659 Amendments of Mathilde ANDROUËT
Amendment 30 #
2023/2720(RSP)
Recital E a (new)
Ea. whereas alien pollinators and invasive species in Europe have a negative impact on native pollinators and are the second biggest cause of biodiversity extinction, after the degradation and destruction of natural habitats;
Amendment 36 #
2023/2720(RSP)
Paragraph 1
1. Welcomes the revised EU Pollinators Initiative – A new deal for pollinators and underlines the urgent need for the Commission, the Member States and regional and local actors to take concrete action to reverse pollinator decline as soon as possible and by 2030 the latest;
Amendment 45 #
2023/2720(RSP)
Paragraph 3
3. Recognises the contribution made by the first EU Pollinators Initiative and appreciates its results;
Amendment 53 #
2023/2720(RSP)
Paragraph 4
4. Recalls that the European Green Deal was adopted as a new holistic strategy enabling the Union to tackle climate and environment-related challenges while leaving no one behind; recalls that the objectives of the Green Deal will be met only when the main goal of the revised EU Pollinators Initiative, namely to reverse pollinator decline, is effectively achieved;
Amendment 60 #
2023/2720(RSP)
Paragraph 6
Amendment 84 #
2023/2720(RSP)
Paragraph 10
10. Takes note of the European Food Safety Authority’s (EFSA) revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) and, calls on the Commission and the Member States to implement it swiftly, calls on the Commission to mandate the EFSA to issue an opinion on the use of pure organic acids to combat the development of Varroa in order to determine whether their use could be more widely authorised, and lastly calls for funding for research into protecting native pollinators from alien pollinators and invasive species;
Amendment 107 #
2023/2720(RSP)
Paragraph 14
14. RegretNotes the lack of coordinated efforts to address light pollution, with some countries adopting national policies and others taking no action;
Amendment 118 #
2023/2720(RSP)
Paragraph 16
16. Stresses that linear infrastructure in the EU should be designed, managed and adapted so as to minimise negative effects in the form of habitat fragmentation, and must not undermine the integrity of the ‘Buzz Lines’ network project or network of ecological corridors and habitats for pollinators, allowing species to move in search of food, shelter and nesting and breeding sites;
Amendment 123 #
2023/2720(RSP)
Paragraph 17
17. Calls on the Commission and the Member States to develop a standardisedcoordination scheme for EU pollinator monitoring scheme to improve the gathering of data about the pollinator population; calls on the Member States to support training and capacity building in order to rapidly obtain the human resources required for pollinator monitoring;
Amendment 133 #
2023/2720(RSP)
Paragraph 18
18. Supports the implementation of the EU pollinator monitoring scheme and the integration of a specific indicator for the common agricultural policy, which will evaluate the policy’s impact on both pollinators and pollination;
Amendment 146 #
2023/2720(RSP)
Paragraph 21
21. Calls on the Commission and the Member States to support research to better understand the interactions, including in terms of competition, between honeybee colonies and native/alien/wild pollinators;
Amendment 150 #
2023/2720(RSP)
Paragraph 22
22. Calls on the Commission and the Member States to actively engage in bee diplomacy as a foreign policy tooltool in free-trade agreements to promote the inclusion of pollinators in international policies;
Amendment 153 #
2023/2720(RSP)
Paragraph 23
23. Recognises the importance of citizen scientists and taxonomists, who need to be supported further so that they can strengthen their expertise and good practices and can share them across Member States; appreciates the successful work of Pollinator Ambassadors in motivatingraising the awareness of citizens and businesses;
Amendment 60 #
2023/2075(INI)
Motion for a resolution
Recital B
Recital B
B. whereas premature deaths as a result of cardiovascular diseases (CVDs), cancers, diabetes and chronic respiratory diseases account for 68 % of all premature deaths in Europe; whereas other NCDs include mental and neurological disorders, kidney diseases, liver diseases, oral diseases, osteoporosis, osteoarthritis and, endometriosis among other condind myocardial infarctions;
Amendment 78 #
2023/2075(INI)
Motion for a resolution
Recital C
Recital C
C. whereas NCDs account for the largest share of countries’ healthcare expenditures, costing EU economies and whereas workers suffering from NCDs are expected to lose potential productive years of output worth EUR 115 billion per year, or 0.8 % of GDP annually as well as entailing other societal costs such as loss of productivity and workforce; whereas in 2018, no more than 2.8 % of total health expenditure in the EU was spent on prevention, whereas the costs of treating NCDs remains high5; _________________ 5 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 15, June 2022.
Amendment 95 #
2023/2075(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas the repercussions of NCDs go beyond individual health to affect the whole economy and social fabric; whereas it is imperative to take global measures on the various issues pertaining to NCDs;
Amendment 103 #
2023/2075(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
Db. whereas the economic effects of NCDs manifest themselves in the loss of potential years of productive life; whereas this has an impact on part of the economy of the Member States;
Amendment 138 #
2023/2075(INI)
Motion for a resolution
Recital F
Recital F
F. whereas most NCDs are impacted by environmental risk factors such as air pollution;
Amendment 193 #
2023/2075(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas people with one or more NCDs were one of the population cohorts most severely affected during the COVID- 19 pandemic;
Amendment 196 #
2023/2075(INI)
Motion for a resolution
Recital H b (new)
Recital H b (new)
Hb. whereas antimicrobial resistance (AMR) significantly disrupts medical procedures such as surgical procedures, dental implants, cancer treatments and organ transplants ; whereas AMR also makes it more difficult to manage prevalent NCDs, including cardiovascular disease, dementia and tumours;
Amendment 203 #
2023/2075(INI)
Motion for a resolution
Recital H c (new)
Recital H c (new)
Hc. whereas one cargo ship produces as much fine particle pollution as all of the cars in France and there are thousands of them sailing around the world as a result of unfettered free trade; whereas this widespread pollution harms air and water quality, and ultimately Europe's citizens;
Amendment 347 #
2023/2075(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Acknowledges that the harmful use of alcohol is a risk factor for multiple NCDs and underlines that the lower the amount of alcohol consumed, the lower the risk is of developing NCDs14; stresses the importance of good-qualitty preventive measures in the Member States, especially for young people; _________________ 14 Global burden of disease 2016 Alcohol Collaborators, ‘Alcohol use and burden for 195 countries and territories,1990–2016: a systematic analysis for the Global Burden of Disease Study 2016’, 23 Augusaoût 2018.
Amendment 394 #
2023/2075(INI)
Motion for a resolution
Paragraph 8 – introductory part
Paragraph 8 – introductory part
8. Notes that an unhealthy diet is one of the major risk factors for NCDs, including cardiovascular diseases, cancer, diabetes, oral and dental diseases and other conditions linked to obesity15; acknowledges that obesity is considered a risk factor for several NCDs; calls on the Commission and the Member States to: _________________ 15 World Health Organization Regional Office for the Eastern Mediterranean, ‘Noncommunicable diseases’.
Amendment 464 #
2023/2075(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Member States to improve physical and sporting activities in schools in order to reduce the risk of NCDs; stresses that physical tests (in respect of sport) should be carried out to detect various risk factors in children;
Amendment 492 #
2023/2075(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and the Member States to accelerate the transition to sustainable energy and transport sectorssuch as nulear energy and to ensure a shift towards sustainable and local food systems;
Amendment 494 #
2023/2075(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Commission and the Member States to limit the expansion of globalisation which is pushing maritime freight cargo towards seas and oceans; calls, therefore, on the Commission to call into question the many free trade agreements;
Amendment 564 #
2023/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the importance of identifying people with a high risk of developing NCDs and diagnosing people as early as possible to improve disease management, prevent complications and save downstream costs for healthcare systems and calls for fair, accessible self- management tools to be set up;
Amendment 675 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Invites the Commission to publish a study on the current state of affairs in respect of and the impact of the shortage of health-care workers in the European Union;
Amendment 684 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19a. Considers that health-care systems need to focus research on the early detection of NCDs, as well as overall improvements in the management of these various diseases;
Amendment 722 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Stresses the urgent need to combat regional disparities in access to health care by striving to ensure availability of quality NCD management on an equitable basis in different geographical areas within Member States with a view to eradicating medical deserts;
Amendment 755 #
2023/2075(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes public-private partnerships as a way of strengthening innovation in healthcare; highlights the European Health Innovation Collaborative, which promotes entrepreneurship and innovation in the healthcare sector and brings together academia, research, and industry to foster collaboration and investment in health technologies; encourages the Commission and the Member States to foster and accelerate public-private partnerships while putting public interests first; underlines the fact that public health is a common good to be defended;
Amendment 779 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Stresses that the COVID-19 pandemic has shown the limits of dependence on third countries for medicines; proposes redoubling EU efforts to solve the problem of medicine shortages, encouraging the relocation of production facilities and specifically examining shortages of generic medicines;
Amendment 805 #
2023/2075(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Calls on the Commission to establish five EU NCD partnerships: ‘beating NCDs – children’, ‘beating NCDs – young people, ‘beating NCDs – adults’, ‘beating NCDs – elderly people’ and ‘beating NCDs – vulnerable groups’; believes that such partnerships should bring together Member States and national authorities to draft roadmaps and innovative proposals to ensure effective and targeted actions against NCDs; invites, however, the Member States to establish a strategy tailored to suit their own population which, rather than compartmentalising care, uses a comprehensive approach with a view to ensuring better patient care;
Amendment 62 #
2023/2074(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas ‘tackling stigma’ is the second point in the Declaration of Helsinki: - foster awareness of the importance of mental well-being; - collectively tackle stigma, discrimination and inequality, and empower and support people with mental health problems and their families to be actively engaged in this process; - design and implement comprehensive, integrated and efficient mental health systems that cover promotion, prevention, treatment and rehabilitation, care and recovery; - address the need for a competent workforce, effective in all these areas; - recognise the experience and expertise of service users and carers as an important basis for planning and developing services;
Amendment 98 #
2023/2074(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas since March 2020 the COVID-19 epidemic and the decisions taken to contain it have turned everyone’s lives upside down, with visible impacts at the economic, social and emotional levels; whereas the major challenge is to maintain a balance between health needs and the impact on life within society;
Amendment 107 #
2023/2074(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the risks may develop at any stage of life, but those that occur at critical periods of development, particularly in early childhood, are especially damaging; whereas research should be focused as a priority on that section of the population;
Amendment 112 #
2023/2074(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Cc. whereas in order to act on the determining factors for mental health, it is often necessary to take measures that go beyond the health sector itself; whereas promotion and prevention programmes should therefore ensure that the sectors of education, work, justice, transport, the environment and housing are involved;
Amendment 217 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses the profound impact of exposure to illness on healthcare staff and on the well-being of carers, and calls urgently for their specific needs for psychological care to be identified and responded to through specific training using dedicated tools;
Amendment 227 #
2023/2074(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
Amendment 263 #
2023/2074(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Member States to increase diagnosis among children, as it is said that most mental health issues develop before the age of 14;
Amendment 265 #
2023/2074(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Stresses that mental health issues cover a very wide spectrum, from moderate and one-off issues to severe, chronic and disabling issues;
Amendment 293 #
2023/2074(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Stresses that, according to the Quebec Public Health Institute (2008), prejudice surrounding mental illness results in nearly 2/3 of people who are experiencing difficulties not seeking the help they are so much in need of;
Amendment 308 #
2023/2074(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is deeply concerned by the poor availability of mental healthcare services and of specific 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 and the lack of funding aggravate the issue;
Amendment 358 #
2023/2074(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Recommends greater use of screening tools to improve the diagnosis of mental health needs, such as the use of screening to detect psychological distress among cancer patients;
Amendment 392 #
2023/2074(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Stresses how important it is to improve the integration of psychological care into the care journey, and to have multidisciplinary teams for illnesses such as cancer and other non-transmissible illnesses;
Amendment 432 #
2023/2074(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls on the Commission to collaborate with the Member States to improve the Europe-wide mapping of gaps in personnel working in mental health, and the responses to be made; stresses that sharing skills strengthens knowledge and improves health systems as a whole;
Amendment 437 #
2023/2074(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Calls on the Member States to take more account of pervasive developmental disorders (PDDs); stresses the importance of providing care for persons suffering from these disorders; points out that measures vary from country to country and that state-of-the-art research must be put in place at EU level;
Amendment 446 #
2023/2074(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Suggests that the Commission and Member States should support a programme to improve the return-to-work rights of employees with mental health issues or other illnesses;
Amendment 459 #
2023/2074(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Invites the Commission and the Member States to invest in further research on mental health, particularly on the interaction between mental health and other illnesses, to achieve comprehensive research;
Amendment 489 #
2023/2074(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for the EU and the Member States to urgently develop psychosocial mental health support structures aimed specifically at victims of natural, climate, humanitarian, geopolitical and conflict- related disasters, and asylum seekers and migrants from all backgrounds;
Amendment 501 #
2023/2074(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Invites the Commission, together with the Member States, to further develop its Mental Health Strategy and draw up concrete targets and goals for the future, including more in-depth initiatives, from a bottom-up perspective;
Amendment 522 #
2023/2074(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Considers that the EU lacks a direct fund for mental health research and innovation and invites the Commission to create a mission on mental health under the Horizon Europe programme and the future programme in the 2028-2035 multiannual financial framework; stresses that health is a prerogative of the Member States and that therefore the Commission must not encroach upon the jurisdiction of Member States;
Amendment 28 #
2023/2010(INI)
Motion for a resolution
Citation 16 a (new)
Citation 16 a (new)
— having regard to the European Environment Agency (EEA) report of 23 November 2020 entitled ‘Air quality in Europe - 2020 report’,
Amendment 30 #
2023/2010(INI)
Motion for a resolution
Citation 16 b (new)
Citation 16 b (new)
— having regard to the International Union for Conservation of Nature (IUCN) report of 27 October 2020 entitled ‘The Mediterranean: Mare plasticum’,
Amendment 31 #
2023/2010(INI)
Motion for a resolution
Citation 16 c (new)
Citation 16 c (new)
— having regard to the Convention on the Conservation of European Wildlife and Natural Habitats (Bern Convention),
Amendment 32 #
2023/2010(INI)
Motion for a resolution
Citation 17
Citation 17
Amendment 70 #
2023/2010(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the international trade fostered by the free trade agreements that are ratified by the Commission affects biodiversity and ecosystems;
Amendment 78 #
2023/2010(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas densification generally entails the risk of cutting city dwellers off from nature and exposing them to many health hazards (air pollution, noise, etc.);
Amendment 84 #
2023/2010(INI)
Motion for a resolution
Recital A c (new)
Recital A c (new)
Ac. whereas, according to the latest figures, there are 1 525 ecoregions on the planet, divided into three categories: terrestrial ecoregions, freshwater ecoregions and coastal and marine ecoregions; whereas each ecoregion is home to a variety of ecosystems and natural environments;
Amendment 89 #
2023/2010(INI)
Motion for a resolution
Recital A d (new)
Recital A d (new)
Ad. whereas ecosystems not only support the life of the organisms that inhabit them but also provide services that are beneficial to mankind; whereas these services account for the equivalent of USD 33 000 billion per year (1.8 times the global gross national product);
Amendment 100 #
2023/2010(INI)
Motion for a resolution
Recital A e (new)
Recital A e (new)
Amendment 103 #
2023/2010(INI)
Motion for a resolution
Recital A f (new)
Recital A f (new)
Af. whereas soil is an essential, complex, multifunctional and living ecosystem of crucial environmental and socio-economic importance, as it performs many essential functions and delivers services that are vital to human activities and the survival of ecosystems;
Amendment 108 #
2023/2010(INI)
Motion for a resolution
Recital A g (new)
Recital A g (new)
Ag. whereas soil organic matter performs many environmental functions; whereas it constitutes a temporary reservoir of organic carbon, which can act as a source of carbon capture or carbon sink;
Amendment 115 #
2023/2010(INI)
Motion for a resolution
Recital A h (new)
Recital A h (new)
Ah. whereas the stock of organic carbon in agricultural soils has decreased;
Amendment 118 #
2023/2010(INI)
Motion for a resolution
Recital A i (new)
Recital A i (new)
Ai. whereas disparities between soil types exist and sensitivity to environmental pressures therefore varies, and whereas, consequently, methods of approach must take into account both the technical and historical aspects of a given territory;
Amendment 121 #
2023/2010(INI)
Motion for a resolution
Recital A j (new)
Recital A j (new)
Aj. whereas soil, which hosts 25% of the world's biodiversity, plays a central role as a habitat and gene pool, whereas it performs key ecosystem services such as the provision of food and of raw materials, carbon sequestration, water purification, nutrient regulation and pest control, whereas it serves as a platform for human activity and whereas it limits the risk of floods and droughts;
Amendment 127 #
2023/2010(INI)
Motion for a resolution
Recital A k (new)
Recital A k (new)
Ak. whereas erosion is a natural phenomenon which can create mudflows that sometimes have disastrous consequences, causing deep gullies to emerge, thus leading to the loss of the soil’s fertile surface layer, and whereas, in the long term, erosion can lead to soil degradation and the loss of cultivable land;
Amendment 131 #
2023/2010(INI)
Motion for a resolution
Recital A l (new)
Recital A l (new)
Al. whereas erosion is both a national and a European concern: 17% of Europe’s territory is affected by erosion, according to the European Environment Agency (EEA);
Amendment 133 #
2023/2010(INI)
Motion for a resolution
Recital A m (new)
Recital A m (new)
Am. whereas, in Europe, a little over a fifth of soils are susceptible to wind erosion, of which 3% (13 million hectares) are highly susceptible;
Amendment 134 #
2023/2010(INI)
Motion for a resolution
Recital A n (new)
Recital A n (new)
An. whereas no Member State is spared from coastal erosion, and whereas that retreat of the coastline leads to soil erosion on Europe’s coasts;
Amendment 135 #
2023/2010(INI)
Motion for a resolution
Recital A o (new)
Recital A o (new)
Ao. whereas soil plays a role in the beauty of our European landscapes, along with forest areas, coastlines, mountainous areas and all of Europe’s ecosystems;
Amendment 136 #
2023/2010(INI)
Motion for a resolution
Recital A p (new)
Recital A p (new)
Ap. whereas voluntary national initiatives and existing national measures are essential to the achievement of greater soil protection with a view to meeting the SDG 15 targets;
Amendment 137 #
2023/2010(INI)
Aq. whereas soil and land degradation has inherent transboundary aspects linked, for example, to climate change and pollution, and whereas it requires a response at EU level with agreements between bordering Member States in order to achieve one of the SDG 15 targets;
Amendment 138 #
2023/2010(INI)
Motion for a resolution
Recital A r (new)
Recital A r (new)
Ar. whereas the outermost regions (ORs) and the overseas countries and territories (OCTs) have specific soil types, such as soil which has developed on an old volcanic base, and consequently they have their own specific characteristics;
Amendment 148 #
2023/2010(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses its commitment to the 2030 Agenda, especially in light of the new geopolitical landscape and the ongoing climate, biodiversity and health crises; warns against further polarisation in the distribution of wealth and income, which would lead to increased inequality and poverty; highlights, against this backdrop, the importance of the SDGs, which provide a universal compass for people’s prosperity and to protect the planet; recalls that a pledge to leave no one behind lies at the heart of the 2030 Agenda and that the achievement of the SDGs should benefit all countries, people and segments of society, giving priority to inhabitants of the European continent;
Amendment 159 #
2023/2010(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Highlights the fact that, at the halfway point in the 2030 Agenda timeline, EU leadership in the global implementation of the SDGs remains crucial; underlines that 2023 offers a unique opportunity to gather momentum and undertake the urgent transformative action required to place our societies firmly on course to achieve the SDGs; warns that the consequences of inaction in this crucial year would primarily be borne by the most vulnerable people;
Amendment 171 #
2023/2010(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes that the implementation process for almost all the SDGs is lagging and that two consecutive years of regression have been recorded for many indicators9owing to constraints imposed by the COVID-19 crisis and particularly the successive lockdowns of the global population; reaffirms the importance of each SDG and highlights the key challenges that persist for sustainable development, particularly in relation to poverty (SDG 1), hunger (SDG 2), health (SDG 3), education (SDG 4), climate change (SDG 13), oceans (SDG 14) and biodiversity (SDG 15); underlines the strategic role that SDG 10, on reducing inequality, can play in the global implementation of the 2030 Agenda; _________________ 9 UN Sustainable Development Report 2022, ‘From Crisis to Sustainable Development: the SDGs as Roadmap to 2030 and Beyond’: https://resources.unsdsn.org/2022- sustainable-development-report.
Amendment 209 #
2023/2010(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
Amendment 229 #
2023/2010(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to continue integrating the SDGs into the European Semester and to use the country- specific non-binding recommendations to systematically measure Member States’ progress and set out concrete proposals for improvement;
Amendment 239 #
2023/2010(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 252 #
2023/2010(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Recalls that voluntary national reviews are the cornerstone of the follow- up and review framework for the 2030 Agenda and a key accountability tool; welcomes the Commission’s initiative to draft and present the first EU and non- binding voluntary review report in 2023;
Amendment 263 #
2023/2010(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reiterates the call on the Commission to establish a new permanent platform for regular and structured engagement with civil society organisations, intermediary organisations and European scientific organisations in order to systematically involve them in a meaningful way in the SDG implementation process;
Amendment 278 #
2023/2010(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Underlines the importance of enhanced cooperation with partners in the Global South, particularly the African Union and civil society representatives, in order to implement the 2030 Agenda globally in order to implement the 2030 Agenda globally, while prioritising our European interests in economic, social and environmental matters;
Amendment 283 #
2023/2010(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses, in this regard, that the EU and its Member States must avoid negative spillover effects at the expense of the Global South, which occur as a result of their past economic and technological model; advocates cooperation with global partners to turn any negative spillover effects into virtuous circles; calls for all EU policies to be subject to a mandatory SDG check to provide more insight on and address any negative effects and ensure that change in this area is measurable;
Amendment 298 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Reiterates that to achieve the SDGs, the 2030 Agenda requires a strong level of societal legitimacy and a genuine political reset; emphasises the invaluable role the Member States play;
Amendment 301 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Emphasises the importance of improved cooperation among Member States in order to achieve SDG 14’s target of combating illegal fishing;
Amendment 304 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Calls on the Commission to promote biodiversity within EU youth programmes such as the European Voluntary Service, and to launch a Green Erasmus programme focused on the restoration and conservation of natural environments; reiterates its calls for a specific mission and funding dedicated to biodiversity within future research programmes;
Amendment 307 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Calls on the Member States to scale up the different scientific modules on biodiversity, in particular;
Amendment 309 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12e. Emphasises that biodiversity protection should take place in cooperation with the territory’s stakeholders so that it adds to the final value of the products concerned (wood of better quality, commercial enhancement of exports);
Amendment 310 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 f (new)
Paragraph 12 f (new)
12f. Calls on the Commission and Member States with one or more coastlines to introduce measures for harmonised data collection, information exchange and best practice on coastline retreat across the Union;
Amendment 311 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 g (new)
Paragraph 12 g (new)
12g. Is of the view that the adoption of the new comprehensive implementation strategy should be preceded by a broad consultation process with Member States, as well as a public participatory consultation process;
Amendment 320 #
2023/2010(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Points out that, in order to assess the Member States’ progress on the SDGs, the Eurostat sustainable development indicators must be improved by filling the gaps for some SDGs and better measuring policies’ impact on territories and specific vulnerable groups;
Amendment 325 #
2023/2010(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Emphasises that Member States will be taking part in the comprehensive collection of data by sharing their progress and any constraints there are regarding specific SDGs;
Amendment 332 #
2023/2010(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes, furthermore, that important data remains unavailable on global, national and regional development policies in the Global South, particularly with regard to the poorest and most marginalised people;
Amendment 342 #
2023/2010(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
Amendment 348 #
2023/2010(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
Amendment 350 #
2023/2010(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Laments the fact that the list of invasive exotic species of concern to the EU includes less than 6% of the invasive exotic species that are present in Europe; calls on the Commission to ensure proper coverage of invasive exotic species affecting threatened species on the EU list and to step up 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;
Amendment 351 #
2023/2010(INI)
Motion for a resolution
Paragraph 16 c (new)
Paragraph 16 c (new)
16c. Emphasises that numerous invasive exotic plants can cause problems for public health; notes that their pollen can be particularly allergenic for some people, as is the case with ragweed (Ambrosia artemisiifolia), to which 10 % of the French population is thought to be sensitive; notes that, for others, sap can cause burns when it comes into contact with the skin, as is the case with giant hogweed (Heracleum mantegazzianum);
Amendment 352 #
2023/2010(INI)
Motion for a resolution
Paragraph 16 d (new)
Paragraph 16 d (new)
16d. Calls on the Commission to ensure that spending related to invasive exotic species and the Union’s programmes takes sufficient account of these impacts on the biodiversity of the outermost regions;
Amendment 353 #
2023/2010(INI)
Motion for a resolution
Paragraph 16 e (new)
Paragraph 16 e (new)
16e. Emphasises the urgent need to work with financial institutions so that they can define and adopt investment strategies and targets to align financial portfolios with the SDGs and regularly report on progress;
Amendment 356 #
2023/2010(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Recalls the broad recognition, when the SDGs were adopted, of the need to ‘go from billions to trillions’ in financing for development but recalls that in its Global Outlook on Financing for Sustainable Development 2019, the OECD emphasised the need not only to ‘mobilise a greater quantity of financial resources for developing countries’ but also to focus on the quality, or sustainable development footprint, of all finance; is alarmed by the fact that the SDG financing gap has instead grown from USD 2.5 trillion to USD 4 trillion per year10; _________________ 10 Organisation for Economic Co-operation and Development (OECD), Global Outlook on Financing for Sustainable Development 2023: No Sustainability Without Equity, OECD Publishing, Paris, 2022: https://doi.org/10.1787/fcbe6ce9-en.
Amendment 372 #
2023/2010(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for the preparation of an EU financing plan for the SDGs; underlines that the 2030 Agenda should guide all EU financing tools and their programming; calls on the Commission to put forward a proposal for a social taxonomy to complement the green taxonomy and help implement the European Green Deal;
Amendment 406 #
2023/2010(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Strongly welcomes the Bridgetown Initiative in this regard and calls on the Commission and the Member States to constructively and proactively engage in the relevant discussions in international forums throughout 2023 so that ambitious reforms can be achieved swiftly; emphasises that this initiative to change the IMF’s rules and to finance infrastructure that is resilient to climate change in poor countries can only work if it directly benefits the local populations concerned;
Amendment 407 #
2023/2010(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Strongly welcomes the Bridgetown Initiative in this regard and calls on the Commission and the Member States to constructively and proactively engage in the relevant discussions in international forums throughout 2023 so that ambitious reforms can be achieved swiftly; emphasises that this initiative to change the IMF’s rules and to finance infrastructure that is resilient to climate change in poor countries can only work if it directly benefits the local populations concerned;
Amendment 438 #
2023/2010(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission to draw up a comprehensive map of the financial envelopes for the EU’s policies, programmes and funds, including investments and structural reforms carried out under the Recovery and Resilience Facility;
Amendment 466 #
2023/2010(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Reiterates that the SDGs are the only globally agreed and comprehensive set of goals on the great challenges ahead and the 2030 Agenda should therefore serve as a guiding light for navigating through the current uncertainties; highlights the opportunity that the SDGs provide to establish a true well-being economy centred onn economy that really works for people and for the planet and to work towards a sustainable world beyond 2030;
Amendment 1 #
2023/0353(NLE)
Draft legislative resolution
Paragraph 1
Paragraph 1
1. GRefuses to gives its consent to the conclusion of the agreement
Amendment 39 #
2023/0228(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) In the light of new technical and scientific developments, the update of the Rules and Regulations of the Organisation for Economic Co-operation and Development (OECD) Scheme for the Certification of Forest Reproductive Material Moving in International Trade21 (‘OECD Forest Seed and Plant Scheme’), the new policy priorities of the Union in relation to sustainability, climate change adaptation and biodiversity and in particular the European Green Deal22, as well as the experience gained during the implementation of Directive 1999/105/EC, that Directive should be replaced by a new act. In order to ensure uniform application of the new rules throughout the Union, the act should take the form of a Regulation. _________________ 21 Decision of the Council Establishing the OECD Scheme for the Certification of Forest Reproductive Material Moving in International Trade [OECD/LEGAL/0355]. 22 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 - The European Green Deal (COM/(2019/)640 final).
Amendment 42 #
2023/0228(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Regulation (EU) 2021/1119 requires relevant Union institutions and Member States to ensure continuous progress in enhancing adaptive capacity, strengthening resilience and reducing vulnerability to climate change. One of the aims of the new EU Strategy on Adaptation to Climate Change is therefore to accelerate the adaptative capacity of the Union to climate change, by amending the rules on FRM, amongst others. The Union legislation should encourage the Union wide production and marketing of FRM. To this end, the possibility for Member States to restrict the approval of certain basic material and to prohibit the marketing of certain FRM to final users, as it it set out in Directive 1999/105/EC, should be abolished, while guaranteeing buyers considerable freedom of choice and giving them the opportunity to experiment with new seeds.
Amendment 45 #
2023/0228(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The new EU Forest Strategy for 2030 has as its key objectives effective afforestation, and forest preservation and restorconservation in the Union, to help increase the absorption of CO2, reduce the incidence and extent of forest fires, and promote the bio-economy, in full respect of ecological principles favourable to biodiversity. Ensuring forest restorconservation and reinforced sustainable forest management are essential for climate adaptation and forest resilience. In this regard, the new EU Forest Strategy states that adapting forests to climate change and restoring forests following climate damages will require large quantities of appropriate FRM. This implies efforts to secure and sustainably use the forest genetic resources on which a more climate- proof forestry depends. Efforts are also needed to increase the production and availability of such FRM, to provide better information on its suitability for climatic and ecological conditions and to enhance its collaborative production and transfer across national borders within the Union. Professional operators should thus be required to provide beforehand information to the users about the suitability of FRM for climatic and ecological conditions.
Amendment 47 #
2023/0228(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In order to ensure a sufficient supply of FRM in response to the increased demand for FRM, it is necessary to remove any actual or potential barriers to trade, which may hinder the free movement of FRM within the Union. This aim can be achieved only if the respective Union rules on FRM impose the highest possible standards in relation to the quality required.
Amendment 48 #
2023/0228(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) The opinion of the Enlarged Board of Appeal of the European Patent Office of 14 May 2020, which follows the adoption by the European Parliament of Resolution 2019/2800 (RSP) on the patentability of plants and essentially biological processes, excludes essentially biological processes from patentability. The national register and the national lists of basic material defined in Article 12 of this Regulation must take this into account.
Amendment 50 #
2023/0228(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) The aim of this Regulation is to ensure the production and marketing of high-quality FRM. To help create resilient forests and restorconserve forest ecosystems, users should be informed prior to the purchase of FRM about the suitability of that FRM for the climatic and ecological conditions of the area where it will be used.
Amendment 52 #
2023/0228(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Only FRM that has been harvested from approved basic material should be allowed to be subsequently certified and placed on the market. FRM should be certified as ‘source- identified’, ‘selected’, ‘qualified’ and ‘tested’ by the competent authorities and be marketed with a reference to those categories. Those types of categories show which of the characteristics of the basic material have been assessed and they indicate the quality of the FRM. For lower quality FRM (‘source-identified’ and ‘selected’ categories), basic material will be checked for basic characteristics. For higher quality FRM (‘qualified’ and ‘tested’ categories), parent trees will be selected for outstanding characteristics and crossing schemes designed. In the case of FRM of the ‘qualified’ category, the superiority of the FRM estimated on the basis of the characteristics of the parent trees. In the case of the ‘'tested’' category, it is necessary to demonstrate the superiority of thate FRM must be demonstrated inas comparisoned with either the basic material from which that FRM has beenit was harvested or as compared with a reference population. The ‘FRM categories 'source-identified’', ‘'selected’', ‘'qualified’' and ‘'tested’ categories of FRM' should be subject to uniform production and marketing requirements, to ensure transparency, equal terms of in order to guarantee transparency, a level playing field for competition and the integrity of the internal market.
Amendment 53 #
2023/0228(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Pursuant to the OECD Forest Seed and Plant Scheme and following the application of Directive 1999/105/EC, the competent authority should assess basic material intended for the production of FRM of the selected category based on the observation of the characteristics of that basic material, taking account of the specific purpose for which the FRM harvested from that basic material is to be used. The overall quality of that category should be ensured. As the population should show a high degree of uniformity, trees that have inferior characteristics (e.g. smaller size) in comparison to the average tree size in the overall population should be removed.
Amendment 67 #
2023/0228(COD)
Proposal for a regulation
Recital 61
Recital 61
Amendment 94 #
2023/0228(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 9 a (new)
Article 3 – paragraph 1 – point 9 a (new)
(9a) 'FRM' means the character of a species that defines its value. That value is determined by the use and sensory perception of buyers or users, by the products, fruits or quantities of the nutrients of the fruits of this species, by the rarity of the species in biodiversity, by the phenotype or genotype of the species according to characteristics specific to its consumption, or by the reproductive function of that species. High-quality seed is therefore seed whose quality varies from one species to another according to the above-mentioned criteria.
Amendment 113 #
2023/0228(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point a
Article 5 – paragraph 1 – point a
(a) FRM of the species listed in Annex I may only be marketcertified, if it is of the categories ‘source-identified’, ‘selected’, ‘qualified’ or ‘tested’, and it has been derived from basic material that has been approved pursuant to Article 4 and if that basic material meets the requirements of Annexes II, III, IV and V, respectively;
Amendment 121 #
2023/0228(COD)
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2a. Member States shall recognise the right of professional operators to conserve and use seed from basic material and FRM.
Amendment 122 #
2023/0228(COD)
Proposal for a regulation
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
In order for FRM derived from basic material subject to the derogation of Article 18 to be marketcertified, all the following conditions shall be fulfilled:
Amendment 123 #
2023/0228(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) FRM of the species listed in Annex I may only be marketcertified, if it is of the ‘source-identified’ category;
Amendment 142 #
2023/0228(COD)
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
Each Member State shall establish, publish and keep updated, in electronic format, a national register of the basic material of the various species approved on its territory pursuant to Articles 4 and 19 and notified pursuant to Article 18. This national register shall comply with the opinion of the Enlarged Board of Appeal of the European Patent Office of 14 May 2020, which confirmed the exclusion from patentability of essentially biological processes for the production of plants or animals.
Amendment 89 #
2023/0227(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Article 9 of the International Treaty on Plant Genetic Resources for Food and Agriculture, signed by all Member States, stipulates, inter alia, that farmers have the right ‘to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate’.
Amendment 99 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) to ensure equal conditions for the competition of the professional operators across the Union and the functioning of the internal market in PRM;, while preserving small structures that offer seeds adapted to the specificities of each growing condition as well as local or national food and cultural particularities.
Amendment 100 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
(d) to contribute to conservation and sustainable use of plant genetic resources and agro-biodiversity;, in particular by prohibiting the use of new GMOs (NGTs) whose studies highlight the dangers to bio-diversity, including cultivated bio- diversity.
Amendment 102 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) to contribute to sustainable agricultural production, adapted to current and future projected climatic conditions;, in particular by promoting the self- generation of farmer‑saved seeds.
Amendment 105 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) to contribute to food security, building in particular on Article 9 of the International Treaty on Plant Genetic Resources for Food and Agriculture, which recognises, on the one hand, ‘the enormous contribution that the local and indigenous communities and farmers of all regions of the world have made and will continue to make for the conservation and development of plant genetic resources’ and, on the other hand, the right of farmers ‘to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate’.
Amendment 80 #
2023/0085(COD)
Proposal for a directive
Recital 16
Recital 16
(16) The assessment made to substantiate explicit environmental claims needs to consider the life-cycle of the product or of the overall activities of the trader and should not omit any relevant environmental aspects or environmental impacts, such as the environmental impact of a product imported from a third country. The benefits claimed should not result in an unjustified transfer of negative impacts to other stages of the life cycle of a product or trader, or to the creation or increase of other negative environmental impacts.
Amendment 113 #
2023/0085(COD)
Proposal for a directive
Recital 30
Recital 30
(30) While unfair commercial practices, including misleading environmental claims, are prohibited for all traders pursuant to Directive 2005/29/EC84, an administrative burden linked to substantiation and verification of environmental claims on the smallest companies could be disproportionate and should be avoided. To this end, microenterprises should be exempted from the requirements on substantiation of Article 3 and 4 unless these enterprises wish to obtain a certificatean alternative to third-party certification should be provided for micro, small and medium-sized enterprises on the basis of a declaration of conformity of explicit environmental claims that will be recognised by the competent authorities across the Union. _________________ 84 Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to- consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (Unfair Commercial Practices Directive) (OJ L 149, 11.6.2005, p. 22) as amended.
Amendment 138 #
2023/0085(COD)
Proposal for a directive
Recital 37
Recital 37
(37) In order to avoid potential disproportionate impacts on the micro, small and medium-sized enterprises, the smallest companies should be exempted from the requirements of Article 5 linked to information on the substantiation of explicit environmental claims unless these enterprises wish to obtain a certificate of conformity of explicit environmental claim that will be recognised by the competent authorities across the Union.
Amendment 166 #
2023/0085(COD)
Proposal for a directive
Recital 54
Recital 54
(54) Small and medium-sized enterprises (SMEs) should be ablegiven sufficient support to benefit from the opportunities provided by the market for more sustainable products but, as they couldgenerally face proportionately higher costs and difficulties with some of the requirements on substantiation and verification of explicit environmental claims. The Member States should provide adequate information by means of easily accessible information portals or similar means and raise awareness of the ways to comply with the requirements of this Directive, ensure targeted and specialised training free of charge, and provide specific and sufficient assistance and support, including financial, so thato SMEs wishing to make explicit environmental claims on their products or as regards their activities are able to do so. Member States actions should be taken in respect of applicable State aid rules.
Amendment 332 #
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, public well-being and health, animal welfare and ecosystems;
Amendment 370 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point j a (new)
Article 3 – paragraph 1 – point j a (new)
(ja) provide relevant information on the environmental impact of the transport of products, in particular in the context of imports.
Amendment 381 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The requirements set out in paragraphs 1 and 2 shall not apply to traders that are micro, small or medium- sized enterprises within the meaning of Commission Recommendation 2003/361/EC110 unless they request the verification with the aim of receiving the certificate of conformity in accordance with Article 10. _________________ 110 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium- sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 392 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 4 – introductory part
Article 3 – paragraph 4 – introductory part
4. When the regular monitoring of the evolution of environmental claims referred to in Article 20 reveals differences in the application of the requirements laid down in paragraph 1 for specific claims and such differences create obstacles for the functioning of the internal market, or where the Commission identifies that the absence of requirements for specific claims leads to widespread misleading of consumers, the Commission may adopt delegatedimplementing acts in accordance with Article 18 to supplement the requirements for substantiation of explicit environmental claims laid down in paragraph 1 by:
Amendment 426 #
2023/0085(COD)
Proposal for a directive
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Where a comparative environmental claim relates to an improvement in terms of environmental impacts, environmental aspects or environmental performance of a product that is subject to the claim compared to environmental impacts, environmental aspects or environmental performance of another product from the same trader, from a competing trader that is no longer active on the market or from a trader that no longer sells to consumers, the substantiation of the claim shall explain how that improvement affects other relevant environmental impacts, environmental aspects or environmental performance of the product subject to the claim and shall clearly state the baseline year for the comparison.
Amendment 431 #
2023/0085(COD)
Proposal for a directive
Article 4 – paragraph 3
Article 4 – paragraph 3
3. The requirements laid down in this Article shall not apply to traders that are micro, small or medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC111 unless they request the verification with the aim of receiving the certificate of conformity in accordance with Article 10. _________________ 111 Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium- sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 503 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The requirements set out in paragraphs 2, 3 and 6 shall not apply to traders that are micro, small or medium- sized enterprises within the meaning of Commission Recommendation 2003/361/EC unless they request the verification with the aim of receiving the certificate of conformity in accordance with Article 10.
Amendment 509 #
2023/0085(COD)
Proposal for a directive
Article 6 – paragraph 1
Article 6 – paragraph 1
Comparative environmental claims shall not relate to an improvement of the environmental impacts, environmental aspects or environmental performance of the product that is the subject of the claim compared to the environmental impacts, environmental aspects or environmental performance of another product from the same trader or from a competing trader that is no longer active on the market or from a trader that no longer sells to consumers, unless. However, they may relate to an improvement in the environmental impacts, environmental aspects or environmental performance of the product that is the subject of the claim compared to the environmental impacts, environmental aspects or environmental performance of the same trader if they are based on evidence proving that the improvement is significant and if they have been achieved in the last five years.
Amendment 555 #
2023/0085(COD)
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 2
Article 8 – paragraph 3 – subparagraph 2
Amendment 621 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 3
Article 10 – paragraph 3
3. The verification and certification requirements shall apply to traders that are micro, small or medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC only if they so request.
Amendment 624 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. When they set up the procedures referred to in paragraphs 1 and 2, Member States shall encourage verifiers to take into account the complexity of the substantiation of the claim and the size and turnover of traders requesting verification and certification when calculating their pricing for the cost of verification and certification, paying particular attention to micro, small and medium-sized enterprises.
Amendment 700 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
Member States shall take appropriate measures to help micro, small and medium sized enterprises apply the requirements set out in this Directive. Those measures shall at least include guidelinaccessible guidelines containing clear examples or similar mechanisms to raise awareness of ways to comply with the requirements on explicit environmental claims. In addition, wWithout prejudice to applicable state aid rules, such measures may include one or more of the following elements:
Amendment 706 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – point d a (new)
Article 12 – paragraph 1 – point d a (new)
(da) access to specialised information portals.
Amendment 732 #
2023/0085(COD)
Proposal for a directive
Article 16
Article 16
Amendment 760 #
2023/0085(COD)
Proposal for a directive
Article 17 – paragraph 2 – point g a (new)
Article 17 – paragraph 2 – point g a (new)
(ga) the size of the company;
Amendment 761 #
2023/0085(COD)
Proposal for a directive
Article 17 – paragraph 3
Article 17 – paragraph 3
Amendment 777 #
2023/0085(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The power to adopt delegatedimplementing acts is conferred on the Commission subject to the conditions laid down in this Article.
Amendment 779 #
2023/0085(COD)
Proposal for a directive
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The power to adopt delegatedimplementing acts as referred to in Article 3(4) and Article 5(8) shall be conferred on the Commission for a period of five years from [OP please insert the date = the date of transposition of this Directive]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 812 #
2023/0085(COD)
Proposal for a directive
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
They shall apply those measures from [OP please insert the date = 2436 months after the date of entry into force of this Directive].
Amendment 6 #
2023/0079(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Access to raw materials is essential for the Union economy and the functioning of the internal market. There is a set of non-energy, non-agricultural raw materials that, due to their high economic importance and their exposure to high supply risk, often caused by a high concentration of supply from a few third countries, are considered critical. Given the key role of many such critical raw materials in realising the green and digital transitions, and in light of their use for defence and space, space and nuclear applications, demand will increase exponentially in the coming decades. At the same time, the risk of supply disruptions is increasing against the background of rising geopolitical tensions and resource competition. Furthermore, if not managed properly, increased demand for critical raw materials could lead to negative environmental and social impacts. Considering these trends, it is necessary to take measures to ensure access to a secure and sustainable supply of critical raw materials to safeguard the Union's economic resilience and open strategic autonomy.
Amendment 9 #
2023/0079(COD)
Proposal for a regulation
Recital 2
Recital 2
Amendment 34 #
2023/0079(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) To strengthen Union capacities along the strategic raw materials value chain, benchmarks should be set to guide efforts and track progress. The aim should be to increase capacities for each strategic raw material at each stage of the value chain, while aiming to achieve overall capacity benchmarks for extraction, processing and recycling of strategic raw materials. Firstly, the Union should increase the use of its own geological resources of strategic raw materials and build up capacity to allow it to extract the materials needed to produce at least 10 % of the Union's consumption of strategic raw materials. Keeping in mind that extraction capacity is highly dependent on the availability of Union geological resources, the achievement of this benchmark is dependent on such availability. Secondly, in order to build a full value chain and prevent any bottlenecks at intermediate stages, the UnionMember States should in addition increase itstheir processing capacity along the value chain andby relocating these processing industries and should thus together be able to produce at leastthe equivalent of 40 % of its annual consumption of strategic raw materials at EU level. Thirdly, it is expected that in the coming decades a growing share of the Union's consumption of strategic raw materials can be covered by secondary raw materials, which would improve both the security and the sustainability of the Union’s raw materials supply. Therefore, Union recycling capacity should be able to produce at least 15 % of the Union’s annual consumption of strategic raw materials. These benchmarks refer to the 2030 time horizon, in alignment with the Union's climate and energy targets set under Regulation (EU) 2021/1119 of the European Parliament and of the Council29 and the digital targets under the Digital Decade30, which they underpin. Furthermore, quality jobs, including skills development and job-to- job transitions, will address risks in the sectoral labour market and help ensure the EU’s competitiveness. _________________ 29 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 (OJ L 243, 9.7.2021, p. 1). 30 Decision (EU) 2022/2481 of the European Parliament and of the Council of 14 December 2022 establishing the Digital Decade Policy Programme 2030 (OJL 323, 19.12.2022, p. 4–26 )
Amendment 41 #
2023/0079(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) It is necessary to put in place appropriate measures to support Strategic Projects aimed at the extraction, processing or recycling of strategic raw materials in the Union that should, together with Member State efforts, contribute to increasing capacities towards the benchmarks. Other measures, notably on exploration or circularity, should also contribute to the reinforcement of different stages of the value chain and thereby contribute to the achievement of the benchmarks. To ensure that the benchmarks are met in time, the Commission, with the help of the European Critical Raw Materials Board (‘the Board’) should track and report progress towards the benchmarks. In case the reported progress towards the benchmarks is generally insufficient, the Commission should assess the feasibility and proportionality of additional measures. A lack of progress only on a single or small set of strategic raw material should in principle not trigger the need for additional Union efforts.
Amendment 47 #
2023/0079(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In order to build capacities in the Union, the Commission should, with the support of the Board,Member States should identify Strategic Projects in the Union that intend to become active in the extraction, processing or recycling of strategic raw materials. Effective support to Strategic Projects has the potential to improve access to materials for downstream sectors as well as to create economic opportunities along the value chain, including for SMEs, and contribute to the creation of employment. Therefore, to ensure the development of Strategic Projects across the Union, such projects should benefit from streamlined and predictable permitting procedures and support in gaining access to finance. In order to focus support and ensure their added value, projects should, before receiving such support, be assessed against a set of criteria. Strategic Projects in the Union should strengthen the Union's security of supply for strategic raw materials, show sufficient technical feasibility and be implemented in an environmentally and socially sustainable manner. They should also provide cross- border benefits beyond the Member State concerned. Where the Commission assesses these criteria to be fulfilled, it should publish the recognition as a Strategic Project in a decision. As a speedy recognition is key to effectively supporting the Union's security of supply, the assessment process should remain light and not overly burdensome.
Amendment 50 #
2023/0079(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In order to diversify the Union's supply of strategic raw materials, the Commission should, with the support of the Board,Member States should identify Strategic Projects in third countries that intend to become active in the extraction, processing or recycling of strategic raw materials. To ensure that such Strategic Projects are effectively implemented, they should benefit from improved access to finance. In order to ensure their added value, projects should be assessed against a set of criteria. Like projects in the Union, Strategic Projects in third countries should strengthen the Union's security of supply for strategic raw materials, show sufficient technical feasibility and be implemented sustainably. For projects in emerging markets and developing economies, the project should be mutually beneficial for the Union and the third country involved and add value in that country, taking into account also its consistency with the Union’s common commercial policy. Such value may be derived from the project’s contribution to more than one stage of the value chain as well as from creating through the project wider economic and social benefits, including the creation of employment in compliance with international standards. Where the Commission assesses these criteria to be fulfilled, it should publish the recognition as a Strategic Project in a decision.
Amendment 64 #
2023/0079(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) As the cooperation of the Member State on whose territory a Strategic Project will be implemented is necessary to ensure its effective implementatios, which remain sovereign, tshat Member State shouldll of course have the right to object to andy project on their territory and to thereby prevent that a project is granted the status of Strategic Project against its will. If it does so, the relevant Member State should provide a reasoned justification for its refusal referring to the applicable criteriatheir will. Similarly, the Union should not grant the status of Strategic Project to projects that will be implemented by a third country against the will of its government and should therefore refrain from doing so where a third country government objects.
Amendment 65 #
2023/0079(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) To prevent misuse of the recognition as Strategic Project, the Commission should be able to repeal its initial decision to recognise a project as strategic if it no longer fulfils the conditions or the recognition was based on an application containing incorrect information. Before it can do so, the Commission should consult the Board and hear the project promoter.
Amendment 69 #
2023/0079(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) In light of their importance for ensuring the security of supply of strategic raw materials, Strategic Projects should be considered to be in the public interest. Ensuring the security of supply of strategic raw materials is of crucial importance for the success of the green and digital transitions as well as the resilience of the defence and space, space and nuclear sectors. To contribute towards security of supply of strategic raw materials in the Union, Member States may provide for support in national permit granting procedures to speed up the realisation of Strategic Projects in accordance with Union law.
Amendment 96 #
2023/0079(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) In order to overcome the limitations of the currently often fragmented public and private investments efforts, facilitate integration and return on investment, the Commission, Member States and promotional banks should better coordinate and create synergies between the existing funding programmes at Union and national level as well as ensure better coordination and collaboration with industry and key private sector stakeholders. To that end, a dedicated sub-group of the Board bringing togethergroup of experts from the Member States and the Commission as well as relevant public financial institutions should be set up. This sub-group should discuss the individual financing needs of Strategic Projects and their existing funding possibilities in order to provide project promoters with a suggestion on how to best access existing financing possibilities. When discussing and making recommendations for the financing of Strategic Projects in third countries, the Boardis group should in particular take into account the Global Gateway strategy42. _________________ 42 Joint Communication to the European Parliament, the Council, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank The Global Gateway (JOIN/2021/30 final).
Amendment 103 #
2023/0079(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) Member States do not have the same capacity when it comes to risk- awareness and anticipation, and not all Member States have developed dedicated structures that monitor the supply chains of critical raw materials and can inform companies about potential risks of supply disruptions. Similarly, although some companies have invested in the monitoring of their supply chains, others lack the capacity to do so. Therefore, in light of the global dimension of critical raw materials supply chains as well as their complexity, the Commission should develop a dedicated monitoring dashboard assessing critical raw materials’ supply risks and ensure the availability of the information gathered for public authorities and private actors, thereby increasing synergies amongst Member States. In order to ensure that Union value chains are sufficiently prepared against potential supply disruptions, the Commission should conduct stress tests assessing the vulnerability of the strategic raw materials supply chains and their exposure to supply risks. Member States should contribute to this exercise by, when possible conducting such stress tests through their national supply and information agencies covering critical raw materials. The Board should ensure the coordination of the implementation of the stress tests by the Commission and Member StateCommission should monitor how the Member States coordinate to conduct the stress tests. When no Member State has the capacity to perform a required stress test on a given strategic raw material, the Commission should conduct it itself. When making the results of such stress tests publicly available, the Commission should also suggest potential strategies that can be adopted by the public authorities and private actors to mitigate supply risks, such as building strategic stocks or further diversifying their supply. For the purpose of gathering the information necessary to conduct the monitoring and stress tests measures, the Commission should coordinate with the relevant standing subgroup of the Board andMember States. The Member States should identify and monitor key market operators that are important to the functioning of the value chain. When no member of the standing sub-groupIf a Member State does not hasve the capacity to perform a required stress test on a given strategic raw material, the Commission should conduct it itself.
Amendment 140 #
2023/0079(COD)
Proposal for a regulation
Recital 55
Recital 55
Amendment 145 #
2023/0079(COD)
Proposal for a regulation
Recital 60
Recital 60
Amendment 245 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
Amendment 247 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 1
Article 6 – paragraph 5 – subparagraph 1
Where the Member State whose territory is concerned by a proposed project objects to granting the proposed project strategic status, it shall present substantiated reasons for doing so during the discussion referred to in paragraph 4. The Board shall discuss the substantiated reasons presented by a Member State for its objection. If, after the discussion, the Member State maintains its objection, the project shall not be considered for the status of Strategic Project.
Amendment 249 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 1
Article 6 – paragraph 6 – subparagraph 1
The Commission shall, taking account of the Board's opinion referred to in paragraph 4, adopt its decision on the recognition of the project as Strategic Project within 60 days and notify the applicant thereof.
Amendment 250 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 6 – subparagraph 2
Article 6 – paragraph 6 – subparagraph 2
Amendment 254 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. Where the Commission finds that a Strategic Project no longer fulfils the criteria set out in Article 5(1) or where its recognition was based on an application containing incorrect information, it may, taking into account the opinion of the Board and the responsible project promoter, repeal the decision granting a project the status of Strategic Project.
Amendment 265 #
2023/0079(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 278 #
2023/0079(COD)
Proposal for a regulation
Article 8 – paragraph 8
Article 8 – paragraph 8
Amendment 372 #
2023/0079(COD)
Proposal for a regulation
Article 15 – paragraph 1 – introductory part
Article 15 – paragraph 1 – introductory part
1. The standing sub-group referred to in Article 35(6), point (a) shall , aAt the request of a project promoter of a Strategic Project, discuss and advise on how the financing of its project can be completed, taking into account the funding already secured and considering at least the following elements:
Amendment 394 #
2023/0079(COD)
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
Amendment 397 #
2023/0079(COD)
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
Amendment 402 #
2023/0079(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
Amendment 403 #
2023/0079(COD)
Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 1
Article 19 – paragraph 3 – subparagraph 1
The Commission, in collaboration with the national authorities participating in the standing sub-group referred to in Article 35(6), point (c), shall ensure that a stress test is performed for each strategic raw material’s supply chain at least every three years. To that end, the standing sub-group referred to in Article 35(6), point (c) shall coordinate and divide the implementation of stress tests for the different strategic raw materials by the different participating authorities.
Amendment 406 #
2023/0079(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. Where, based on the information gathered pursuant to paragraphs 1, 2 and 3, the Commission considers that there a is clear indication of the risk of a supply disruption, the Commission shall alert the Member States, the Board and the Union governance bodies responsible of crisis vigilance or crisis management mechanisms whose scope covers relevant critical or strategic raw materials.
Amendment 409 #
2023/0079(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
Amendment 410 #
2023/0079(COD)
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. By [OP please complete: 2 year after the date of entry into force of this Regulation] and every 2 years after that, the Commission shall, based on the information received pursuant to Article 21(1), share with the BoardMember States:
Amendment 411 #
2023/0079(COD)
Proposal for a regulation
Article 22 – paragraph 2 – introductory part
Article 22 – paragraph 2 – introductory part
2. The Commission, taking account of the views of the Board, shall adopt a benchmark indicating a safe level of Union stocks of strategic raw materials, which shall:
Amendment 412 #
2023/0079(COD)
Proposal for a regulation
Article 22 – paragraph 3 – introductory part
Article 22 – paragraph 3 – introductory part
3. The Commission, taking account of the views of the Board, may issue opinions addressed to Member States:
Amendment 413 #
2023/0079(COD)
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
6. Ahead of the participation of at least two Member States in international or multilateral fora in the areas of strategic stocks for strategic raw materials, the Commission shall ensure a prior coordination either between the Member States concerned and the Commission or by a dedicated meeting of the Board.
Amendment 414 #
2023/0079(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
The strategic technologies referred to in the first subparagraph shall include, but are not limited to, batteries for energy storage and e-mobility, equipment related to hydrogen production and utilisation, equipment related to renewable and nuclear energy generation, traction motors, heat pumps, data transmission and storage, mobile electronic devices, equipment related to additive manufacturing, robotics, drones, rocket launchers, satellites and advanced chips.
Amendment 653 #
2023/0079(COD)
Proposal for a regulation
Article 30 – paragraph 4 – point a – point iii
Article 30 – paragraph 4 – point a – point iii
Amendment 679 #
2023/0079(COD)
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. The Board shallMember States shall jointly and periodically discuss:
Amendment 688 #
2023/0079(COD)
Proposal for a regulation
Article 33 – paragraph 3 – point b
Article 33 – paragraph 3 – point b
Amendment 689 #
2023/0079(COD)
Proposal for a regulation
Article 34
Article 34
Amendment 690 #
Amendment 708 #
Amendment 717 #
2023/0079(COD)
Proposal for a regulation
Annex I – Section 1 – paragraph 1 – point p a (new)
Annex I – Section 1 – paragraph 1 – point p a (new)
(pa) Uranium.
Amendment 719 #
2023/0079(COD)
Proposal for a regulation
Annex II – Section 1 – paragraph 1 – point hh a (new)
Annex II – Section 1 – paragraph 1 – point hh a (new)
(hha) Uranium.
Amendment 57 #
2022/2183(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Supports the just transition to agro- ecological and organic farming; reiterates its support for the ambitions, targets and goals of the farm to fork, strategy, with a view to maintaining crop yields in the Member States in the context of the food shortages caused by the conflict in Ukraine, as well as for the biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals, including those related to the reduction in the use of pesticides and their associated risks and the setting of EU food waste reduction targets;
Amendment 99 #
2022/2183(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls for the strict application of the One Health principle in all policies that affect the availability andprinciple of the accessibility of food; stresses that EU food safety must never be jeopardised;
Amendment 114 #
2022/2183(INI)
Draft opinion
Paragraph 3
Paragraph 3
Amendment 141 #
2022/2183(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Emphasises that biofuel production negatively affects food security; denounces, moreover, the focus on short-term policy measures, for example, on fertilisers;
Amendment 165 #
2022/2183(INI)
Draft opinion
Paragraph 6
Paragraph 6
Amendment 180 #
2022/2183(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls for a strategy to regionalislocate the supply chain of the most important commodities to the Member States and to ensure the supply of local and sustainable animal and plant proteins;
Amendment 189 #
2022/2183(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Underscores the need for independent policymaking based on facts and the values of food sovereignty according to a principle of proximity in each Member State;
Amendment 194 #
2022/2183(INI)
Draft opinion
Paragraph 9
Paragraph 9
Amendment 207 #
2022/2183(INI)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls for the food sovereignty of the Member States to be guaranteed by increasing support for responsible and sustainable agriculture;
Amendment 210 #
2022/2183(INI)
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9b. Calls for strict environmental and health compliance clauses to be imposed regarding the quality of imported agricultural products when international trade treaties are reviewed;
Amendment 212 #
2022/2183(INI)
Draft opinion
Paragraph 9 c (new)
Paragraph 9 c (new)
Amendment 63 #
2022/0426(COD)
Proposal for a directive
Recital 4
Recital 4
(4) In order to tackle the steady increase of the number and relevance of offences concerning trafficking in human beings committed for purposes other than sexual or labour exploitation, it is necessary to include forced marriage and, illegal adoption and surrogacy in the forms of exploitations explicitly listed in the Directive and to ensure that the Member States address within their national legal systems the widest range of forms of exploitation, insofar as these fulfil the constitutive elements of trafficking in human beings.
Amendment 135 #
2022/0426(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Directive 2011/36/EU
Article 2 – paragraph 3
Article 2 – paragraph 3
(1) in Article 2, paragraph 3, “or forced marriage, or illegal adoption, or surrogacy” is added at the end of the paragraph.
Amendment 400 #
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. 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. Given the amount of water needed for the re-use system, the costs for economic operators, the additional costs for consumers and the potential health impact, the Commission should carry out a comprehensive impact assessment before proposing re-use targets for sectors.
Amendment 327 #
2022/0347(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
5. proportionate and non- discriminatory measures that maintaining air quality where it is good and, improving it in other cases;e it in other cases and in no case restrict the exercise of fundamental freedoms for all citizens.
Amendment 370 #
2022/0347(COD)
Proposal for a directive
Article 3 – paragraph 2 – subparagraph 3 – point d a (new)
Article 3 – paragraph 2 – subparagraph 3 – point d a (new)
(d a) economic, social and environmental impact studies following the application of the previous sets of measures.
Amendment 427 #
2022/0347(COD)
Proposal for a directive
Article 5 – paragraph 1 – point i a (new)
Article 5 – paragraph 1 – point i a (new)
(i a) to assess the consequences on the quality of life (reduction of air pollution, economic, social and environmental impacts of the measures applied)
Amendment 634 #
2022/0347(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. When drawing up the short-term action plans referred to in paragraph 1 Member States may, depending on the individual case, provide for effective measures to control and, where necessary, temporarily suspend activities which contribute to the risk of the respective limit values or target values or alert threshold being exceeded. Depending on the share of the main pollution sources to the exceedances to be addressed, tThose short- term action plans shall considermay includinge measures in relation to transport , construction works, industrial installations and the use of products and domestic heating. Specific actions aiming at the protection of sensitive population and vulnerable groups, including children, shall also be considered in the framework of those plawhose environmental, social and economic impact will have been the subject of a prior study in order to determine whether the advantage/disadvantage ratio makes their implementation relevant. These gradual measures, depending on the intensity of the overruns of the limit values, may affect transport, construction work and industrial installations.
Amendment 45 #
2022/0298(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The Europe’s Beating Cancer Plan6 supports the need for action in the field of protection of workers against carcinogenic substances. Improved protection of workers exposed to asbestos will also be important in the context of the green transition and the implementation of the European Green Deal, including in particular the renovation wave for Europe7. Citizens’ recommendations in the framework of the Conference on the Future of Europe8 also highlighted the importance of fair working conditions, in particular the revision of Directive 2009/148/EC. __________________ 6 https://ec.europa.eu/health/system/files/202 2-02/eu_cancer-plan_en_0.pdf 7 Renovation Wave: doubling the renovation rate to cut emissions, boost recovery and reduce energy poverty, COM(2020) 662 final 8 Conference on the Future of Europe. Report on the final outcome (May 2022). https://prod-cofe-platform.s3.eu-central- 1.amazonaws.com/8pl7jfzc6ae3jy2doji28f ni27a3?response-content- disposition=inline%3B%20filename%3D% 22CoFE_Report_with_annexes_EN.pdf%2 2%3B%20filename%2A%3DUTF- 8%27%27CoFE_Report_with_annexes_E N.pdf&response-content- type=application%2Fpdf&X-Amz- Algorithm=AWS4-HMAC-SHA256&X- Amz- Credential=AKIA3LJJXGZPDFYVOW5V %2F20220917%2Feu-central- 1%2Fs3%2Faws4_request&X-Amz- Date=20220917T104038Z&X-Amz- Expires=300&X-Amz- SignedHeaders=host&X-Amz- Signature=6806caf5fd75a86ad4e907b934b 2194de4c3c0c756a8d2a34c5e8b68985ffbd e
Amendment 60 #
2022/0298(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Special control measures and precautions are needed for workers exposed or likely to be exposed to asbestos, such as subjecting workers to a decontamination procedure and related training, in order to significantly contribute to reducing the risks related to such exposure for workers and their families.
Amendment 62 #
2022/0298(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Preventive measures for the protection of the health of workers exposed to asbestos and the commitment envisaged for Member States with regard to the surveillance of their and their families’ health are important, in particular the continuation of health surveillance after the end of exposure.
Amendment 71 #
2022/0298(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) points out that asbestos is present in many products that are still in use, such as abrasives, adhesives, car and bicycle parts, lubricants, paints, textiles, etc., and most of them are imported into the EU and handled by workers.
Amendment 74 #
2022/0298(COD)
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) highlights the need, with a view to protecting workers and their families, for drastic controls on imports of products from third countries which still permit the use of asbestos at levels higher than those authorised by the Member States.
Amendment 78 #
2022/0298(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Since the objective of this Directive, namely to protect workers and their families against risks to their health and safety arising from or likely to arise from exposure to asbestos at work, including the prevention of such risks, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
Amendment 123 #
2022/0298(COD)
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1
Article 2 – paragraph 1 – subparagraph 1
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by two years after the date of entry into force of this Directive at the latest. They shall immediately communicate the text of those measures to the Commission. Member States may, including in the context of free trade agreements, limit imports of products with a manufacturing process that exposes workers to a concentration of asbestos higher than European standards. The revision of the Treaties and of free trade agreements must include restrictions on the trading of products of that kind.
Amendment 118 #
2022/0216(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) In accordance with Article 1 of the Charter of Fundamental Rights of the European Union, which states that ‘human dignity is inviolable. It must be respected and protected,' and Article 3 of same, the quality and safety standards of SoHOs must respect the physical and mental integrity of the persons concerned, ensure SoHOs are donated with the free and informed consent of those persons and prohibit eugenic principles, financial gain from the human body or its parts and cloning,
Amendment 123 #
2022/0216(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients. In accordance with Article 3 of the Charter of Fundamental Rights of the European Union, these safety standards are based on the fundamental principle that the human body cannot be commercialised, which holds that no SoHO may be sold, as well as on the principle of the unavailability of the human body and the principle that the human body or parts thereof cannot be used for financial gain.
Amendment 126 #
2022/0216(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Directives 2002/98/EC16and 2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules, which can create obstacles to cross-bordersharing ofthese substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for these substances, which achieves safety and quality for all parties involved, enhances legal certainty and supports continuous supply, whilst facilitating innovation for the benefit of public health. In order to achieve a coherent application of the legal framework, it is appropriate to repeal Directives 2002/98/EC and 2004/23/EC and to replace them by a Regulation. _________________ 16 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). 17 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
Amendment 127 #
2022/0216(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, with respect for the special characteristics of each of the substances recognised in the technical guidelines set out in this Regulation.
Amendment 129 #
2022/0216(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) This Regulation should apply to blood and blood components, as regulated by Directive 2002/98/EC, as well as to tissues and cells, including haematopoietic peripheral blood, umbilical-cord blood and bone-marrow stem cells, reproductive cells and tissues, foetal tissues and cells and adult and embryonicderived solely from postnatal embryonic remnants and adult stem cells, as regulated by Directive 2004/23/EC. Since donation and human application of SoHOs other than blood, tissues and cells are increasingly common, it is necessary to extend the scope of this Regulation to any SoHO, regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, to avoid that certain groups of donors or recipients are not protected by an appropriate Union level quality and safety framework. This will, for example, ensure the protection of donors and recipients of human breast milk, intestinal microbiota, blood preparations that are not used for transfusion, and any other SoHO that may be applied to humans in the future.
Amendment 130 #
2022/0216(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) Solid organs are excluded from the definition of SoHOs for the purposes of this Regulation and, thus, from its scope. Their donation and transplantation are significantly different and are regulated in a dedicated legal framework, set out in Directive 2010/53/EU18 of the European Parliament and of the Council18, with the exception of blood-type conversions for the purposes of organ transplants. Shortcomings have not been raised regarding the existing quality and safety provisions for organs. Nonetheless, when organs are removed from a donor for the purposes of separating tissues or cells for human application, for example heart valves from a heart or pancreatic islets from a pancreas, this Regulation should apply. _________________ 18 Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
Amendment 139 #
2022/0216(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination or contamination of caregivers, friends or family, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply.
Amendment 141 #
2022/0216(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, dispensing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.
Amendment 144 #
2022/0216(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) SoHOs can also be combined with other regulated products before, exclusively, human application. In these circumstances, close interaction between this regulatory framework and other related frameworks is also necessary to ensure a high level of human health protection for all cases where these substances are used.
Amendment 156 #
2022/0216(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a resuthe donation will not have any short- or medium-term adverse effects on the health of the donationrecipient. This Regulation should therefore include principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a need for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to imply a significant risk.
Amendment 157 #
2022/0216(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products exclusively for human application regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. This Regulation should therefore include principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a need for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to imply a significant risk.
Amendment 160 #
2022/0216(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) When a harmful genetic condition is detected in the offspringchildren resulting from medically assisted reproduction with third party donation, the transmission of that information enables the prevention of further use of donations affected by that genetic risk. It is thus important that relevant information in such cases is effectively communicated between SoHO entities and acted upon appropriately.
Amendment 162 #
2022/0216(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law and founded on respect for human dignity, voluntary donation, and the principle that SoHOs cannot be used for financial gain. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary.
Amendment 170 #
2022/0216(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member States. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health. The authorisation of the use of such SoHOs in one Member State in no way obliges another Member State to adopt the same provisions or to transpose them into its own legislation. Indeed, some Member States prohibit all use of embryos for scientific and medical purposes, including for research.
Amendment 187 #
2022/0216(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, pProgrammes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a factor which can contributes to high safety standards for SoHOs and therefore to the protection of human health. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessaryacceptableto ensure that donors are not financially disadvantaged by their donation. Thus, financially neutralcompensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed, posing risks to their own health and to that of prospective recipients. Such compensation should, therefore, be set by national authorities, at a level appropriate in their Member State to reach such objectives. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors, (March 2018). Available at: https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 191 #
2022/0216(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify the competent authority or authorities for each area, for example by geography, topic or substance, they shouldall also be required to designate a single independent national authority that ensures appropriately coordinated communication with other Member States’ competent authorities and with the Commission. The SoHO National Authority should be considered the same as the designated competent authority in Member States where only one competent authority is designated.
Amendment 195 #
2022/0216(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities – whose induction training they shall ensure – that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to direct health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of donors, recipients or offspringchild from medically assisted reproduction, competent authorities should, where necessary, be able to prioritise transparency of their enforcement activities over the protection of confidentiality of the party that has infringed the Regulation.
Amendment 201 #
2022/0216(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State, decide on the regulatory status of a particular substance, product or activity under this Regulation.
Amendment 204 #
2022/0216(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) Given the World Health Organization's1 a recommendation that health-care personnel should be informed about, and trained in, patient blood management, prescribers should be made more aware of therapeutic alternatives to the application of this SoHO Regulation. This practice is also liable to limit the flow of SoHOs and ensure security of supply. _________________ 1 a World Health Organization Resolution WHA 63.12, ‘Availability, safety and quality of blood products’, 21.5.2010.
Amendment 207 #
2022/0216(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release and distribution, competent authorities should assess and authorise SoHO preparations to verify that a high level of safety, quality and efficacy is achieved consistently by the application of that specific series of activities, performed in that specific manner. When SoHOs are prepared with newly developed and validated collection, testing or processing methods, consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. The extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that SoHO preparation and use. Where a new or modified SoHO preparation poses negligible risks for recipients (or offspringfoetuses, newborns or children in the case of medically assisted reproduction), the vigilance reporting requirements provided for in this Regulation should be adequate to demonstrate safety and quality. This should apply for well-established SoHO preparations that are introduced in a new SoHO entity but have been robustly demonstrated as safe and effective by their use in other entities.
Amendment 235 #
2022/0216(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are the member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P- TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection, processing, storage and distribution. It should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this Regulation if, and only if, they respect the interests of the Member States and include consultation with specialised stakeholders to ensure the transparency of the process. _________________ 26 Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
Amendment 238 #
2022/0216(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council 27, is a Union agency with the mission of strengthening Europe'’s defences against communicable diseases. The work of the ECDC on developing and updating guidelines on safety and quality of SoHOs from a communicable disease threat perspective, should be considered an important contribution in the field of SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC established an expert network for the Microbial Safety of SoHOs, which ensures the implementation of the requirements on the ECDC’s relations with the Union Member States and EEA Member States stated in Regulation (EC) No 851/2004, regarding transparent,strategic and operational collaboration on technical and scientific issues, surveillance, responses to health threats, scientific opinions, scientific and technical assistance, collection of data, identification of emerging health threats, and public information campaigns related to the safety of SoHOs. This SoHO expert network should provide information or advice in relation to relevant outbreaks of communicable diseases, in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. _________________ 27 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European cCentre for dDisease pPrevention and cControl (OJ L 142, 30.4.2004, p. 1).
Amendment 260 #
2022/0216(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) Given the negative effects of the COVID-19 pandemic on the frequency and quantity of plasma donation in some countries, Member States are invited to develop plasmapheresis programmes to increase their collection capacity and donor base.
Amendment 283 #
2022/0216(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as, to make it possible to share the elements used to determine the regulatory status of a substance and to improved the transparency of national reporting and supervisory activities.
Amendment 294 #
2022/0216(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspringpersons born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied accordingly.
Amendment 302 #
2022/0216(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need. In this context, the objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 314 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. This Regulation shall apply exclusively to SoHOs intended for human application, to SoHO preparations, to products manufactured from SoHOs and intended for human application, to SoHO donors and recipients who have not been duly declared dead, and to the following SoHO activities:
Amendment 317 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h a (new)
Article 2 – paragraph 1 – point h a (new)
(ha) SoHO dispensing;
Amendment 320 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point m a (new)
Article 2 – paragraph 1 – point m a (new)
(ma) The exchange and sharing of data or information on quantities or stocks of SoHOs, and the promotion of activities related to security of supply;
Amendment 328 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients, as well as continuity of SoHO supply, shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 342 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves freely and voluntarily to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not; donors will have a guarantee that their donations are anonymous to recipients, and they will be unpaid;
Amendment 348 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8a) 'donation' means a philanthropic act by a person of freely and voluntarily agreeing to provide a third party with a SoHO from that person's own body. Donations are deemed to be unpaid-for. Donations of reproductive cells are not covered by this Regulation in the case of post-mortem usage, which should be prohibited in all Member States.
Amendment 357 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
(10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm, or in vitro fertilisation or any other laboratory or medical intervention that promotes conceptionwhere conception meets the ethical rules laid down by the competent authorities of each Member State;
Amendment 373 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘donor recruitment’ means any activity aimed at informing the public and encouraging persons to become SoHO donors;
Amendment 375 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
(14) ‘'collection’' means a process by which SoHOs are removed, procured, excreted, secreted or obtained by any other manner, including any preparatory steps, such as hormone treatment, needed to facilitate the process; SoHOs cannot be procured from a donor who has not expressly requested that and whose state of health does not permit an informed choice to be made. Collection of SoHOs shall be strictly prohibited in connection with medically assisted suicide by a donor, since the substances injected may impair the quality of the donation.
Amendment 384 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
Amendment 385 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
(17) ‘'storage’' means the maintenance of SoHOs under appropriate controlled conditions until distribution or dispensing;
Amendment 388 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18
Article 3 – paragraph 1 – point 18
Amendment 389 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) 'disposal' means completely destroying SoHOs for whatever reason. Strict monitoring rules must be complied with so as to ensure that the ultimate purpose of the disposal process is achieved.
Amendment 390 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) 'dispensing' means the provision of SoHOs or SoHO preparations, possibly following a medical prescription, for application to a specific recipient;
Amendment 391 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 20
Article 3 – paragraph 1 – point 20
(20) ‘import’ means activities carried out to bring SoHOs or SoHO preparations into the Union from a third country, including the organisation of such activities and physical verification of coherence with associated documentation, the appropriateness of transport conditions, the integrity of packaging and the adequacy of labelling before release; each Member State will remain free to accept or reject SoHOs imported from a third country;
Amendment 401 #
2022/0216(COD)
(a) death, i.e. the irreversible cessation of an individual's vital functions by natural causes or as a result of medically assisted suicide;
Amendment 404 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point i
Article 3 – paragraph 1 – point 28 – point i
(i) prolonged sub-optimal health of a SoHO donor following single or multiple donations;after stating a willingness to donate, or following single or multiple donations, or after detection of contagious or chronic diseases or infections that are or may be communicable.
Amendment 415 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 40
Article 3 – paragraph 1 – point 40
(40) ‘SoHO establishment’ means a SoHO entity that carries out both processing and storage or processing and release or storage and release of SoHOs;
Amendment 417 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘'critical SoHO’' means a SoHO for which an insufficient supply will result in serious harm or risk of harm to patrecipients;
Amendment 419 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42
Article 3 – paragraph 1 – point 42
(42) ‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHOs and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for patrecipients;
Amendment 422 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 45
Article 3 – paragraph 1 – point 45
(45) ‘'technical guidelines’' means a description of a series of methodological procedures and parameters that, if followed, achieve a level of quality and safety of a SoHO activity or a SoHO preparation that is considered to be acceptable as a means to comply with regulatory standards in line with the criteria laid down by the Member States' competent authorities;
Amendment 440 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘'compensation’' means making good of any quantifiable losses associated with donation; such compensation should never be intended or provided with a view to encouraging donations;
Amendment 453 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64a) 'financial neutrality of a donation' means that there will be no financial gains or losses for a donor as a result of a donation;
Amendment 464 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70a) 'patient blood management' means an innovative organisational approach for the best possible management of patients undergoing surgery at risk of bleeding, based on the following three pillars: (a) optimising the patient's blood mass; (b) minimising blood loss; (c) improving the patient's tolerance to anaemia;
Amendment 466 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 b (new)
Article 3 – paragraph 1 – point 70 b (new)
(70b) ‘donor base resilience’ means the capacity of the donation collection system to rely on a large number of donors to address the emergence of a health crisis;
Amendment 467 #
2022/0216(COD)
(70c) ‘free and informed consent’ means that the donor’s agreement has been obtained freely without coercion and after access to clear, comprehensive information in line with his or her capacity to understand;
Amendment 469 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 d (new)
Article 3 – paragraph 1 – point 70 d (new)
(70d) 'national self-sufficiency' means Member States' lack of dependence on another State as regards the collection and manufacture of SoHOs, the transport of those substances and any other SoHO activity.
Amendment 474 #
2022/0216(COD)
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. Member States may introduce additional measures to help set up a national and European supply chain and to achieve the objective of national self- sufficiency. Such measures may also aim to reinforce the principle of voluntary and unpaid donation.
Amendment 476 #
2022/0216(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point a
Article 5 – paragraph 3 – point a
(a) have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined by the Constitutions of the Member Stateseach Member State's own legislation;
Amendment 487 #
2022/0216(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Personnel shall not have engaged in any activity, beyond an appropriate point in time prior to working for the competent authorities concerned, which may detract from their independence.
Amendment 490 #
2022/0216(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner, including in connection with the application of contracts for the supply of medicinal products all or some of whose active substances are derived from SoHOs, and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health.
Amendment 497 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities safely, efficiently and effectively;
Amendment 530 #
2022/0216(COD)
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Exceptional derogation from the obligation to authorise SoHO preparations in situations where there is no therapeutic alternative 1. By way of derogation from Article 21 of this Regulation, and after consulting the relevant best practices approved and documented by the SCB in accordance with Article 68(1)(c), the competent authorities may authorise, on an exceptional basis and at the request of a prescribing doctor within a SoHO entity, SoHO preparations in situations where the procedures referred to in Article 21 have not been followed, provided that: (a) provision has been made for the use of such preparations for a given patient, in cases where that patient has no therapeutic alternative, when treatment cannot be postponed or when his or her condition is life-threatening; (b) the preparation is deemed to be safe and effective on the basis of the available clinical data. 2. The competent authorities shall inform the national SoHO authority of the authorised derogation. The national SoHO authority shall inform the Commission and the other Member States of any decision to authorise the distribution or preparation for immediate application of SoHOs in accordance with paragraph 1.
Amendment 535 #
2022/0216(COD)
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Competent authorities shall authorise as SoHO establishments the SoHO entities that both process and store or process and release or store and release SoHOs in accordance with Article 27.
Amendment 539 #
2022/0216(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. Importing SoHO entity authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation or the entity has ceased to conduct SoHO activities. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific importing SoHO entity authorisation, that Member State may decline to recognise the validity of the importing SoHO entity authorisation of another Member State pending verif. That refusal shall end once the Member State which has adopted a more stringent measure has verified that the correct application of that the more stringent measure has been metmeasure by the Member State which granted the authorisation has been met. It may be based on the principle of voluntary and unpaid donation, in accordance with Article 4(1)(a) of this Regulation.
Amendment 570 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 5
Article 32 – paragraph 5
5. Inspectors may be assisted by technical experts provided that the competent authorities ensure that those experts comply with the requirements of this Regulation, in particular with the obligations set out in Articles 7 and 76. Competent authorities shall ensure that inspectors have not worked as assessors as defined in Article 24 of this Regulation for at least one year.
Amendment 590 #
2022/0216(COD)
Proposal for a regulation
Article 46 – paragraph 2 – point d
Article 46 – paragraph 2 – point d
(d) SoHOs imported into the Union in case of emergency authorised directly by competent authorities pursuant to Article 28(9);
Amendment 610 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point g
Article 53 – paragraph 1 – point g
(g) document the results of the donor health evaluation referred to in point (f), including donor vaccination schedules;
Amendment 657 #
2022/0216(COD)
Proposal for a regulation
Article 55 – paragraph 3 – point c a (new)
Article 55 – paragraph 3 – point c a (new)
(ca) the regular renewal of their consent to the donation at the end of a period set by each Member State;
Amendment 673 #
2022/0216(COD)
Proposal for a regulation
Chapter VII – title
Chapter VII – title
VII SOHO RECIPIENT AND OFFSPRING PROTECTION
Amendment 674 #
2022/0216(COD)
Proposal for a regulation
Article 57 – title
Article 57 – title
Objectives regarding SoHO recipient and offspring protection
Amendment 678 #
2022/0216(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspringchildren from medically assisted reproduction from risks posed by SoHO preparations. They shall do so by identifying, minimising or eliminating those risks.
Amendment 681 #
2022/0216(COD)
Proposal for a regulation
Article 58 – title
Article 58 – title
Standards concerning SoHO recipient and offspring protection
Amendment 684 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. SoHO entities shall establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.
Amendment 685 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. SoHO entities shall establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.
Amendment 698 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point c a (new)
Article 58 – paragraph 2 – point c a (new)
(ca) a list of contagious or chronic diseases or infections that are or may be communicable, which must be explicitly formalised and shared between Member States.
Amendment 738 #
2022/0216(COD)
Proposal for a regulation
Article 59 – title
Article 59 – title
Implementation of the standards concerning recipient and offspring protection
Amendment 771 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point f a (new)
Article 62 – paragraph 3 – point f a (new)
Amendment 830 #
2022/0216(COD)
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. The Commission shallmay perform controls, including audits, inat the request of Member States to verify the effective application of the requirements relating to:
Amendment 835 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shallMember States may establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM.
Amendment 836 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1 a (new)
Article 71 – paragraph 1 a (new)
The Commission shall ensure that those guidelines reflect the interests of Member States and, where appropriate, may adopt implementing acts laying down standards in line with those interests.
Amendment 280 #
2022/0196(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 39(1) and 192(1) thereof,
Amendment 288 #
2022/0196(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Article 39 TFEU lays down the objectives of the CAP, in particular to increase agricultural productivity, to ensure a fair standard of living for farmers, to stabilise markets, to assure the availability of supplies and to ensure that supplies reach consumers at reasonable prices.
Amendment 290 #
2022/0196(COD)
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1b) This Regulation must take account of the effects of the global geopolitical climate on Europe’s agricultural production chain in order to adapt its provisions with a view to guaranteeing the food sovereignty of the Member States and to ensuring reasonable food prices for consumers.
Amendment 293 #
2022/0196(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Directive 2009/128/EC of the European Parliament and of the Council37 established a framework to achieve a sustainable use of pesticidelant protection products by reducing the risks and impacts of their use of pesticides on human health and the environment. The evaluation38 of that Directive found that it has not achieved its overall objectives and that the Member States did not implement it in a satisfactory manner. This conclusion was confirmed in reports from the Commission to the European Parliament and Council in 201739 and 202040 . __________________ 37 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides (OJ L 309, 24.11.2009, p. 71): 38 [Reference to be inserted.] 39 Report from the Commission to the European Parliament and the Council on Member State National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides COM(2017)587 final. 40 Report from the Commission to the European Parliament and the Council on the experience gained by Member States on the implementation of national targets established in their National Action Plans and on progress in the implementation of Directive 2009/128/EC on the sustainable use of pesticides COM(2020) 204 final.
Amendment 325 #
2022/0196(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Commission Communication entitled ‘the European Green Deal’47 set out a roadmap of key measures, including legislative, to significantly reduce the use and risk of chemical pesticides. In the Farm to Fork Strategy48 , EU Biodiversity Strategy for 203049 and the Zero Pollution Action Plan50 , the Commission committed to take action to reduce by 50% the overall use and risk from chemical pesticides by 2030 and reduce by 50% the use of more hazardous pesticides (plant protection products containing one or more active substances approved as candidates for substitution in accordance with Article 24 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council51 and listed in Part E of the Annex to Commission Implementing Regulation (EU) No 540/201152 , or containing one or more active substances listed in the Annex to Commission Implementing Regulation (EU) 2015/40853 ) by 2030. The sustainable usage of plant protection products in an environmentally friendly manner that in no way harms people’s health and guarantees of a fair standard of living for farmers, is also complementary to the promotion of organic farming and achieving the Farm to Fork Strategy target of at least 25% of the Union’s agricultural land under organic farming by 2030. It supports the objectives of the EU strategic framework on health, food security and safety at work54 and thereby contributes to the implementation of principle 10 of the European Pillar of Social Rights on a healthy, safe and well- adapted work environment. __________________ 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 The European Green Deal COM/2019/640 final. 48 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system, COM/2020/381 final. 49 Communication from the Commission to the European Parliament the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030 Bringing nature back into our lives, COM/2020/380 final. 50 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. 51 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 52 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1). 53 Commission Implementing Regulation (EU) 2015/408 of 11 March 2015 on implementing Article 80(7) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market and establishing a list of candidates for substitution (OJ L 67, 12.3.2015, p. 18). 54 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU strategic framework on health and safety at work 2021-2027 Occupational safety and health in a changing world of work, COM/2021/323 final.
Amendment 329 #
2022/0196(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In 2020 EU Member States used an average of 3.30 kg of plant protection products per hectare of cultivated land (versus 3.13 kg per hectare in 2019). However, the country with the highest use consumes twenty times the amount of these products as the country with the lowest use. It would therefore appear necessary to provide for an intermediate stage between now and 2030, taking as a reference value the EU average in 2020 of 3.30 kg of plant protection products used per hectare of cultivated land, to enable the Member States with the highest use to achieve this value; the objective of a 50% reduction in the use of plant protection products will subsequently apply in order to achieve a plant protection product- neutral agriculture by 2050, as proposed in the vision paper published in March 2023 by the French National Research Institute for Agriculture, Food and the Environment (INRAE).
Amendment 390 #
2022/0196(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the different levels of historical progress and differences in intensity of pesticide use between Member States, it is necessary to allowfford Member States somthe requisite flexibility when setting their own binding nato set their own national reductional targets (“national 2030 reduction targets”)by 2030 at the earliest, in order to guarantee there is sufficient output to ensure food sovereignty for Member States, food safety for consumers and fair remuneration for farmers. Intensity of use is best measured by dividing the total quantity of active substances placed on the market, and therefore used, in the form of plant protection products in a particular Member State by the surface area over which the active substances were applied. Intensity in the use of chemical pesticides, and in particular of the more hazardous pesticides, correlates with greater dependency on chemical pesticides, greater risks to human health and the environment and less sustainable farming practices. It is therefore appropriate to allow Member States to take their lower intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. It is also appropriate to require them to take their higher intensity of use of chemical pesticides than the Union average into account in setting their national 2030 reduction targets. In addition, in order to give recognition to past efforts by Member States, they should also be allowed to take into account historical progress prior to the adoption of the Farm to Fork Strategy when setting national 2030 reduction targets. Conversely, where Member States have increased, or made only limited reductions in, their use and risk of chemical plant protection products, they should now make a greater contribution to the achievement of the Union 2030 reduction targets, while also taking account of their intensity of pesticide use. In order to ensure a fair and collective effort towards the achievement of Union-wide targets and an adequate level of ambition, minimum limits should be laid down for national 2030 reduction targets. The EU’s outermost regions, as listed in Article 349 of the Treaty, are located in the Atlantic, Caribbean and Indian Ocean. Due to permanent constraints such as their remoteness to the European continent, insularity and high exposure to climate change, it is appropriate to allow Member States to take into account the specific needs of these regions as regards the use of plant protection products and measures tailored to specific climatic conditions and crops. In order to ensure a fair and collective effort towards the achievement of Union-wide targets, where a Member State reaches the level of its 2030 national reduction target before 2030, it should not be required to undertake additional reduction efforts, but it should closely monitor annual fluctuations in the use and risk of chemical plant protection products and in the use of more hazardous plant protection products to ensure progress towards meeting the respective 2030 national reduction target. In the interests of transparency, Member State responses to any Commission recommendations in relation to the level of ambition of national targets and the annual progress made towards them should be publicly accessible.
Amendment 441 #
2022/0196(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The implementation of policies and measures in the areas of sustainable use of plant protection products has an impact on the environment, public health and working conditions. Member States should therefore ensure that the public, farmers’ representatives and social partners are given sufficient opportunities to participate in and to be consulted on the preparation of Member State national action plans in accordance, where applicable, with Directive 2001/42/EC of the European Parliament and of the Council58 . __________________ 58 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30).
Amendment 468 #
2022/0196(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) An approach to pest control that follows integrated pest management in ensuring careful consideration of all available means that discourage the development of populations of harmful organisms, while keeping the use of chemical plant protection products to levels that are economically and ecologically justified, pending reliable alternative solutions, and minimising risks to human health and the environment is necessary for the protection of human health and the environment. ‘Integrated pest management’ emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems, technically and financially encourages natural pest control mechanisms and uses chemical control only when all other control means are exhausted or where no reliable alternative solution is available. To ensure that integrated pest management is implemented consistently on the ground, it is necessary to lay down clear rules in this Regulation. In order to comply with the obligation to follow integrated pest management, a professional user should consider and implement, where their reliability has been scientifically and technically approved, all methods and practices that avoid the use of plant protection products. Chemical plant protection products should only be used when all other control means have been exhausted. In order to ensure and monitor compliance with this requirement, it is important that professional users keep a record of the reasons why they apply plant protection products or the reasons for any other action taken in line with integrated pest management and of advice received in support of their implementation of integrated pest management from independent advisors. These records are also required for aerial applications.
Amendment 514 #
2022/0196(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Use of plant protection products may have particularly negative impacts in certain areas that are frequently used by the general public or by vulnerable groups, communities in which people live and work and ecologically sensitive areas, such as Natura 2000 sites protected in accordance with Directive 2009/147/EC of the European Parliament and of the Council67 and Council Directive 92/43/EEC68 . If plant protection products are used in areas used by the general public, the possibility of exposure of humans to such plant protection products is high. In order to protect human health and the environment, the use of plant protection products in sensitive areas and within 3 metres of such areas, should therefore be prohibited. Derogations from the prohibition should only be allowed under certain conditions and on a case-by-case basis by each Member State. __________________ 67 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7). 68 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
Amendment 532 #
2022/0196(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Precision farming refers to agricultural management systems carefully tailoring crop management to fit localised conditions such as those found within land parcels. The application of existing technology, including the use of Union space data and services (Galileo and Copernicus), has the potential to significantly reduce pesticide usage. It is therefore necessary to provide for a legislative framework that incentivises the development of precision farming. Application of plant protection products from an aircraft, including application by planes, helicopters and drones, is usually less precise than other means of application and may therefore potentially cause adverse impacts on human health and the environment. Aerial application should therefore be prohibited, with limited derogations on a case-by-case basis by each Member State where it has a less negative impact on human health and the environment than any alternative application method or there is no viable alternative application method. It is also necessary to record the numbers of aerial applications carried out on the basis of permits granted for aerial application in order to have clear data on how many aerial applications for which permits were granted actually took place.
Amendment 580 #
2022/0196(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) Statistical data on plant protection products collected in accordance with Regulation (EC) No 1185/2009 of the European Parliament and of the Council74 should be used in calculating these harmonised risk indicators and progress towards achieving binding Union and national targets based on the Farm to Fork Strategy. Given that pesticide use fluctuates between years depending, in particular, on the weather, a three year baseline period is appropriate to take account of such fluctuations. The baseline period for the calculation of harmonised risk indicators 1 and 2 is 2011–2013, as this was the first three year period for which data was received by the Commission under Regulation (EC) No 1185/2009 and coincides with the entry into force of Directive 2009/128/EC. The baseline period for the calculation of progress towards the Union 2030 reduction targets for 2030 at the earliest is 2015– 2017, as this was the three most recent years for which data was available at the time of the announcement of the Farm to Fork Strategy. The 2015–2017 baseline period must be subject to a prior weighting to take account of the upheavals resulting from the COVID-19 crisis, the new geopolitical context and the risks of global food shortages, and the baseline period for the calculation of a new harmonised risk indicator 2a is 2022–2024, as this will be the first three year period for which data on the areas treated under each authorisation for an emergency situation in plant protection will be available. __________________ 74 Regulation (EC) No 1185/2009 of the European Parliament and of the Council of 25 November 2009 concerning statistics on pesticides (OJ L 324, 10.12.2009, p. 1).
Amendment 648 #
2022/0196(COD)
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48a) Sufficient funding must be provided to farmers and all stakeholders in the agricultural sector in order to support the gradual transition towards rational and sustainable agriculture. The loss of income will have to be objectively compensated in order to avoid any repercussion on the selling prices of agricultural materials. Industry and suppliers will need to be fully involved to contribute to this funding so that the profits made on the sale of plant protection products are reinvested in research into reliable and innovative solutions that safeguard public health and food safety. The European Regional Development Fund (ERDF) could be used to support national and regional research organisations.
Amendment 653 #
2022/0196(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) The implementation of this Regulation by Member States will result in new and enhanced obligations for farmers and other pesticides users. Some of them constitute statutory management requirements and standards of good agricultural and environmental conditions of land as listed in Annex III to Regulation (EU) 2021/2115 of the European Parliament and of the Council78, which, in accordance with that Regulation, farmers must comply with to receive CAP payments, whereas other requirements, which go beyond the baseline of mandatory requirements, may be rewarded with additional payments under voluntary regimes like eco-schemes pursuant to Article 31 of Regulation (EU) 2021/2115. Article 31(5), points (a) and (b), and Article 70(3), points (a) and (b), of Regulation (EU) 2021/2115 provide that the CAP funding is only available for practices implemented under an eco- scheme or agri-environmental-climate commitment which go beyond the relevant statutory management requirements and the standards of good agricultural and environmental conditions of land established under that Regulation and the relevant minimum requirements for the use of fertiliser and plant protection products, animal welfare, as well as other relevant mandatory requirements established by national and Union law. Since farmers and other users need to be financially supported in their transition toward a more sustainable use of pesticides which fully compensates for the loss of productivity, Regulation (EU) 2021/2115 needs to be amended to allow the financing of requirements imposed in accordance with this Regulation during a transitional period and beyond if necessary. This exceptional option for Member States to provide additional funding for measures taken in implementing this Regulation should apply to any obligation for farmers and other users resulting from the application of this Regulation, including compulsory farming practices imposed by the crop-specific rules for integrated pest management. Further, pursuant to Article 73(5) of Regulation (EU) 2021/2115, investments by farmers to comply with new requirements imposed by Union law may be supported for a maxinimum of 24 months from the date on which they become mandatory for the holding. Similarly, a longer transition period should be set out for investments complying with requirements imposed on farmers in accordance with this Regulation. Regulation (EU) 2021/2115 should therefore be amended accordingly. In addition, structural funding must be put in place to support agronomic research organisations in order to ensure that reliable alternatives to the most dangerous plant protection products are rapidly made available. __________________ 78 Regulation (EU) 2021/2115 of the European Parliament and of the Council of 2 December 2021 establishing rules on support for strategic plans to be drawn up by Member States under the common agricultural policy (CAP Strategic Plans) and financed by the European Agricultural Guarantee Fund (EAGF) and by the European Agricultural Fund for Rural Development (EAFRD) and repealing Regulations (EU) No 1305/2013 and (EU) No 1307/2013, OJ L 435, 6.12.2021, p. 1.
Amendment 661 #
2022/0196(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) The application of this Regulation should be deferred in order to allow competent authorities and operators to prepare for the requirements introduced by it, and to take into account the impact of the new global geopolitical situation on the Member States’ food sovereignty,
Amendment 2322 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. A distributor shall only sell a plant protection product authorised for professional use to a purchaser or his or her representative when that distributor has checked, at the time of purchase, that the purchaser or representative is a professional user and holds a training certificate for following courses for professional users issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5)as been made fully aware of all the risks associated with its use.
Amendment 2332 #
2022/0196(COD)
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Where a purchaser is a legal person, a distributor may sell a plant protection product authorised for professional use to a representative of the purchaser of the plant protection product when that distributor has checked, at the time of purchase, that the representative is the holder of a training certificate for following courses for professional users issued in accordance with Article 25 or has a proof of entry in a central electronic register for following such courses in accordance with Article 25(5)has been made fully aware of all the risks associated with its use upon delivery of the product, either by having signed a leaflet detailing these health risks and providing instructions for safe handling or by having been issued a training certificate.
Amendment 2380 #
2022/0196(COD)
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
3. The training referred to in paragraph 1 could form part of the training interventions set up by Member States according to Article 78 of Regulation (EU) No 2021/2115. Member States should offer distance training, using appropriate digital materials, and in-person training to make it easier for the relevant audiences to participate.
Amendment 2564 #
2022/0196(COD)
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
2. Each Member State shall carry out official controls to verify compliance by operators with the provisions of this Regulation relating to application equipment. Member States shall take appropriate follow-up measures to remedy any specific or systemic shortcomings identified through controls performed by the Commission experts in accordance with paragraphs 3 and 4. They shall give the necessary assistance to ensure that the Commission experts have access to all premises or parts of premises, and goods, and to information, including computer systems, relevant for the execution of their duties.
Amendment 2567 #
2022/0196(COD)
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
Amendment 2572 #
2022/0196(COD)
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
Amendment 2685 #
2022/0196(COD)
Proposal for a regulation
Article 36 – paragraph 2 – point c
Article 36 – paragraph 2 – point c
(c) specify available non-chemical methods to combat those pests that are proven to be technically and economically efficient;
Amendment 55 #
2022/0160(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Directive (EU) 2018/2001
Article 3 – paragraph 1
Article 3 – paragraph 1
Amendment 138 #
2022/0160(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 16a – paragraph 1
Article 16a – paragraph 1
(1) Member States shall ensure that the permit-granting process referred to in Article 16(1) shall not exceed one year for projects in renewables go-to areas. Where duly justifiis conducted oin the ground of extraordinary circumstances, this one- year period may be extended by up to three months. In such a case, Member States shall clearly inform the developer about the extraordinary circumstances that justified the extensionaccordance with the national law in force.
Amendment 142 #
2022/0160(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 16a – paragraph 2
Article 16a – paragraph 2
(2) The permit-granting process for the repowering of plants and for new installations with an electrical capacity of less than 150 kW, co-located energy storage facilities as well as their grid connection, located in renewables go-to areas shall not exceed six months. Where duly justified on the ground of extraordinary circumstances, such as on grounds of overriding safety reasons where the repowering project impacts substantially on the grid or the original capacity, size or performance of the installation, that one year period may be extended by up to three months. Member States shall clearlybe conducted in accordance with the national law in form the project developer about the extraordinary circumstances that justify the extensionce.
Amendment 180 #
2022/0160(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Directive (EU) 2018/2001
Article 16b – paragraph 1
Article 16b – paragraph 1
(1) Member States shall ensure that the permit-granting process referred to in Article 16(1) shall not exceed two years, for projects outside renewables go-to areas. Where duly justifiis conducted oin the grounds of extraordinary circumstances, that two-year period may be extended by up to three months. In such a case, Member States shall clearly inform the developer about the extraordinary circumstances that justified the extensionaccordance with the national law in force.
Amendment 197 #
2022/0160(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive (EU) 2018/2001
Article 16c – paragraph 1
Article 16c – paragraph 1
(1) Member States shall ensure that the permit-granting process referred to in Article 16(1) for the installation of solar energy equipment, including building- integrated solar installations, in existing or future artificial structures, with the exclusion of artificial water surfaces, shall not exceed three monthsis conducted in accordance with the national law in force, provided that the primary aim of such structures is not solar energy production. By derogation from Article 4(2) of Directive 2011/92/EU and Annex II, points 3(a) and (b), alone or in conjunction with point 13(a) to that Directive, such installation of solar equipment shall be exempted from the requirement, if applicable, to carry out a dedicated environmental impact assessment under Article 2(1) of Directive 2011/92/EU.
Amendment 204 #
2022/0160(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 16d
Article 16d
Amendment 210 #
2022/0160(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
Directive 2010/31/EU
Article 9a – paragraph 1
Article 9a – paragraph 1
Member States shall ensure that all new buildings are designed to optimise their solar energy generation potential on the basis of the solar irradiance of the site, enabling the later cost-effective attempt, where possible and in particular for new buildings, to foster the use of geothermal technology and rainwater harvesting systems for use in sanitary systems and for mainstallation of solar technologiining green spaces.
Amendment 211 #
2022/0160(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
Directive 2010/31/EU
Article 9a – subparagraph 2
Article 9a – subparagraph 2
Amendment 218 #
2022/0160(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
Directive 2012/27/EU
Article 3 – paragraph 5
Article 3 – paragraph 5
Amendment 169 #
2022/0140(COD)
Proposal for a regulation
Citation 2
Citation 2
Having regard to the proposal from the European Commission, reject the proposal for a regulation on the European Health Data Space.
Amendment 170 #
2022/0140(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes that would benefit the society such as research, innovation, policy- making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union valueexisting EU regulations on the protection of health data and respect for individual and collective freedoms.
Amendment 178 #
2022/0140(COD)
Proposal for a regulation
Recital 2
Recital 2
Amendment 183 #
2022/0140(COD)
Proposal for a regulation
Recital 3
Recital 3
Amendment 191 #
2022/0140(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.
Amendment 206 #
2022/0140(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data, across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union ation to offer better protection is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it if they wish to do so and under conditions respecting anonymity and the principle that no profit should be made.
Amendment 223 #
2022/0140(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Natural persons should be further empowered to exchange, in a voluntary and informed manner, and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high-quality, safe and efficient healthcare services to the natural person.
Amendment 229 #
2022/0140(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Natural persons may not want to allow access to some parts ofhave the right to deny access to their personal electronic health data while enabling access to other parts so that they can be consulted by clearly identified people and organisations. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. A if natural persons have clearly and voluntarily agreed to such sharing, and in particular according to Regulation (EU) 2016/679, where vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider can, which would thus be imposed on other Member States that do not takhave the data into account when providing health servicesame mechanisms.
Amendment 230 #
2022/0140(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Natural persons may not want to allowhave the right to deny access to some parts or all of their personal electronic health data while enabling access to other parts so that they can be consulted by clearly identified people and organisations. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have l only ife threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. Ae natural persons have clearly and voluntarily agreed to such sharing, and in particular according to Regulation (EU) 2016/679, where vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. These situations must be expressly identified and defined. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider can and be applied to the national laws of other Member States which do not takhave the data into account when providing health servicesame mechanisms.
Amendment 244 #
2022/0140(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.
Amendment 248 #
2022/0140(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Access and sharing of electronic health data should be enabled for all the data that exist in the EHR of a natural person, only when technically feasiblehe person in question has given their explicit consent. However, some electronic health data may not be structured or coded, and the transmission between healthcare providers may be limited or only possible in formats that do not allow for translation (when data is shared cross-borders). In order to provide enough time to prepare for implementation, dates of deferred application should be determined to allow for achieving legal, organisational, semantic and technical readiness for the transmission of different categories of electronic health data. When need for the exchange of new categories of electronic health data is identified, related dates of application should be determined in order to allow for the implementation of this exchange.
Amendment 269 #
2022/0140(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross- border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’). As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. As a condition for the implementation of the EHDS,Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals, which should apply the same level of digital security requirements in order to ensure an optimal level of health data protection for users. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities. _________________ 47 Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).
Amendment 276 #
2022/0140(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States shouldMember States who so wish should be able to join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.
Amendment 279 #
2022/0140(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructureAll Member States who wish to shall be able to join the digital infrastructure MyHealth@EU and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.
Amendment 284 #
2022/0140(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In the context of MyHealth@EU, a central platform, whose infrastructure shall be managed by a European actor on European soil, should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor.
Amendment 287 #
2022/0140(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.
Amendment 293 #
2022/0140(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store in the Member States of the Union and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self- certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48. _________________ 48 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
Amendment 305 #
2022/0140(COD)
Proposal for a regulation
Recital 35
Recital 35
Amendment 323 #
2022/0140(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) For the secondary use of the clinicalelectronic health data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically:, for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.
Amendment 327 #
2022/0140(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health-related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators, policy- makers, regulators and doctors to use those data for different purposes, including research, innovation, policy-making, regulatory purposes, patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use, while excluding banking organisations, insurance companies and any other private profit-making actor whose main activity is not scientific research or any work strictly related to healthcare from the list of entities which may collect such health data.
Amendment 336 #
2022/0140(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person- generated data, such as data from medical devices, wellness applications or other wearables and digital health applications. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 351 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented of difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding, should be made available by data holders to health data access bodies, in order to maximise the impact of the public investment and support research, innovation, patient safety or policy making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associations, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sector.
Amendment 358 #
2022/0140(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agencies may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. Public sector bodies may carry out such research activities by using third parties, including sub-contractors, as long as the public sector body remain at all time the supervisor of these activities. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be strictly prohibited. Offenders would be liable to both financial and criminal penalties.
Amendment 383 #
2022/0140(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) Health data access bodies and single data holders should be allowed to charge fees based on the provisions of Regulation […] [Data Governance Act COM/2020/767 final] in relation to their tasks. Such fees may take into account the situation and interest of SMEs, individual researchers or public bodies. Data holders should be allowed to also charge fees for making data available. Such fees should reflect the costs for providing such services. Private data holders may also charge fees for the collection of data. In order to ensure a harmonised approach concerning fee policies and structure, the Commission may adopt implementing acts. Provisions in Article 10 of the Regulation [Data Act COM/2022/68 final] should apply for fees charged under this Regulation.
Amendment 408 #
2022/0140(COD)
Proposal for a regulation
Recital 52
Recital 52
Amendment 412 #
2022/0140(COD)
Proposal for a regulation
Recital 53
Recital 53
Amendment 422 #
2022/0140(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) Given the sensitivity of electronic health data, data users should notonly have an unrestricted access to such dataccess to the data required for the purpose for which they requested access. All secondary use access to the requested electronic health data should be done through a secure processing environment. In order to ensure strong technical and security safeguards for the electronic health data, the health data access body or, where relevant, single data holder should provide access to such data in a secure processing environment, complying with the high technical and security standards set out pursuant to this Regulation. Some Member States took measures to locate such secure environments in Europe. The processing of personal data in such a secure environment should comply with Regulation (EU) 2016/679, including, where the secure environment is managed by a third party, the requirements of Article 28 and, where applicable, Chapter V. Such secure processing environment should reduce the privacy risks related to such processing activities and prevent the electronic health data from being transmitted directly to the data users. The health data access body or the data holder providing this service should remain at all time in control of the access to the electronic health data with access granted to the data users determined by the conditions of the issued data permit. Only non-personal electronic health data which do not contain any electronic health data should be extracted by the data users from such secure processing environment. Thus, it is an essential safeguard to preserve the rights and freedoms of natural persons in relation to the processing of their electronic health data for secondary use. The Commission should assist the Member State in developing common security standards in order to promote the security and interoperability of the various secure environments.
Amendment 444 #
2022/0140(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) Certain categories of electronic health data can remain particularly sensitive even when they are in anonymised format and thus non-personal, as already specifically foreseen in the Data Governance Act. Even in situations of the use of state of the art anonymization techniques, there remains a residual risk that the capacity to re-identify could be or become available, beyond the means reasonably likely to be used. Such residual risk is present in relation to rare diseases (a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Union), where the limited numbers of case reduce the possibility to fully aggregate the published data in order to preserve the privacy of natural persons while also maintaining an appropriate level of granularity in order to remain meaningful. It can affect different types of health data depending on the level of granularity and description of the characteristics of data subjects, the number of people affected or and for instance in cases of data included in electronic health records, disease registries, biobanks, person generated data etc. where the identification characteristics are broader and where, in combination with other information (e.g. in very small geographical areas) or through the technological evolution of methods which had not been available at the moment of anonymisation, can lead to the re- identification of the data subjects using means that are beyond those reasonably likely to be used. The realisation of such risk of re-identification of natural persons would present a major concern and is likely to put the acceptance of the policy and rules on secondary use provided for in this Regulation at risk. Furthermore, aggregation techniques are less tested for non-personal data containing for example trade secrets, as in the reporting on clinical trials, and enforcement of breaches of trade secrets outside the Union is more difficult in the absence of a sufficient international protection standard. Therefore, for these types of health data, there remains a risk for re-identification after the anonymisation or aggregation, which could not be reasonably mitigated initially. This falls within the criteria indicated in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final]. These types of health data would thus fall within the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final] for transfer to third countries. The protective measures, proportional to the risk of re-identification, would need to take into account the specificities of different data categories or of different anonymization or aggregation techniques and will be detailed in the context of the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final]. More broadly, it will have to be ensured that all Member States using the EHDS – hosting and transferring users’ health data – have the physical infrastructure required, geographically located within the European Union. It will therefore need to be checked that the facilities supporting the IT systems for the EHDS application are owned by entities originating in the European Union. This thus implies that the storage, processing and transfer of health data will be governed by EU law, offering users, as well as public and private bodies, the highest level of protection in terms of rights and freedoms.
Amendment 469 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthens the protection and rights of natural persons in relation to the availability, sharing and control of their electronic health data, which must remain mainly anonymous and thus non- personal, except in the event of a life- threatening emergency or with the express agreement of the natural person;
Amendment 510 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) ‘personal electronic health data’ means data concernstituting health data and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, or data processed in relation to the provision of healthcare services, processed in an electronic form;
Amendment 517 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concernstituting health data and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 554 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or software intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records; with a view to ensuring that data are completely secure, they must be stored and backed up entirely in an EU Member State;
Amendment 627 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Amendment 669 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 1
Article 3 – paragraph 8 – subparagraph 1
Natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit all or some of their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.
Amendment 841 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point a
Article 10 – paragraph 2 – point a
(a) ensure the implementation of the rights and obligations provided for in Chapters II and III by adopting necessary national, regional or local technical solutions and by establishing relevant rules and mechanisms, that is using solutions whose owners, whether public or private, and the infrastructure on which they rely are located in the European Union, so that EU law alone shall govern in the context of the EHDS;
Amendment 890 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives. Members of the digital health authority shall expressly be required to avoid any conflicts of interest.
Amendment 907 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. All infrastructure for this solution shall be located in the European Union and all actors involved shall be governed solely by EU law.
Amendment 958 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – introductory part
Article 17 – paragraph 1 – introductory part
1. Manufacturers of EHR systems shall be located in the European Union and provide services whose use shall be governed solely by EU law, meaning that the infrastructure on which they rely shall be located in the European Union, and:
Amendment 1134 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. Data holders shall make the following categories of non-personal electronic data available for secondary use in accordance with the provisions of this Chapter:
Amendment 1260 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. Where the consent of the natural person is required by national law, health data access bodiesAs a matter of principle, the right to object is to be granted to natural persons whose health data is used for secondary purposes, so that they are able to fully consent to the use of the said health data. This right shall be freely on the obligations laid down in this Chapter to provide access to electronic health dataexercised, without constraint, by the user, who may at any time decide to review the choice they made regarding the use of their health data for secondary purposes.
Amendment 1366 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Article 35 – paragraph 1 – introductory part
Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited and subject to sanction applicable in the jurisdiction of the Member State in which the offence occurred:
Amendment 1378 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point b
Article 35 – paragraph 1 – point b
(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract, of a bank loan and its present or future terms, or to modify their contributions and insurance premiums;
Amendment 1709 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re- identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.
Amendment 1812 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
Amendment 1826 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 4
Article 46 – paragraph 4
4. Following the issuance of the data permit, the health data access body shall immediately request the electronic health data from the data holder. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless the health data access body specifies that it will provide the data within a longer specified timeframe.
Amendment 1873 #
2022/0140(COD)
Proposal for a regulation
Article 47 – paragraph 3
Article 47 – paragraph 3
3. Where an applicant has requested a result in an anonymised form, including statistical format, based on a data request, the health data access body shall assess, within 2 months and, where possible, provide the result to the data user within 2 months.
Amendment 1886 #
2022/0140(COD)
Proposal for a regulation
Article 49
Article 49
Access to electronic health data from a 1. access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shall be addressed to health data access bodies. 2. issue a data permit in accordance with Article 46 or provide an answer to a data request in accordance with Article 47. The data holder shall then provide access to the electronic health data in a secure processing environment in compliance with Article 50 and may charge fees in accordance with Article 42. 3. 51, the single data provider and the data user shall be deemed joint controllers. 4. shall inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this Article in order to enable the health data access body to fulfil its obligations under Article 37(1) and Article 39.rticle 49 deleted single data holder Where an applicant requests In such case, the data holder may By way of derogation from Article Within 3 months the data holder
Amendment 2024 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer rolealso contribute to and enrich the work of the EHDS Board within the scope of their expertise and competence in the EHDS field.
Amendment 2033 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The composition, organisation, functioning and cooperation of the sub- groups shall be set out in the rules of procedure put forward by the Commission to high-level representatives of the digital health authorities and organisations responsible for health data access in all Member States.
Amendment 2058 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point b – point v
Article 65 – paragraph 2 – point b – point v
(v) the establishment and application of penalties;
Amendment 2103 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. ANo later than after 52 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self- certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies.
Amendment 2107 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 2
Article 70 – paragraph 2
2. ANo later than after 75 years from the entry into force of this Regulation, the Commission shall carry out an overall evaluation of this Regulation, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment.
Amendment 30 #
2022/0092(COD)
Proposal for a directive
Recital 1
Recital 1
(1) In order to tackle unfair commercial practices which prevent consumers from making sustainable consumption choices, such as practices associated with the early obsolescence of goods, misleading environmental claims (“greenwashing”), non-transparent and non-credible sustainability labels or sustainability information tools, specific rules should be introduced in Union consumer law. This would enable national competent bodies to address those practices effectively. By ensuring that environmental claims are fair, consumers will be able to choose products that are genuinely better for the environment than competing products. This will encourage competition towards more environmentally sustainable products, thus reducing negative impact on the environmento enable sustainable consumption choices, the products and services offered must be competitive, particularly in terms of their price compared to similar non-sustainable products and services.
Amendment 44 #
2022/0092(COD)
Proposal for a directive
Recital 6
Recital 6
(6) Comparing products or services based on their environmental or social aspects, including through the use of sustainability information tools or their greenhouse gas emission balance (‘carbon footprint’), is an increasingly common marketing technique. In order to ensure that such comparisons do not mislead consumers, Article 7 of Directive 2005/29/EC should be amended to require that the consumer is provided with information about the method of the comparison, the products which are the object of comparison and the suppliers of those products, and the measures to keep information up to date. This should ensure that consumers make better informed transactional decisions when using such services. The comparison should be objective by, in particular, comparing products which serve the same function, using a common method and common assumptions, and comparing material and verifiable features of the products being compared.
Amendment 117 #
2022/0092(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Since tThe objectives of this Directive, namely, enabling better informed transactional decisions by consumers to promote sustainable consumption, eliminating practices that cause damage to the sustainable economy and mislead consumers away from sustainable consumption choicessupporting a circular economy with a low carbon footprint, and ensuring a better and consistent application of the Union consumer legal framework, cannot be sufficiently achieved by the Member States individually but can rather, by reason of the Union-wide character of the problem, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary to achieve those objectives. It is therefore the responsibility of the Member States to alert the Commission of cases of fraud, deception or practices that mislead consumers about products or services claiming to be sustainable.
Amendment 119 #
2022/0092(COD)
Proposal for a directive
Recital 35 a (new)
Recital 35 a (new)
(35a) To maintain the policy of promoting sustainable consumption, a sanctions regime is required for practices listed in Annex I of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005. Products and services sold by one or more traders who have not ensured that such products and services comply with Annex II of Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005, including products and services that come from outside the EU or are sold by one or more traders from outside the EU, should be prohibited.
Amendment 215 #
2022/0092(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 2 – point b
Article 2 – paragraph 1 – point 2 – point b
Directive 2011/83/EU
Article 5 – paragraph 1 – point i
Article 5 – paragraph 1 – point i
(i) where applicable, the reparability score or carbon footprint for the goods;
Amendment 237 #
2022/0092(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 3 – point b
Article 2 – paragraph 1 – point 3 – point b
Directive 2011/83/EU
Article 6 – paragraph 1 – point u
Article 6 – paragraph 1 – point u
(u) where applicable, the reparability score or carbon footprint for the goods;
Amendment 241 #
2022/0092(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4 a (new)
Article 2 – paragraph 1 – point 4 a (new)
Directive 2011/83/EU
Article 24 – paragraph 1 – point a (new)
Article 24 – paragraph 1 – point a (new)
(4a) in Article 24 paragraph 1, point (a) is inserted as follows: (a) Member States may suspend or prohibit certain products or services imported from outside the EU or sold by one or more traders from outside the EU, until an audit has been carried out by the competent authorities or, failing that, until compliance with the criteria in Annex II to Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 has been duly attested.
Amendment 16 #
2021/2101(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the digital transition must go hand in hand with the ongoing green transition (which together are referred to as the twin transitions)form part of the green transition, addressing the energy-intensive nature of the digital economy (rare earth minerals, management and use of servers, etc.) with a view to harmonising them as much as possible;
Amendment 28 #
2021/2101(INI)
Motion for a resolution
Recital E
Recital E
E. whereas, in spite of the fact that the COVID-19 pandemic14 has resulted in a massive expansion of telework and ICT- based mobile work (TICTM)14, jobs tend to be more concentrated in cities and urban centres than in smaller towns, suburbs and rural areas; whereas there are marked differences in the ability to telework between high- and low-paid workers, white- and blue-collar workers and between genders15; whereas TICTM and the digitalisation of services can facilitate relocalisation away from cities with a view to improving quality of life, supporting the environment and bringing about a more balanced geographical distribution of employment and the population; _________________ 14Draft Council conclusions on telework in the context of remote work, paragraph 17. 15Commission working paper of May 2020 entitled ‘Teleworkability and the COVID- 19 crisis: a new digital divide?’.
Amendment 43 #
2021/2101(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. WelcomesNotes that implementing the first policy objective (PO 1) under the cohesion policy package for 2021 to 2027 and its first policy objective (PO 1) focusing on the development of ‘a more competitive and smarter Europe by promoting innovative and smart economic transformation and regional ICT connectivity’may make it possible to bridge the digital divide between territories16; _________________ 16Article 5(1)(a) of Regulation (EU) 2021/1060.
Amendment 47 #
2021/2101(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Highlights the role that the new cohesion policy can play in advancing the twin digital and green transitions; underlines that the digital and innovation components of the new cohesion policy will be key in enabling a sustainable transformation of European society and the economy and reaching the goals of the European Green Dealeconomy;
Amendment 95 #
2021/2101(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses the need for a socially fair and inclusive digitalisation process that leaves no one behind; underlines that support under the ERDF-CF should contribute to an inclus competitive digital society;
Amendment 106 #
2021/2101(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Asks the Commission and the Member States to develop a global strategy, that integrates a gender perspective across all levelfocuses on women who have fallen behind on digital practices in order to tackle social inequalities associated with digitalisation, with a view to enhancing its positive effects;
Amendment 121 #
2021/2101(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Notes that the COVID-19 pandemic has accelerated the rise of e-health solutions; stresses that these transitional solutions must be a back-up for health care provided by people; warns that some people, such as the elderly or socially disadvantaged, who may be less able to use or afford the necessary technologies, may be left behind;
Amendment 123 #
2021/2101(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Underlines the crucial role of small and medium-sized enterprises (SMEs) in creating decent jobs, sustainable growth and rural development and believes that public investments through cohesion policy and other instruments will contribute to better social, economic and territorial cohesion in all EU regions; highlights that different types of SMEs require different types of support and incentives at the EU, national, regional and local levels, depending on their circumstances and level of technology adoption; stresses that, with a view to supporting SMEs with the digitisation process in a secure environment, a strategy must be drawn up that addresses cybersecurity issues and focuses on the research and development of sovereign solutions;
Amendment 26 #
2021/2100(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the COVID-19 pandemic has highlighted the need to ringfence the budget for healthcare systems and their destination, namely the health of nationals and Europeans alone;
Amendment 29 #
2021/2100(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the EU instruments aimed at compensating for some of these problems are mostly limited tomust remain ‘soft’ law;
Amendment 35 #
2021/2100(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas public health policies are not an EU competence and must not become one;
Amendment 37 #
2021/2100(INI)
Motion for a resolution
Recital E
Recital E
E. whereas previous analyses have shown that strengthening cohesion policy is necessary in order to reduce disparities between the standards of healthcare provision in the EUsupport the construction and maintenance of health infrastructures and to train caregivers;
Amendment 40 #
2021/2100(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas the pandemic and the governments’ lack of preparation have significantly undermined hospital systems and caregivers; whereas the health restrictions and vaccine requirements for caregivers are infringements of fundamental freedoms; whereas medical secrecy must be preserved in all situations;
Amendment 67 #
2021/2100(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Highlights that certain less- developed regions are a long way from uniformly matching the standards of healthcare provision available in more developed parts of the EU, and that convergence in this sense is unlikely to be achieved without help at EU level, particularly through itsthe cohesion policy;
Amendment 78 #
2021/2100(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Recommends that, when defining healthcare policies at regional and national level, there should be a willingness to overcome silo approaches between health, social and economic policies, with the goal of improving dialogue, synergies and planned investments from the structural funds and other relevant EU programmes, which are able to cater for citizens’ unmet health and social needenhance the quality of care and prevent any future health restrictions;
Amendment 93 #
2021/2100(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Underlines the importance of continuing to build a comprehensive health infrastructure and to reducereducing the existing disparities to the greatest possible extent; recalls that cohesion policy can make a significant contribution to the building of health infrastructure in every part of the EU, especially in the less- developed regions, in order to create resilient healthcare systems throughout the entire EU, which can respond to current and future challenges;
Amendment 94 #
2021/2100(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls for the use of cohesion policy funds for the development of specialised centres of excellence for specific diseases across the EU, which would also cover its neighbouring countries and contribute to cross-border healthcare cooperationcontribute to better knowledge in the field of healthcare; reiterates, in this context, the need to use all existing EU instruments, such as EU4Health and Horizon Europe, in synergy, in order to support the development of a network of such centres, equitably distributed across the entire territory of the EU;
Amendment 96 #
2021/2100(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Emphasises that citizens in rural areas and the outermost regions often encounter barriers to equality of access to healthcare that limit their ability to obtain the care they need, especially in the form of basic health infrastructure; stresses that, in order for them to acquire sufficient access, as well as the appropriate healthcare which they need, services must be available and obtainable in a timely manner, in accordance with the principle of territorial continuity, based on the need to redress the structural imbalances brought about by their remoteness and insularity;
Amendment 115 #
2021/2100(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for bold cohesion policy measures, in accordance with the legal provisions in force in the EU, in order to combat the phenomenon of medical deserts, attempt to mitigate the lack of healthcare workers in rural areas, and aimed at motivating themmotivate those workers to commence or resume practice there;
Amendment 129 #
2021/2100(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Points out that the COVID-19 crisis has shown the need to step up investments to reinforce healthcare systems’ preparedness, responsiveness and resilience, while ensuring cross-border cooperation across the EU, and that therefore solidarity, sustainability and equityinternational cooperation, and that therefore national solidarities are key to overcoming this crisis and its devastating socio-economic consequences;
Amendment 137 #
2021/2100(INI)
Motion for a resolution
Subheading 2
Subheading 2
Amendment 163 #
2021/2100(INI)
20a. Stresses that the causes of various illnesses, especially COVID-19, should be researched and analysed in accordance with Article 168 of the Treaty on the Functioning of the European Union, which states that Union action ‘shall cover the fight against the major health scourges, by promoting research into their causes’;
Amendment 165 #
2021/2100(INI)
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
Amendment 170 #
2021/2100(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the CommissionMember States to encourage better management of cross- border healthcare, as EU patients still face challenges in accessing healthcare in other Member States and only a minority of potential patients are aware of their rights to seek cross-border healthcare;
Amendment 177 #
2021/2100(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Believes that exchanging knowledge and scaling-up practices through Interreg will contribute to reinforcing preparedness and response facilities across borders, which have become a major factor during the crisis caused by the pandemic;
Amendment 181 #
2021/2100(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Highlights that several Interreprojects resulting pfrojectsm international cooperation have contributed to cross-border regions’ fight against COVID-19 throughout the EU, for example through the mobility of intensive care patients and healthcare professionals, and the development of medical equipment;
Amendment 50 #
2021/2079(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Highlights the deficit in terms of population, raw materials and resources of all kinds, and notes that in many islands access to drinking water is a central issue in people’s lives, the sustainability of the island and its tourism carrying capacity; recalls also that significant illegal immigration in the outermost regions destabilises local economies by minimising wages and creating chronic insecurity, which undermines the establishment of viable businesses and structures;
Amendment 63 #
2021/2079(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes with concern the long-term effects of the COVID-19 crisis and of illegal immigration, which is exacerbating an already precarious situation for EU islands in many areas;
Amendment 68 #
2021/2079(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Regrets the EU’s lack of vision and lack of protection for European islands;
Amendment 70 #
2021/2079(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
Amendment 79 #
2021/2079(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Calls on the Commission to take greater account of the specific climatic characteristics of the outermost regions, including Martinique, Guadeloupe, Mayotte, French Guiana, Réunion and Saint Martin;
Amendment 103 #
2021/2079(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Considers the use of renewable energy to be a priority and believes it could bring substantial benefits to islands; calls, therefore, for the development of a wide range of renewable energy – other than wind energy – to be supported; welcomes the green hydrogen programmes which islands have launched;
Amendment 108 #
2021/2079(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls, as part of the necessary development of small islands, for every effort to be made to enable their electricity interconnection and encourage photovoltaic solutions;
Amendment 116 #
2021/2079(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for urgent measures to counteract the depopulation of islands and to improve quality of life, support local businesses, maintain essential public services such as health and education, fight against irregular immigration and protect jobs; calls also for the development of professional training and employment establishments for island inhabitants to be promoted;
Amendment 123 #
2021/2079(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the Commission to allocate the budget resources needed to expedite the funding of the conversion of road, rail and maritime freight fleets;
Amendment 145 #
2021/2079(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls for the creation, by those countries with a maritime area, of a European Agency of the Sea – along the lines of the European Space Agency – which should rightfully be based in overseas France; considers that this intergovernmental agency, which countries outside the European Union, such as the United Kingdom, could join, would have the following strategic development priorities: - exploration of energy and mineral resources:hydrocarbons, polymetallic nodules and mixed sulphides - research into renewable marine energy sources - research into biological, animal and plant resources - research into maritime transport and surveillance; considers that this cooperation should not undermine national sovereignty over the maritime areas concerned, or the role of national navies in monitoring such areas; considers also that, in the long term, this Agency could be a forum for in-depth diplomatic cooperation on maritime issues, as well as a starting point for commercial projects on a European scale;
Amendment 1 #
2021/2075(INI)
Motion for a resolution
Citation 5
Citation 5
Amendment 16 #
2021/2075(INI)
Motion for a resolution
Recital A
Recital A
A. whereas cities continue to be on the front line of the COVID-19 crisis, with dwindling economic activity, high rates of infection and often inadequate resources; whereas the pandemic has also exacerbated the prevailing shortcomings in urban areas, exposing their vulnerabilities; whereas the pandemic has made clear the need to improve connections with the rural areas surrounding cities;
Amendment 21 #
2021/2075(INI)
Motion for a resolution
Recital B
Recital B
B. whereas longstanding inequalities have been deepened by the pandemic; whereas cities face challenges such as social exclusion and a lack of accessibility as well as environmental issues; whereas the pandemic has reinforced the separation between consumption in large cities and the production of goods sold there, to the detriment of local urban or peri-urban production;
Amendment 28 #
2021/2075(INI)
Motion for a resolution
Recital C
Recital C
C. whereas cities must be directly involved in the recovery from COVID-19; whereas recovery efforts must strive to address longstanding vulnerabilities and go beyond addressing the health impacts of COVID-19 to tackle the persistent inequalities; whereas the pandemic has made it necessary to maintain a local production activity which is capable of mitigating shortages from the major supplier countries for goods and services;
Amendment 35 #
2021/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas cities, towns and functional urban areas, such as metropolitan areas, are key economic pillars to boost growth, create jobs and enhance the Union’s competitiveness in a globalised economy; whereas it is necessary to maintain the poorest social strata and the middle classes in large urban centres and to encourage local production there; whereas immigration in the large urban centres should be restricted in order to prevent a flight of the middle classes and a reduction in the living wage in these centres;
Amendment 42 #
2021/2075(INI)
Motion for a resolution
Recital E
Recital E
E. whereas these areas are responsible for the biggest proportion of energy consumption and greenhouse gas emissions in the EU and play a key role in the Union’s fight against climate change; whereas it is therefore necessary to limit non-vital imports of foreign goods into these urban areas, and whereas it is important to maintain a local economy in order to avoid greenhouse gas emissions;
Amendment 53 #
2021/2075(INI)
Motion for a resolution
Recital F
Recital F
F. whereas multi-level governance including the active involvement of urban authorities, based on coordinated action by the EU, the Member States and regional and local authorities, and in accordance with the partnership principle as laid down in the Common Provisions Regulation, are essential elements for the implementation of all EU policies;
Amendment 67 #
2021/2075(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Underlines that overconcentration of thepopulations, including immigrant populations, in certain urban areas has already led to repercussions such as congestion, the growing challenge of affordable housing, pollution, a deterioration in quality of life, insecurity, urban sprawl, and a significant risk of poverty and social exclusion for certain segments of the population;
Amendment 77 #
2021/2075(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Member States to promote the inclusion of marginalised communities such asthe poorest social classes and the middle classes, including families, people with disabilities, more isolated older people, and homeless people and ethnic minorities such as Roma; calls for funding needs to be addressed at a local level, including those of urban areas, in order to support these marginalised communities sustainably; recalls that sufficient national resources are key to the successful implementation of policy measures put forward by the EU Roma strategic framework for equality, inclusion and participationintenance of living standards for the poorest classes on a sustainable basis;
Amendment 87 #
2021/2075(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
Amendment 96 #
2021/2075(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Stresses the role played by cities towards gender equalityin exacerbating violence against women; underlines that action aimed at bridging the gender gap under cohesion policy should employ an intersectional approach that alsshould, as a priority, employ measures to tmakes age, race and disabilities into consideration; stresses, moreover, that the beneficiaries of cohesion policy should not adopt any discriminatory policies, least of women’s daily lives safe, physically as well as culturally against minorities, such as the LGBTI communitnd socially;
Amendment 109 #
2021/2075(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Emphasises the fact that the COVID-19 pandemic has led to spikes in domestic violence; calls on the Commission and the Member States to allocate cohesion policy funding and mobilise urban authorities to address the global increase in gender-based violence in the Member States;
Amendment 115 #
2021/2075(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Draws attention to unemployment and youth unemployment in particular, which has been exacerbated by the COVID-19 pandemic; calls on the Member States to actively involve urban authorities in devising programmes that meet the needs of young people in cities; calls on the Member States to focus the Youth Employment Initiative efforts on their own nationals in order to improve their employability;
Amendment 125 #
2021/2075(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recognises that a synchronised strategy responding to both COVID-19, shortages and climate change must be implemented to usher in an economic recovery that accelerates the sustainable transition;
Amendment 132 #
2021/2075(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Considers that in line with its commitments under the Paris Agreement, the Union must prioritise circular economy frameworks, local production, sustainable urban mobility, rapid investment in green infrastructure and renewable energy in cities, and respect for the ‘do not harm’ principle;
Amendment 151 #
2021/2075(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Stresses that the commitment of urban areas is crucial for the transition to a climate-neutral society; believes, therefore, that more funding must be made available for urban areas to achieve the targets of the European Green Deal; calls on the Member States to draw on nuclear energy production to strengthen the transition to a decarbonised society;
Amendment 166 #
2021/2075(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Underlines that among the many inequalities exposed by the COVID-19 pandemic, the digital divide is a serious one; notes that the pandemic has accelerated digitalisation; recalls that digitalisation and digital connectivity must be a priority for local communities in their recovery, including in peripheral or rural areas and in small towns;
Amendment 169 #
2021/2075(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for actions and policies for a just digital transition, which should be deployed across various levels, from cities to the EU itself; calls for digital inclusion to be recognised as a right for the new generation and for a clear commitment to achieve universal internet connectivity for cities; calls on the Member States to do more to tackle 'white spots', both in cities and in rural areas;
Amendment 201 #
2021/2075(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Welcomes the Urban Agenda for the EU as a new model of multi-level governance; believes that this should not remain a voluntary process;
Amendment 219 #
2021/2075(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Highlights the importance of EU funding for implementing social inclusion locally for the poorest social strata as well as the middle classes and families; calls for its impact to be strengthened through a common management and reporting framework in order to prevent a flight of workers, craftspeople and low-paid occupations to peripheral and rural areas; calls, to that end, on the Member States to limit the effects of immigration on urban areas and to tackle housing tension;
Amendment 226 #
2021/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
Amendment 142 #
2021/0223(COD)
(30) Users of alternative fuel vehicles should be able to pay easily and conveniently at all publicly accessible recharging and refuelling points, without the need to enter into a contract with the operator of the recharging or refuelling point or a mobility service provider. Therefore, for recharging or refuelling on an ad hoc basis, all publicly accessible recharging and refuelling points should accept payment instruments that are widely used in the Union, and in particular electronic and cash payments through terminals and devices used for payment services. That ad hoc payment method should always be available to consumers, even when contract-based payments are offered at the recharging or refuelling point.
Amendment 165 #
2021/0223(COD)
Proposal for a regulation
Recital 55
Recital 55
Amendment 254 #
2021/0223(COD)
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. Operators of recharging points shall, at the publicly accessible recharging points operated by them, provide end users with the possibility to recharge their electric vehicle on an ad hoc basis using a payment instrument that is widely used in the Union. To that end, such as cash or the following payment methods:
Amendment 261 #
2021/0223(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point a – point iii
Article 5 – paragraph 2 – point a – point iii
Amendment 289 #
2021/0223(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From the date referred to in Article 24 all operators of publicly accessible hydrogen refuelling stations operated by them shall provide for the possibility for end users to refuel on an ad hoc basis using a payment instrument that is widely used in the Union. To that end, operators of hydrogen refuelling stations shall ensure that all hydrogen refuelling stations operated by them accept cash and electronic payments through terminals and devices used for payment services, including at least one of the following:
Amendment 330 #
2021/0223(COD)
Proposal for a regulation
Article 13 – paragraph 8
Article 13 – paragraph 8
8. Each Member State shall take due accountassess the relevance of anythe recommendations frommade by the Commission in its national policy framework. If the Member State concerned does not address a recommendation or a substantial part thereof, that Member State shall provide a written explanation to the Commission.
Amendment 48 #
2021/0218(COD)
Proposal for a directive
Recital 1
Recital 1
(1) The European Green 5 Deal5 establishes the objective of the Union becoming climate neutral in 2050 in a manner that contributes to the European economy, growth and job creation. That objective, and the objective of a 55% reduction in greenhouse gas emissions by 2030 as set out in the 2030 Climate Target Plan6 that was endorsed both by the European Parliament7 and by the European Council8, requires an energy transition and significantly higher shares of renewable energy sources in an integrated energy system. _________________ 5 Communication from the Commission COM(2019) 640 final of 11.12.2019, The European Green Deal. 6 Communication from the Commission COM(2020) 562 final of 17.9.2020, Stepping up Europe’s 2030 climate ambition Investing in a climate-neutral future for the benefit of our people 7 European Parliament resolution of 15 January 2020 on the European Green Deal (2019/2956(RSP)) 8 European Council conclusions of 11 December 2020, https://www.consilium.europa.eu/media/47 296/1011-12-20-euco-conclusions-en.pdf
Amendment 52 #
2021/0218(COD)
Proposal for a directive
Recital 2
Recital 2
(2) RSome renewable energyies plays a fundamental role in delivering the European Green Deal and for achieving climate neutrality by 2050, given that the energy sector contributes over 75% of total greenhouse gas emissions in the Union. By reducing those greenhouse gas emissions, some renewable energyies also contributes to tackling environmental-related challenges such as biodiversity loss.
Amendment 62 #
2021/0218(COD)
Proposal for a directive
Recital 3
Recital 3
Amendment 83 #
2021/0218(COD)
Proposal for a directive
Recital 7
Recital 7
(7) Member States’ cooperation to promote renewable energy can take the form of statistical transfers, support schemes or joint projects. It allows for a cost-efficient deployment of renewable energy across Europe and contributes to market integration. Despite its potential, cooperation has been very limited, thus leading to suboptimal results in terms of efficiency in increasing renewable energy. Member States should therefore be obliged to test cooperation through implementing a pilot project. Projects financed by national contributions under the Union renewable energy financing mechanism established by Commission Implementing Regulation (EU) 2020/129414would meet this obligation for the Member States involved. _________________ 14 Commission Implementing Regulation (EU) 2020/1294 of 15 September 2020 on the Union renewable energy financing mechanism (OJ L 303, 17.9.2020, p. 1)invited to cooperate with each other by implementing a pilot project in the context of an agreement between sovereign nations.
Amendment 93 #
2021/0218(COD)
Proposal for a directive
Recital 8
Recital 8
Amendment 127 #
2021/0218(COD)
Proposal for a directive
Recital 39
Recital 39
Amendment 141 #
2021/0218(COD)
Proposal for a directive
Article premier – paragraph 1 – point 2 – point a
Article premier – paragraph 1 – point 2 – point a
Directive (EU) 2018/2001
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Amendment 175 #
2021/0218(COD)
Proposal for a directive
Article premier – paragraph 1 – point 4 – point a
Article premier – paragraph 1 – point 4 – point a
Directive (EU) 2018/2001
Article 1 – paragraph 1 – point 4 – point a
Article 1 – paragraph 1 – point 4 – point a
Amendment 179 #
2021/0218(COD)
Proposal for a directive
Article premier – paragraph 1 – point 4 – point b
Article premier – paragraph 1 – point 4 – point b
Directive (EU) 2018/2001
Article 1 – paragraph 1 – point 4 – point b
Article 1 – paragraph 1 – point 4 – point b
Amendment 133 #
2021/0214(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) The European Green Deal, with its ambitious targets, has increased costs for European producers. An instrument ensuring a level playing field with third countries, which do not have the same ambitious climate policies as the EU, is thus required.
Amendment 136 #
2021/0214(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Tackling climate and other environmental-related challenges and reaching the objectives of the Paris Agreement are at the core of the European Green Deal. The value of the European Green Deal has only grown in light of the very severe effects of the COVID-19 pandemic on the health and economic well- being of the Union’s citizens, the need to develop European policies promoting localism and the relocation of the most strategic industries.
Amendment 157 #
2021/0214(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The initiative for a carbon border adjustment mechanism (‘CBAM’) is a part of the ‘Fit for 55 Package’. That mechanism is to serve as an essential element of the EU toolbox to meet the objective of a climate-neutral Union by 2050 in line with the Paris Agreement by addressing risks of carbon leakage resulting from the increased Union climate ambition, while at the same time preventing investment drain and ensuring a level playing field in order to preserve the competitiveness of European industry.
Amendment 167 #
2021/0214(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Existing mechanisms to address the risk of carbon leakage in sectors or sub- sectors at risk of carbon leakage are the transitional free allocation of EU ETS allowances and financial measures to compensate for indirect emission costs incurred from GHG emission costs passed on in electricity prices respectively laid down in Articles 10a(6) and 10b of Directive 2003/87/EC. However, free allocation under the EU ETS weakens the price signal that the system provides for the installations receiving it compared to full auctioning and thus affects the incentives for investment into further abatement of emissions.
Amendment 209 #
2021/0214(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The CBAM seeks to replace these existing mechanisms by addressing the risk of carbon leakage in a different way, namely by ensuring equivalent carbon pricing for imports and domestic products. To ensure a gradual transition from the current system of free allowances to the CBAM, the CBAM should be progressively phased in while free allowances in sectors covered by the CBAM are phased out. The combined and transitional application of EU ETS allowances allocated free of charge and of the CBAM should in no case result in more favourable treatment for Union goods compared to goods imported into the customs territory of the Union during a pilot phase that will allow for its effectiveness to be assessed following a transitional period making it possible to ensure that genuinely equivalent carbon pricing of direct and indirect emissions between the European Union and third countries has been achieved.
Amendment 270 #
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. The CBAM is a climate measure which should prevent the risk of carbon leakage and supportpartially linked to the Union’s increased ambition on climate mitigation, while ensuring WTO compatibility.
Amendment 315 #
2021/0214(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) However, while the EU ETS sets an absolute cap on the GHG emissions from the activities under its scope and allows tradability of allowances (so called ‘cap and trade system’), the CBAM should not establish quantitative limits to import, so as to ensure that trade flows are not restricted. Moreover, while the EU ETS applies to installations based in the Union, the CBAM should be applied to certain goods imported into the customs territory of the Union. Overseas territories should benefit from special treatment to avoid any negative effects deriving from the application of the CBAM on their production.
Amendment 324 #
2021/0214(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) The CBAM system has some specific features compared with the EU ETS, including on the calculation of the price of CBAM certificates, on the possibilities to trade certificates and on their validity over time. These are due to the need to preserve the effectiveness of the CBAM as a measure preventing carbon leakage over time and to ensure that the management of the system is not excessively burdensome in terms of obligations imposed on the operators and of resources for the administration, while at the same time preserving an equivalent level of flexibility available to operators under the EU ETS. European SMEs and VSEs should benefit from a derogation system to prevent and limit the administrative burden caused by the implementation of the CBAM.
Amendment 364 #
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, particularly for SMEs and VSEs. 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. fourthly, the impact of Covid-19 on global supply chain disruption and the rise in raw materials prices.
Amendment 466 #
2021/0214(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) The Commission should evaluate the application of this Regulation before the end of the transitional period and report to the European Parliament and the Council. The report of the Commission should in particular focus on possibilities to enhance climate actions towards the objective of a climate neutral Union by 2050. The Commission should, as part of that evaluation, initiate collection of information necessary to possibly extend the scope to indirect emissions, as well as to other goods and services at risk of carbon leakage, and to develop methods of calculating embedded emissions based on the environmental footprint methods47 . __________________ 47Commission Recommendation 2013/179/EU of 9 April 2013 on the use of common methods to measure and communicate the life cycle environmental performance of products and organisations (OJ L 124, 4.5.2013, p. 1).
Amendment 513 #
2021/0214(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) As the CBAM aims to encourage cleaner production processes, the EU stands ready to work with low and middle- income countries towardsincome should be used primarily to support the de- carbonisation of their manufacturing industries. Moreover, the Union should support less developed countries with the necessary technical assistance in order to facilitate their adaptation to the new obligations established by this regulationEuropean industry, technological innovation within it and its competitiveness. These resources should be allocated directly to Member States for redistribution under a sector-by-sector approach.
Amendment 517 #
2021/0214(COD)
Proposal for a regulation
Recital 55 a (new)
Recital 55 a (new)
(55a) This assistance should be financed under the expenditure programmes in the Union budget, in particular the Neighbourhood, Development and International Cooperation Instrument (NDICI) or the Instrument for Pre- Accession Assistance (IPA III) and not through revenue generated by the CBAM.
Amendment 528 #
2021/0214(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) The financial interests of the UnionMember States should be protected through proportionate measures throughout the expenditure cycle, including the prevention, detection and investigation of irregularities, the recovery of funds lost, wrongly paid or incorrectly used and, where appropriate, administrative and financial penalties.
Amendment 540 #
2021/0214(COD)
Proposal for a regulation
Article premier – paragraph 1
Article premier – paragraph 1
1. This Regulation establishes a carbon border adjustment mechanism (the ‘CBAM’) for addressing greenhouse gas emissions embedded in the goods referred to in Annex I, upon their importation into the customs territory of the Union, in order to prevent the risk of carbon leakage and encourage third countries to align with European standards.
Amendment 562 #
2021/0214(COD)
Proposal for a regulation
Article premier – paragraph 3
Article premier – paragraph 3
3. The mechanism will progressively become an alternative to the mechanisms established under Directive 2003/87/EC to prevent the risk of carbon leakage, notably the allocation of allowances free of charge in accordance with Article 10a of that Directive, without prejudice to the maintenance of EU ETS allowances allocated free of charge until 2030 and only provided that the CBAM has proven to be effective in preventing the risk of carbon leakage.
Amendment 956 #
2021/0214(COD)
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
The revenues generated from the sale of CBAM certificates shall be allocated to Member States to be used for the decarbonisation of European industries and the deployment of low-carbon technologies, as they face higher production costs as a result of the ambitious targets set under the European Green Deal, as well as to cover the administrative costs of the CBAM.
Amendment 966 #
2021/0214(COD)
Proposal for a regulation
Article 25 – paragraph 5 – point a (new)
Article 25 – paragraph 5 – point a (new)
(a) The Commission shall report annually to the European Parliament and the Council, with a view to drawing up an exhaustive list of unfair practices and fraud and circumvention practices related to the MACF in third countries.
Amendment 1140 #
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 shall present a 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 and services that may be subject to the risk of carbon leakage in the future, without undermining the proper functioning of the internal market or increasing costs for consumers.
Amendment 1159 #
2021/0214(COD)
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
3. The report by the Commission shall, if appropriate, be accompanied by a legislative proposal. The proposal should consider, inter alia, the option to maintain the allocation of free allowances for EU exports and to allocate a refund for the carbon costs that EU producers incur under the EU Emissions Trading System.
Amendment 1244 #
2021/0214(COD)
Proposal for a regulation
Article 36 – paragraph 3 – point d a (new)
Article 36 – paragraph 3 – point d a (new)
da) In order to ensure carbon neutrality and a level playing field, Article 31 shall only apply when carbon costs are equal for the EU and third countries.
Amendment 15 #
2021/0200(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The European Green Deal31 combines a comprehensive set of mutually reinforcing measures and initiatives aimed at achieving climate neutrality in the Union 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 use. 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, and persons with disabilities and persons with a minority racial or ethnic background. It must therefore be ensured that the transition is just and inclusive, leaving no one behind. _________________ 31 Commission Communication - The European Green Deal, COM(2019) 640 final of 11 December 2019.
Amendment 20 #
2021/0200(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to implement those commitments as well as the Union’s contributions under the Paris Agreement33 adopted under the UNFCCC, the Union regulatory framework to achieve the greenhouse gas emission reduction tarit would be appropriate to adapt the Union regulatory framework, revoke free-trade agreements that increase the flow of goods and thus greenhouse gas emissions, and implement agricultural and industrial activity relocation policies to encouraget should be adaptedrt supply chains and localism, in order to achieve the targets for reducing this type of greenhouse gas emission. _________________ 33 Paris Agreement (OJ L 282, 19.10.2016, p. 4).
Amendment 27 #
2021/0200(COD)
Amendment 29 #
2021/0200(COD)
Proposal for a regulation
Recital 11
Recital 11
Amendment 31 #
2021/0200(COD)
Proposal for a regulation
Recital 12
Recital 12
Amendment 47 #
2021/0200(COD)
Proposal for a regulation
Article premier – paragraph 1 – point 1
Article premier – paragraph 1 – point 1
Regulation (EU) 2018/842
Article 1
Article 1
Amendment 128 #
2020/2276(INI)
Motion for a resolution
Paragraph 31 a (new)
Paragraph 31 a (new)
31a. Following the model of the European Space Agency, calls for the creation of a European Maritime Agency for maritime states, the seat of which should, legitimately, be in Overseas France. The strategic development focus of this intergovernmental agency, which countries outside the European Alliance, such as the United Kingdom, could join, would be on: - exploration of energy and mining resources:hydrocarbons, polymetallic nodules and sulphurised mixtures; - research into renewable marine energy; - research into biological, animal and plant resources; - research into maritime transport and surveillance. This cooperation should not call into question national sovereignty over the maritime areas concerned or the role of national navies in their surveillance. In the long term, this Agency could be a forum for in-depth diplomatic cooperation on maritime issues, as well as a starting point for commercial projects on a European scale.
Amendment 32 #
2020/2140(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Points out that cohesion policy has already proven its added value and will be even more indispensable in the aftermath of the COVID-19 crisis; underlines that eliminating the root causes of irregularities via streamlining and strengthening of administrative capacitiethe presentation of feasibility studies for projects would help beneficiaries and authorities concentrate on results and contribute to reducing the error rate;
Amendment 38 #
2020/2140(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Notes with concern that, at the end of the sixth year of implementation, absorption rates for the European Regional Development Fund (ERDF) and Cohesion Fund (CF) are 6,6% lower than at the same stage in the previous programming period; and draws attention to the risk that, as the eligibility period draws to an end and given the circumstances of the COVID-19 crisis, Member States may prioritise spending over performance and regularity.
Amendment 11 #
2020/2120(INI)
Motion for a resolution
Recital B
Recital B
B. whereas there are concerns about the long-term social, and economic, environmental and cultural consequences on the ORs of the COVID- 19 crisis and Brexit, and whereas these crises legitimately reinforce the demand that Article 349 TFEU be applied, which provides for a special status for the ORs, be applied and complied withthe EU and respective Member States to take particular account of the specific situation of the ORs and contribute to their development;
Amendment 14 #
2020/2120(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the ORs represent a real asset for the European Union, allowing its influence to reach the Atlantic and Indian oceans and also, through the OCTs, the Pacific ocean; whereas this key asset in many areas (biodiversity, raw materials, fishery resources, access to space, population growth) deserves to be highlighted, respected and protected; whereas the geographical remoteness of the European decision-making centres makes our overseas compatriots feel that their difficulties (illegal immigration, endemic poverty, structural economic underdevelopment) are not sufficiently addressed in the formulation of European public policy; whereas developing a comprehensive and ambitious catch-up plan should mark a renewal of relations between the European Union and its ORs, while respecting their individual situations and identities;
Amendment 22 #
2020/2120(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes with satisfaction the extension and maintenance until 2027 of several tax derogations for the ORs (AIEM, dock dues, etc.)specific tax measures for the ORs, and recalls the importance of maintaining the arrangements based on Article 349 TFEU for the ORs, which must reconcile the twin imperatives of protectdeveloping local production and tackling the high cost of living;
Amendment 24 #
2020/2120(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission services and the national and regional authorities to strike a balance between legitimate and essential controls on the use of EU funds and simplifying and making more flexible the administrative rules needed to optimise them, in order to encourage local initiatives and productive investment;
Amendment 39 #
2020/2120(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for the ORs to be fully integrated into the discussions of the Conference on the Future of Europe, in particular via the Conference of Presidents of the ORs, in order to provide a perspective from the outermost regionsgeopolitical perspective;
Amendment 62 #
2020/2120(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses the need to encourage local initiatives by supporting VSMEs, and SMEs and thein all sectors of activity, particularly the agricultural, industrial, tourism, craft, building and construction, and digital sectors;
Amendment 97 #
2020/2120(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls for the creation, by those countries with a maritime area, of a European Agency of the Sea – along the lines of the European Space Agency – which should rightfully be based in overseas France; considers that this intergovernmental agency, which countries outside the European coalition, such as the United Kingdom, could join, should have the following strategic development priorities: - exploration of energy and mineral resources: hydrocarbons, polymetallic nodules and mixed sulphides; - research into renewable marine energy sources; - research into biological, animal and plant resources; - research into maritime transport and surveillance; takes the view that this cooperation would not undermine national sovereignty over the maritime areas concerned, or the role of the national navy in monitoring such areas; considers that such an agency could eventually become the forum for wide-ranging diplomatic cooperation on maritime issues, and the starting point for Europe-wide commercial projects;
Amendment 120 #
2020/2120(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Encourages the emergence of new environment-related professions and support for grassroots actors involved in biodiversity protection, including associationsbiodiversity protection;
Amendment 130 #
2020/2120(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Reaffirms the objective of achieving energy autonomy for the ORs and sStrongly supports the objective of achieving 100% renewable energycarbon neutrality in 2050 in the ORs in line with the European commitment to achieving carbon neutrality by 2050;
Amendment 135 #
2020/2120(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the European Commission to take greater account of the specific climate situation of the ORs, including Martinique, Guadeloupe, Mayotte, French Guiana, Réunion and Saint Martin;
Amendment 139 #
2020/2120(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Calls for every effort to be made to ensure the electricity interconnection of small islands and encourage photovoltaic solutions so that they can develop as needed;
Amendment 140 #
2020/2120(INI)
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
21c. Alerts the European Commission to the need to take greater account of the health disasters occurring in the French ORs – within the European definition – which are Martinique, Guadeloupe, Réunion, Mayotte, French Guiana and Saint Martin; calls for the necessary financial resources to be provided as quickly as possible to tackle this critical issue for the inhabitants of these departments, regions and collectivities, and in particular to: - combat the scourge of Sargasso algae that are ravaging the ecosystem of Guadeloupe in particular; - tackle the consequences of pollution of the soil and subsoil, watercourses and shorelines of Guadeloupe and Martinique by chlordecone, a highly carcinogenic substance; - ensure that everyone in Guadeloupe, Martinique and Mayotte has constant access to drinking water;
Amendment 141 #
2020/2120(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls for strong support to be provided to the ORs in order to promote a new sustainable economic model with structural initiatives for developing the circular economy, and stresses in particular that this model should not be jeopardised by inappropriate regulations;
Amendment 153 #
2020/2120(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Stresses the need to protect the OR economielocal markets from aggressive trade practices, such as clearance markets and the abuse of monopoliedominant positions;
Amendment 156 #
2020/2120(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls for the creation of a specific tax status for enterprises in the ORs in order to increase their competitiveness, particularly within their region;
Amendment 167 #
2020/2120(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Calls on the European Commission to allocate the budget resources needed so that the conversion of road, rail and maritime freight fleets can be funded more quickly;
Amendment 176 #
2020/2120(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Commission to ensure that the ORs benefit fully from international agreements (EPAs, FTAs, etc.) concluded between the EU and third countries; calls for vigilance with regard to the consequences of these agreements on the OR economies and their export routes to the EU market and recommends that effective measures be put in place as part of trade policy, including safeguard clauses and specific checks by the Chief Trade Enforcement Officer, while ensuring that the principle of ‘equivalence’ does not lead to situations which discriminate against the ORs and that EU market opportunities for OR agricultural products are maintained in the long term;
Amendment 199 #
2020/2120(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Stresses that the ORs are strongly affected by migration flows from their immediate neighbourhood; warns of the impact of managing migration flows on local public policies and calls for the new Pact on Asylum and Migration to take account of the real challenges facing the ORs in this area, particularly Mayotte and French Guiana, are at the forefront of the battle against long- standing and endemic illegal immigration that is mainly due to nationals wishing to leave their regional environment in order to achieve stability and a standard of living that is far higher than in their country of origin; notes that such nationals try on a daily basis, mainly by abusing the humanitarian aim of the asylum procedure, to settle in the European Union, which jeopardises local economic and social balances that are already very fragile;
Amendment 205 #
2020/2120(INI)
Motion for a resolution
Paragraph 31 a (new)
Paragraph 31 a (new)
31a. Points out that the ORs need the protection of the European Union which must not, through naivety or blindness, ignore their fate;
Amendment 207 #
2020/2120(INI)
Motion for a resolution
Paragraph 31 b (new)
Paragraph 31 b (new)
31b. Urges its President to remind the Council, the Commission and the Member States of their protection duties;
Amendment 13 #
2020/2087(INI)
Amendment 31 #
2020/2087(INI)
Motion for a resolution
Recital J
Recital J
J. regretting, likewise, that the Fund’s assistance does not cover the additional costs of rebuilding energy- and resource- efficient infrastructure that is more disaster-resilient and climate-resilient, as called for in the European Green Deal;
Amendment 38 #
2020/2087(INI)
Motion for a resolution
Recital M
Recital M
M. whereas, because of climate change, emergency situations are likely to intensify and multiply; highlighting, therefore, the usefulness of the budgetary mechanism of dynamic allocation, introduced in 2014, which enabled the Fund, amongst other things, to provide record support of EUR 1.2 billion for the earthquakes in Italy in 2016-2017;
Amendment 49 #
2020/2087(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Expresses its deep concern that extreme weather events and natural disasters will onlycould increase and intensify alongside climate change;
Amendment 56 #
2020/2087(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses with concern that, in recent years, Europeans have had to face multiple emergencies that have devastated human lives, property, the environment and cultural heritage;
Amendment 78 #
2020/2087(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Is of the view that the risks of natural, ecological and health disasters have now become systemic and thait the least developed and most fragile territories, such as islands, hare often the most affected by the impact of climate changedest;
Amendment 92 #
2020/2087(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Is of the opinion that climate change and the intensification of natural disasters are making territories and regions increasingly vulnerable; calls on the Commission, accordingly, to consider revising the EUSF in order better to take into account disasters on a regional scale;
Amendment 120 #
2020/2087(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. ConsidFurthers thato the establishment of a SEAR may have the advantage of some flexibility, but notes that, in its current form, the EUSF allocation remainsprevious paragraph, and although the EUSF and the EAR have been merged uncdertain, since it depends on the amounts mobilised by the EAR; undertakes, accordingly, closely to monitor the management of the SEAR in order to see whether the funding amount and allocation key provided for in this new financial instrument meet the needs of the EUSF, in view of the extension of its scope and the scale and proliferation of emergencies resulting, in particular, from climate change the new Solidarity and Emergency Aid Reserve (SEAR) package, considers that the maximum annual budget of EUR 1 billion (at 2018 prices) set out in the Commission’s revised proposal of 27 May 2020 on the CFP for 2021-2027 should be ring-fenced for the exclusive benefit of the Member States and accession countries to provide them with financial assistance in the event of major disasters;
Amendment 136 #
2020/2087(INI)
23. Believes that, in the future, the EUSF budget will have tocould be increased in order to make it a real tool for EU solidarity;
Amendment 1 #
2020/2076(INI)
Draft opinion
Recital A
Recital A
A. whereas a domestic industry is a motor of growth, innovation the coronavirus health crisis is having a lasting impact on European economies and cannot be ignored in future strategy formulation, making it extremely important for European countries to take full advantage of Europeand social well-being within the EUtructural funds to rebuild their economies;
Amendment 8 #
2020/2076(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas the coronavirus health crisis has revealed that deindustrialisation is a factor contributing to destabilisation and lasting fragility and has created a colossal dependence on China for manufactures;
Amendment 9 #
2020/2076(INI)
Draft opinion
Recital B
Recital B
B. whereas the EU’s SMEs have traditionally generated a high share of the EU’s employment, and in so doing have ensured social and economic well-being and prosp, by creating a sound fabric of very small businesses and SMEs, it is possible to guarantee sustainable economic dynamism, diversification of production and a solid territyorial network;
Amendment 24 #
2020/2076(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas the paths towards development and economic independence are those of cutting-edge technology and the production of digital goods and services;
Amendment 25 #
2020/2076(INI)
Draft opinion
Recital B b (new)
Recital B b (new)
Bb . whereas future industrial strategies can no longer exclude environmental considerations;
Amendment 26 #
2020/2076(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Recalls that the EU’s industrial future is linked to an alignment of the economy with the principles of the European Green Deal, a roadmap towards a new growth policy for the EU, bringing citizens, cities and regions together, and allowing for a just transitione need for relocation and public investment in industrial activities, particularly strategic industries, organised by Member States or at level 1 of the nomenclature of territorial units (NUTS1);
Amendment 38 #
2020/2076(INI)
Draft opinion
Paragraph 1 – point a (new)
Paragraph 1 – point a (new)
(a) Takes the view that Member States should introduce a per-kilometre duty on imports in a bid to promote short and intra-Community circuits for pollution containment purposes and launch a concerted supply channel revolution;
Amendment 39 #
2020/2076(INI)
Draft opinion
Paragraph 1 – point c (new)
Paragraph 1 – point c (new)
(c) Stresses the need to secure supply in the absence of local solutions, especially by ensuring a geographical spread of supply sources;
Amendment 42 #
2020/2076(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. NotTakes that investment in innovative means of production should foster cohesion amongst all EU regions, allowing them to accomplish fair and inclusive economic growthe view that the use of national or European companies in strategic sectors must be obligatory;
Amendment 52 #
2020/2076(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Stresses that in supporting SMEs through the European Structural and Investment Funds (ESIF) the goal should be, inter alia, an innovative and smart economic transformation, a gree need for strategic national health, military, energy and low carbon EU, as well as an EU which is more connected and aims to ensure long- term and susfood stocks and for regular stocktakinable employmentg;
Amendment 68 #
2020/2076(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Reiterates that the public sector has an important new role to play in facilitating a just transition by promoting a green and fair energy transition, green and blue investments, the circular economy, as well as climate adaptation and risk prevention in all EU regaffirms the importance of establishing a hierarchy of European standards, with strategic protection taking precedence over competition and, in certain cases, over environmental considerations, while keeping in mind the imperative need to switch to less pollutant options;
Amendment 88 #
2020/2076(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Notes that the EU’s cohesion policy needs adequate financing from the ESIF to foster economic, social and territorial cohesion in all EU regions by helping to reduce economic and social disparities, achieve positive convergence and foster sustainable developmentBelieves it mandatory to support European innovation and research in the scientific, digital and energy fields, including nuclear research, especially into waste recycling options;
Amendment 92 #
2020/2076(INI)
Draft opinion
Paragraph 5 – point a (new)
Paragraph 5 – point a (new)
(a) Calls for the fortification of research sectors with policies ensuring a high level of patent protection and effective defences against industrial espionage;
Amendment 93 #
2020/2076(INI)
Draft opinion
Paragraph 5 – point b (new)
Paragraph 5 – point b (new)
(b) Stresses the need to support innovation and research regarding the circular economy;
Amendment 96 #
2020/2076(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Believes that the EU should be attentive to preserving and developing an industrial strategy and production which ensure European strategic autonomy, as well as the availability and delivery of essential products and equipment for citizens if the need arises in the single marketNotes the need for training to be provided in companies engaged in strategic industries or in the circular economy;
Amendment 109 #
2020/2076(INI)
Draft opinion
Paragraph 7
Paragraph 7
Amendment 46 #
2020/2074(INI)
Motion for a resolution
Recital H
Recital H
H. whereas the climate crisis ishallenges are closely linked to other crises such as biodiversity and the COVID-19 pandemictrade globalisation and excessive urbanisation, which are threatening biodiversity and specific ecological balances;
Amendment 53 #
2020/2074(INI)
Motion for a resolution
Recital I
Recital I
I. whereas the transition to a climate- neutral, sustainable and circular economy must involve citizens and all sectors of society, including local, regional and regnational authorities, and must be backed by robust and inclusive social measures to ensure a fair transition that supports job retention and creation;
Amendment 61 #
2020/2074(INI)
Motion for a resolution
Recital J
Recital J
J. whereas energy sources derived from fossil fburning fossil fuels without using existing decarbonisation techniquels undermines efforts to achieve climate neutrality;
Amendment 69 #
2020/2074(INI)
Motion for a resolution
Recital L
Recital L
Amendment 84 #
2020/2074(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
Amendment 135 #
2020/2074(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Believes that Cohesion Policy should focus on the implementation of the Paris Agreement and the fight against climate change through an effective methodology for monitoring climate spending and its performance, including its negative effects for EU regionconservation of biodiversity and local environmental balances;
Amendment 143 #
2020/2074(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Underlines the key role of local, regional and regnational authorities in achieving a fair transition to a climate- neutral economy for all, with social and economic cohesion at its core;
Amendment 178 #
2020/2074(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
Amendment 179 #
2020/2074(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 188 #
2020/2074(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Emphasises that all sectors need to be represented and supported in the transition towards climate-neutral industrial processes, while maintaining international competitiveness; believes that the proliferation of free trade agreements is an aggravating factor in environmental degradation and calls on the Commission to encourage the implementation of a process of industrial relocation within the Union;
Amendment 209 #
2020/2074(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for the updated Circular Economy Action Plan to continue to support the transition towards a circular economy, to tackle issues linked to resource inefficiency and to drive sustainable consumption;
Amendment 215 #
2020/2074(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Calls for the EU’s updated Circular Economy Action Plan to also continue to tackle issues linked to excessive urban expansion in the Union and to drive local consumption;
Amendment 18 #
2020/2040(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the principle of equality between women and men is a core value of the EU, enshrined in the Treaties and the Charter of Fundamental Rights of the European Union; whereas gender mainstreaming should therefore be implemented and integrated as a horizontal principlealways be evaluated in all EU activities and policies;
Amendment 37 #
2020/2040(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the involvement of local and regional authorities, gender equality institutions and non-governmental organisations in partnership agreements and monitoring committees is still insufficient;
Amendment 45 #
2020/2040(INI)
Motion for a resolution
Recital E
Recital E
E. whereas gender-disaggregated data and the adoption of appropriate selection procedures are considered useful for promoting gender equalityis considered useful for understanding the local realities of gender equality and the need for EU support in particular sectors or regions;
Amendment 55 #
2020/2040(INI)
Motion for a resolution
Recital G
Recital G
G. whereas preliminary studies suggest that the COVID-19 pandemic has exacerbated existing inequalities, by disproportionately impacting women and marginalised groups, not only because they are often in precarious jobs, but also because they often make up the majority in sectors exposed to the pandemic, such as education and health;
Amendment 83 #
2020/2040(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Believes that EU rules should be written in a clear and explicit way, and be bindingact as an incentive in relation to gender equality;
Amendment 87 #
2020/2040(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 92 #
2020/2040(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises the importance of a coordinated governance frameworkmonitoring on gender equality, national guidelines and technical support, and stronger scrutiny at EU level after the adoption of operational programmin particular to compensate for the impact of the COVID-19 pandemic on precarious jobs and on the most exposed activities;
Amendment 96 #
2020/2040(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Points out the insufficient training and capacity-building of Managing Authorities and implementing partners as regards the gender dimension of the European Structural and Investment Funds (ESI Funds), as well as insufficient gendergender equality-oriented monitoring and evaluation systems;
Amendment 99 #
2020/2040(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses the lack of a binding gender equality strategy at national and regional level and a lack of awareness as regards the benefits of pursuing gender equality for socio-economic growth and sustainable development;
Amendment 106 #
2020/2040(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Encourages the Member States to coordinate closely with local and regional authorities and civil society partners, in particular in the framework of the partnership agreement and when drafting the partnership principle, to take into account challenges related to effective equality policies at local and regional level;
Amendment 113 #
2020/2040(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers that programme stakeholders and monitoring committees still lack expertise on the implementation of a gender perspectiveequality in concrete projects, especially in European Regional Development Fund (ERDF) interventions; considers there to be a lack of guidelines, training programmes and concrete examples of good practice to address this;
Amendment 120 #
2020/2040(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Believes that all programmes implemented under cohesion policy should ensuretake into account gender equality throughout their preparation, implementation, monitoring and evaluation, as well as equal opportunities for all, without discrimination based on gender or sexual orientation;
Amendment 146 #
2020/2040(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for a strong political commitment to gender equality at EU and national level in order to enhance the attention given by national and local stakeholders to gender equality, both from a human rights perspective and as a crucial factor for socio-economic development,the enhancement of precarious and low-paid occupations with high social value, which are mostly occupied by women; stresses the need for a strong political commitment to defend gender equality in law and to promote further commitment in this area;
Amendment 154 #
2020/2040(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for compulsory requirementsincentive-based evaluation criteria on gender equality objectives to be introduced in all post-2020 operational programmes, with specific and interdisciplinary measures to be translated into all operations;
Amendment 162 #
2020/2040(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Strongly supports the ex ante requirement of developingEncourages the Member States to carry out ex ante evaluations and to draw up a national gender equality strategy to underpin cohesion policy interventions;
Amendment 166 #
2020/2040(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 183 #
2020/2040(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that gender mainstreamingequality must be applied in all stages of the budgetary process; stresses the need to track spending on gender equality in all budget lines, not just in targeted measures, and to assess the final impact of the budgetary lines on gender equality; requests that the Commission, in cooperation with the European Court of Auditors, propose a methodology to that end; recommends the use of criteria such as the national median wage and the median annual gross income in purchasing power parity;
Amendment 186 #
2020/2040(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Ccalls on all institutions to provide guidance documents and training sessions, so as to disseminate concrete examples of good practices on genderin mainstreaming gender equality; stresses, moreover, that at the project selection stage the criteria for gender mainstreaming gender equality should be strengthened through higher scoring and requirements for more practical actions; recommends making use of the existing tools developed by the European Institute for Gender Equality (EIGE) such as its toolkit for gender budgeting in the ESI Funds;
Amendment 194 #
2020/2040(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls on the Commission to include the necessary recommendations on promoting the gender dimension and gender equality-related issues in its communication on the launch of the new cohesion policy 2021-2027;
Amendment 30 #
2020/2039(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the free movement of labour is one of the ‘four freedoms’ of the European Union and its single markethas an impact on demographics and causes economic and social imbalances in some regions with population deficits;
Amendment 42 #
2020/2039(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the health and economic crisis generated by the COVID-19 pandemic made clear that solidarity between generations is one of the driving forces of the recovery process and that health infrastructures have to be accessible to the population in the whole territory;
Amendment 44 #
2020/2039(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the health and economic crisis generated by the COVID-19 pandemic made clear that solidarity between generations is one of the driving forces of the recovery processfactors that fosters social equilibrium;
Amendment 54 #
2020/2039(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas insular and mountainous regions suffer from a structural on the geographic, social and economic point of view and therefore they are particularly affected by the depopulation trend;
Amendment 59 #
2020/2039(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Underlines that the free movement of labour represents a cornerstone of EU competitiveness; notes, nevertheless, that it affects demographics, which has major implications for EU regions and their economic, social and territorial cohesion;
Amendment 64 #
2020/2039(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Observes in this context significant demographic contrasts at both Union and Member State level between core, metropolitan regions and periphery, often ruraland in comparison with rural, insular and mountainous areas;
Amendment 68 #
2020/2039(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Observes that GDP per capita, income level, employment rate, fertility rate and population ageing are among the most important factors with a direct impact on demographics; notes that the current employment dynamics in particular are generating demographic flows within European regions leading to socio-spatial disparities and challenges that post-2020 cohesion policy will need to address; underlines that migration patternsby European citizens is mainly from eastern, southeastern and central regions of the EU to northern and northwestern regions mostly involve young, educated and skilled workersof the EU;
Amendment 91 #
2020/2039(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes that in general rural, post- industrial, insular, mountainous and remote areas are facing a number of specific situations: a considerable decline in population numbers, lower than national or EU average levels of income and difficulties of territorial integration with other regions, making them more exposed to the risk of depopulation; points out that rural regions currently account for 28 % of Europe’s population but this is predicted to fall significantly in the future;
Amendment 97 #
2020/2039(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Draws attention to some of the drivers of demographic change, forcing inhabitants from the abovementioned areas to leave and discouraging others from moving there: offshoring and the absence of genuine national reshoring policies, failure to implement pro-birth policies, poor infrastructure, including a lack of fast broadband internet and missing transport networks, fewer job opportunities, lack of public services and difficult access to health services, fewer education opportunities, making it more difficult to adapt to technological change, and a lack of cultural venues and leisure activities;
Amendment 105 #
2020/2039(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that this lack of diversification in the regional economic structure of certain regions, with particular regard to insular regions, risks creating a negative ‘label’, also among their inhabitants, manifesting dissatisfaction with the quality of life and the facilities and services at their disposal; highlights in this context the brain drain effect, leading to the emigration of highly trained and qualified people from a particular region or country to another; points out, in particular, that the ‘exodus’ of medical staff such as doctors and nurses and teaching staff has led to a deterioration in the quality of medical care and education, making it difficult, especially in rural areas, to access high-quality care and education;
Amendment 107 #
2020/2039(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses that this lack of diversification in the regional economic structure of certain regions risks creating a negative ‘label’, also among their inhabitants, manifesting dissatisfaction with the quality of life and the facilities and services at their disposal; highlights in this context the brain drain effect, leading to the emigration of highly trained and qualified people from a particular region or country to another, irrespective of whether they are highly trained and irrespective of whether they are qualified; points out, in particular, that the ‘exodus’ of medical staff such as doctors and nurses and teaching staff has led to a deterioration in the quality of medical care and education, making it difficult, especially in rural areas, to access high-quality care and education;
Amendment 109 #
2020/2039(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Is of the view that urban areas are also exposed to depopulation, with one in five cities in Europe facing population losses since 1990; notes, however, that urban shrinkage is not always a continuous linear process and can be episodic or temporary, depending on the territorial and economic context;
Amendment 113 #
2020/2039(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Underlines a pattern of ‘inner peripheralisation’, in the sense that eastern and southern European regions report a substantially negative net population migration rate, while northern and western European regions report a substantially positive rate, receiving constantly large numbers of international economic migrants in addition to influxes of Europeans;
Amendment 119 #
2020/2039(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Acknowledges that the metropolitan areas around major cities register a positive migration rate, with characteristic rural-to-urban population movements as well as movements of people from non-EU countries to these urban areas, as a consequence of an increasingly urbanised concentration in employment growth patterns;
Amendment 124 #
2020/2039(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Underlines, on the other hand, that overconcentration of the population in certain urban areas has already led to side- effects, such as congestion, rising housing and transport costs, pollution, deterioration of the quality of life, and urban sprawl, as well as a significant risk of poverty and, social exclusion and insecurity for certain segments of the population, and thus local authorities being unable to provide services to all residents of urban areas;
Amendment 127 #
2020/2039(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that economic migration has a direct impact on the inclusivenesslevel of insecurity of cities, requiring tailored policy responses in different territorial contexts;
Amendment 145 #
2020/2039(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Stresses that local, regional and regnational authorities should play a decisive role in developing territorial strategies, taking into consideration the development needs and the potential of the areas concerned, including the economic, social and demographic trends; points out that community-led local development strategies are a useful tool that can be used to create jobs and increase accessibility to services at local level;
Amendment 147 #
2020/2039(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Considers that the Urban Agenda for the EU, which identifies major priorities and actions for improving the quality of life in urban areas could serve as a model for providing proper instruments promoting growth, integration, cooperation and innovation and tackling social challenges; insists alsoinsists on developing strategies aimed at enhancing the knowledge economy and smart specialisation in European regions, including through developing knowledge networks and providing support for human and industrial capital investments with a high rate of employability;
Amendment 151 #
2020/2039(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Recalls the need for strategies aimed at reversing labour migration; calls on local and regional authorities to tackle the brain drain in ‘sending’ regions through prevention, mitigation and appropriate responses; underlines in this context that there are already several initiatives in various Member States, such as incentives for workers with highly specialised skills, aimed at turning the brain drain into a brain gain for the regions in question; considers that this strategy aimed at reversing brain drain in ‘sending’ regions of the EU should also be applied in the ‘sending’ regions of non-EU countries;
Amendment 165 #
2020/2039(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Stresses that the COVID-19 health crisis has affected all Member States and regions to different extents, and is likely to lead to new trends as regards demographic flows; recalls in this context that the additional resources provided through REACT-EU in order to ensure a sound and robust recovery of the EU’s economy from the crisis could significantly help to keep people in employment, including through support for small and medium-size enterprises and for short-time work schemes and the self- employed;
Amendment 170 #
2020/2039(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that the Recovery and Resilience Facility will provide large-scconditionale financial support to make Member States’ economies more resilient and better prepared for the future, and insists that Member States should propose measures for addressing demographic change; highlights the importance of the instruments for a transition to sustainability such as the Just Transition Fund and its implementation mechanism, which aim to support the communities affected by the energy transition and avoid the risk of depopulationto improve mobility of people and goods in rural, insular and mountainous areas;
Amendment 179 #
2020/2039(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Reiterates the need for further simplification of cohesion policy instruments in order to allow for an easier, but at the same time sound management of financial resources and for maximising synergies among the various EU funds; emphasises the need to reduce red tape and ensure coherent legislation throughout the project implementation process and a focused technical assistance at all stages;
Amendment 202 #
2020/2039(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Member State to include demographic challenges in their national development policies and long- term strategies for sustainable development correlated with the European Semester, thus ensuring proper financing for demographic issues;
Amendment 203 #
2020/2039(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Member State to include demographic challenges in their national development policies and long- term strategies for sustainable development correlated with the European Semester, thus ensuring proper financing for demographic issues;
Amendment 210 #
2020/2039(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the regions at risk of depopulation to focus investments on universal accessibility and redeployment to quality public services and infrastructure and job creation; insists on investment in education, reskilling of workers, reshoring of business, creating entrepreneurial conditions and supporting SMEsmicro- enterprises/SMEs, innovative industries, short supply chains and localism;
Amendment 217 #
2020/2039(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Calls on the regions at risk of depopulation to focus investments on universal accessibility to quality services and infrastructure and job creation; insists on investment in education, reskilling of workers, creating entrepreneurial conditions and supporting micro and SMEs;
Amendment 220 #
2020/2039(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Considers that, within the framework of the economic recovery, the Commission should think about ways to retain local jobs and businesses in the ‘sending’ regions; considers that national and local authorities should support their economies through public procurement; considers that avoiding major migrations and offshoring provides an opportunity to reduce greenhouse gas emissions and thus to meet European Green Deal targets;
Amendment 228 #
2020/2039(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Considers it appropriate to involve national, regional and local authorities in long-term cooperative governance and planning initiatives at various levels; asks the Commission and the Member States to disseminate good practices on the use and benefits of this type of governance and of planning tools to support polycentric development;
Amendment 256 #
2020/2039(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Insists that investments should be focused on information and communication technologymobility infrastructures and local health , since this has the potential to reduce the distance between the users and to attract high- skilled workers; stresses the importance of funding the development and uptake of these technologielabour skills among companies and schools in rural, insular, mountainous and isolated regions and regions in industrial transition;
Amendment 262 #
2020/2039(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Considers that municipalities should promote ‘open innovation’ initiativsocial, cultural and business initiatives, besides "open innovation" ones, making use of the knowledge to accelerate the innovation process and to develop a collaborative approach with relevant partners and stakeholders with a view to creating innovationcultural and business friendly ecosystems;
Amendment 263 #
2020/2039(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Considers that municipalities should promote ‘open innovation’ initiatives, making use of the knowledge to accelerate the innovation process and to developthe establishment of centres of innovation supported by a cpollaborative approach with relevant partners aicy of defending digital and ind ustakeholders with a view to creatrial sovereignty ing innovation ecosystemsdividual Member States and in the EU as a whole;
Amendment 270 #
2020/2039(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Recommends, where appropriate, the that the Member States should, where appropriate, embark on the task of rethinking and reform ofing education and training systems inand the Member States, combined with policiesystem of remuneration for highly qualified researchers and workers to prevent a permanent brain drain from the ‘sending’ regions; insists on using local at regional advantages, as well as the development of economic and social facilities, not only to prevent the brain drain, but also to reverse this phenomenon both within and outside Europe;
Amendment 280 #
2020/2039(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to ensure that the initiative on the long-term vision for rural, insular and mountainous areas includes practical solution and means of support to address demographic changes; invites the Commission, in agreement with the Member States, to propose a ‘new deal’ on demographics in the EU as a multi-level policy approach;
Amendment 5 #
2020/1998(BUD)
Draft opinion
Paragraph 1
Paragraph 1
1. Recognises the need for the EU budget to continue to support recovery, convergence, fair and inclusive sustainable growth and the competitiveness of the European economy and other EU priorities such as social, economic and territorial cohesion and regional development, climate action, digitalisation and innovation, security and the management of migration, including tighter controls at the EU’s external borders, while acknowledging that the COVID-19 pandemic has provided a new and unexpected challenge that the EU and its Member States need to respond to determinedly and provide solutions at the EU level;
Amendment 14 #
2020/1998(BUD)
Draft opinion
Paragraph 2
Paragraph 2
2. Reminditerates that cohesion is a shared competence between the EU and Member States and that as a main public investment policy it will play a major role in the recovery from the COVID-19 pandemic; emphasises that cohesion policy is based on a solidarity and its goal is to reduce economic, social and territorial disparities between Member States and within the EU and regions; emphasizses in that context that programmes managed under the European Structural and Investment Funds (ESIF) Funds support and contribute significantly to sustainable solutions for fair and inclusive economic growth, and investments and competitiveness, as well as high -quality, safe and secure working and living conditions of thefor citizens, including equal opportunities, social justice and non- discrimination; maintains that the competitiveness of businesses and farms is based on due protection for national economies and balanced international trade;
Amendment 31 #
2020/1998(BUD)
Draft opinion
Paragraph 5
Paragraph 5
5. Welcomes the enhanced flexibility in cohesion policy – increased co- financing, anti-crisis use of EU funds -– introduced in March and April 2020, and believes that it - should also be maintained also in MFF 2021-2027; would like the European Structural and Investment Funds (ESIF) to provide a greater degree of cohesion among countries via the redistribution of the funds, including by making all European regions eligible for all the funds;
Amendment 51 #
2020/1998(BUD)
9. Calls on the Member States to share clearly and determinedly their post-crisis plans, ambitions and expectations as well as acknowledge their shared role in preparation for a coordinated EU approach, resulting in improved distribution of European Structural and Investment Funds (ESIF) among Member States.
Amendment 149 #
2020/0380(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Member States should raise awareness on the Union contribution fromuse of the Reserve and inform the public accordingly as transparency, communication and visibility activities are essential in making Union action visible on the grounkeeping European citizens properly informed. Those activities should be based on accurate and updated information.
Amendment 327 #
2020/0380(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
Member States shall be responsible for informing and publicising to Union citizens the role, the results and impact of the Union contribution fromuse of the Reserve through information and communication actions.
Amendment 3 #
2020/0104(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The outbreak of the COVID-19 pandemic in early 2020 changed the economic outlook for the years to come in the Union and in the world, calling for an urgent and coordinated response from the Union in order to cope with the enormous economic and social consequences for all Member. The challenges linked to the demographic context have been amplified by COVID-19. The current COVID-19 pandemic as well as the previous economic and financial crisis have shown that developing sound and resilient economies and financial systems built on strong economic and social structures helps Member States to respond more efficiently to shocks and recover more swiftly from them. The medium and long-term consequences of the COVID-19 crisis will critically depend on how quickly Member States’ economies will recover from the crisis, which in turn depends on the fiscal space Member States have available to take measures to mitigate the social and economic impact of the crisis, and on the resilience of their economies. Reforms and investments to address structural weaknesses of the economies and strengthen their resilience will therefore be essential to set the economies back on a sustainable recovery path and avoid further widening of the divergences in the Union. In addition, Member States’ increased dependence on imports from outside Europe has led to serious shortages in European healthcare systems. This underlines the need to relocalise a large part of the production chain and to establish short supply chains to strengthen Member States’ resilience.
Amendment 16 #
2020/0104(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Past experiences have shown that investment is often drastically cut during crises. However, it is essential to support investment in this particular situation to speed up the recovery and strengthen long- term growth potential. Investing in green and digital technologies, capacities and processes aimed at assisting clean energy transition, boosting energy efficiency in housing and other key sectors of the economic are important to achieve sustainable growth and help create jobs. It will also help make the Union more resilient and less dependent by diversifying key supply chains and relocalising them within the EU.
Amendment 50 #
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, as well as all other programmes favouring relocalisation and short supply chains. To boost actions that fall within the priorities of the European Green Deal and the Digital Agenda, the plan should also set out measures that are relevant for the green and digital transitions. The measures should enable a swift deliver of targets, objectives and contributions set out in national energy and climate plans and updates thereof. All supported activities should be pursued in full respect of the climate and environmental priorities of the Union, in particular in keeping with the new cross- cutting thematic objective of ‘fostering crisis repair in the context of the COVID- 19 pandemic and preparing a green digital and resilient recovery of the economy’ as set out in the proposal for a regulation 2020/0101 (COD).
Amendment 59 #
2020/0104(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure a meaningful financial contribution commensurate to the actual needs of Member States to undertake and complete the reforms and investments included in the recovery and resilience plan, it is appropriate to establish a maximum financial contribution available to them under the Facility as far as the financial support (i.e. the non- repayable financial support) is concerned. That maximum contribution should be calculated on the basis of the population, the inverse of the per capita Gross Domestic Product (GDP) and, the relative unemployment rate of each Member State and the GDP gap, measured quarterly, between 2020 and 2019.
Amendment 70 #
2020/0104(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to ensure the national ownership and a focus on relevant reforms and investments, Member States wishing to receive support should submit to the Commission a recovery and resilience plan that is duly reasoned and substantiated. The recovery and resilience plan should set out the detailed set of measures for its implementation, including targets and milestones, and the expected impact of the recovery and resilience plan on growth potential, job creation and economic and social resilience; it should also include measures that are relevant for the green and the digital transitions; it should also include an explanation of the consistency of the proposed recovery and resilience plan with the relevant country-specific challenges and priorities identified in the context of the European Semester, measures which would support the necessary restoration of Member States’ economies through relocalisation and by promoting short supply chains. Close cooperation between the Commission and the Member States should be sought and achieved throughout the process.
Amendment 77 #
2020/0104(COD)
Proposal for a regulation
Recital 24
Recital 24
Amendment 120 #
2020/0104(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 131 #
2020/0104(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
A maximum financial contribution shall be calculated for each Member State for the allocation of the amount referred to in Article 5(1)(a), using the methodology set out in Annex I, based on the population, the inverse of the per capita Gross Domestic Product (GDP) and, the relative unemployment rate of each Member State and the GDP gap, measured quarterly, between 2020 and 2019.
Amendment 158 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point a
Article 15 – paragraph 3 – point a
(a) (a) an explanation of the way the relevant country-specific challenges and priorities identified in the context of the European Semester are expected to be addressedchallenges and priorities arising from the health crisis can be addressed and how the harmful consequences of this crisis will be tackled in the individual countries;
Amendment 169 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point c
Article 15 – paragraph 3 – point c
(c) an explanation of howwhether the measures in the plan are expected to contribute to the green and the digital transitions or to the challenges resulting from them;
Amendment 172 #
2020/0104(COD)
Proposal for a regulation
Article 15 – paragraph 3 – point d
Article 15 – paragraph 3 – point d
(d) envisaged milestones, targets and an indicative timetable for the implementation of the reforms over a maximum period of four years, and of the investments over a maximum period of seven years;
Amendment 186 #
2020/0104(COD)
Proposal for a regulation
Article 16 – paragraph 3 – point a
Article 16 – paragraph 3 – point a
(a) whether the recovery and resilience plan is expected to contribute to effectively address challenges — notably those revealed by the health crisis — identified in the relevant country-specific recommendations addressed to the Member State concerned or in other relevant documents officially adopted by the Commission in the European Semester;
Amendment 204 #
2020/0104(COD)
Proposal for a regulation
Article 17 – paragraph 4 – point c – point 2
Article 17 – paragraph 4 – point c – point 2
Amendment 87 #
2020/0101(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In order to complement the actions already available under the scope of support of the ERDF, as extended by Regulations (EU) 2020/460 and (EU) 2020/558 of the European Parliament and of the Council5, Member States should continue to be allowed to use the additional resources primarily for investments in products and services for health services, for providing support in the form of working capital or investment support to SMEs, in operations contributing to the transition towards a digital and green economy, infrastructure providing basic services to citizens or economic support measures for those regions most dependent on sectors most affected by the crisis. Technical assistance should also be supported. It is appropriate that the additional resources are focused exclusively under the new thematic objective “Fostering crisis repair in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the economy”, which should also constitute a single investment priority, to allow for simplified programming and implementation of the additional resources. _________________ 5 Regulation (EU) 2020/460 of the European Parliament and of the Council of 30 March 2020 amending Regulations (EU) No 1301/2013, (EU) No 1303/2013 and (EU) No 508/2014 as regards specific measures to mobilise investments in the healthcare systems of Member States and in other sectors of their economies in response to the COVID-19 outbreak (Coronavirus Response Investment Initiative) (OJ L99, 31.3.2020, p. Regulation (EU) 2020/558 of the European Parliament and of the Council of 23 April 2020 amending Regulations (EU) No 1301/2013 and (EU) No 1303/2013 as regards specific measures to provide exceptional flexibility for the use of the European Structural and Investments Funds in response to the COVID-19 outbreak, (OJ L 130, 23.4.2020, p. 1).
Amendment 124 #
2020/0101(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) With a view to allow the targeting of these additional resources to the geographic areas where they are most needed, as an exceptional measure and without prejudice to the general rules for allocating Structural Funds resources, the additional resources allocated to the ERDF and the ESF are not to be broken down per category of region. However, Member States are expected to take into account the different regional needs and development levels in order to ensure that focus is maintained on less developed regions, in accordance with the objectives of economic, social and territorial cohesion set out in Article 173 TFEU. Member States should also involve local and regional authorities, as well as relevant bodies representing civil society, in accordance with the partnership principles.
Amendment 137 #
2020/0101(COD)
Proposal for a regulation
Recital 17
Recital 17
Amendment 8 #
2020/0100(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The proposal for establishing the Just Transition Fund was adopted by the Commission on 14 January 202011. For the better programming and implementation of the Fund, territorial just transition plans are to be adopted, setting out the key steps and timeline of the transition process and identifying the territories most negatively affected by the transition towards a climate neutral economy and with less capacity to deal with the transition challenges. _________________ 11 COM(2020) 22 final
Amendment 18 #
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 economy, as described in the territorial just transition plans. The investments supported may cover energy and transport infrastructure, district heating networks, green mobilityboiler equipment, green mobility, by way of derogation from Article 192 of the Treaty on the Functioning of the European Union, smart waste management, 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 housingthe renovation of social housing and the relocation within the EU of the production of material goods. 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. 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 may be used.
Amendment 67 #
2020/0100(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 73 #
2020/0100(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. For grants awarded pursuant to calls for proposals launched as from 1 January 2025, Union support awarded to eligible projects shall be provided without any pre-allocated national share and on a competitive basis at Union level until exhaustion of remaining resources. The award of such grants shall take into account the need to ensure predictability of investment and the promotion of regional convergence.
Amendment 78 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – introductory part
Article 8 – paragraph 1 – introductory part
Only projects contributing to the objectives referred to in Article 3 and fulfilling allsome of the conditions set out below shall be eligible for Union support under the Facility:
Amendment 96 #
2020/0100(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. The amount of the grant shall not exceed 15% of the amount of the loan provided by the finance partner under this Facility. For projects located in territories in NUTS level 21, 2 or 3 regions with a GDP per capita not exceeding 75% of the average GDP of the EU-27 as referred to in Article [102(2)] of Regulation [new CPR], the amount of the grant shall not exceed 20% of the amount of the loan provided by the finance partner.
Amendment 25 #
2020/0036(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Commission has, in its Communication of 11 December 2019 entitled ‘The European Green Deal’19, set 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 there are no net emissions of greenhouse gases in 2050 and where economic growth is decoupled from resource use. 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 must be just and inclusive, leaving no one behind. The transition must comply with Article 192(5) of the Treaty on the Functioning of the European Union, which provides for temporary derogations for Member States that deem the costs of such a policy to be disproportionate. _________________ 19 Commission Communication - The European Green Deal, COM(2019) 640 final of 11 December 2019.
Amendment 36 #
2020/0036(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Intergovernmental Panel on Climate Change’s (IPCC) Special Report on the impacts of global warming of 1.5 °C above pre-industrial levels and related global greenhouse gas emission pathways20 provides a strong scientific basis for tackling climate change and illustrates the need to step upfor taking climate action. It confirms that greenhouse gas emissions need to be urgently reduced, and that climate change needs to be limited to 1.5 °C, in particular to reduce the likelihood of extreme weather events. The Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services’ (IPBES) 2019 Global Assessment Report21 showed worldwide erosion of biodiversity, with climate change as the third most important driver of biodiversity loss.22 . _________________ 20IPCC, 2018: Global Warming of 1.5°C. An IPCC Special Report on the impacts of global warming of 1.5°C above pre- industrial levels and related global greenhouse gas emission pathways, in the context of strengthening the global response to the threat of climate change, sustainable development, and efforts to eradicate poverty [Masson-Delmotte, V., P. Zhai, H.-O. Pörtner, D. Roberts, J. Skea, P.R. Shukla, A. Pirani, W. Moufouma- Okia, C. Péan, R. Pidcock, S. Connors, J.B.R. Matthews, Y. Chen, X. Zhou, M.I. Gomis, E. Lonnoy, T. Maycock, M. Tignor, and T. Waterfield (eds.)]. 21IPBES 2019: Global Assessment on Biodiversity and Ecosystem Services. 22European Environment Agency’s Tthe European environment – state and outlook 2020 (Luxembourg: Publication Office of the EU, 2019).
Amendment 40 #
2020/0036(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) A fixed long-term objective is crucial to contribute to economic and societal transformation, the protection and creation of jobs, growth, and the achievement of the United Nations Sustainable Development Goals, as well as to move in a fair and cost-effective manner towards the temperature goal of the 2015 Paris Agreement on climate change following the 21st Conference of the Parties to the United Nations Framework Convention on Climate Change (the ‘Paris Agreement’).
Amendment 46 #
2020/0036(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) The Union’s and the Member States’ climate action aims to protect people and the planet, welfare, prosperity, health, food systems, the integrity of eco- systems and biodiversity against the threat of climate change, in the context of the 2030 agenda for sustainable development and in pursuit of the objectives of the Paris Agreement, and to maximize prosperity within the planetary boundaries and to increase resilience and reduce vulnerability of society to climate change, in compliance with Article 192(5) TFEU, which provides for temporary derogations in the event of disproportionate costs.
Amendment 54 #
2020/0036(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Achieving climate neutrality should require a contribution 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 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 objectiveis essential.
Amendment 65 #
2020/0036(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The digital transformation, technological innovation, and research and development are also important drivers for achieving the climate- neutrality objective.
Amendment 67 #
2020/0036(COD)
Proposal for a regulation
Recital 6 c (new)
Recital 6 c (new)
(6c) This energy transition must not exclude any of the energy-production sectors, including nuclear, if their scientific advances demonstrate a real evolution in terms of reducing greenhouse gas emissions.
Amendment 76 #
2020/0036(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The Union is a global leader in the transition towards climate neutrality, and is determined to help raise global ambition and to strengthen the global response to climate change, using all tools at its disposal, including climate diplomacy.
Amendment 110 #
2020/0036(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Pursuit of the European and national climate neutrality objective must be aligned with effective post-pandemic economic recovery in all Member States; the fundamental European objectives of territorial cohesion, homogeneous regional development and effective European business competitiveness at global level must always be guaranteed and never compromised by any measures taken under the new Climate Act.
Amendment 120 #
2020/0036(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The Commission, in its Communication ‘The European Green Deal’, announced its intention to assess and make proposals for increasing the Union’s greenhouse gas emission reduction target for 2030 to ensure its consistency with the climate-neutrality objective for 2050. In that Communication, the Commission underlined that all Union policies should contribute to the climate-neutrality objective and that all sectors should play their part. By September 2020, the Commission should, based on a comprehensive impact assessment and taking into account its analysis of the integrated national energy and climate plans submitted to the Commission in accordance with Regulation (EU) 2018/1999 of the European Parliament and of the Council36, review the Union’s 2030 target for climate and explore options for a new 2030 target of 50 to 55 % emission reductions compared with 1990 levels. Where it considers necessary to amend the Union’s 2030 target, it should make proposals to the European Parliament and to the Council to amend this Regulation as appropriate. In addition, the Commission should, by 30 June 2021, assess how the Union legislation implementing that target would need to be amended in order to achieve emission reductions of 50 to 55 % compared to 1990. In order for the climate-neutrality objective to be just and achievable, it should not undermine the economic and social balances of the Member States and of the sectors they involve in pursuit of this objective. _________________ 36Regulation (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 132 #
2020/0036(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) To ensure the Union and the Member States remain on track to achieve the climate-neutrality objective and progress on adaptation, the Commission should regularly assess progress. Should the collective progress made by Member States towards the achievement of the climate-neutrality objective or on adaptation be insufficient or Union measures inconsistent with the climate- neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience or reduce vulnerability, the Commission should take the necessary measures in accordance with the Treaties. The Commission should also regularly assess relevant national measures, and issue recommendations where it finds that a Member State’s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate change, in compliance with Article 192(5) TFEU, which provides for temporary derogations for Member States that deem the costs to be disproportionate.
Amendment 147 #
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, workers, investors and consumers, to ensure that the transition towards climate neutrality is irreversible, to ensure gradual reduction 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 participatto assist in the assessment of the consistency of measures and progress with the climate-neutrality objective, each Member State should, as part of its long- term strategy under Article 15 of Regulation (EU) 2018/1999, set out an indicative trajectory for progressively reducing net greenhouse gas emissions 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. _________________ 37 OJ L 123, 12.5.2016, p. 1Union aiming at a zero rate - in line with future macroeconomic scenarios - from 2050.
Amendment 156 #
2020/0036(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Climate change is by definition a trans-boundary challenge and a coordinated action at Union levelby the Member States concerned, supported by the Union, is needed to effectively supplement and reinforce national policies. Since the objectives of this Regulation, namely to achieve climate neutrality in the Union by 2050, cannot be sufficiently achieved by the Member States alone, but can rather, by reason of the scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives,
Amendment 256 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point h
Article 3 – paragraph 3 – point h
(h) the need to ensure a just and socially fair transition, preserving jobs and authorising the derogations necessary to that effect, in accordance with Article 192(5) of the Treaty on the Functioning of the EU;
Amendment 337 #
2020/0036(COD)
Proposal for a regulation
Article 9
Article 9
Amendment 3 #
2019/2211(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Acknowledges that Europe’s economy is showing signs of less dynamic growth; highlights that more must be done to support Member States which are experiencing slower growth and high unemployment, particularly where young people are concerned; reiterates that the Single Market must not operate in such a way as to violate human rights; stresses the need to protect personal data and intellectual property in the context of the Digital Single Market; reiterates the need to combat plant relocations in order to reduce the number of international shipments which generate greenhouse gas emissions.
Amendment 5 #
2019/2211(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Acknowledges that Europe’s economy is showing signs of less dynamic growth; highlights that more must be done to support Member States which are experiencing slower growth and high unemployment, particularly where young people are concerned; underlines that a rating agency recently downgraded from “stable” to “negative” the annual outlook for sovereign creditworthiness in the Euro area for 2020;
Amendment 26 #
2019/2211(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Points out that the European Semester must consistently contribute to the elimination of social, economic and territorial inequalities and disparities between EU regions; emphasises that Member States play a key role in the economic and social development of the regions and in generating economic growth in the European Union; reiterates that it is essential that national governments work together in order for the European Green Pact to succeed; emphasises that achieving the objectives of the European Green Pact will depend mainly on the efforts of the Member States, which are natural intermediaries between the European Union and the regions.
Amendment 34 #
2019/2211(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Points out that the European Semester mustshould consistently contribute to the elimination of social, economic and territorial inequalities and disparities between EU regions;
Amendment 49 #
2019/2211(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Remarks that the growth of the EU economy can’t be secured without a new approach to spending policy; therefore every single region in the EU should be provided with all the tools that allow the private sector to invest and exploit the hidden potential of the territory; calls on the Commission to create a pattern fit for business and trade in all lagging areas of the EU to improve local citizens’ lives and employment rates;
Amendment 55 #
2019/2211(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Reiterates the crucial role of cohesion policy, as the main investment policy in Europe, in the recovery process; underlines the need to increase the budget for cohesion policy for the 2021-2027 period, in order to maintain its European added value, thus contributing to economic growth, social inclusion, innovation and environmental protection; calls for the European Regional Development Fund, the European Social Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund to become the key instruments in bringing about low-carbon economies.
Amendment 74 #
2019/2211(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the inclusion of the Sustainable Development Goals in the European Semester, with the aim of putting people, their health and the planet at the centre of economic policy; notes that, in this respect, special attention must be paid to the labour market, by safeguarding existing jobs and creating new ones; calls for respect for the environment and the reduction of carbon emissions to become a mandatory criterion for the award of public contracts.
Amendment 81 #
2019/2211(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. WBelcomesieves that the inclusion of the Sustainable Development Goals in the European Semester, with should have the aim tof putting people, their health and the planet at the centre of economic policy; notes that, in this respect, special attention must be paid to the labour market, by safeguarding existing jobs and creating new ones;
Amendment 87 #
2019/2211(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Takes note of the objectives of the Sustainable Europe Investment Plan but expresses concern about the actual results obtainable through the leverage effect and about the innovation and effectiveness of the supported projects;
Amendment 89 #
2019/2211(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Reminds that the transition to a “zero emissions” productive model can’t be implemented without adequate graduality and attention to side effects on the economic, social and cultural frameworks in which stakeholders play;
Amendment 105 #
2019/2211(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Believes that the relationship between cohesion policy and economic governance processes under the European Semester should be balanced, reciprocal and focused on positive incentives; supports further recognition of the territorial dimension, which would be beneficial for the European Semester; calls for the European Agricultural Fund for Rural Development to be substantially increased to support changes in the agricultural sector, to modernise it, to prevent carbon emissions and the excessive use of plant protection products and GMOs; encourages the use of short supply chains in order to shorten delivery journeys which generate greenhouse gas emissions.
Amendment 110 #
2019/2211(INI)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls for a support to all aspects of European Territorial Cooperation (cross- border, transnational and interregional cooperation, both internally and externally),thereby working towards the overall objective of economic, social and territorial cohesion;
Amendment 114 #
2019/2211(INI)
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Stresses that SMEs are a fundamental engine of development and employment in EU economy, in particular in Mediterranean regions and countries, and that - for structural reasons -they hardly can exploit the full potential of the single market if charged with heavy tax and administrative burdens; asks the Commission therefore to eliminate unnecessary burdens and barriers.
Amendment 38 #
2019/0254(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) The EAFRD should be able to support Community-led local development set up in accordance with the new rules laid down by Regulation (EU) XXXX/XXXX [New CPR]. However, in order to avoid unspent funds for Community-led local development in the programming year 2021, Member States that decide to extend their rural development programmes to 31 December 2021 and that also make use of the possibility to transfer amounts from direct payments to rural development, should be able to apply the 5 % minimum allocation for Community-led local development only to the EAFRD contribution to the rural development extended to 31 December 2021 calculated before the transfer of amounts from direct payment has been done. With a view to ensuring the prosperity of local farming activities, Member States shall undertake to support short supply chains aligned to local needs.
Amendment 46 #
2019/0254(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) As regards prefinancing arrangements from the EAFRD, it should be made clear that where Member States decide to extend the 2014–2020 period to 31 December 2021, this should not lead to any additional prefinancing granted for the programmes concerned. Extending the 2014-2020 funding period in no way affects the funding capacity for the period 2021-2027. The enterprises and farms eligible for this funding shall maintain their funding capacity for the following period.
Amendment 58 #
2019/0254(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) The concept of ‘uniform value’ shall be understood in relation to local and national standards of living, cultures and economic interests.
Amendment 59 #
2019/0254(COD)
Proposal for a regulation
Recital 28 b (new)
Recital 28 b (new)
(28b) Maintaining CAP funding necessitates ensuring equal treatment in each of the Member States, including compliance with the exporting country’s health and environmental standards.
Amendment 148 #
2019/0254(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 6
Article 10 – paragraph 1 – point 6
Regulation (EU) No 1307/2013
Article 25 – paragraph 11 –subparagraph 4 a (new)
Article 25 – paragraph 11 –subparagraph 4 a (new)
Member States may decide to suspend, in whole or in part, international free trade treaties which would affect the results used to determine EU funding for the period 2014-2020.
Amendment 1 #
Amendment 2 #
2019/0183(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Regulation (EC) No 2012/2002 and Regulation (EU) No 1309/2013 in order to provide financial assistance to Member States to cover serious financial burden inflicted on them following a withdrawal of the United Kingdom from the Union without an agreement
Amendment 4 #
2019/0183(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The European Union Solidarity Fund (‘the Fund’) was established by Council Regulation (EC) No 2012/20028 . The Fund was created to provide financial assistance to Member States following emergency situations as a concrete sign of European solidarity in situations of distress, to respond to major natural disasters, and to express European solidarity with disaster-stricken regions within Europe. _________________ 8Council Regulation (EC) No 2012/2002 of 11 November 2002 establishing the European Union Solidarity Fund (OJ L 311, 14.11.2002, p. 3).
Amendment 5 #
2019/0183(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) The European Globalisation Adjustment Fund (EGF) was established1a to show solidarity towards workers made redundant as a result of major structural changes in world trade patterns due to globalisation and global financial and economic crises, and can also support beneficiaries in small labour markets or in exceptional circumstances, in particular with regard to collective applications involving small and medium- sized enterprises (SMEs), even if the number of redundancies is below the normal threshold for mobilisation of the EGF. _________________ 1aRegulation (EC) No 1927/2006 of the European Parliament and of the Council of 20 December 2006 on establishing the European Globalisation Adjustment Fund (OJ L 406, 30.12.20016, p.1).
Amendment 39 #
2019/0183(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 2012/2002
Article 1 – paragraph 1 – subparagraph 1 a
Article 1 – paragraph 1 – subparagraph 1 a
For the purpose of this Regulation, the notion of “major disasters” covers natural disasters as well as situations where serious financial burden is inflicted on a Member State as a direct consequence of the withdrawal of the United Kingdom from the Union without an agreement.
Amendment 57 #
2019/0183(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 2012/2002
Article 3 a – paragraph 4
Article 3 a – paragraph 4
(4) A Member State shall be eligible to apply for assistance under this Article, if the financial burden it has suffered is estimated to be either over EUR 1 500 000 000 in 2011 prices, or more than 0.3 % of its GNI, together with the loss of 2 % of jobs in a given sector of the economy.