Activities of Dolors MONTSERRAT
Plenary speeches (4)
Statement by the candidate for President of the Commission (debate)
Situation in Venezuela (debate)
Preparation of the European Council of 17-18 October 2024 (debate)
Managing migration in an effective and holistic way through fostering returns (debate)
Institutional motions (4)
MOTION FOR A RESOLUTION on the situation in Venezuela
MOTION FOR A RESOLUTION on the devastating floods in central and eastern Europe, the loss of lives and the EU’s preparedness to act on such disasters exacerbated by climate change
JOINT MOTION FOR A RESOLUTION on the devastating floods in central and eastern Europe, the loss of lives and the EU’s preparedness to act on such disasters exacerbated by climate change
JOINT MOTION FOR A RESOLUTION on the situation in Venezuela
Written questions (8)
Attacks on judicial independence by Spanish Government ministers
Tributes to terrorists in Navarre and the Basque Country in Spain
Corruption and rule of law in Spain
Transposition of Directive (EU) 2018/851
Spain’s medium-term fiscal-structural plan
Spain’s 2025-2028 medium-term fiscal-structural plan
Spain’s medium-term fiscal-structural plan
Labeling and designation of non-animal origin products
Amendments (1031)
Amendment 231 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 13
Paragraph 13
13. RegretNotes that fossil energy subsidies in the EUnion have remained stable between 2010 and 2020, at around EUR 50 billion per year, and even increased in 2022 to EUR 123 billion in 2022; recall; reminds that the 8th Environmental Action Programme requires the Commission and the Member States to ‘set a deadline for the phasing out of fossil fuel subsidies consistent with the ambition of limiting global warming to 1.5 °C’;
Amendment 238 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 14
Paragraph 14
14. Is concernedStresses that governments worldwide spent USD 620 billion in 2023 on subsidising the use of fossil fuels, which is significantly morean higher amount than the USD 70 billion that was spent in 2023 on support for consumer-facing clean energy investments; encourages all Parties to end all direct and indirect fossil fuel subsidiesprioritize technological neutrality in their subsidy policies and to gradually phase out the fossil fuel subsidies that do not contribute to fostering the competitiveness of our energy, agricultural, and transport sectors, while ensuring the availability of reliable alternatives and the food security as soon as possible;
Amendment 63 #
2023/2113(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Underlines the important role of the Councils of the Judiciary in safeguarding judicial independence; considers it necessary to evaluate the reforms that are in the process of being adopted in different Member States and encourages the adaptation of the composition and functioning of these bodies to the standards established by the European Commission and the Council of Europe, and which have been endorsed by the EU Court of Justice.
Amendment 64 #
2023/2113(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Points out that the prosecution service is a key element for the capacity of the judiciary to fight crime and corruption; highlights the importance of guaranteeing the autonomy and independence of the prosecution service; stresses the need for safeguards to be put in place to help preserve the independence of the prosecution service so that it is free from undue political pressure, especially from the Government.
Amendment 65 #
2023/2113(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Observes that the setting up of parliamentary committees to investigate if so called “lawfare” or judicialisation of politics have occurred means, in practice, subjecting judicial procedures and decisions to parliamentary review with evident interference in the judicial independence and the separation of powers.
Amendment 66 #
2023/2113(INI)
Motion for a resolution
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Considers that "ad hominem" legal reforms violate basic principles of the rule of law such as equality before the law and judicial independence.
Amendment 67 #
2023/2113(INI)
Motion for a resolution
Paragraph 2 e (new)
Paragraph 2 e (new)
2e. Notes with concern the draft amnesty law presented in the Spanish Parliament, which in its current proposal covers crimes of embezzlement, terrorism, acts against the rule of law and constitutional integrity, with its main beneficiaries being political leaders associated with the current government majority; notes that the amnesty would mean the closure of the investigation of Russian interference in the events in Catalonia that occurred in September and October 2017, and that the European Parliament has accredited; notes the serious concern expressed by all judicial associations, lawyers' associations, as well as by civil servants and very diverse civil society organizations.
Amendment 80 #
2023/2113(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Points out that the reduction of penalties for the crime of embezzlement in Spain is a worrying step back which is at odds with the EU's objectives and commitments in the fight against corruption; stresses the lack of consistency between the fight against corruption and the reduction of penalties for the crime of embezzlement.
Amendment 4 #
2023/2075(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (new)
– having regard to its resolution on “Strengthening Europe in the fight against cancer”, adopted on 16 February 2022,
Amendment 5 #
2023/2075(INI)
Motion for a resolution
Citation 1 b (new)
Citation 1 b (new)
– having regard to its resolution of 12 July 2023 on the COVID-19 pandemic: lessons learned and recommendations for the future’ (2022/2076(INI)),
Amendment 85 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs and the health needs of ageing populations represent challenges to the health systems of the Member States, which require the development of specific NCD prevention, detection and treatment policies contributing to healthy ageing;
Amendment 87 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs on individuals and societies and the health needs of ageing populations, 40% of which live with multimorbidity, represent challenges to the healthcare systems of the Member States;
Amendment 163 #
2023/2075(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas people living with one or more NCDs were one of the most severely affected population groups during the COVID-19 pandemic; whereas investment in NCD prevention and management remains limited, despite access to care, essential complications screening and diagnosis being severely disrupted during the COVID-19 pandemic, potentially leading to severe complications over the longer term;
Amendment 262 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Acknowledges that social, economic, cultural, and environmental determinants of health, and health inequities increase the risk of NCDs and underlines the need to create favourable conditions that address these factors; emphasizes the importance of a more robust implementation of the Health in All Policies principle, in dialogue with the public health community, and with thorough consideration of the health impacts of sectoral policies;
Amendment 270 #
2023/2075(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Underlines that the ‘One Health’ approach should guide the reduction and use optimisation of antimicrobials, to prevent and fight the Antimicrobial Resistance (AMR) as well as the development of new medicines, including antimicrobial agents;
Amendment 273 #
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 calls for an harmonisation in the definitions of tobacco and related products across EU legislation;
Amendment 319 #
2023/2075(INI)
Motion for a resolution
Paragraph 5 – point b a (new)
Paragraph 5 – point b a (new)
ba. publish annual reports on the progress towards achieving a tobacco-free generation by 2040;
Amendment 383 #
2023/2075(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Recalls the Commission and Member States to enhance the provision of better information to consumers including moderate and responsible drinking information through digital labelling;
Amendment 433 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – point b a (new)
Paragraph 8 – point b a (new)
ba. promote behavioural changes via communication, and mass media campaigns for healthy diets and encourage public food procurement and service policies for healthy and sustainable diets;
Amendment 453 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Highlights that the Mediterranean diet is recognized as a healthy, balanced diet that plays a protective role in the primary and secondary prevention of the main chronic degenerative diseases;
Amendment 500 #
2023/2075(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that per- and polyfluorinated alkyl substances (PFAS) can lead to health problems such as diabetes1a, obesity and cancer16 ; calls on the Commission to implement the PFAS restriction proposal submitted to European Chemicals Agency on 13 January 202317 ; _________________ 1a GlobalData Healthcare, 'High exposure to PFAS more than doubles risk of developing diabetes in women'. Clinical Trials Arena 16 European Environment Agency, ‘What are PFAS and how are they dangerous for my health?’. 17 European Chemicals Agency, ‘ECHA publishes PFAS restriction proposal’, 2023.
Amendment 540 #
2023/2075(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Encourages the Commission and the Member States to achieve the UN Sustainable Development Goals that target communicable diseases in order to promote the prevention of NCDs such as cancer related to infectious diseases; welcomes vaccination programmes, in this regard such as in the fight against human papillomavirus transmission; cluding the adoption of gender-neutral human papillomavirus (HPV) vaccinations for all adolescents and young adults, in the fight against HPV;
Amendment 573 #
2023/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Recommends EU funding support for pan-European public health literacy initiatives, such as the suggestion of creating a European Atlas of Early Warning Signs for Cancer, building on the model for cancer prevention created by the European Code Against Cancer;
Amendment 624 #
2023/2075(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that nurses, doctors, general practitioners and other primary care professionals , as well as pharmacists, have a significant role in referring patients for 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 629 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Stresses the importance of providing multidisciplinary holistic care, both preventive and curative, in which patients' lifestyle and dietary habits are improved and which allows for the personalisation of a patient's lifestyle and treatment system that facilitates maximum sustainability and health options, as offered by Integrative Medicine, scientifically recognised, approved by public health authorities and practiced by healthcare professionals; urges the Commission and Member States to prioritise the regulation, research, teaching and implementation of science- based Integrative Medicine in all the EU national healthcare systems;
Amendment 638 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Recommends urgent actions, including a Commission level study on the current status and impacts of the EU’s health workforce shortage and increased investment in its availability measuring and mapping exercises at the EU level; supports the proposed actions by the European Commission to address the pan-European problem of medicines shortages, encourage re-shoring of production; recognises that health workforce shortage can be a worsening factor in the response to future health emergencies and therefore recommends that the European Health Emergency Response Authority (HERA) be provided with explicit mandate to map and propose remedial measures to combat health workforce shortage;
Amendment 642 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
18c. Encourages the Commission and Member States to embed engagement with patient organisations and people living with NCDs into all activities and initiatives related to the design and implementation of prevention and care activities;
Amendment 646 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 d (new)
Paragraph 18 d (new)
18d. Emphasises the need to deploy person-centred and fully integrated care across the entire chronic diseases care pathway and to strengthen community and priority care, with a focus on chronic diseases requiring access to care across specialties and care levels such as diabetes;
Amendment 647 #
2023/2075(INI)
Motion for a resolution
Paragraph 18 e (new)
Paragraph 18 e (new)
18e. Highlights the valuable role of community pharmacies and recognises their valuable contribution in continuously providing an essential and quality service to support the treatment of NCDs and keep the general public informed; stresses that pharmacists are an independent, reliable and trustworthy source of information; suggests that pharmacists play a more active role in pharmacovigilance activities to assess and monitor the effectiveness of medicines and invites Member States to include them in their health, care and research programmes; calls for greater recognition of pharmacies in rural areas, which enable such areas to retain their populations and ensure the well-being of citizens;
Amendment 671 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Invites the Commission and Member States to promote basic and clinical research on the use and potential beneficial effects of medical ozone for its complementary use in prevention and treatment of different NCDs;
Amendment 680 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Emphasizes that the results of NCDs treatment can be hampered by malnutrition, therefore optimal nutritional care is an essential part of NCDs care; calls on the Commission and Member States to develop recommendations for incorporating clinical nutrition into all aspects of NCDs care, including treatment, support and research;
Amendment 807 #
2023/2075(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Acknowledges that many chronic diseases can lead to organ failure for which transplantation is the best therapy; notes that the EU action plan on organ donation and transplantation (2009-2015) resulted in a considerable increase in organ donation and transplantation in the EU over its period of implementation; calls on the Commission to establish a 2nd EU action plan on organ donation and transplantation during the 2024-2027 mandate;
Amendment 198 #
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 and that people who are diagnosed with severe mental health and associated chronic conditions are likelier to die prematurely, to have a reduced quality of life, mobility, and social participation across the lifespan;
Amendment 202 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights that mental health and associated chronic conditions, like chronic pain, frequently co-occur, due to shared neural circuit physiology mechanisms and risk factors including social disadvantage (e.g. poverty, unemployment, and lack of access to healthcare services). People who suffer from both mental health and associated chronic conditions, such as chronic pain, depression, bipolar disorder and schizophrenia, have substantially poorer physical health, increased risk of cancer and cardiovascular-related diseases, all contributing to lower life expectancy;
Amendment 208 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses that severe mental illness patients experience a higher prevalence of physical co-morbidities and multi-morbidities and therefore there is a need for integrated and holistic care delivery which considers their mental and physical health needs;
Amendment 210 #
2023/2074(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Underlines the profound impact of disease exposure on both the healthcare workforce and the caregivers’ wellbeing, urging to identify and address their specific psychological care needs through dedicated instruments;
Amendment 251 #
2023/2074(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls for the measurement and monitoring of access to mental health services across Europe. This should include data on the access and availability of categories of mental health services, such as psycho-oncology as part of cancer care;
Amendment 253 #
2023/2074(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Believes that mental health must be made a priority of the European Union of Health and believes the link between mental and physical health should be recognised and reflected in its programs and measures; urges the Commission and the Member States to address the mental health crisis brought on by the COVID-19 pandemic, particularly among young people and children and calls for a comprehensive EU mental health strategy that focuses on youth mental health and integrates actions for all social groups, particularly the most vulnerable; urges the Commission and the Member States to include mental health impacts in their work on health crisis and pandemic emergency response and preparedness;
Amendment 273 #
2023/2074(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Is deeply concerned that, despite progress in some countries, people with mental health and associated chronic conditions frequently experience discrimination and stigma and often do not havewhich can be a barrier for recognition and access to adequate healthcare, which can lead to severe human rights violations;
Amendment 291 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls for the EU and Member states to enhance and advance cultural change in their countries, to decrease stigma and discrimination about mental health and associated chronic conditions, through targeted awareness campaigns, such as campaigns targeted at healthcare professionals, patients, vulnerable groups, as well as the general public;
Amendment 305 #
2023/2074(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is deeply concerned by the poor availability of mental healthcare services in the Member States, as exemplified by the alarmingly long waiting lists for appointments with psychiatrists and psychologists and the limited options for therapeutic treatment, as well as for in- and outpatient clinic treatment; considers that the shortage in staff in this specific sector, the lack of integration of mental health services within the framework of health delivery (e.g. as part of cancer care), and the lack of funding aggravate the issue;
Amendment 318 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Urges the European Commission to work with Member States on improving pan-European mapping of, and response to mental health workforce gaps;
Amendment 322 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Advocates developing community mental health services in primary care;
Amendment 324 #
2023/2074(INI)
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8c. Supports the implementation of a mental health strategy at EU level that would act as a support system for the Member States; calls on the governments of the Member States to prioritise mental health;
Amendment 351 #
2023/2074(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Recommends a further use of screening tools to improve diagnosis of mental health needs, an example being the use of screening practices to detect psychological distress in cancer patients;
Amendment 353 #
2023/2074(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Underlines the importance of early diagnosis and intervention for mental health conditions; highlights the need to provide early access to management programmes for people with a high risk of developing mental health or associated chronic conditions, to serve as preventive programmes;
Amendment 389 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses the significance of integrating mental healthcare with physical care, culture and arts and other leisure activities providing effective, evidence-based, and human rights- focused care, and broadening the scope of available services to enable greater access to treatment; urges increased investment in community-based mental health support and services, as well as enhanced access to mental healthcare within national health systems;
Amendment 394 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
Amendment 408 #
2023/2074(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Member States to improve access to treatment and support for mental health and associated chronic conditions by implementing multidisciplinary care;
Amendment 411 #
2023/2074(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Highlights that mental health and associated chronic conditions, are best conceptualised as biopsychosocial experiences and therefore, patients need to have access to integrated care services involving multiple disciplines. When treated in isolation, the treatment of mental health conditions is less successful if patients also have associated chronic conditions, and vice versa;
Amendment 414 #
2023/2074(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Highlights the need to involve people with lived experiences of mental health conditions and illnesses featuring associated chronic conditions, in developing integrated services;
Amendment 442 #
2023/2074(INI)
16. Urges the Member States to ensure that people on medical leave because of mental health conditions do not face discrimination; urges the Member States to implement national plans that promote the integration, reintegration and adaptation of people with mental health and associated chronic conditions into the labour market, in order to reduce inequities and tackle social determinants, as well as ensure reasonable, flexible, work adjustments for workers;
Amendment 448 #
2023/2074(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Recognise that good working conditions can have a positive impact on physical and mental health, wellbeing, and productivity of Europeans and European society;
Amendment 453 #
2023/2074(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Urges the Commission and the Members States to establish mechanisms for financial and rehabilitation support for workers with mental health and associated chronic conditions;
Amendment 464 #
2023/2074(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
Amendment 467 #
2023/2074(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Understanding how brain diseases progress and finding treatments and cures for these diseases is a long-term endeavour; brain research and innovation must therefore be considered as a health and research priority in the EU and facilitated to address the root causes and challenges of brain disorders and apply research models, including the use of animals as well as complementary models that should be maintained, while also fostering the use of advanced technologies such as modern neuroscience tools, molecular, physiological and imaging approaches, artificial intelligence, machine learning, and data science;
Amendment 506 #
2023/2074(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the EU and Member States to implement the Mental Health in All Policies approach, through the inclusion of mental health and mental health problems in health impact assessments and in non-health national/regional education, family, labour and community policies design;
Amendment 113 #
2023/0373(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) EU carriers and non-EU carriers transporting plastic pellets in the Union, including maritime transport.
Amendment 128 #
2023/0373(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) ‘loss’ means a one-off or prolonged escape of plastic pellets from installation’s boundary to the environment or from road vehicles, rail wagothe trans por inland waterway vessels transporting plastic pelletst of plastic pellets, including maritime transport;
Amendment 136 #
2023/0373(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘EU carrier’ means any natural or legal person established in a Member State, engaged in the transport of plastic pellets as part of its economic activity by using road vehicles, rail wago, including maritime trans por inland waterway vesselst;
Amendment 142 #
2023/0373(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point g
Article 2 – paragraph 1 – point g
(g) ‘non-EU carrier’ means any natural or legal person established in a third country, engaged in the transport of plastic pellets as part of its economic activity in the Union by using road vehicles, rail wago, including maritime trans por inland waterway vesselst;
Amendment 389 #
2023/0135(COD)
Proposal for a directive
Article 15 a (new)
Article 15 a (new)
Article15a Prohibition of pardons and amnesties Member States shall take the necessary measures to prohibit any pardon for the benefit of those who have been held liable for any of the criminal offences referred to in Articles 7 to 14 and to prohibit any amnesty for any of the criminal offences referred to in Articles 7 to 14.
Amendment 168 #
2023/0132(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.
Amendment 170 #
2023/0132(COD)
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) This Directive should recognize that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.
Amendment 242 #
2023/0132(COD)
Proposal for a directive
Recital 51 a (new)
Recital 51 a (new)
(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients;
Amendment 264 #
2023/0132(COD)
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU should be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.
Amendment 279 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and ithe objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rel, on day one a reference medicinal productfter loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies and, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment ands, obtaining pricing and reimbursement request, and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC of the reference medicinal product, there can be no commercial usrelevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 292 #
2023/0132(COD)
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studactivities to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing toregulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one ofafter loss of the patent or SPC protection, under fair competitive conditions.
Amendment 303 #
2023/0132(COD)
Proposal for a directive
Recital 65
Recital 65
(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product. and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC. _________________ 1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU 2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine
Amendment 340 #
2023/0132(COD)
Proposal for a directive
Recital 76
Recital 76
(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to placmake the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.
Amendment 385 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Directive shall apply to medicinal products for human use intended to be placed on the market in the Member States and which are either prepared industrially or manufactured by a method involving an industrial process.
Amendment 511 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
Amendment 515 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 30 b (new)
Article 4 – paragraph 1 – point 30 b (new)
(30 b) ‘platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to.
Amendment 704 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 706 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawnrefused.
Amendment 713 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. TBased on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to enterrecognise the procedure and shall informwithin 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 715 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 797 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.
Amendment 810 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 9
Article 56 – paragraph 9
9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, in the Union or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub- paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product and any data in its possession relating to the volume of prescriptions.
Amendment 1215 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 1225 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 1233 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 1241 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product should be designated as a value added medicinal product.
Amendment 1257 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, for:the purpose of: (i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations; (ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282; (iii) obtaining pricing and reimbursement approval; (iv) complying with any other regulatory or administrative requirement in the Union or elsewhere; and the subsequent practical requirements associated with such activities.
Amendment 1317 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), may cover include the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers. This exception shall not cover the placing on the market in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products purposes.
Amendment 1346 #
2023/0132(COD)
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a 1. Applications, decision-making procedures and decisions to regulate marketing authorizations or the prices of generics, biosimilars, hibryds and biohibrids or to determine their inclusion within the scope of public health insurance system of medicinal products shall be considered by Member States as regulatory or administrative procedures which, as such, are independent from the enforcement of intellectual property rights. 2. The protection of intellectual property rights shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of generics, biosimilars, hibryds and biohibrids or its inclusion within the public health insurance system. 3. The applications, decision-making procedures and decisions referred to in paragraph 1 shall not be subject to conditions which expose applicants to a risk of infringement of the intellectual property rights. Paragraphs 1, 2 and 3 shall apply without prejudice to the Union and national legislation relating to the protection of intellectual property.
Amendment 1454 #
2023/0132(COD)
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure wholesale distributors comply with their supply obligations.
Amendment 1465 #
2023/0132(COD)
Proposal for a directive
Article 175 – paragraph 2 – point d a (new)
Article 175 – paragraph 2 – point d a (new)
Amendment 1480 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 1 – point b a (new)
Article 177 – paragraph 1 – point b a (new)
(ba) are antibiotics;
Amendment 1489 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 2
Article 177 – paragraph 2
2. Medicinal products may be advertised to the general public where, by virtue of their composition and purpose, they are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.
Amendment 1499 #
2023/0132(COD)
Proposal for a directive
Article 177 – paragraph 4
Article 177 – paragraph 4
4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Amendment 1513 #
2023/0132(COD)
Proposal for a directive
Article 185 – paragraph 1 – point g
Article 185 – paragraph 1 – point g
(g) no samples of medicinal products containing substances classified as antibiotic, psychotropic or narcotic within the meaning of international conventions may be supplied.
Amendment 1583 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.
Amendment 468 #
2023/0131(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place for critical medicinal products, and especially those that do not have alternatives, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans. Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Veryfication System, which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.
Amendment 578 #
2023/0131(COD)
Proposal for a regulation
Article 4 – title
Article 4 – title
Member State authorisation of generics of centrally authorisedcertain categories of medicinal products
Amendment 581 #
2023/0131(COD)
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
A generic medicinal product of a reference medicinal product authorised by the Union may be authorised by the competent authorities of the Member States in accordance with [revised Directive 2001/83/EC] under the following conditions:
Amendment 584 #
2023/0131(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) the application for marketing authorisation is submitted in accordance with Article 9, 10, 13 of [revised Directive 2001/83/EC] or for active substances used in fixed dose combination medicinal products that have previously been used in the composition of authorised medicinal products;
Amendment 586 #
2023/0131(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Point (b), first subparagraph, shall not apply to those parts of summary of product characteristics and package leaflet referring to indications, posologies, pharmaceutical forms, methods or routes of administration or any other way in which the medicinal product may be used which were still covered by a patent or a supplementary protection certificate for medicinal products at the time when the generic medicinal product was marketed and where the applicant for the generic medicinal product has requested not to include this information in their marketing authorisation.
Amendment 749 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 3
Article 24 – paragraph 1 – subparagraph 3
Where the action referred to in the first subparagraph is to withdraw a medicinal product with no alternative therapeutic equivalent from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated.
Amendment 835 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for a marketing authorisation, made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.
Amendment 844 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – introductory part
Article 40 – paragraph 3 – subparagraph 1 – introductory part
An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics:.
Amendment 848 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
Amendment 857 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point b
Article 40 – paragraph 3 – subparagraph 1 – point b
Amendment 860 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c
Article 40 – paragraph 3 – subparagraph 1 – point c
Amendment 867 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 2
Article 40 – paragraph 3 – subparagraph 2
In theits scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.
Amendment 875 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b
Article 40 – paragraph 4 – subparagraph 1 – point b
(b) provide information on all direct financial support received from any public authority of publicly funded body based in the European Union, for research related to the development of the priority antimicrobial.
Amendment 949 #
2023/0131(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date offrom the entry into force of this Regulation. 15 years after the date of entry into force of this Regulation], or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.
Amendment 1162 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1177 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) thirteen years for orphan medicinal products addressing a high unmetwhich fulfil one of the following requirements: i. there is no medicinal product authorised in the Union for such condition or where ii. despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal need as referred to in Article 70;product, in addition to having a significant benefit, will bring exceptional therapeutic advancement or iii. the condition affects not more than 0,5 in 10,000 persons in the Union when the application for an orphan designation is submitted.
Amendment 1200 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 1232 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1237 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
Article 72 – paragraph 1 – subparagraph 2
Amendment 1240 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 1 a (new)
Article 72 – paragraph 1 a (new)
1 a. The period of market exclusivity shall be prolonged by an additional 24 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition. If the newly approved therapeutic indication meets one of the requirements listed in Article 71(2) point (b), and where the first orphan marketing authorisation was not granted a period of market exclusivity as referred in Article 71(2) point (b), the period of market exclusivity shall be prolonged by 36 months in total.
Amendment 1242 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
Amendment 1263 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 a (new)
Article 72 – paragraph 2 a (new)
2 a. The holder of an orphan marketing authorisation shall be entitled to a total maximum period of [15] years of orphan marketing exclusivity from the time the orphan medicinal product in question first obtains an authorization as defined in Article 69.
Amendment 1265 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 b (new)
Article 72 – paragraph 2 b (new)
2 b. As an alternative to the reward foreseen under Article 86 [of revised Directive] and upon request from the applicant, the period of market exclusivity for orphan medicinal products referred to in Article 71(2), points (a) and (b) shall be prolonged by an additional 24 months where an application for orphan marketing authorisation is submitted in respect of a designated orphan medicinal product pursuant to [Revised Regulation] and that application includes the results of all studies conducted in compliance with an agreed paediatric investigation plan. The first subparagraph shall also apply where completion of the agreed paediatric investigation plan fails to lead to the authorisation of a paediatric indication, but the results of the studies conducted are reflected in the summary of product characteristics and, if appropriate, in the package leaflet of the medicinal product concerned. The 24- month extension of the period of market exclusivity will be reflected in the marketing authorisation.
Amendment 1266 #
2023/0131(COD)
2 c. An orphan medicinal product which benefits from the prolongation of market exclusivity as referred to in paragraph 4, shall not benefit from the rewards referred to in Article 86 [of revised Directive].
Amendment 1267 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 d (new)
Article 72 – paragraph 2 d (new)
2 d. The limitation referred to in paragraph 3 shall not apply where the period of orphan marketing exclusivity is extended in accordance with paragraph 4 in relation to such extension.
Amendment 1270 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 3
Article 72 – paragraph 3
3. The orphan medicinal products which benefit from the prolongation of market exclusivity referred to in the paragraph 2 shall not benefit from the additional period of data protection referred to in Article 81(2), point (d), of [revised Directive 2001/83/EC].
Amendment 1392 #
2023/0131(COD)
Proposal for a regulation
Article 112 – paragraph 1 a (new)
Article 112 – paragraph 1 a (new)
Amendment 1465 #
2023/0131(COD)
(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1469 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1472 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point c
Article 116 – paragraph 1 – point c
(c) its decision to temporarily suspend the marketing of a medicinal product in that Member State no less than sixtwo months before the start of the temporary suspension of supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1475 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption. The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. The Agency shall make available the information to the concerned Member State, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1492 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for anycritical medicinal product placed on the market. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for whicvh a shortage prevention plan shall be maintaned and kept up to date, including due to the lack of availability of alternatives. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1493 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set outestablished in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available to the Agency and the competent authority of the Member State where the medicinal product has been placed on the market.
Amendment 1516 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. 2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit aupdated versions of the shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may setestablish a deadline for the submission of the information requested.
Amendment 1547 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(ca) assess information on potential or actual shortages provided by marketing authorisation holders authorised to place on the market in a Member State in accordance with Article 5 of [revised Directive 2001/83/EC] as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers thereof, wholesale distributors, representative associations of interested parties or other legal persons or entities authorised or entitled to supply medicinal products to the public.
Amendment 1673 #
2023/0131(COD)
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”). The Union list of critical m,edicinal products shall be coordinated with the list identified in the Member States by the competent authority of that Member State and shall supersede all national lists.
Amendment 90 #
2023/0085(COD)
Proposal for a directive
Recital 19
Recital 19
(19) It would be misleading to consumers if an explicit environmental claim pointed to the benefits in terms of environmental impacts or environmental aspects while omitting that the achievement of those benefits leads to negative trade-offs on other environmental impacts or environmental aspects. To this end the information used to substantiate explicit environmental claims should ensure that the interlinkages between the relevant environmental impacts and between environmental aspects and environmental impacts can be identified along with potential trade-offs. The assessment used to substantiate explicit environmental claims should identify if improvements on environmental impacts or environmental aspects lead to the kind of trade-offs that significantly worsen the performance as regards other environmental impacts or environmental aspects, for example if savings in water consumption lead to a notable increase in greenhouse gas emissions, or in the same environmental impact in another life-cycle stage of the product, for example CO2 savings in the stage of manufacturing leading to a notable increase of CO2 emissions in the use phase. For example, a claim on positive impacts from efficient use of resources in intensive agricultural practices may mislead consumers due to trade-offs linked to impacts on biodiversity, or ecosystems or animal welfare. An environmental claim on textiles containing plastic polymer from recycled PET bottles may also mislead consumers as to the environmental benefit of that aspect if the use of this recycled polymer competes with the closed-loop recycling system for food contact materials which is considered more beneficial from the perspective of circularity.
Amendment 129 #
2023/0085(COD)
Proposal for a directive
Recital 32
Recital 32
(32) The Commission Recommendation (EU) 2021/2279 contains guidance on how to measure the life cycle environmental performance of specific products or organisations and how to develop Product Environmental Footprint Category Rules (PEFCRs) and Organisation Environmental Footprint Sectorial Rules (OEFSRs) that allow comparison of products to a benchmark. Such category rules for specific products or traders can be used to support the substantiation of claims in line with the requirements of this Directive. Therefore, the Commission should be empowered to adopt delegated acts to establish product group or sector specific rules where this may have added value. However, in case the Product Environmental Footprint method does not yet cover an impact category, which is relevant for a product group, the adoption of PEFCR may take place only once these new relevant environmental impact categories have been added. For example, as regards marine fisheries, the PEFCR should for example reflect the fisheries- specific environmental impact categories, in particular the sustainability of the targeted stock. Concerning space, the PEFCR should reflect defence and space- specific environmental impact categories, including the orbital space use. As regards food and agricultural products, biodiversity and nature protection, as well as farming practices, including positive externalities of extensive farming and animal welfaredifferent farming methods and forest management practices, should, for example, also be integrated before the adoption of PEFCR could be considered. As regards textiles, the PEFCR should for example reflect the microplastics release, before the adoption of PEFCR could be considered.
Amendment 245 #
2023/0085(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘trader’ means trader as defined in Article 2, point (b), of Directive 2005/29/EC, excluding cooperatives and trade associations;
Amendment 338 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point g
Article 3 – paragraph 1 – point g
(g) identify whether improving environmental impacts, environmental aspects or environmental performance subject to the claim leads to significant harm in relation to environmental impacts on climate change, resource consumption and circularity, sustainable use and protection of water and marine resources, pollution, biodiversity, animal welfare and ecosystems;
Amendment 453 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Where the explicit environmental claim is related to future environmental performance of a product or trader it shall include a time-bound commitmentaspiration for improvements inside own operations and value chains.
Amendment 104 #
2023/0042(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The widespread adoption of zero- emission heavy-duty vehicles in the market depends on the existence of favourable conditions that allow road hauliers to operate these vehicles efficiently and with greater profitability compared to conventional diesel trucks. Key enabling conditions that fall outside the direct control of vehicle manufacturers include the availability of charging and refuelling infrastructure, effective carbon pricing measures (such as road user charges that vary based on CO2 emissions), and supportive and well- coordinated vehicle regulations. It is essential to monitor the state of these enabling conditions on an annual basis. If any of these conditions are proofed to be inconsistent with the CO2 targets set for vehicle manufacturers, a reassessment of the targets should take place.
Amendment 186 #
2023/0042(COD)
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) This regulation aims to speed the shift towards carbon-neutral mobility based on the principle of technological neutrality. In addition to the ongoing efforts to enhance the accessibility of zero-emission vehicles, a mechanism based on a carbon correction factor is introduced to duly account the contribution from the use of sustainable renewable transport fuels including biofuels, biomass fuels, and RFNBOs (Renewable Fuels of Non-Biological Origin) when evaluating the compliance of newly registered heavy-duty vehicles with regards to reducing CO2 emissions.
Amendment 192 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EU) 2019/1242
Article 2 – paragraph 1 – subparagraph 1 – point b
Article 2 – paragraph 1 – subparagraph 1 – point b
(b) N1, which do not fall under Regulation (EU) 2019/631, N2 and N3, except motor vehicles used in vehicle combinations with a gross vehicle weight ≥ 50 tonnes or motor vehicles used in combinations complying with an EMS mission profile, EMS being understood as a vehicle combination as defined under Article 4.4.(b) of Directive 96/53/EC;
Amendment 196 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
(c) O3 and O4 provided their positive effect on energy consumption is accurately taken into account in any CO2 emission calculation.
Amendment 203 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point c
Article 1 – paragraph 1 – point 2 – point c
Regulation (EU) 2019/1242
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Notwithstanding Article 2(3) of Regulation (EU) 2017/2400 and vehicles exempted under Article 2(1) point (b) of the present regulation, , approved vehicles falling under Article 2(3), point (b), of Regulation (EU) 2018/858 shall not be subject to the CO2 emission targets set out in Article 3a of this Regulation, unless the manufacturer chooses to include those vehicles in the calculation of its specific CO₂ emissions and targets when reporting the vehicle in accordance with Part B of Annex IV to this Regulation.
Amendment 226 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 a (new)
Article 3 – paragraph 1 – point 23 a (new)
(23a) ‘CO2 neutral fuel’ means a renewable and/or synthetic fuel as defined by Directive 2018/2001 including biofuel, biogas, biomass fuel, Renewable liquid and gaseous transport Fuel of Non Biological Origin – RFNBO or Recycled Carbon Fuel – RCF, where the emissions of the fuel in use (eu) can be taken to be net zero, meaning that the CO2 equivalent of the carbon incorporated in the chemical composition of the fuel in use (eu) is of biogenic origin and/or has been avoided being emitted as CO2 into the atmosphere or has been captured from ambient air or has avoided its existing fate. Other renewable and/or synthetic fuels not listed in Directive 2018/2001 can fulfil this definition provided that they meet the above criteria and the sustainability criteria of said Directive and associated delegated acts;
Amendment 239 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 b (new)
Article 3 – paragraph 1 – point 23 b (new)
(23b) ‘Carbon Correction Factor (CCF)’ means a factor which applies a correction to the CO2 tailpipe emissions of vehicles for compliance assessment, to reflect the GHG emission intensity and the share of CO2 Neutral Fuels, as defined in paragraph 24 of this article;
Amendment 259 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point b
Article 3a – paragraph 1 – point b
(b) for all vehicle sub-groups referred to in point 1.1.1 of Annex I for the reporting periods of the years 2030 to 2034 by 45 30%,
Amendment 276 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point c
Article 3a – paragraph 1 – point c
(c) for all vehicle sub-groups referred to in point 1.1.1 of Annex I for the reporting periods of the years 2035 to 2039 by 65 55%,
Amendment 291 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point d
Article 3a – paragraph 1 – point d
(d) for all vehicle sub-groups referred to in point 1.1.1 of Annex I for the reporting periods of the years 2040 onwards by 9075%.
Amendment 303 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 1 – paragraph 1a (new)
Article 1 – paragraph 1a (new)
1a. for trailers for the reporting periods of the years 2030 onwards by 7.5%.
Amendment 305 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1b (new)
Article 3a – paragraph 1b (new)
1b. for semi-trailers for the reporting periods of the years 2030 onwards by 15%.
Amendment 330 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3b – paragraph 1
Article 3b – paragraph 1
1. For vehicles referred to in point 4.2 of Annex I, manufacturers shall comply with the minimum shares of zero-emission vehicles in their fleet of new heavy-duty vehicles as laid down in point 4.3 of Annex I. For new urban buses the share of zero- emissions vehicles shall be 10average CO2 emissions shall be reduced by 70% as from the reporting period of the year 2030.;
Amendment 359 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EU) 2019/1242
Article 4 – paragraph 1 – point c (new)
Article 4 – paragraph 1 – point c (new)
(4a) (4a new) in Article 4, first paragraph, the following point (c) is inserted: ‘(c) the application of the Carbon Correction Factor (CCF) determined in accordance with paragraph 7 of Annex I.’
Amendment 447 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18
Article 1 – paragraph 1 – point 18
Regulation (EU) 2019/1242
Article 15
Article 15
The Commission shall, in review by 31 December 2027 at the latest the effectiveness and impact of this Regulation and submit a report to the European Parliament and to the Council with the conclusions. By 31 December 20285, review the effectiveness and impact of this Regulation and submit a report to the European Parliament and to the Council with the result of the review. and every year thereafter, the Commission shall report to the European Parliament and to the Council, on the state of the enabling conditions for the market adoption of zero-emission heavy-duty vehicles in the Union. In this report, the Commission shall assess in particular, but not limited to, the following elements: (a) registrations of zero-emission heavy- duty vehicles in Member States; (b) an assessment of the roll-out of the necessary recharging and refuelling infrastructure, of the possibility of introducing engine CO2 emission performance standards, in particular for vocational vehicles, and of the real-world representativeness of the CO2 emission and fuel consumption values determined in accordance with Regulation (EU) 2017/2400; (c) the implementation of road user charges differentiated by CO2 emissions in Member States; (d) the average price of allowances under the new the emissions trading system covering road transport; (e)strictly for the purpose of this Regulation, considerations of heavy-duty vehicles and vehicle combinations taking into account weights and dimensions applicable to national transport, for example modular and intermodal concepts, while also assessing possible transport safety and efficiency aspects, intermodal, environmental, infrastructural and rebound effects as well as the geographical situation of Member States; (f) an assessment of the VECTO simulation tool to ensure that this tool is updated continually and in a timely manner; (g) an assessment of the possibility of developing a specific methodology to include the potential contribution to CO2 emissions reductions of the use of synthetic and advanced alternative liquid and gaseous renewable fuels, including e- fuels, produced with renewable energy and meeting the sustainability and greenhouse gas emissions saving criteria referred to in Directive (EU) 2018/2001 of the European Parliament and of the Council; (h) an assessment of the feasibility of introducing an open, transparent and non-discriminatory pooling mechanism between manufacturers; (i) an assessment of the level of the excess CO2 emissions premium to ensure that it exceeds the average marginal costs of the technologies needed to meet the CO2 emissions targets; (j) other measures that support the deployment of zero-emission heavy-duty vehicles; If one or more of the enabling conditions, especially under paragraphs (b), (c) or (d), are not aligned with the targets for vehicle manufacturers in Art. 3a and b of this Regulation, the targets should be reviewed and excess CO2 emissions premiums according to Art. 8 of this Regulation be waived.
Amendment 478 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.1 – paragraph 3 – subparagraph 6 a (new)
Annex I – point 2 – point 2.1 – paragraph 3 – subparagraph 6 a (new)
Regulation (EU) 2019/1242
Annex I – point 2 – point 2.1 – paragraph 3 – subparagraph 6a (new)
Annex I – point 2 – point 2.1 – paragraph 3 – subparagraph 6a (new)
CCFi: is the Carbon Correction Factor for the fuel or blend of fuels in use i, as defined in article 3 point (25) and calculated according to paragraph 7 of this Annex.
Amendment 521 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 1 – subparagraph 1.1 – table 1.2, row 3
Annex I – paragraph 1 – subparagraph 1.1 – table 1.2, row 3
N Rigid One of the following digits, as listed in Appendix 2 of Annex I to Regulation (EU) 2018/858, is used to supplement the code for bodywork indicated in entry 38 of the certificate of conformity: 09, 10, 15, 16, 17, 18, 19, 20, 23, 24, 25, 26, 27, 28, 31;
Amendment 528 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 2 – subparagraph 2.1
Annex I – paragraph 2 – subparagraph 2.1
2.1. Calculation of the specific CO2 emissions of a new heavy-duty vehicle The specific emissions in g/km of a new heavy-duty vehicle v attributed to a sub-group sg or of its primary vehicle shall be calculated in accordance with the following formula: 𝐶𝑂2𝑣 = ∑𝑚𝑝𝑊𝑠𝑔,𝑚𝑝 × 𝐶𝑂2𝑣,𝑚𝑝 × (𝟏 ― 𝑪𝑪𝑭𝒊 ) 𝐶𝑂2p𝑣 = ∑𝑚𝑝𝑊𝑠𝑔,𝑚𝑝 × 𝐶𝑂2p𝑣,𝑚𝑝 × (𝟏 ― 𝑪𝑪𝑭𝒊 ) Where, ∑𝑚𝑝 is the sum over all mission profiles mp listed in Table 2; sg is the sub-group to which the new heavy-duty vehicle v has been attributed according to Section 1 of this Annex; Wsg,mp, is the mission profile weight specified in points 2.1.1 to 2.1.3; CO2v,mp is the CO2 emissions in g/km of the new heavy-duty vehicle v determined for a mission profile mp, reported in accordance with Articles 13a and 13b and normalised pursuant to Annex III; CO2pv,mp is the CO2 emissions in g/km of the primary vehicle of the new heavy-duty vehicle v, determined for a mission profile mp, reported in accordance with Articles 13a and 13b; CCFi is the Carbon Correction Factor for the fuel or blend of fuels in use i, as defined in article 3 point (25) and calculated according to paragraph 7 of this Annex. For zero-emissions motor vehicles the values of CO2v,mp and CO2pv,mp shall be set to 0.
Amendment 584 #
2023/0042(COD)
Proposal for a regulation
ANNEX I – paragraph 5 – table 5.2.
ANNEX I – paragraph 5 – table 5.2.
Amendment 588 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 6 a (new)
Annex I – paragraph 6 a (new)
6 a. CALCULATION OF THE CARBON CORRECTION FACTOR (CCF) For each fuel or blend of fuels i, the CCF shall be calculated according to the following method: 6.1. For CO2-Neutral Fuels, as defined in article 3 point (25) and used in compliance with Art. 4 bis, CCFi = 1; 6.2. For fuels other than CO2-Neutral Fuels, CCFi = 0; 6.3. For blends of CO2-Neutral Fuels and fuels other than CO2-Neutral Fuels, the CCF shall be calculated according to the following formula: 𝑺𝑯𝑨𝑹𝑬𝑺𝒏,𝒊 𝑺𝑯𝑨𝑹𝑬𝑺𝒏 ― 𝟏,𝒊 + 𝟏𝟎𝟎 𝟏𝟎𝟎 𝑪𝑪𝑭𝒊 = 𝟐 Where: CCFi is the Carbon Correction Factor for a specific blend of conventional and CO2-Neutral Fuel i SHARESn,i percentage of renewable fuel i reported in Shares database, referred to the last available reporting period n and calculated as the average share over all EU member states. SHARESn - 1,i percentage of renewable fuel i reported in Shares database, referred to the second last available reporting period n and calculated as the average share over all EU member states. The Shares database is accessible at: https://ec.europa.eu/eurostat/web/energy/ data/shares
Amendment 61 #
2022/0432(COD)
Proposal for a regulation
Recital 2
Recital 2
Amendment 81 #
2022/0432(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi- constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi- constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those casixtures.
Amendment 138 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) No 1272/2008
Article 2 – paragraph 7a
Article 2 – paragraph 7a
Amendment 220 #
2022/0396(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In line with the Green Deal33, the new Circular Economy Action Plan (CEAP)34commits to reinforcing the essential requirements for packaging in view of making all packaging reusable or recyclable by 2030, and to consider other measures to reduce (over)packaging and packaging waste, drive design for re-use and recyclability of packaging, reduce the complexity of packaging materials and introduce requirements for recycled content in plastic packaging. The new CEAP also commits to reduce food waste and encourages circular approaches to the use of water.It commits the Commission to assess the feasibility of Union-wide labelling that facilitates the correct separation of packaging waste at source. _________________ 33 https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=COM%3A2019%3 A640%3AFIN 34 https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=COM:2020:98:FIN &WT.mc_id=Twitter
Amendment 223 #
2022/0396(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Plastic is a widely used material for the packaging of agri-food products, as it ensures their safety while keeping their quality and conformity throughout the supply chain, including transport, as well as contributing to increasing the shelf life of fresh and highly perishable products. Most non-plastic food contact materials are not currently covered by specific European legislation and recycling technologies currently available do not always guarantee a high quality recycled plastic. For this reason, any initiative aimed at substituting single-use packaging, including plastic products, in the food sector, should be done in a technically and economically feasible way. Chemical recycling constitutes a complementary option to mechanical recycling to achieve the targets set in this Regulation, especially for plastic packaging in contact with food.
Amendment 227 #
2022/0396(COD)
Proposal for a regulation
Recital 7
Recital 7
Amendment 230 #
2022/0396(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The European Parliament’s Resolution of 10 February 2021 on the New Circular Economy Action Plan39reiterated the objective of making all packaging reusable or recyclable in an economically viable way by 2030 and called on the Commission to present a legislative proposal including waste reduction measures and targets and ambitious essential requirements in the Packaging and Packaging Waste Directive to reduce excessive packaging, including in e-commerce, improve recyclability and minimise the complexity of packaging, increase recycled content, phase out hazardous and harmful substances, and promote re-use. At the same time, it underlined the need to comply with food hygiene and food safety standards. _________________ 39 https://www.europarl.europa.eu/doceo/doc ument/TA-9-2021-0040_EN.html
Amendment 234 #
2022/0396(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) In its resolution of 15 September 2022 on the consequences of drought, fire, and other extreme weather phenomena: increasing the EU’s efforts to fight climate change, the European Parliament stressed how water is an increasingly valuable yet scarce resource and underlined the importance of sustainable water management for guaranteeing food security, calling on the Commission to refrain from proposing further EU legislation that endangers or risks endangering EU food security. In light of its scarcity, the use of water should be prioritised in sectors where it is essential, such as agriculture.
Amendment 241 #
2022/0396(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) An item, which is an integral part of a product and is necessary to contain, support or preserve that product throughout its lifetime and where all elements are intended to be used, consumed or disposed of together, should not be considered as being packaging given that its functionality is intrinsically linked to it being part of the product. However, in light of the disposal behaviour of consumers regardingefforts to establish appropriate recycling and composing streams, tea and coffee bags as well as coffee or tea system single-serve units, which in practice are disposed of together with the product residue leading to the contamination of compostable and recycling streams, those specific items, should be treated as packaging. This is in line with the objective to increase the separate collection of bio-waste, as required by Article 22 of Directive 2008/98/EC of the European Parliament and of the Council41. Furthermore, to ensure coherence regarding end-of-life financial and operational obligations, also all coffee or tea system single-serve units necessary to contain coffee or tea should be treated as packaging. _________________ 41 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 246 #
2022/0396(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In line with the waste hierarchy set out in Article 4(21) of Directive 2008/98/EC, and with the requirement set in paragraph 2 of Article 4 of the same Directive, which foresees that specific waste streams may depart from the hierarchy where this is in line with life- cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packagingand recycling of packaging while delivering the best environmental outcome. In addition, the measures aim at increasing the use of recycled content in packaging, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.
Amendment 257 #
2022/0396(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) It is estimated that 88 million tonnes of food waste are generated in the Union each year and over 50 % of food waste is estimated to come from households and consumers. Packaging can play an important role in reducing food waste as it preserves essential elements of food, so that its composition and organoleptic properties are not compromised, it ensures food protection from mechanical damage and physical shocks, and it is an effective barrier against microbiological degradation, oxygen or loss of aromas, therefore increasing the shelf life of agri-food products. Packaging for fresh vegetables and fruit can ensure that consumers have access to fresh, healthy products that last longer, therefore encouraging their consumption and healthy eating habits. According to the European Food Safety Agency (EFSA), food packaging protects food from microorganisms and makes it easier to store and to prolong the shelf life of food. Packaging and other articles such as containers also improve hygiene and make it more convenient for people to buy, sell and handle food. Any initiative to reduce the amount of packaging placed on the market and packaging waste should not outweigh the Union's ambitions of food waste reduction and carefully consider the food safety of the products concerned.
Amendment 291 #
2022/0396(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Designing packaging with the objective of its recycling, once it becomes packaging waste, is one the most efficient measures to improve the packaging circularity and raise packaging recycling rates and the use of recycled content in packaging, while assuring marketing and consumer acceptance and preserving all its functions. Packaging design for recycling criteria have been established for a number of packaging formats under voluntary industry schemes or by some Member States for the purpose of the modulation of extended producer responsibility fees. In order to prevent barriers to the internal market and provide industry with a level playing field, and with the objective to promote the sustainability of packaging assuring marketing and consumer acceptance and preserving all its functions, it is important to set mandatory requirements regarding the recyclability of packaging, by harmonising the criteria and the methodology for assessing packaging recyclability based on a design for recycling methodology at the Union level. In order to meet the objective set out in the CEAP that, by 2030, all packaging should be recyclable or reusable, in an economically viable manner, packaging recyclability performance grades should be established based on design for recycling criteria for packaging categories as listed in Annex II. However, packaging should comply with them only as of 1 January 2030 in order to give sufficient time to the economic operators to adapt.
Amendment 297 #
2022/0396(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) Careful consideration should be given to situations when the packaging's technical and qualitative characteristics conflict with total recyclability when determining the design for recycling criteria. The product's performance and its effects on the environment, particularly in terms of hygiene, healthiness and food safety, must then be carefully considered.
Amendment 300 #
2022/0396(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) As design for recycling assessment in itself does not ensure that packaging is recycled in practice, it is necessary to establish a uniform methodology and criteria for assessing the recyclability of packaging in practice based on the state-of- the-art separate collection, sorting and recycling processes and infrastructure actually available in the Union. Related reporting from Member States and, where relevant, economic operators should support establishing the recyclability “at scale” thresholds and update, on this basis, the recyclability performance grades with respect to the specific packaging materials and categories, preserving the added value conveyed to the final consumer with the packaging.
Amendment 303 #
2022/0396(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to establish harmonised rules on packaging design to ensure its recyclability while ensuring packaging performs all its functions and assuring marketing and consumer acceptance, the power to adopt delegated acts should be delegated to the Commission to set out detailed criteria for packaging design for recycling per packaging materials and categories, as well as for the assessment of the packaging recyclability at scale including for categories of packaging not listed in this Regulation. These criteria shall not conflict with the quality requirements and technical functionality that the packaging shall ensure. In order to give economic operators and Member States sufficient time to collect and report the necessary data to establish the “at scale” recycling methodology, the manufacturers should ensure that packaging is recycled at scale as of 2035. That should ensure that packaging complies with the design for recycling criteria, and is also recycled in practice on the basis of the state of the art processes for separate collection, sorting and recycling.
Amendment 321 #
2022/0396(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Some Member States are taking action to encourage recyclability of packaging through modulation of extended producer responsibility fees; such initiatives taken at the national level may create regulatory uncertainty for the economic operators, in particular where they supply packaging in several Member States. At the same time, modulation of extended producer responsibility fees is an effective economic instrument to incentivise more sustainable packaging design leading to better recyclable packaging while improving the functioning of the internal market. It is therefore necessary to harmonise criteria for the modulation of extended producer responsibility fees based on the recyclability performance grade obtained through recyclability assessment, while not setting the actual amounts of such fees, and to ensure that such fees are earmarked to finance the net cost of collection, sorting and recycling of packaging. As the criteria should be related to the criteria on packaging recyclability, it is appropriate to empower the Commission to adopt such harmonised criteria at the same time as establishing the detailed design for recycling criteria per packaging categories.
Amendment 328 #
2022/0396(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) To ensure packaging circularity, packaging should be designed and manufactured in such a way as to allow for the increased substitution of virgin materials with recycled materials. The increased use of recycled materials supports the development of the circular economy with well-functioning markets for recycled materials, reduces costs, dependencies and negative environmental impacts related to the use of primary raw materials, and allows for a more resource- efficient use of materials. In relation to the different packaging materials, the lowest input of recycled materials is in plastic packaging. In order to address these concerns in the most appropriate manner, it is necessary to increase the uptake of recycled plastics, by establishing mandatory targets for recycled content in plastic packaging at different levels depending on the contact-sensitivity54of different plastic packaging applications, the availability, prices and market volumes of recycled plastic,and ensuring that the targets become binding byfrom2030. In order to incrementally ensure packaging circularity, increased targets should apply as of 2040. _________________ 54 Contact sensitive packaging refers to plastic packaging of products covered by Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (OJ L 338 13.11.2004, p. 4), Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p. 59), 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), Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176), Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1), Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43), 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) and Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13–59).
Amendment 337 #
2022/0396(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unit of packaging contains a certain minimum percentage of recycled content recovered from post- consumer plastic waste calculated as an average of the plastic packaging placed by a producer on the Union market. This provision should not apply to food or feed contact plastic packaging in those cases when the recycled content risks affecting human and animal health and/or compromising the food safety of products.
Amendment 352 #
2022/0396(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure uniform conditions for the implementation of the rules on calculationg and verifying, per unit of post-consumer plastic waste in packaging,ication of the share of recycled content recovered from post-consumer plastic waste present and establishing the format for technical documentation, the Commission should be empowered to adopt implementing provisions, in accordance with Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council55. _________________ 55 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 364 #
2022/0396(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The bio-waste waste stream is oftencould be contaminated with conventional plastics and the material recycling streams are oftencould be contaminated with compostable plastics. This cross-contamination could leads to waste of resources, lower quality secondary raw materials and should be prevented at source. As the proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, it is justified andTherefore, it is necessary to lay down clear and common rules on the use of compostableand disposal of plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human healthlabeled as compostable, including the possibility to mandating applications. This is particularly the case when the use of compostable packaging helps collect or disposrecycle of bio-waste. All plastic packaging labeled as compostable should not go into material recycling.
Amendment 376 #
2022/0396(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) For limited packaging applications made of biodegradable plastic polymers, tThere is a demonstrable environmental benefit of using compostable packaging, which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where appropriate waste collection schemes and waste treatment infrastructures are available in a Member State, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging not labeled as compostable should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams.
Amendment 378 #
2022/0396(COD)
Proposal for a regulation
Recital 37
Recital 37
Amendment 383 #
2022/0396(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to facilitate conformity assessment with requirements on compostable packaging, it is necessary to provide for presumption of conformity for compostable packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council56for the purpose of expressing detailed technical specifications of those requirements and take into account, in line with the latest scientific and technological developments, the parameters, including composting times and admissible levels of contamination, which reflect the actual conditions in bio- waste treatment facilities, including anaerobic digestion processes. quality of the output,composting proper processingtimes and admissible levels of contamination. _________________ 56 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance (OJ L 316, 14.11.2012, p. 12).
Amendment 389 #
2022/0396(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Packaging should be designed, where relevant for a given shape, so as to minimise its volume and weight while maintaining its ability to perform the packaging functions. The manufacturer of packaging should assess the packaging against the performance criteria, as listed in Annex IV of this Regulation. In view of the objective of this Regulation to reduce packaging and packaging waste generation and to improve circularity of packaging across the internal market, it is appropriate to further specify the existing criteria and to make them more stringent. The list of the packaging performance criteria, as listed in the existing harmonised standard EN 13428:200057, should therefore be modified. While marketing and consumer acceptance remain relevant for packaging designpresentation,design and differentiation functionality, they should not be part ofthe mainperformance criteria justifying on their own additional packaging weight and volume. However, this should not compromise product or packagingspecifications for craft and industrial products and food , beveragesand agricultural products that are registered aundprotected under theEU geographical indication protection schemeer or otherwiseprotected by the Union intellectual property law orEU geographical indication protection schemes, including third country geographical indication that have been given distinctive recognition by the Union, as part of the Union’s objective to protect Intellectual property rights,cultural heritage and traditional know- how.Traditional packaging associated with products that have been granted distinctive recognition or that are subject to geographical indication of origin protection shall, however, seek to reduce packaging weight to the smallest amount possible while protecting the shape of the packaging in accordance with the overall ambitions of this proposal. On the other hand, recyclability, the use of recycled content, and re-use may justify additional packaging weight or volume, and should be added to the performance criteria. Packaging with double walls, false bottoms and other characteristics only aimed to increase the perceived product volume should not be placed on the market, as it does not meet the requirement for packaging minimisation. The same rule should apply to superfluous packaging not necessary for ensuring packaging functionality. _________________ 57 Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction.
Amendment 397 #
2022/0396(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) In order to facilitate conformity assessment with requirements on packaging minimisation, it is necessary to provide presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and specify measurable design criteria, including where appropriate, maximum weight or empty space limits for specific packaging formats as well as by-default, standardised packaging designs that comply with the packaging minimisation requirement. Packaging design and minimisation should not compromise the requirements specified under EU rules on food contact materials and they should not affect the food safety of the products.
Amendment 399 #
2022/0396(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) To promote the circularity and sustainable use of packaging, reusable packaging and systems for re-use should be incentivised without prejudice to Article 4(2) of Directive 2008/98/EC and where re-use does not pose risks to the quality of food and/or compromises food safety of the products. For that purpose, it is necessary to clarify the notion of reusable packaging and to ensure that it is linked not only to the packaging design, which should enable a maximum number of trips or rotations and maintaining the safety, quality and hygiene requirements when being emptied, unloaded, refilled or reloaded, but also to the setting up of systems for re-use respecting minimum requirements as set out in this Regulation. In order to facilitate conformity assessment with requirements on reusable packaging, it is necessary to provide for presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and define reusable packaging criteria and formats, including minimum number of trips or rotations, standardised designs, as well as requirements for systems for re-use, including hygiene requirements. In light of the significant amount of water needed to implement a re-use system, especially for food and beverages and at industrial level, Member States should maintain a level of flexibility in adopting such provision. The Commission should produce a risk assessment of the implementation of reusable packaging vis-à-vis EU water management strategy and European water waste reduction targets.
Amendment 407 #
2022/0396(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) It is necessary to inform consumers and to enable them to appropriately dispose of packaging waste, including compostable lightweight and very lightweight plastic carrier bags. The most appropriate manner to do this is to establish a harmonised labelling system based on the material composition of packaging for sorting of waste, and to pair it with corresponding labels on waste receptacles. To this end, the Commission and Member States shall provide the necessary tools and incentives, including economic ones, with special attention to micro and small enterprises.
Amendment 417 #
2022/0396(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) In order to inform end-users about reusability, availability of systems for re- use and location of collection points as regards reusable packaging, such packaging should bear a QR code or other data carrier that provides such information. The QR code should also facilitate tracking and the calculation of trips and rotations. In addition, reusable sales packaging should be clearly identified at the point of sale.
Amendment 427 #
2022/0396(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) In order to safeguard the functioning of the internal market, it is necessary to ensure that packaging from third countries entering the Union market comply with this Regulation, whether imported as self-standing packaging or in a packaged product. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to that packaging. Importers should therefore ensure that the packaging they place on the market comply with those requirements and that documentation drawn up by manufacturers are available for inspection by the competent national authorities. To comply with these obligations, adequate support should be provided to non-professional importers, especially to micro and SMEs.
Amendment 438 #
2022/0396(COD)
Proposal for a regulation
Recital 61
Recital 61
Amendment 447 #
2022/0396(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) Reusable packaging has to be safe for its users. Therefore, economic operators offering their products in reusable packaging have to ensure that, before a reusable packaging is used again, it is subject to a reconditioning process, for which requirements should be laid down. For foodstuffs reusable packaging should guarantee that food safety is not compromised.
Amendment 448 #
2022/0396(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) Reusable packaging becomes waste, in the sense of the Article 3(1) of Directive 2008/98/EC, when its holder discards it, intends to discard it or is obligated to discard it. Reusable packaging in a reconditioning process is normally not t considered to be waste.
Amendment 462 #
2022/0396(COD)
Proposal for a regulation
Recital 67
Recital 67
(67) In order to reduce the increasing proportion of packaging that is single use and the growing amounts of packaging waste generated, it is necessary to establish quantitative re-use and refill targets on packaging in sectors, which have been assessed as having the greatest potential for packaging waste reduction, namely food and beverages for take-away, large-white goods and transport packaging. This was appraised based on factors such as existing systems for re-use, necessity of using packaging and the possibility of fulfilling the functional requirements in terms of containment, tidiness, health, hygiene and safety. Differences of the products and their production and distribution systems, were also taken into account. The setting of the targets is expected to support the innovation and increase the proportion of re-use and refill solutions. The use ofIn acccording with Article 4(2) of Directive 2008/98/EC, restrictions shall not apply to single -use packaging for food and beverages filled and consumed within the premises in the HORECA sector should not be allowedthat provides a better overall environmental outcome supported by life cycle thinking, as well as a better overall economic and health impact.
Amendment 469 #
2022/0396(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) To increase their effectiveness and ensure the equal treatment of economic operators, the re-use and refill targets should be placed on the economic operators. In cases of targets for beverages, they should be additionally placed also on the manufacturers, as these actors are able to control the packaging formats used for the products they offer. The targets should be calculated as a percentage of sales in reusable packaging within a system for re-use or through refill or, in case of transport packaging, as a percentage of uses. The targets should be material neutral. A detailed assessment should be conducted to ensure that reuse targets can be met in a safe, economically feasible, and environmentally sustainable manner that would bring concrete benefits compared to recyclable alternatives. Moreover, the targets should be realistic and feasible, giving economic operators sufficient time to adapt. In order to ensure uniform conditions for the implementation of targets for re-use and refill, the power to adopt an implementing act in accordance with Article 291 of the Treaty on the methodology for their calculation, should be delegated to the Commission.
Amendment 474 #
2022/0396(COD)
Proposal for a regulation
Recital 69
Recital 69
(69) Certain uses of single use transport packaging formats are not necessary, as there is a wide range of well-functioning reusable alternatives. In order to ensure that such alternatives are effectively used, it is appropriate to require economic operators, when transporting products between different sites of the same economic operator or between the economic operator and the linked or partner enterprises, to use only reusable transport packaging with respect to packaging formats such as pallets, foldable plastic boxes, and plastic crates, intermediate bulk containers, both rigid and flexible, or drums. The same obligation should, for the same reasons, apply to economic operators transporting products within one Member State. Pursuant to Article 4(2) of Directive 2008/98/EC, exceptions must be possible if, according to a life cycle assessment, the use of easily recyclable single-use packaging is more suitable than the use of reusable packaging.
Amendment 490 #
2022/0396(COD)
Proposal for a regulation
Recital 90
Recital 90
(90) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the waste generation by eliminating excessive packaging and restrict the uses of certain packaging formats, extending the life span of packaging, re-designing products so that no packaging or less packaging can be used, including bulk sales, and by shifting from single use packaging to reusable packaging where it make sense from a climate and environmental standpoint considering the whole life cycle of packaging.
Amendment 499 #
2022/0396(COD)
Proposal for a regulation
Recital 91
Recital 91
(91) To achieve an ambitious and sustained reduction in the overall packaging waste generation, targets should be laid down for the reduction of packaging waste per capitamaterial to be achieved by 20340. Meeting a target of 5 % reduction in 2030 compared to 2018 should entail an overall absolute reduction of approximately 19 % on average across the Union in 2030 compAccording to the existing harmonised standared to the 2030 baseline. Member States should reduce packaging waste generation by 10 %, compared to 2018, by 2035; this is estimated to reduce packaging waste by 29 % compared to the 2030 baseline. In order to ensure that the reduction efforts continue beyond 2030, a reduction target of 10 % from 2018, which would mean a reduction of 29 % compared to baseline, should be set for 2035 and, for 2040, a reduction target of 15 % from 2018, which means a reduction of 37 % compared to baselineEN 13428:200030, waste prevention through material reduction should be a core guiding principle, whereby the substitution of one packaging material for another is not a basis for should be establishedrce reduction.
Amendment 505 #
2022/0396(COD)
Proposal for a regulation
Recital 92
Recital 92
Amendment 524 #
2022/0396(COD)
Proposal for a regulation
Recital 101 a (new)
Recital 101 a (new)
(101a) The first stage in ensuring recycling and creating a robust Union market for secondary raw materials is the separate collection of packaging. A national incentive to create effective and targeted collection systems is the implementation of collection obligations, which will increase the amount of waste sorted and recycled at scale.
Amendment 528 #
2022/0396(COD)
Proposal for a regulation
Recital 103
Recital 103
(103) Deposit and return systems should be obligatory for single use plastic beverage bottles and metal beverage containers. Member States might also decide to include other packaging in these systems, in particular single use glass bottles, and should ensure that deposit and return systems for single-use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging, where technically and economically feasible. They should consider establishing deposit and return systems also for reusable packaging. In such situations, a Member State should be allowed, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Regulation.
Amendment 544 #
2022/0396(COD)
(108) As a specific packaging waste generation prevention measure, Member States should actively encourage the re-use and refill solutions. They should support the establishment of systems for re-use and refill and monitor their functioning and compliance with the hygiene standards. Member States are encouraged to take also other measures, such as setting up deposit and return systems covering reusable packaging formats, or using economic incentives or establishing requirements for final distributors to make available a certain percentage of other products than those covered by re- use and refill targets in reusable packaging or through refill provided that such requirements will not result in fragmentation of single market and creation of trade barriers.
Amendment 567 #
2022/0396(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Inter-institutional Agreement on Better Law-Making, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and Union value added and should provide the basis for impact assessments of possible further measures. The evaluation should have a dedicated part to, inter alia, the impact of this Regulation on the agri-food system. The Commission should submit to the European Parliament, to the Council, the European Economic and Social Committee, and to the Committee of the Regions a report on the implementation of this Regulation and its impact on the environmental sustainability of packaging and the functioning of the internal market.
Amendment 582 #
2022/0396(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation applies to all packaging, with the exception of packaging approved for the transport of dangerous goods regardless of the material used, and to all packaging waste, whether such waste is used in or originates from industry, other manufacturing, retail or distribution, offices, services or households.
Amendment 590 #
2022/0396(COD)
2. This Regulation applies without prejudice to Union regulatory requirements for packaging such as those regarding safety, quality, the protection of health and the hygiene of the packed products, or to transport requirements, as well as without prejudice to the provisions of the Directive 2008/98/EC as regards the management of hazardous waste and the requirements provided for in paragraph 2 of Article 4 of Directive 2008/98/EC.
Amendment 597 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point f
Article 3 – paragraph 1 – point 1 – point f
(f) tea or coffee bagcompostable coffee bags and system single-serve units and permeable tea or coffee single-serve units necessary to contain a tea or coffee product and intended to be used and disposed of together with the product;
Amendment 618 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point g
Article 3 – paragraph 1 – point 1 – point g
(g) coffee or tea systemprotective beverage single-serve unit necessary to contain a coffee or tea product and intended to be used and disposed of together with the product;
Amendment 635 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) ‘plastic packaging’ means a packaging that is wholly or predominantly made of plastic.
Amendment 640 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 19
Article 3 – paragraph 1 – point 19
(19) ‘composite packaging’ means a unit of packaging made of two or more different materials, excluding materials used for labels, closures and sealing, which cannot be separated manually and therefore form a single integraloatings, linings, paints, inks, adhesives, closures, sealing and lacquers, which are considered as part of the weight of the main packaging material, which cannot be separated manually and therefore form a single integral unit, unless a given material constitutes an insignificant part of the packaging unit and in no case more than 10% of the total mass of the packaging unit;
Amendment 686 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 b (new)
Article 3 – paragraph 1 – point 32 b (new)
(32b) ‘'recyclability' means the compatibility of packaging with the management and processing of waste, based on separate collection, sorting in separate streams, recycling at scale, and use of recycled materials to replace primary raw materials;
Amendment 690 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32
Article 3 – paragraph 1 – point 32
(32) ‘recycled at scale’ means collected, sorted and recycled through installed state-of-the-art infrastructure and processesthat the packaging meets the requirements of Article 6(2)(a) and is accepted for recycling by packaging responsibility organisations in the majority of Member States, where the packaging is placed on the market and the producer is registered under the obligations set out in Article 39, covering at least 75 % of the Union population, including packaging waste exported from the Union that meets the requirements of Article 47(5);
Amendment 708 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 a (new)
Article 3 – paragraph 1 – point 32 a (new)
(32a) 'high quality recycling’ means any recovery operation, as defined in Article 3, point (17), of Directive 2008/98/EC, that ensures that the distinct quality of the waste collected and sorted is preserved or recovered during that recovery operation, so that the resulting recycled materials are of sufficient quality to substitute primary raw materials;
Amendment 717 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 34
Article 3 – paragraph 1 – point 34
(34) ‘integrated component’ means a packaging component that may be distinct from the main body of the packaging unit, and may be of a different material, but is integral to the packaging unit and its functioning and does not need to be separated from the main packaging unit in order to consume the product and is typically discarded at the same time as the packaging unit, although not necessarily in the same disposal routeis recommended to be disposed together with the main body of the packaging;
Amendment 722 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 35
Article 3 – paragraph 1 – point 35
(35) ‘separate component’ means a packaging component that is distinct from the main body of the packaging unit, which may be of a different material, that needs to becan be manually disassembled completely and permanently from the main packaging unit in order to access the product, and that is typically discarded prior to anby the end consumer, and that is recommended to be disposed separately from the packaging unit;
Amendment 737 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 38
Article 3 – paragraph 1 – point 38
(38) ‘secondary raw materials’ means materials that have been obtaineundergone all necessary checking, sorting and othrough recycling processeser preliminary operations to remove waste materials that are not targeted by the subsequent reprocessing and can substitute primary raw materials;
Amendment 743 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 39 a (new)
Article 3 – paragraph 1 – point 39 a (new)
(39a) "recycled content in plastic packaging" refers to the quantity of material contained in the packaging derived through any recycling process or pre- and post-consumer waste, whether mechanically, physically, or chemically recycled.
Amendment 747 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 39 b (new)
Article 3 – paragraph 1 – point 39 b (new)
(39b) 'pre-consumer plastic waste' means plastic waste that is generated from production and converting of plastic material.
Amendment 797 #
2022/0396(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 811 #
2022/0396(COD)
Proposal for a regulation
Article 4 – paragraph 6 a (new)
Article 4 – paragraph 6 a (new)
6a. Medicinal products, as defined in Article 1, point (2) of Directive 2001/83/EC, that have been lawfully placed on the market before the date of application referred to in Article 65 of this Regulation or the date of entry into force of specific measures, and that have not been repackaged or relabelled after these dates, may be further made available on the market until their expiry date without being required to comply with the specific rules laid down in Articles 6, 7, 11 and 13.
Amendment 817 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Packaging shall be so manufactured that the presence and concentration of substances of concernthat meet the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1% weight by weight (w/w) as laid down the Regulation (EC) No 1907/2006 as constituents of the packaging material or of any of the packaging components is minimised, including with regard to their presence in emissions and any outcomes of waste management, such as secondary raw materials, ashes or other material for final disposal.
Amendment 822 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. WOher than the substances criteria laid down in Article 5(1) and without prejudice to the restrictions on chemicals set out in Annex XVII of Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food contact packaging in Regulation (EC) No 1935/2004, the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.
Amendment 844 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Recyclability requirements established in delegated acts adopted pursuant to Article 6(5)by CEN - European Committee for Standardization shall not restrict the presence of substances in packaging or packaging components for reasons relating primarily to chemical safety. They shall address, as appropriate, substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present, and shall, as appropriate, identify the specific substances concerned and their associated criteria and limitations.
Amendment 868 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. All packaging shall be recyclable from 1 January 2030.
Amendment 873 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) it is designed for recycling or, for compostable packaging, is compliant with point a), b) and c) of Annex III;
Amendment 881 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point b
Article 6 – paragraph 2 – subparagraph 1 – point b
Amendment 885 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point c
Article 6 – paragraph 2 – subparagraph 1 – point c
Amendment 890 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point d
Article 6 – paragraph 2 – subparagraph 1 – point d
Amendment 899 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point e – point i (new)
Article 6 – paragraph 2 – subparagraph 1 – point e – point i (new)
i) it is effectively and efficiently separately collected in accordance with Article 43(1) and (2);
Amendment 900 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point e – point ii (new)
Article 6 – paragraph 2 – subparagraph 1 – point e – point ii (new)
ii) it is sorted into defined waste streams without affecting the recyclability of other waste streams;
Amendment 901 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point e – point iii (new)
Article 6 – paragraph 2 – subparagraph 1 – point e – point iii (new)
iii) except for compostable plastics, it can be recycled so that the resulting secondary raw materials are of sufficient quality to substitute primary raw materials;
Amendment 917 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
Point (a) shall apply from 1 January 2030 and point (eb) shall apply from 1 January 2035.
Amendment 926 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Recyclable packaging shall, from 1 January 2030, comply with the design for recycling criteria as laid down in the delegated acts adopted pursuant to paragraph 4 and, from 1 January 2035, also with the recyclability at scale requirements laid down in the delegated acts adopted pursuant to paragraph 6. Where such packaging complies with those delegated acts, it shall be considered to comply with paragraph 2, points (a) and (e).:
Amendment 940 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point a (new)
Article 6 – paragraph 3 – point a (new)
(a) from either 1 January 2030 or 36 months years after the publication in the Official Journal of the European Union of the harmonised standard developed by CEN-European Committee for Standardisation referred to in paragraph 4, whichever is the latest, comply with design for recycling criteria, and,
Amendment 941 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point b (new)
Article 6 – paragraph 3 – point b (new)
Amendment 944 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
The Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in ordershall request the CEN European Committee for Standardisation, to develop, at the latest by 31 December 2026, harmonised standards to establish design for recycling criteria and recycling performance grades based on th, as appropriate, on the indicative criteria and parameters listed in Table 2 and 3 of Annex II for the packaging categories listed in Table 1 of that Annex, as well as. From the date of publication of the references to harmonised standards in the Official Journal of the European Union, packaging which is in conformity with those standards shall be presumed to be in conformity with the requirement laid down in paragraph 1. The Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in order to establish rules concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations set out in Article 40(1), based on the packaging recycling performance grade, and for plastic packaging, the percentage of recycled content. Design-for-recycling criteria shall consider state of the art collection, marketing and consumer acceptance criteria, existing industry commitments, sorting and recycling processes and shall cover all packaging components.
Amendment 973 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
The Commission is empowered to adopt delegated acts, in close cooperation with stakeholders, in accordance with Article 58 to amend Table 1 of Annex II in order to adapt it to scientific and technical development in material and product design, collection, sorting and recycling infrastructure.
Amendment 978 #
2022/0396(COD)
From either 1 January 2030, or 36 months after the publication in the Official Journal of the European Union of the harmonised standard developed by CEN referred to in paragraph 4, packaging shall not be considered recyclable if it corresponds to performance grade E under the design for recycling criteria established in the delegated act adopted pursuant to paragraph 4 for the packaging category, to which the packaging belongs.
Amendment 990 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
These criteria shall be based at least onould consider as appropriate the parameters as listed in Table 23 of Annex II.
Amendment 1013 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point d a (new)
Article 6 – paragraph 6 – point d a (new)
(da) specific provisions should be approved for inert packaging placed on the market in very small quantities (i.e., approximately 0,1 % by weight) in the Union.
Amendment 1024 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 7 – point a
Article 6 – paragraph 7 – point a
(a) the manner in which to express the result of the recyclability assessment in recyclability performance grades from A to E, as described in Table 3 of Annex II, based on the percentage of the packaging unit, in weight, which is recyclable according to paragraph 1;
Amendment 1044 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 8 – subparagraph 4 a (new)
Article 6 – paragraph 8 – subparagraph 4 a (new)
Small components (50 mm in two dimensions) provide a specific challenge to current packaging material recycling facility capabilities. Small components may be placed on the market in derogation of paragraphs 2 and 3 until the Delegated Act defining the Design for Recycling standards is implemented. The Design for Recycling criteria shall take into account the needs for small components and be compatible with the state of the art collection, sorting, and recycling procedures.
Amendment 1058 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – introductory part
Article 6 – paragraph 10 – introductory part
10. Until 31 December 2034, tThis Article shall not apply to the following:
Amendment 1060 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point b
Article 6 – paragraph 10 – point b
(b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 and by Regulation (EU) 2019/6;
Amendment 1064 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c
Article 6 – paragraph 10 – point c
(c) contact sensitive plastic packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746.
Amendment 1068 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c a (new)
Article 6 – paragraph 10 – point c a (new)
(ca) outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC and in Article 4, point (26), of Regulation (EU) 2019/6.
Amendment 1073 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c b (new)
Article 6 – paragraph 10 – point c b (new)
(cb) items that are sold along with the product with the objective to be used for the application or dispensing of the product by the end user and will therefore be in contact with the products covered under points (a), (b), (ba) or (c);
Amendment 1076 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The financial contributions to be paid by producers to comply with their extended producer responsibility obligations as referred to in Article 40 shall be modulated on the basis of the recyclability performance grade, as determined in accordance with the delegated acts referred to in paragraphs 4 and 6 of this Article and, as regards plastic packaging, also in accordance with the Article 7(6). Financial contributions shall, in line with Article 8a of Directive 2008/98/EC, be destined to finance the net cost of collection, sorting and recycling infrastructures of the packaging type it is paid for, following the categories set in Annex II, Table 1.
Amendment 1093 #
2022/0396(COD)
1. From 1 January 2030, the plastic part inprovided technical feasibility, availability of the material and compliance with food safety national and European requirements, plastic packaging shall contain the following minimum percentage of recycled content recovered from pre-consumer or post-consumer plastic waste, per unit of packaging:
Amendment 1120 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) 30 % for contact sensitive plastic packaging made from polyethylene terephthalate (PET) as the major component;
Amendment 1128 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) 10 % for contact sensitive plastic packaging made from plastic materials other than PET, except single use plastic beverage bottles;
Amendment 1147 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 (new)
Article 7 – paragraph 1 – subparagraph 1 (new)
Targets shall be calculated as an avarage of the plastic packaging placed by a producer on the Union market.
Amendment 1172 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from pre-consumer or post- consumer plastic waste, per unit of packaging:
Amendment 1190 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1 (new)
Article 7 – paragraph 2 – subparagraph 1 (new)
Targets shall be calculated as an avarage of the plastic packaging placed by a producer on the Union market.
Amendment 1223 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Paragraphs 1 and 2 shall not apply to compostable plastic packaging as well as to bio-based plastic packaging, inks, adhesives, varnishes and coatings used on packaging.
Amendment 1239 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. ByFrom 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be modulated based on the percentage of recycled content used in the packagingtaking into account the cost of packaging waste management and the revenues from sales of secondary materials. The non-use of recycled contents as authorized by a derogation from this Article shall be considered in the modulation of the financial contributions.
Amendment 1262 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. By 31 December 2026, the Commission is empowered toshall adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unit of plastic packaging, and the format for the technical documentation referred to in Annex VII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1274 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7 a (new)
Article 7 – paragraph 7 a (new)
7a. Paragraphs 1 and 2 shall apply not earlier than 36 months after the adoption of the implementing acts pursuant to paragraph 7.
Amendment 1290 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1
Article 7 – paragraph 9 – subparagraph 1
By 31 JanuaryDecember 20285, the Commission shall assess the need for derogations from the minimum percentage laid down in paragraph 1, points b and d, for specific plastic packaging, or for the revision of the derogation established under paragraph 3 for specific plastic packaging.
Amendment 1296 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1 a (new)
Article 7 – paragraph 9 – subparagraph 1 a (new)
By 31 December 2035, the Commission shall assess the need for derogations from the minimum percentages laid down in paragraph 2 point a, b and c for specific plastick packaging.
Amendment 1298 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1 b (new)
Article 7 – paragraph 9 – subparagraph 1 b (new)
These assessments shall be based on market availability and prices of recycled plastics on an annual basis from the year of entry into force of this Regulation. These assessments shall consider Eurostat data for the EU-27 achieved plastic packaging recycling levels, recycled plastic price indices and annual rates of price change based on a monitoring tool to be established by the European Commission, and be based on the uptake of new recycling technologies and their impact on available market volumes.
Amendment 1302 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – introductory part
Article 7 – paragraph 9 – subparagraph 2 – introductory part
Based on this assessment, the Commission is empowered toshall, at the latest by 31 December 2026 and by 31 December 2036 respectively, adopt delegated acts in accordance with Article 58 to amend this Regulation in order to:
Amendment 1307 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point a
Article 7 – paragraph 9 – subparagraph 2 – point a
(a) provide for derogations from the scope, timing or level of minimum percentage laid down in paragraph 1, points a, b and d, and in paragraph 2, points a, b and c for specific plastic packaging, and, as appropriate,.
Amendment 1311 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point b
Article 7 – paragraph 9 – subparagraph 2 – point b
Amendment 1354 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation], packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit, and vegetables and very lightweight plastic carrier bags shall be compostable in industrially controlled conditions in bio-waste treatment facilities.
Amendment 1357 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation]2030, packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit and vegetables and very lightweight plastic carrier bags shall be compostable in industrially controlled conditions in bio-waste treatment facilities and therefore allowed to be collected in bio-waste receptacles.
Amendment 1364 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 1375 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. By [OP: Please insert the date = 24 months from the date of entry into force of this Regulation], packaging other than that referred to in paragraphs 1 and 2, including packaging made of biodegradshall comply with the criteria listed in Annex III. Packaging made with compostable material that is not labele plastic polymers,d as compostable shall be allowed to material recycling where appropriate waste collection schemes and waste treatment infrastructure are available to ensure they enter the bio-waste waste management stream without affecting the recyclability of other waste streams.
Amendment 1385 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. TAfter an assessment of the Expert Group, the Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend paragraphs 1 and 2 of this Article by adding other types of packaging to the types of packaging covered by those paragraphs when it is justified and appropriate due to technological and regulatory developments impacting the disposal of compostable packaging and under the conditions set out in Annex III. A public register containing the lists of such applications should be established and updated by the Commission.
Amendment 1392 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. By 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be collected and managed by dedicated extended producer responsibility scheme.
Amendment 1393 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 b (new)
Article 8 – paragraph 5 b (new)
5b. Compostable packaging can be placed on the market providing the presence of a minimum content of renewable raw material determined as percentage of carbon of biological origin present in packaging compared to the total carbon present therein. For this purposes, the current European standard on the subject based on radiocarbon methods EN 16640 shall be used. Agricultural biomass used for the manufacture of compostable packaging complies with the criteria laid down in Article 29, paragraphs 2 to 5, of Directive (EU) 2018/2001. Forest biomass used for the manufacture compostable packaging complies with the criteria laid down in Article 29, paragraphs 6 and 7 of that Directive.
Amendment 1395 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 c (new)
Article 8 – paragraph 5 c (new)
5c. By [OP: please insert the date = 12 months from the entry into force of this Regulation] compostable packaging shall contain a minimum content of renewable raw material of at least 60%.
Amendment 1403 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. PBy January 2030, packaging shall be designed so that its weight and volume is reduced to the minimum necessary for ensuring its functionalitys, as listed in the definition of packaging in Article 3(1), taking account of the material that the packaging is made of. and its design, for a given material and a given shape.
Amendment 1423 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. PBy January 2030, packaging not necessary to comply with any of the performance criteria set out in Annex IV and packaging with characteristics that are only aimed to increase the perceived volume of the product, including double walls, false bottoms, and unnecessary layers, shall not be placed on the market, unless the packaging design is subject to geographical indications of originshall not be placed on the market, unless the product or packaging design is subject to intellectual property protection or benefits from the Union’s geographical indications of origin protection or have been given distinctive product recognition by the Union, in each case protected under Union legislation.
Amendment 1430 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1 – introductory part
Article 9 – paragraph 3 – subparagraph 1 – introductory part
Amendment 1438 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2
Article 9 – paragraph 3 – subparagraph 2
For the purpose of assessing the compliance with this paragraph, space filled by paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene, styrofoam chips or other filling materials shall be considered as empty space unless required to protect and to transport the goods.
Amendment 1447 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point b
Article 9 – paragraph 4 – subparagraph 1 – point b
(b) the identification of the design requirements, including those related to intellectual property rights, which prevent further reduction of the packaging weight or volume, for each of these performance criteria;
Amendment 1451 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point c
Article 9 – paragraph 4 – subparagraph 1 – point c
(c) any test results, studies such as modelling and simulation studies or other relevant sources used to assess the minimum necessary volume or weight of the packaging.
Amendment 1457 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
4a. Packaging produced or imported prior the deadlines listed in paragraphs 1, 2 and 3, may be commercialised until 36 months after entry into force of this Regulation.
Amendment 1458 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 b (new)
Article 9 – paragraph 4 b (new)
4b. Space necessary to comply with the performance criteria in Annex IV, shall not be considered as empty space.
Amendment 1472 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point d
Article 10 – paragraph 1 – point d
(d) it is capable of being emptied, unloaded, refilled or reloaded, reloaded or re-used as tableware or kitchenware, while ensuring compliance with the applicable safety and hygiene requirements;
Amendment 1475 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
(e) it is capable of being reconditioned in accordance with Part B of Annex VI, whilst maintaining its ability to perform its intended function; or, if it is originally designed to be reused as tableware or kitchenware, it is proven by design characteristics such as washability, repairability, durability without losing product functionality, economic benefit for the consumer, and general consumer perception.
Amendment 1479 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point f
Article 10 – paragraph 1 – point f
(f) it can be emptied, unloaded, refilled or reloaded, reloaded or re-used as tableware or kitchenware while maintaining the quality and safety of the packaged product and allowing for the attachment of labelling, and the provision of information on the properties of that product and on the packaging itself, including any relevant instructions and information for ensuring safety, adequate use, traceability and shelf- life of the product;
Amendment 1483 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point g
Article 10 – paragraph 1 – point g
(g) it can be emptied, unloaded, refilled or reloaded, reloaded or re-used as tableware or kitchenware without risk to the health and safety of those responsible for doing so;
Amendment 1491 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Compliance with the requirements set out in paragraph 1, including the minimum indicative number of trips or rotation per packaging application, shall be demonstrated in the technical information concerning the packaging referred to in Annex VII.
Amendment 1499 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
From [OP: Please insert the date = 4236 months after the entry into force of this Regulation], packaging shall be marked with a label containing information on its material composition. This obligation does not apply to transport packaginge delegated act referred to in paragraph 5, information to facilitate consumer sorting shall be marked on the packaging or shall be available through digital means according to Article 11(4). This obligation does not apply to transport packaging, to packaging mentioned in Article 7(3), retail packaging subject to final packaging, as in te case of over-the counter food sales, and to reusable gas receptacles. However, it applies to e- commerce packaging.
Amendment 1518 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Packaging subject to deposit and return systems referred to in Article 44(1) shall, in addition to the labelling referred to in the first subparagraph, be marked with a harmonised label established in the relevant implementing act adopted pursuant to paragraph 5.
Amendment 1521 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. From [OP: Please insert the date = 48 months after the date of entry into force of this Regulation],e implementing act referred to in paragraph 5, reusable packaging shall bear a label on packaging reusability andor shall be available through a QR code or other type of digital data carrier that provides further information on packaging reusability including the availability of a system for re-use and of collection points, and that facilitates the tracking of the packaging and the calculation of trips and rotations. In addition, reusable sales packaging shall be clearly identified and distinguished from single use packaging at the point of sale. The marketing authorisation holder is permitted to transmit the package leaflet's information via a digital data carrier for medicinal products as defined in Article 1, point (2) of Directive 2001/83/EC and as required by Articles 59 and 52 of that same Directive.
Amendment 1533 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Where a unit ofplastic packaging covered by Article 7 is marked with a label containing information consumer relevant information on the share of recycled content, that label from post-consumer plastic waste, that label or a QR code or other type of digital data carrier shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5) and shall be based on the methodology pursuant to Article 7(7). Where a unit of plastic packaging is marked with a label containing information on the share of biobased plastic content, that label shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5).
Amendment 1538 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1
Article 11 – paragraph 4 – subparagraph 1
Labels referred to in paragraphs 1 to 3 and the QR code or other type of digital data carrier referred to in paragraph 2 shall be placed, printed or engraved visibly, clearly legibly and indelibly on the packaging. Where this is not possible or not warranted on account of the nature and size of the packaging, they shall be affixed to the grouped packaging information should be conveyed to consumers via digital means of communication as QR code or they shall be affixed to the grouped packaging. Information must be provided through the outer packaging, as defined in Article 1, Point (24), of Directive 2001/83/EC, for all immediate packaging, as defined in Article 1, Point (23), of Directive 2001/83/EC. From [Please insert the date = 24 months after the entry into force of this Regulation] the Commission shall adopt guidance regarding provision of information by digital means.
Amendment 1555 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
4a. The information referred to in paragraphs 1 through 3 may, as a derogation from paragraph 4, be provided by electronic means that are specified on the package or on a label that is attached to it.In such cases, the following requirements apply: a) no user data shall be collected or tracked; b) the information shall not be displayed with other information intended for sales or marketing purposes.
Amendment 1558 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. By [OP: Please insert the date = 182 months after the date of entry into force of this Regulation], the Commission shall adopt implementing acts to establish a harmonised label and specifications for the labelling requirements and formats for the labelling of packaging referred to in paragraphs 1 to 3 and the labelling of waste receptacles referred to in Article 12. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1560 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 6
Article 11 – paragraph 6
6. By [OP: Please insert the date = 124 months after the date of entry into force of this Regulation], the Commission shall adopt implementing acts to establish the methodology for identifying the material composition of packaging referred to in paragraph 1packaging materials by means of digital marking technologies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1565 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
7. Without prejudice to requirements concerning other harmonised EU labels, Member States shall not require economic operators shall noto provide or display labels, marks, symbols or inscriptions that are likely to mislead or confuse consumers or other end users with respect to the sustainability requirements for packaging, other packaging characteristics or packaging waste management options, for which harmonised labelling has been laid down in this Regulation. From [Please insert the date = 24 months after the entry into force of this Regulation] the Commission shall adopt guidance regarding aspects that are likely to mislead or confuse consumers or other end users.
Amendment 1576 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8
Article 11 – paragraph 8
8. Packaging included in an extended producer responsibility scheme or covered by a deposit and return system other than that referred to in Article 44(1) mayshall be identified by means of a corresponding symbol throughout the territory in which that scheme or system applies. That symbol shall be clear and unambiguous and shall not mislead consumers or users as to the recyclability or reusability of the packagingharmonised symbol to be designed via an implementing act by the Commission in accordance with the examination procedure referred to in Article 59(3).
Amendment 1579 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8 a (new)
Article 11 – paragraph 8 a (new)
8a. Packaging produced or imported prior the deadlines referred to in paragraphs 1, 2 and 3, may be put into the market until 36 months after the entry into force of this Regulation.
Amendment 1587 #
2022/0396(COD)
Proposal for a regulation
Article 12 a (new)
Article 12 a (new)
Article12a Packaging and Packaging Waste Forum The Commission shall ensure that it maintains a balanced participation of Member States’ representatives and all interested parties involved with the packaging industry, including waste treatment industry representatives, manufacturers and packaging suppliers, distributors, retailers, craft industry representatives, importers, SMEs, environmental protection groups, and others when it defines the sustainability requirements and other requirements and criteria established in this Regulation. These parties shall contribute in particular to preparing design for recycling criteria for different packaging and recycling performance grades based on the criteria and parameters listed in Table 2 of Annex II for packaging categories listed in Table 1 of that Annex. To that end, the Commission shall establish an expert group, in which those parties shall meet, referred to as “Packaging and Packaging Waste Forum”.
Amendment 1590 #
2022/0396(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
By 1 January 202836 months from the date of entry into force of the delegated act referred to in Article 11(5), labels that enable the separate collection of each material specific fraction of packaging waste that is intended to be discarded in separate receptacles shall be affixed, printed or engraved visibly, legibly and indelibly on all waste receptacles for collection of packaging waste.
Amendment 1611 #
2022/0396(COD)
Proposal for a regulation
Article 13 – paragraph 6 a (new)
Article 13 – paragraph 6 a (new)
6a. With regard to this Regulation, for medicinal products, as defined in Article 1, point (2), of the Directive 2001/83/EC, the information provided shall be of the marketing authorisation holder, as provided by Article 6.1a of the Directive 2001/83/EC.
Amendment 1618 #
2022/0396(COD)
Proposal for a regulation
Article 13 – paragraph 9 a (new)
Article 13 – paragraph 9 a (new)
9a. The provisions of paragraphs 1 to 6 shall not apply to custom transport packaging for configurable devices and systems, that are destined to be used use in industrial and healthcare environments.
Amendment 1636 #
2022/0396(COD)
Proposal for a regulation
Article 16 – paragraph 10 a (new)
Article 16 – paragraph 10 a (new)
10a. To fulfil the obligations under this article, Member States shall provide support tools for non professional importers, especially micro and SME importers.
Amendment 1659 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. EBy January 2030, economic operators who supply products to a final distributor or an end user in grouped packaging, transport packaging or e- commerce packaging, shall ensure that the empty space ratio is maximum 40 %inimised, under the restrictions outlined in Part I of Annex IV. The packaging minimisation shall take into careful consideration the protection of the goods and its transport.
Amendment 1674 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1
Article 21 – paragraph 2 – subparagraph 1
Amendment 1676 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point a
Article 21 – paragraph 2 – subparagraph 1 – point a
Amendment 1678 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point b
Article 21 – paragraph 2 – subparagraph 1 – point b
Amendment 1707 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. EFrom 1 January 2030 economic operators shallould not place on the market packaging in the formats and for the purposes listed in Annex V.
Amendment 1714 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 1734 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Member States may exempt economic operators from point 3 of Annex V if they comply withEconomic operators shall be exempted if they meet the definition of micro-company in accordance wienterprise according to the rules set out in the Commission Recommendation 2003/361, as applicable on [OP: Please insert the date = the date of entry into force of this Regulation], and. In addition, Member States shall grant an exemption where it is not technically feasible not to use packaging or to obtain access to the infrastructure that is necessary for the functioning of a reuse system or when duly justified by concerns related to public health, food hygiene and food safety, product integrity or environmental issues.
Amendment 1746 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend Annex V in order to adapt it to technical and scientific progress with the objective to reducing packaging waste. When adopting those delegated acts, the Commission shall consider the potential of the restrictions on the use of specific packaging formats to reduce the packaging waste generated while ensuring an overall positive environmental impact, and shall take into account the availability of alternative packaging solutions that meet requirements set out in legislation applicable to contact sensitive packaging, as well as their capability to prevent microbiological contamination of the packaged productBy [OP: Please insert the date = 8 years after the date of entry into force of this Regulation], the Commission shall assess the results of such restrictions on the reduction of packaging waste generated as well as on their overall environmental impact, and submit a report to the European Parliament and to the Council.
Amendment 1761 #
2022/0396(COD)
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Economic operators who place reusable packaging on the market shall ensure that a system for re-use of such packaging is in place, which meets the requirements laid down in Article 24 and Annex VI., except in cases where packaging is re-used as tableware or kitchenware
Amendment 1767 #
2022/0396(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Economic operators making use of reusable packaging shall recondition such packaging in compliance with Part B of Annex VI, prior to offering it again for use by end users. Packaging made to be re-used, as kitchenware or tableware, is exempt from this obligation.
Amendment 1773 #
2022/0396(COD)
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2a. Conveying reusable packaging to reconditioning is not considered to be waste.
Amendment 1784 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
Amendment 1800 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 1829 #
2022/0396(COD)
Amendment 1864 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
Amendment 1892 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
Amendment 1915 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
Amendment 1918 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 6 – introductory part
Article 26 – paragraph 6 – introductory part
6. The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging non-alcoholic beverages in the form of water, water with added sugar, water with other sweetening matter, flavoured water, soft drinks, soda lemonade, iced tea and similar beverages which are immediately ready to drink, pure juice, juice or must of fruits or vegetables and smoothies without milk and non- alcoholic beverages containing milk fat, shall ensure thatshall contribute to achieve the following targets:
Amendment 1952 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 7 – point b
Article 26 – paragraph 7 – point b
Amendment 1956 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 7 – subparagraph 1 (new)
Article 26 – paragraph 7 – subparagraph 1 (new)
This obligation does not apply to food businesses as defined in Article 3, point (2), of Regulation (EC) No 178/2002, which are engaged in logistics and wholesale B2B distribution and large scale industrial production and processing.
Amendment 1968 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 8 – point b
Article 26 – paragraph 8 – point b
Amendment 1983 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 9 – point a
Article 26 – paragraph 9 – point a
(a) from 1 January 20305 years after publication of the implementing acts pursuant to Article 27 (4), 10 % of such packaging used is reusable packaging within a system for re- use;
Amendment 1993 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 9 – point b
Article 26 – paragraph 9 – point b
Amendment 2023 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 10 – point b
Article 26 – paragraph 10 – point b
Amendment 2057 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 12 – subparagraph 2
Article 26 – paragraph 12 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, trays, plastic crates, intermediate bulk containers, drums and canisters, of all sizes and materials, excluding cardboard and including flexible formats.
Amendment 2081 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 13 – subparagraph 2
Article 26 – paragraph 13 – subparagraph 2
This obligation applies to pallets, boxes, excluding cardboard, plastic crates intermediate bulk containers, and drumplastic crates, of all sizes and materials, excluding cardboard, including flexible formats.
Amendment 2107 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15
Article 26 – paragraph 15
15. Economic operators shall be exempted from the obligation to meet the targets in paragraphs 2 to 6 if, during a calendar year, they have a sales area of not more than 100 m2, including also all storage and dispatch areas and if it is not technically feasible to use reusable packaging or to obtain access to the infrastructure necessary for the functioning of a re-use system.
Amendment 2117 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 a (new)
Article 26 – paragraph 15 a (new)
15a. Economic operators shall be exempted from the obligation to meet the targets in this article when duly justified by concerns related to public health, food hygiene and safety, product integrity or environmental issues.
Amendment 2121 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 b (new)
Article 26 – paragraph 15 b (new)
15b. Economic operators shall be exempted from the obligation to meet the targets in this article if, in accordance with paragraph 2 of Article 4 of Directive 2008/98/EC, they can show that alternative packaging formats deliver a better overall environmental outcome justified by life-cycle thinking, as well as a better overall economic and human health impact.
Amendment 2126 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 c (new)
Article 26 – paragraph 15 c (new)
15c. Economic operators shall be exempted from the obligation to meet the targets in this article for specific packaging formats if, by 2025 and for at least three consecutive calendar years, the Member State in which they operate has already attained the recycling target of the respective packaging material set for 2030, as required under article 46(1) point (d).
Amendment 2133 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 16 – point a
Article 26 – paragraph 16 – point a
Amendment 2145 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 16 – point c
Article 26 – paragraph 16 – point c
Amendment 2216 #
2022/0396(COD)
Proposal for a regulation
Article 38 – paragraph 1 – introductory part
Article 38 – paragraph 1 – introductory part
1. Each Member State shall reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018the year of entry into force of this Regulation as reported to the Commission in accordance with Decision 2005/270/EC, for each of the different materials contained in packaging waste detailed in Article 46, by
Amendment 2223 #
Amendment 2229 #
Amendment 2241 #
Amendment 2264 #
2022/0396(COD)
Proposal for a regulation
Article 38 – paragraph 5
Article 38 – paragraph 5
Amendment 2300 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 2030, Member States shall ensure that systems and infrastructures are set up to provide for the return and separate collection of 90% of all packaging waste from the end users in a given year for each packaging format listed in Table 1 of Annex II, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling. Packaging that comply with Design for Recycling criteria, as defined in the standards resulting from Article 6(4), shall be collected to ensure recycling.
Amendment 2346 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 2030, Member States shall ensure that systems and infrastructures are set up to provide for the return and separate collection of 90% of all packaging waste from the end users in a given year for each packaging format listed in Table 1 of Annex II, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling. Packaging that comply with Design for Recycling criteria, as defined in the standards resulting from Article 6(4), shall be collected to ensure recycling.
Amendment 2692 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 1
Annex II – Table 2 – row 1
Recyclability Assessment of recyclability per unit, in weight Performance Grade
Amendment 2694 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 2
Annex II – Table 2 – row 2
Grade A hHigher or equal to 95 % st compatibility with design for recycling
Amendment 2697 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 3
Annex II – Table 2 – row 3
Grade B hHigher or equal to 90 % to medium compatibility with design for recycling
Amendment 2700 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 4
Annex II – Table 2 – row 4
Amendment 2703 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 5
Annex II – Table 2 – row 5
Grade D higher or equal to 70 % Medium to low compatibility with design for recycling
Amendment 2706 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 – row 6
Annex II – Table 2 – row 6
Grade E lower than 70 % Not compatible with design for recycling
Amendment 2710 #
2022/0396(COD)
Indicative parameters that may be considered, as appropriate, when establishing design criteria for recycling under Article 6 Indicative parameters that may be considered when developing design criteria for recycling under Article 6: 1. Additives 2. Labels 3. Closure systems and small parts 4. Adhesives 5. Printing inks 6. Colours 7. Material composition 8. Barriers / coatings Ease of dismantling
Amendment 2720 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 2
Annex V – row 2
Amendment 2727 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 3
Annex V – row 3
Amendment 2731 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 4
Annex V – row 4
Amendment 2735 #
2022/0396(COD)
Proposal for a regulation
Annex V – row 5
Annex V – row 5
Shampoo bottles, hand Single use and body Single use For cosmetics, hygiene and toiletry products 5. hotel miniature lotion bottles, hotel miniature of less than 50 ml for liquid products or less plastic sachets packaging than 100 g for non-liquid products packaging around miniature bar soap
Amendment 414 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h
Article 2 – paragraph 1 – point h
(h) ‘carbon farming’ means a carbon removal activity related to land management of farm practices, bio-energy or biochar production at farm-level, and/or livestock rearing that results in the increase of carbon storage in living biomass, dead organic matter and soils by enhancing carbon capture and/or reducing the release of carbon to the atmosphere; , as well as mitigation actions for agricultural and forestry production, increasing adaptation to the impacts of climate change, fostering climate resilience and lowering GHG emissions while not threatening food security, in line with the Paris Agreement.
Amendment 533 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 6
Article 4 – paragraph 6
6. By way of derogation from paragraph 5, where duly justified, tThe baseline may be based on the individual carbon removal performance of that activity on the starting date of the carbon farming activity.
Amendment 697 #
2022/0394(COD)
Proposal for a regulation
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. The Commission will provide technical certification methodologies for the different types of activities.
Amendment 53 #
2022/0345(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Directive 91/271/EEC sets the legal framework for the collection, treatment and discharge of urban wastewater and the discharge of biodegradable wastewaters from certain industrial sectors. Its objective is to protect the environment from being adversely affected by insufficiently treated urban wastewater discharges. This Directive should continue to pursue the same objective, whilst also contributing to the protection of public health, when for instance urban wastewater is discharged in bathing waters or in water bodies used for the abstraction of drinking water, or when urban wastewater is used as an indicator for parameters relevant for public health. It should also improve access to sanitation and to key information related to the governance of the urban wastewater collection and treatment activities. Finally, this Directive should contribute to the progressive eliminareduction of greenhouse gas (GHG) emissions from urban wastewater collection and treatment activities, notably by further reducing nitrogen emissions but also by promoting energy efficiency and production of renewable energies, and thus should contribute to the 2050 objective of Climate Neutrality established under Regulation (EU) 2021/1119 of the European Parliament and of the Council37. _________________ 37 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).
Amendment 58 #
2022/0345(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Small agglomerations constitute a significant pressure on 11 % of the surface water bodies in the Union39. To better tackle the pollution from such agglomerations, and to prevent discharges of untreated urban wastewater into the environment, the scope of this Directive should include all agglomerations of 1 0500population equivalent (p.e.) and above. _________________ 39 EEA report, European waters: Assessment of status and pressures 2018, No 7/2018.
Amendment 66 #
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 0500 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.
Amendment 70 #
2022/0345(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Exceptionally, where it can be demonstrated that the establishment of a centralised urban wastewater collecting system would produce no environmental benefit or involve excessive costs, Member States should be allowed to use individual systems to treat urban wastewater, as long as they ensure the same level of treatmentenvironmental protection as secondary and tertiary treatment. For this purpose, Member States should establish national registers to identify individual systems used on their territory and take all necessary measures to ensure that the design of such systems is adequate, that the systems are properly maintained and that they are subject to a regular compliance control. In particular, Member States should ensure that individual systems used for the collection and storage of urban wastewater are impervious and leak-proof, and that monitoring and inspection of the systems are carried out at regular and fixed intervals.
Amendment 74 #
2022/0345(COD)
Proposal for a directive
Recital 7
Recital 7
(7) During rainfall, storm water overflows and urban runoff discharges 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, including climatic ones. They should be based on an integrated quantitative and qualitative water management in urban areas. In addition, control at source through nature-based solutions should be mainstreamed as a first step to avoid pollution in urban runoff, as well as co- ordination of measures to control the quantity of urban runoff at source. 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 87 #
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. 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 0500 p.e. and above.
Amendment 105 #
2022/0345(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Recent scientific knowledge underpinning several Commission strategies43highlight the need to take action to address the issue of micro-pollutants, which are now detected in all waters in the Union. 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 20407with 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 106 #
2022/0345(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The quaternary treatment necessary to remove micro-pollutants from urban wastewater will imply additional costs, such as costs related to monitoring and new advanced equipment to be installed in certain urban wastewater treatment plants. In order to cover these additional costs and in accordance with the polluter-pays principle expressed in Article 191(2) of the Treaty on the Functioning of the European Union (TFEU), it is essential that the producers placing on the Union market products containing substances which, at the end of their life, are found as micro- pollutants in urban wastewaters (‘micro- pollutant substances’) take responsibility for the additional treatment required to remove those substances, generated in the context of their professional activities. A system of extended producer responsibility is the most appropriate means to achieve this, as it would limit the financial impact on the taxpayer and water tariff, while providing an incentive to develop greener products. Extended producer responsibility schemes should be implemented before the deadline for compliance with quaternary treatment. Pharmaceuticals and cosmetic residues currently represent the main sources of micro-pollutants found in urban wastewater requiring an additional treatment (quaternary treatment). Therefore, extended producer responsibility should apply to those two product groups. The list of product groups should be adapted, if and as necessary, in the future in line with scientific and technological development, the evolution of the range of products placed on the market and new data from monitoring.
Amendment 129 #
2022/0345(COD)
Proposal for a directive
Recital 14
Recital 14
(14) Exonerations from the extended producer responsibility obligations should nevertheless be possible where products are placed on the market in small quantities, i.e. less than 2 tonnes of products, since the additional administrative burden for the producer would in such cases be disproportionate compared to the environmental benefits. Exonerations should also be possible when the producer can demonstrate that no micro-pollutants are generated at the end of life of a product. It might be the case for instance where it can be proven that the residues from a product are inherently biodegradable or rapidly biodegradable in the wastewaters and the environment or not reaching the urban wastewater treatment plants. The Commission should be empowered to adopt implementing acts to establish detailed criteria to identify the products placed on the market that do not generate micro-pollutants in wastewaters at the end of their life. When developing these criteria, the Commission should take into account scientific or other available technical information, including relevant international standards.
Amendment 155 #
2022/0345(COD)
(16) The evaluation has also shown that the wastewater treatment sector offers the opportunity to significantly reduce its own energy consumption and to produce renewable energy, for example by better use of the available surfaces in urban wastewater treatment plants for solar energy production or by producing biogas from sludge. The evaluation also illustrated that, without clear legal obligations, only partial progress can be expected in this sector. In this context, Member States should be required to ensure that the total annual energy used by all urban wastewater treatment plants on their national territory treating a load of 10 000 p.e. and above does not exceed the production of energy from renewable sources as defined in Article 2(1) of Directive (EU) 2018/2001 of the European Parliament and of the Council44, by those urban wastewater treatment plants. That objective should be progressively met with interim targets by 31 December 20407. Reaching this energy neutrality target will contribute to reduce the avoidable greenhouse gas (GHG) emissions from the sector by 46 %, while supporting the achievement of the 2050 climate neutrality objectives and related national and Union objectives, [such as the objectives set out in Regulation (EU) 2018/842 of the European Parliament and of the Council45. Encouraging EU-based biogas or solar energy production while enhancing energy efficiency measures in line with the Energy Efficiency First principle46, which means taking utmost account of cost-efficient energy efficiency measures in shaping energy policy and making relevant investment decisions, will also help reduce the Union energy dependence, one of the objectives expressed in the Commission "Repower EU" Plan47. It is also in line with Directive (EU) 2018/844 of the European Parliament and of the Council48and with Directive (EU) 2018/2001 in which urban wastewater treatment sites are qualified as ‘go-to' areas for renewables, meaning a location designated as particularly suitable for the installation of plants for the production of energy from renewable sources. In order to reach the objective of energy neutrality via optimal measures for each urban wastewater treatment plant and for the collection system, Member States should ensure that energy audits are carried out in accordance with Article 8 of Directive 2012/27/EU of the European Parliament and of the Council49every four years. Those audits should include an identification of the potential for cost- effective use or production of renewable energy following the criteria set out in Annex VI to Directive 2012/27/EU. _________________ 44 Directive (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). 45 Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26). 46 Commission Recommendation (EU) 2021/1749 of 28 September 2021 on Energy Efficiency First: from principles to practice — Guidelines and examples for its implementation in decision-making in the energy sector and beyond 47 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 Plan (COM/2022/230 final). 48 Directive (EU) 2018/844 of the European Parliament and of the Council of 30 May 2018 amending Directive 2010/31/EU on the energy performance of buildings and Directive 2012/27/EU on energy efficiency (OJ L 328, 21.12.2018, p. 210). 49 Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC (OJ L 315, 14.11.2012, p. 1).
Amendment 180 #
2022/0345(COD)
Proposal for a directive
Recital 24
Recital 24
(24) In order to protect the environment and human health, Member States should identify the risks caused by urban wastewaters management. As such, control at source should be promoted to prevent pollution in urban wastewater. On the basis of that identification, and where necessary to comply with the requirements of the Union water legislation, Member States should take more stringent measures for the urban wastewater collection and treatment than the measures required to comply with the minimum requirements set out in this Directive. Depending on the situation, those more stringent measures can include, inter alia, the establishment of collecting systems, the development of integrated urban wastewater management plans or the application of secondary, tertiary or quaternary treatment to urban wastewater for agglomerations or urban wastewater treatment plants that do not reach the p.e. thresholds triggering the application of the standard requirements. They can also include more advanced treatment than the treatment necessary to respect the minimum requirements or disinfection of treated urban wastewaters necessary to comply with Directive 2006/7/EC of the European Parliament and of the Council55. _________________ 55 Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality and repealing Directive 76/160/EEC (OJ L 64, 4.3.2006, p. 37).
Amendment 184 #
2022/0345(COD)
Proposal for a directive
Recital 24 a (new)
Recital 24 a (new)
(24a) Due to the environmental benefits of urban wastewater collection and treatment, Member States should have the possibility to adapt their urban wastewater collection and treatment infrastructures where this is necessary to address increased loads of domestic wastewater.
Amendment 205 #
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, access to sanitation and treatment by individual systems. Moreover, full coherence with Regulation (EC) 166/2006 of the European Parliament and of the Council65should 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 239 #
2022/0345(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
This Directive lays down rules on the collection, treatment, and discharge of urban wastewater , to protect the environment and human health while progressively eliminatreducing greenhouse gas emissions to sustainable levels and improving the energy balance of urban wastewater collection and treatment activities. It also lays down rules on access to sanitation, on transparency of the urban wastewater sector and on the regular surveillance of public health relevant parameters in urban wastewaters .
Amendment 256 #
2022/0345(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) 'agglomeration' means an area where the pollution load of urban wastewater is sufficiently concentrated (150 p.e. per hectare or above) in the area of permanent housing for urban wastewater to be collected and conducted to an urban wastewater treatment plant or to a final discharge point;
Amendment 270 #
2022/0345(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
(6) 'storm water overflow’ means discharge of untreated urban wastewater in receiving waters from combined sewers caused by excessive rainfall;
Amendment 286 #
2022/0345(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
(12) 'tertiary treatment' means treatment of urban wastewater by a process which removes nitrogen andor phosphorus from the urban wastewaters depending on receiving water conditions;
Amendment 366 #
2022/0345(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) all their sources of domestic wastewater are connected to the collecting system whereby the connections will provide an environmental benefit.
Amendment 373 #
2022/0345(COD)
Proposal for a directive
Article 3 – paragraph 2 – introductory part
Article 3 – paragraph 2 – introductory part
2. By 31 December 20307, Member States shall ensure that all agglomerations with a p.e. of between 1 0500 and 2 000 comply with the following requirements:
Amendment 378 #
2022/0345(COD)
Proposal for a directive
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) all their sources of domestic wastewater are connected to the collecting system whereby the connections will provide an environmental benefit.
Amendment 390 #
2022/0345(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
Member States shall ensure that individual systems are designed, operated and maintained in a manner that ensures at least the same level of treatment as the secondary and tertiary treatments referred to in Articles 6 and 7 or the standards set under 2000/60/EC.
Amendment 400 #
2022/0345(COD)
Proposal for a directive
Article 4 – paragraph 3
Article 4 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with the procedure referred to in Article 27 to supplement this Directive byMember States shall establishing minimum requirements on the design, operation, and maintenance of individual systems and by specifyingshall establish the requirements for the regular inspections referred to in paragraph 2, second subparagraph. The Commission shall provide guidance on the abovementioned minimum requirements on the design, operation, and maintenance of individual systems across Europe.
Amendment 401 #
2022/0345(COD)
Proposal for a directive
Article 4 – paragraph 4 – introductory part
Article 4 – paragraph 4 – introductory part
4. Member States that use individual systems to treat more than 2 % of the urban wastewater load from agglomerations of 2 000 p.e. and above shall provide the Commission with a detailed justification for the use of individual systems in each of the agglomerations, where there is a risk to the environment or human health from the use of the individual systems in the agglomerations. That justification shall:
Amendment 407 #
2022/0345(COD)
Proposal for a directive
Article 4 – paragraph 4 – point c
Article 4 – paragraph 4 – point c
Amendment 414 #
2022/0345(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. By 31 December 20307, Member States shall ensure that an integrated urban wastewater management plan is established for agglomerations of 100 000 p.e. and above.
Amendment 420 #
2022/0345(COD)
Proposal for a directive
Article 5 – paragraph 2 – subparagraph 1 – introductory part
Article 5 – paragraph 2 – subparagraph 1 – introductory part
By 31 December 20325, Member States shall establish a list of agglomerations of between 10 000 p.e. and 100 000 p.e. where, considering historic data and state- of-the-art climate projections, one or more of the following conditions apply:
Amendment 426 #
2022/0345(COD)
Proposal for a directive
Article 5 – paragraph 2 – subparagraph 1 – point b
Article 5 – paragraph 2 – subparagraph 1 – point b
Amendment 446 #
2022/0345(COD)
Proposal for a directive
Article 5 – paragraph 3
Article 5 – paragraph 3
3. By 31 December 203542, Member States shall ensure that an integrated urban wastewater management plan is established for agglomerations referred to in paragraph 2.
Amendment 467 #
2022/0345(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. For agglomerations of between 1 0500 p.e. and 2 000 p.e., Member States shall ensure that urban wastewater entering collecting systems is subject to secondary treatment, where there is a clear environmental need, in accordance with paragraph 3 or an equivalent treatment before discharge by 31 December 20307.
Amendment 476 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 1 – subparagraph 1
Article 7 – paragraph 1 – subparagraph 1
By 31 December 20307, Member States shall ensure that discharges from 50 % of urban wastewater treatment plants treating a load of 100 000 p.e. and above and not applying tertiary treatment on [OP please insert the date = the date of entry into force of this Directive] are subject to tertiary treatment in accordance with paragraph 4 where there is a an environmental need to be adressed.
Amendment 484 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
By 31 December 203542, Member States shall ensure that all urban wastewater treatment plants treating a load of 100 000 p.e. and above are subject to tertiary treatment in accordance with paragraph 4 where there is an environmental need to be addressed.
Amendment 497 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
By 31 December 20325, Member States shall establish a list of areas on their territory that are sensitive to eutrophication and update that list every five years starting on 31 December 20307.
Amendment 503 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 3 – subparagraph 1
Article 7 – paragraph 3 – subparagraph 1
By 31 December 203542, Member States shall ensure that for 50 % of the agglomerations of between 10 000 p.e. and 100 000 p.e. that are discharging into areas included in the list referred to in paragraph 2 and not applying tertiary treatment on [OP please insert the date = the date of entry into force of this Directive] urban wastewater entering collecting systems is subject to tertiary treatment in accordance with paragraph 4 before discharge into those areas where there is an environmental need to be addressed.
Amendment 515 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 3 – subparagraph 2
Article 7 – paragraph 3 – subparagraph 2
By 31 December 20407, Member States shall ensure that urban wastewater entering collecting systems is subject to tertiary treatment in accordance with paragraph 4 before discharge into areas included in a list referred to in paragraph 2 with regard to all agglomerations of between 10 000 p.e. and 100 000 p.e. where there is an environmental need to be addressed.
Amendment 544 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 5 – point a
Article 7 – paragraph 5 – point a
(a) 82,5 % for total phosphorus and 80 % for total nitrogen by 31 December 203542;
Amendment 553 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 5 – point b
Article 7 – paragraph 5 – point b
(b) 90 % for total phosphorus and 85 % for total nitrogen by 31 December 20407.
Amendment 560 #
2022/0345(COD)
Proposal for a directive
Article 7 – paragraph 6
Article 7 – paragraph 6
6. Discharges from urban waste water wastewater treatment plants of 10 000 p.e. and above into a relevant catchment area of an area sensitive to eutrophication included in a list referred to in paragraph 2 shall also be subject to paragraphs 3, 4 and 5.
Amendment 573 #
2022/0345(COD)
Proposal for a directive
Article 8 – paragraph 1 – subparagraph 1
Article 8 – paragraph 1 – subparagraph 1
By 31 December 20307, Member States shall ensure that 50 % of discharges from urban wastewater treatment plants treating a load of 100 000 p.e. and above are subject quaternary treatment in accordance with paragraph 5 where there is an environmental need to be addressed.
Amendment 585 #
2022/0345(COD)
Proposal for a directive
Article 8 – paragraph 1 – subparagraph 2
Article 8 – paragraph 1 – subparagraph 2
By 31 December 203542, Member States shall ensure that all urban wastewater treatment plants treating a load of 100 000 p.e. and above are subject to quaternary treatment in accordance with paragraph 5 where there is an environmental need to be addressed.
Amendment 596 #
2022/0345(COD)
Proposal for a directive
Article 8 – paragraph 2 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1
On 31 December 20307, Member States shall haveundertake a risk assessment to established a list a list of areas on their national territory where the concentration or the accumulation of micro-pollutants represents a risk for human health or the environment. Member States shall review that list every five years thereafter and update it if necessary.
Amendment 628 #
2022/0345(COD)
Proposal for a directive
Article 8 – paragraph 4 – subparagraph 1
Article 8 – paragraph 4 – subparagraph 1
By 31 December 203542, Member States shall ensure that for 50 % of the agglomerations of between 10 000 p.e and 100 000 p.e., urban wastewater entering collecting systems is subject to quaternary treatment in accordance with paragraph 5 before discharge into areas included in a list referred to in paragraph 2.
Amendment 632 #
2022/0345(COD)
Proposal for a directive
Article 8 – paragraph 4 – subparagraph 2
Article 8 – paragraph 4 – subparagraph 2
By 31 December 20407, Member States shall ensure that urban wastewater entering collecting systems is subject to quaternary treatment in accordance with paragraph 5 before discharge into areas included in a list referred to in paragraph 2 with regard to all agglomerations of between 10 000 p.e and 100 000 p.e. where there is an environmental need to be addressed.
Amendment 845 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) by 31 December 20325 for urban wastewater treatment plants treating a load of 100 000 p.e. and above and the collecting systems connected to them;
Amendment 853 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) by 31 December 20307 for urban wastewater treatment plants treating a load of between 10 000 p.e. and 100 000 p.e. and the collecting systems connected to them.
Amendment 864 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. Member States shall ensure that the total annual energy from renewable sources, as defined in Article 2(1) of Directive (EU) 2018/2001, producgenerated at national level on- or off-site by urban wastewater treatment plants treating a load of 10 000 p.e. and above by their owners or their operators, or bought from external sources, is equivalent to at least:
Amendment 885 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – point a
Article 11 – paragraph 2 – point a
(a) 50 % of the total annual energy used by such plants by 31 December 20307;
Amendment 900 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) 75 % of the total annual energy used by such plants by 31 December 203542;
Amendment 912 #
2022/0345(COD)
Proposal for a directive
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) 100 % of the total annual energy used by such plants by 31 December 20407.
Amendment 1003 #
2022/0345(COD)
Proposal for a directive
Article 17 – paragraph 4 – subparagraph 1
Article 17 – paragraph 4 – subparagraph 1
For agglomerations of 100 000 p.e. and above, Member States shall, by 1 January 202530, ensure that antimicrobial resistance is monitored at least twice a year at the inlets and outlets of urban wastewater treatment plants and, when relevant, in the collecting systems.
Amendment 1011 #
2022/0345(COD)
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. By [OP please insert the date = the last day of the secondfourth year after the date of entry in force of this Directive], Member States shall identify the risks caused by urban wastewater discharges to the environment and human health and at least those related to the following:
Amendment 1021 #
2022/0345(COD)
Proposal for a directive
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. Where risks have been identified in accordance with paragraph 1, Member States shall adopt appropriate measures to address them, which shallmay include where appropriate the following measures:
Amendment 1025 #
2022/0345(COD)
Proposal for a directive
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) establishing collecting systems in accordance with Article 3 for agglomerations with a p.e. of less than 1 0500;
Amendment 1029 #
2022/0345(COD)
Proposal for a directive
Article 18 – paragraph 2 – point a a (new)
Article 18 – paragraph 2 – point a a (new)
(aa) by way of derogation of subparagraph (a) of paragraph (2), establishing individual systems in accordance with Article 4 for agglomerations with a p.e. of less than 1 000;
Amendment 1034 #
2022/0345(COD)
Proposal for a directive
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) applying secondary treatment in accordance with Article 6 to discharges of urban wastewater from agglomerations with a p.e. of less than 1 0500;
Amendment 1054 #
2022/0345(COD)
Proposal for a directive
Article 19 – paragraph 1
Article 19 – paragraph 1
Without prejudice to the principles of subsidiarity and proportionality, whilst taking into account the local, regional and cultural perspectives and circumstances for sanitation, Member States shall take all necessary measures to improve access to sanitation for all, in particular for vulnerable and marginalised groups.
Amendment 1056 #
2022/0345(COD)
Proposal for a directive
Article 19 – paragraph 2 – introductory part
Article 19 – paragraph 2 – introductory part
For that purpose, Member States shall by 31 December 202730:
Amendment 1145 #
2022/0345(COD)
(a) by 31 December 20257, set up a data set containing information collected in accordance with Article 21 including information concerning the parameters referred to in Article 21(1), point (a), and the results of the tests with regard to the pass/fail criteria established in Part D of Annex I and update that data set annually thereafter;
Amendment 1146 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point b
Article 22 – paragraph 1 – point b
(b) by 31 December 20257, set up a data set indicating the percentage of urban wastewater which is collected and treated in accordance with Article 3 and update that data set annually thereafter;
Amendment 1147 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point c
Article 22 – paragraph 1 – point c
(c) by 31 December 20257, set up a data set containing information on measures taken to implement Article 4(4) and on the percentage of the urban wastewater load from agglomerations above 2 000 p.e. which is treated in individual systems and update that data set annually thereafter;
Amendment 1149 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point d
Article 22 – paragraph 1 – point d
(d) by 31 December 20257, set up a data set containing information on the number of samples collected and the number of samples taken in accordance with Part D of Annex I that have failed;
Amendment 1157 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point e
Article 22 – paragraph 1 – point e
(e) by 31 December 20257, set up a data set containing information on green house gas emissions with a breakdown between different gasses and on the total energy used and renewable energy produced by each urban wastewater treatment plant of 10 000 p.e. and above as well as a calculation of the percentage of achievement of the targets set out in Article 11(2) and update that data set annually thereafter;
Amendment 1158 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point f
Article 22 – paragraph 1 – point f
(f) by 31 December 20257, set up a data set containing information on measures taken in accordance with point 3 of Annex V and update that data set annually thereafter;
Amendment 1159 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point g
Article 22 – paragraph 1 – point g
(g) by 31 December 20257, set up a data set containing the monitoring results referred to in accordance with Article 17(1) and (4) and update that data set annually thereafter;
Amendment 1160 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point h
Article 22 – paragraph 1 – point h
(h) by 31 December 20257, set up a data set containing the list of areas identified as sensitive to eutrophication in accordance with Article 7(2) and update that data set every 5 years thereafter;
Amendment 1163 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point i
Article 22 – paragraph 1 – point i
(i) by 31 December 20302, set up a data set containing the list of areas identified as areas where the concentration or the accumulation of micro-pollutant represents a risk for human health or the environment in accordance with Article 8(2) and update that data set every 5 years thereafter;
Amendment 1164 #
2022/0345(COD)
Proposal for a directive
Article 22 – paragraph 1 – point j
Article 22 – paragraph 1 – point j
(j) by 12 January 202931, set up a data set containing information on measures taken to improve access to sanitation in accordance with Article 19, including information on the share of their population that has access to sanitation and update that data set every 6 years thereafter.
Amendment 1169 #
2022/0345(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert date = the last day of the twenty-thirdforty-seventh month after the date of entry into force of this Directive], Member States shall establish a national implementation programme for this Directive.
Amendment 1179 #
2022/0345(COD)
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. By …[OP: please insert the date = the last day of the thirty-fiffifty-ninth month after the date of entry into force of this Directive], Member States shall submit to the Commission their national implementation programmes, except where they demonstrate, based on the monitoring results referred to in Article 21, that they are in compliance with Articles 3 to 8.
Amendment 1183 #
2022/0345(COD)
Proposal for a directive
Article 24 – paragraph 1 – subparagraph 1
Article 24 – paragraph 1 – subparagraph 1
Member States shall ensure that adequate and up-to-date information on urban wastewater collection and treatment is available to the public online, for agglomerations greater than 1 000 p.e in a user- friendly and customised way, in each agglomeration, 2 years after the date of entry into force of this Directive. The information shall include at least the data listed in Annex VI.
Amendment 1191 #
2022/0345(COD)
Proposal for a directive
Article 24 – paragraph 2 – introductory part
Article 24 – paragraph 2 – introductory part
2. In addition, Member States shall ensure that all persons connected to collecting systems in agglomerations greater than 1 500 p.e., receive regularly and at least once a year, in the most appropriate form, including on their invoice or by smart applications, without having to request it, the following information:
Amendment 1252 #
2022/0345(COD)
Proposal for a directive
Article 26 – paragraph 4
Article 26 – paragraph 4
4. Where there is a claim for compensation in accordance with paragraph 1, supported by evidence from whicthat allows to establish a causality link may be presumed between the damage and the violation, Member States shall ensure that the onus is on the person responsible for the violation to prove that the violation did not cause or contribute to the damage.
Amendment 1273 #
2022/0345(COD)
Proposal for a directive
Article 30 – paragraph 1 – subparagraph 1 – introductory part
Article 30 – paragraph 1 – subparagraph 1 – introductory part
By 31 December 20340 and by 31 December 20450, the Commission shall carry out an evaluation of this Directive based in particular on the following elements:
Amendment 1343 #
2022/0345(COD)
Proposal for a directive
Annex V – point 2 – point a – paragraph 1
Annex V – point 2 – point a – paragraph 1
an indicative objective that storm water overflow, represents no more than 1 % of the annual collected urban wastewater load calculated in dry weather condi specific objective of reduction of pollution from storm water overflows shall be established in the Integrated urban wastewater management plans, according to the local needs of environmental protections;
Amendment 1353 #
2022/0345(COD)
Proposal for a directive
Annex V – point 2 – point a – paragraph 2 – point i
Annex V – point 2 – point a – paragraph 2 – point i
(i) 31 December 203542 for all agglomerations of 100 000 p.e. and above;
Amendment 1355 #
2022/0345(COD)
Proposal for a directive
Annex V – point 2 – point a – paragraph 2 – point ii
Annex V – point 2 – point a – paragraph 2 – point ii
(ii) 31 December 20407 for agglomerations of 10 000 p.e. and above identified in accordance with paragraph 2 of Article 5;
Amendment 1358 #
2022/0345(COD)
Proposal for a directive
Annex V – point 2 – point b
Annex V – point 2 – point b
(b) the progressive eliminareduction of untreated discharges of urban runoff through separate collection networks, unless it can be demonstrated that those discharges do not cause adverse impacts on the quality of receiving waters;
Amendment 274 #
2022/0196(COD)
Proposal for a regulation
–
–
– The European Parliament rejects the Commission proposal.
Amendment 2199 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 8 a (new)
Article 18 – paragraph 8 a (new)
8a. Points 1 to 8 of this Article 18 will not apply in treatments with phytosanitary products on agricultural plantations located in sensitive areas.
Amendment 2537 #
2022/0196(COD)
Proposal for a regulation
Article 29 – paragraph 2 a (new)
Article 29 – paragraph 2 a (new)
2a. Notwithstanding what is established in this Article, the competent authorities of the Member States shall make available the necessary tools to professional users who do not have the capacity, access or availability to use electronic media to ensure that they can properly access and submit the information required.
Amendment 219 #
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. In any case, a clearly distinct section in the clinical history separate from the information recorded by professionals should be created. 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. 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 239 #
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 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. None of the provisions of this regulation shall be construed as limiting health professionals’ obligation to behave in line with the relevant codes of conduct, ethical guidelines or other provisions governing ethical conduct with regard to the exchanging of, or access to, information, particularly in extreme or life-threatening situations.
Amendment 249 #
2022/0140(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) In order to avoid an exponential quantitative increase in the risks of misuse (intentional or accidental) of individual citizens’ health data, a risk management plan should be defined and the ethical and deontological aspects of medical practice in this context of interoperability in the primary use of data and all ethical aspects and respect for citizens' autonomy in the secondary use of health data should be taken into account.
Amendment 262 #
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) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine, including 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 310 #
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 voluntary 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. Labelling schemes may also include information for users on data protection rights and an indication of whether the application provider or browser operator has access in any way to the data generated by the application. The Commission may set out in implementing acts the details regarding the format and content of such label.
Amendment 391 #
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 will be further developed and the use of anonymised electronic health data which is devoid ofithout any personal data should be made available when possible and if the data user asks itwill be facilitated wherever possible, excluding possibilities for re-use of data that cannot be anonymised or pseudonymised. Requests for pseudonymised data shall be duly justified. 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). 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 475 #
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 for all electronic health applications that use data and produce wearables, health apps, telemedicine platforms, etc., with those data;
Amendment 546 #
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 926 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. Member States shall ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.
Amendment 1217 #
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 enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59. The requirement in the first subparagraph shall not apply to data holders who fall within the category of small enterprises in the context of health professional practices. _________________ 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 27 #
2022/0135(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) Ecuador has made substantial progress in preparing for the visa-free status, notably with the introduction of the biometric passport and the Regulation to the Organic Law on Human Mobility. In addition, reasons of regional coherence, being a trading partner of the Union through the Multi-Party Treaty, support the opportunity to include Ecuador on the list of visa-free countries, without prejudice to the Commission carrying out the necessary technical assessment prior to the negotiation of the relevant bilateral agreement.
Amendment 31 #
2022/0135(COD)
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6 b) The Commission should further assess within 3 months of the final adoption of this Regulation the situation of Ecuador with regard to the criteria set out in this Regulation before the opening of negotiations on bilateral agreement on visa waiver between the Union and that country
Amendment 43 #
2022/0135(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a a (new)
Article 1 – paragraph 1 – point a a (new)
(a a) in point 1 of Annex I, (“STATES”) the reference to Ecuador is deleted.
Amendment 49 #
2022/0135(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b a (new)
Article 1 – paragraph 1 – point b a (new)
Amendment 605 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9 – point b
Article 1 – paragraph 1 – point 9 – point b
Directive 2010/75/EU
Article 13 – paragraph 2 – subparagraph 2
Article 13 – paragraph 2 – subparagraph 2
Without prejudice to Union competition law, information considered as confidential business information or commercially sensitive information shall only be shared with the Commission and with the following individuals having signed a confidentiality and non-disclosure agreement: civil servants and other public employees representing Member States or Union agencies, and representatives of non-governmental organisations promoting the protection of human health or the environment. The exchange of information considered as confidential business information or sensitive commercial information shall remain limited to what is required to draw up, review and, where necessary, update BAT reference documents, and such confidential business information or sensitive commercial information shall not be used for other purposes..
Amendment 799 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Article 15 – paragraph 3 – subparagraph 1 – introductory part
The competent authority shall set the strictest possible emission limit values that are consistent with the lowest emissions achievable by applying BAT in the installation, and that ensure that, under normal operating conditions, emissions do not exceed the emission levels associated with the best available techniques (BAT- AELs) as laid down in the decisions on BAT conclusions referred to in Article 13(5). The emission limit values shall be based on an assessment by the operator analysing the feasibility of meeting the strictest end of the BAT-AEL range and demonstrating the best performance the installation can achieve by applying BAT as described in BAT conclulowest possible emission limit that the installation can achieve, under normal operating conditions, by applying BAT as described in BAT conclusions while taking into account fluctuations of the performance of the best available techniques and the circumstances where the installation operates at the highest state of the emissions. The emission limit values shall be set through either of the following:
Amendment 829 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 3 a
Article 15 – paragraph 3 a
Amendment 866 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 4 – subparagraph 1 – point b a (new)
Article 15 – paragraph 4 – subparagraph 1 – point b a (new)
(ba) investment cycle related to the sustainability transition of the operators' group.
Amendment 1495 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 31
Article 1 – paragraph 1 – point 31
Directive 2010/75/EU of the EP and the Council on Industrial Emissions
Article 79 – paragraph 2
Article 79 – paragraph 2
2. The penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person having committed the infringement. The level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the violation of the economic benefits derived from that violation. The level of the fines shall be gradually increased for repeated infringements. In the case of a violation committed by a legal person, the maximum amount of such fines shall be at least 8 % of the operator’s annual turnover in the Member State concernednature and severity of the violation concerned, and not exceed the level necessary for fines to be effective and dissuasive.
Amendment 119 #
2022/0099(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
Amendment 139 #
2022/0099(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11 a) The transition of the Metered- Dose-Inhalers(MDIs) to low-GWP technologies will require information exchange, cooperation and monitoring between the European Commission, Member States and competent authorities, the European Medicines Agency and the Health Emergency Preparedness and Response Authority, to avoid shortages and ensure sustained patient access to life-saving medication. Healthcare professionals and patients relying on MDIs medicines shall be informed and educated on the use of upcoming MDIs.
Amendment 155 #
2022/0099(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) The Commission shall work in close cooperation with the European Medicines Agency to coordinate a smooth approval process in respect of fluorinated substances and alternatives for medical use, so that all environmental and health aspects are taken into account.
Amendment 184 #
2022/0099(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) In implementing this Regulation, the Commission should establish a so- called Consultation Forum to ensure a balanced participation of Member States’ representatives and representatives of civil society, including environmental organisations, public health organisations, representatives of manufacturers, operators and certified persons.
Amendment 191 #
2022/0099(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) 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 in respect of the establishment of a list of products and equipment for which the recovery of gases or their destruction is technically and economically feasible and the specification of the technologies to be applied; labelling requirements; the exclusion from quota requirements of HFCs in accordance with decisions of the Parties to the Protocol; concerning the amounts due for the allocation of quota and the mechanism to allocate remaining quotas; 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 and exported to any entity not covered by the Protocol; the update of global warming potentials of listed substances. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, in particular consultation with the Consultation Forum as set up according to Article 33 of this Regulation, including at expert level and that those consultations be conducted in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making38 . 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. _________________ 38 OJ L 123, 12.5.2016, p. 1.
Amendment 193 #
2022/0099(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) lays down rules on containment, use, recovery and destruction of fluorinated greenhouse gases and on related ancillary measures, and facilitates the safe and efficient use of alternative substances;
Amendment 202 #
2022/0099(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘operator‘ means the undertaking exercising actual power over the technical functioning of products and equipment covered by this Regulation or the ownerentity where designated by a Member State as being responsible for the operator’s obligations in specific cases;
Amendment 207 #
2022/0099(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘placing on the market’ means the supplying or making available to another person witharty in the Union, for the first time, for payment or free of charge, the customs release for free circulation in the Union, and the use of substances produced or the use of products or equipment manufactured for own use;
Amendment 238 #
2022/0099(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Operators and manufacturers of equipment and installations that contain fluorinated greenhouse gases listed in Annexes I or II, or other relevant alternatives to fluorinated greenhouse gases, as well as undertakings in possession of such equipment during its transport or storage, shall take all necessary precautions to prevent the unintentional release of any such gases. They shall take all measures that are technically and economically feasible to minimise leakage of the gases.
Amendment 240 #
2022/0099(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. During the production, storage, transport, and transfer from one container or system to another or to an equipment or installation, of fluorinated greenhouse gases listed in Annexes I and II, the undertaking shall take all necessary precautions to limit release of fluorinated greenhouse gases listed in Annexes I and II to the greatest extent possible. This paragraph also applies where fluorinated greenhouse gases listed in Annexes I and II are produced as by-products. , as well as to other relevant alternatives to fluorinated greenhouse gases.
Amendment 243 #
2022/0099(COD)
Proposal for a regulation
Article 4 – paragraph 4 – subparagraph 1
Article 4 – paragraph 4 – subparagraph 1
Where a leakage of fluorinated greenhouse gases listed in Annex I or II is detected, or other relevant alternatives to fluorinated greenhouse gases, the operators, manufacturers of equipment and installations and the undertakings in possession of the equipment during its transport, or storage, shall ensure that the equipment or installation is repaired without undue delay.
Amendment 246 #
2022/0099(COD)
Proposal for a regulation
Article 4 – paragraph 6 – subparagraph 1
Article 4 – paragraph 6 – subparagraph 1
Natural persons carrying out the tasks referred to in Article 10(1), points (a) to (c), shall be certified in accordance with Article 10 and shall take precautionary measures to prevent leakage of fluorinated greenhouse gases listed in Annexes I and II, or other relevant alternatives to fluorinated greenhouse gases.
Amendment 247 #
2022/0099(COD)
Proposal for a regulation
Article 4 – paragraph 6 – subparagraph 2
Article 4 – paragraph 6 – subparagraph 2
Undertakings carrying out the installation, servicing, maintenance, repair or decommissioning of the equipment listed in Article 5(2), points (a) to (f), shall be certified in accordance with Article 10 and shall take precautionary measures to prevent leakage of fluorinated greenhouse gases listed in Annexes I and II, or other relevant alternatives to fluorinated greenhouse gases.
Amendment 250 #
2022/0099(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1
Article 5 – paragraph 1 – subparagraph 1
Operators of equipment that contains 5 tonnes of CO2 equivalent or more of fluorinated greenhouse gases listed in Annex I or 1 kilogram or more of fluorinated greenhouse gases listed in Annex II, Section I, and other relevant alternatives to fluorinated greenhouse gases, not contained in foams, shall ensure that the equipment is checked for leaks.
Amendment 264 #
2022/0099(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 267 #
2022/0099(COD)
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1 – introductory part
Article 5 – paragraph 2 – subparagraph 1 – introductory part
Paragraph 1 applies to operators of the following equipment that contains fluorinated greenhouse gases listed in Annex I or in Annex II, Section I, or other relevant alternatives to fluorinated gases:
Amendment 277 #
2022/0099(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Operators of the equipment listed in Article 5(2), points (f) and (g), and containing fluorinated greenhouse gases listed in Annex I in quantities of 500 tonnes of CO2 equivalent or more and installed from 1 January 2017, shall ensure that equipment is provided with a leakage detection system which alerts the operator or a service company of any leakage. For the purposes of Article 5(2), point (g), the leakage detection system shall have a higher sensitivity than a pressure or density monitoring device.
Amendment 288 #
2022/0099(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Any recovered fluorinated greenhouse gases listed in Annex I and Annex II, Section 1, shall not be used for filling or refilling other equipment unless the gas has been recycled or reclaimed.
Amendment 293 #
2022/0099(COD)
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
Operators of products and equipment not listed in paragraphs 1, 6 and 7 that contain fluorinated greenhouse gases listed in Annex I and Annex II, Section 1, shall arrange for the recovery of the gases, unless it can be established that it is not technically feasible or entails disproportionate costs. The operators shall ensure that the recovery is carried out by appropriately qualified natural persons, so that the gases are recycled, reclaimed or destroyed or shall arrange for their destruction without prior recovery.
Amendment 296 #
2022/0099(COD)
Proposal for a regulation
Article 8 – paragraph 8
Article 8 – paragraph 8
8. The Commission is empowered to adopt delegated acts in accordance with Article 32 to supplement this Regulation by establishing a list of products and equipment for which the recovery of fluorinated greenhouse gases listed in Annex I and Annex II, Section 1, or destruction of products and equipment containing such gases without prior recovery of these gases shall be considered technically and economically feasible, specifying, if appropriate, the technologies to be applied.
Amendment 304 #
2022/0099(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
Without prejudice to existing Union legislation, Member States shall encouragsure the development of producer responsi -bility schemes for the recovery of fluorinated greenhouse gases listed in Annexes I and II and their recycling, reclamation or destruction, taking into account already applicable producer responsibility schemes.
Amendment 315 #
2022/0099(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Member States shall ensure that training programmes for natural persons recovering fluorinated greenhouse gases listed in Annex I and Annex II, Section I, and other relevant alternatives to fluorinated greenhouse gases, from air- conditioning equipment in motor vehicles falling within the scope of Directive 2006/40/EC of the European Parliament and of the Council42 are available, pursuant to paragraph 5. _________________ 42 Directive 2006/40/EC of the European Parliament and of the Council of 17 May 2006 relating to emissions from air conditioning systems in motor vehicles and amending Council Directive 70/156/EEC (OJ L 161, 14.6.2006, p. 12).
Amendment 319 #
2022/0099(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point e
Article 10 – paragraph 3 – point e
(e) energy efficiencinstallation and maintenance of equipment to improve the energy efficiency and heat recovery aspects.
Amendment 323 #
2022/0099(COD)
Proposal for a regulation
Article 10 – paragraph 6 a (new)
Article 10 – paragraph 6 a (new)
6 a. The Member States shall establish or adapt certification schemes and training programmes pursuant to paragraphs 1, 2, 3 and 6 within six months from entry into force of this regulation.
Amendment 325 #
2022/0099(COD)
Proposal for a regulation
Article 10 – paragraph 7
Article 10 – paragraph 7
7. Existing certificates and training attestations issued in accordance with Regulation (EU) No 517/2014 shall remain valid, in accordance with the conditions under which they were originally issued. The validity of existing certificates may be subject to additional requirements to reflect the extension of the certification scheme to other relevant alternatives to fluorinated greenhouse gases.
Amendment 337 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The placing on the market of products and equipment, listed in Annex IV, including parts thereof, listed in Annex IV after 15 years of the date listed, with an exemption for military equipment, shall be prohibited from the date specified in that Annex, differentiating, where applicable, according to the type or global warming potential of the gas contained.
Amendment 347 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 2
Article 11 – paragraph 1 – subparagraph 2
Products and equipment unlawfully placed on the market after the date referred to in the first subparagraph, shall not be subsequently used or supplied, or made available to other personarties within the Union for payment or free of charge or exported. Such products and equipment may only be stored or transported for subsequent return to the origin country or for disposal and for the recovery of the gas prior to the disposal pursuant to Article 8.
Amendment 362 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1 – introductory part
Article 11 – paragraph 4 – subparagraph 1 – introductory part
Following a substantiated request by a competent authority of a Member State and taking into account the objectives of this Regulation, the Commission may, exceptionally, by means of implementing acts, authorise an exemption for up to four years to allow the placing on the market of products and equipment listed in Annex IV, including parts thereof after 15 years of the date listed, containing fluorinated greenhouse gases or whose functioning relies upon those gases, where it is demonstrated that:
Amendment 374 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 5 – subparagraph 1
Article 11 – paragraph 5 – subparagraph 1
Only undertakings that hold a certificate required under Article 10(1), point (a) or the training attestation required under Article 10(2), or undertakings that employ persons holding such a certificate or a training attestation shall be allowed to purchase fluorinated greenhouse gases listed in Annex I or Annex II, Section 1, and other relevant alternatives to fluorinated greenhouse gases. for the purpose of carrying out the installation, servicing, maintenance or repair of the equipment containing those gases, or whose functioning relies upon those gases, referred to in Article 5(2), points (a) to (g), and Article 10(2).
Amendment 375 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 5 – subparagraph 2
Article 11 – paragraph 5 – subparagraph 2
This paragraph shall not prevent non- certified undertakings, who do not carry out such activities, from collecting, transporting or delivering fluorinated greenhouse gases listed in Annex I and Annex II, Section 1, and other relevant alternatives to fluorinated greenhouse gases.
Amendment 392 #
2022/0099(COD)
Proposal for a regulation
Article 12 – paragraph 17 a (new)
Article 12 – paragraph 17 a (new)
17 a. Fluorinated greenhouse gases listed in Annex II, Section 3, placed on the market for the purpose of fumigation shall be labelled without prejudice to existing labelling requirements included under Regulation (EC) 1272/2008, Regulation (EU) 528/2012 and Regulation (EC) 1107/2009. Where additional information is required under this Regulation, it shall be assessed in conjunction with other labelling parameters defined according to Regulation (EC) 1272/2008, Regulation (EU) 528/2012 and Regulation (EC) 1107/2009.
Amendment 394 #
2022/0099(COD)
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 1
Article 13 – paragraph 3 – subparagraph 1
From 1 January 2024, the use of fluorinated greenhouse gases listed in Annex I, with a global warming potential of 2 50150 or more, for the servicing or maintenance of stationary refrigeration equipment (excluding chillers) is prohibited.
Amendment 402 #
2022/0099(COD)
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 3 – introductory part
Article 13 – paragraph 3 – subparagraph 3 – introductory part
The prohibition referred to in the first subparagraph shall not apply to the following categories of fluorinated greenhouse gases until 1 January 20304:
Amendment 406 #
2022/0099(COD)
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 3 – point a
Article 13 – paragraph 3 – subparagraph 3 – point a
(a) reclaimed fluorinated greenhouse gases listed in Annex I with a global warming potential of 2 50150 or more used for the maintenance or servicing of existing refrigeration equipment, provided that they have been labelled in accordance with Article 12(6);
Amendment 409 #
2022/0099(COD)
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 3 – point b
Article 13 – paragraph 3 – subparagraph 3 – point b
(b) recycled fluorinated greenhouse gases listed in Annex I with a global warming potential of 2 50150 or more used for the maintenance or servicing of existing refrigeration equipment provided they have been recovered from such equipment. Such recycled gases may only be used by the undertaking which carried out their recovery as part of maintenance or servicing or the undertaking for which the recovery was carried out as part of maintenance or servicing.
Amendment 416 #
2022/0099(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The use of desflurane as inhalation anaesthetic is prohibionly permitted as from 1 January 2026, except when such use is strictly required and no other anaesthetic can be used on medical grounds. The user shall provide evidence, upon request, on the medical justification to the competent authority of the Member State and the Commission, or when it is used in conjunction with a gas capture technology.
Amendment 422 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point c
Article 16 – paragraph 2 – point c
(c) supplied directly by a producer or an importer to undertakings, for export out of the Union, not contained in products ore-charged equipment referred to in Article 19(1), where those hydrofluorocarbons are not subsequently made available to any other party within the Union, prior to export;
Amendment 427 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point d
Article 16 – paragraph 2 – point d
(d) supplied directly by a producer or an importer for use in military equipment;
Amendment 434 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point e a (new)
Article 16 – paragraph 2 – point e a (new)
(e a) contained in products or in pre- charged equipment which are exported outside the Union.
Amendment 438 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point e b (new)
Article 16 – paragraph 2 – point e b (new)
(e b) supplied directly by a producer or an importer to an undertaking producing metered dose inhalers for the delivery of pharmaceutical ingredients, before 31 December 2029;
Amendment 440 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point e c (new)
Article 16 – paragraph 2 – point e c (new)
(e c) from 1 January 2030 and until 31 December 2035, supplied directly by a producer or an importer to an undertaking producing metered dose inhalers for the delivery of pharmaceutical ingredients, for export out of the Union.
Amendment 441 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 1 – introductory part
Article 16 – paragraph 4 – subparagraph 1 – introductory part
Following a substantiated request by a competent authority of a Member State, or an Agency of the EU, or the Consultation Forum, and taking into account the objectives of this Regulation, the Commission may, exceptionally by means of implementing acts, authorise an exemption for up to four years to exclude from the quota requirement laid down in paragraph 1 hydrofluorocarbons for use in specific applications, or specific categories of products or equipment, where it is demonstrated in the request that:
Amendment 446 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 1 – point a
Article 16 – paragraph 4 – subparagraph 1 – point a
(a) for those particular applications, products or equipment, alternatives are not available, or cannot be used for technical or safety reasons or risks to public health; and
Amendment 452 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 2
Article 16 – paragraph 4 – subparagraph 2
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 34(2). Where requests concerning protection on imperative grounds of urgency so require, the Commission shall adopt delegated acts in accordance with the procedure provided for in Article 32 in order to authorise an exemption referred to in paragraph 4 of this Article.
Amendment 468 #
2022/0099(COD)
Proposal for a regulation
Article 17 – paragraph 6
Article 17 – paragraph 6
6. The Commission is empowered to adopt delegated acts in accordance with Article 32 to amend paragraph 5 as regards the amounts due for the allocation of quota and the mechanism to allocate remaining quotas, where necessary to prevent major disruptions of the market of hydrofluorocarbons or any disruption to the supply of pharmaceutical products, or where the mechanism is not fulfilling its purpose and is having undesirable or unintended effects, including on public health. The Consultation Forum shall be consulted on the potential unintended effects that form a basis for a delegated act.
Amendment 525 #
2022/0099(COD)
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
By 31 December 2024 the Commission shall, by means of a delegated act, adopt a common general framework that Member States shall use to design centralised electronic systems.
Amendment 541 #
2022/0099(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
The Commission shall establish a Consultation Forum for providing advice and expertise direction in relation to the implementation of this Regulation. A dedicated sub-group of the Consultation Forum shall be established to ensure close cooperation with the European Medicines Agency as well as Member State authorities to evaluate unintended effects on public health. It shall deliver a yearly report as of 2025 which the European Commission shall act on in accordance with Article 32. The rules of procedure of the Consultation Forum shall be established by the Commission and shall be published.
Amendment 570 #
2022/0099(COD)
Proposal for a regulation
Annex VIII – point 1 – paragraph 2 – indent 2
Annex VIII – point 1 – paragraph 2 – indent 2
– in addition, where relevant, a quota corresponding to the reference value referred to in Annex VII, point 4(ii). From 1 January 2030 a quota corresponding to the reference value referred to in Annex VII, point 4(ii), multiplied by the maximum quantity for the year for which the quota is allocated divided by the maximum quantity for the year 2024. In case where after allocating the full amount of quotas as referred to in the second subparagraph, the maximum quantity is exceeded, all quotas allocated under Annex VII, point 4(i) will be reduced proportionally.
Amendment 588 #
2022/0099(COD)
Proposal for a regulation
Annex III – section 1 – row 37
Annex III – section 1 – row 37
Amendment 590 #
2022/0099(COD)
Proposal for a regulation
Annex III – section 1 – row 37
Annex III – section 1 – row 37
Amendment 593 #
2022/0099(COD)
Proposal for a regulation
Annex III – section 2 – row 4
Annex III – section 2 – row 4
Amendment 595 #
2022/0099(COD)
Proposal for a regulation
Annex III – section 2 – row 4
Annex III – section 2 – row 4
Amendment 600 #
2022/0099(COD)
(11) Refrigerators -that contain HFCs with GWP of 2 500 or more. 1 January and freezers 2020 Stationary 1 January refrigerators -that contain HFCs with GWP of 2 500 or more. for commercial 1 January use (self- 2020 and freezers for commercial -that contain HFCs with GWP of 150 or more. 1 January use 2022 contained(hermetically equipment)sealed -that contain other fluorinated greenhouse gases with 1 January equipment) GWP of 150 or more. (self-contained equipment). 2024
Amendment 608 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 12
Annex IV – point 12
(12) Ana) Any stationary self-contained refrigeration equipment (except chillers) that contains fluorinated greenhouse gases with GWP of 5 or 1 January more. 2025 b) Any transported refrigeration equipment that contains fluorinated 1 January greenhouse gases with GWP of 150 or more. more than 300. 2025 34
Amendment 615 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 14
Annex IV – point 14
(14) Stationary refrigeration equipment, that contains, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 2 1 January 1500 or more except equipment intended for application designed to 2024 cool products to temperatures below – 50 °C.
Amendment 620 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 15
Annex IV – point 15
(15) Multipack centralizedStationary refrigeration systems for commercial use with a , power racks and/or refrigerated remote cabinets assembly with a total rated capacity of 410 kW or more that 1 January contain, or whose functioning relies upon, fluorinated greenhouse gases listed in Annex I with GWP of 150 or 1 January more, except in the primary refrigerant circuit of cascade systems where 2022 fluorinated greenhouse gases with a GWP of less than 1 500 may be used. 2024 with GWP of 5 or more, except chillers.
Amendment 632 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 17
Annex IV – point 17
(17) Plug-in room and other self-contained air-conditioning and heat pump 1 January equipment that contain fluorinated greenhouse gases with GWP of 150 20258 or more.
Amendment 640 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 18
Annex IV – point 18
(18) Stationary split air-conditioning and split heat pump equipment : (a) Single split air-to-air systems containing less than 3 kg of fluorinated greenhouse 1 January greenhouse gases listed in Annex I, that contain, or whose functioning relies upon, 2025 relies upon, fluorinated greenhouse gases listed in Annex I with GWP of 750 or more; (b) Split systems of a rated capacity of up to and including 12 kW Other split equipment containing, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 1750 or more, except when required to meet safety standards; ; 1 January 2027 9 (c) Split systems of a rated capacity of more than 12 kW containing, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 750 or more, except when required to meet safety standards. Deleted
Amendment 654 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 23
Annex IV – point 23
Amendment 660 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 2 a (new)
Annex IV – point 2 a (new)
(2a) Until 1 January 2045 for high voltage switchgears and until 1 January 2038 for medium voltage, the prohibitions on placing on the market set out in point 23 shall not apply to the spare parts necessary for the maintenance and repair of equipment already installed and to the extensions of the already installed gas- insulated switchgear.
Amendment 668 #
2022/0099(COD)
Proposal for a regulation
Annex VI – title
Annex VI – title
Method of calculating the total GWP of a mixture referred to in Article 3(12)
Amendment 669 #
2022/0099(COD)
Proposal for a regulation
Annex VI – paragraph 6 - note
Annex VI – paragraph 6 - note
Note: For ‘other foams’, which related to polyurethane foam and others, referred to under row 19 of Annex IV, the ‘mixture’ must be understood as the mixture of blowing agents excluding substances listed under Annex I.
Amendment 675 #
2022/0099(COD)
Proposal for a regulation
Annex VII – point 1
Annex VII – point 1
Maximum Quantity Years in tonnes CO2 equivalent 2024 – 2026 41 701 077 2027 – 2029 17 688 36029 694 719 2030 – 2032 9 132 09717 688 360 2033 – 2035 8 445 7139 132 097 2036 – 2038 6 782 2658 445 713 2039 – 2041 6 136 732782 265 2042 – 2044 5 491 199 2045 – 2047 4 845 666 2048 onwards 4 200 133 3 621 953
Amendment 93 #
2022/0094(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Where harmonised standards lay down the rules for the assessment of performances with regard to essential characteristics relevant for the construction codes of Member States, harmonised standards should be rendered mandatory for purpose of application of this Regulation, as only such standards reach the goal of permitting the free circulation of products, whilst ensuring the Member States’ ability to request safety and environmental, including climate-related, product characteristics in view of their specific national situation. differences in climate, geology and geography and other different conditions prevailing in the Member States.When pursued together, these two goals require that products are assessed by a single assessment method, therefore the method needs to be mandatory. However, voluntary standards can be used to make product requirements, specified for the relevant product family or category by Delegated Acts, even more concrete, following the path of Decision 768/2008 of the European Parliament and of the Council. In line with Decision 768/2008, those standards should be able to provide a presumption of conformity with the requirements covered by them.
Amendment 102 #
2022/0094(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) In view of enhancing the circularity of construction products, in line with the goals of the Circular Economy Action Plan, manufacturers should favour re-use, remanufacturing and recycling of their products, as well as through appropriate use of by-products. The (preparation for) re-use, remanufacturing and recycling require certain design, namely by facilitating the separation of components and materials at the later stage of recycling and avoiding mixed, blended or intricate materials. As the usual instructions for use will not necessarily reach the economic operators in charge of (preparation for) re- use, remanufacturing and recycling, the necessary information in this regard should be made available in product databases or systems and on the manufacturer’s websites, in addition to the instructions for use.
Amendment 109 #
2022/0094(COD)
Proposal for a regulation
Recital 47
Recital 47
Amendment 112 #
2022/0094(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
This Regulation establishes harmonised rules for the making available on the market and direct installation of construction products, regardless of whether undertaken in the framework of a service or not, by establishing:
Amendment 113 #
2022/0094(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) harmonised rules on how to express the environmental, including climate, and safety performance of construction products in relation to their essential characteristics;
Amendment 116 #
2022/0094(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) environmental, including climate, functional and safety product requirements for construction products.
Amendment 121 #
2022/0094(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘essential characteristics’ means those characteristics of the product which relate to the basic requirements for construction works as set out in Annex I Part A Point 1 or the environmental characteristics which have been listed in Annex I Part A Point 2;
Amendment 125 #
2022/0094(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 71 a (new)
Article 3 – paragraph 1 – point 71 a (new)
(71 a) ‘by-product’ means aby-product as defined in Article 5 of Directive 2008/98/EC.
Amendment 132 #
2022/0094(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The basic requirements for construction works, set out in Annex I Part A Point 1 shall constitute the basis for the identification of essential characteristics of construction products. The essential characteristics of construction products shall be identified by the Commission, taking into account the regulatory needs of the Member States. The identified essential characteristics, together with the essential environmental characteristics listed in Annex I, Part B, shall form the basis for the preparation of standardisation requests and harmonised technical specifications.
Amendment 135 #
2022/0094(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
The essential characteristics specidentified in accordance with paragraph 1 or the essential environmental characteristics listed in Annex I Part A Point 2 and the methods for their assessment shall be laid down in standards which are rendered mandatory for purposes of application of this Regulation. The essential characteristics of products shall be identified in view of the basic requirements for construction works, taking account of the regulatory needs of Member States.
Amendment 159 #
2022/0094(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 184 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – introductory part
Article 22 – paragraph 2 – subparagraph 1 – introductory part
Unless product safety or the safety of construction works or their performance is thereby negatively impacted, the manufacturer shas the following obligationsll if technically possible and economically reasonable and feasible:
Amendment 188 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point a – introductory part
Article 22 – paragraph 2 – subparagraph 1 – point a – introductory part
(a) design and manufacture products and their packaging in such a way that their overall environmental, including climate sustainability reaches the state of the art level, unless a lower level:
Amendment 190 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point a – introductory part
Article 22 – paragraph 2 – subparagraph 1 – point a – introductory part
(a) design and manufacture products and their packaging in such a way that their overall environmental, including climate sustainability reaches the state of the art level, as specified in the applicable harmonised technical specifications, unless a lower level:
Amendment 192 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point a – point i
Article 22 – paragraph 2 – subparagraph 1 – point a – point i
(i) is proportionate when compared to the environmental sustainability improvement triggered by them at the level of the construction works; andor
Amendment 193 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point a – point ii
Article 22 – paragraph 2 – subparagraph 1 – point a – point ii
(ii) is either necessary to improve the environmental sustainability at the level of the construction works.
Amendment 198 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point b
Article 22 – paragraph 2 – subparagraph 1 – point b
(b) under the conditions set out in point (a)(i) and (ii) give preference to recyclable materials and materials gained from recycling or otherwise unused by- products;
Amendment 206 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point f
Article 22 – paragraph 2 – subparagraph 1 – point f
(f) make available, in product databases, instructions for use and on permalinks or QR-Codes of their own websites, information on how to repair the products and any additional information necessary for repairing, including relevant warnings;
Amendment 209 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point g
Article 22 – paragraph 2 – subparagraph 1 – point g
(g) make available on the market itself or by specially designated distributors or by manufacturers of spare parts, with reasonably short delivery time, spare or equivalent parts for their products for 10 years after the last product of the respective type has been placed on the market or directly installed and inform proactively about this availability;
Amendment 213 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 2 – subparagraph 1 – point j
Article 22 – paragraph 2 – subparagraph 1 – point j
(j) accept to regain free of charge, directly or via their importers and distributors, ownership of surplus and unsold products that are in a state equivalent to the one in which they were placed on the market, unless more than 5 years have passed since the product was placed on the market for the first time.
Amendment 221 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
Amendment 224 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
Amendment 239 #
2022/0094(COD)
Proposal for a regulation
Article 83 – paragraph 1 – subparagraph 1
Article 83 – paragraph 1 – subparagraph 1
Where Member States provide incentives for a product category covered by a delegated act establishing performance classes in accordance with Article 4(4), point (a) or a “traffic-light-labelling” in accordance with Article 22(5), those incentives shall aim at the highest two populated classes / colour codes, or at higher classes / better colour codes.
Amendment 241 #
2022/0094(COD)
Proposal for a regulation
Article 83 – paragraph 1 – subparagraph 2
Article 83 – paragraph 1 – subparagraph 2
Where a delegated act defines classes of performance are defined in relation to more than one sustainability parameter, it shall be indicated therein in relation to which parameter this Article should be implemented.
Amendment 242 #
2022/0094(COD)
Proposal for a regulation
Article 83 – paragraph 1 a (new)
Article 83 – paragraph 1 a (new)
1 a. Member States may also provide incentives for the promotion of environmentally friendly construction products.
Amendment 243 #
2022/0094(COD)
Proposal for a regulation
Article 83 – paragraph 2
Article 83 – paragraph 2
Amendment 252 #
2022/0094(COD)
Proposal for a regulation
Article 84 – paragraph 1
Article 84 – paragraph 1
1. The Commission is empowered to supplement this Regulation by delegated acts according to Article 87 by establishing sustainability requirements applicable to public contracts, including implementation, monitoring and reporting of those requirements by Member Statethat may be applied by Member States to public contracts.
Amendment 255 #
2022/0094(COD)
Proposal for a regulation
Article 84 – paragraph 2
Article 84 – paragraph 2
2. Requirements adopted pursuant to paragraph 1 for public contracts awarded by contracting authorities, as defined in Article 2(1) of Directive 2014/24/EU or Article 3, point (1) of Directive 2014/25/EU, or contracting entities, as defined in Article 4(1) of Directive 2014/25/EU, may take the form of mandatovoluntary technical specifications, selection criteria, award criteria, contract performance clauses, or targets, as appropriate.
Amendment 258 #
2022/0094(COD)
Proposal for a regulation
Article 84 – paragraph 3 – introductory part
Article 84 – paragraph 3 – introductory part
3. When establishing requirements pursuant to paragraph 1 for public contracts, the Commission shallmay take into account the following criteria:
Amendment 268 #
2022/0094(COD)
Proposal for a regulation
Article 91 – paragraph 1
Article 91 – paragraph 1
No sooner than 84 years after the date of application of this Regulation, the Commission shall carry out an evaluation of this Regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of products and construction works and built environment. The Commission shall present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. Member States shall provide the Commission with the information necessary for the preparation of that report.
Amendment 282 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 1 – point 1.8 – paragraph 2 – point a
Annex I – Part A – point 1 – point 1.8 – paragraph 2 – point a
(a) use of by-products, raw and secondary materials of high environmental sustainability and thus with a low environmental footprint;
Amendment 289 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – introductory part
Annex I – Part A – point 2 – paragraph 2 – introductory part
Harmonised technical specifications shall tocover the extent possible coverssential characteristics "environmental sustainability" which comprises the following essnvironmential characteristics related to life cycle assessmentimpact indicators:
Amendment 292 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point a
Annex I – Part A – point 2 – paragraph 2 – point a
(a) climate change effects Global Warming Potential total (GWP—total) (mandatory);
Amendment 295 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point a a (new)
Annex I – Part A – point 2 – paragraph 2 – point a a (new)
(a a) Global Warming Potential fossil fuels (GWP—fossil) (mandatory);
Amendment 297 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point a b (new)
Annex I – Part A – point 2 – paragraph 2 – point a b (new)
(a b) Global Warming Potential biogenic (GWP—biogenic) (mandatory);
Amendment 300 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point a c (new)
Annex I – Part A – point 2 – paragraph 2 – point a c (new)
(a c) Global Warming Potential land use and land use change (GWP—luluc) (mandatory);
Amendment 301 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point b
Annex I – Part A – point 2 – paragraph 2 – point b
(b) ozone depletionDepletion potential of the stratospheric ozone layer [ODP) (mandatory);
Amendment 303 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point c
Annex I – Part A – point 2 – paragraph 2 – point c
(c) acidification potential, Accumulated Exceedance (AP) (mandatory);
Amendment 305 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point d
Annex I – Part A – point 2 – paragraph 2 – point d
(d) eEutrophication aquatic freshwaterpotential, fraction of nutrients reaching freshwater end compartment (EP-freshwater) (mandatory);
Amendment 307 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point e
Annex I – Part A – point 2 – paragraph 2 – point e
(e) eutrophication aquatic marinepotential, fraction of nutrients reaching marine end compartment (EP-marine)(mandatory);
Amendment 309 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point f
Annex I – Part A – point 2 – paragraph 2 – point f
(f) eutrophication terrestrialpotential, Accumulated Exceedance (EP - terrestrial) (mandatory);
Amendment 312 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point g
Annex I – Part A – point 2 – paragraph 2 – point g
(g) photocformation potential of troposphemrical ozone (POCP) (mandatory);
Amendment 314 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point h
Annex I – Part A – point 2 – paragraph 2 – point h
(h) abiotic depletion –potential for non- fossil resources (ADP minerals, & metals; ) (mandatory);
Amendment 316 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point i
Annex I – Part A – point 2 – paragraph 2 – point i
(i) abiotic depletion –for fossil fuelsresources potential (ADP-fossil) (mandatory);
Amendment 317 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point j
Annex I – Part A – point 2 – paragraph 2 – point j
(j) water (user) deprivation potential, deprivation-weighted water consumption (WDP) (mandatory);
Amendment 319 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point k
Annex I – Part A – point 2 – paragraph 2 – point k
Amendment 321 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point l
Annex I – Part A – point 2 – paragraph 2 – point l
Amendment 323 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point m
Annex I – Part A – point 2 – paragraph 2 – point m
Amendment 325 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point n
Annex I – Part A – point 2 – paragraph 2 – point n
Amendment 327 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point o
Annex I – Part A – point 2 – paragraph 2 – point o
Amendment 330 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point p
Annex I – Part A – point 2 – paragraph 2 – point p
Amendment 332 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 3
Annex I – Part A – point 2 – paragraph 3
For the essential characteristic "environmental sustainability", all environmental impact indicators a) to m) must be declared as a whole. Harmonised technical specifications shall indicate that for the essential characteristic of climate change effects under point (a)"environmental sustainability" it is mandatory for the manufacturer to declare the performance of the product as set out in Articles 11(2) and 22(1).
Amendment 335 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 4
Annex I – Part A – point 2 – paragraph 4
Amendment 24 #
2022/0068(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Pursuant to the statement in the minutes of the European Council meeting of 25 November 2018, any future agreement between the EU and the United Kingdom concerning Gibraltar will require the prior agreement of the Kingdom of Spain. Given Gibraltar's particular geographical situation, its status under international law, its specific characteristics and its special relationship with Spain, measures adopted by the EU under this Regulation which affect the territory of Gibraltar or any agreement concluded between the EU and the United Kingdom concerning that territory should also require the prior consent of the Kingdom of Spain.
Amendment 62 #
2022/0068(COD)
Proposal for a regulation
Article 2 – paragraph 7 a (new)
Article 2 – paragraph 7 a (new)
7a. Where they concern the territory of Gibraltar or any agreement between the EU and the United Kingdom relating to that territory, the adoption of measures pursuant to paragraph 1 of this Article shall require the prior consent of the Kingdom of Spain.
Amendment 35 #
2021/2013(INI)
Motion for a resolution
Recital A
Recital A
A. whereas health is fundamental to the well-being of Europeans and equitable access to healthcare is a pillar of the EU; whereas safe, affordable medicines are needed to combat all diseases; whereas patients should be at the centre of all health policies, alongside investment and research, and in every aspect of the medicine regulatory lifecycle;
Amendment 51 #
2021/2013(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the disruption of the global supply chain ensuing from the COVID-19 pandemic has highlighted the EU’s dependency on third countries in the health sector; whereas the EU's open strategic autonomy and security of supply should be ensured by diversification of supply chains for essential medicines and medicinal products, including European manufacturing sites, as well as by applying public procurement rules that should not consider price as the sole criterion;
Amendment 91 #
2021/2013(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
C a. whereas a competitive and resilient European research-based pharmaceutical industry is more responsive to patients’ needs and to strategic interest for public health, economic growth, jobs, trade, and scientific and technological progress;
Amendment 149 #
2021/2013(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Stresses the importance of improving patients and healthcare professionals’ education on medicines by setting up a dedicated Europe-wide online resource centre;
Amendment 150 #
2021/2013(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Welcomes the upcoming creation of the European Health Emergency Preparedness and Response Authority (HERA) and calls for the allocation of sufficient resources and power autonomy to broadly address all the cross-borders threats to health that EU could face in the middle term and beyond the sole COVID- 19 pandemic, including resources for the development of new therapeutics against viral and bacterial pathogens;
Amendment 175 #
2021/2013(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Considers the serious and constantly increasing risks of AMR to public health, environment, food production, and economic growth; recognises the value of public health campaigns aimed at the prevention of infections using vaccines;
Amendment 190 #
2021/2013(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Calls on the Commission to propose as soon as possible a legal framework to encourage innovation for new antibiotics with incentives either comparable to the area of orphan drugs or paediatrics or new innovative incentives to stimulate innovation to bring new antibiotics the market;
Amendment 207 #
2021/2013(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission to incorporate new criteria into the system of incentives for research into and the development of new medicines for unmet therapeutic needs, prioritising projects promoted by the pharmaceutical industry combating rare diseases, paediatric cancers (especially to incentivise First-in-Child development of paediatric anticancer medicines), neurodegenerative diseases and AMR, with the aim of finding more therapeutic options and meeting the needs of patients and health systems; calls on the Commission to promote the creation of an EU framework to guide and regularly evaluate the implementation of national plans to fight these diseases;
Amendment 247 #
2021/2013(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to promote dialogue with the Member States and stakeholders to assess new criteria for national pricing, such as whether a product is ‘Made in Europe’, whether the EU invested in the product to support research, or whether prices should be adapted to the value of the therapeutic benefit of the medicine, or whether it is a generic or biosimilar medicine, and the primary and broader needs of the population;
Amendment 256 #
2021/2013(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Calls on the Commission to apply public procurement rules that should not consider price as the sole and main selection criterion;
Amendment 310 #
2021/2013(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Stresses that cost savings generated from the use of biosimilars should be reinvested in a transparent and tangible way; calls on the European Commission to encourage Member States to support the transparent practices of biosimilar-related cost savings; calls on the European Commission to facilitate arrangements such as gainsharing programmes;
Amendment 319 #
2021/2013(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7 b. Calls on the Commission to ensure that EU funding for biomedical research and development includes clauses that contribute to the availability and affordability of final products;
Amendment 330 #
2021/2013(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Welcomes the fact that the Commission will launch a pilot project to better understand the root causes of the delayed arrival of medicines on the market; further welcomes the fact that the Commission will continue to monitor mergers between pharmaceutical companies to avoid distortions of competition; stresses the need to reduce medicine approval times, setting a time limit for approval at national level, and align them with European Medicines Agency (EMA) times, in order to ensure rapid and equal access to medicines for everyone in the EU;
Amendment 339 #
2021/2013(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Highlights the benefits of public- private partnership tenders for national health systems in funding research into and the production of innovative medicines, only if driven by public interest considerations;
Amendment 398 #
2021/2013(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls on the Commission to create a High-Level Forum on Better Access to Medicines to identify multi-stakeholder solutions to introducing new health technologies that can broaden access, reduce delays and mitigate the impact of shortages;
Amendment 422 #
2021/2013(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space, which will integrate data from real-world evidence;
Amendment 434 #
2021/2013(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the Commission to expand the role of EMA in the assessment of drug-device/diagnostic combination products to simplify the fragmented supervisory framework; believes that greater regulatory agility and efficiency can be achieved by adopting a more expertise-driven scientific assessment on marketing authorisations within the European Medicines Agency(EMA);
Amendment 459 #
2021/2013(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Calls on the Commission to legitimise EMA’s PRIME scheme and include a PRIME designation in the legislative framework;
Amendment 463 #
2021/2013(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Calls on the Commission to facilitate assessment processes that allow for early and iterative dialogue on data and evidence as they are generated; calls on the EMA and national medicine agencies to prioritise the submission of data from randomised controlled clinical trials that compare an investigational medicine against the standard treatment;
Amendment 471 #
2021/2013(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Requests the Commission to work with Member States to reduce fragmentation in the application of the General Data Protection Regulation, which substantially increases the complexity and burden of conducting clinical research in Europe;
Amendment 476 #
2021/2013(INI)
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12 e. Notes that decisions taken regarding the EU's pharmaceutical regulatory environment will have implications beyond Europe's borders, given that several third countries recognize and rely on EU requirements, particularly when it comes to the facilitation of exports and the waiving of requirements to test these in third countries when they come from the EU; therefore emphasizes the importance of maintaining such mutual recognition agreements with third countries and ensuring that these remain up to date;
Amendment 519 #
2021/2013(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanomedicines and nanotechnology, next- generation vaccines, including the m-RNA derivatives, e-health and the ‘Million plus genomes’ initiative can bring enormous benefits in relation to the prevention, diagnosis, treatment and post-treatment of all diseases; urges the Commission to develop appropriate regulatory frameworks, to guide new business models, and to run information campaigns to raise awareness and encourage the use of these innovations;
Amendment 524 #
2021/2013(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Recognises that ATMPs are fundamentally different from traditional pharmaceuticals as they address the root causes of disease and that their fundamental durability and potential curative nature can allow them to be the future of medicine; acknowledges that regulatory bodies such as the EMA are set to review and approve dozens of ATMPs over the coming years, underlining the need for the Commission to establish in addition to its ATMP Action Plan a robust regulatory landscape that facilitates access for all the eligible European patients, and to continue to build on Europe’s position as a major player in ATMPs in order for Europe to remain globally competitive in ATMP development;
Amendment 527 #
2021/2013(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15 b. Calls on the Commission to establish a coordinating body to facilitate cross-border treatments and to ensure that patients across Europe enjoy equitable access to innovative therapies; urges the Commission to work with the EMA to create a one-stop-shop for ATMP developers to seek guidance and communication on their applications;
Amendment 528 #
2021/2013(INI)
Motion for a resolution
Paragraph 15 c (new)
Paragraph 15 c (new)
15 c. Calls on the Commission to establish a regulatory framework for nanomedicines and nanosimilars, and calls for these products to be approved through a compulsory centralised procedure;
Amendment 618 #
2021/2013(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Supports the Commission in its efforts to conduct a structured dialogue with players in the pharmaceutical value chain, public authorities, non-governmental patient and health organisations and the research community to address the root causes of shortages of medicines and the weaknesses in the global medicines manufacturing and supply chain;
Amendment 659 #
2021/2013(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Stresses the need for the pharmaceutical industry to be environmentally friendly and climate- neutral throughout the life cycles of medicinal products; calls on the Commission to strengthen inspection and auditing throughout the production chain, particularly outside the EU; urges the Commission to ensure quality environmental sustainability standards for active pharmaceutical ingredients imported from non-EU countries; calls on the Commission to address the problem of domestic pharmaceutical waste, with measures to reduce packaging and the size of containers to ensure they are no larger than necessary, and to bring medical prescriptions into line with real therapeutic needs; notes that the creation of electronic systems of information and identification of packaging would be an effective way to reduce it; acknowledges steps taken already by the pharmaceutical industry like, for example, the Eco-Pharmaco- Stewardship initiative;
Amendment 397 #
2021/0367(COD)
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where waste listed in Annex III, IIIA, IIIB or IV, waste not classified or mixtures of wastes not classified under one entry in either Annex III or Annex IV are exported from the Union and destined for recovery in countries to which the OECD Decision applies, with or without transit through countries to which the OECD Decision applies, the provisions of Title II shall apply mutatis mutandis, with the adaptations and additional provisions listed in paragraphs 2, 3 and 5 and subject to the periodic monitoring as referred to in Article 41a and Article 41b and the safeguard mechanism as referred to in Article 42.
Amendment 404 #
2021/0367(COD)
Proposal for a regulation
Article 41 a (new)
Article 41 a (new)
Article 41 a 1. The Commission shall periodically monitor the countries to which the OECD Decision applies, with a view to ensuring that the countries concerned have the ability to recover the waste in an environmentally sound manner as referred to in Article 56, and that such exports do not lead to environmental or human health damages in the country of destination. 2. The Commission shall monitor in priority the countries to which the OECD Decision applies, and to which the exports of waste represent at least 10% in tonnes of total exports of waste to countries to which the OECD Decision applies as from the entry into force of this Regulation. 3. The Commission shall ensure that each country to which the OECD Decision applies: (a) has a comprehensive waste management strategy or plan that covers its entire territory and shows its ability and readiness to ensure the environmentally sound management of waste; b) has a legal framework for waste management in place, which includes at least the following elements: (i) permitting or licensing systems for waste treatment facilities; (ii) permitting or licensing systems for transport of waste; (iii) provisions designed to ensure that the residual waste generated through the recovery operation for the wastes concerned by the request is managed in an environmentally sound manner as referred to in Article 56; (iv) adequate pollution controls following relevant BATs (Best Available Techniques) are applying to all waste management operations, from initial treatment to final recycling including binding emission limits for the protection of air, soil and water equivalent to those applicable in EU. (v) effective measures entailing a cost of carbon to reduce the emissions of greenhouse gases from all operations under point (iv); (vi) provisions on enforcement, inspection and penalties designed to ensure the implementation of domestic and international requirements on waste management and waste shipment; (c) is a Party to the multilateral agreements referred to in Annex VIII, and has taken the necessary measures to implement its obligations under those agreements; (d) has put in place a strategy for enforcement of domestic legislation on waste management and waste shipment, covering control and monitoring measures, including information on the number of inspections of shipments of waste and of waste management facilities carried out and on penalties imposed in cases of infringements of the relevant domestic rules. 4. As part of such monitoring, the Commission shall assess requests from natural or legal persons which are accompanied by relevant information and data showing that export of waste from the Union leads to environmental or human health damages in a country to which the OECD Decision applies. 5. Where the Commission is not satisfied that the requirements set out in this Article are complied with and that the country to which the OECD Decision applies does not have the ability to recover the waste in an environmentally sound manner as referred to in Article 56, it shall add the concerned country to the list of countries to which exports are prohibited.
Amendment 409 #
2021/0367(COD)
Proposal for a regulation
Article 41 b (new)
Article 41 b (new)
Amendment 412 #
2021/0367(COD)
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
1. The Commission shall monitor the levels of export of waste from the Union to countries to which the OECD Decision applies, with a view to ensuring that suchincrease in exports do not lead to serious environmental or human health damages in the country of destination. As part of such monitoring, the Commission shall assess requests from natural or legal persons which are accompanied by relevant information and data showing that export of waste from the Union leads to serious environmental or human health damages in a country to which the OECD Decision applies.
Amendment 423 #
2021/0367(COD)
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. In cases where the export of wasteany category of waste listed in Annex IX to the Basel convention from the Union to a country to which the OECD Decision applies has considerably increased within a short period of time,increased by a volume of 20% in tonnes in one month when compared to an average volume of last6 months period and there is insufficient evidence available demonstrating that the country concerned has the ability to recover this waste in an environmentally sound manner as referred to in Article 56, the Commission shall request the competent authorities of the country concerned to provide, within 630 days, information on the conditions under which the waste in question is recovered and the ability of the country concerned to manage the waste in question. The Commission may grant an extension of this time limit if the country concerned makes a reasoned request for an extension thereofability of the country concerned to manage the waste in question.
Amendment 249 #
2021/0214(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) It is essential to also avoid the risk that Union exports to global markets are replaced by more carbon intensive goods or by goods that are not subject to equivalent carbon costs. The Commission should address the problem of carbon leakage risk on export markets before the end of the transitional period and consider WTO-compatible solutions to equalise CO2 costs, taking into account the carbon pricing schemes developed by third countries. Pending the development of such legislation, Union exports should be covered with the allocation of free ETS allowances until other countries take equivalent and effective steps to impose carbon costs on their domestic production, including the one dedicated to exports.
Amendment 256 #
2021/0214(COD)
Proposal for a regulation
Recital 12 b (new)
Recital 12 b (new)
(12b) If the Union wants to promote the best environment and climate standards worldwide, additional measures should be adopted to ensure that European companies are able to compete in an international level playing field. A combination of Union measures should address the direct and indirect costs linked to exported Union products. For this purpose, in addition to the measures included in this Regulation, the Commission should update the State Aid framework to ensure sufficient compensation of indirect costs for the exports in sectors at risk of carbon leakage.
Amendment 262 #
2021/0214(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) As an instrument to prevent carbon leakage and reduce GHG emissions the CBAM should ensure that imported products are subject to a regulatory system that applies carbon costs equivalent to the ones that otherwise would have been borne under the EU ETS, resulting in an equalisation of carbon costs in imported and domestic production and fair competition in international trade. The CBAM is a climate measure which should prevent the risk of carbon leakage and support the Union’s increased ambition on climate mitigation, while ensuring WTO compatibility and industrial competitiveness.
Amendment 306 #
2021/0214(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The GHG emissions to be regulated by the CBAM should correspond to those GHG emissions covered by Annex I to the EU ETS in Directive 2003/87/EC, namely carbon dioxide (‘CO2’) as well as, where relevant, nitrous oxide (‘N2O’) and perfluorocarbons (‘PFCs’). The CBAM should initially apply to direct emissions of those GHG from the production of goods up to the time of import into the customs territory of the Union, and after the end of a transition period and upon further assessment, as well to indirect emissions, mirroring the scope of the EU ETS.
Amendment 365 #
2021/0214(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The goods under this Regulation should be selected after a careful analysis of their relevance in terms of cumulated GHG emissions and risk of carbon leakage in the corresponding EU ETS sectors while limiting complexity and administrative burden. In particular, the actual selection should take into account basic materials and basic products covered by the EU ETS with the objective of ensuring that imports of energy intensive products into the Union are on equal footing with EU products in terms of EU ETS carbon pricing, and to mitigate risks of carbon leakage. Other relevant criteria to narrow the selection should be: firstly, relevance of sectors in terms of emissions, namely whether the sector is one of the largest aggregate emitters of GHG emissions; secondly, sector’s exposure to significant risk of carbon leakage, as defined pursuant to Directive 2003/87/EC; thirdly, the need to balance broad coverage in terms of GHG emissions while limiting complexity and administrative effort. Account should also be taken of the need to have a balanced scope of goods covered under this Regulation to avoid market distortions among the different sectors affected.
Amendment 605 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 7 – point d
Article 2 – paragraph 7 – point d
(d) the third country or territory has committed to climate neutrality by 2050 and has accordingly formally formulated and communicated, where applicable, to the United Nations Framework Convention on Climate Change a mid-century, long- term low greenhouse gas emissions development strategy aligned with that objective, and has implemented that obligation in its domestic legislation;
Amendment 610 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 7 – point e
Article 2 – paragraph 7 – point e
(e) the third country or territory has, when implementing the roadmap pursuant to point (c), demonstrated substantial progress towards the alignment of domestic legislation with Union law in the field of climate action on the basis of that roadmap, including towards carbon pricing at an equivalent level as the Union at least insofar as the generation of electricity is concerned. The implementation of an emission trading system for electricity, with a price equivalent to the EU ETS, shall be finalised by 1 January 203026;
Amendment 715 #
2021/0214(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. The Commission is empowered to adopt implementing acts concerning detailed rules regarding the elements of the calculation methods set out in Annex III, including determining system boundaries of production processes, emission factors, installation-specific values of actual emissions and default values and their respective application to individual goods as well as laying down methods to ensure the reliability of data on the basis of which the default values shall be determined, including the level of detail and the verification of the data. WThere necessary, those acts shall provide that the default values can be adapted to particular areas, regions or countries to take into account specific objective factors such as geography, natural resources, market conditions, prevailing energy sources, or industrial processes. The implementing acts shall build upon implementing acts shall be equivalent to the existing legislation for the verification of emissions and activity data for installations covered by Directive 2003/87/EC, in particular Implementing Regulation (EU) No 2018/2067.
Amendment 735 #
2021/0214(COD)
Proposal for a regulation
Article 8 – paragraph 3 – subparagraph 1
Article 8 – paragraph 3 – subparagraph 1
The Commission is empowered to adopt implementing acts concerning the principles of verification referred to in paragraph 1 as regards the possibility to waive the obligation for the verifier to visit the installation where relevant goods are produced and the obligation to set thresholds for deciding whether misstatements or non-conformities are material and concerning the supporting documentation needed for the verification report. The Commission shall ensure that the provisions in these implementing acts are equivalent to those set in the Implementing Regulation (EU) 2018/2067.
Amendment 752 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The authorised declarant shall keep records of the documentation, certified by an independent verifier accredited peursonuant to Article 18, required to demonstrate that the declared embedded emissions were subject to a carbon price in the country of origin of the goods and keep evidence of the proof of the actual payment for that carbon price which should not have been subject to an export rebate or any other direct or indirect form of compensation on exportation.
Amendment 761 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The Commission is empowered to adopt implementing acts establishing the methodology for calculating the reduction in the number of CBAM certificates to be surrendered, regarding the conversion of the carbon price paid in foreign currency into euro at yearly average exchange rate in accordance with paragraph 1, and regarding the qualifications of the independent person certifying the information as well as elements of proof of the carbon price paid and the absence of export rebates or other forms of compensation on exportation being applied as referred to in paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 29(2).
Amendment 776 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Commission shall, upon request by an operator of an installation located in a third country, register the information on that operator and on its installation in a central databaseCBAM registry referred to in Article 14(4).
Amendment 786 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 7
Article 10 – paragraph 7
7. An operator may disclose tThe information on the verification ofed embedded emissions referred to in paragraph 5 to an authorised declarantshall be publicly accessible via the CBAM registry. The authorised declarant shall be entitled to avail itself of that disclosed information to fulfil the obligation referred to in Article 8.
Amendment 834 #
2021/0214(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The information in the database referred to in paragraph 2 shall be confidentialmade public, except for those parts that need to be protected as confidential according to the relevant EU legislation, and equivalent to the one made publicly available for EU producers under the EU emission trading database.
Amendment 876 #
2021/0214(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b a (new)
Article 17 – paragraph 1 – point b a (new)
(ba) the declarant has not repeatedly been liable for the penalties set in Article 26 and has not been involved in practices of circumvention pursuant to Article 27.
Amendment 916 #
2021/0214(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. The competent authority may shall review the CBAM declaration within the period ending with the fourth year after the year in which the declaration should have been submittedout delay after its submission according to Article 6(1). The review may consist in verifying the information provided in the CBAM declaration on the basis of the information communicated by the customs authorities in accordance with Article 25(2) and any other relevant evidence, and on the basis of any audit deemed necessary, including at the premises of the authorised declarant.
Amendment 926 #
2021/0214(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Where a CBAM declaration in accordance with Article 6 has not been submitted, the competent authority of the Member State of establishment of the authorised declarant shall assess the CBAM obligations of that declarant on the basis of the information at its disposal and calculate the total number of CBAM certificates due at the latest by the 31 December of the fourth year following thatyear when the CBAM declaration should have been submitted.
Amendment 960 #
2021/0214(COD)
Proposal for a regulation
Article 24 a (new)
Article 24 a (new)
Article 24a Measures to address downstream carbon leakage Before the end of the comprehensive transition period, a centralised arrangement at Union level shall be adopted to compensate downstream sectors or sub-sectors which are exposed to the risk of carbon leakage due to significant costs that are actually incurred from greenhouse gas emission costs passed on as a consequence of the gradual phase-out of free allocation in favour of the obligation to surrender CBAM certificates. Compensation shall be proportionate to greenhouse gas emission costs actually passed through in price increase of goods covered by this Regulation in order to avoid negative effects on the internal market as well as overcompensation of costs incurred. Where the amount of compensation available is not sufficient to compensate eligible costs for downstream operators, the amount of compensation available for all eligible installations shall be reduced in a uniform manner. The Commission is empowered to adopt a delegated act in accordance with Article 28 to supplement this Regulation for the purpose referred to in this Article.
Amendment 1058 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 5 a (new)
Article 27 – paragraph 5 a (new)
5a. The Commission shall publish all cases of circumvention investigations and their results in an annual report. This report shall also include information on the status of ongoing appeal procedures against penalties. The report shall also contain aggregated information on the emission intensity per country of origin for the different products listed in Annex I.
Amendment 1131 #
2021/0214(COD)
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
2. Before the end of the transitional period, the Commission shThe Commission shall evaluate the application of this Regulation before the end of the administrative transitionall present aeriod and report to the European Parliament and the Council on the application of this Regulation. The report shall contain, in particular, the assessment of the possibilities to further extend the scope of embedded emissions to indirect emissions and to other goods at risk of carbon leakage than those already covered by this Regulation, as well as an assessment of the governance system. It shall also contain the assessment of the possibility to further extend the scope to embedded emissions of transportation services as well as to goods further down the value chain. The first report of the Commission shall in particular focus on possibilities to enhance climate actions towards the objective of a climate neutral Union by 2050. The Commission shall, as part of that evaluation: (a) assess the impact on the competitiveness of the European industry and downstream sectors, the impact on SMEs, possible disproportionate administrative burden, circumvention practices, distortion in trade patterns and possibilities to enhance climate actions towards a climate neutral Union by 2050, accompanied by proposals to avoid negative impacts on such sectors; (b) present a proposal to address the problem of carbon leakage in export markets; (c) extend the scope of Annex I to other goods and services that may be subject to the risk of carbon leakage in the future. risk of carbon leakage, such as finished goods.
Amendment 1306 #
2021/0214(COD)
Proposal for a regulation
Annex III – point 6
Annex III – point 6
Amendment 180 #
2021/0211(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Greenhouse gases that are not directly released into the atmosphere should not be considered emissions under the EU ETS and allowances should be surrendered for those emissions unless they are stored in a storage site in accordance with Directive 2009/31/EC of the European Parliament and of the Council46 , or they are permanently chemically bound in a product so that they do not enter the atmosphere under normal use. The Commission should be empowered to adopt implementing acts specifying the conditions where greenhouse gases are to be considered as permanently chemically bound in a product so that they do not enter the atmosphere under normal use, including obtaining a carbon removal certificate, where appropriate, in view of regulatory developments with regard to the certification of carbon removals. _________________ 46Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140, 5.6.2009, p. 114)The Commission should also be empowered to adopt implementing acts specifying the conditions under which greenhouse gases transferred for further use should be accounted for at the point of release into the atmosphere.
Amendment 212 #
2021/0211(COD)
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17a) Measures should be included in this Directive to prevent the carbon leakage produced as a result of more stringent rules applied in EU ports than in non-EU countries. Special attention needs to be paid to transhipment operations in non-EU neighbouring ports, which could benefit from an unfair playing field if sufficient compensatory measures are not foreseen. This difference in the applicable rules would imply a shift in deep sea traffic towards ports outside the EU and would generate feeder ship traffic that only registers 50 % of its emissions. The traffic – whose origin is at a neighbouring, non-EU transhipment port – should be treated as intra-EU traffic and ship-owners should acquire 100 % of their emission rights when their ships are en route to an EU port. Also, a gradual phase-in of the EU ETS should be set for deep sea routes performing at least 30 % of transhipment operations in EU ports.
Amendment 278 #
2021/0211(COD)
Proposal for a directive
Recital 29
Recital 29
Amendment 291 #
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 free allocation tontends to complement and progressively replace the existing mechanisms by addressing the risk of carbon leakage in a different way. 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,and once the CBAM has fully demonstrated its effectiveness in equalising CO2 costs between importersd and traders to adjust to the new regime. 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 fadomestic products and in protecting the competitiveness of European exports, the free allocation received by these sector)s should be equal to 100 % during the transitional period between the entry into force of [CBAM Regulation] and 2025, 90 % in 2026 and should be reduced by 10 percentage points each year to reach 0 % and thereby 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 sectorsgradually phased out. However, a transitional phasing-out of free allowances is needed to allow producers, importers and traders to adjust to the new regime. The free allocation should be phased out only after a comprehensive transitional period between 2026 and 2030. 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 314 #
2021/0211(COD)
Proposal for a directive
Recital 30 a (new)
Recital 30 a (new)
(30a) 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. Existing carbon pricing mechanisms in third countries should lead to an adjustment of the CBAM factor.
Amendment 394 #
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 into the atmosphere. 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 and when to account for the eventual release of carbon dioxide and how to avoid double counting to ensure appropriate incentives are in place for capturing the CO2, taking also into account the treatment of these fuels under Directive (EU) 2018/2001.
Amendment 651 #
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 660 #
2021/0211(COD)
(v) ‘shipping company’ means the shipowner or any other organisation or person, such as the manager or the bareboat charterer, that has assumed the responsibility for the operation of the ship from the shipowner and that, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed by the International Management Code for the Safe Operation of Ships and for Pollution Prevention, set out in Annex I to Regulation (EC) No 336/2006 of the European Parliament and of the Council(*); ___. When the ultimate responsibility for the purchase of the fuel or the operation of the ship is assumed by a different entity pursuant to a contractual agreement, this entity shall be responsible under this contractual agreement to cover the costs arising from the implementation of this Directive. Operation of the ship for the purposes of this Article shall mean determining the cargo carried, the route or the speed of the ship. __________ (*) Regulation (EC) No 336/2006 of the European Parliament and of the Council of 15 February 2006 on the implementation of the International Safety Management Code within the Community and repealing Council Regulation (EC) No 3051/95 (OJ L 64, 4.3.2006, p. 1).
Amendment 665 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Directive 2003/87/EC
Article 3 – paragraph 1 – point x
Article 3 – paragraph 1 – point x
Amendment 678 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Directive 2003/87/EC
Article 3 – paragraph 1 – point z a (new)
Article 3 – paragraph 1 – point z a (new)
(za) “port of call” means the port where a ship stops to load or unload cargo or to embark or disembark passengers; consequently, for the purpose of this Directive stops for the sole purposes of refuelling, obtaining supplies, relieving the crew, going into dry-dock or making repairs to the ship 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, stops in a transhipment port of a non-EU neighbouring country and stops for the sole purpose of taking shelter from adverse weather or rendered necessary by search and rescue activities are excluded;
Amendment 679 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Directive 2003/87/EC
Article 3 – paragraph 1 – point z b (new)
Article 3 – paragraph 1 – point z b (new)
(z b) “transhipment port” means the port where the movement of one type of cargo to be transhipped exceeds 60 % of the total traffic of that port. Cargo, container or goods are transhipped when they are unloaded from the ship to the port for the sole purpose of loading them on another ship.
Amendment 680 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Directive 2003/87/EC
Article 3 – paragraph 1 – point z c (new)
Article 3 – paragraph 1 – point z c (new)
(z c) “deep sea routes” means those shipping routes connecting two or more continents and performed by regular services covering more than 3 000 km long where ships would carry out transhipment operations at any port in its route. Such routes shall be incorporated in a list and reconsidered on an annual basis by the Commission.
Amendment 681 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Directive 2003/87/EC
Article 3 – paragraph 1 – point z d (new)
Article 3 – paragraph 1 – point z d (new)
(z d) "transhipment operation” means an operation in which any cargo, container or good is unloaded from a ship to the port for the sole purpose of loading it on another ship.
Amendment 682 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Directive 2003/87/EC
Article 3 – paragraph 1 – point z e (new)
Article 3 – paragraph 1 – point z e (new)
(z e) "Non-EU neighbouring countries" means all non-EU countries connected by the same sea basin to an EU Member State or adjacent to an EU Member State.
Amendment 700 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Directive 2003/87/EC
Article 3g – paragraph 1 a (new)
Article 3g – paragraph 1 a (new)
1a. In order to prevent carbon leakage due to the relocation of transhipment operations from EU-ports to transhipment ports in non-EU neighbouring countries, the following rules shall apply: - In the case of voyages with departure in an EU Member State and arrival in a non-EU country or with departure in a non-EU country and arrival in an EU Member State, with a stop in a non-EU transhipment port, the allocation of allowances and surrender requirements shall apply in respect of one hundred percent (100 %) of emission for the segment of the voyage between the EU Member State and the non-EU transhipment port, and fifty percent (50%) for the rest of the voyage; - In the case of voyages with origin in an EU Member State and arriving in another EU Member State, with a stop in a non- EU transhipment port, the allocation of allowances and surrender requirements shall apply in respect of one hundred percent (100 %) of emissions for the whole voyage.
Amendment 747 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Directive 2003/87/EC
Article 3ga a (new)
Article 3ga a (new)
Article 3gaa Gradual phase-in for the maritime transport at risk of carbon leakage In order to avoid carbon leakage and traffic routes distortion to non-EU neighbouring for ships engaged in deep- sea routes performing at least 30 % of transhipment operations in a call in an EU port, shipping companies shall be liable to surrender allowances according to the following schedule: (a) 15 % of verified emissions reported for 2023; (b) 28 % of verified emissions reported for 2024; (c), 40 % of verified emissions reported for 2025; (d), 52 % of verified emissions reported for 2026; (e), 64 % of verified emissions reported for 2027; (e), 76 % of verified emissions reported for 2028; (e), 88 % of verified emissions reported for 2029; (f) 100 % of verified emissions reported for 2030 and each year thereafter. To the extent that fewer allowances are surrendered compared to the verified emissions from maritime transport for the years between 2023 and 2030, and once the difference between verified emissions and allowances surrendered has been established in respect of each year, a corresponding quantity of allowances shall be cancelled rather than auctioned pursuant to Article 10.
Amendment 803 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive 2003/87/EC
Article 9 – paragraph 3
Article 9 – paragraph 3
In [the year following entry into force of this amendment], the Union-wide quantity of allowances shall be decreased by [-- million allowances (to be determined depending on year of entry into force)]. In the same year, the Union-wide quantity of allowances shall be increased by 79 million allowances for maritime transport. Starting in [the year following entry into force of this amendment], the linear factor shall be 4,25,09 %. The Commission shall publish the Union-wide quantity of allowances within 3 months of [date of entry into force of the amendment to be inserted].;
Amendment 928 #
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 2a
Article 10a – paragraph 1 – subparagraph 2a
Amendment 966 #
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 1020 #
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 1035 #
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 1105 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point c – point ii
Article 1 – paragraph 1 – point 12 – point c – point ii
(d) Where the annual reduction rate exceeds 2,51,6 % or is below 0,2 %, the benchmark values for the period from 2026 to 2030 shall be the benchmark values applicable in the period from 2013 to 2020 reduced by whichever of those two percentage rates is relevant, in respect of each year between 2008 and 2028.;
Amendment 1145 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point e
Article 1 – paragraph 1 – point 12 – point e
Directive 2003/87/EC
Article 10a - paragraph 6 - subparagraph 1
Article 10a - paragraph 6 - subparagraph 1
Member States shouldall adopt financial measures in accordance with the second and fourth subparagraphs in favour of sectors or subsectors which are exposed to a genuine risk of carbon leakage due to significant indirect costs that are actually incurred from greenhouse gas emission costs passed on in electricity prices, provided that such financial measures are in accordance with State aid rules, and in particular do not cause undue distortions of competition in the internal market. The financial measures adopted should not compensate indirect costs covered by free allocation in accordance with the benchmarks established pursuant to paragraph 1. Where a Member State spends an amount higher than the equivalent of 25 % of their auction revenues of the year in which the indirect costs were incurred, it shall set out the reasons for exceeding that amount.;
Amendment 1192 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point g
Article 1 – paragraph 1 – point 12 – point g
Directive 2003(87/EC
Article 10a – paragraph 8 – subparagraph 3
Article 10a – paragraph 8 – subparagraph 3
The Innovation Fund shall cover the sectors listed in Annex I and Annex III, including environmentally safe carbon capture and utilisation (“CCU”) that contributes substantially to mitigating climate change, as well as products substituting carbon intensive ones produced in sectors listed in Annex I, and to help stimulate the construction and operation of projects aimed at the environmentally safe capture and geological storage (“CCS”) of CO2, as well as of innovative renewable energy and, energy storage and carbon removal technologies; in geographically balanced locations. The Innovation Fund may also support break- through innovative technologies and infrastructure to decarbonise the maritime sector and for the production of low- and zero-carbon fuels in aviation, rail and road transport. Special attention shall be given to projects in sectors covered by the [CBAM regulation] to support innovation in low carbon technologies, CCU, CCS, renewable energy and energy storage, in a way that contributes to mitigating climate change.
Amendment 1390 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19 b (new)
Article 1 – paragraph 1 – point 19 b (new)
Directive 2003/87/EC
Article 29 a
Article 29 a
(19b) Article 29a is replaced by the following: "Article 29a Measures in the event of excessive price fluctuations 1. If, for more than sixtwo consecutive months, the allowance average price is more than three1,5 times the average price of allowances during the two preceding years on the European carbon market, the Commission shall immediately convene a meeting of the Committee established by Art or if the allowance pricle 9 of Decision No 280/2004/EC. 2. paragraph 1 does not correspond to changing market fundamentals, one of the following measures may be adopted, taking into account the degree of price evolution: (a) States to bring forward the auctioning of a part of the quantity to be auctioned; (b) States to auction up to 25 % of the remaining allowances in the new entrants reserve. Those measures shall be adopted in accordance with the management procedure referredincreases more than 15 % in a period of less than 12 months, 100 million allowances shall be released from the reserve and added to the volume of allowances to be auctioned by the Member States, pursuant to in Article 23(4). 3. Any measure shall take utmost account of the reports submitted by the Commission to the European Parliament and to the Council pursuant to Article 29, as well as any other relevant information provided by Member States. 4. application of these provisions shall be laid down in the acts referred to in Article 10(4). (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02003L0087-20210101)1(7) of Decision (EU) 2015/1814. If the price evolution referred to in a measure which allows Member a measure which allows Member The arrangements for the Or. en
Amendment 1411 #
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 1665 #
2021/0211(COD)
Proposal for a directive
Annex I – paragraph 1 – point c – point vii
Annex I – paragraph 1 – point c – point vii
Directive 2003/87/EC
Annex I – table – last row
Annex I – table – last row
“Maritime transport Greenhouse gases covered by Regulation (EU) 2015/757”; Maritime transport activities of ships covered by Regulation (EU) 2015/757 of the European Parliament and of the Council performing voyages with the purpose of transporting passengers or cargo for commercial purposes This activity shall not include: (a) Voyages performed in the framework of a public service contract or subject to public service obligations in accordance with Regulation (EEC) No 3577/92; (b) Voyages to and/or from the outermost regions of the EU; (c) Voyages performed by a ship with total annual emissions lower than 10 000 tonnes per year; (d) Humanitarian voyages; (e) Search and rescue voyages or parts of normal voyages by ships where search and rescue activities had to be carried out; (f) Force majeure for all or part of the voyage; (g) Ships for civil protection and rescue.
Amendment 1676 #
2021/0211(COD)
Proposal for a directive
Annex I – point 2
Annex I – point 2
Directive 2003/87/EC
Annex III
Annex III
Amendment 1679 #
2021/0211(COD)
Proposal for a directive
Annex I – point 2Directive 2003/87/EC
Annex I – point 2Directive 2003/87/EC
Annex III
Amendment 1684 #
2021/0211(COD)
Proposal for a directive
Annex I – point 2
Annex I – point 2
Directive 2003/87/EC
Annex III a
Annex III a
Amendment 1703 #
2021/0211(COD)
Proposal for a directive
Annex I – point 4
Annex I – point 4
Directive 2002/87/EC
Annex IV – Part C
Annex IV – Part C
Amendment 139 #
2021/0207(COD)
Proposal for a directive
Recital 22 a (new)
Recital 22 a (new)
(22a) The application of the emission trading system to intra-EU flights could lead to distortions of competition between intra-EU and international flights. The Commission should continuously monitor and assess these distortions following the implementation of this Directive and report to the European Parliament and the Council on the potential risk of carbon leakage. For its assessment, the Commission will take into account the third countries implementing CORSIA, the different regulatory measures, the prices of allowances for airlines, the geographical situation of EU airports and their vulnerability to unfair competition from third countries, the increase in flight prices and the impact on EU tourism destinations. In view of the overall competitiveness of the EU aviation sector, the Commission shall consider the revision of this Directive to level the playing field vis-a-vis third countries, including through the extension of the emission trading system to flights from and to airports located in third countries.
Amendment 187 #
2021/0207(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2003/87/EC
Article 3 c – paragraph 7
Article 3 c – paragraph 7
7. By way of derogation from Articles 12(2a), 14(3) and Article 16, Member States shall consider the requirements set out in those provisions to be satisfied and shall take no action against aircraft operators in respect of emissions taking place until 2030 from flights between an aerodrome located in an outermost region of a Member State and an aerodrome located in the same Member StateEEA outside that outermost region, in Switzerland or in the United Kingdom.;
Amendment 191 #
2021/0207(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 d – paragraph 1
Article 3 d – paragraph 1
1. In 2024, 215% of the quantity of allowances in respect of which free allocation would have taken place as published in accordance with Article 3c shall be auctioned.’,
Amendment 201 #
2021/0207(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive 2003/87/EC
Article 3 d – paragraph 1 a
Article 3 d – paragraph 1 a
1a. InFrom 2025 to 2029, 50% of the quantity of allowances in respect of which free allocation would have taken place in that year, calculated from the publication in accordance with Article 3c shall be auctioned.
Amendment 204 #
2021/0207(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive 2033/87/EC
Article 3 d – paragraph 1 b
Article 3 d – paragraph 1 b
Amendment 212 #
2021/0207(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive 2003/87/EC
Article 3 d – paragraph 1 c
Article 3 d – paragraph 1 c
1c. As from 1 January 202730, all of the quantity of allowances in respect of which free allocation would have taken place in that year shall be auctioned. ’,
Amendment 317 #
2021/0207(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive 2003/87/EC
Article 25 a – paragraph 7 – subparagraph 1 a (new)
Article 25 a – paragraph 7 – subparagraph 1 a (new)
The Commission shall continuously monitor and assess the distortions of competition and report to the European Parliament and the Council. The Commission will take into account the list of countries applying CORSIA, the different regulatory measures, the prices of allowances for aircraft operators, the geographical situation of EU airports and their vulnerability to unfair competition from third countries, the increase in flight prices and the impact on EU tourism destinations. In view of the overall competitiveness of the EU aviation sector and the risk of carbon leakage, the Commission shall consider a revision of this Directive to level the playing field vis a vis third countries, including through the extension of the emission trading system to flights from and to airports located in third countries.
Amendment 47 #
2021/0202(COD)
Proposal for a decision
Recital 13
Recital 13
(13) The review paid particular attention to the percentage figure for the determination of the number of allowances to be placed in the reserve, as well as to the numerical value of the threshold for the total number of allowances in circulation and the number of allowances to be released from the reserveAccording to the Commission’s latest report on the market stability reserve, by 2022, operation of the reserve will cause there to be more allowances in the reserve than are circulating in the market.
Amendment 49 #
2021/0202(COD)
Proposal for a decision
Recital 14
Recital 14
(14) The analysis carried out in the context of the reserve’s review and the expected developments relevant to the carbon market demonstrate that a rate of 12 % of the total number of allowances in circulation to be placed in the reserve each year after 2023 is insufficient to prevent a significant increase of the surplus of allowances in the EU ETS. Therefore, after 2023 the percentage figure should continue to be 24 %, and the minimum number of allowances to be placed in In 2019, before the pandemic, the price of emission allowances stood at around EUR 25 per tonne. During 2021, these prices leapt from around EUR 30 to well over EUR 80. This trend does not appear to reflect a surplus of allowances, quite the contrary. These prices are severely harming the EU’s industrial fabric, which is also having to cope withe reserve should also continue to be 200 millionising international natural gas prices.
Amendment 65 #
2021/0202(COD)
Proposal for a decision
Recital 15
Recital 15
(15) If the rate of the total number of allowances in circulation to be placed in the reserve each year reverts to 12 % after 2023, a potentially harmful surplus of allowances in the EU ETS may disturbshare of the allowances in the reserve can contribute to greater market stability. In addition, theA rate of 24 % after 2023 shcould be established separately from the general, taking into account the results of the review of Directive 2003/87/EC and Decision (EU) 2015/1814 to strengthen the EU Emissions Trading System in line with the Union’s increased climate ambition for 2030 to ensure market predictability.
Amendment 79 #
2021/0202(COD)
Proposal for a decision
Article 1 – paragraph 1
Article 1 – paragraph 1
Decision (EU) 2015/1814
Article 1 – paragraph 5 – subparagraph 1
Article 1 – paragraph 5 – subparagraph 1
In Article 1(5), first subparagraph, of Decision (EU) 2015/1814, the last sentence is replaced by the following: ‘By way of derogation from the first and second sentences, 3 of Regulation (EU) 2015/1814, the following is added: ‘Six months after the adoption of the revision to Directive 2003/87/EC, the Commission may propose a revision of this Decision to amend the rates set out in the first subparagraph of Article 1(5). To that end, the Commission shall analyse the expected functil 31 December 2030, the percentages and thoning of the European carbon market and a projection of the functioning of the reserve based on the new parameters for Directive 1200 mill3/87/EC. The Commission shallowances analyse the refserred to in those sentve’s effects on growth, employment, the Union’s industrial competitivences shall be doubleds and the risk of carbon leakage, including a new carbon border adjustment mechanism.’
Amendment 133 #
2021/0201(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to contribute to the increased ambition to reduce greenhouse gas net emissions from at least 40 % to at least 55 % below 1990 levels, binding annual targets for net greenhouse gas removals should be set out for each Member Statethe Union in the land use, land use change and forestry sector in the period from 2026 to 2030 (in analogy to the annual emission allocations set out in Regulation (EU) 2018/842 of the European Parliament and of the Council32 ), resulting in a target of 310 millions of tonnes CO2 equivalent of net removals for the Union as a whole in 2030. The methodology used to establish the national targets for 2030 should take into account the average greenhouse gas emissions and removals from the years 20168, 20179 and 201820, reported by each Member State, and reflect the current mitigation performance of the land use, land use change and forestry sector, and each Member State’s share of the managed land area in the Union, taking into account the capacity of that Member State to improve its performance in the sector via land management practices or changes in land use that benefit the climate and biodiversity. No Member State should have a target in 2030 that is less ambitious than the baseline net removals representing the no - debit principle. __________________ 32Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26).
Amendment 189 #
2021/0201(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The land sector has the potential to become rapidly climate-neutral by 2035 in a cost-effective manner, and subsequently generate more greenhouse gas removals than emissions. A collective commitment aiming to achieve climate-neutrality in the land sector in 2035 at EU level can provide the needed planning certainty to drive land- based mitigation action in the short term, considering that it can take many years for such action to deliver the desired mitigation outcomes. Moreover, the land sector is projected to become the largest sector in the EU greenhouse gas flux profile in 2050. It is therefore particularly important to anchor that sector to a trajectory that can effectively deliver net zero greenhouse gas emissions by 2050. By mid-2024, the Member States should submit their updated integrated national energy and climate plans in accordance with Article 14 of Regulation (EU) 2018/1999 of the European Parliament and of the Council34 . The plans should include relevant measures by which each Member State best contributes to the collective target of climate neutrality in the land sector at EU level in 2035. On the basis of these plans, the Commission should propose national targets, ensuring that the Union-wide greenhouse gas emissions and removals in the land use, land use change and forestry sector and the emissions from the agriculture non-CO2 sectors are at least balanced by 2035. Contrary to the EU level target of climate neutrality for the land sector by 2035, such national targets will be binding and enforceable on each Member State. __________________ 34Regulation (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, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p.1).
Amendment 265 #
2021/0201(COD)
Proposal for a regulation
Recital 13
Recital 13
Amendment 390 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/841
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
2. The 2030 Union target for net greenhouse gas removals is 310 million tonnes CO2 equivalent as a sum of the Member States targets established in accordance with paragraph 3 of this Article, and shall be based on the average of its greenhouse gas inventory data for the years 20168, 20179 and 201820. The proposed national targets may not be less ambitious than the baseline net removals representing the no debit principle.
Amendment 404 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/841
Article 4 – paragraph 2 – subparagraph 2
Article 4 – paragraph 2 – subparagraph 2
Each Member State shall ensure that, taking into account the flexibilities provided for in Articles 12 and, 13, 13aa and 13b, the annual sum of its greenhouse gas emissions and removals on its territory and in all of the land reporting categories referred to in Article 2(2), points (a) to (j), in each year in the period from 2026 to 2030 does not exceed the limit established by a linear trajectory, ending in 2030 on the target set out for that Member State in Annex IIa. The linear trajectory of a Member State shall start in 2022.
Amendment 517 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point b
Article 1 – paragraph 1 – point 9 – point b
Regulation (EU) 2018/841
Article 11 – paragraph 1 – subparagraph 2 a (new)
Article 11 – paragraph 1 – subparagraph 2 a (new)
Spain may, besides the flexibilities referred to in the first subparagraph, points (a) and (b), use additional compensations pursuant to Article 13aa.
Amendment 524 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10 – point a
Article 1 – paragraph 1 – point 10 – point a
Regulation (EU) 2018/841
Article 11 – paragraph 3
Article 11 – paragraph 3
Amendment 546 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EU) 2018/841
Article 13 – paragraph 3
Article 13 – paragraph 3
3. The compensation referred to in paragraph 2 may only cover sinks accounted for as emissions against the forest reference level of that Member State and may not exceed 250 % of the maximum amount of compensation for the Member State concerned set out in Annex VII for the period from 2021 to 2025.
Amendment 562 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 12 a (new)
Article 1 – paragraph 1 – point 12 a (new)
Regulation (EU) 2018/841
Article 13 a a (new)
Article 13 a a (new)
Amendment 573 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Regulation (EU) 2018/841
Article 13 b – paragraph 1
Article 13 b – paragraph 1
1. A land use flexibility mechanism corresponding to a quantity of up to 178267 million tonnes of CO2 equivalent shall be established in the Union Registry established pursuant to Article 40 of Regulation (EU) No 2018/1999, subject to the fulfilment of the Union target referred to in Article 4(2). The flexibility mechanism shall be available in addition to the flexibilities provided for in Article 12.
Amendment 603 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Regulation (EU) 2018/841
Article 13 b – paragraph 4
Article 13 b – paragraph 4
4. The amount of the compensation referred to in paragraph 3 of this Article may only cover sinks accounted for as emissions against the target of the Member State in Annex IIa of this Regulation and may not exceed 750 % of the maximum amount of compensation for the Member State concerned set out in Annex VII for the period from 2026 to 2030.
Amendment 608 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EU) 2018/841
Article 13 c
Article 13 c
Amendment 287 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point b – point ii
Article 1 – paragraph 1 – point 5 – point b – point ii
Regulation (EU) 2018/842
Article 7 – paragraph 1 – point (a)
Article 7 – paragraph 1 – point (a)
Amendment 66 #
2021/0197(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The European Green Deal combines a comprehensive set of mutually reinforcing measures and initiatives aimed at achieving climate neutrality in the EU by 2050, and sets out a new growth strategy that aims to transform the Union into a fair and prosperous society, with a modern, resource-efficient and competitive economy, where economic growth is decoupled from resource us and vibrant industries that remain world-leaders in their respective segment and global innovation drivers while securing high-paid quality jobs in Europe. It also aims to protect, conserve and enhance the Union's natural capital, and protect the health and well-being of citizens from environment-related risks and impacts. At the same time, this transition affects women and men differently and has a particular impact on some disadvantaged groups, such as older people, persons with disabilities and persons with a minority racial or ethnic background. It must thereforeIt must be ensured that the transition is just and inclusive, leaving no one behind.
Amendment 77 #
2021/0197(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) All sectors of the economy are expected to contribute to achieving those net greenhouse gas emission reductions, including the road transport sector and fuel suppliers.
Amendment 84 #
2021/0197(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In line with Regulation (EU) 2019/631 the emissions of the entire life cycle of vehicles should be taken into account in order to ensure that emissions are reduced in the most effective manner. Given the strengthened target for 2030, it is important to ensure that a methodology of full life-cycle CO2 emissions for vehicles follows suit. It is therefore necessary that the Commission develop no later than December 31, 2023, an harmonized methodology to report the carbon footprint of the life-cycle of vehicles in order to consider the global impact of passenger cars and light commercial vehicles on the environment. This regulation should be reviewed in 2028 to incorporate this harmonized methodology of an extended carbon accounting as new indicator for further reduction targets beyond 2030.
Amendment 91 #
2021/0197(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In order to achieve a reduction in net greenhouse gas emissions of at least 55 % by 2030 compared to 1990, it is necessary to strengthen the reduction requirements set out in Regulation (EU) 2019/631 of the European Parliament and of the Council25 for both passenger cars and light commercial vehicles. A clear pathway also needs to be set for further reductions beyond 2030 to contribute to achieving the climate neutrality objective by 2050. Without ambitious action on greenhouse gas emission reductions in road transport, higher emission reductions would be needed in other sectors, including sectors where decarbonisation is more challenging. _________________ 25Regulation (EU) 2019/631 of the European Parliament and of the Council of 17 April 2019 setting CO2 emission performance standards for new passenger cars and for new light commercial vehicles, and repealing Regulations (EC) No 443/2009 and (EU) No 510/2011 (OJ L 111, 25.4.2019, p. 13).
Amendment 100 #
2021/0197(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The strengthened CO2 emission reduction requirements should incentivise an increasing share of net zero-emission vehicles and fuels being deployed on the Union market whilst providing benefits to consumers and citizens in terms of air quality and energy savings, as well as ensuring that innovation and employment levels in the automotive value chain can be maintained in Europe and that mobility remains accessible and affordable for everyone. Within the global context, also the EU automotive chain must be a leading actor in the on- going transition towards net zero-greenhouse gas emission mobility and fuel solutions. The strengthened CO2 emission reduction standards armust be technology neutral in reaching the fleet- wide targets that they set. Different technologies are and remain available to reach the zero-emission fleet wide targets. ZLow and zero-emission vehicles currently include battery electric vehicles, fuel-cell and other hydrogen powered vehicles, depending on their respective full lifecycle emissions and technological innovations are continuing. Zero and low-emission vehicles, which also include well performing plug-in hybrid electric vehicles, and vehicles powered by alternative fuel which can continue to play a role in the transition pathway.
Amendment 118 #
2021/0197(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Against that background, a new strengthened CO2 emission reduction targets should be set for both new passenger cars and new light commercial vehicles for the period 2030 onwards2030. Thoseis targets should be set at a level that will deliver a strong signal to accelerate the uptake of zero-emission vehicles on the Union market and to stimulate innovation in zero-emission technologies in a cost- efficient way.
Amendment 128 #
2021/0197(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The targets in the revised CO2 performance standards should be accompanied by a European strategy to address the challenges posed by the scale- up of the manufacturing of low- and zero- emission vehicles and associated technologies and fuels, as well as the need for up- and re-skilling of workers in the sector and the economic diversification and reconversion of activities while maintaining automotive employment levels in Europe. Where appropriate, financial support should be considered at the level of the EU and Member States to crowd in private investment, including via the European Social Fund Plus, the Just Transition Fund, the Innovation Fund, the Recovery and Resilience Facility and other instruments of the Multiannual Financial Framework and the Next Generation EU, in line with State aid rules. The revised environmental and energy state aid rules will enable Member States to support business to decarbonize their production processes and adopt greener technologies in the context of the New Industrial Strategy.
Amendment 147 #
2021/0197(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The updated New Industrial Strategy26 foresees the co-creation of green and digital transition pathways in partnership with industry, public authorities, social partners and other stakeholders. In this context, a transition pathway should be developed for the mobility ecosystem to accompany the transition of the automotive value chain. The pathway should take particular heed of SMEs in the automotive supply chain, of the consultation of social partners including by Member States, and also build on the European Skills Agenda with initiatives like the Pact for Skills to mobilise the private sector and other stakeholders to up-skill and re-skill Europe’s workforce in view of the green and digital transitions. The appropriate actions and incentives at European and national level to boost the affordability of low- and zero emission vehicles should also be addressed in the pathway. The progress made on this comprehensive transition pathway for the mobility ecosystem should be monitored every two years as part of a progress report to be submitted by the Commission, looking inter alia at the progress in the deployment of low- and zero- emission vehicles, their price developments, deployment of alternative fuels development and infrastructure roll- out as required under the Alternative Fuels Infrastructure Regulation, the potential of innovative technologies to reach climate neutral mobility, international competitiveness, investments in the automotive value chain, up-skilling and re- skilling of workers and reconversion of activities. The progress report will also build on the two-yearly progress reports that Member States submit under the Alternative Fuels Infrastructure Regulation. The Commission should consult social partners in the preparation of the progress report, including the results in the social dialogue. Innovations in the automotive supply chain are continuing. Innovative technologies such as the production of electro-fuels with air capture, if further developed, could offer prospects for affordable climate neutral mobility. The Commission should therefore keep track of progress in the state of innovation in the sector as part of its progress report. _________________ 26 Commission Communication - Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery, COM(2021) 350 final of 5 May 2021
Amendment 159 #
2021/0197(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Those EU fleet-wide targets are toshould be complemented by the necessary roll-out of recharging and refuelling infrastructure as set out in. For this reason, considering the weak and slow implementation of Directive 2014/94/EU of the European Parliament and of the Council27 . _________________ 27Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on, this proposal should be accompanied by an ambitious proposal for a Regulation on Alternative Fuel Infrastructure, providing for ambitious mandatory targets for the deployment of alternative fuels infrastructure (OJ L 307 28.10.2014, p. 1)throughout the 27 Member States.
Amendment 173 #
2021/0197(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Manufacturers should be provided with sufficient flexibility in adapting their fleets over time in order to manage the transition towards low- and zero-emission vehicles in a cost-efficient manner, and it is therefore appropriat. The progressively more ambitious emission reduction targets as set in Regulation (EU) 2019/631 have increased the costs of compliance for manufacturers. It is therefore of the utmost importance to maintain the approach of decreasing target levels in five-year steps.
Amendment 181 #
2021/0197(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) With the stricter EU fleet-wide targets forom 2030 onwards, manufacturers will have to deploy significantly more zero-emission vehicles on the Union market. In that context, the incentive mechanism for zero- and low-emission vehicles (‘ZLEV’) would no longer serve its original purpose and would risk undermining the effectiveness of Regulation (EU) 2019/631. The ZLEV incentive mechanism should therefore be removed as of 2030. Before that date and therefore throughout this decade, the incentive mechanism for ZLEV will continue to support the deployment of vehicles with emissions from zero up to 50 g CO2/km, including battery electric vehicles, fuel-cell electric vehicles using hydrogen and well performing plug-in hybrid electric vehicles. After that date, plug-in hybrid electric vehicles continue to count against the fleet-wide targets that vehicle manufacturers must meetlow- and zero- emission vehicles on the Union market. The incentive mechanism for ZLEV will continue to support the deployment of vehicles with emissions from zero up to 50 g CO2/km.
Amendment 200 #
2021/0197(COD)
Proposal for a regulation
Recital 18
Recital 18
Amendment 201 #
2021/0197(COD)
Proposal for a regulation
Recital 21
Recital 21
Amendment 213 #
2021/0197(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The progress made under Regulation (EU) 2019/631 towards achieving the reduction objectives set for 2030 and beyond should be reviewed in 20268. For this review, all aspects considered in the two yearly reporting should be considered.
Amendment 214 #
2021/0197(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) The regulations review is an important part of tracking the Union progress towards its climate ambitions while ensuring that concrete reduction targets can be met through an harmonized methodology for reporting on the life-cycle of vehicles, and taking into account industrial and social consequences of the defined targets.
Amendment 235 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point -a (new)
Article 1 – paragraph 1 – point 1 – point -a (new)
Regulation (EU) 2019/631
Article 1 – paragraph 4 – point a
Article 1 – paragraph 4 – point a
(-a) in paragraph 4 point (a) is replaced by the following: "(a) for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021determined in accordance with point 6.1.1 of Part A of Annex I; as set in Regulation (EU) 2019/631;" Or. en (Regulation 2019/631 https://eur-lex.europa.eu/legal- content/EN/TXT/?uri=celex%3A32019R0631)
Amendment 240 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point -a a (new)
Article 1 – paragraph 1 – point 1 – point -a a (new)
Regulation (EU) 2019/631
Article 1 – paragraph 4 – point (b)
Article 1 – paragraph 4 – point (b)
(-aa) paragraph 4 point (b) is replaced by the following "(b) for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021 determined in accordance with point 6.1.1 of Part B of Annex I. as set in Regulation (EU) 2019/631." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32019R0631)
Amendment 242 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point -a b (new)
Article 1 – paragraph 1 – point 1 – point -a b (new)
Regulation (EU) 2019/631
Article 1 – paragraph 4 – point b
Article 1 – paragraph 4 – point b
(-ab) paragraph 4 point (b) is replaced by the following "(b) for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021 determined in accordance with point 6.1.1 of Part B of Annex I. as set in Regulation (EU) 2019/631." Or. en (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32019R0631)
Amendment 257 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point a – point i
Article 1 – paragraph 1 – point 1 – point a – point i
Regulation (EU) 2019/631
Article 1 – paragraph 5 – point a
Article 1 – paragraph 5 – point a
(i) in point (a), the figure “37,5 %” is replaced by ‘545 %’,
Amendment 263 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point a – point ii
Article 1 – paragraph 1 – point 1 – point a – point ii
Regulation (EU) 2019/631
Article 1 – paragraph 5 – point b
Article 1 – paragraph 5 – point b
(ii) in point (b), the figure “31 %” is replaced by ‘540 %’,
Amendment 272 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Regulation (EU) 2019/631
Article 1 – paragraph 5 a (new)
Article 1 – paragraph 5 a (new)
Amendment 290 #
2021/0197(COD)
Amendment 322 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 – introductory part
Article 1 – paragraph 1 – point 4 – introductory part
Regulation (EU) 2019/631
Article 4
Article 4
(4) in Article 4(1), the following subparagraph is added, is amended as follows:
Amendment 323 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation 2019/631
Article 4 – paragraph 1 – subparagraph 2
Article 4 – paragraph 1 – subparagraph 2
Amendment 325 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation 2019/631
Article 4 – paragraph 1– subparagraph 2
Article 4 – paragraph 1– subparagraph 2
‘For the purposes of point (c),where the specific emission target determined in accordance with Part A, point 6.3., of Annex I or Part B, point 6.3., of Annex I is negative, the specific emission target shall be 0 g/km.’;
Amendment 332 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EU) 2019/631
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
(4a) in Article 4 the following paragraph is added: ‘3a. Manufacturers, other than manufacturers which have been granted a derogation, may form a pool or may trade credits for the purposes of meeting their obligations. For the purposes of determining each manufacturer’s average specific emissions of CO2,a potential over-achievement of a manufacturer’s CO2 target in one category (M1or N1) could be combined with an exceedance in the other category (M1 or N1) by the same or another manufacturer. Due to the different target definitions of M1 & N1, this specific credit transfer mechanism option can only combine the difference between a manufacturer’s specific emission target and its specific emissions in one category (M1 or N1) with the difference between a manufacturer’s specific emission target and its specific emissions in the other category (M1 or N1).When the credit trading in one category allows to compensate the exceedance of the other category, the combination shall be considered to have met the two specific emissions targets. For fleet compliance, the maximum amount of grammes that can be traded between M1 and N1 segments of the same or a different manufacturer is capped to 7g WLTP.’
Amendment 341 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EU) 2019/631
Article 6 – paragraph 6
Article 6 – paragraph 6
Amendment 355 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2019/631
Article 10 – paragraph 2
Article 10 – paragraph 2
Amendment 373 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 a (new)
Article 1 – paragraph 1 – point 6 a (new)
Regulation (EU) 2019/631
Article 11a (new)
Article 11a (new)
Amendment 378 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 a (new)
Article 1 – paragraph 1 – point 6 a (new)
Regulation (EU) 2019/631
Article 12 – paragraph 3a (new)
Article 12 – paragraph 3a (new)
(6a) In Article 12, the following paragraph is inserted: ‘3a. ‘The Commission shall draw up, no later than 31 December 2023, a common Union methodology for the assessment and the consistent data reporting of the full life-cycle CO2 emissions of fuels and energy consumed by vehicles on the EU market.’
Amendment 394 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2019/631
Article 14a – paragraph 1
Article 14a – paragraph 1
By 31 December 2025, and every two years thereafter, the Commission shall report on the progress towards zero emission road mobility. The report shall in particular monitor and assess the need for possible additional measures to facilitate the transition, including through financial means.
Amendment 402 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2019/631
Article 14a – paragraph 2
Article 14a – paragraph 2
In the reporting, the Commission shall consider all factors that contribute to a cost-efficient progress towards climate neutrality by 2050. This includes the deployment of zero- and low-emission vehicles, to be analysed not under a purely tailpipe-emissions-based measurement, but under a holistic life- cycle analysis-based approach to emissions, taking into account also the green-house gas intensity at mineral extraction, production and end-of-life stages, allowing inter alia for the accounting of green steel and recycled materials, as well as the energy mix in the respective Member State of circulation, progress in achieving the targets for the roll-out of recharging and refuelling infrastructure as required under the Alternative Fuels Infrastructure Regulation, the potential contribution of innovation technologies and sustainable alternative fuels to reach climate neutral mobility, impact on consumers, progress in social dialogue as well as aspects to further facilitate an economically viable and socially fair transition towards zero emission road mobility.;
Amendment 426 #
2021/0197(COD)
The report shall, where appropriate, be accompanied by a proposal for amending this Regulation and identifying a clear pathway for further CO2 emissions reductions by introducing EU fleet-wide targets for new passenger cars fleet and for new light commercial vehicles fleet from 1 January 2035 and from 1 January 2040, based on a LCA methodology developed by the European Commission no later than 31 December 2023.
Amendment 430 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10 – point a a (new)
Article 1 – paragraph 1 – point 10 – point a a (new)
Regulation (EU) 2019/631
Article 15 – paragraph 2
Article 15 – paragraph 2
Amendment 440 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10 – point b
Article 1 – paragraph 1 – point 10 – point b
Regulation (EU) 2019/631
Article 15 – paragraphs 3 and 5
Article 15 – paragraphs 3 and 5
(b) paragraphs 23 to 5 are deleted,
Amendment 457 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point a
Annex I – paragraph 1 – point 1 – point a
Regulation (EU) 2019/631
Annex I – Part A – point 6.1
Annex I – Part A – point 6.1
EU fleet-wide targets for 2025 onwards’and 2030,
Amendment 466 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point b
Annex I – paragraph 1 – point 1 – point b
Regulation (EU) 2019/631
Annex I – Part A – point 6.1.2
Annex I – Part A – point 6.1.2
Amendment 480 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point c
Annex I – paragraph 1 – point 1 – point c
Regulation (EU) 2019/631
Annex I – Part A – point 6.1.3
Annex I – Part A – point 6.1.3
Amendment 505 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation (EU) 2019/631
Annex 1 – Part A – point 6.3.1
Annex 1 – Part A – point 6.3.1
6.3.1 Specific emissions targets for 2025 to 2029onwards:
Amendment 528 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation 2019/631
Annex I – Part A – Point 6.3.2.
Annex I – Part A – Point 6.3.2.
6.3.2 Specific emissions targets for 2030 to 2034onwards
Amendment 546 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation (EU) 2019/631
Annex I – Part A – point 6.3.3
Annex I – Part A – point 6.3.3
Amendment 557 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point a
Annex I – paragraph 1 – point 2 – point a
Regulation (EU) 2019/631
Annex I – Part B – point 6.1
Annex I – Part B – point 6.1
The EU fleet-wide targets for 2025 onwardsand 2030
Amendment 564 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point b
Annex I – paragraph 1 – point 2 – point b
Regulation (EU) 2019/631
Annex I – Part B – point 6.1.2
Annex I – Part B – point 6.1.2
Amendment 572 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point c
Annex I – paragraph 1 – point 2 – point c
Regulation (EU) 2019/631
Annex I – Part B – point 6.1.3
Annex I – Part B – point 6.1.3
Amendment 589 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point d
Annex I – paragraph 1 – point 2 – point d
Regulation (EU) 2019/631
Annex I – Part B – point 6.2.2
Annex I – Part B – point 6.2.2
Amendment 599 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point e
Annex I – paragraph 1 – point 2 – point e
Regulation (EU) 2019/631
Annex I – Part B – point 6.2.3
Annex I – Part B – point 6.2.3
Amendment 615 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point e a (new)
Annex I – paragraph 1 – point 2 – point e a (new)
Regulation (EU) 2019/631
Annex I – Part B – point 6.3.1
Annex I – Part B – point 6.3.1
Amendment 622 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point f
Annex I – paragraph 1 – point 2 – point f
Regulation (EU) 2019/631
Annex I – Part B – point 6.3.2
Annex I – Part B – point 6.3.2
6.3.2. Specific emissions targets for 2030 to 2034onwards
Amendment 629 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point f
Annex I – paragraph 1 – point 2 – point f
Regulation (EU) 2019/631
Annex I – Part B – point 6.3.2
Annex I – Part B – point 6.3.2
Specific emissions target = (specific emissions reference target – (øtargets - EU fleet-wide target2030)correction) ZLEV factor
Amendment 638 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point f
Annex I – paragraph 1 – point 2 – point f
Regulation (EU) 2019/631
Annex I – Part B – point 6.3.2
Annex I – Part B – point 6.3.2
EU fleet-wide target2030correction = (øtarget – EU fleet-widetarget2021) · (1- reduction factor2030) øtargets is the average, weighted on the number of new light commercial vehicles of each individual manufacturer, of all the specific emissions reference targets determined in accordance with point 6.2.2; 1, by 31 October 2024 and every second year thereafter, the figures Øtarget for new light commercial vehicles in the preceding two calendar years starting with 2022 and 2023.The new respective Øtarget shall apply from 1 January of the calendar year following the date of the adjustment; ZLEV factor is (1 + y – x),unless this sum is larger than 1,05 or lower than 1,0 in which case the ZLEVfactor shall be set to 1,05 or 1,0, as the case may be; where: y is the share of zero- and low-emission vehicles in the manufacturer's fleet of new passenger cars calculated as the total number of new zero- and low-emission vehicles, where each of them is counted as ZLEVspecific in accordance with the following formula, divided by the total number of new passenger cars registered in the relevant calendar year: ZLEVspecific = 1 – (specific emissions of CO2 / 50) x is [x] %’
Amendment 639 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point f
Annex I – paragraph 1 – point 2 – point f
Regulation (EU) 2019/631
Annex I – Part B – point 6.3.2
Annex I – Part B – point 6.3.2
Amendment 643 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point g
Annex I – paragraph 1 – point 2 – point g
Regulation (EU) 2019/631
Annex I – Part B – point 6.3.3
Annex I – Part B – point 6.3.3
Amendment 656 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 a (new)
Annex I – paragraph 1 – point 2 a (new)
Regulation (EU) 2019/631
Annex I – Part C (new)
Annex I – Part C (new)
Amendment 5 #
2020/2273(INI)
Motion for a resolution
Citation 17 b (new)
Citation 17 b (new)
- having regard to its report on the European Forest Strategy - The Way Forward1a, _________________ 1a Texts adopted, P9_TA(2020)0257
Amendment 20 #
2020/2273(INI)
Motion for a resolution
Citation 17 a (new)
Citation 17 a (new)
- having regard to its resolution of 15 November 2017 on an Action Plan for nature, people and the economy1a, _________________ 1a Texts adopted, P8_TA(2017)0441
Amendment 37 #
2020/2273(INI)
Motion for a resolution
Citation 10
Citation 10
Amendment 46 #
2020/2273(INI)
Motion for a resolution
Citation 12
Citation 12
Amendment 60 #
2020/2273(INI)
Motion for a resolution
Recital A
Recital A
A. whereas Parliament has declared a climate and environmental emergency and approved an ambitious Climate Law report; whereas biodiversity loss and climate change represent equal threats to life on our planeapproved an ambitious Climate Law report;
Amendment 76 #
2020/2273(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas agriculture supports 9.6 million jobs in Europe, Natura 2000 has been estimated to support 52 000 direct and indirect jobs in conservation management, and 3.1 million (a quarter) of tourism jobs have links to protected areas;1a _________________ 1aIEEP(2017). Natura 2000 and Jobs Scoping Study. Executive summary.
Amendment 80 #
2020/2273(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas the security of supply of food and the production of renewable energy has to be ensured when setting new targets on the Biodiversity Strategy;
Amendment 81 #
2020/2273(INI)
Motion for a resolution
Recital B c (new)
Recital B c (new)
Bc. whereas Europe accounts for more protected areas than any other region of the world and the last decades saw a great increase in both the number of protected areas and the total surface area that has received protected status;1a _________________ 1aEuropean Environment Agency (2012). Protected Areas in Europe – an Overview.
Amendment 143 #
2020/2273(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the new EU Biodiversity Strategy for 2030 and its level of ambition; recognises, however, the need for a realistic and balanced approach in the implementation of the Strategy in which all three dimensions (Society, Environment and Economy) of sustainability are acknowledged;
Amendment 169 #
2020/2273(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Recalls the conclusions of the IPBES report of 2019, according to which nature is declining at a rate unprecedented in human history and around 1 million species are threatened with extinction; strongly regrets that the Union has neither fully met the 2020 biodiversity strategy objectives nor the global Aichi Biodiversity Targets; indicates, that in Europe climate change is the main driver behind biodiversity loss;1a _________________ 1a Dullinger, I., Gattringer, A., Wessely, J., Moser, D., Plutzar, C., Willner, W., Egger, C., Gaube, V., Haberl, H., Mayer, A., Bohner, A., Gilli, C., Pascher, K. Essl, F. & Dullinger, S. 2020: A socio- ecological model for predicting impacts of land-use and climate change on regional plant diversity. Global Change Biology.
Amendment 181 #
2020/2273(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Stresses the need for a well- balanced Biodiversity Strategy taking into account both environmental, economic and health aspects;
Amendment 184 #
2020/2273(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Regrets that while the Union has neither fully met the 2020 biodiversity strategy objectives nor the global Aichi Biodiversity Targets, good progress has been achieved in protecting and sustainably using biodiversity both in marine and terrestrial areas1a; _________________ 1a https://ec.europa.eu/fisheries/press/sustai nable-fisheries-commission-takes-stock- progress-implementation-eus-common- fisheries_en
Amendment 188 #
2020/2273(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Recognises the efforts made until now by the EU Member States and by different sectors and stakeholders, especially in agriculture and forestry; highlights the fact that sustainable and effective management of natural processes is of the utmost importance for maintaining biodiversity, particularly in relation to the negative impact of climate change; acknowledges that the EU already has the largest coordinated network of protected areas in the world;
Amendment 196 #
2020/2273(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that the pandemic has demonstrated the importance of the ‘One Health’ principle in policy-making and that transformative changes in the lifestyle of the whole society are needed; calls for an urgent rethinking of how to align the Union’s current policies with the changes needed; highlights how the pandemic has also demonstrated the importance of a resilient food system to ensure that European citizens have access to safe, affordable and high quality products even under challenging conditions and this should not be taken for granted;
Amendment 226 #
2020/2273(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls on the Commission to carry out holistic and cumulative impact assessments of the implementation of the strategy’s measures and targets on the social and economic sustainability of agriculture and forestry in and outside of the EU, and on food security and prices;
Amendment 233 #
2020/2273(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Expresses strong support for the targets of protecting at least 30 % of the Union’s marineNotes the targets of protecting a maximum of 30 % of the Union’s marine and terrestrial areas; believes that these targets should be set at Union level and should be achieved through a bottom-up approach through Member States’ designations while taking into account the different characteristics of each Member State such as size, share of natural areas and sustainable forest management as well as the national and local circumstances, voluntary approaches and interrestrial areas, and of strictly protecting at least 10 % of these areas, including primary and old-growth forestnationally recognised definitions to ensure consistency of collected data; notes the target of strictly protecting at least 10 % of these areas, including primary forests and other carbon-rich ecosystems and extensive agricultural land; while the references to strictly protected areas and primary forests require further clarification regarding their definitions; stresses that these should be binding and implemented byat Member States’ level in accordance with science-based and site-specific criteria ands well as biodiversity needand climate needs; expresses strong support for these targets to be part of a clear international framework to ensure a level playing field; highlights the need of additional financial support for land owners of protected areas; underlines that in addition to increasing protected areas, the quality of protected areas should be ensured and clear conservation plans implemented and proper compensation for impacted stakeholders provided;
Amendment 270 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Underlines that for the successful conservation of protected areas, including strictly protected areas, decision-making at the site level together with the Member States should be promoted, taking into account regional characteristics within the EU and the international obligations resulting from the post-2020 Global Biodiversity Framework to be agreed at the upcoming 15th Conference of the Parties to the Convention on Biological Diversity;
Amendment 298 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Recalls the European Parliament Resolution of 15 November 2017 on an Action Plan for nature, people and the economy and reiterates its call to the Commission to fully implement the Habitats Directive by developing an assessment procedure to enable the protection status of species in particular regions to be amended as soon as the desired conservation status is reached;
Amendment 310 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 c (new)
Paragraph 4 c (new)
4c. Notes that urban areas accounted for 22.5%of the EU’s total land area in 2014, of which cities represented 4%1a and suburbs and towns 13%, together covering one sixth of the land area, and are expected to grow; calls for a proportional share of at least one sixth of protected areas to be realised in urban areas, as this is not only crucial to contribute to the overall protection targets, but also for improving air quality, providing opportunities for recreation, and increasing overall well-being; _________________ 1aOECD: https://stats.oecd.org/Index.aspx?DataSet Code=BUILT_UP and Eurostat: https://ec.europa.eu/eurostat/statistics- explained/index.php/Territorial_typologie s_manual_-_degree_of_urbanisation
Amendment 322 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 d (new)
Paragraph 4 d (new)
4d. Calls on the Commission to set targets for using renaturation in urban areas as an opportunity;
Amendment 325 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 e (new)
Paragraph 4 e (new)
4e. Calls on the Commission and the Member States, to clarify and harmonise the definitions and terminology, concepts and statistics in use (e.g. intact forests) and to ensure the coherence of the policies and measures adopted;
Amendment 326 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 f (new)
Paragraph 4 f (new)
4f. Emphasises that it is important that the EU and global biodiversity strategies have the same level of ambition, especially when it comes to the level of protection; underlines that the updated zero draft of the post-2020 global biodiversity framework, which takes into account the outcomes of the second meeting of the Open-ended Working Group on the Post-2020 Global Biodiversity Framework, doesn’t include a reference to strict protection; therefore, calls the Commission to ensure that any land protection target is flexible enough to allow implementation to take into account the precise conditions and opportunities of each country and rights of land and forest owners, with strict protection being a voluntary option for land and forest owners;
Amendment 327 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 g (new)
Paragraph 4 g (new)
4g. Emphasises the importance of peatlands, which are the largest (fossil) carbon reservoirs on earth, although they occupy only 3% of the land surface; calls for species' protection and climate reasons, that the protection of peatlands and wetland habitats should be given a particularly high priority;
Amendment 331 #
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 an EU-wide restoration target of at least 30 % of the EU’s land and sdegraded ecosystems, while taking into account the different characteristics of each Member State, such as its size and the percentage of its territory comprising natural areas, which should be implemented by each Member State consistently throughout their territory; considers that in addition to an overall restoration target,objective, other carbon- rich ecosystem- specific targets should be setopportunities for restauration could be considered, 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 allowede need to prioritise positive incentives and voluntary bottom- up participatory process in order to increase the acceptance, motivation and commitment to biodiversity protection and restoration, and thus, calls for a careful approach towards any new legally binding instruments;
Amendment 368 #
2020/2273(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Member States to safeguard the genetic diversity of wild species through in situ and ex situ conservation measures and to apply these measures in an integrated manner, following the One Plan Approach;
Amendment 396 #
2020/2273(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Underlines that the Biodiversity Strategy’s actions must adequately tackle all five main direct drivers of change in nature: in the European Union: climate change and invasive alien species; pollution; changes in land and sea use; and direct exploitation of organisms; climate change; pollunotes that these five drivers stem from a combination of current production; and invasive alien speciconsumption patterns, population dynamics, trade, technological innovations and governance models;1a _________________ 1aIPBES (2020), The global assessment report on Biodiversity and Ecosystem Services;
Amendment 471 #
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 also present an EU-level strategy on desertification and land degradation;
Amendment 478 #
2020/2273(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Calls on Member States to encourage more conservation farming where possible, which reduces soil management practices to a minimum, through the use of innovative technologies such as ‘no-till-drills’, in order to help restore and build soil organic matter, soil moisture, carbon storage in the uppermost soil layers and prevent soil erosion overall;
Amendment 489 #
2020/2273(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission to set specific ambitious targets on urban biodiversity, nature-based solutions and green infrastructure and to develop a Trans-European Network forinclude Green Infrastructure (TEN-G) linked toin the Trans-European Nature Network (TEN-N);
Amendment 495 #
2020/2273(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Underlines the importance of urban green areas and green infrastructures for the physical and mental well-being of the population, especially the most vulnerable groups such as children and the elderly, and for the adequate education of future generations in healthy lifestyles;
Amendment 523 #
2020/2273(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Expresses its support for the 2030 targets of bringing at least 25 % of agricultural land under organic farm management, which should become the norm in the long term, and ensuring thatprovided it is market driven, and ensuring that, through the voluntary approach, at least 10 % of agricultural land consists ofat EU level is under high-diversity landscape features, which should be implemented at farm level, targets which should both be incorporated into EU legislationbiodiversity-benefitting productive features and management practices; considers it imperative that farmers receive financial and other support, and training in the transition towards agroecological practicesmore sustainable practices, and appropriate market remuneration will be set for this way of production;
Amendment 541 #
2020/2273(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Calls on the Commission to propose measures to help Member States tackling the problem of coexistence of livestock farming with large carnivores; recalls the need to have clear guidelines to implement measures that comply with the Directive92/43/EU on Habitats and address the problem of wolf hybridisation;
Amendment 542 #
2020/2273(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Stresses that many Member States already follow as many ecological practices as possible; underlines that it must be taken into account that not all farmers have the possibility to switch to organic farming; mentions that conventional farming can also contribute to increasing biodiversity;
Amendment 566 #
2020/2273(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses that all commercial 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 which should be avoided and reduced, as far as possible;
Amendment 572 #
2020/2273(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Underlines that the achievement of a protection objective through a conservation figure (percentage) has lower importance, than the quality of protection zones that are established, which really cover an area with an ecological value;
Amendment 621 #
2020/2273(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that priority for protected areas must be environmental conservation and restoration and that no activity in these areas should undermine this goal; calls on the Commission to avoid future marine renewable energy developments and bottom-trawlingnon- selective fishing within Marine Protected Areas;
Amendment 626 #
2020/2273(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Underlines the great potential that the Blue Economy can also bring to the conservation and recovery of marine resources, especially for the benefit of communities living in and around marine protected areas, and the leading role that Europe can play in the world in this sector, in accordance with the 2030 Sustainable Development Agenda;
Amendment 648 #
2020/2273(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Underlines thate importance of the new EU Forest Strategy must be fully aligned with the as a holistic strategy on forest related matters, which should be fully aligned and coherent with the targets of the Climate Law and the Biodiversity Strategy; calls for the inclusion in, including the Nature Restoration Plan of specific binding targets for the protection and restoration of forest ecosystems, which should also be incorportake into account the specific situation in the Member Stateds into the Forest Strategy consultation with national authorities;
Amendment 667 #
2020/2273(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Stresses that the Union’s tree planting initiatives should be based on proforestation, sustainable reforestation and the greening of urban areassustainable afforestation, the implementation of agroforestry, climate adapted reforestation and the greening of urban areas, acknowledging Member States’ legal competences concerning the implementation in the fields of forestry as well as urban and spatial planning; calls on the Commission to ensure that these initiatives are carried out only in a manner compatible with and conducive to the biodiversity objectives;
Amendment 697 #
2020/2273(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission to urgently present a proposal for an EU legal framework based on mandatory due diligence that ensures sustainable and deforestation-free value chainReiterates its call to the Commission to present an impact assessed proposal to take action favouring the restoration of forests globally and for sustainable and deforestation-free value chains, while ensuring competitiveness of EU based businesses, especially SMEs;
Amendment 708 #
2020/2273(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Regrets in this context the decisions taken by third countries that go in the wrong direction of the EU Biodiversity objectives for 2030 such as the Brazilian decision in 2019 to allow sugarcane cultivation in the Amazon region; calls for sanctions in case of such decisions;
Amendment 735 #
2020/2273(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on the Member States to adopt effective actions for climate adaptation to prevent and fight forest fires and compensate their negative effects on the rural economy, biodiversity and the provision of ecosystems services; underlines the need to develop science- based fire management to tackle the effects of climate change in forests and recognises the capacity of agroforestry to increase biomass productivity, reduce the costs of forest maintenance and prevent forest fires;
Amendment 752 #
2020/2273(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls on the Commission to prepare a long-term EU action plan on climate and biodiversity thatBelieves that the European Green Deal should be the framework to improves coherence and interconnections for future actions, and integrates commitments under the post-2020 Global Biodiversity Framework and the Paris Agreement;
Amendment 755 #
2020/2273(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Considers that sustainably managed forests and resulting wood- based products are essential in achieving the UN SDGs and European Green Deal targets and in tackling climate change by strengthening carbon stocks in forests and wood-products and by facilitating material substitution; Emphasises that to ensure consistency, these benefits should be horizontally recognised in EU's forest- related policies, including those on biodiversity;
Amendment 766 #
Amendment 779 #
2020/2273(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. WelcomNotes the Commission’s targets of reducing the use of more hazardous and chemical pesticides by 50 %, the use of fertilisers by at least 20 % and nutrient losses by at least 50 % by 2030, which should be made binding; acknowledges that these targets could have a significant negative impact on the sustainability of the sector, farmers’ income, and food security, and should therefore be subject to an impact assessment prior to setting any targeted reduction; considers that the derogation envisaged in Article 53(1) of Regulation (EC) No 1107/2009 should be clarified and must only be applied for health and environmental reasoso that the derogation meets the actual needs of agricultural operators to deal with the most risky pathogens;
Amendment 793 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 – subparagraph 1 (new)
Paragraph 18 – subparagraph 1 (new)
Calls on the Commission to establish a plan for the compensation of the loss of income of farmers, which may result due to the biodiversity targets set and the interlinked decline in production;
Amendment 797 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Welcomes the inclusion of urban and peri-urban areas; stresses that the simple development of Urban Greening Plans for cities is too unambitious compared to the clearly formulated targets for the agricultural sector; calls on the Commission to formulate ambitious and binding targets for urban areas such as a reduction of mowing of urban green spaces as well as on cutting hedges and trees during the bird breeding and rearing season, minimum share of green roofs on new buildings and the reduction of the use of plant protection products and fertilisers on areas that are not used for food production, etc.;
Amendment 815 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Underlines that European farmers play a crucial role in the protection of nature and make important contributions to biodiversity;
Amendment 818 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 c (new)
Paragraph 18 c (new)
18c. Is convinced that the Biodiversity Strategy needs to work with farmers to further increase contributions to biodiversity based on specific support for farmers from the MFF;
Amendment 821 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 d (new)
Paragraph 18 d (new)
18d. Stresses that the Biodiversity Strategy should fully take into account the upcoming agreement on the CAP Strategic Plans and avoid additional legal burdens and uncertainty for farmers after the agreement of the new CAP;
Amendment 824 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 f (new)
Paragraph 18 f (new)
18f. Calls, in this regard, on the Commission and the Member States to ensure equal product and production standards and effective controls of the agricultural products imported from third countries with a view to ensuring a level playing field for European food production and a high level of protection and underlines that the supply with high- quality foodstuff from EU farmers must be an overall target;
Amendment 825 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 g (new)
Paragraph 18 g (new)
18g. Stresses the decrease of biodiversity due to light pollution; calls on the Commission to set up a strategy against light pollution;
Amendment 826 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 h (new)
Paragraph 18 h (new)
18 h. Calls on the Commission to establish an EU-plan on planting useful trees in cities and urban areas; proposes that every second new planted tree should be contributing in being useful (e.g. fruit trees), which can furthermore contribute to increasing biodiversity in cities;
Amendment 827 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 i (new)
Paragraph 18 i (new)
18 i. Calls on the Commission to include public lawn and public green spaces in cities and urban areas similar to the proposed strictly protected areas targets, to help to increase biodiversity and the protection of pollinators in these areas;
Amendment 828 #
2020/2273(INI)
Motion for a resolution
Paragraph 18 j (new)
Paragraph 18 j (new)
18 j. Calls on the Commission to prepare an action plan on soil sealing of parking spots within cities and urban areas;
Amendment 859 #
2020/2273(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission to promote the updating of studies on exposure to electromagnetic fields generated by energy and telecommunications infrastructures, in line with the latest technological developments, and to work with stakeholders to improve the quality and availability of relevant scientific evidence in the fields of biodiversity;
Amendment 864 #
Amendment 869 #
2020/2273(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Regrets that the list of Union concern represents less than 6 % of IAS present in Europe; calls on the Commission to ensure proper coverage of IAS affecting threatened species on the EU list and to reinforce prevention by introducing mandatory risk assessments prior to the first import of non-native species and by adopting white lists by 2030 at the latest; calls on specific risk management measures to be set up at EU level so as to obtain a common toolbox to effectively control newly identified threats;
Amendment 882 #
2020/2273(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Notes that the correct implementation of the Nature Directives falls not only on Member States but also on the Commission, and in particular as regards the need for an assessment procedure under the Habitats Directive to enable the protection status of species in particular regions to be amended as soon as the desired conservation status is reached;
Amendment 893 #
2020/2273(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Expresses concern that IAS already pose a severe threat to food security, the environment and livelihoods, irreversibly damaging protected areas including the biodiversity they harbour and this is being exacerbated by climate change; acknowledges that plant protection products play a critical role by providing a rapid response to defend areas from existing and newly introduced IAS;
Amendment 904 #
2020/2273(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to ensure effective biodiversity mainstreaming and proofing across EU spending and programmes on the basis of the EU Taxonomy and the ‘do no significant harm’ principle and to cooperate closely with the co-legislators in developing the tracking methodology; calls on the Commission to provide a comprehensive assessment of how the EUR 20 billion per year needed for nature could be mobilised, to make corresponding proposals for the Union’s annual budget and to examine the need for a dedicated funding instrument for TEN-N; considers that efforts should be made to reach 10 % annual given the existence of the dedicated LIFE Programme for nature and biodiversity; welcomes the agreement to mainstream spending onfor biodiversity under the multiannual financial framework (MFF) as soon as possible from 2021 onwartargets by 7.5% from 2024 and 10% from 2026 onwards; calls for a significant share of this funding to support farmers in reaching the biodiversity targets; calls on the Commission to develop a “biodiversity business case” so that the active preservation of biodiversity done by farmers or land owners will also be funded by private funds;
Amendment 942 #
2020/2273(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to provide an assessment of all subsidies harmfulcounterproductive to the EU - environment with a view to their phasing out by 2030 at the latestpolicy; reiterates its calls for theax reforientation of taxation systems towards an increased use of environmental taxationms supporting the transition to a sustainable economy;
Amendment 969 #
2020/2273(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Highlights the need for a legally binding biodiversity governance framework, similar to the Climate Law, which steers a path to 2050 through a set of binding objectives, including targets for 2030 and the COP15 commitments, and which establishes a monitoring mechanism with smart indicators; calls on the Commission to submit a legal proposal to this end in 2022Welcomes the creation of a comprehensive biodiversity governance framework, based on co-responsibility and co-ownership by all relevant actors, to map obligations and commitments and set out a roadmap to guide their implementation, and which establishes a monitoring mechanism with smart indicators; underlines the need to conduct a thorough impact assessment of the progress and suitability of this governance framework in 2023 before considering further updates and the need for an enhanced approach;
Amendment 1001 #
2020/2273(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Calls on the Commission for a strategy on supporting local value chains as key element for reaching the proposed targets; stresses that small-scaled agriculture requires additional support for realising the proposed targets;
Amendment 1011 #
Amendment 1013 #
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 focussed on restoration and conservation; reiterates its calls for a specific mission and funding dedicated to biodiversity within future research programmesexchange of knowledge and professionals in the field of restoration and conservation; reiterates its calls to consider establishing a specific mission for biodiversity research and future research programmes to contribute to achieving the overall MFF biodiversity target; points out the importance of showing society the additional efforts required in biodiversity-friendly production methods and the accompanying necessity of additional (private and/or public) funding;
Amendment 1026 #
2020/2273(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls for more research on the social and economic impacts of biodiversity conservation policies, in order to design policies that support rural and coastal communities of farmers, livestock breeders, fishermen and artisans living in and all around the protected areas, to ensure their survival and a new sustainable transformative development according to the recovery of biodiversity;
Amendment 1027 #
2020/2273(INI)
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26a. Calls on the Commission to facilitate agricultural innovation and the access to these technologies for European farmers in the pursuit of further protecting biodiversity by incentivising technologies, including biopesticides and digital tools with a proportionate and evidence-based regulatory framework which can support the need for monitoring and decision-making;
Amendment 1067 #
2020/2273(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Calls on the Commission to continue encouraging and supporting international initiatives to restore biodiversity, and degraded land around the world, such as the African Union-led Great Green Wall project, which has given back to people in the Sub-Saharan area, from Senegal to Ethiopia, a great extension of recuperated land to cultivate while restoring biodiversity;
Amendment 1068 #
2020/2273(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Supports global negotiations that promote a global level playing field for the sustainable EU bioeconomy and help avoiding leakage effects to regions with less stringent environmental regulation, thus promoting employment in the EU, as well as competitiveness, resilience and strategic autonomy of European industries;
Amendment 1177 #
2020/2273(INI)
Motion for a resolution
Paragraph 30 a (new)
Paragraph 30 a (new)
30a. Calls on the Commission to establish an evidence-based evaluation of the implementation of the strategy’s measures and targets, in particular of the individual and cumulative impacts on the social and economic sustainability of agriculture in the EU, food security and prices, farmland availability and prices and the potential risks of displacing biodiversity losses abroad by the replacement of local agricultural production with imports;
Amendment 1187 #
2020/2273(INI)
Motion for a resolution
Paragraph 30 b (new)
Paragraph 30 b (new)
30b. Underlines that the correct implementation of nature legislation not only falls on Member States but also with the Commission including the need for an assessment procedure to enable the protection status of species in particular regions to be amended as soon as the desired conservation status is reached, in accordance with Article 19 of Council Directive 92/43/EEC on the conservation of natural habitats and of wild fauna and flora;
Amendment 1197 #
2020/2273(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Underlines that the successful implementation of the strategy depends on the involvement of all actors and sectors directly concerned and requires local and regional acceptance; calls on the Commission to create a stakeholder platform for discussion and to ensure an inclusive, equitable and just transition; emphasises the importance of thorough and comprehensive impact assessments of the overall Strategy and any legislative action related to the Strategy; stresses the need to avoid unnecessary administrative burdens in the implementation of the Strategy;
Amendment 237 #
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; whereas currently, the food system is responsible for a rangeinvolved in a series 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 transformfurther adapt 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 311 #
2020/2260(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the European model of a multifunctional agricultural sector, driven, among others, by family farms, continues to ensure quality food production, local supply chains, good agriculture practices, high environmental standards and vibrant rural areas throughout the EU;
Amendment 420 #
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, cooperatives, producers' organizations, 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;
Amendment 440 #
2020/2260(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas European agriculture represents 1% of global greenhouse gas emissions; where as this sector has reduced CO2 and nitrate emissions by 20% and 18% respectively since1990 and the consumption of antibiotics by 20% between 2011 and 2016;
Amendment 460 #
2020/2260(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas the Farm to Fork Strategy should reward farmers, agro-cooperatives and other operators in the food chain who have already undergone the transition to sustainable practices, enable the transition for the others, and create additional opportunities for their businesses;
Amendment 471 #
2020/2260(INI)
Motion for a resolution
Recital E c (new)
Recital E c (new)
Ec. whereas the Farm to Fork Strategy must take into account all three pillars of sustainability (economic, social and environmental) in this broader discussion;
Amendment 646 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Underlines that the Commission should base legislative proposals on scientifically sound ex-ante impact assessments, describing the methods of calculation of the targets and the baselines and reference periods of each individual target after consultation with the Member States; the cumulative effects of the legislative proposals should be taken into account;
Amendment 729 #
2020/2260(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Welcomes the decision to revise the directive on the sustainable use of pesticides and the reduction targets for pesticides, fertilisers, and antibiotics; emphasises the importance of pursuing these targets through holistic and circular approaches, such as agroecological practices; insists that each Member State should establish robust quantitative reduction targets, accompanied by well- defined support measures ensuring accountability at all levels to help reach these targets; reiterates its call for the translation into legislation of the above targets and objectives, as well as support for implementation at farm level and further research and development for innovative farming solutions; reiterates its call for the translation into legislation of the above targets and objectives; acknowledges that these targets could have significant negative impact on the sustainability of the sector, farmers income and food security and should therefore be subject to an impact assessment prior to setting any targeted reduction; and calls on the Commission to clarify how it will deal with individual Member States’ contributions to Union-wide targets and to clarify the baselines for these targets;
Amendment 800 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Calls on the Commission to ensure that these targets are EU targets to which all Member States must contribute through action at national level; underlines in this context that successes already achieved, as well as Member States' different starting points, circumstances and conditions are to be taken into account, in accordance with the principle of subsidiarity;
Amendment 972 #
2020/2260(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Emphasises that EU agriculture is the only major system in the world that reduced significantly greenhouse gas (GHG) emissions;
Amendment 1118 #
2020/2260(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Welcomes the notion of rewarding carbon sequestration in soils; stresses, however, that intensive and industrial agriculture and farming models with negative impacts on biodiversity should not receive climate funding or be incentivised; calls for the proposals to be in line with the environmental objectives and the ‘do no harm’ principle of the Green Deal;
Amendment 1170 #
2020/2260(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Underlines the importance of seed security and diversity, 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 particular New Breeding Techniques (NBT) 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;
Amendment 1227 #
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; stresses that regional marketing of agricultural products and partnerships play an important role in the promotion of sustainable supply chains; acknowledges that when local production is not available, imports are needed;
Amendment 1458 #
2020/2260(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Underlines that cooperation is the tool allowing interactions with other key systems (e.g. energy system, manufacture system, transport systems etc.), and boosts the uptake of digital solutions and novel technologies in the primary production sector;
Amendment 1462 #
2020/2260(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Highlights that agro-cooperatives require in this respect a supportive legislative environment to further develop innovative business models that can deliver on the objectives of the farm to fork strategy and contribute to the achievement of the UN Sustainable Development Goals;
Amendment 1496 #
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 ifto stimulate 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; 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 1582 #
2020/2260(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
Amendment 1640 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for 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 and 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; stresses the urgency to apply a nutrition labelling system which integrates dietary guidelines to support consumers to make healthier food choices and that provides them with better, more detailed and easier to understand but not over simplistic information about the food they consume, also taking into consideration the level of processing of food and the benefits of low-processed high-quality food at the base of traditional European diets and consumption patterns;
Amendment 1693 #
2020/2260(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls the Commission to guarantee, through the European Food Safety Authority (EFSA), a common European nutrition labelling system based on the most complete and recent scientific evidences, integrating the different values of quality and processed food on determining healthy diets; stresses the need for monitoring actions by the EFSA to supervise and insure the commonly agreed correct application of the labelling system by the national agencies for food safety, taking into account the diversity of traditional products coming from different European countries;
Amendment 1727 #
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) in order to support the Circular Economy Action Plan (CEAP); 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; while not affecting the packaging role in preserving food safety or quality and incentivizing the development of sustainable packaging solutions;
Amendment 1771 #
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; underlines 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; stresses that price incentives should prioritise fiscal advantages and public investment over additional taxation;
Amendment 1889 #
2020/2260(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Highlights the recognition in the strategy that Europeans’ diets are not in line with recommendations for healthy eating, and that a population-wide shift in consumption patterns is needed towards more healthy and plant-based foods and less red and processed meat, sugars, salt, and fats, which will also benefit the environmentlifestyles; emphasises that EU-wide guidelines for sustainable and healthy diets would bring clarity to consumers on what constitutes a healthy and sustainable diet and inform Member States’ own efforts to integrate sustainability elements in national dietary advice; calls on the Commission to develop such guidelines and specific actions to effectively promote healthy plant-based diets;
Amendment 1992 #
2020/2260(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls for a revision of public procurement legislation, including minimum mandatory criteria in schools and other public institutions to encourage organic and local food production and to promote more healthy diets by creating a food environment that enables consumers to make the healthy choice;
Amendment 2146 #
2020/2260(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Underlines that we cannot afford to lose time by refraining from using cutting edge technologies such as new animal and plant breeding techniques, artificial intelligence and digital technologies; in particular, new breeding techniques (NBTs) could improve the tolerance of plant varieties to water stress and pests, as well as the disease resistance of animals; each NBT should be analysed and discussed by experts on a case by case basis and according to strict scientific criteria;
Amendment 2175 #
2020/2260(INI)
Motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Calls the Commission to include the areas of integrated production in the EU's 25% organic farming area target, taking into account that these alternative environmentally friendly production methods are nationally regulated by Member States;
Amendment 11 #
2020/2201(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the legal and political impact of the only bottom-up instruments for citizens in the EU, namely the European Citizens’ Initiative (ECI), complaints to the European Ombudsman and petitions to Parliament, is rather minimalmust be strengthened;
Amendment 45 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas medicine shortages are a growing public health threat with a serious impact on health care systems and public health;
Amendment 91 #
2020/2071(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the loss of European sovereignty and independence in the health sector is linked to the relocation of production, with 40% of medicinal end products marketed in the EU now originating in third countries; whereas the onlyone way to save money is to rely heavily on subcontractors to produce pharmaceutical raw materials in Asia, where labour costs and environmental standards are lower, with the result that 80% of active ingredients are manufactured outside the EU, mainly in China and India;
Amendment 157 #
2020/2071(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance excessive stockpiling can lead to a market imbalance if cooperation between Member States is insufficient;
Amendment 187 #
2020/2071(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Ja. whereas a strong, innovative and competitive pharmaceutical industry in Europe is in the vital interest of the EU and its Member States;
Amendment 190 #
2020/2071(INI)
Motion for a resolution
Recital J b (new)
Recital J b (new)
Jb. whereas the pharmaceutical industry needs the right legal framework to do research, development and production of pharmaceuticals within the EU;
Amendment 213 #
2020/2071(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Points out that, while public health policies are a Member State matter,the "Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care" it is very clear that pharmaceutical legislation needs to be done by the European Union and partly exercised by the EMA and it is incumbent upon the EU to coordinate and complement national measures to guarantee affordable and high- quality health services for the European citizens;
Amendment 275 #
2020/2071(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 397 #
2020/2071(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that procurement procedures with only one successful tenderer with only one production site of the basic substance may exacerbate vulnerability should supplies be disrupted; calls on the Commission and the Member States to introduce procurement procedures under which contracts may be awarded to a number of successful tenderers where each has at least more than one production site in different countries (including one within the EU) for the tendered medicinal product, in order to maintain market competition and reduce the risk of shortages, while guaranteeing high-quality treatment for patients;
Amendment 406 #
2020/2071(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Ask the Commission to examine if it is possible to create a legislative framework that encourage and enables healthcare systems to do tenders that award pharmaceutical companies that guarantee the supply of pharmaceuticals in difficult circumstances by focussing on production inside the EU and guarantee at least two different sources for the basic substance; ask the Commission to examine if legislative requirements to ensure more sustainable delivery of pharmaceuticals can be mandated under EU law;
Amendment 423 #
2020/2071(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to to make concreate one or more European non-profitproposals how models of public private pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health caretnership like the US Biomedical Advanced Research and Development Authority can be established in the EU to operate in the public interest; stresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 529 #
2020/2071(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Calls on the Commission to develop European health strategies on the basis of a common basket of drugs for the treatment of cancer and infections whose prices are harmonised, in a bid to counter recurrent shortages and ensure that patients have access to treatment; calls on the Commission to also examine, whether a harmonised price for those drugs may solve the problems of shortages for those life-saving drugs;
Amendment 120 #
2020/0322(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) TIn line with the "One Health" and "Health in all policies" approaches, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. The Union should urge Member States to implement the health-specific country-specific recommendations and support Member States to strengthen the resilience, responsiveness and readiness of healthcare systems in order to address future challenges, including pandemics. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.
Amendment 133 #
2020/0322(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Prevention, preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ prevention, preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted training and knowledge exchange activitiParticular attention must be paid to cross- border regions. To support Member States in this endeavour, the Commission and Union agencies should provide targeted training and facilitate the sharing of best practices for healthcare staff and public health staff should be providedto improve their knowledge and ensure necessary skills should be provided by the Commission and Union Agencies. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 135 #
2020/0322(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7 a) Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firmer action at Union level to support cooperation and coordination among the Member States, in particular between neighbouring border regions. The national plans of Member States sharing a border with at least one other Member State must therefore include plans to improve the preparedness, prevention and response to health crises in border areas in neighbouring regions, including through mandatory cross-border training for healthcare staff and coordination exercises for the medical transfer of patients. The Commission should regularly report on the state of play of cross-border crisis preparation in neighbouring regions.
Amendment 152 #
2020/0322(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach in fighting against such threats. The joint procurement of medical countermeasures should, therefore, be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. In times of crisis, the Union should also aim to support access to medical countermeasures for Eastern Partnership and low- and middle-income countries. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . The Member States should ensure a sufficient reserve of critical medical products at Member State level to counter the risk of shortages of critical products. _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 154 #
2020/0322(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 .The functioning of the Joint Procurement Agreement and rescEU should abide by high standards of transparency, including in relation to the disclosure of the exact amount ordered and provided to each participating country, and the delivery of procured products, and details of the liability of participating countries; _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 163 #
2020/0322(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Joint procurement should be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments should be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 165 #
2020/0322(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Regulatory flexibility should be considered and allowed to ensure faster supply to the markets of the different Member States, for example by accepting each other Marketing Authorizations in case of emergencies;
Amendment 167 #
2020/0322(COD)
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9 b) The joint procurement shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure all actors involved shall fulfil their contractual responsibilities. Clear and transparent stages should be defined for the process, scope, specifications, timelines and formalities;
Amendment 168 #
2020/0322(COD)
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9 b) If joint deployment is deployed, qualitative criteria should also be considered in the awarding process in addition to cost. Such criteria should also take into consideration, for example, the ability of the manufacturer to ensure security of supply during a health crisis;
Amendment 173 #
2020/0322(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Unlike for communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other potentially serious cross- border threats to health do not currently necessitate monitoring by EU Agencies. A risk-based approach, whereby monitoring is carried out by Member States and available information is exchanged through EWRS, is therefore more appropriate for such threats. Nevertheless, the ECDC should have the ability to monitor the impact of communicable diseases on non- communicable diseases, including the continuity of screening, diagnosis, monitoring, treatment and care in the healthcare system;
Amendment 176 #
2020/0322(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance. In times of crisis, particular attention should also be paid to the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and to the mental health implications of the crisis and psychosocial needs of the population.
Amendment 180 #
2020/0322(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In case of cross-border health threats due to a communicable disease, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and, together with pharmacies and other licensed health care establishments, also testing for assessing exposure to and immunity from the disease in the general population. These services in return are dependent on rapid risk assessments by the ECDC to safeguard patients, in need of a therapy from a substance of human origin, from a transmission of such communicable disease. Such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. The ECDC should therefore set up and operate a network of national blood and transplant services, as well as pharmacy services and other licensed health services and establishments, and their authorities to serve this dual purpose.
Amendment 188 #
2020/0322(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) Regular dialogue and exchange of information between authorities, industry, relevant entities of the pharmaceutical supply chain, healthcare professionals' and patients' organizations should also be ensured to start early discussions about expected potential serious cross-border threats to health in the market by way of sharing expected supply constraints or raising of specific clinical needs, allowing better coordination, synergies and appropriate reaction when needed.
Amendment 199 #
2020/0322(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts and representatives of health and care workers, including nurses and medical doctors, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers. All members of the Advisory Committee should provide declarations of interest in line with the applicable rules in each case. The advisory committee should work in close cooperation with national advisory bodies. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, Union export control mechanisms, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
Amendment 209 #
2020/0322(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) The Commission and the Member States should actively work towards a new global treaty for pandemic preparedness and response under the framework of the World Health Organization and with close involvement of other relevant organizations, building on and improving the existing global health instruments, especially the International Health Regulations (2005)1a to ensure a firm and tested foundation. Such a Treaty should support and focus on strengthening the international health framework and improving cooperation with regard to early detection, prevention, response and resilience to future pandemics. _________________ 1aWorld Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 225 #
2020/0322(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. TIn keeping with "One Health" and "Health in all policies approaches", the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. The strengthened Union health framework addressing serious cross-border health threats shall work in synergy with and in a manner that is complementary to other Union policies and funds, such as actions implemented under the ESIF, Horizon Europe, the Digital Europe Programme, rescEU, ESI, ESF+ and SMP.
Amendment 235 #
2020/0322(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issue, the surveillance of the impact of such diseases on non- communicable diseases and of related special health issues, such as mental health impacts of the crisis and the impact of deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions.
Amendment 281 #
2020/0322(COD)
Proposal for a regulation
Chapter II – title
Chapter II – title
II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 293 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point b a (new)
Article 5 – paragraph 3 – point b a (new)
(b a) the mapping of the strategic production capacities for the Union as a whole;
Amendment 295 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point c a (new)
Article 5 – paragraph 3 – point c a (new)
(c a) the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during health emergencies;
Amendment 308 #
2020/0322(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Union preparedness and response plan shall include cross-border and interregional preparedness elementplans to establish coherent, multi-sectoral, cross- border public health measures, in particular considering capacities for testing, contact tracing, laboratories, training of healthcare staff and specialised treatment or intensive care across neighbouring regions. The plans shall include preparedness and response means to address the situation of those citizens with higher risks.
Amendment 330 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their preparedness and response planning and implementation at national and, where appropriate, regional and cross-border levels.
Amendment 341 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
(i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery at national and, where relevant, regional and cross-border levels; coordination mechanisms;
Amendment 348 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; access to diagnostic serviceinformation relevant for the internal market and Union strategic reserves of medical products, including national stockpiles and capacities to contribute to the security of supply of critical medical products at Union level; equal access to diagnostic services and tools and medical products during emergencies; the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 357 #
2020/0322(COD)
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; health logistics mechanisms andthat meet the specific legal requirements of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017; essential supplies for health; and dedicated, trained and equipped human resources for emergencies; and
Amendment 359 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; a reserve of critical medical products at Member State level; and dedicated, trained and equipped human resources for emergencies; and
Amendment 363 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new)
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new)
(iii a) pandemic stockpile/strategic stockpile: each State shall provide information on the number and availability of medical countermeasures and other essential medicines and medical devices for the control of the threats set out in Article2(1), as well as the capacity for their safekeeping and storage. In order to have a greater response capacity, storage shall be carried out in the premises and centres closest and most accessible to the population centres, which meet the necessary requirements to provide the service in accordance with the regulations applicable to medicinal products, medical devices and other medical countermeasures.
Amendment 364 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c
Article 7 – paragraph 1 – subparagraph 1 – point c
(c) implementation of national response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health impacts, the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and other specific issues.
Amendment 369 #
2020/0322(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
Amendment 396 #
2020/0322(COD)
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1 a. The Commission report shall include the state of cross-border preparedness and response planning in neighbouring regions.
Amendment 414 #
2020/0322(COD)
Proposal for a regulation
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
1 a. The Commission and the Member States shall, where relevant, conduct a dialogue with relevant stakeholders, including health and care workers organizations, industry and supply chain stakeholders, and patients organizations;
Amendment 420 #
2020/0322(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The Commission shall organise those activities in cooperation with the Member States concerned or potentially concerned. In cross-border regions, mandatory joint cross-border training and sharing of best practices for healthcare staff and public health staff shall be organised.
Amendment 433 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health within a reasonable time frame. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 452 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(d a) Joint procurement shall be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments shall be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 453 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d a (new)
Article 12 – paragraph 2 – point d a (new)
(d a) The functioning of the Joint Procurement Agreement should abide by high standards of transparency, including in relation to the disclosure of the exact amount ordered and provided to each participating country, and delivery of procured products, and details of the liability of participating countries;
Amendment 456 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d b (new)
Article 12 – paragraph 2 – point d b (new)
Amendment 457 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d b (new)
Article 12 – paragraph 2 – point d b (new)
(d b) regulatory flexibility should be considered and allowed to ensure faster supply to the markets of the different Member States, for example by accepting each other Marketing Authorizations in case of emergencies;
Amendment 458 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d c (new)
Article 12 – paragraph 2 – point d c (new)
(d c) if joint deployment is deployed, qualitative criteria shall also be considered in the awarding process in addition to cost. Such criteria shall also take into consideration, for example, the ability of the manufacturer to ensure security of supply during a health crisis;
Amendment 463 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 3 – introductory part
Article 12 – paragraph 3 – introductory part
3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing any action, including, but not limited to joint procurement procedures, stockpiling in facilities that meet the specific legal requirements for the storage of medical countermeasures and with the greatest proximity and accessibility to the greatest number of population centres and donation of medical countermeasures under different mechanisms established at Union level, in particular under:
Amendment 468 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 3 – point a
Article 12 – paragraph 3 – point a
(a) stockpiling under the rescEU referred to in Article 123 of Decision No 1313/2013/EU;
Amendment 472 #
2020/0322(COD)
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
3 a. The Union shall strive to also support access to counter-measures for Eastern Partnership and low- and middle- income countries.
Amendment 478 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b a (new)
Article 13 – paragraph 2 – point b a (new)
(b a) monitor the impact of communicable diseases on the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 479 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b b (new)
Article 13 – paragraph 2 – point b b (new)
(b b) monitor the impact of communicable diseases on mental health;
Amendment 482 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence, complications, hospitalisation and mortality, the mental health impact and deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 486 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point h a (new)
Article 13 – paragraph 2 – point h a (new)
(h a) identify any weakness in the global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of communicable diseases;
Amendment 494 #
2020/0322(COD)
Proposal for a regulation
Article 13 – paragraph 3 – point f a (new)
Article 13 – paragraph 3 – point f a (new)
(f a) information on the availability of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of the disease.
Amendment 504 #
2020/0322(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 539 #
2020/0322(COD)
Proposal for a regulation
Article 16 a (new)
Article 16 a (new)
Amendment 565 #
2020/0322(COD)
Proposal for a regulation
Article 19 – paragraph 3 – point i a (new)
Article 19 – paragraph 3 – point i a (new)
(i a) the existing and potential production sites, with the sole aim of allowing the Union to map the strategic production capacities for the Union as a whole;
Amendment 566 #
2020/0322(COD)
Proposal for a regulation
Article 19 – paragraph 3 – point j
Article 19 – paragraph 3 – point j
(j) requests and offers for cross-border emergency assistance; , such as the medical transfer of patients or provision of healthcare staff by one Member State to another, in particular in cross-border areas in neighbouring regions;
Amendment 581 #
2020/0322(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point b
Article 21 – paragraph 1 – point b
(b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals. In addition, the Commission shall broaden its communication activity to cover the general public by establishing and managing a portal to share verified information and fight against disinformation;
Amendment 593 #
2020/0322(COD)
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and relevant regional authorities and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions.
Amendment 613 #
2020/0322(COD)
(ii) identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment, non- pharmaceutical countermeasures, global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow-up of the disease concerned and public health research needs;
Amendment 619 #
2020/0322(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts and representatives of health and care workers, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on sanitary, biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad- hoc basis.
Amendment 625 #
2020/0322(COD)
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2 a. All members of the Advisory Committee shall provide declarations of interest in line with the applicable rules in each case.
Amendment 633 #
2020/0322(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) mechanisms to monitor shortages of, develop, procure, ensure security of supply, manage and deploy medical countermeasures;
Amendment 634 #
2020/0322(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point c a (new)
Article 25 – paragraph 1 – point c a (new)
(c a) A Union export control mechanism with the aim of enabling the Union to guarantee timely and effective access to counter-measures.
Amendment 637 #
2020/0322(COD)
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
5. Personal data may also be exchanged in the context of automated contact tracing, using contact tracing applications, in full compliance with the Regulation (EU) 20176/679 ('GDPR').
Amendment 116 #
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 in a coordinated way between public authorities, industry and other entities of the pharmaceuticals' manufacturing, distribution and provision chains. A two- way dialogue between authorities and all the industry stakeholders is key and should be ensured to prevent and better manage medicines shortage. 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 122 #
2020/0321(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) As experienced during the COVID-19 crisis, regulatory capacity to adapt and activate exceptional measures to facilitate Marketing Authorisations for emergency medicines and medical devices is key for an effective and coordinated response to health emergencies at Union level. This capacity should be applied even beyond crisis situations, for example applying the Rolling Review procedures to critical medicinal products, covering procedures for changes in suppliers of APIs or for the designation of new manufacturing sites, leading to prevention and better mitigation of medicines shortage, in coherent and consistent coordination with Member States, avoiding fragmentation of the internal market and inefficient outcomes. The National Agencies should align their regulatory capacity to the EMA enhanced one, in terms of reduced times, efficiency and flexibility to prevent shortages and effectively respond to patients' clinical needs.
Amendment 140 #
2020/0321(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The COVID-19 pandemic has exacerbated the problem of shortages for certain medicinal products considered as critical in addressing the pandemic, and has highlighted the structural limitations in the Union’s ability to rapidly and effectively react to such challenges during public health crises and the need for a more active and extended involvement of the European institutions addressing the health of the European citizens.
Amendment 150 #
2020/0321(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) During the first stages of the COVID-19 pandemic, uncoordinated actions at national level, such as national hoarding and stockpiling, undermined industry ability to deliver equitable supply in all markets. This represents a lesson learned to avoid in any future crisis situations and highlights the urgent need for a more solid and effective coordination at Union level.
Amendment 177 #
2020/0321(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) This Regulation aims at establishing the foundations of a European Union of Health coordination and early-warning digitalized interoperable system, to monitor and report medicines shortage, based on shared definitions and procedures, in order to be prepared and better react during a crisis. The existing best practices of digital reporting systems at national level should be shared and taken into account after a common evaluation.
Amendment 184 #
2020/0321(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A harmonised system of monitoringEuropean Union of Health digitalized and interoperable early-warning system of shortages of medicinal products and medical devices should be established, which will facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which may have a serious impact on public health. That system should be complemented with improved structures to ensure appropriate management of public health crises and coordinate and provide advice on the research and development of medicinal products which may have the potential to address public health emergencies. In order to facilitate the monitoring and reporting on potential or actual shortages of medicinal products and medical devices, the Agency should be able to ask and obtainccess information and data from the concerned marketing authorisation holders, manufacturers and Member States through designated points of contact, relevant entities of the pharmaceuticals' supply chain and Member States' national agencies, directly via the uploaded information at national level available in the European Union of Health early-warning, interoperable and digitalized system, avoiding duplications of reporting requirements at different levels.
Amendment 190 #
2020/0321(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) With respect to medicinal products, an executive steering group should be established within the Agency to ensure a robust response to major events and to coordinate urgent actions within the Union in relation to the management of issues relating to the supply of medicinal products. The Steering Group should establish lists of critical medicinal products to ensure monitoring of those products and it should be able to provide advice and recommendations on the necessary action to take to safeguard the quality, safety, and efficacy of medicinal products and ensure a high level of human health protection. The Steering Group should take into account and integrate in its works the outcomes of the ongoing discussions in the context of the European Commission Structured Dialogue on manufacturing and supply chain among institutions, national authorities and stakeholders, in order to achieve the best results in preventing and responding to shortage of medicines.
Amendment 214 #
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. teroperable infrastructure, taking advantage of all the potential of the supercomputing, the Artificial Intelligence and the Big Data science to develop predicting models and take better and more timely-effective decisions, without compromising the privacy rights.
Amendment 242 #
2020/0321(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prepare for and managevent, prepare for, manage and coordinate at European level the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
Amendment 248 #
2020/0321(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a a (new)
Article 1 – paragraph 1 – point a a (new)
(aa) Set up the European Union of Health digitalized and interoperable early-warning system of shortages of medicinal products and medical devices, interconnecting national reporting systems, with common definitions and data collection procedures, as a basis to better prevent, manage and coordinate health emergencies at Union level;
Amendment 278 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device, no matter the cause;
Amendment 290 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medicinal product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients, while following real, adequate prescription needs.
Amendment 307 #
2020/0321(COD)
Proposal for a regulation
Article 2 a (new)
Article 2 a (new)
Article 2 a The setting of a European Union of Health digitalized and interoperable early-warning system 1. In order to better manage health crisis, a European Union of Health digitalized and interoperable early-warning system to monitor and report all medicines shortage is hereby established, through an infrastructure which is in place and functional also under normal circumstances. 2. Through such a harmonized, digitalized and interoperable system, the reporting shall be based on collecting data at the national level, with data collected on common definitions and procedures, covering both Centralised and National Marketing Authorisations. The Agency shall receive, when relevant, aggregated data from national databases to monitor any potential cross-border shortages.
Amendment 313 #
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, a representative of the Patients' organizations, a representative of the Healthcare Professionals' organizations and one senior representative per Member State. Each Member State shall appoint their representative. Members may be accompanied by experts in specific scientific or technical fields. The list of the members of the Steering Group shall be transparent and made public on the EMA web-portal.
Amendment 324 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and, marketing authorisation holders to attend its meetings, representatives of healthcare professionals, and of patients to attend its meetings, when their contribution may inform the discussions of the Steering Group.
Amendment 423 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 435 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 450 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point b
Article 9 – paragraph 1 – point b
(b) specify the methods of and criteria for the monitoring, data collection and reporting through the European Union of Health digitalized and interoperable early-warning system of shortage of medicines, established in Article 2bis(new), and provided for in Articles 4, 7 and 8;
Amendment 480 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients, potential alternative production sites, minimum stock levels, etc.;
Amendment 541 #
2020/0321(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities; , including healthcare professionals to support them in their work and in the communication with patients;
Amendment 696 #
2020/0321(COD)
Proposal for a regulation
Article 25 – paragraph 4 – point a
Article 25 – paragraph 4 – point a
(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring both patient and product safety;
Amendment 701 #
2020/0321(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while at the same time ensuring both patient and product safety;
Amendment 84 #
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, taking into account the fact that approximately 60% of communicable human diseases are of animal origin and that more work and resources should be dedicated to preventing and researching zoonotic diseases. It should monitor the capacity of the national health systems to respond to communicable disease threats, 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 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 94 #
2020/0320(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should be tasked to communicate continuously and comprehensively to the Centre data on the surveillance of communicable diseases and other special health issues such as antimicrobial resistance and healthcare- associated infections related to communicable diseases, available scientific and technical data and information relevant to the Centre’s mission, to notify the Centre rapidly of any serious cross-border threats to health, information on preparedness and response planning and actual health system capacity to address the threat and its possible consequences, and provide relevant information that may be useful for coordinating the response, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threats.
Amendment 109 #
2020/0320(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and of the related special health issues in the Union, the Centre should be tasked with the further development of digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence, in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological surveillance systems, with shared objectives and competences that make it possible to progress a European action agenda. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation.
Amendment 118 #
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 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 and climate 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 129 #
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. In addition, the Centre should coordinate a multidisciplinary Working Group for Prevention and Early Detection, made up of representatives of the European Environment Agency (EEA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), to implement a holistic approach to the prevention and early detection of communicable diseases, systematically integrating the analysis and assessment of risks associated with environmental, climate and food factors with epidemiological surveillance, the weaknesses of national health systems and the concentration of vulnerable groups in the population.
Amendment 145 #
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 multi-sectoral Union and 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 220 #
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 f
Article 3 – paragraph 2 – point f
(f) facilitate the development and implementation of actions, funded by relevant Union funding programmes and instruments, including the implementation of joint actions; in particular the actions of the EU4Health programme 2021-2027 to strengthen the resilience of national health systems to cross-border health threats, and Europe’s Beating Cancer Plan, in view of the well-defined causal links between communicable diseases and the development of cancer (such as the hepatitis B virus and the human papillomavirus).
Amendment 316 #
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 h
Article 5 – paragraph 4 – point h
Amendment 341 #
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 2
Article 5a – paragraph 2
2. The Centre shall develop a framework for the prevention of communicable diseases and special issues, including vaccine preventable diseases, DNA sequencing and gene therapy, antimicrobial resistance, health education, health literacy and behaviour change.
Amendment 351 #
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 coordinate a multidisciplinary Working Group for Prevention and Early Detection, made up of representatives of the European Environment Agency (EEA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), to implement a holistic approach to the prevention and early detection of communicable diseases, systematically integrating the analysis and assessment of risks associated with environmental, climate and food factors with epidemiological surveillance, the weaknesses of national health systems and the concentration of vulnerable groups in the population.
Amendment 356 #
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 4 a (new)
Article 5a – paragraph 4 a (new)
4a. The Centre, in coordination with the European Medicines Agency (EMA), the Commission and the Member States, shall develop initiatives and tools to expand vaccination coverage in Europe, improving the quality and availability of coverage data, and to increase acceptance of vaccines and counter vaccine hesitancy.
Amendment 360 #
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 a
Article 5b – paragraph 1 – subparagraph 2 – point a
(a) contribute to the development, regular review and updating of multi- sectoral preparedness plans and blueprints of multi-sectoral threat- specific preparedness plans for adoption by the HSC;
Amendment 462 #
2020/0320(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 5
Article 11a – paragraph 5
5. The Centre shall, upon request of the Commission, facilitate the development of field response capabilities and crisis management expertise among the Centre’s staff and experts from EU and EEA countries, EU candidate countries and potential candidates, as well as European Neighbourhood Policy and EU partner countries, upon request of the Commissionhelping to achieve Goal 3.3 of the Sustainable Development Goals, which seeks, by 2030, to ‘end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases’.
Amendment 2 #
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, particularly for small and medium-sized enterprises (SMEs), 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 challenges such as sustainability or population ageing. Consequently, in order to achieve the Union's policy objectives, in particular the dual objective of accelerating the climate and digital transitions, and to support a swift, inclusive 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 14 #
2020/0108(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The InvestEU Fund should contribute to improving the competitiveness and socio-economic convergence and cohesion, cohesion and long-term economic growth of the Union, including in the fields of innovation and digitisation, to the efficient use of resources in accordance with the circular economy, to the sustainability and inclusiveness of the Union's economic growth and to the social resilience and integration of the Union capital markets, including through solutions that address the fragmentation of Union capital markets and that diversify sources of financing for Union enterprises. To that end, the InvestEU Fund should support projects that are technically and economically viable by providing a framework for the use of debt, risk sharing and equity instruments backed up by a guarantee from the Union budget and by financial contributions from implementing partners as relevant. The InvestEU Fund should be demand-driven, while at the same time it should focus on providing strategic, long-term benefits in relation to key areas of Union policy which otherwise would not be funded or would be insufficiently funded, thereby contributing to meeting policy objectives of the Union. Support under the InvestEU Fund should cover a wide range of sectors and regions, but should avoid excessive sectoral or geographical concentration and should facilitate access of projects composed of partner entities in multiplewith high growth potential and in key strategic sectors in all regions across the EU.
Amendment 28 #
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 actions and to the achievement of an overall target of 2530 % of the Union budget expenditures supporting climate objectives. Actions under the InvestEU Programme are expected to contribute 3at least 40 % of the overall financial envelope of the InvestEU Programme to climate 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 52 #
2020/0108(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Tourism is an important area for the Union economy and the sector, which, employing more than 22 million people. The tourism sector experienced a particularly severe contraction as a result of COVID-19 pandemic with revenue losses having reached an estimated 85 % for hotels, restaurants, tour operators, travel agencies and long distancerail, and 90 % for cruises and airlines as of May 2020. . The InvestEU Programme should contribute to strengthening its long- term competitiveness by supporting operations promotinga sustainable, innovative and digital tourismrecovery in the tourism sector.
Amendment 56 #
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, in particular SMEs, 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. 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 58 #
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 and digital transitions but which also enhance the competitiveness of the Member States' economies, including the need to rebuild the Member States' productive capacity and create future- oriented investments promoting entrepreneurship and job creation, and of enhanced resilience, in areas ofcluding by decreasing dependence on vulnerable supply chains. Projects should bring Union added value and should either be cross-border or generate real added value in more than one Member State or region through spill-over effects. No support should flow directly into the national budgets or substitute national budgetary expenditure, such as social benefits. Areas of strategic importance include (i) critical healthcare provision, manufacturing and stockpiling of pharmaceuticals, medical devices and medical supplies, strengthening of health crisis response capacity and of the civil protection system, (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, green and digital technologies and game-changing innovations where the investment is strategically important for the Union’s industrial future, including artificial intelligence, blockchain, software, robotics, semiconductors, microprocessors, edge cloud technologies, high-performance computing, cybersecurity, quantum technologies, photonics, industrial biotechnology, renewable energy technologies, in particular to implement the offshore renewable energy strategy, energy storage technologies including batteries, sustainable transport technologies, clean hydrogen and fuel cell applications, decarbonisation technologies for industry, carbon capture and storage, circular economy technologies biomedicine, nanotechnologies, pharmaceuticals 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. The distribution of the financial envelope should in particular ensure support for the parallel climate and digital transitions. 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 66 #
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 not in line with the strategic and economic interests of the Union, for instance for projects that would increase dependency on vulnerable or undiversified supply chains.
Amendment 69 #
2020/0108(COD)
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
(29 a) The visibility of the Union funding from the InvestEU Fund, and in particular the strategic European investment window and its identified strategic priorities, should be ensured through effective communication, highlighting Union-funded actions and results in order to adequately promote the Union added value of the InvestEU Programme as part of the recovery.
Amendment 84 #
2020/0108(COD)
Proposal for a regulation
Recital 59
Recital 59
(59) In the context of the InvestEU Fund, there is a need to provide support for project development and capacity building to develop the organisational capacities and market development activities needed to originate quality projects. Such support should also target financial intermediaries that are key to help small companies’ access financing and realise their full potential, and it should include technical assistance. Particular emphasis should be put on reducing the administrative burden, in particular for SMEs. Moreover, the aim of the advisory support is to create the conditions for the expansion of the potential number of eligible recipients in nascent market segments, in particular where the small size of individual projects considerably raises the transaction cost at the project level, such as for the social finance ecosystem, including philanthropic organisations, or for the cultural and creative sectors. The capacity- building support should be complementary and in addition to actions taken under other Union programmes that cover specific policy areas. An effort should also be made to support the capacity building of potential project promoters, in particular local organisations and authorities.
Amendment 86 #
2020/0108(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the InvestEU should be carried out to address the unprecedented impact of the Covid-19 crisis and, in line with the objectives of the strategic European investment window, support long-term growth, quality jobs and competitiveness. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [EURI].
Amendment 110 #
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 aone or more Member States and that operate in the Union, and whose activities are of strategic importance to the Union, in particular in view of the green and digital transitions and of enhanced resilience, while enhancing the competitiveness of the Member States' economies, including the need to rebuild the Member States' productive capacity and promote entrepreneurship and job creation, in one of the following areas:
Amendment 115 #
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 deviceines, vaccines, active pharmaceutical ingredients, pharmaceutical raw materials, medical devices, diagnostic tools and medical supplies, strengthening of health crisis response capacity and of the civil protection system;
Amendment 120 #
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, water, health, 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 125 #
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, greelow- carbon and digital technologies and game- changing innovations where the investment is strategically important for the Union’s industrial future, including
Amendment 132 #
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 and low carbon transport technologies, clean hydrogen and fuel cell applications, decarbonisation technologies for industry, carbon capture and storage, circular economy technologies,
Amendment 138 #
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, biotechnologies, pharmaceuticals and advanced materials;
Amendment 144 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point e – point vii – paragraph 1
Article 7 – paragraph 1 – point e – point vii – paragraph 1
In addition, in the case of investments in space, defence and cybersecurity, and in specific types of projects with actual and direct security implications in critical sectors, the final recipients shall not be controlled by a third country or third country entities and shall have their executive management in the Union with a view to protect the security of the Union and its Member States. Financial support shall not be provided when a project is not in line with the strategic and economic interests of the Union, for instance for projects that would increase dependency on vulnerable or undiversified supply chains.
Amendment 153 #
2020/0108(COD)
Proposal for a regulation
Article 7 – paragraph 4 – introductory part
Article 7 – paragraph 4 – introductory part
4. The Commission shall develop sustainability guidance that, in accordance with Union environmental and social objectives and standards, including Regulation (EU) 2020/852, allows to:
Amendment 30 #
2020/0104(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10 a) The Facility should support projects that respect the principle of additionality of Union funding and that generate a genuine European added value. The Facility should not be a substitute for recurring national expenditures and should not run counter to the strategic and economic interests of the Union, and should therefore not finance investment plans of third countries.
Amendment 40 #
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 2530 % of the EU budget expenditures supporting climate objectives. The Facility should only finance projects respecting the “do not significant harm” principle referred to in Regulation (EU) 2020/852.
Amendment 50 #
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 cohesiono contribute to addressing the challenges of the policy areas identified under this Regulation through the promotion of economic, social and territorial cohesion and to contribute to the objectives of Union policies, the United Nations Sustainable Development Goals, the European Pillar of Social Rights, the Paris Agreement and to the strengthening of the Single Market. 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 2050, therebycontributing to restoring the growth potential of the economies of the Union in the aftermath of the crisis, fostering employment creation in the aftermath of the COVID-19 pandemic and to promotinge sustainable growth and the digital economy.
Amendment 64 #
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 consistent 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. In addition, the recovery and resilience plans should be consistent with the principle of European added-value. 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 under the policy areas identified in this Regulation and for the green and digital transitions. The measures shoul and 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. At least 40 % of the recovery and resilience plans should be dedicated to mainstreaming climate and biodiversity actions and environmental sustainability objectives.
Amendment 111 #
2020/0104(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
It lays down its objectives, the financing, the forms of Union funding and the rules for providing such funding which shall be clearly defined in size, duration and scope.
Amendment 131 #
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 contribute to address the challenges of the policy areas referred in Article 3 in order to promote the Union’s economic, social and territorial cohesion and long- term competitiveness by 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 and the strengthening of the strategic autonomy of the Union, 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 and generating European added value.
Amendment 135 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1 a. The Facility shall contribute to the objectives of Union policies, in particular where it leads to job creation and maintenance of sustainable employment at a considerable scale, via the implementaion of measures, such as: - measures contributing to the Union’s climate and environmental objectives, including energy efficiency and energy savings, the deployment of technology and infrastructures for clean and sustainable renewable energy and energy storage, including clean hydrogen, batteries and fuel cell applications, and decarbonisation technologies for industry and carbon capture and storage technologies; - projects and enterprises that implement the circular economy by integrating resource efficiency aspects in the production and product life-cycle; - measures to strengthen the resilience, accessibility and capacity of health systems and civil protection systems, in particular in the face of crises and pandemics; - strategic investment to support final recipients that are established in one or more Member States and that operate in the Union, and whose activities are of strategic importance to the Union, notably in the area of research, innovation, manufacturing and stockpiling of pharmaceuticals, medicines, medical devices and vaccines; - productive and sustainable investments in enterprises, in particular microenterprises, SMEs and start-ups, in particular investments contributing to the transition towards a climate-neutral economy; - upskilling and reskilling of workers and job-seekers, including self-employed, with the aim of bridging the skills gap necessary for the just transition towards a climate-neutral economy; - measures that foster digital infrastructure, digitization of national systems and workplace, improve access to digital working and promote digital skills.
Amendment 142 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2 a. The Facility shall not run counter to the strategic and economic interests of the Union. In this respect, support shall not be provided to projects that are part of the strategic investment plans of third countries.
Amendment 144 #
2020/0104(COD)
Proposal for a regulation
Article 4 – paragraph 2 b (new)
Article 4 – paragraph 2 b (new)
2 b. Support from the Facility shall not substitute recurring national budgetary expenditure and respect the principle of additionality of Union funding.
Amendment 169 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1 a. 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 plans shall be consistent with the ‘do not significant harm’ principle referred to in Regulation (EU) 2020/852 and at least 40 % of the amount of each Recovery and Resilience Plan shall contribute to mainstreaming climate and biodiversity actions and environmental sustainability objectives. By means of a delegated act, the Commission shall adopt an effective methodology to track and identify the fulfilment of this requirement, in line with the criteria laid down in the EU taxonomy established by Regulation (EU) 2020/852.
Amendment 170 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 1 b (new)
Article 14 – paragraph 1 b (new)
1 b. Member States’ access to the Recovery and Resilience Facility shall be dependent on the endorsement of a national objective of achieving a climate- neutral Union by 2050.
Amendment 177 #
2020/0104(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The recovery and resilience plans shall be consistent withcontribute to the implementation of the relevant country-specific challenges and prioritierecommendations identified in the context of the European Semester, in particular those relevant for or resulting from the green and digital transition. T, as well as to achieving the Union’s objective of climate neutrality by 2050 and the Union's new 2030 climate targets. Therefore, 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 […]
Amendment 202 #
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 the challenges resulting from ithem;
Amendment 204 #
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) a detailed explanation of how the measures are expected to ensure that at least 40% of the amount requested for the recovery and resilience plan contribute to mainstreaming climate and biodiversity actions and environmental sustainability objectives in line with Article 14(1) and (2);
Amendment 209 #
2020/0104(COD)
(c b) an explanation of how the measures in the plan are expected to contribute the implementation of the commitments of the Union and of its Members States, in particular the relevant documents adopted in the context of the latest European Semester, the Paris Agreement, the national energy and climate plans and updates thereof under Regulation (EU)2018/1999, the territorial just transition plans under the Just Transition Fund, the partnership agreements and operational programmes under other Union funds;
Amendment 214 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c c (new)
Article 15 – paragraph 3 – point c c (new)
(c c) an explanation of how the measures in the plan are expected to bring European added-value;
Amendment 231 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. When assessing the recovery and resilience plan and in the determination of the amount to be allocated to the Member State concerned, the Commission shall take into account the analytical information on the Member State concerned available in the context of the European Semester as well as the justification and the elements provided by the Member State concerned, as referred to in Article 15(3), and any other relevant information including, in particular, the one contained in the National Reform Programme, the Just Transition Plan and the National Energy and Climate Plan of the Member State concerned and, if relevant, information from technical support received via the Technical Support Instrument.
Amendment 245 #
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 themaddressing the challenges from the scope and objectives set out in Articles 3 and 4;
Amendment 248 #
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 the green transition or to addressing the challenges resulting from it and whether at least 40% of the amount requested for the recovery and resilience plan contribute to mainstreaming climate and biodiversity actions and environmental sustainability objectives based on the methodology provided by the Commission in accordance with Article 14(1 a);
Amendment 252 #
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 is consistent with and contributes to the national reform programmes, the national energy and climate plans and updates thereof under Regulation (EU) 2018/1999, the territorial just transition plans under the Just Transition Fund, the partnership agreements and operational programmes under other Union funds;
Amendment 270 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The Commission shall adopt a decision within four months of the official submission of the recovery and resilience plan by the Member State, by means of an implementing delegated act. In the event that the Commission gives a positive assessment to a recovery and resilience plan, that decision shall set out the reforms and investment projects to be implemented by the Member State, including the milestones and targets, and the financial contribution allocated in accordance with Article 11.
Amendment 293 #
2020/0104(COD)
Proposal for a regulation
Article 19 – paragraph 3 – introductory part
Article 19 – paragraph 3 – introductory part
3. Upon completion of the relevant agreed milestones and targets indicated in the recovery and resilience plan as approved in the implementingdelegated act of the Commission, the Member State concerned shall submit to the Commission a duly justified request for payment of the financial contribution and, where relevant, of the loan tranche. Such requests for payment may be submitted by the Member States to the Commission on a biannual basis. The Commission shall assess, within two months of receiving the request, whether the relevant milestones and targets set out in the decision referred to in Article 17(1) have been satisfactorily implemented. For the purpose of the assessment, the operational arrangement referred to in Article 17(6) shall also be taken into account. The Commission may be assisted by experts.
Amendment 316 #
2020/0104(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The recipients of Union funding shall acknowledge the origin and ensure the visibility of the Union funding, in particular when promoting the actions and their results, by clearly labelling the funding as Union funding and providing coherent, effective and proportionate targeted information to multiple audiences, including the media and the public. The recipients shall ensure the visibility of spending under the Facility by clearly labelling the supported projects as “EU Recovery Initiative”.
Amendment 361 #
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 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 and the Union's new 2030 climate targets in line with the criteria laid down in the EU taxonomy established by Regulation (EU) 2020/852;
Amendment 380 #
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, in particular for SMEs , stimulating job creation and mitigating the adverse effects of the crisis, while avoiding adverse impacts of those measures on climate and environment in line with the criteria laid down in EU taxonomy established by Regulation (EU) 2020/852.
Amendment 123 #
2020/0102(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2 coronavirus and associated respiratory disease (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, and more specifically the severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has 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, carers and the elderly the hardest.
Amendment 14 #
2020/0100(COD)
(3 a) The Just Transition Fund is an essential part of the Union Recovery and Resilience Package and should remain a key part of the package, with corresponding significant resources.
Amendment 15 #
2020/0100(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) A public sector loan facility (the ‘Facility’) should be provided. It constitutes the third pillar of the Just Transition Mechanism, supporting public sector entities in their investments. Such investments should meet the development needs resulting from the transition challenges described in the territorial just transition plans as adopted by the Commission. The activities envisaged for support should be consistent with and complement those supported under the other two pillars of the Just Transition Mechanism. and should support the overarching objectives of the European Green Deal, in particular the “do not significant harm" principle referred to in Regulation (EU) 2020/852 of the European Parliament and of the Council1a, and be in line with the framework for sustainable activities set out in EU taxonomy established by that Regulation. The activities envisaged for support should be consistent with and complement those supported under the other two pillars of the Just Transition Mechanism, in order to ensure that all three pillars are working towards the same objectives and should not crowd out private sector investment that will be facilitated through the Just Transition Mechanism. _________________ 1aRegulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
Amendment 25 #
2020/0100(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to enhance the economic diversification of territories impacted by the transition, the Facility should cover a wide range of investments, on condition that they contribute to meet the development needs in the transition towards a climate neutral and circular economy, as described in the territorial just transition plans. The investments supported may cover low carbon energy and transport infrastructure, district heating networks, green mobility, smart waste managementand water management and infrastructure, clean energy and energy efficiency measures including renovations and conversions of buildings, support to transition to a circular economy, land restoration and decontamination, as well as up- and re-skilling, training and social infrastructure, including social housing. Infrastructure developments may also include solutions leading to their enhanced resilience to withstand disasters. Comprehensive investment approach should be favoured in particular for territories with important transition needs. Investments in other sectors could also be supported if they are consistent with the adopted territorial just transition plans and directly benefit the communities in the affected regions and reduce the socio- economic costs of the transition towards a climate-neutral Europe by 2050. By supporting investments that do not generate sufficient revenues, the Facility aims at providing public sector entities with additional resources necessary to address the social, economic and environmental challenges resulting from the adjustment to climate transition. In order to help identify investments with a high positive environmental impact eligible under the Facility, the EU taxonomy on environmentally sustainable economic activities mayshall be used and the "do not significant harm" principle referred to in Regulation (EU) 2020/852 adhered to.
Amendment 42 #
2020/0100(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) In order to ensure an effective implementation of the Facility, it may be necessary to provide advisory support for the preparation, development, and implementation of projects, particularly regarding compliance with relevant sustainability criteria. This support should be provided through the InvestEU Advisory Hub.
Amendment 47 #
2020/0100(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The objective of this Regulation, namely to leverage public investment in territories, most impacted by the transition towards climate neutrality and circular economy by addressing the corresponding development needs, cannot be sufficiently achieved by the Member States alone. The main reasons in this regard are the difficulties for public entities to support investments, which do not generate sufficient streams of own revenues and benefit the territories most negatively impacted by climate transition, without EU grant support and the need for a coherent implementation framework under direct management. Since those objectives can be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. 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 53 #
2020/0100(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
The Facility shall provide support benefitting Union territories facing serious social, environmental and economic challenges deriving from the transition process towards a climate-neutral and circular economy of the Union by 2050 at the latest.
Amendment 82 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the projects achieve measurable impact in addressing serious social, economic or environmental challenges deriving from the transition process towards a climate-neutral economyand circular economy, are in line with the EU taxonomy established by Regulation (EU) 2020/852 and the "do not significant harm" principle referred to in that Regulation and benefit territories identified in a territorial just transition plan, even if they are not located in those territories;
Amendment 100 #
2020/0100(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Key performance and sustainability indicators to monitor implementation and progress of the Facility towards the achievement of climate neutrality and other environmental objectives of the Union, the adherence to the "do not significant harm" principle referred to in Regulation (EU) 2020/852, and the objectives set out in Article 3 are established in Annex II.
Amendment 101 #
2020/0100(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The performance reporting system shall ensure that data regarding the sustainability and other key performance indicators referred to in paragraph 1 are collected efficiently, effectively and in a timely, reliable and independent fashion. Beneficiaries in cooperation with finance partners shall provide to the Commission the data regarding those indicators.
Amendment 75 #
2020/0036(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) The COVID-19 pandemic is having a severe impact on the public health systems of Member States and on their economies, impacting Member States’ capacity to finance the transition towards a climate-neutral economy. Therefore, the Commission’s proposed recovery plan, ‘Next Generation EU’, is a crucial instrument to achieve the objectives of this Regulation.
Amendment 103 #
2020/0036(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Paris Agreement sets out a long-term goal to keep the global temperature increase to well below 2 °C above pre-industrial levels and to pursue efforts to keep it to 1.5 °C above pre- industrial levels23 , and stresses the importance of adapting to the adverse impacts of climate change, in a manner that does not threaten food production,24 and making finance flows consistent with a pathway towards low greenhouse gas emissions and climate-resilient development25 . _________________ 23 Article 2.1.a of the Paris Agreement. 24 Article 2.1.b of the Paris Agreement. 25 Article 2.1.c of the Paris Agreement.
Amendment 134 #
2020/0036(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Achieving climate neutrality should require astrong contributions from all economic sectors. In light of the importance of energy production and consumption on greenhouse gas emissions, the transition to a sustainable, affordable and secure energy system, while reducing energy poverty, 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. A technology-neutral approach should be taken to reach that goal.
Amendment 152 #
2020/0036(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Union has beenis pursuing and leading on an ambitious policy on climate action and has put in place a regulatory framework to achieve its 2030 greenhouse gas emission reduction target. The legislation implementing this target consists, inter alia, of Directive 2003/87/EC of the European Parliament and of the Council26 , which establishes a system for greenhouse gas emission allowance trading within the Union, Regulation (EU) 2018/842 of the European Parliament and of the Council27 , which introduced national targets for reduction of greenhouse gas emissions by 2030, and Regulation (EU) 2018/841 of the European Parliament and of the Council28 , which requires Member States to balance greenhouse gas emissions and removals from land use, land use change and forestry. _________________ 26Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a system for greenhouse gas emission allowance trading within the Union and amending Council Directive 96/61/EC (OJ L 275 of 25 October 2003, p. 32). 27Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26). 28 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1).
Amendment 198 #
2020/0036(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union should aim to achieve a balance between anthropogenic economy- wide emissions and removals, through natural and technological solutions, of greenhouse gases domestically within the Union by 2050. The Union-wide 2050 climate-neutrality objective should be pursued by all Member States collectively, and teach Member State should set out to achieve climate neutrality individually with the support of the Union. The Member States, the European Parliament, the Council and the Commission should take the necessary measures to enable its achievement. Measures at Union level will constitute an important part of the measures needed to achieve the objective.
Amendment 209 #
2020/0036(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The Commission is exploring the development of a regulatory framework for the certification of carbon removals in accordance with its Circular Economy Action Plan and the Farm to Fork Strategy. The restoration of eco-systems and the development of a carbon removals market for land-based greenhouse gas sequestration would assist in restoring, maintaining and managing natural sinks and would promote biodiversity.
Amendment 216 #
2020/0036(COD)
Proposal for a regulation
Recital 12 b (new)
Recital 12 b (new)
(12b) The Commission should come forward with a definition of natural and other carbon sinks to give clarity in this Regulation.
Amendment 222 #
2020/0036(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The Union should continue its climate action and international climate leadership after 2050, in order to protect people and the planetvide protection against the threat of dangerous climate change, in pursuit of the temperature goals set out in the Paris Agreement and following the scientific recommendations of the IPCC and of Member State Climate advisory bodies.
Amendment 226 #
2020/0036(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) National climate advisory bodies play an important role in informing the public and contributing to the policy debate around climate change in those Member States where they exist, and the establishment of such bodies at Member State level should be encouraged. The cooperation of those bodies with the Commission and with the other climate advisory bodies in EEA countries is important. The European Environment and Sustainable Development Advisory Councils (EEAC) is a network of national and regional advisory bodies which brings together experts, fosters information exchange and provides independent advice.
Amendment 230 #
2020/0036(COD)
Proposal for a regulation
Recital 13 b (new)
Recital 13 b (new)
(13b) The Commission should develop a strategy for the Union’s future climate policy for the post-2050 period once climate neutrality has been achieved.
Amendment 250 #
2020/0036(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In taking the relevant measures at Union and national level to achieve the climate-neutrality objective, Member States and the European Parliament, the Council and the Commission should take into account the contribution of the transition to climate neutrality to the health and economic well- being of citizens, the prosperity of society and the competitiveness of the economy; energy and food security and affordability; fairness and solidarity across and within Member States considering their economic capability, cost efficiency and national circumstances and the need for convergence over time; the need to make the transition just and socially fair; best available scientific evidence, in particular the findings reported by the IPCC, Member State climate advisory bodies and the Joint Programming Initiative “Connecting Climate Knowledge for Europe” (JPI Climate); the need to integrate climate change related risks into investment and planning decisions; cost- effectiveness and technological neutrality in achieving greenhouse gas emissions reductions and removals and increasing resilience; progression over time in environmental integrity and level of ambition.
Amendment 320 #
2020/0036(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The Commission should ensure a robust and objective assessment based on the most up to date scientific, technical and socio-economic findings, and representative of a broad range of independent expertise, and base its assessment on relevant information including information submitted and reported by Member States, reports of the European Environment Agency, best available scientific evidence, including the reports of the IPCC, Member States climate advisory bodies and the Joint Programming Initiative “Connecting Climate Knowledge for Europe” (JPI Climate). Given that the Commission has committed to exploring how the EU taxonomy can be used in the context of the European Green Deal by the public sector, this should include information on environmentally sustainable investment, by the Union and Member States, consistent with Regulation (EU) 2020/… [Taxonomy Regulation] when such information becomes available. The Commission should use European statistics and data where available and seek expert scrutiny. The European Environment Agency should assist the Commission, as appropriate and in accordance with its annual work programme.
Amendment 348 #
2020/0036(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to provide predictability and confidence for all economic actors, including businesses, SMEs, workers, investors and consumers, to ensure that the transition towards climate neutrality is irreversible, to ensure gradualpredictable and phased reductions over time and to assist in the assessment of the consistency of measures and progress with the climate- neutrality objective, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to set out a trajectory for achieving net zero greenhouse gas emissions in the Union by 2050. It is of particular importance that the Commission carries 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-Making37 . 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. _________________ 37Commission should monitor the progress by Member States in achieving net zero greenhouse gas emissions in the Union by 2050. OJ L 123, 12.5.2016, p. 1.
Amendment 387 #
2020/0036(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes a framework for the irreversible and gradual, predictable and phased reduction of greenhouse gas emissions and enhancement of removals by natural or other sinks in the Union.
Amendment 429 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Union-wide emissions and removals of greenhouse gases regulated in Union law shall be balanced at the latest by 2050, thus reducing emissions to net zero by that date and beyond. Each Member State shall seek to achieve climate neutrality by 2050 through the collective actions of the Union.
Amendment 459 #
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 theMember State and collective achievement of the climate- neutrality objective set out in paragraph 1, taking into account the importance of promoting fairness and solidarity among Member States.
Amendment 512 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4a. Where the Commission considers it appropriate to set an intermediary emissions reduction target for 2040, with a view of achieving climate neutrality by 2050, by 30 September 2028 it shall make a legislative proposal to the European Parliament and to the Council to that effect, following a detailed impact assessment. The impact assessment shall take into account the criteria outlined in Article 3 (3).
Amendment 523 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 4 b (new)
Article 2 – paragraph 4 b (new)
4b. Where the Commission considers it appropriate to set out targets for carbon removals by sinks for 2040 and for 2050, with a view to achieving climate neutrality by 2050, by 30 September 2028 it shall make legislative proposals to the European Parliament and the Council, following a detailed impact assessment. The impact assessment shall take into account the criteria outlined in Article 3 (3).
Amendment 525 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 4 c (new)
Article 2 – paragraph 4 c (new)
4c. Where the Commission considers it appropriate to develop a framework to certify greenhouse gas removals from land use, with a view of achieving climate neutrality by 2050, it shall make a legislative proposal to the European Parliament and to the Council to that effect, following a detailed impact assessment that is based on scientifically robust accounting methods.
Amendment 537 #
2020/0036(COD)
Proposal for a regulation
Article 3 – title
Article 3 – title
3 Trajectory for aAchieving climate neutrality
Amendment 552 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission is empowered to adopt delegated acts in accordance with Article 9 to supplement this Regulation by setting out a trajectory at Union levelshall assess the effectiveness of this Regulation to achieve the climate-neutrality objective set out in Article 2(1) until 2050. At the latest within six months after each global stocktake referred to in Article 14 of the Paris Agreement, the Commission shall review the traaluate progress towards the climate-neutrality objectoryive.
Amendment 560 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 570 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – introductory part
Article 3 – paragraph 3 – introductory part
3. When setting a trajectory assessing the progress towards the carbon neutrality goal, considering accordance with paragraph 1 2040 emissions reduction target, and considering the development of a framework to certify greenhouse gas removals, the Commission shall consider the following:
Amendment 590 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point a
Article 3 – paragraph 3 – point a
(a) cost-effectiveness and, economic efficiency and employment;
Amendment 627 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point c
Article 3 – paragraph 3 – point c
(c) best available, cost effective and scalable technologyies;
Amendment 640 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point d
Article 3 – paragraph 3 – point d
(d) energy efficiency, energy affordability, reducing energy poverty and security of supply;
Amendment 647 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point d a (new)
Article 3 – paragraph 3 – point d a (new)
(da) the need to reduce dependency on fossil fuels and to move to more renewable and sustainable energy;
Amendment 681 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point g
Article 3 – paragraph 3 – point g
(g) investment needs and opportunitiesencouragement of investment and innovation;
Amendment 766 #
2020/0036(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall develop and implement adaptation strategies and plans that include comprehensive risk management frameworks, based on robust climate and vulnerability baselines and progress assessments. Member States shall promote nature-based solutions and eco- system based adaption, which represent important greenhouse gas sequestration potential and address biodiversity loss.
Amendment 797 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point a
Article 5 – paragraph 1 – subparagraph 1 – point a
(a) the collective progress made by all Member States towards the achievement of the climate-neutrality objective set out in Article 2(1) as expressed by the trajectory referred to in Article 3(1);
Amendment 834 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point a
Article 5 – paragraph 2 – point a
(a) the consistency of Union measures with the climate-neutrality objective set out in Article 2(1) as expressed by the trajectory referred to in Article 3(1);
Amendment 852 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Where, based on the assessment referred to in paragraphs 1 and 2, the Commission finds that Union measures are inconsistent with the climate-neutrality objective set out in Article 2(1) or inadequate to ensure progress on adaptation as referred to in Article 4, or that the progress towards either the climate-neutrality objective or on adaptation as referred to in Article 4 is insufficient, it shall take the necessary measures in accordance with the Treaties, at the same time as the review of the trajectory referred to in Article 3(1).
Amendment 870 #
2020/0036(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Commission shall assess any draft measure or legislative proposal in light of the climate-neutrality objective set out in Article 2(1) as expressed by the trajectory referred to in Article 3(1) before adoption, and include this analysis in any impact assessment accompanying these measures or proposals, and make the result of that assessment public at the time of adoption.
Amendment 892 #
2020/0036(COD)
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1 – point a
Article 6 – paragraph 1 – subparagraph 1 – point a
(a) the consistency of national measures identified, on the basis of the National Energy and Climate Plans or the Biennial Progress Reports submitted in accordance with Regulation (EU) 2018/1999, as relevant for the achievement of the climate-neutrality objective set out in Article 2(1) with that objective as expressed by the trajectory referred to in Article 3(1);
Amendment 926 #
2020/0036(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Where the Commission finds, under due consideration of the collective and Member State-level progress assessed in accordance with Article 5(1), that a Member State’s measures are inconsistent with that objective as expressed by the trajectory referred to in Article 3(1) ore climate-neutrality objective or are inadequate to ensure progress on adaptation as referred to in Article 4, it may issue recommendations to that Member State. The Commission shall make such recommendations publicly available.
Amendment 961 #
2020/0036(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point d
Article 7 – paragraph 1 – point d
(d) best available scientific evidence, including the latest reports of the IPCC and National Climate Advisory bodies; and
Amendment 980 #
2020/0036(COD)
Proposal for a regulation
Article 7 a (new)
Article 7 a (new)
Article 7a Member State climate advisory bodies and European Climate Advisory Forum 1. By 1 January 2022, Member States shall establish a national climate advisory body within their territory. 2. By 1 January 2025, the Commission shall, in cooperation with of national climate advisory bodies, establish a European Climate Advisory Forum (the ‘Forum’), which will provide independent scientific advice for the Union and the EEA. 3. Depending on the subject area, one member from each national climate advisory body shall participate in the Forum. 4. The Forum shall report annually on greenhouse gas emissions reductions and removals and Union-wide progress towards the carbon neutrality objective. It shall also identify actions and opportunities to reduce emissions and enhance removals. 5. All of the Forum’s reports shall be made publicly available.
Amendment 1025 #
2020/0036(COD)
Proposal for a regulation
Article 9
Article 9
Amendment 1047 #
2020/0036(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9a Review clause The Commission shall, six months after each global stocktake referred to in Article 14 of the Paris Agreement, conduct a review of all the elements of this Regulation, in light of the criteria set out in Article 3(3) to ensure the objective of the Paris Agreement of holding the increase in the global average temperature to well below 2 °C above pre- industrial levels and to pursue efforts to limit the temperature increase to 1,5 °C above pre-industrial level and submit, if appropriate, legislative proposals to the European Parliament and Council.
Amendment 193 #
2020/0006(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) EU state aid rules must be flexible if eligible regions in transition are to attract private investment. When drafting the new guidelines, the Commission should therefore also take into account the problems of structural change in the regions concerned, in order to ensure that these regions are given sufficient flexibility to carry out their projects in a socially and economically viable manner.
Amendment 195 #
2020/0006(COD)
Proposal for a regulation
Recital 12 b (new)
Recital 12 b (new)
(12b) Support for productive investment in enterprises other than SMEs through the Just Transition Fund should not be limited to the areas eligible for State aid under the applicable State aid rules pursuant to Article 107(3)(a)and (c) TFEU. On the contrary, State aid rules should allow all regions receiving assistance through the JTF to effectively address the threat of job losses at an early stage. This should also be ensured by adapting the general block exemption Regulation accordingly;
Amendment 196 #
2020/0006(COD)
Proposal for a regulation
Recital 12 c (new)
Recital 12 c (new)
(12c) The areas most affected by the transition to a climate-neutral economy should be given the opportunity to actively address the associated structural change as early as possible. This requires adjustments to state aid law, e.g. through a new guideline of the European Commission on the basis of Article 107 (3) (b) or (c)TFEU, so that it is ensured that aid is permissible under the applicable rules regardless of the status of the assisted regions;
Amendment 242 #
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. Support shall also be provided to at least all coal mining territories in the EU, where coal is still harvested and to territories where important structural changes take place after phasing out mining activities.
Amendment 448 #
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 TFEUthe respective territories, 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.
Amendment 528 #
2020/0006(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. The JTF priority or priorities shallmay comprise the JTF resources consisting of all or part of the JTF allocation for the Member States and the resources transferred in accordance with Article [21a] of Regulation (EU) [new CPR]. The total of the ERDF and ESF+ resources transferred to the JTF priority shall be at least equal to one and a half times the amount of support from the JTF to that priority but shall not exceed three times that amount. The transfer of money from the ERDF and ESF+ to the JTF has to be excluded.
Amendment 117 #
2019/2816(RSP)
Paragraph 10
10. Asks for a special focus to be putUnderlines the need to gather new and more detailed data on emission hot spots, such as hospitals and pharmaceutical production plants, and the use of digital and big data monitoring systems;
Amendment 183 #
2019/2816(RSP)
Paragraph 21 a (new)
21 a. Calls on the European Medicines Agency to facilitate joint inspections of manufacturing discharges at overseas pharmaceuticals factories supplying the EU;
Amendment 195 #
2019/2816(RSP)
Paragraph 25 a (new)
25 a. Calls on the Commission to support research on the assessment of mixture effects, chronic exposition on low dose and antimicrobial resistance development, especially in relation to vulnerable groups of population;
Amendment 197 #
2019/2816(RSP)
Paragraph 26
26. Stresses that measures must be based on scientific evidence and calls on all relevant players to ensure that actions taken do not jeopardise access to safe and effective pharmaceutical treatments for human patients and animals; in this regard, supports the Commission’s intention to reduce waste by allowing that medicines be dispensed in quantities better matching needs, including by optimising the package size, and to explore the possibility to safely extend expiry dates for medicines to avoid that medicines that can still be safely used are unnecessarily thrown away;
Amendment 200 #
2019/2816(RSP)
Paragraph 27
27. Considers that the overall per capita drug consumption should be reduced, without jeopardising patients’ healthcausing difficulties in the access to medicines and not reducing the effectiveness of treatments; is of the opinion that the overall per animal veterinary medicines consumption should also decrease and better alternatives should be found;
Amendment 2 #
2019/2132(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Recalls that ensuring the effective and uniform application of EU law is crucial for upholding the rule of law, which is one of the founding values of the Union and its Member States, as set out in Article 2 of the Treaty on European Union; is, therefore, worried about the increasing number of petitions expressing citizens’ concerns over violations of the rule of law in the Member States, including regarding disputed reforms of national judiciaries; stresses that non-compliance with the rule of law, including by sub-national entities, has a direct impact on citizens’ lives, as demonstrated in petitions received and by the outcome of Special Eurobarometer 489; calls on the Commission to respect the commitments made in its 2019 communication entitled ‘Strengthening the rule of law within the Union: A blueprint for action’ (COM(2019)0343), in order to promote a culture of respect for the rule of law, reinforce cooperation with national authorities and ensure an effective common response to actual threats within the Union; points out that Article 4 of the Treaty on European Union requires the Union to respect the equality of Member States before the Treaties, as well as their fundamental structures, political and constitutional, especially those that seek to ensure their territorial integrity, maintain public order and safeguard national security;