Union measures inconsistent with the climate- neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience or reduce vulnerability, the Commission should take the necessary measures in accordance with the Treaties. The Commission should also regularly assess relevant national measures, and issue recommendations where it finds that a Member State’s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate change.
Amendment 456 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. The relevant Union institutions and the Member States shall take the necessary measures at Union and national level respectively, to enable the collective achievement of the climate-neutrality objective set out in paragraph 1, taking into account the importance of promoting fairness and, solidarity and a just transition among Member States.
Amendment 467 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. By September 2020, the Commission shall review the Union’s 2030 target for climate referred to in Article 2(11) of Regulation (EU) 2018/1999 in light of the climate-neutrality objective set out in Article 2(1), and explore optionon the basis of a thorough impact assessment and explore as many feasible and cost-effective options as possible in economic and, in particular, social terms for a new 2030 target of 50 to 55% emission reductions compared to 1990. It will also have to include a cost- benefit assessment at Member State level. Where the Commission considers that it is necessary to amend that target, it shall make proposals to the European Parliament and to the Council as appropriate.
Amendment 555 #
2020/0036(COD)
1. The Commission is empowered to adopt delegated acts in accordance with Article 9 to supplement this Regulation by setting outBy 30 September 2025, the Commission shall set, on the basis of the criteria set out in paragraph 3, a trajectory at Union level tofor achieveing the climate-neutrality objective set out in Article 2(1) until 2050and make an appropriate legislative proposal to that effect. At the latest within six months after each global stocktake referred to in Article 14 of the Paris Agreement, the Commission shall review the trajectory.
Amendment 636 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point d
Article 3 – paragraph 3 – point d
(d) energy efficiency, energy affordability, reduction of energy poverty and vulnerability, and security of supply;
Amendment 649 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point d a (new)
Article 3 – paragraph 3 – point d a (new)
(da) technological neutrality and the right of Member States to determine their energy mix;
Amendment 672 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point f a (new)
Article 3 – paragraph 3 – point f a (new)
(fa) different national circumstances of the Member States;
Amendment 48 #
2020/0006(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The regulatory framework governing the Union’s cohesion policy for the period from 2021 to 2027, in the context of the next multi-annual financial framework, contributes to the fulfilment of the Union’s commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals by concentrating Union funding on green objectives. This Regulation implements one of the priorities set out in the Communication on the European Green Deal (‘the European Green Deal’)11 and is part of the Sustainable Europe Investment Plan12 providing dedicated financing under the Just Transition Mechanism in the context of cohesion policy to address the economic and social costhallenges of the transition to a climate-neutral and circular economy by 2050 at the latest, where any remaining greenhouse gas emissions are compensated by equivalent absorptions. _________________ 11 COM(2019) 640 final, 11.12.2019. 12 COM(2020) 21, 14.1.2020.
Amendment 72 #
2020/0006(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) In order to be successful, the transition has to be fair, inclusive and socially acceptable for all, reduce inequalities and leave no one behind. Therefore, both the Union and the Member States must take into account its economic and social implications from the outset, and deploy all possible instruments to mitigate adverse consequences. The Union budget has an important role in that regard.
Amendment 92 #
2020/0006(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation establishes the Just Transition Fund (‘JTF’) which is one of the pillars of the Just Transition Mechanism implemented under cohesion policy. The aim of the JTF is to mitigate the adverse effects of the climate transition by supporting the most affected territories and workers concerned. In line with the JTF specific objective, actions supported by the JTF should directly contribute to facilitate and alleviate the impact of the transition by creating new sustainable employment opportunities, by mitigating the negative repercussions on employment and adverse social consequences and by financing the diversification and modernisation of the local economy and by mitigating the negative repercussions on employment. This is reflected in the JTF specific objective, which is established at the same level and listed together with the policy objectives set out in Article [4] of Regulation EU [new CPR].
Amendment 99 #
2020/0006(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) The application of Union support and funding through the JTF shall ensure that all eligible projects in every Member State are consistent with all Member States’ obligation, set out in Regulation (EU)XX/XXX establishing the framework for achieving climate neutrality and amending Regulation (EU) 2018/1999 [new European Climate Law], to achieve national climate neutrality by 2050 at the latest;
Amendment 106 #
2020/0006(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) In view of the importance of tackling climate change in line with the Union’s commitments to implement the Paris Agreement, the commitment regarding the United Nations Sustainable Development Goals and the increased ambition of the Union as proposed in the European Green Deal, the JTF should provide a key contribution to mainstream climate actions and accelerate the transition to a climate-neutral economy by 2050 at the latest. Resources from the JTF own envelope are additional and come on top of the investments needed to achieve the overall target of 25% of the Union budget expenditure contributing to climate objectives. Resources transferred from the ERDF and ESF+ will contribute fully to the achievement of this target.
Amendment 113 #
2020/0006(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The resources from the Just Transition Fund cannot deliver the transition to climate neutrality on its own. The other two pillars of the Just Transition Mechanism will offer an additional set of measures and financing opportunities, next to the JTF, with the objective of facilitating and accelerating the transition of the most affected regions. A dedicated just transition scheme under InvestEU will attract private investments that benefit the regions in transition and help their economies find new sources of growth such as projects for decarbonisation, economic diversification of the regions, energy, transport and social infrastructure. Public sector loan facility with the European Investment Bank backed by the EU budget will be used for concessional loans to the public sector, for example for investments in energy and transport infrastructure, district heating networks, and renovation or insulation of buildings.
Amendment 122 #
2020/0006(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The resources from the JTF should complement the resources available under cohesion policy as well as national and regional investments, private capital and should by no means replace such investments.
Amendment 140 #
2020/0006(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Transitioning to a climate-neutral economy is a challenge for all Member States. It will be particularly demanding for those Member States that but also an enormous opportunity. Additional support will be needed for the regions that still rely heavily on fossil fuels or greenhouse gas intensive industrial activities which need to be phased out or which need to adapt due to the transition towards climate neutrality and that lack the financial means to do so. The JTF should therefore cover all Member States, but the distribution of its financial means should reflect the capacity of Member States to finance the necessary investments to cope with the transition towards climate neutrality.
Amendment 163 #
2020/0006(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) This Regulation identifies types of investments for which expenditure may be supported by the JTF. All supported activities should be pursued in full respect of the climate, social and environmental priorities of the Union. The list of investments should include those that support local economies and are sustainable in the medium and long- term, taking into account all the objectives of the European Green Deal and the European Pillar of Social Rights. The projects financed should contribute to a transition to a climate-neutral and circular economy. For declining sectors, such as energy production based on coal, lignite, peat and oil shale or extraction activities for these solid fossil fuels, support should be linked to the phasing out of the activity and the corresponding reduction in the employment level. As regards transforming sectors with high greenhouse gas emission levels, support should promote new activities through the deployment of new technologies, new processes or products, leading to significant emission reduction, in line with the EU 2030 climate objectives and EU climate neutrality by 205013 while maintaining and enhancing employment and avoiding environmental degradation. Particular attention should also be given to activities enhancing innovation and research in advanced and sustainable technologies, as well as in the fields of digitalisation and connectivity, provided that such measures help mitigate the negative side effects of a transition towards, and contribute to, a climate- neutral and circular economy. _________________ 13 As set out in “A Clean Planet for all European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy”, Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank - COM(2018) 773 final.
Amendment 185 #
2020/0006(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to enhance the economic diversification of territories impacted by the transition, the JTF should provide support to productive investment inwith job creation potential in green and sustainable SMEs. Productive investment should be understood as investment in fixed capital or immaterial assets of enterprises in view of producing goods and services thereby contributing to gross- capital formation and employment. For enterprises other than SMEs, productive investments should only be supported if they are necessary for mitigating job losses resulting from the transition, by creating or protecting a significant number of jobs and they do not lead to or result from relocation. Investments in existing industrial facilities, including those covered by the Union Emissions Trading System, should be allowed if they contribute to the transition to a climate-neutral economy by 2050 and go substantially below the relevant benchmarks established for free allocation under Directive 2003/87/EC of the European Parliament and of the Council14 and if they result in the protection of a significant number of jobs. Any such investment should be justified accordingly in the relevant territorial just transition plan. In order to protect the integrity of the internal market and cohesion policy, support to undertakings should comply with Union State aid rules as set out in Articles 107 and 108 TFEU and, in particular, support to productive investments by enterprises other than SMEs should be limited to enterprises located in areas designated as assisted areas for the purposes of points (a) and (c) of Article 107(3) TFEU. _________________ 14Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32).
Amendment 206 #
2020/0006(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) The JTF support should be conditional on the effective and measurable implementation of a transition process in a specific territory in order to achieve a climate-neutral economy by 2050 at the latest. In that regard, Member States should prepare, in cooperation with the relevant stakeholders and supported by the Commission, territorial just transition plans, detailing the transition process, consistently with and possibly going beyond their National Energy and Climate Plans. To this end, the Commission should set up a Just Transition Platform, which would build on the existing platform for coal regions in transition to enable bilateral and multilateral exchanges of experience on lessons learnt and best practices across all affected sectors.
Amendment 233 #
2020/0006(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) In order to supplement and amend certain non-essential elements of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to set out the annual breakdown of available allocations per Member State in accordance with Annex I, as well as in respect of the amendment of the elements contained in Annex III of this Regulation regarding the common output and result indicators. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making15 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts; these experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 15 OJ L 123, 12.5.2016, p.13.
Amendment 234 #
2020/0006(COD)
Proposal for a regulation
Recital 18
Recital 18
Amendment 247 #
2020/0006(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes the Just Transition Fund (‘JTF’) to provide support to territories facing serious socio-economic challenges deriving from the transition process towards a climate-neutral economy of the Union by 2050, ensuring that all Member States achieve climate neutrality by 2050 at the latest.
Amendment 267 #
2020/0006(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
In accordance with the second subparagraph of Article [4(1)] of Regulation (EU) [new CPR], the JTF shall contribute to the single specific objective ‘enabling regions and people to address the social, economic and environmental impacts of the transition towards a climate- neutral economy’ by 2050 at the latest.
Amendment 279 #
2020/0006(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The JTF shall support the Investment for jobs and growth goalsocial, socio-economic and environmental impact of the transition in affected regions in all Member States.
Amendment 283 #
2020/0006(COD)
Proposal for a regulation
Article 3 – paragraph 2 – subparagraph 1
Article 3 – paragraph 2 – subparagraph 1
The resources for the JTF under the Investment for jobs and growth goal available for budgetary commitment for the period 2021-2027 shall be EUR 7.5 billion in 2018 prices, which may be increased, as the case may be, by additional resources allocated in the Union budget, and by other resources in accordance with the applicable basic act. The funding of the JTF shall not be to the detriment of resources allocated to the other MFF funds.
Amendment 294 #
2020/0006(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Commission shall adopt a decision by means of an implementing act settingis empowered to adopt delegated acts in accordance with Article 10 to set out the annual breakdown of resources, including any additional resources referred to in paragraph 2, by Member State in accordance with the methodology set out in Annex I.
Amendment 295 #
2020/0006(COD)
Proposal for a regulation
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3a. Access to the funds made available under the JTF shall be conditional on national commitment to climate neutrality by 2050 at the latest, as well as commitment to the accomplishment of the intermediate GHG emission reduction targets for 2030 and 2040. If a Member State fails to produce an appropriate schedule for a phase-out of high GHG emission technologies in accordance with Article 7, yearly allocations for that Member State will be redistributed by the Commission to those Member States that have put in place such plans. The mid-term assessment of the JTF must evaluate each Member State’s progress towards the net zero emission target by 2050 at the latest and intermediate targets for 2030 and 2040. Insufficient progress in the reduction of the greenhouse gas emissions, according to the mid-term assessment, shall entail reduction in yearly allocations for that Member State.
Amendment 305 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – introductory part
Article 4 – paragraph 2 – subparagraph 1 – introductory part
In accordance with paragraph 1, the JTF shall exclusively support the following activities provided that they are eligible under Regulation on the establishment of a framework to facilitate sustainable investment (EU) [new EU Taxonomy Regulation]:
Amendment 313 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point a
Article 4 – paragraph 2 – subparagraph 1 – point a
(a) productive and sustainable investments in SMEs, including start-ups, leading to sustainable job creation, economic diversification and reconversion;
Amendment 339 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point c
Article 4 – paragraph 2 – subparagraph 1 – point c
(c) investments in sustainable research and innovation activities and fostering the transfer of advanced sustainable zero- emission technologies;
Amendment 369 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point d a (new)
Article 4 – paragraph 2 – subparagraph 1 – point d a (new)
(da) targeted energy efficiency measures to address energy poverty;
Amendment 393 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point f
Article 4 – paragraph 2 – subparagraph 1 – point f
(f) investments in regeneration and decontamination of sites, land restoration and repurposing projects, while ensuring appropriate application of the polluter pays principle;
Amendment 406 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point g
Article 4 – paragraph 2 – subparagraph 1 – point g
(g) investments in enhancing the non- toxic circular economy, including through waste prevention, reduction, resource efficiency, reuse, repair and recycling;
Amendment 423 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point h
Article 4 – paragraph 2 – subparagraph 1 – point h
(h) upskilling and reskilling of workers, including self-employed, regardless of the sector;
Amendment 444 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 2
Article 4 – paragraph 2 – subparagraph 2
Additionally, the JTF may support, in areas designated as assisted areas in accordance with points (a) and (c) of Article 107(3) of the TFEU and in compliance with Union State aid rules as set out in Article 107 and Article 108 of the TFEU, productive investments in enterprises other than SMEs, provided that such investments have been approved as part of the territorial just transition plan based on the information required under point (h) of Article 7(2). Such investments shall only be eligible where they are necessary for the implementation of the territorial just transition plan, are sustainable and do not increase or maintain dependency on fossil fuels, nor lead to unsustainable use of biomass or any use of food crops for energy generation purposes which would risk increasing food crop prices.
Amendment 452 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 3
Article 4 – paragraph 2 – subparagraph 3
Amendment 463 #
2020/0006(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) the decommissioning or, the construction or any other form of investment in of nuclear power stations;
Amendment 486 #
2020/0006(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) investment related to the production, processing, distribution, storage, transport or combustion of fossil fuels;
Amendment 516 #
2020/0006(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 2
Article 6 – paragraph 1 – subparagraph 2
The Commission shall only approve a programme where the identification of the territories most negatively affected by the transition process, contained within the relevant territorial just transition plan, is duly justified and the relevant territorial just transition plan is consistent with the National Energy and Climate Plan of the Member State concerned, as well as with the commitment to a climate-neutral economy by 2050 at the latest, including the intermediate targets for 2030 and 2040.
Amendment 551 #
2020/0006(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) a description of the transition process at national level towards a climate- neutral economy by 2050 at the latest, including a timeline for key transition steps such as decomissioning of fossil fuel installations and overall phase-out dates for high GHG emission technologies, which are consistent with the latest version of the National Energy and Climate Plan (‘NECP’);
Amendment 571 #
2020/0006(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) an assessment of the transition challenges faced by the most negatively affected territories, including the social, economic, and environmental impact of the transition to a climate-neutral economy, identifying the potential number of affected jobs and job losses, the development needs and objectives, to be reached by 2030 linked to the transformation or closure of greenhouse gas-intensive activities in those territories consistent with the transition away from fossil fuel use;
Amendment 592 #
2020/0006(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point i
Article 7 – paragraph 2 – point i
Amendment 620 #
2020/0006(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The power to adopt delegated acts referred to Article 3(3) and in Article 8(4) shall be conferred on the Commission for an indeterminate period of time from [the date of the entry into force of this Regulation].
Amendment 622 #
2020/0006(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. The delegation of power referred to in Article 3(3) and Article 8(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 624 #
2020/0006(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State and conduct stakeholder consultation in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 627 #
2020/0006(COD)
6. A delegated act adopted pursuant to Article 3(3) and Article 8(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 11 #
2019/2824(RSP)
Recital A
A. whereas the mission statement of the Strategic Plan for Biodiversity 2011- 2020 is to take effective and urgent action to halt the loss of biodiversity in order to ensure that by 2020 ecosystems are resilient and continue to provide essential services, thereby securing and conserving the planet's variety of life, and contributing to human well-being, and poverty eradication;
Amendment 37 #
2019/2824(RSP)
Paragraph 2
2. Expresses its concern that the 2020 Aichi Biodiversity Targets will not be met with the current trajectory of biodiversity loss, and reiterates its calls on all Parties to step up their efforts; urges the Commission and Member States to commit to immediate, substantial and additional efforts on biodiversity conservation and restoration so as to meet the EU targets, for example by providing more comprehensive information and seeking closer involvement of civil society and members of the public from different age groups and social backgrounds;
Amendment 52 #
2019/2824(RSP)
Paragraph 3 a (new)
3a. Stresses that biodiversity is not only indispensable for the production of food, fuel and medicines but also, together with a healthy natural environment, important for long-term economic development;
Amendment 41 #
2019/2816(RSP)
Recital B
B. whereas the wide use of pharmaceuticals in human and veterinary medicines, including antimicrobial agents, has increased their concentrations in many environmental reservoirs such as soils, sediments and waterbodies in the past 20 years; whereas the largest source of pharmaceuticals entering the environment is their use andexcessive use without medical supervision, followed by their disposal;
Amendment 42 #
2019/2816(RSP)
Recital C
C. whereas pharmaceuticals reach the environment through the discharge of effluent from urban wastewater treatment plants, the spreading of animal manure and aquaculture, discharge of effluent from manufacturing plants, the spreading of sewage sludge, grazing livestock, the treatment of pets, improper disposal into landfill of unused pharmaceuticals and contaminated waste and their further dissemination by sometimes heavy rainfall;
Amendment 80 #
2019/2816(RSP)
Paragraph 3
3. Notes however with concern the very soft nature of the measures included in the communication; considers that legislative measures are needed in addition to non-legislative measures to properly tackle pharmaceutical pollution at European level;
Amendment 91 #
2019/2816(RSP)
Paragraph 5 a (new)
5a. Considers it necessary to organise, in collaboration with the Member States, campaigns to inform and educate the public about the dangers of over- consumption of non-prescribed medicines; draws attention to the increase in the number of supermarket and online sales of medicines without medical recommendation and to the danger of media advertising for such points of sale outside of pharmacies or suitably accredited establishments;
Amendment 98 #
2019/2816(RSP)
Paragraph 7
7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that they are ineffectively filtered by wastewater treatment plants, requiring periodic adaptation of purification processes in line with the new products and technologies on the market;
Amendment 143 #
2019/2816(RSP)
Paragraph 13 a (new)
13a. Stresses that health professionals must be kept continuously up to date regarding the latest developments in research and good practices when it comes to preventing the spread of AMR;
Amendment 146 #
2019/2816(RSP)
Paragraph 14
14. Highlights the importance of the design, development and manufacturing phases to minimise the environmmore rapid, ambitious and targeted measures to reduce the environmental risks posed by pharmaceuticals, while acknowledging the need for further research for a better understanding of the extent of the currental impact of pharmaceuticals on human health and the environment;
Amendment 171 #
2019/2816(RSP)
Paragraph 18
18. Calls for monitoring data from the Water Framework Directive to include suitable parameters regarding the impact of pharmaceuticals that must be used for post-market evaluation;
Amendment 190 #
2019/2816(RSP)
Paragraph 24
24. Considers it appropriate that pharmaceutical companies submit a joint environmental risk assessment per active substance, including the time necessary for the disappearance of these substances from the environment, based on half-life calculations for radioactive substances, so as to have coherent information, avoid duplication of work and reduce animal testing;
Amendment 230 #
2019/2816(RSP)
Paragraph 32
32. Is concerned that monitoring of pharmaceuticals in the environment is still very limited; stresses the need to strengthen post-marketing control mechanisms intothrough comprehensive monitoring, also with regard to environmental effectswith the introduction of new indicators where necessary, including environmental impact monitoring, as the current surveillance system (pharmacovigilance) is not adequately and systematically covering the environmental data deficit;
Amendment 20 #
2019/2814(RSP)
Recital C
C. whereas legislative differences between Member States in breeders’ standards of animal welfare have led to big differences in prices of companion animals that may be sold on the internal market, which is and are exploited by illegal traders;
Amendment 29 #
2019/2814(RSP)
Recital E
E. whereas a large number of counterfeit pet passports are often counterfeitregistered, with veterinarians often involved in this illegal practice;
Amendment 34 #
2019/2814(RSP)
Recital F
F. whereas illegally bred companion animals are very often not vaccinated or have not been duly treated for other diseases; whereas there are various zoonotic risks associated with the illegal trafficking of companion animals, including the introduction of rabies from endemic parts of Europe into countries that are rabies- free, as well as the spreading of parasites such as Echinococcus multilocularis and others4; _________________ 4 European Commission (2015). Study on the welfare of dogs and cats involved in commercial practices. Specific Contract SANCO 2013/12364, Final Report. https://ec.europa.eu/food/sites/food/files/an imals/docs/aw_eu-strategy_study_dogs- cats-commercial-practices_en.pdf , pp. 65- 66; also EU Dog & Cat Alliance (2016). Briefing on the review of pet movement legislation under the “Animal Health Law.” https://s3-eu-west- 1.amazonaws.com/assets.dogandcatwelfare .eu/live/media/publicationtemp/EU_Dog_C at_Alliance_briefing_AHL_pet_movement _review.pdf
Amendment 59 #
2019/2814(RSP)
Paragraph 3
3. Calls for a clear linkage between the EU Pet Passport and Pet Microchip Registration to ensure that the origin of the companion animal remains clear even if the Pet Passport is replaced, through the systematic entry in passports of specific bar codes that can be easily read by those responsible;
Amendment 68 #
2019/2814(RSP)
Paragraph 6 a (new)
6a. Considers it necessary for citizens to be better informed about the trade in companion animals and the possible risks of purchasing animals online or without regard for legal procedures;
Amendment 88 #
2019/2814(RSP)
Paragraph 15
15. Considers that Member States should be encouraged to set up a compulsory register of authorised companion animal breeders and sellers that can be accessed by those responsible in other Member States;
Amendment 97 #
2019/2814(RSP)
Paragraph 20
20. Advocates collaborative cross- agency working in Member States to tackle the illegal trade in companion animals, including developing an intelligence system to record and share data in respect of illegally traded commercial animal consignments and a warning system to flag up any anomalies detected;
Amendment 107 #
2019/2814(RSP)
Paragraph 24
24. Calls on the Member States to carry out more information and awareness- raising campaigns to encourage buyers to adopt rather than purchase companion animals;
Amendment 15 #
2019/2804(RSP)
Recital A
A. whereas Europe’s health and care systems face serious challenges in the context of an ageing society that are, with an ever- increasing threat from infectious illnesses as a result of growing resistance to antibiotics, creating concerns about the sustainability of future provision of healthcare but, on the other hand, are creating new opportunities due to the emergence of new technologies;
Amendment 20 #
2019/2804(RSP)
Draft motion for a resolution
Recital B
Recital B
B. whereas health systems need to maximise the effectiveness and efficiency, equitable access and sustainability of health services and long-term care, deliver seamless care across services and providers, and deliver improvements that matter to patients and their changing care needsand growing health and care needs, well-being and quality of life;
Amendment 21 #
2019/2804(RSP)
Recital B
B. whereas health systems need to maximise the effectiveness and efficiency of health services and long-term care, provide new services in line with the evolution of society, deliver seamless care across services and providers, and deliver improvements that matter to patients and their changing care needs;
Amendment 22 #
2019/2804(RSP)
Recital C
C. whereas innovative digital solutions for health and care can boost health and quality of life of citizensprevention of diseases and promotion of healthy lifestyles, improve citizens’ quality of life and enable more efficient ways of organiszing and delivering health and care services;
Amendment 26 #
2019/2804(RSP)
Recital F
F. whereas patients’ expectations are rising, and there is a need for an empowerment of citizens regarding their health through user-centred services and more ways for people to interact with health services and health professionals;
Amendment 40 #
2019/2804(RSP)
Paragraph 2
2. Considers that the actions proposed by the Commission can contribute to strengthening the resilience and sustainability of Europe’s health and care systems but also to stimulating growth and promoting the European industry in the domain, in particular by helping to maximise the potential of the digital single market with a wider deployment of digital products and services in health and care, as well as the deployment of new services, especially for isolated and inaccessible areas with inadequate medical staff and services;
Amendment 44 #
2019/2804(RSP)
Paragraph 3
3. Is of the opinion that the digital transformation of health and care needs to be patient-centredsupport citizen-centred services as well as empowering citizens to play a more active role in disease prevention and promotion of health, as well in health and care services, answering the needs of citizen;
Amendment 52 #
2019/2804(RSP)
Paragraph 4 a (new)
4a. Stresses that the future of digital health will need to develop secure and effective anonymization and pseudonymization techniques enabling sensible data to be used in health research;
Amendment 57 #
2019/2804(RSP)
Paragraph 5 a (new)
Amendment 64 #
2019/2804(RSP)
Paragraph 7
7. Regrets that, at present, many citizens in Europe have limited electronic access to their personal health data, in particular in cross-border -healthcare provisionwhen they need to have recourse to cross-border medical care;
Amendment 68 #
2019/2804(RSP)
Paragraph 10
10. Calls on the Commission to continue promoting the cooperation of Member States’ health authorities to connect to the eHealth digital infrastructure in order to extend its use to also cover the interoperability of Member States’ electronic record systems by supporting the development and adoption of a European electronic health record exchange format, particularly when patients have recourse to gross-border medical care;
Amendment 82 #
2019/2804(RSP)
Paragraph 18
18. Calls on the Commission to facilitatestep up European coordinated action to support pooling andthe secure exchange in practice of genomic and other health data in order to advance the progress of researchers and personalised medicine and thereby identify the best treatments, while ensuring full compliance with data protection legislation and ethical principles;
Amendment 85 #
2019/2804(RSP)
Paragraph 19
19. Calls on the Commission, together with the Member States and accredited institutions, to proceed with the testing of specific applications for high-security cross-border health data exchange for research and health policy to improve prevention, diagnosis and treatment of diseases;
Amendment 90 #
2019/2804(RSP)
Paragraph 21
21. Believes that the development of a shared frameworkstandards to harmonise the collection of health data, storage and use in the EU could improve the quality of research and health services provided to citizens, also facilitation universal access;
Amendment 99 #
2019/2804(RSP)
Paragraph 23
23. Considers that digital healthcare tools are well positioned tocould address challenges of accessibility to health information and health literacy, both essential for health promotion, better disease prevention and more effective disease management; considers that these tools, when built with the contribution of the appropriate health professionals and civil society users, allow for more accuracy and completeness of information enabling the promotion of healthy habits and prevention activities, as well as the support to decisions in health and patient adherence to treatments.
Amendment 103 #
2019/2804(RSP)
Paragraph 24
24. Stresses the importance of person- centred approaches to organising health and care, including by using digital solutions and tools which have a great potential in improving the quality, equity and sustainability of health services but also people’s health and well- being;
Amendment 109 #
2019/2804(RSP)
Paragraph 25
25. Calls on the Commission to work with relevant actors, especially national health systems, to support more cooperation across borders and enlarge the deployment of digitally enabled care models;
Amendment 112 #
2019/2804(RSP)
Paragraph 26
26. Calls on the Commission and Member States to ensure that health professionals improve competences and skills by means of regular training programmes that take into account the rapid evolution of the IT sector;
Amendment 114 #
2019/2804(RSP)
Paragraph 27
27. Calls on the Commission to work with Member States and the regional and local authorities to develop networks to educate citizens in the use of digital healthcare, enabling universal access; considers that, in order to achieve that goal, there is a need to improve systems’ interoperability and users skills, with the highest possible protection of sensitive data with tools and mechanisms provided by the public health systems;
Amendment 117 #
2019/2804(RSP)
Paragraph 27 a (new)
27a. Calls on the Commission and Member States to ensure that all measures to improve citizens digital skills and access to and use of their health data take into consideration sensitive groups such as older citizens, info- excluded people and people with disabilities;
Amendment 120 #
2019/2804(RSP)
Paragraph 29
29. Calls on the Commission to assist Member States and the regional authorities in raising awareness about innovative procurement and investment possibilities for digital transformation in public health and care and in leveraging public and private investment for the large-scale deployment of digitally enabled, integrated person- centred care;
Amendment 8 #
2019/2803(RSP)
Recital A a (new)
Aa. whereas continuous efforts are needed to secure recognition of the importance of pollinators for agricultural productivity;
Amendment 49 #
2019/2803(RSP)
Recital J a (new)
Ja. whereas healthy bees are essential for agricultural activity in the European Union, given that 84 % of plant species and 76 % of European food production depend on pollination by bees;
Amendment 60 #
2019/2803(RSP)
Paragraph 2
2. Recognises that there are various positive elements in the Initiative in terms of setting strategic objectives and a set of urgent actions to be taken by the EU and its Member States to protect bees;
Amendment 106 #
2019/2803(RSP)
Paragraph 9
9. Stresses that the reduction of pesticide use should therefore be set as a target in Member States’ strategic plans, and pesticide reduction and substitution with less toxic products should be set as a ‘common indicator’ with which to monitor success;
Amendment 119 #
2019/2803(RSP)
Paragraph 12 a (new)
12a. Calls on the Commission and the Member States to raise awareness and promote funding opportunities in this area; points out that common instruments and models for the development of strategies and plans for pollinators based on existing best practices will encourage the adoption of additional measures at national, regional and local level;
Amendment 162 #
2019/2803(RSP)
Paragraph 19
19. Calls for more funds for researchspecialist research programmes in this field and for the suitable monitoring of wild pollinators;
Amendment 168 #
2019/2803(RSP)
Paragraph 20
20. Considers it appropriate to encourage partnership arrangements with academic circles and cooperation with researchers in different fields to support the development of low-risk pesticides that are harmless to pollinators;
Amendment 1 #
2019/2712(RSP)
Citation 12
— having regard to the Intergovernmental Panel on Climate Change (IPCC) special report entitled ‘Global Warming of 1.5°C’, its fifth assessment report (AR5) and its synthesis report, and the Global Commission on Adaptation’ report on Adaptation (GCA), the IPCC special report on Climate Change and Land, and the IPCC special report on the Ocean and Cryosphere in a Changing Climate;
Amendment 24 #
2019/2712(RSP)
Recital C a (new)
Ca. whereas climate change disproportionately affects developing countries, despite developing countries emitting far less CO2 than developed countries;
Amendment 108 #
2019/2712(RSP)
Paragraph 11 a (new)
11a. Stresses that in order to reach the Paris Agreement objectives, we need concrete implementing measures and enforcement at national and EU level;
Amendment 109 #
2019/2712(RSP)
Paragraph 11 b (new)
11b. Emphasises that all climate policies have to be pursued following the principle of a just transition, in close cooperation with civil society and social partners; believes, therefore, that strengthened social partnership and civil society engagement at national and EU level is a necessary condition to achieve carbon-neutrality of all sectors of society in a fair, inclusive and socially sustainable manner; is of the opinion that nature-based solutions, the restoration and conservation of ecosystems and biological diversity is vital as enabler of climate change mitigation and adaptation;
Amendment 146 #
2019/2712(RSP)
Paragraph 19
19. Reiterates that adaptation action is an inevitable necessity for all countries if they are to minimise negative effects of climate change and make full use of the opportunities for climate-resilient growth and sustainable development; stresses the need to develop systems and tools to keep track of progress and effectiveness of national adaptation plans and actions; calls on Member States to strengthen their national energy and climate plans and bring them in line with the Paris Agreement goals;
Amendment 148 #
2019/2712(RSP)
Paragraph 19 a (new)
19a. Recognises that climate change is not a localised challenge and that climatic impacts outside the EU have implications within the EU as well; for instance, hurricanes, droughts, floods and forest fires have the potential to impact EU food and water security, as well as the supply chains of services and goods; calls on the Commission and the Member States to prioritise scaling-up international climate finance for adaptation, to equal climate finance for mitigation, and also provide climate finance for loss and damage;
Amendment 160 #
2019/2712(RSP)
Paragraph 21 a (new)
21a. Stresses the importance of the replenishment process of the Green Climate Fund and encourages Member States to at least double their contributions for the initial resource mobilisation in USD value;
Amendment 187 #
2019/2712(RSP)
Paragraph 23 b (new)
23b. Underlines that in the course of the sustainable energy transition, the problem of energy poverty needs to be tackled by strengthened energy consumers’ rights and information, enhanced energy efficiency measures in buildings, especially for low-income households, and through social policies;
Amendment 188 #
2019/2712(RSP)
Paragraph 23 c (new)
23c. Believes that democratisation of the energy system is crucial for the sustainable energy transition to be successful; calls, therefore, on improving citizens’ rights and abilities to participate in the production of safe and clean energy;
Amendment 192 #
2019/2712(RSP)
Paragraph 24
24. Expresses its satisfaction with the growing global mobilisation of an ever- broader range of non-state actors committed to climate action with concrete and measurable deliverables; highlights the critical role of civil society, the private sector and sub-state governments in pressurising and driving public opinion and state action; and in sharing knowledge and best practices on the development and implementation of mitigation and adaptation measures; calls on the EU, the Member States and all Parties to stimulate, facilitate and engage with non-state actors, who increasingly become frontrunners in the fight against climate change;
Amendment 204 #
2019/2712(RSP)
Paragraph 26 a (new)
26a. Emphasises that young people and future generations bear the disproportionate burden of climate consequences; demands, therefore, better inclusion in climate policy decision- making of young people at local, regional, national and EU level;
Amendment 259 #
2019/2712(RSP)
Paragraph 33
33. Strongly supports the continuation and further strengthening of the Union’s political outreach and climate diplomacy, which is essential for raising the profile of climate action in partner countries and global public opinion; encourages the Commission and the Member States to approach EU climate diplomacy in a holistic manner by incorporating the interlinkages between climate change and the following areas: sustainable development, agriculture, conflict resolution, migration and humanitarian concerns in order to facilitate the global transition towards net zero emissions, climate resilience, sustainable development and food and water security.
Amendment 3 #
2019/2213(BUD)
Draft opinion
Paragraph 1
Paragraph 1
1. Points to the need to ensure that sufficient resources are allocated in the 2021 budget to allow the Union to rapidly take the concrete actions needed to address the climate and environment emergency; insists that the next budget should help the Union to meet its obligations under the Paris Agreement, shoul and be fully aligned with the objectives of limiting global warming to under 1.5 °C, and should contribute to reversing the decline in biodiversity; underlines in this regard also the importance of effective climate and biodiversity proofing of the budget;
Amendment 19 #
2019/2213(BUD)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Emphasises that in addition to achieving the Union’s climate and environmental ambitions, sufficient resources should be allocated for achieving a just transition; Stresses that the resources for achieving just transition should not be to the detriment of other EU programmes.
Amendment 58 #
2019/2213(BUD)
Draft opinion
Paragraph 6
Paragraph 6
6. Highlights that adequate resources should be allocated in the 2021 budget for the drawing-up and implementation of the future European plan to fight cancer; stresses that sufficient funding should also be allocated to tackle rare and non- communicable diseases, with special focus on research and prevention, as well as on fighting antimicrobial resistance; Stresses that resources allocated to ´A Europe Fit for the Digital Age´ should lead to an efficient, accessible and sustainable digital European Health Data Space where privacy, security, safety and accuracy of health data are guaranteed and where the control of personal health data stays with the European citizens.
Amendment 69 #
2019/2213(BUD)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Emphasises the need to ensure sufficient resources for the drawing up and implementation of the zero-pollution action plan for water, air and soil;
Amendment 71 #
2019/2213(BUD)
Draft opinion
Paragraph 8
Paragraph 8
8. Points to the importance of ensuring that sufficient financial resources are allocated in the 2021 budget to ensure adequate funding for the Union agencies, enabling them to fulfil their mandate and execute their tasks under the conditions of sustainable and predictable budgetary allocation; recalls in this regard also the current funding structure of ECHA.
Amendment 35 #
2019/2208(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. Whereas the lack of harmonization has a deep impact on return practices among Member States;
Amendment 83 #
2019/2208(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses the importance of ensuring compliance with return decisions and recalls the key principle enshrined in the directive that voluntary returns should be prioritised over forced returns, especially as it is less expensive and more sustainable;
Amendment 103 #
2019/2208(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights that under Article 7 of the directive, a return decision shall provide for an appropriate period for voluntary departure, of at least 30 days, which Member States have to extend where necessary, taking into account the specific circumstances of the individual case; stresses that a relatively short period for voluntary departure may hinder or altogether prevent voluntary departure;
Amendment 114 #
2019/2208(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that a broad definition of the risk of absconding may lead to Member States frequently refraining from granting a period for voluntary departure; recalls the need for a closed and exhaustive list of criteria’s to define strictly the risk of absconding; recalls that lifting the voluntary departure period also leads to the imposition of an entry ban, which may further undermine voluntary departure;
Amendment 126 #
2019/2208(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that return and entry-ban decisions on removal should be individualised, clearly justified with reasons in law and in fact, issued in writing, and complete with information about available remedies, in a language the person understands;
Amendment 136 #
2019/2208(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights that the directive allows for the temporary suspension of the enforcement of a removal, pending a decision relating to return; underlines the importance of such suspensive effect in cases where there is a risk of refoulement; notes that in most countries, appeal against return is not automatically suspensive, which may diminish protection and increase administrative burdens; an automatic suspensive remedy is necessary to harmonize the practices and ensure that people are not returning before the final decision;
Amendment 146 #
2019/2208(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Notes with regret the limited use of Article 6(4) of the directive; is concerned about the failure of Member States to issue a temporary residence permit where return has proven not to be possible; underlines the fact that granting residence permits to individuals who cannot return to their country of origin could help to prevent protracted irregular stays and facilitate individuals’ social inclusion and contribution to society; notes that this would also help to get people out of administrative limbos where they are left;
Amendment 206 #
2019/2208(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Notes that the directive establishes that returnees may lawfully be detained where other less coercive measures cannot be applied; expresses regret that despite the obligation to apply detention as a measure of last resort, in practice, very few viable alternatives to detention are developed and applied by Member States; calls on Member States, as a matter of urgency, to offer viable community-based alternatives to detention, which are proven to be better for migrants and Member States, since they cost less and have a less negative impact on migrants, especially children and vulnerable people;
Amendment 240 #
2019/2208(INI)
20a. Calls on the Commission and Member States to ensure the sustainability of returns by monitoring them and by funding reintegration programs in cooperation with third countries of origin.
Amendment 1 #
2019/2206(INI)
Motion for a resolution
Citation 3
Citation 3
— having regard to Articles 1, 2, 3, 4, and 18, 19 and 47 of the Charter of Fundamental Rights of the European Union,
Amendment 7 #
2019/2206(INI)
Motion for a resolution
Citation 4
Citation 4
— having regard to Articles 2, 3, 5, 8 and 813 of the European Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR),
Amendment 10 #
2019/2206(INI)
Motion for a resolution
Citation 12
Citation 12
— having regard to the judgements of the European Court of Human Rights related to Regulation (EU) No 604/2013, and in particular Sharifi v. Austria of 5 December 2013 (Chamber judgment), Mohammadi v. Austria of 3 July 2014 (Chamber judgment), Sharifi and Others v. Italy and Greece of 21 October 2014 (Chamber judgment), and Tarakhel v. Switzerland of 4 November 2014 (Grand Chamber judgment), and ECtHR - M.S.S. v Belgium and Greece [GC]; Application No. 30696/09, Judgement of 21 November 2011, related to Regulation (EC) No 343/2003 of 18 February 2003 (Dublin II)
Amendment 13 #
2019/2206(INI)
Motion for a resolution
Citation 27 a (new)
Citation 27 a (new)
— having regard to the European Parliament Resolution of 12 April 2016 on the situation in the Mediterranean and the need for a holistic EU approach to Migration (2015/2095(INI));
Amendment 14 #
2019/2206(INI)
Motion for a resolution
Citation 27 b (new)
Citation 27 b (new)
— having regard to the ECJ judgement of the 2 April 2020 on the joined cases C-715/17, C-718/17 and C- 719/17 Commission v Poland, Hungary and the Czech Republic;
Amendment 20 #
2019/2206(INI)
Motion for a resolution
Recital A
Recital A
A. whereas 2.5 million people applied for asylum in the European Union in the period 2015-2016, a fourfold increase compared to 2012-2013714,200 asylum applications were lodged in the EU in 2019;
Amendment 41 #
2019/2206(INI)
Motion for a resolution
Recital C
Recital C
C. whereas in the case of most asylum applications, the set of hierarchical criteria and the deadlines laid down as part of Dublin procedures are not met and transfers are not carried out;
Amendment 43 #
2019/2206(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas studies on the implementation of the Dublin III Regulation highlight systematic disregard towards family provisions and incorrect application of the principle of the best interest of the child, which have resulted in unnecessary and unreasonable transfer procedures;
Amendment 46 #
2019/2206(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the provisions on dependent persons (article 16) and the discretionary clauses (article 17) could be widely used to support family unity;
Amendment 48 #
2019/2206(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Amendment 51 #
2019/2206(INI)
Motion for a resolution
Recital C d (new)
Recital C d (new)
Cd. whereas the preventive action provision of the Dublin III Regulation (Article 33) has never been used;
Amendment 53 #
2019/2206(INI)
Motion for a resolution
Recital C e (new)
Recital C e (new)
Amendment 55 #
2019/2206(INI)
Motion for a resolution
Recital C f (new)
Recital C f (new)
Cf. whereas implementation of the Dublin III Regulation does not effectively address secondary movements which are largely due to asylum seekers' social- connections with specific countries, protection-based concerns, health reasons and systemic deficiencies in the asylum systems where application are made;
Amendment 56 #
2019/2206(INI)
Motion for a resolution
Recital C g (new)
Recital C g (new)
Cg. whereas Article 28 of the Dublin Regulation allows detention as an exceptional measure "to secure transfer procedures", where there is "significant risk of absconding" of the applicant; whereas this definition remains unclear and the interpretation varies from a Member State to another;
Amendment 59 #
2019/2206(INI)
Motion for a resolution
Recital C h (new)
Recital C h (new)
Ch. whereas the use of detention and coercive transfers raises concerns with respect to asylum seekers' right to liberty, dignity and physical integrity;
Amendment 62 #
2019/2206(INI)
Da. whereas some of the flaws are inherent in the design of the Regulation and cannot be solved through better implementation alone;
Amendment 78 #
2019/2206(INI)
Motion for a resolution
Subheading 1
Subheading 1
Incorporating the principle of solidarity into the management of asylum seekersDublin Regulation
Amendment 79 #
2019/2206(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
Amendment 94 #
2019/2206(INI)
Motion for a resolution
Paragraph 1 – point 1 (new)
Paragraph 1 – point 1 (new)
(1) Points out that the Dublin Regulation, as designed and implemented, has failed to guarantee a fair distribution of responsibility between Member States and swift access to international protection;
Amendment 98 #
2019/2206(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Considers that the Dublin System, and in particular the first country of irregular entry criterion places a significant burden on a minority of Member states;
Amendment 99 #
2019/2206(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Urges the EU to establish an automatic, permanent and mandatory relocation mechanism ensuring the full respect of the principle of solidarity and fair sharing of responsibility enshrined in art.80 of TFEU; including for those rescued at sea;
Amendment 109 #
2019/2206(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that ad hoc agreements are no substitute for a harmonised and sustainable policy at EU levelCommon European and Asylum System; deplores the fact that efforts to overhaul the Dublin III Regulation have been blocked in the Council;
Amendment 117 #
2019/2206(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes that the crisis management tool provided for in Article 33 did not provide effective support to the Member States, nor did it offer a response to the consequences of the COVID-19 crisis; considers that a solidarity-based crisis management mechanism, endowed with a financial instrument managed by the Commission,mechanism for early warning, preparedness and crisis management as set out in Article 33 has not been applied to date, considers that a solidarity-based mechanism in the EU should be established to ensure continuity of the right of asylum in the EU uander the best possible conditions not to hinder arrivals and deflect responsibility; emphasizes that the protection of fundamental rights of asylum applicants should always remain at the centre of this mechanism; also notes that the provisions set out in the Temporary Protection Directive has yet to be invoked;
Amendment 124 #
2019/2206(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Considers that such a mechanism should allow for the participation of civil society organization providing professional assistance to people in need of international protection during the assessment of their asylum application, particularly of legal nature;
Amendment 130 #
2019/2206(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Member States to makexpand the use of the discretionary clause in Article 17 when exceptional, to address challenging situations and humanitarian circumstances so warrant,, as for example to relocate and provide decent reception conditions to asylum seekers currently living in the Greek hotspots in an atmosphere of extreme tension and to provide decent receptioninhumane, degrading, unsanitary and unsafe conditions;
Amendment 134 #
2019/2206(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Takes the view that provisions on family unity, which are the first in the hierarchy of criteria, should be efficiently implemented, and that provisions on dependent persons (article 16) and the discretionary clauses (article 17) should be used more widely to support family unity;
Amendment 136 #
2019/2206(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. In the absence of a permanent solidarity mechanism, supports the expanded use of discretionary clauses of Article 17 as a solidarity tool for responsibility sharing in particular in situations of large number of spontaneous arrivals and in the specific context of sea arrivals and disembarkation procedures;
Amendment 140 #
2019/2206(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 155 #
2019/2206(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Highlights the significant operational backing for Dublin proceduresand technical support provided by the European Asylum Support Office (EASO) in the hotspotto Member States; calls on the Commission and the Member States to facilitate the work of EASO staff by allowing interviews in a language other than that of the country in which they are conductedand the Commission to increase assistance to Member States, especially those at the border of the EU; calls for the establishment of a European Asylum Agency, with sufficient financial and human resources, supporting Member States with Dublin procedures;
Amendment 159 #
2019/2206(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to monitor that interviews are conducted in the language of the asylum seeker or in a language that the applicant is reasonably supposed to understand;
Amendment 161 #
2019/2206(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. PDeplores that the rights of asylum seekers, including that to legal assistance, are often neglected when implementing the Dublin III Regulation, points out that the protection of fundamental rights must be at the heart of the measures taken to implementEU asylum policies and of the implementation process of the Dublin III Regulation, including the protection of childrenminors, victims of trafficking, victims of torture, and the most vulnerable;
Amendment 169 #
2019/2206(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Recalls that asylum seekers have the right to be fully informed on the procedures; regrets that the level of information provided to asylum seekers differs consistently from one Member state to another; urges the Member states to guarantee that minors have tailored, child-friendly information and specific support; stresses that providing legal assistance and interpretation are key to ensure applicants' right to information;
Amendment 174 #
2019/2206(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Points out that transfers of asylum seekers, and in particular vulnerable people, minors and families can result in violations of their human rights; urges Member states to properly assess the risks to which applicants would be exposed in the Member States of destination; stresses in particular that transfers must be carried out in a way that under no circumstances exposes individuals to a risk of refoulement, irrespective of whether the asylum system of return is affected by systemic deficiencies;
Amendment 175 #
2019/2206(INI)
Motion for a resolution
Paragraph 7 c (new)
Paragraph 7 c (new)
7c. Deplores that Member states resort too often to the detention of applicants waiting to be transferred; urges Member states to make concrete efforts to find valid alternatives to detention;
Amendment 180 #
2019/2206(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the Commission to monitor compliance with the hierarchy of criteria more closely; regards it as essential to clarify the conditions for applying the family reunification criterion and toenable a better use of the family provisions, including by harmoniseing the standards of proof required; callacross Member states oin the Member States and the Commission to protect the best interests of children and to clarify the criteria for keeping children in detentiondirection of less stringent and more achievable standards; calls the Commission and the Member states to speed up family reunification procedures including through an immediate transfer to a country in which the applicant has family;
Amendment 188 #
2019/2206(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Regrets that Member states do not proactively contribute to the identification and verification of the family links; deplores that the burden of proof is almost entirely left to the applicants;
Amendment 191 #
2019/2206(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Points out that the narrow definition of family contributes to the lack of compliance with the hierarchy of criteria and the dysfunctionality of the system;
Amendment 192 #
2019/2206(INI)
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8c. Calls on the Member States and the Commission to ensure an adequate verification of the best interest of the child, avoiding that the complexity of the procedures results in the failure to implement this principle, in particular for the unaccompanied minors of age between 16 and 18;
Amendment 193 #
2019/2206(INI)
Motion for a resolution
Paragraph 8 d (new)
Paragraph 8 d (new)
8d. Regrets that Member states apply different interpretation of the best interest of the child; calls therefore the Commission to clarify the definition in line with EU legislation and to identify which family reunification possibilities, security and safety considerations, background information should be taken into consideration;
Amendment 194 #
2019/2206(INI)
Motion for a resolution
Paragraph 8 e (new)
Paragraph 8 e (new)
8e. Urges the Member States and the Commission to clarify that detention is never in the best interest of the child and that a minor should never be detained because of the migratory status of their family; calls to expand the sources used for the monitoring and identification of unlawful practices to include information provided by international and non- governmental organizations where it is reliable, up-to-date and specific;
Amendment 195 #
2019/2206(INI)
Motion for a resolution
Paragraph 8 f (new)
Paragraph 8 f (new)
8f. Deplores that insufficient identification mechanisms and erroneous methods of age assessment often further exacerbate the situation of minors, causing delays or affecting negatively the outcome of the Dublin procedure; calls for an harmonized age assessment that do not endanger minors' rights, health and psychological well-being;
Amendment 206 #
2019/2206(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that the number of transfer procedures has increased significantly, generating considerable human, material and financial costs; deplores, however, the fact that in only 11% of cases are transfers actually carried out, a further factor in the permanent overloading of asylum systems; stresses the lack of cooperation and information-sharing between Member States; regards efforts to combat secencourages Member states to apply the discretiondary movements as essential in order to reduce the number of transfer requests; proposes thatclause more swiftly in cases where it becomes evident that transfers cannot be carried out, or where the coinditions which trigger transfer procedures be clarified and harmonisedvidual situation of the applicant requires so;
Amendment 219 #
2019/2206(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers that in some cases the rules on transfer of responsibility under Dublin III undermine the efficiency of asylum procedures and the carrying-out of transfers and, according to the evidence, that in many cases asylum seekers remain outside of the system due to disproportionate use of the criterion of the first countribute to the increase in the number of secondary movements by encouraging asylum-seekers to remain outside the systemy of irregular entry and the insufficient consideration of the meaningful links and the particular needs of the applicants; calls on the Commission to revise the rules, in order to give Member States sufficient time to carry out transfers and do away with transfer of responsibility in cases where anincrease trust between Member States and between them and the asylum seeker absconds;
Amendment 228 #
2019/2206(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Considers that providing asylum seekers with legal assistance in connection with Dublin procedures, in particular in the hotspots, would simplify the process of obtaining asylum would enhance rights-compliant procedures, simplify Dublin procedures and improve decision- making; calls on the Member States to improve the information made available to asylum seekers on the complex Dublin procedures, to ensure that it is clear and accessible to everyone;
Amendment 232 #
2019/2206(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Member States to increase the resources necessary to make Dublin III operational, particularly the number of asylum officers; calls on the European Commission to increase the funds available for the provision of legal assistance, especially funding for civil society professionals offering legal assistance to people in need of international protection during the Dublin procedure;
Amendment 235 #
2019/2206(INI)
Motion for a resolution
Subheading 4
Subheading 4
A singlerights-centred asylum application in the EU
Amendment 239 #
2019/2206(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that the principle of a single asylum application in the EU is consistently flouted, a state of affairs at odds with the very purpose of the Dublin III Regulation; considernotes that the competent national authorities should share their relevant information on a European database such as Eurodac, in order to speed up procedures and prevent multiple asylum applications, while protecting personal datare are multiple reasons for submission of additional asylum applications;
Amendment 249 #
2019/2206(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Notes that the rate of protection for asylum seekers varies greatly between Member States for certain nationalities; considers that a common list of safe countries and a shared country-risk analysis, or at least greater convergence, would reduce these disparities, and thus also the number of secondary movements; stresses that the return of persons not eligible for asylum is a prerequisite for the effectiveness of the Dublin III Regulation and this can contribute to onward movement; considers that accounting for individual needs of the applicant in the Dublin procedures would reduce secondary movements; calls for the inclusion of a relocation criteria considering the "genuine links" with a particular Member state as an efficient approach to reduce secondary movements;
Amendment 261 #
2019/2206(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 276 #
2019/2206(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Proposes that EASO be given an expanded role in analysing the flows of and pathways taken by asylum seekers, in order to better anticipate and understand pressures on asylum systemssupporting Member states in the implementation of the Dublin III Regulation;
Amendment 282 #
2019/2206(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Urges the Commission and the Council to work towards convergence in the bilateral agreements concluded between Member States and with thirdimplementation of the Dublin III Regulation by taking stock of the elements countries, in order to optimise implementation of the Dublin III Regubuting to greater efficiency, and compliance with human rights legislation;
Amendment 286 #
2019/2206(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Urges the Council to find a sustainable solution and take the necessary steps to adopt a position on the Dublin Recast Regulation by qualified majority;
Amendment 287 #
2019/2206(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Proposes that a fairer system of allocation be a priority for any reform of the Dublin system while keeping the protection of fundamental rights of applicants at the centre of the functioning of the solidarity mechanism;
Amendment 38 #
2019/2201(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas, on March 2019, the European Commission, as a response to a Parliament’s request, declared it would continue to apply strict conditionality to its financial assistance to Moldova, and together with the EEAS, will monitor and assess Moldova's progress in implementation of DCFTA/AA with the EU in all sectoral areas, through both bilateral and Eastern Partnership regional channels;
Amendment 96 #
2019/2201(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Underlines that the situation in Moldova should be closely monitored in the long term, including during the pre- electoral period, in accordance with the normal OSCE/ODIHR practices and standards, particularly in the current period of crisis, as the forthcoming presidential elections will be a test for democracy and the rule of law in the country;
Amendment 138 #
2019/2201(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
Amendment 9 #
2019/2169(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas gender equality is a core value of the EU, a fundamental right and a key principle of the European Pillar of Social Rights and at the same time a prerequisite for an innovative, competitive and prosperous European economy;
Amendment 13 #
2019/2169(INI)
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas gender-based violence remains one of the greatest challenges facing our societies, and whereas it is deeply-rooted in gender inequality, still does not receive sufficient media attention and is overlooked both inside and outside the EU;
Amendment 25 #
2019/2169(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that, working together, the EU institutions and Member States need to deepen their engagement with civil society, including women’s movements and organisations, and with international organisations, in order to make progress on gender equality and continue being global leaders.
Amendment 46 #
2019/2169(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Welcomes the Commission initiative to launch an EU network on the prevention of gender-based violence and domestic violence, bringing together all Member States and stakeholders to exchange good practices and to fund training, capacity-building and support services.
Amendment 47 #
2019/2169(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes that violence against women on the grounds that they are women or violence deliberately affecting women is one of the greatest challenges facing our societies; urges the Commission therefore to take steps to prevent and combat gender violence and to support and protect the victims of such offences;
Amendment 72 #
2019/2169(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Believes that, in view of the rapid transformation and digitalisation of the economy and of the labour market, where 90% of jobs require basic digital skills, it is crucial that women help to build the future and that many more girls than is currently the case acquire IT skills so they can play a role in shaping the digital world of tomorrow.
Amendment 89 #
2019/2169(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Welcomes the fact that the Commission has stepped up its efforts to ensure respect for EU standards on work- life balance so that both women and men can have a genuine opportunity to choose how they develop their personal and professional lives;
Amendment 1 #
2019/2159(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
— having regard to Regulation (EU) 1380/2013 of the European Parliament and the Council of 11 December 2013 on the Common Fisheries Policy,
Amendment 3 #
2019/2159(INI)
Motion for a resolution
Citation 1 b (new)
Citation 1 b (new)
— having regard to Regulation (EU) of the European Parliament and of the Council of 5 June 2019 amending Regulation (EU) 1343/2011 on certain provisions of fishing in the GFCM (General Fisheries Commission for the Mediterranean) Agreement area,
Amendment 5 #
2019/2159(INI)
Motion for a resolution
Citation 1 c (new)
Citation 1 c (new)
— having regard to Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (the 'Habitats Directive'),
Amendment 6 #
2019/2159(INI)
Motion for a resolution
Citation 1 d (new)
Citation 1 d (new)
— having regard to Directive 2014/89/EU of the European Parliament and the Council of 23 July 2014 establishing a framework of maritime spatial planning ('Maritime Spatial Planning Directive'),
Amendment 7 #
2019/2159(INI)
Motion for a resolution
Citation 1 e (new)
Citation 1 e (new)
— having regard to Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive),
Amendment 8 #
2019/2159(INI)
Motion for a resolution
Citation 1 f (new)
Citation 1 f (new)
— having regard to Regulation (EU) No 508/2014 of the European Parliament and of the Council pf 15 May 2014 on the European Maritime and Fisheries Fund and repealing Council Regulations (EC) No 2328/2003, (EC) No 861/2006, (EC) No 1198/2006 and (EC) No 791/2007 and Regulation (EU) No 1255/2011 of the European Parliament and of the Council,
Amendment 9 #
2019/2159(INI)
Motion for a resolution
Citation 1 g (new)
Citation 1 g (new)
— having regard to Regulation of the European Parliament and of the Council of ... 2021 on the European Maritime, Fisheries and Aquaculture Fund and amending Regulation (EU) 2017/10041a _________________ 1aOJ L ... (not yet published in the Official Journal)
Amendment 10 #
2019/2159(INI)
Motion for a resolution
Citation 1 h (new)
Citation 1 h (new)
— having regard to the amendments adopted by the European Parliament on 10 March 2021 on the proposal for regulation of the European Parliament and of the Council amending Council regulation (EC) No1224/2009, and amending Council regulations (EC) No 768/2008, (EC) No1967/2006, (EC) No 1005/2008. and Regulation (EU) No 2016/1139 of the European Parliament and of the Council as regards fisheries control1b, _________________ 1b TA-PROV...
Amendment 11 #
2019/2159(INI)
Motion for a resolution
Citation 2
Citation 2
— having regard to the mid-term strategy (2017-2020) of GFCM towards the sustainability of Mediterranean and Black Sea fisheries and the decision on a new strategy for the period 2021-2025,
Amendment 12 #
2019/2159(INI)
Motion for a resolution
Citation 2 a (new)
Citation 2 a (new)
— having regard to the GFCM decision on building together of a new strategy for Mediterranean and Black Sea fisheries and aquaculture for the period 2021-2025, which was taking during the High-Level Meeting of 3 November 2020,
Amendment 13 #
2019/2159(INI)
Motion for a resolution
Citation 2 b (new)
Citation 2 b (new)
— having regard to the EC proposals on the European Green Deal and on the EU Biodiversity strategy for 2030,
Amendment 14 #
2019/2159(INI)
Motion for a resolution
Citation 3
Citation 3
— having regard to Ministerial Declarations adopted at the meetings in Burgas (31 May 2018) and Bucharest (9 May 2019) on a Common Maritime Agenda for the Black Sea, which have been signed by all 6 littoral Black Sea states,
Amendment 15 #
2019/2159(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
— having regard to the Charter of the Organization of Black Sea Economic Cooperation, which aims at improving the policy dialogue, among other numerous policies, in the areas of environmental protection and exchange of statistical data,
Amendment 16 #
2019/2159(INI)
Motion for a resolution
Citation 3 b (new)
Citation 3 b (new)
— having regard to the Strategic Research and Innovation Agenda for the Black Sea (SRIA), which was launched in 2019 and aims at advancing a shared vision for a productive, healthy, resilient and sustainable Black Sea by 2030,
Amendment 18 #
2019/2159(INI)
Motion for a resolution
Citation 5
Citation 5
— having regard to the 1992 Convention for the Protection of the Black Sea aAgainst Pollution and its Protocols, to which Bulgaria and Romania are parties and in respect of which the European Union has observer status, and also having regard to the work of the Commission on the protection of the Black Sea Against Pollution on the basis of this Convention,
Amendment 19 #
2019/2159(INI)
Motion for a resolution
Citation 5 a (new)
Citation 5 a (new)
— having regard to the Protection of the Black Sea Ministerial Declaration of 7 April 1993,
Amendment 20 #
2019/2159(INI)
Motion for a resolution
Citation 5 b (new)
Citation 5 b (new)
— having regard to the Black Sea integrated monitoring and assessment programme for years 2017-2022 (BSIMAP 2017-2022),
Amendment 21 #
2019/2159(INI)
Motion for a resolution
Citation 6
Citation 6
— having regard to the BlackSea4Fish project with the financial support of the EU and annual budget of around 1 100 000 EUR for ensuring the sustainable management of fish stocks in the Black Sea,
Amendment 22 #
2019/2159(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
— having regard to the Recommendation GFCM/42/2018/9 on establishing a regional research programme towards the sustainable exploitation of rapa whelk (Rapana venosa) in the Black Sea, which aims at providing an estimate of the distribution, abundance, size and age structure of the rapa whelk population in the participating countries - Bulgaria, Romania, Turkey, Georgia and Ukraine,
Amendment 25 #
2019/2159(INI)
Motion for a resolution
Citation 6 b (new)
Citation 6 b (new)
— having regard to the 1995 FAO code of conduct for responsible fisheries,
Amendment 26 #
2019/2159(INI)
Motion for a resolution
Citation 6 c (new)
Citation 6 c (new)
Amendment 27 #
2019/2159(INI)
Motion for a resolution
Citation 6 d (new)
Citation 6 d (new)
— having regard to Recommendation GFCM/33/2009/8 of the GFCM on the establishment of a list of vessels presumed to have carried out IUU fishing in the GFCM area of application,
Amendment 28 #
2019/2159(INI)
Motion for a resolution
Citation 6 e (new)
Citation 6 e (new)
— having regard to the online regional platform - GFCM Regional Repository of National Legislation (GFCM-Lex), which encompasses national legislation on the conservation of marine living resources and ecosystems in three GFCM countries at the moment aiming at covering the whole GFCM area (including the Black Sea) in the future,
Amendment 29 #
2019/2159(INI)
Motion for a resolution
Citation 7
Citation 7
— having regard to the Berne Convention, the Bon Convention (CMS), CITES, the Convention on Biological Diversity (CBD), the Pan-European Action Plan for Sturgeons (PANEUAP) adopted within the framework of the Berne Convention,
Amendment 32 #
2019/2159(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
— having regard to its resolution on Measures to promote recovery of fish stocks above MSY from 21 January 20211c, _________________ 1c P9_TA(2021)0017
Amendment 34 #
2019/2159(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
— having regard to the Black Sea Assistance Mechanism, which aims at providing guidance and support to governments, private investors, trade and industrial associations, research institutions, universities and the general public regarding opportunities to engage in Blue economy maritime activities in the Black Sea region,
Amendment 35 #
2019/2159(INI)
Motion for a resolution
Citation 9 b (new)
Citation 9 b (new)
— having regard to the EU Black Sea Synergy Initiative, and the three reports on the implementation of the Black Sea Synergy from 2008, 2015 and 2019,
Amendment 36 #
2019/2159(INI)
Motion for a resolution
Citation 9 c (new)
Citation 9 c (new)
— having regard to the EU strategy for the Danube region, which among other things aims at facilitating and coordinating key issues such as biodiversity, socio-economic development and others, in the countries from the Danube River basin,
Amendment 37 #
2019/2159(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the Black Sea is a semi- enclosed sea, which is only connected to an ocean by the Mediterranean via the Marmara and the Aegean Seas and is bordered upon by six countries (Bulgaria, Romania, Turkey, Georgia, Ukraine, the Russian federation), of which only two are EU Member States (Bulgaria and Romania);
Amendment 41 #
2019/2159(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the Black Sea has a large anoxic layer (87%) and its oxic layer has thinned by 20 to 25 metres over the last 20 years; whereas with the exception of few anaerobic bacteria, marine life is absent at depths below 50-200 m under the sea surface;
Amendment 42 #
2019/2159(INI)
Motion for a resolution
Recital C
Recital C
C. whereas eight species fished in the Black Sea are of major interest to the fishing sector (European anchovy (Ergaulis encrasicolus), European sprat (Sprattus sprattus), horse mackerel (Trachurus mediterraneus), turbot (Scophthalmus maximus), whiting (Merlangius merlangus), red mullet (Mullus barbatus), Rapa whelk (Rapana venosa), Piked dogfish (Squalus acanthias), most of which form part of shared stocks, while two species are subject to quotas – sprat (Sprattus sprattus), which has an autonomous quota) and turbot (quota set by the GFCM); Scophthalmus maximus), which has a TAC quota set by the GFCM; where as the quota for sprat for the period 2020-2022 remained unchanged since 2011 at the rate of 11 445 tonnes per year for the EU (8 032,5 tonnes for Bulgaria and 3 442,5 tonnes for Romania), while that for turbot was increased for the EU from 114 to 150 tonnes per year, divided equally between Bulgaria and Romania;
Amendment 44 #
2019/2159(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas a system of maximum sustainable yields for the economically important species in place in the Black Sea countries will be beneficial for the biodiversity, but also the sustainability of the fishing sector in mid- and long-term; whereas Romania has put in place a national quota for other species than the 2 quoted on EU level - such as rapa whelk (Rapana venosa), mussels (Mytilus galloprovincialis), gobies (Ponticola cephalargoides), clam (Chanelea gallina), whiting (Merlangius merlangus), piked/spiny dogfish (Squalus acanthias);
Amendment 45 #
2019/2159(INI)
Motion for a resolution
Recital D
Recital D
D. whereas, according to 2018 figures, annual fish consumption per capita in Bulgaria (7.00 kg) and Romania (7.99 kg) is well below the EU average (24.36 kg), which can be seen as an opportunity for the local fishing sector to grow;
Amendment 46 #
2019/2159(INI)
Motion for a resolution
Recital E
Recital E
E. whereas on average 91% of the Black Sea fishing fleet of all 6 littoral countries consists of small vessels,; which make upereas almost 95% of the Bulgarian fleetand 87% of the Romanian fleet falls under this category;
Amendment 49 #
2019/2159(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas the small-scale fishing is characteristic for the Black Sea and Lower Danube region;
Amendment 50 #
2019/2159(INI)
Motion for a resolution
Recital F
Recital F
F. whereas illegal, unreported and unregulated fishing vessels are operating in the Black Sea; whereas per the latest available data of GFCM from 4-8 November 2019 there have been 65 vessels identified as IUU fishing vessels;
Amendment 52 #
2019/2159(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the EMFF allocated more than EUR 88 million to Bulgaria and more than EUR 168 million to Romania for the period 2014-2020; whereas the absorption rates of both countries according to the latest available information until 31.12.2020 remain among the lowest in the EU at rates of funds spent at 36,34% for Bulgaria and 33,72% for Romania; whereas lower absorption rates could mean missed opportunities for the fishing communities in these countries;
Amendment 55 #
2019/2159(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
H a. whereas climate change has an impact on the increase of the aerial temperature, which on the other hand has an impact on the marine temperature, which affects the biodiversity and the marine species; whereas this change has an impact on the fishing sector through the resources, which it depends on;
Amendment 56 #
2019/2159(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
H b. whereas the European Commission has proposed the EU Green Deal and the EU Biodiversity strategy for 2030, which foresee legislative packages changing the acquis communataire in relation to the environment; whereas this would create new opportunities and measures to better integrate environmental aspects in sectorial policies, restore species and habitats and promote more environmentally friendly investments and policies;
Amendment 58 #
2019/2159(INI)
Motion for a resolution
Recital I
Recital I
I. whereas according to the report drawn as part of the EMBLAS-Plus project on the Black Sea, the Black Sea has almost twice as much waste as the Mediterranean Sea, which undoubtedly has consequences for the biodiversity and respectively for the stocks and the fishing sector;
Amendment 59 #
2019/2159(INI)
Motion for a resolution
Recital J
Recital J
J. whereas the Black Sea has three endemic sub-species of cetaceans, two of which have the status of endangered species; whereas - Black Sea common dolphin (Delphinus delphis ponticus), Black Sea common bottlenose dolphin (Tursiops truncatus ponticus) and Black Sea harbour Porpoise (Phocoena phocoena relicta), all of which are classified as endangered species and two of them Black Sea common bottlenose dolphin (Tursiops truncatus ponticus) and Black Sea harbour Porpoise (Phocoena phocoena relicta) are included under the Habitats Directive; whereas all of these these are carnivores which feed mainly on fish;
Amendment 60 #
2019/2159(INI)
Motion for a resolution
Recital K
Recital K
K. whereas the veined rapa whelk (Rapana venosa) is a source of income, but is an invasive species thatconsidered as an invasive species without natural enemies in the Black Sea, which poses a serious threat to the populations of other organisms, however at the same time it has become an important source of income and is also a species subject of commercial fishing;
Amendment 62 #
2019/2159(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the Black Sea ecosystem depends on major European rivers such as the Danube; whereas both the Danube and the Black Sea are home to certain species, including the sturgeons (Acipenseriformes) and the Pontic shads (Clupeiformes);
Amendment 65 #
2019/2159(INI)
Motion for a resolution
Recital M
Recital M
M. whereas factors such as the degradation of the habitat of these species, disruption of their migration corridors and their overexploitation for caviar and their flesh, as well as pollution, have brought Danube and Black Sea sturgeon to the verge of extinction; whereas, due to the drastic reduction in the number of reproductive sturgeon, this species can no longeronly very rarely breed in the wild nowadays;
Amendment 66 #
2019/2159(INI)
Motion for a resolution
Recital M a (new)
Recital M a (new)
M a. whereas the drastic decrease of the number of spawners, associated with the population decline, trigger the failure of the natural reproduction, reducing the chance of the few remaining male and female sturgeons to meet and spawn;
Amendment 67 #
2019/2159(INI)
Motion for a resolution
Recital M b (new)
Recital M b (new)
M b. whereas the data held by the research institutes indicate that the populations of sturgeon species are fragmented, missing certain generations, and the species of sturgeon natural reproduction is deficient, the number of adults migrating to the Danube for reproduction is extremely low and the 5 sturgeon species (sterlet (Acipenser ruthenus), Russian sturgeon (Acipenser gueldenstaedtii), starry sturgeon (Acipenser stellatus), European sturgeon (Acipenser sturio) and beluga sturgeon (Huso huso)) are on the verge of extinction, while the species ship sturgeon (Acipenser nudiventris) is already considered extinct;
Amendment 68 #
2019/2159(INI)
Motion for a resolution
Recital M c (new)
Recital M c (new)
M c. whereas the EU fishery sector already applies high standards, which need to be reviewed and adjusted in order to ensure environmental and social sustainability along the entire value chain, including labour rights and animal health and welfare, and provide high- quality fishery products;
Amendment 69 #
2019/2159(INI)
Motion for a resolution
Recital M d (new)
Recital M d (new)
M d. whereas the recreational fisheries sector can provide opportunities, such as activity or income diversification, while being compatible with environmental objectives, given that recreational angling is a very selective form of fishing;
Amendment 70 #
2019/2159(INI)
Motion for a resolution
Recital N
Recital N
N. whereas the COVID-19 pandemic is having a serious impact on the Black Sea fishing sector; whereas analyses showed that the fisheries sector in the Black Sea suffered drastically during the pandemic with reduction of up to 80% of the work of the operating ships as well as initial reduction with around 75% of the production;
Amendment 72 #
2019/2159(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the need to strengthen cooperation with third countries in the region with a view to efficiently managing fisheries resources and meeting challengUnderlines the high strategic and geopolitical stakes in the Black Sea basin due to the very specific environmental conditions, which demand special attention, tailored approach and collective actions aiming at sustainable Blue Economy and Growth; stresses the need to further strengthen and deepen the cooperation among all littoral Black Sea countries with a view to efficiently managing fisheries resources and meeting challenges; calls in this regard for a regional capacity plan, which ensures appropriate balance among available natural resources, environmental safety and the fleet capacity of all Black Sea littoral countries;
Amendment 76 #
2019/2159(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Highlights that cooperation on equal footing in the field of fisheries management is needed in the Black Sea region because of the shared stocks and global challenges, which go beyond national borders;
Amendment 79 #
2019/2159(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Urges the inclusion of all Black Sea countries in the GFCM-Lex project in order to facilitate and coordinate better and faster the common management of fish stocks;
Amendment 80 #
2019/2159(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that statistics show that a large proportion of keyIs concerned that after decades of increasing human pressure on the Black Sea marine and the Danube river's ecosystems and fisheries resources, the latest data suggests that more than 75% of the fish stocks are being overfished; stresses that this has been a growing trend in recent years; notes that there have been some positive trends in the past years for some stocks, for example the turbot, whose TAC quota has been increased for the period 2020-2022, however there is no significant improvement on a general scale for the Black Sea yet;
Amendment 83 #
2019/2159(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Recognizes the role of the administrations in the whole Black Sea basin, which bring together different policies and which execute monitoring, control, sustainable management, which contribute to improving the sustainability of the fishing sector;
Amendment 84 #
2019/2159(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2 b. Calls on the Bulgarian and Romanian authorities to help the sector through securing resources specifically targeted at improving the selectivity of the fishing vessels through better mesh nets; believes that such a targeted measure will reduce the quantities and varieties of unwanted by-catch;
Amendment 85 #
2019/2159(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2 c. Calls for integrating of the institutional and human capital of the Black Sea littoral countries for joint research and applied activities aiming at improvement of the bio resources of the Black Sea and the stocks of the economically important species;
Amendment 89 #
2019/2159(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for funding for scientific bodies researching stocks both of fish species, including migratory species such as the sturgeon and the Black Sea shads, and non-fish species (veined whelks, mussels, etc.);
Amendment 90 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Welcomes the regional research programme on the population of the rapa whelk initiated by GFCM as it will help reach consensus on the species; believes that this can help develop science-based exploitation, which could bring socio- economic profits to the communities and environmental benefits for the Black Sea ecosystem by limiting the impact of this invasive species;
Amendment 91 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Stresses the importance of applying zero-tolerance policy towards IUU fishing in the Black Sea; welcomes the efforts of GFCM in this regard and urges all littoral states to put and combine efforts against IUU fishing also in their waters;
Amendment 92 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3 c. Urges all littoral states to promote sustainable fishing which among other things includes combating overfishing and or limiting to zero by-catches of endangered species, such as the sturgeons, shads and others;
Amendment 93 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
3 d. Urges all intergovernmental institutions and organs, with participation of all Black Sea littoral states among others, to facilitate and monitor and in line with their commitments to share data on fishery resources in a thorough and all-inclusive manner in order to ensure high ecosystem status of the marine habitats;
Amendment 94 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3 e. Reminds that reliable official statistics, collected regularly through a harmonised methodology among all littoral states, regular monitoring and common regulatory measures are crucial for the success of proper fisheries management in the Black Sea; calls in this regard the respective authorities in both member states and also the cooperating countries to conduct regular and thorough research on the fish resources for which national funding and aid is be key;
Amendment 95 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 f (new)
Paragraph 3 f (new)
3 f. Stresses the need also for local and regional communication cooperation within the different Black Sea littoral states, so that common and coherent approach to the management of the fish stocks can be executed;
Amendment 96 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 g (new)
Paragraph 3 g (new)
3 g. Reminds the potential, which the new technologies provide and the high added value to the research and planning of the fisheries management which they can have; reminds that there are projects funded through the EMFF which aim among other things at mapping the sea bottom and its research as well as presence of plastics in it, among other things;
Amendment 97 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 h (new)
Paragraph 3 h (new)
3 h. Urges the Black Sea littoral states to invest in digitalisation of statistics and data about the fisheries stock in the Black Sea basin in order to facilitate the better and sustainable management of the stocks; calls for a common methodology on tabling and using this data;
Amendment 98 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 i (new)
Paragraph 3 i (new)
3 i. Calls on the fishing industry in the region to consider making use of the underrated and not used resources of fishing, which also constitute a source of proteins;
Amendment 99 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 j (new)
Paragraph 3 j (new)
3 j. Invites the scientific communities in the member states to research the potential of the oxygen free environment;
Amendment 100 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 k (new)
Paragraph 3 k (new)
3 k. Highlights the role of the non- governmental sector in the decision- making process vis-à-vis the Black Sea; recommends setting up a mechanism of inclusion of the NGO sector in this process;
Amendment 101 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 l (new)
Paragraph 3 l (new)
3 l. Welcomes the support that was provided to the fisheries and aquaculture sector through the EMFF programmes in order to soften the harsh effects of the Covid-19 pandemic on the local fishing sector; recalls however that not all affected stakeholders could benefit from that support due to administrative requirements and limitations, which has put some in more unfavourable situation than others;
Amendment 102 #
2019/2159(INI)
Motion for a resolution
Paragraph 3 m (new)
Paragraph 3 m (new)
3 m. Underlines the important work, which the Black Sea Advisory Council does both on regional, but also EU level with providing expertise on the fisheries sector and the trends, which affect it; calls in this regard the Bulgarian and Romanian authorities to contribute for the functioning of the Council, so that it can fulfil its functions and also allow all stakeholders, the small-scale fishers included, to take part in the work and the decision-making process of this advisory council;
Amendment 103 #
2019/2159(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses that through the fishing sector seafood can be offered for sale on local markets where consumption rates for such products are low; invites the competent authorities in Bulgaria and Romania to help the fishing and aquaculture sectors increase awareness about local consumption and the cumulative positive effects the sustainably grown or caught fisheries have for the local economy;
Amendment 104 #
2019/2159(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Recognizes and underlines that Black Sea fisheries contribute to regional and local economies significantly by generating direct revenues and incomes, driving wider spending and providing crucial jobs either independently or via cooperation with other sectors such as tourism and transport; calls for deepening the cooperation among all sectors, which use the marine environment in order to achieve better results and balance between the interests of the environment, the industry and the artisanal fishers;
Amendment 106 #
2019/2159(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Recalls that the fishing fleet of the Black Sea comprises mostly by small-scale fishing vessels, which underlines the need for a more tailor-made approach and policies towards this segment of the fishing sector; is worried that the small- scale fishers have uncertain livelihoods and lower incomes compared to other sectors, which makes them vulnerable to unforeseen developments or crisis; calls on the competent authorities in the littoral member states to include representatives of the small-scale fishing sector in the policy draft and discussions in a transparent and inclusive manner;
Amendment 107 #
2019/2159(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points out that there is rising global demand for the proteins found in fishery and aquaculture products, to which both the fisheries and the aquaculture production can have great contribution; considers that the possibility of supporting marine aquaculture can help the sector develop and grow in the years to come and also reduce the pressure on the wild stocks; is of the opinion, that sustainable aquaculture would require also further scientific research on issues such as density and side effects, which need to be taken into account, when designing policies for the aquaculture sector in the Black Sea;
Amendment 108 #
2019/2159(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on local fishing communities to consider classifyingintroducing designations origin for the Black Sea products as coming from an area of regional or local importance; calls on the local and regional authorities help these communities in their efforts of doing so;
Amendment 109 #
2019/2159(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Member States in the region to consider supporting the sector by, for example, developing specialised trade channels and marketsthrough inclusion in their national programmes for 2021-2027 or other national instruments, allocations for campaigns dedicated to the benefits of fish consumption and the importance of sustainable fisheries production and to support the sector create local food chains, to facilitate easier access to the market, especially for the small-scale fishers and to develop, improve or facilitate the fisheries infrastructure (f.e. fish markets or fish auction places etc.);
Amendment 112 #
2019/2159(INI)
7 a. Urges the competent authorities in Romania and Bulgaria to include in their respective EMFAF Operational programmes for the period 2021-2027an instalment of a targeted scheme for young fishers in order to rejuvenate the fishing sector, including supporting the first acquisition of a fishing vessel, and also measures targeted at reducing pollution by supporting investments in replacing the old fishing vessels engines with new more environment friendly ones;
Amendment 113 #
2019/2159(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Underlines that the pressure on adapting to new challenges should not fall solely on the fisheries and aquaculture sector, as these sectors already apply high environmental and social standards; calls therefore that the other marine activities should be in focus as well, such as recreational fisheries, coastal tourism, harbour and shipping activities and resources exploitation activities, which need to uplift their standards for successful Blue transition;
Amendment 114 #
2019/2159(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses the role of Fisheries Local Action Groups (FLAGs) in exchanging and promoting best practices of interest for the sciences, local stakeholders and the industry both among the members of the respective fishing communities, but also through international cooperation; urges the competent authorities in Bulgaria and Romania to foresee national support for exchange of best practices with the other Black Sea littoral states, which have shown good practices in stock management for the economically important species, such as turbot, among others;
Amendment 115 #
2019/2159(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Pays attention to the necessity of preserving the good practices in the fisheries sector through reducing the economic burdens for the artisanal fishers and their associations;
Amendment 116 #
2019/2159(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls for training in the sector to be made more attractiveand education in the sector on both secondary and higher education level to be made more attractive through for example targeted information campaigns, open days for perspective students in cooperation with the public and private sector;
Amendment 117 #
2019/2159(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Reminds that the low education level of the fishers (11% in Bulgaria and 53% in Romania) requires proactive measures on different levels in order to ensure that there is skilled and well trained labour force, which is familiar with the necessary technical, social and environmental standards, and which will help achieve better levels of sustainability of the stocks; calls for a strong societal dimension in the Black Sea region sustainable blue growth with respect to key principles of the European Pillar of Social Rights, especially with regard to precarious, seasonal and undeclared workers and to the access of women in the sector;
Amendment 118 #
2019/2159(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
9 b. Welcomes the efforts for establishing demonstration centers in Romania, Turkey and Bulgaria, which has been in cooperation with GFCM and which has the potential of increasing the attractivity of the fisheries for the local businesses and stakeholders;
Amendment 119 #
Amendment 124 #
2019/2159(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for targeted measures and adequate resources to reduce pollution throughout the basin through joint programmes and budgets; calls for extensive research and estimates on the plastic pollution and the effects of plastics and other pollutants on the living organisms in the Black Sea; calls for systemic measurement of the nitrogen pollution in the Black Sea Basin;
Amendment 128 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Recalls that the fisheries and aquaculture sectors do not case temperature rise and thus climate change, but rather suffer from its sequences such as increased aerial temperature, which increases the marine temperature in the upper layers;
Amendment 131 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10 b. Calls on the Black Sea littoral states to invest in scientific research and data collection with regard to the effect of the climate change on the Black Sea and Lower Danube ecosystems; reminds that this should include providing enough resources to the scientific community to conduct research on the spot with regards to the migratory routes, wintering, feeding and reaching reproductive maturation, which will also have an effect on the characteristics and availability of stocks;
Amendment 134 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
Amendment 135 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 d (new)
Paragraph 10 d (new)
10 d. Is very concerned by the real threat of extinction for the remaining 5 sturgeon species in the Black Sea and Danube Delta basin; acknowledges the efforts undertaken by the authorities in Bulgaria and Romania, which have introduced a complete ban on sturgeon fishing in the Black Sea since 2008 and in the Danube river since 2011 and which was prolonged for 5 more years (until 2026); welcomes the refishing efforts with sturgeons, which have been undertaken and supported by experts from the non- governmental and state structures;
Amendment 136 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 e (new)
Paragraph 10 e (new)
10 e. Is concerned that the research on climate change and its effects on the Black Sea is not sufficient, while still crucial in the years to come; calls on the littoral states to fund such research, which covers the fish species (their physiology, migratory routes and reproduction) as well as the changes in their food chain, which has an effect on the stocks;
Amendment 137 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 f (new)
Paragraph 10 f (new)
10 f. Is of the opinion that regular measurements of the dynamics of the stocks is necessary so that adequate management measures can be designed; reminds that due to the overfishing and the anthropogenic pressure, the stocks of the economically significant species are more sensitive and vulnerable to climate change;
Amendment 138 #
2019/2159(INI)
Motion for a resolution
Paragraph 10 g (new)
Paragraph 10 g (new)
10 g. Urges the respective control authorities to exercise effective control on NATURA 2000 sights and MPAs in the Black Sea;
Amendment 140 #
2019/2159(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Invites the Member States to develop the ex situ farming of sturgeon; invites the Member States to provide retraining programmes and access to other livelihoods for sturgeon fishermens, with an eye to reducing illegal catch levels;
Amendment 142 #
2019/2159(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Stresses the urgent need to establish areas, in which wild populations of sturgeons, shads and other fish species can recover; calls on the competent authorities in the member states concerned to come up with a proposal in this direction, which will be both beneficial for the biodiversity conservation and for the fishery management;
Amendment 144 #
2019/2159(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Reminds that further scientific research is needed for the population of some molluscs such as the striped white venus clam (Chamalea gallina) in order to make better mapping of the distribution of the species and also explore the possibility of using it for marine aquaculture;
Amendment 145 #
2019/2159(INI)
12 c. Invites the Black Sea littoral states to find a common approach on helping the cetaceans reach stable population levels and improve their conservation status;
Amendment 146 #
2019/2159(INI)
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12 e. Calls on the Commission and the competent authorities in Bulgaria and Romania to provide funding for research on the state of the Black Sea shads (Alosa spp.) currently listed in Annex V of the Habitats Directive 92/43/EEC, with scientific and socio-economic analyses included, assessing the need to move Alosa spp. in Annex II or even Annex I of this Directive, if the necessary criteria are met;
Amendment 151 #
2019/2159(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Calls on the Commission to urgently consider transferring the sturgeons (Acipenseriformes) currently listed in Annex V of the Habitats Directive 92/43/EEC to Annex II or even Annex I of it;
Amendment 152 #
2019/2159(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Instructs its President to forward this resolution to the Council and to the Commiss, the Commission, the governments and parliaments of the Member States, the governments and parliaments of the Ukraine, the Russian Federation, Georgia and Turkey, the General Fisheries Commission for the Mediterranean and the Black Sea, the Organisation of the Black Sea Economic cooperation, the Commission on the Protection of the Black Sea Against Pollution.
Amendment 7 #
2019/2157(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas forests contribute effectively to territorial balance, economic growth and employment in rural and urban areas, and help maintain the competitiveness of the forestry sector and the development of the bioeconomy while also providing a guarantee of biodiversity and ecosystem services;
Amendment 114 #
2019/2157(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Stresses that according to scientific research, sustainably managed forests have a higher CO2 absorption capacity than unmanaged forests; urges, therefore, that the new forest strategy should promote sustainable forest management practices as part of national emission-reduction policies; recognises the positive impact of sustainable forest management on European forest biodiversity; notes that forest protection and production do not act in contradiction, but can in fact be complementary to one another;
Amendment 159 #
2019/2157(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Notes that development of the bioeconomy, the promotion of measures stimulating the development of forestry products on national markets, such their use in buildings, and the enhancing of research and innovation activities will ensure the forestry sector is future- oriented;
Amendment 163 #
2019/2157(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Emphasises the importance of vocational training and retraining programmes for forestry specialists in the use of new technologies and their adaptation to ongoing change, including the creation of a communications platform for the exchange of good practices, and considers it important to involve forest owners and managers in this process and to encourage them to follow sustainable forest conservation and biodiversity promotion practices;
Amendment 187 #
2019/2157(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Emphasises that local and regional authorities have a key role to play in ensuring the long-term sustainability of forests as they could play a part in regional-level sustainable development plans, the development of long-life-cycle carbon-absorbing forestry products and the promotion of SME entrepreneurial spirit in the forestry sector;
Amendment 194 #
2019/2157(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Emphasises that a robust combination of financial instruments, national funding and private-sector financing is essential to ensure continued investment in modern technologies, in environmental and climate measures that reinforce the multifunctional role played by forests and in creating decent working conditions;
Amendment 4 #
2019/2156(INI)
Motion for a resolution
Citation 11
Citation 11
— having regard to the draft feasibility study on options to step up EU action against deforestation, commissioned by the Commission’s Directorate General for Environment (20178),
Amendment 28 #
2019/2156(INI)
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
- having regard to its resolution of 15 January 2020 on the European Green Deal
Amendment 31 #
2019/2156(INI)
Motion for a resolution
Recital -A (new)
Recital -A (new)
-A. whereas the year 2020 is the deadline for a number of forest-related international commitments, such as target 15.2 of the UN Sustainable Development Goals (SDGs), which aims to halt deforestation by 2020, and the Aichi biodiversity target 5, adopted in 2010under the UN Convention on Biological Diversity (CBD), which states that “by 2020 the rate of loss of all natural habitats, including forests, is at least halved and where feasible brought close to zero, and degradation and fragmentation is significantly reduced”; whereas these commitments are still far from being met;
Amendment 44 #
2019/2156(INI)
Motion for a resolution
Recital A
Recital A
A. whereas forests are essential to preserve the world’s biodiversity and climate, and to directly sustain millions of people’s livelihoods; however whereas, despite all efforts so far, conservation, preservation and sustainable use of the world’s forests as well as the protection of indigenous peoples and local communities cannot be adequately ensured by current policies;
Amendment 59 #
2019/2156(INI)
Motion for a resolution
Recital B
Recital B
B. whereas newly planted forests cannot replace primary forests; whereas stepping up action to protect existing forests and actively and sustainably restore the integrity of forest ecosystems before createing new forest coverage has to play a crucial role in the EU’s sustainability policies;
Amendment 72 #
2019/2156(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the EU is also indirectly involved in the deforestation and degradation of world forests, including through the consumption of products related to deforestation; whereas EU consumption represents around 10% of the global share of deforestation embodied in total final consumption of commodities such as palm oil, beef, soy, cocoa, maize, timber, including fuelwood for energy, and rubber;
Amendment 84 #
2019/2156(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas a recent Global Witness investigation revealed that, between 2013 and 2019, EU-based financial institutions were the main international source of funds and backed six agribusiness companies linked to forest destruction in the Amazon, Congo Basin, and Papua New Guinea to the tune of €7 billion1a; _________________ 1a https://www.globalwitness.org/en/campaig ns/forests/why-eu-action-tackle- deforestation-should-not-let-finance- hook/
Amendment 89 #
2019/2156(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas current voluntary commitments from companies and banks to tackle deforestation have failed to deliver the change in behaviour needed to halt this disastrous environmental destruction;
Amendment 93 #
2019/2156(INI)
Motion for a resolution
Recital D
Recital D
D. whereas action at all levels, including regulatory measures, as well as substantial investment, will be needed to protect the world's forests more effectively;
Amendment 96 #
2019/2156(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas reforestation, the regeneration of degraded forests and agro-forestry activities to provide tree crown cover on farmland are the only available source of negative emissions able to contribute significantly to achievement of the Paris Agreement objectives ;
Amendment 97 #
2019/2156(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas indigenous peoples and local communities are increasingly under threat and facing human rights violations for their efforts to protect their forests, land, and environment;
Amendment 100 #
2019/2156(INI)
Motion for a resolution
Recital E
Recital E
E. whereas increased protection of forests and other natural ecosystems, protects the cultures and livelihoods of indigenous peoples and local communities and provides opportunities for economic development, particularly at the level of local communities;
Amendment 110 #
2019/2156(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas, protecting existing forests and sustainably increasing forest cover can provide livelihoods, increase income for local communities and allow for sustainable bio-economies to be developed; whereas forests represent a promising green economic sector, with the potential to create between 10 and 16 million jobs worldwide;.
Amendment 113 #
2019/2156(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 118 #
2019/2156(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the amount of EU funding provided to support the protection and restoration of forests and sustainable forest management in partner countries is insufficient given the scale of the problem; whereas the protection, restoration and sustainable management of natural ecosystems, as well as their related co- benefits and human rights aspects, need to be better integrated into EU funding mechanisms;
Amendment 125 #
2019/2156(INI)
Motion for a resolution
Recital G
Recital G
Amendment 142 #
2019/2156(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Welcomes the Commission Communication ‘Stepping up EU Action to Protect and Restore the World’s Forests’ and considers it a good basis for the development of decisive EU action to protect and restore forests and other natural ecosystems while protecting human rights; underlines that implementing a comprehensive set of measures and initiatives, including new legislation, is essential to reduce the EU’s footprint on the world’s natural ecosystems;
Amendment 143 #
2019/2156(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Agrees with the priorities for stepping up EU action presented in COM(2019)352; notes, however, that the EU should be more ambitious; the communication; underlines that the five priorities laid out in the communication are equally important and should be implemented simultaneously; notes, however, that the EU should be more ambitious in its actions and policy measures in order to adequately address the urgency of deforestation and forest degradation worldwide; is of the opinion that EU action against deforestation should tackle its main drivers, including palm oil, soy, beef, maize, rubber, cocoa, and fuelwood for energy;
Amendment 152 #
2019/2156(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 166 #
2019/2156(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that the EU has the powers, responsibility and funds available to also protect European forests as part of the world’s forests; calls, therefore, on the Commission and the Member States to ensure that measures aimed at protecting and restoring the world’s foreststhe highest standards of environmental protection are consistently applied to European forests;
Amendment 170 #
2019/2156(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission and Member States to recognise that the protection of native forests provides an outstanding climate mitigation benefit, deriving from the size and longevity of their ecosystem carbon stocks, which are greater in primary forests than in production forests even at harvest maturity;
Amendment 184 #
2019/2156(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the crucial role and rights of iIndigenous pPeoples and local communities in the protection of the world’s forests and calls on the Commission to take this role into account in the design, adoption, implementation and enforcement of forest protection measures, both at EU level, in partner countries, in dialogue with other consumer countries and in key international forums;
Amendment 191 #
2019/2156(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the importance of developing and implementing incentive mechanisms for smallholder farmers to maintain and enhance ecosystem services and products provided by sustainable forest management and agriculture;
Amendment 202 #
2019/2156(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses the role of civil society, Indigenous People and Communities in environmental protection and sustainable consumption and calls on the Commission and the Member States to ensure transparency and public participation in forest-related measures in order to promote forest protection and human rights;
Amendment 207 #
2019/2156(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Takes the view that a single definition of the concept of non- deforestation- free supply chain is central to addressing the problem of commodities contributing to deforestation, and calls on the Commission to propose such a definition; considers that this definition should be as ambitious as possible, and aim at including forest degradation as well as deforestation and degradation and conversion of natural ecosystems that do not qualify as forests, as well as related human rights violations;
Amendment 217 #
2019/2156(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to ensure that studies on certification schemes for non-deforestation commodities are carried out without delay and to submit these studies, together with a proposal for follow-up actions, to the European Parliament for further consideration with a view to developing a single certification scheme;
Amendment 225 #
2019/2156(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Recommends that the Commission pay particular attention to the possibilities of regulating access to the Union market iEmphasises that robust regulatory measures on the basis of due diligence are needed to ensure that there are no products entering the EU market that contribute to deforestation, forest degradation and conversion or der to promote non-deforestation products, including the possibility of introducing due diligence regulation for forest-risk commoditiesgradation of natural ecosystems, biodiversity loss or violations of human rights, including the rights of Indigenous Peoples and Local Communities, in any phase of the supply chain; calls therefore on the Commission to present without delay a proposal for an effective European legal framework based on due diligence to guarantee deforestation-free supply chains for all products placed on the EU market;
Amendment 235 #
2019/2156(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
Amendment 248 #
2019/2156(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls on the private sector to be more involved in the fight against deforestation and human rights violations embodied in their supply chains and investments, fulfilling without further delay their zero deforestation commitments; calls, at the same time, on the Commission to step up cooperation with the private sector and to develop appropriate instruments to incentivise volunteers based on the principle of shared responsibilityfrontrunners, as well as encourage companies to transition to global sustainable supply chains;
Amendment 272 #
2019/2156(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that the methods used to achieve the objectives set out in the Clean Energy for all Europeans package must not lead to deforestation and forest degradation in other parts of the world; calls, therefore, on the Commission to review by 2021 the relevant aspects of the report annexed to Commission Regulation (EU) 2019/807 and, if necessary, to revise this Regulation without undue delay, and in any case before 2023, in order to phase out as soon as possible high ILUC-risk biofuels used in Europe; on the basis of scientific knowledge and in accordance with the precautionary principle;
Amendment 274 #
2019/2156(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Emphasises the importance of reducing negative impacts of the EU food system on forests and other ecosystems; calls therefore for EU action that creates new incentives to promote sustainable food systems and diets, including reducing waste and pressure on the global food system stemming from EU consumption;
Amendment 284 #
2019/2156(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Welcomes the Commission's plan to ensure that the topic of deforestation is part of country-level political dialogues and recommends that the Commission includeformalises partnership agreements, which include the protection of forests and ecosystems, the promotion of human rights, in particular the rights of iIndigenous pPeoples and local communities, as well as support for the effective participation of civil society organisations and environmentalists in these dialogues;
Amendment 289 #
2019/2156(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Welcomes the Commission's plan to help partner countries develop and implement national frameworks for forests and their sustainable management, but considers that such assistance should produce measurable results demonstrating its cost-effectiveness and recommends that the Commission include this aspect in its reflections and actionsensuring the recognition of land tenure rights of Indigenous Peoples and Local Communities and incorporating substantial direct support to civil society in partner countries to ensure a balanced and equitable political dialogue; points out that such frameworks should reflect not only domestic needs but also global commitments such as the Paris Agreement;
Amendment 308 #
2019/2156(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Calls on the Commission to continue to support forest conservation through the creation and effective management of protected forest areas, while exploring high conservation values and high carbon stocks;
Amendment 329 #
2019/2156(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Welcomes the Commission's plan to strengthen cooperation on policies and measures to protect the world’s forests in key international forums, and calls on the Commission to endeavour to cooperate with these forums with a view, inter alia, to harmonising the terminology and concepts in use (e.g. sustainable forest management or deforestation and human rights violation-free supply chains) and to ensuring the coherence of the policies and measures adopted;
Amendment 332 #
2019/2156(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the Commission's intention of promoting sustainable supply chains in order to increase the benefits of the circular economy domestically and globally; underlines that this can only be done through mandatory due diligence obligations in line with OECD guidelines which fully respect environmental, social and safety standards as well as fully implementing the UN Guiding Principles on Business and Human Rights; expects the Commission to present a legislative initiative on due diligence, which includes the introduction of a transparent and functioning mandatory ‘social and environmental traceability’ along the entire supply chain;
Amendment 334 #
2019/2156(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Stresses the importance of establishing an online platform for multi- stakeholder and Member State dialogue on deforestation, forest degradation and ways of sustainably increasing world’s forest cover in order to build alliances, enter into joint commitments to significantly reduce deforestation and exchange experiences and information;
Amendment 340 #
2019/2156(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to ensure that all newly adopted tradeand future trade and investment agreements, both comprehensive and relevant sub- agreements, are fully compatible with the Paris Agreement and the SDGs, that environmental and climate provisions are legally binding and enforceable and that they contain provisions relating to forests andincluding safeguards to prevent them from being implemented in a manner that could lead to deforestation and forest degradation;
Amendment 355 #
2019/2156(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Recommends that the Commission assess the possibility of including forest protection provisionbinding and legally enforceable provisions relating to forests, ecosystems and human rights in existing trade agreements which do not yet contain such provisions or in which such provisions are not binding and legally enforceable in practice;
Amendment 361 #
2019/2156(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Underlines the need to ensure the consistency of EU trade policy with the objectives of deforestation-free policies by guaranteeing the protection and restoration of forests and other natural ecosystems in trading partner countries whilst defending human rights, ensuring good land governance, supporting local livelihoods and maintaining the cultural integrity of Indigenous Peoples, local communities and smallholders;
Amendment 366 #
2019/2156(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to ensure that the impact of trade agreements on the state of forests, natural ecosystems and human rights is systematically evaluated in the framework of sustainability impact assessments and other relevant assessment methods, and that the conclusions of these assessments are subsequently taken into account when deciding whether to conclude such agreements;
Amendment 374 #
2019/2156(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to include binding targets for the protection and restoration of forest ecosystems, including native European forests, as part of the EU's future forest strategy; recalls that newly planted forests cannot replace primary forests;
Amendment 386 #
2019/2156(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Considers it necessary to redirect financial flows, both private and public, in the relevant industrial sectors towards activities that do not cause deforestation; underlines the need to introduce mandatory due diligence on deforestation risk for the finance sector to ensure it is not enabling or contributing to deforestation, forest degradation, ecosystem conversion and degradation, or human rights violations.
Amendment 401 #
2019/2156(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission to integrate forest and human rights-related elements systematically into development policies and all investment and support programmes aimed at producer countries, and to consider making investments and support conditional on compliance with these elements;
Amendment 411 #
2019/2156(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to contribute to exchanges of innovative EU practice regarding the circular economy, sustainable bio-economy, renewable energy, smart agriculture and other relevant areas with other countries;
Amendment 64 #
2019/2125(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the EU, through continuous actions at bilateral and multilateral level, contributed to advancing human rights in 2018 has continued to give firm support to measures advancing and upholding human rights as a core concept in terms of multilateral relations, in particular by strengthening the political dialogue with non-EU countries, and by establishing new international agreements, inter alia trade and economic partnerships;
Amendment 133 #
2019/2125(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses the importance of advancing gender equality and women’s rights worldwidective EU involvement in worldwide efforts to promote gender equality and full enjoyment of human rights by all girls and women; emphasises that, in spite of progress, women and girls continue to suffer discrimination and violence; stresses that many societies still struggle to provide women and girls with equal rights under the law and equal access to education, healthcare, decent work and political and economic representation;
Amendment 323 #
2019/2125(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Stresses that women and girl victims of armed conflicts have the right to receive the necessary medical care, including access to contraception, emergency contraception and abortion services;
Amendment 362 #
2019/2125(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the ratifications of the UN Convention on the Rights of Persons with Disabilities; reiterates the importance of efficient implementation by both the EU Member States and the EU institutions; stresses, in particular, the need to credibly mainstream the principle of universal accessibility and to ensure all the rights of persons with disabilities throughout all relevant EUEU development policies;
Amendment 447 #
2019/2125(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Stresses the need for effective digital cooperation between governments, the private sector, civil society, the academic and technical communities, the social partners and other stakeholders to ensure a secure and inclusive digital future for all, in line with international human rights legislation and in close compliance with UN provisions and measures regarding security, technology, sustainable development and diplomacy;
Amendment 36 #
2019/0017(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Maritime transport has an considerable impact on the global climate, as a result of carbon dioxide (CO2) as well as methane, nitrous oxide and black carbon emissions from shipping. In 2015, it emitted 13% of the total Union greenhouse gas emissions from transport15 . International maritime shipping remainshas been the only means of transportation not included in the Union's commitment to reduce greenhouse gas emissions. Maritime transport also produces emissions with air polluting properties that have detrimental effects on human health and the environment. __________________ 15https://www.eea.europa.eu/data-and- maps/indicators/transport-emissions-of- greenhouse-gases/transport-emissions-of- greenhouse-gases-10.
Amendment 38 #
2019/0017(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Internationally, CO2 emissions from maritime transport are projected to increase by 50% to 250% in the period to 2050. CO2 emissions from maritime transport are also growing rapidly in the Union, increasing by 48% between 1990 and 2008. Without action to tackle emissions from maritime transport, such emissions are expected, by 2050, to increase by 86% above 1990 levels, which would undermine the climate efforts undertaken by other sectors, the Union's objective of becoming an economy with net-zero greenhouse gas emissions by 2050 at the latest, and the goal of the Paris Agreement.
Amendment 40 #
2019/0017(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) EU environmental policy must contribute to maintaining, protecting and improving the quality of the environment, protecting public health and promoting international initiatives in the field of transport and elsewhere, in a bid to resolve regional and global environmental problems, in particular combating climate change.
Amendment 41 #
2019/0017(COD)
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1b) There is an urgent need for enhanced action to tackle maritime emissions. As the Union's primary instrument for monitoring, reporting and verification of greenhouse gas emissions and air pollution from maritime transport, this Regulation constitutes a basis for the inclusion of the maritime transport sector in the EU Emissions Trading System (EU ETS), in addition to the adoption of other measures, ensuring that the maritime transport sector contributes to the efforts of reaching the Union's 2050 economy- wide climate neutrality target as well as the 2030 and 2040 targets.
Amendment 42 #
2019/0017(COD)
Proposal for a regulation
Recital 1 c (new)
Recital 1 c (new)
(1c) Maritime transport is also a source of air pollution emissions, such as Sulphur Oxide (SOx), Nitrogen Oxide (NOx), particulate matter (PM), Ozone Depleting Substances (ODS) or Volatile Organic Compounds (VOC)1a. Air polluting emissions impact both the environment and the health of citizens, in particular for those living or working in coastal and port areas. It is estimated that air pollution in Europe causes approximately 400 000 premature deaths per year. Air pollution is also considered to be the largest environmental health risk in Europe.1b It is therefore crucial that the Union adopts additional measures addressing air pollution from maritime transport. __________________ 1ahttp://www.emsa.europa.eu/main/air- pollution/air-pollution.html 1bhttps://www.eea.europa.eu/publications/ air-quality-in-europe-2019
Amendment 45 #
2019/0017(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The European Parliament's Resolution of February 2014 on a 2030 framework for climate and energy policies has repeatedly called on the Commission and the Member States to set a binding Union 2030 target of reducing greenhouse gas emissions by at least 4055% compared to 1990 levels and to achieve climate neutrality in the Union by 2050 at the latest. The European Parliament has also notstressed that all sectors of the economy, including the maritime transport sector, would need to contribute to the reduction of greenhouse gas emissions in line with the polluter-pays principle if the Union is to deliver its fair share of global efforts and reach its climate targets. Rapid efforts to decarbonise the maritime transport sector are all the more important in view of the resolution by the Parliament of 28 November 2019 on the climate and environment emergency.
Amendment 47 #
2019/0017(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The European Parliament's Resolution of February 2014 on a 2030 framework for climate and energy policies called on the Commission and the Member States to set a binding Union 2030 target of reducing greenhouse gas emissions by at least 40 % compared to 1990 levels. The European Parliament also noted that all sectors of the economy would need to contribute to the reduction of greenhouse gas emissions if the Union is to deliver its fair share of global efforts. It is in addition necessary to combine careful analysis of both long-term and short-term climate commitments with the need to address urgent economic and social issues, such as energy security, high energy costs for industry and households, and the need for job creation and economic recovery.
Amendment 50 #
2019/0017(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) In its Conclusions of 24 Octo12 December 201491a, the European Council endorsed a binding Union target of an at least 40% domestic reductiothe objective of achieving a climate-neutral EU by 2050, in lin greenhouse gas emissions by 2030 compared to 1990. The European Council also stated the importance of reducing greenhouse gas emisse with the objectives of the Paris Agreement. The European Council also stated that all relevant EU legislations and risks related to fossil fuel dependency in the transport sector and invipolicies need to be consistent with, and contributed the Commission to examine further instruments and measures for a comprehensive and technology-neutral approach, including for the promotion of emissions reduction, renewable energy sources, and energy efficiency in transport. o, the fulfilment of the climate neutrality objective while respecting a level playing field. __________________ 1a https://www.consilium.europa.eu/media/4 1768/12-euco-final-conclusions-en.pdf
Amendment 51 #
2019/0017(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
Amendment 52 #
2019/0017(COD)
Proposal for a regulation
Recital 5
Recital 5
Amendment 54 #
2019/0017(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) In its communication on the European Green Deal of 11 December 2019, the Commission stated its intention to extend the EU ETS to the maritime sector, regulate access of the most polluting ships to Union ports and oblige docked ships to use shore-side electricity.
Amendment 64 #
2019/0017(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Article 22 of the EU MRV Regulation states that the Commission will, in the event of an international agreement on a global monitoring, reporting and verification system or on global measures to reduce greenhouse gas emissions from maritime transport, review the EU MRV Regulation and, if appropriate, propose amendments in order to ensure alignment withalign the Regulation with that international agreement. It is important that, international agreementrrespective of any global measures, the Union remains able to be ambitious and demonstrate climate leadership by maintaining or adopting more stringent measures within the Union.
Amendment 68 #
2019/0017(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The impact assessment indicated that a partial alignment of the two monitoring, reporting and verification systems could contribute to reducing the administrative burden for shipping companies, while preserving the key objectives of the EU MRV Regulation. This will also ensure the European fleet a level playing field at international level. Such a partial alignment should however not modify the governance, scope, verification, transparency or CO2 reporting requirements of the EU MRV Regulation as it would severely undermine its objectives and affect its capacity to inform future policy-making decisions and to incentivise the uptake of energy efficiency measures and behaviours in shipping. Any amendments to the EU MRV Regulation should therefore limit the alignment with the global IMO DCS in relation to definitions, monitoring parameters, monitoring plans and templates.
Amendment 70 #
2019/0017(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Global IMO DCS provisions on data to be monitored and reported annually should be taken into account so as to ensure that streamlined data is collected for ships' activities falling under both systems. In order to do so, the parameter "deadweight tonnage" should be reported butin addition to "cargo carried" should remain on a voluntary basis. "Time at sea" should be replaced by the global IMO DCS definition of “hours underway". Finally, calculation of “distance travelled” should be based on global IMO DCS25 to reduce administrative burden. __________________ 25 IMO Resolution MEPC 282 (70).
Amendment 86 #
2019/0017(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The transition to climate neutral shipping has yet to be achieved and regulatory measures in that regard have been hitherto inadequate. Ports can have a significant role in the decarbonisation of maritime transport. Operators of ships calling at Union ports should be obliged to ensure, through means such as connecting to shore-side electricity, that when at berth their ships do not emit greenhouse gas or air-polluting emissions. This would be particularly important in the case of berths located close to urban areas, in order to reduce the effects of air pollution on human health. Given the differential impacts of ships in relation to greenhouse gas and air-polluting emissions, most polluting ships, including large passenger ships, should be required to comply with that requirement first.
Amendment 97 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph -1 (new)
Article 1 – paragraph -1 (new)
Regulation (EU) 2015/757
Recital 23
Recital 23
(23) Other greenhouse gases, climate forcers or air pollutants should not be covered by the Union MRV system at this stage to avoid requi-1) Recital 23 is replaced by the following: "(23) The Union MRV system should be extended to cover also other grements to install nothouse gases, climate forcers and air pollutants, where sufficiently reliable or commercially available measuring equipment, which could impede the implementation of the Union MRV system. (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32015R0757) exists, to better protect the climate, the environment and human health." Or. en
Amendment 107 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph -1 a (new)
Article 1 – paragraph -1 a (new)
Regulation (EU) 2015/757
Article 2 – paragraph 1
Article 2 – paragraph 1
Amendment 111 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph -1 b (new)
Article 1 – paragraph -1 b (new)
Regulation (EU) 2015/757
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(-1b) Article 3, paragraph 1, point b is replaced by the following: "(b) ‘port of call’ means the port where a ship stops to load or unload a substantial part of cargo or to embark or disembark passengers; consequently, stops for the sole purposes of refuelling, obtaining supplies, relieving the crew, going into dry-dock or making repairs to the ship and/or its equipment, stops in port because the ship is in need of assistance or in distress, ship-to- ship transfers carried out outside ports, and stops for the sole purpose of taking shelter from adverse weather or rendered necessary by search and rescue activities are excluded; " Or. en ((https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02015R0757- 20161216&from=EN))
Amendment 112 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a – introductory part
Article 1 – paragraph 1 – point a – introductory part
(a) points (b) and (d) isare replaced by the following:
Amendment 122 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 3 – point a – introductory part
Article 1 – paragraph 3 – point a – introductory part
(a) points (e) and (f) areis replaced by the following:
Amendment 123 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 3 – point a
Article 1 – paragraph 3 – point a
Regulation (EU) 2015/757
Article 9 – paragraph 1 – point f
Article 9 – paragraph 1 – point f
Amendment 131 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 4 – point a a (new)
Article 1 – paragraph 4 – point a a (new)
Regulation (EU) 2015/757
Article 10 – paragraph 1 – point j a (new)
Article 10 – paragraph 1 – point j a (new)
(aa) In Article 10, paragraph 1, the following point is added : (ja) cargo carried.
Amendment 132 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 5 – point a
Article 1 – paragraph 5 – point a
Regulation (EU) 2015/757
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Where there is a change of company, the previous company shall submit to the Commission and to the authorities of the flag State concerned, on the day of the completion of the change or as close as practical to the day of the completion of the change and no later than threone months thereafter, a report covering the same elements as the emissions report but limited to the period corresponding to the activities carried out under its responsibility. The new company shall ensure that each ship under its responsibility complies with the requirements of this Regulation with regard to the remainder of the reporting period following the change.;
Amendment 134 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 5 a (new)
Article 1 – paragraph 5 a (new)
Regulation (EU) 2015/757
Chapter II a (new) – Article 12 a (new)
Chapter II a (new) – Article 12 a (new)
Amendment 143 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 5 b (new)
Article 1 – paragraph 5 b (new)
Regulation (EU) 2015/757
Article 21 – paragraph 1
Article 21 – paragraph 1
(5b) Article 21, paragraph 1, is replaced by the following: "1. By 30 June each year, the Commission shall make publicly available the information on CO2 emissions reported in accordance with Article 11 as well as the information set out in paragraph 2 of this Article. " Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32015R0757)
Amendment 148 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 6 a (new)
Article 1 – paragraph 6 a (new)
Regulation (EU) 2015/757
Article 21 a (new)
Article 21 a (new)
(6a) The following Article 21a is inserted: "Article 21a Environmental performance labelling of ships 1. So as to incentivise emissions reductions and increase the transparency of information, the Commission shall set up a holistic Union labelling system for the environmental performance of the ships which shall apply to the ships covered by this Regulation. 2. By 1 July 2021, the Commission shall adopt delegated acts in accordance with Article 23 to supplement this Regulation by setting out the detailed provisions of the functioning of the Union labelling system for the environmental performance of ships as well as the technical standards which constitute its basis."
Amendment 150 #
2019/0017(COD)
Proposal for a regulation
Article 1 – paragraph 6 a (new)
Article 1 – paragraph 6 a (new)
Regulation (EU) 2015/757
Article 22 – paragraph 3
Article 22 – paragraph 3
(6a) In Article 22, paragraph 3 is replaced by the following: "3. In the event that an international agreement on a global monitoring, reporting and verification system for greenhouse gas emissions or on global measures to reduce greenhouse gas emissions from maritime transport is reached, the Commission shall review this Regulation and shall, if appropriate, propose amendments to this Regulation in order to ensure alignmen it with that international agreement. such international agreement. Any such international agreement on global measures shall be without prejudice to the Union's ability to maintain or adopt more stringent measures within the Union. " Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32015R0757)
Amendment 156 #
2019/0017(COD)
Proposal for a regulation
Article 1 a (new)
Article 1 a (new)
Directive 2003/87/EC
Chapter II a (new)
Chapter II a (new)
Amendment 111 #
2016/0062R(NLE)
Motion for a resolution
Recital F
Recital F
F. whereas the lack of effectiveness of prosecution and the judicial systems, failure to provide information about what action to take and how to report such occurrences and the lack of adequate social and medical services are frequent reasons for the non- reporting of gender- based violence;
Amendment 224 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Calls for a constructive dialogue and effective short, medium and long- term collaboration with various institutions, authorities and NGOs, as well as with the Council and Member States in cooperation with the Council of Europe to address Member States’ reservations, objections and concerns and clarify misleading interpretations of the Istanbul Convention in order to make progress in this area;
Amendment 231 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Council to ensure that Parliament will be fully involved in the Convention’s monitoring process after EU accession to the Istanbul Convention; calls on Parliament to submit regular progress reports and to identify solutions for the implementation of its provisions;
Amendment 250 #
2016/0062R(NLE)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission and Member States to organise and carry out information campaigns regarding the Istanbul Convention and its provisions and to support partnerships between authorities and NGOs and jointly run programmes, in order to facilitate the implementation of its provisions;