1671 Amendments of Ondřej KNOTEK
Amendment 15 #
2023/2075(INI)
Motion for a resolution
Citation 12 a (new)
Citation 12 a (new)
– having regard to the European Parliament resolution of 12 July 2023 on the COVID-19 pandemic entitled 'Lessons learned and recommendations for the future' (2022/2076(INI)),
Amendment 38 #
2023/2075(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
Amendment 54 #
2023/2075(INI)
Motion for a resolution
Recital A
Recital A
A. whereas non-communicable diseases (NCDs) are diseases that are not passed from person to person; whereas non-communicable diseases (NCD’s) cause 90 % of all deaths in the EU4 ; and NCDs continue to grow across the EU; _________________ 4 World Health Organization, ‘Monitoring noncommunicable disease commitments in Europe 2021’, 8 December 2021.
Amendment 56 #
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 health problems and neurological disorders, liver diseases, kidney diseases, oral diseases, osteoporosis, osteoarthritis and endometriosis among other conditionsallergy and auto-immune diseases, oral diseases, rheumatologic diseases and endometriosis among other conditions; whereas data gaps in specific disease areas can result in a misjudgment of the prevalence of these diseases and their burden;
Amendment 89 #
2023/2075(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the increasing burden of NCDs affecting individuals and societies and the health needs of ageing populations represent challenges to the health systems of the Member States;
Amendment 96 #
2023/2075(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas NCDs such as type 2 diabetes increasingly affect children; whereas many people living with NCDs such as diabetes are often diagnosed too late and many people already show signs of complications; 1a _________________ 1a https://link.springer.com/article/10.1007/s 11892-014-0508-y Diabetes Research and Clinical Practice, Volume 183, 2022, 109118, ISSN 0168-8227 https://doi.org/10.1016/j.diabres.2021.109 118.
Amendment 102 #
2023/2075(INI)
Motion for a resolution
Recital D b (new)
Recital D b (new)
Amendment 124 #
2023/2075(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Amendment 166 #
2023/2075(INI)
Motion for a resolution
Recital G a (new)
Recital G a (new)
Ga. whereas antimicrobial resistance (AMR) is a challenge for medical procedures such as surgeries and cancer treatments; whereas AMR leads to increased disease incidence, hospitalisations, mortality rates and healthcare expenses; 1a _________________ 1a https://www.thelancet.com/journals/lancet /article/PIIS0140-6736(21)02724- 0/fulltext
Amendment 169 #
2023/2075(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas not all NCDs can be prevented as some factors are not modifiable such as age, family history, genetics, gender, auto-immunity (e.g. type 1 diabetes) and/or not known such as some neurological disorders;
Amendment 180 #
2023/2075(INI)
Motion for a resolution
Recital H
Recital H
H. whereas innovation with regard to development of technologies, medicines and healthcare practises is crucial to ensure the elimination or reduction of harm caused by preventable risk factors, early detection, improved disease management, integration of care and new and better treatments for NCDs;
Amendment 189 #
2023/2075(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas people suffering from NCDs run a higher risk of being affected by communicable diseases such as COVID-19; whereas data shows that people suffering from NCD’s run a higher risk of complications and dying from COVID-19; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 22-06/eu-ncd- initiative_publication_en_0.pdf page 57
Amendment 220 #
2023/2075(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
Amendment 230 #
2023/2075(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the Healthier together – EU non-communicable diseases (NCD) initiative, Europe’s Beating Cancer Plan, EU4Health work programme and the Commission Communication entitled ‘A comprehensive approach to mental health’; calls on the Commission to strengthen the ‘Healthier together – EU NCD’ initiative by including other NCDs such as chronic kidney diseases, by introducing a holistic EU strategy on NCDs complemented by action plans for specific NCDs; welcomes national plans and actions already taken against NCDs by Member States;
Amendment 549 #
2023/2075(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Stresses that primary prevention is crucial for reducing the occurrence of many types of NCDs; notes that secondary prevention is key for the optimal management of NCDs and contributes to reduce the risk of complications, comorbidities and death;
Amendment 562 #
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 for example through the implementation of health checks and early detection programmes in order to improve disease management, prevent complications and save downstream costs for healthcare systems;
Amendment 568 #
2023/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the European Beating Cancer Plan; stresses the importance of early detection and that 25 Member States had introduced population-based screening programmes for breast cancer, 22 for cervical cancer and 20 for colorectal cancer in their National Cancer Control Plans in 2020; welcomes the 2022 Council Recommendation on strengthening prevention through early detection: A new EU approach on cancer screening which include strategies for earlier detection of breast, cervical, colorectal cancer and extend recommended screenings in Europe for lung, prostate and gastric cancers; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 22-02/eu_cancer-plan_en_0.pdf: page 14
Amendment 580 #
2023/2075(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages Member States to reduce undiagnosed NCDs by introducing joint targeted health checks for high-risk individuals addressing the main shared metabolic risk factors, ensuring such as high blood pressure, high blood glucose, high BMI and high LDL cholesterol as well incentivising self-tests such as stool collection to detect colorectal cancer and self-test for cervical cancer, ensuring timely access to quality care and support NCD patients’ self- management;
Amendment 590 #
2023/2075(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Highlights the importance of early intervention in the case of mental health problems; stresses that daycares, schools and workplaces can play an important role in recognising mental health problems at early stages and that timely support can be provided; 1a _________________ 1a https://health.ec.europa.eu/system/files/20 23-06/com_2023_298_1_act_en.pdf
Amendment 594 #
2023/2075(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Notes that some NCDs are closely linked such as diabetes, chronic kidney diseases and cardiovascular diseases and that important synergies can be achieved by improving diagnosis, early detection, screening and integrated care19 ; _________________ 19 European Commission, ‘Healthier together – EU non-communicable diseases initiative’, p. 30, June 2022.
Amendment 620 #
2023/2075(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Stresses that nurses, doctors, general practitioners. dental health professionals, dietitians and nutritionists and other primary healthcare professionals have a significant role in referring patients for diagnostic tests and treating NCDs; encourages the Member States to offer training to healthcare professionals to better identify high-risk individuals, prevent and treat NCDs;
Amendment 681 #
2023/2075(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Strongly welcomes digital health solutions such as telemedicine, which can enable better accesses to healthcare in rural areas as well protect immunosuppressed NCD patients from exposure to infectious diseases;
Amendment 723 #
2023/2075(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
Amendment 735 #
2023/2075(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Welcomes the pharmaceutical package and calls for the strengthening of the European medicines market to ensure access to medicines and innovative treatments such as Advanced Therapy Medicinal Products (ATMPs) and alleviate medicine shortages, reduce barriers to cross-border business, while strengthening incentives for investment in innovation; underlines that data protection and intellectual property rights are crucial to ensure competitiveness in the EU by incentivising innovators to develop new products and further ongoing research efforts;
Amendment 775 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Acknowledges that organ failure can affect patients suffering from chronic diseases and that transplantation can be the best treatment; notes that the EU Action Plan on Organ Donation and Transplantation (2009-2015) contributed to increase organ donation and transplantation over Europe; acknowledges the potential benefits of organoids and xenotransplantation to address the current shortage of organs available for transplantation; calls on the European Commission to present a new action plan on organ donation and transplantation and to foster research and development on organoids and xenotransplantation;
Amendment 782 #
2023/2075(INI)
Motion for a resolution
Paragraph 24 b (new)
Paragraph 24 b (new)
24b. Takes note of the scoping study made by the European Commission on evidence to tackle high-burden under- researched medical conditions; regrets that some chronic diseases including chronic kidney diseases and mental health are still underfunded compared to the burden they pose to patients, national healthcare systems and the society at large; calls on the European Commission and Member States to dedicate appropriate funding through Horizon Europe and national research programmes to stimulate the development of new diagnoses and treatments;
Amendment 824 #
2023/2075(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27a. Stresses that good quality data are important to support development of evidence-based and targeted policies for improved health; notes that correlating health data with environmental, social and economic data and strengthening elements of existing health monitoring systems such as European Health Data Space is important in this regard;
Amendment 831 #
2023/2075(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Welcomes the Commission Expert Group on Public Health and the sub-group on NCDs; calls on the Commission to establish a European expert network including patient's representatives for prevention and control of NCD co- morbidities and complications;
Amendment 57 #
2023/2061(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Strongly recommends the inclusion of a new policy objective new financial allocation iandustrial transition within the EU cohesion policy beyond 2027 support of large enterprises; stresses that this objective should promote European strategic autonomy and address the adverse effects of the green and digital transitions, particularly focusing on mitigating the negative repercussions on employment through support and diversification of local and regional economies;
Amendment 69 #
2023/2061(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Recommends the creation of a new ‘Just Transition Fund 2.0’ in the upcoming programming period after 2027, which should be endowed with more financial means, have a wider scope, focus on the appropriate NUTS level and be fully integrated in the Common Provisions Regulation16 ; _________________ 16 Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159).;
Amendment 79 #
2023/2061(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to expand the ‘financing not linked to costs’ approach in order to reduce reporting exercises, strengthen the focus on outcomes and impacts rather than on expenditure and achieve a more efficient implementation and use of the funds;
Amendment 96 #
2023/2061(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Recalls that less developed regions are likely to face a disproportionate burden during the green transition, especially concerning the transport sector's shift to decarbonized solutions;
Amendment 107 #
2023/2061(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls on the Commission to put forward the necessary proposal to ensure the continuity of the Just Transition Mechanism and that it is endowed with sufficient funds to include support for regions that are dependent on the automotive and parts-supply industry, in particular in the relevant Just Transition Fund mainstreamed within the cohesion policy, so that synergies and spillover effects can be promoted with various European funds and programmes to address the regional transformation process;
Amendment 130 #
2023/2061(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Recognises the significance of providing support to all companies in the sectors undergoing the transition, with special emphasis on SMEs, which may have limited resources to achieve the necessary transformation; stresses the importance of targeted assistance to help SMEs acquire, upgrade and maintain physical assets and infrastructure, and to invest in research and development; emphasises the need for dedicated funding programmesiority, capacity-building initiatives and technical assistance specifically tailored to the needs of SMEs in order to ensure their successful integration into the sector’s evolving landscape;
Amendment 78 #
2023/2048(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 113 #
2023/2048(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 49 #
2023/2044(INI)
Motion for a resolution
Recital G
Recital G
G. whereas talent retention does not refer exclusively to stopping the emigration of highly qualified persons from one country to another, or from one region to another, but also to attracting populations whose professional background is related to jobs and skills that are still in high demand in rural and sparsely populated areas; whereas regional attractiveness depends on various factors such as residents-wellbeing, economy and labour market, natural environment, connectedness, housing, cultural capital and tourism;
Amendment 153 #
2023/2044(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Stresses the importance of synergies between different funding tools to channel an adequate level of funding towards regions in, or at risk of, a talent development trap through a multi-fund approach; calls on the Commission to considerably reduce the administrative complexity which the managing authorities have encountered in implementing the multi-fund approach;
Amendment 152 #
2023/2028(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Calls on the Commission and the Member States to take action against the alarming increase in antisemitism in the Union; is of the opinion that the will to accommodate other religious minorities in some cases has created an unjustifiable acceptance of antisemitism;
Amendment 154 #
2023/2028(INI)
Motion for a resolution
Paragraph 9 b (new)
Paragraph 9 b (new)
Amendment 12 #
2023/0264(BUD)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Insists that the Commission must guarantee that EU funds are not allocated or linked to any form of terrorism and/or religious and political radicalization while ensuring notably that individuals or groups affiliated, linked to, or supporting terrorist organisations are excluded from Union funding; reiterates its position that salaries of education civil servants responsible for drafting and teaching school textbooks paid by Union funds, must be made conditional on full compliance with UNESCO standards of peace and tolerance; is concerned about antisemitism, hate speech and incitement to violence taught in Palestinian school textbooks, funded by the EU; stresses that conditionality of EU financial assistance in the educational sector needs to be duly considered; underlines the importance of proper training of Palestinian teachers, in line with UNESCO education standards.
Amendment 159 #
2023/0232(COD)
Proposal for a directive
Recital 27
Recital 27
(27) In order to describe soil degradation it is necessary to establish soil descriptors that can be measured or estimated. Even if there is significant variability between soil types, climatic conditions and land uses, the current scientific knowledge allows to set criteria at Union level for some of those soil descriptors. However, Member States should be able to adapt the criteria for some of these soil descriptors based on specific national or local conditions and define the criteria for other soil descriptors for which common criteria at EU level cannot be established at this stage. For those descriptors for which clear criteria that would distinguish betweenThe assessment of soil health should be based on a Soil Health Index relying on multiple indicators and reflecting the overall healthy and unhealthy condition cannot be identified now, only monitoring and assessment are required. This will facilitate the development of such criteria in futurequality of the soil. The Commission should be empowered to adopt a delegated act to establish the Soil Health Index.
Amendment 254 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘soil health’ means the physical, chemical and biological condition of the soil determining its capacity to function as a vital living system and to provide ecosystem services, taking into account the land use;
Amendment 283 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 20
Article 3 – paragraph 1 – point 20
(20) ‘soil contamination’ means the presence of a chemical or substance in the soil in a concentration that may beis harmful to human health or the environment;
Amendment 401 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1
Article 8 – paragraph 5 – subparagraph 1
Member States shall ensure that new soil measurements are performed at least every 56 years.
Amendment 421 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 1 – subparagraph 3
Article 9 – paragraph 1 – subparagraph 3
Member States shall ensure that soil health assessments are performed at least every 56 years and that the first soil health assessment is performed by … (OP: please insert the date = 5 years after date of entry into force of the Directive).
Amendment 428 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – introductory part
Article 9 – paragraph 2 – subparagraph 1 – introductory part
A soil is considered healthy in accordance with this Directive where the following cumulative conditions are fulfilled:values for all soil descriptors listed in part A and B of Annex I, meet the criteria laid down in the Soil Health Index;
Amendment 430 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – point a
Article 9 – paragraph 2 – subparagraph 1 – point a
Amendment 436 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – point b
Article 9 – paragraph 2 – subparagraph 1 – point b
Amendment 443 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 a (new)
Article 9 – paragraph 2 – subparagraph 1 a (new)
The Commission shall be empowered to adopt a delegated act to establish a Soil Health Index, which shall be used to assess the overall health and quality of soil, taking into account multiple indicators and the overall health and quality of the soil including its physical, chemical and biological properties.
Amendment 447 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 3
Article 9 – paragraph 2 – subparagraph 3
Amendment 453 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 3
Article 9 – paragraph 2 – subparagraph 3
Soil is unhealthy where at least one of the criteria referred to in subparagraph 1 is not met, leading to a siginificant deterioration in soil quality (‘unhealthy soil’).
Amendment 538 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
Member States shall ensure that the following principles are respected in case of land take, while taking into account local specificities and socio-economic interests:
Amendment 571 #
2023/0232(COD)
Proposal for a directive
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Member States shall manage the risks for human health and the environment of potentially contaminated sites and contaminated sites, and keep them to acceptable levels, taking account of the environmental, social and economic impacts of the soil contamination and of the risk reduction measures taken pursuant to Article 15 paragraph 4. Risk assessment for human health shall always take into account the land use. Member States shall also take into account of the environmental, social and economic impacts of the risk reduction measures taken pursuant to Article 15 paragraph 4.
Amendment 585 #
2023/0232(COD)
1. Member States shall systematically and actively identify all sites where a soil contamination is suspected based on evidence collected through all availableproportional means (‘potentially contaminated sites’).
Amendment 598 #
2023/0232(COD)
Proposal for a directive
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Where appropriate, Member States shall ensure that all potentially contaminated sites identified in accordance with Article 13 are subject to soil investigation.
Amendment 621 #
2023/0232(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. By … (OP : please insert date = 4 years after entry into force of the Directive), Member States shall, in accordance with paragraph 2, draw up a register of contaminated sites and potentially contaminated sites.
Amendment 635 #
2023/0232(COD)
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1 – introductory part
Article 18 – paragraph 1 – subparagraph 1 – introductory part
Member States shall electronically report the following data and information to the Commission and to the EEA every 56 years:
Amendment 663 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 8, 9, 10, 15 and 16 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Directive.
Amendment 666 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 3
Article 20 – paragraph 3
3. The delegation of power referred to in Articles 8, 9, 10, 15 and 16 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 669 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 6
Article 20 – paragraph 6
6. A delegated act adopted pursuant to Articles 8, 9, 10, 15 and 16 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 673 #
2023/0232(COD)
Proposal for a directive
Article 22 – paragraph 2
Article 22 – paragraph 2
Member States shall determine what constitutes a sufficient interest and impairment of a right, consistently with the objective of providing the public with wide access to justice. For the purposes of paragraph 1, any non-governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed to have rights capable of being impaired and their interest shall be deemed sufficient.
Amendment 684 #
2023/0232(COD)
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The penalties referred to in paragraph 1 shall include fines proportionate to the turnover of the legal person or to the income of the natural person having committed the violation. The level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the violation of the economic benefits derived from that violation. In the case of a violation committed by a legal person, such fines shall be proportionate to the legal person’s annual turnover in the Member State concerned, particularly taking into account, inter alia, the specificities of small and medium-sized enterprises (SMEs).
Amendment 753 #
2023/0232(COD)
Proposal for a directive
Annex I – Part A – Row 2
Annex I – Part A – Row 2
Part A: soil descriptors with criteria for healthy soil condition established at Union level Soil erosion Soil ≤ 2 t ha-1 y-1 Badlands and other erosion unmanaged natural land rate areas, except if they represent (tonnes a significant disaster risk per hectare per year) deleted deleted deleted deleted
Amendment 767 #
2023/0232(COD)
Proposal for a directive
Annex I – Part C - Row 2 and Row 5a
Annex I – Part C - Row 2 and Row 5a
Part C: soil descriptors without criteria Aspect of soil degradation Soil descriptor Excess nutrient content in soil Nitrogen in soil (mg g-1) and deficient nutrient Nitrogen in soil (mg g-1) content in soil Extractable phosphorus (mg per kg) Soil erosion Soil erosion rate (tonnes per hectare per year)
Amendment 222 #
2023/0226(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47 ) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necessary to clarify the status of category 1 NGT plants for the purposes of organic production. The use of new genomic techniques is currently incompatible with the concept of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibiAs category 1 NGT plants could also have been obtained with conventional breeding techniques, their use should be permitted in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
Amendment 491 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1a. Plant varieties that may arise and occur naturally or may be produced by conventional breeding or are considered to be conventional plants (such NGT plants) should not be subject to Patent legislation but to Plant Variety Rights legislation, which allows the use of the so- called Plant breeders ‘exemption and Farm saved Seeds exemption‘.
Amendment 493 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 1 b (new)
Article 5 – paragraph 1 b (new)
Amendment 495 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 515 #
2023/0226(COD)
Proposal for a regulation
Article 6 – title
Article 6 – title
Verification procedure of category 1 NGT plant status prior to the deliberate release for any other purpose than placing on the market
Amendment 560 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working days from the date of receipt of a verification request. The competent authority shall make available the verification reportask the European Food Safety Authority ('the Authority') for scientific opinion on the verification report and shall make it available to the other Member States and to the Commission without undue delay.
Amendment 566 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make commentsreasoned comments together with scientific justification as regards the fulfilment of the criteria set out in Annex I, to the verification report within 20 days from the date of receipt of that report.
Amendment 576 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
Amendment 584 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
Amendment 594 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Acompetent authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plantadopts its decision based on EFSA's opinion within 4520 working days from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2)EFSA's opinion. The competent authority shall transmit the decision without undue delay to the requested, to other Member States and to the Commission.
Amendment 1052 #
2023/0226(COD)
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant prepared by new genomic techniques is considered equivalent to a conventional plants when if it differs from the recipient/parental plant by no more than 20only by genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools4 which can be combined with each other.
Amendment 1066 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 1 a (new)
Annex I – point 1 a (new)
(1a) Criteria specific for the use of targeted mutagenesis on the condition that the number of modifications per any gene cannot exceed 3;
Amendment 1067 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 1 b (new)
Annex I – point 1 b (new)
(1b) Criteria specific for the use of cisgenesis on the condition that only one modification can occur per one genome site;
Amendment 1074 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – introductory part
Annex I – point 3 – introductory part
(3) on the condition that the genetic modification does not interrupt an endogenous gene or that the resulting DNA sequences context in the recipient plant already occurs in a species from the breeders’ gene pool :
Amendment 1083 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – point a
Annex I – point 3 – point a
(a) targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;
Amendment 1089 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – point b
Annex I – point 3 – point b
(b) targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;
Amendment 1091 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3 – point b a (new)
Annex I – point 3 – point b a (new)
(ba) translocation of a continuous endogenous DNA sequence existing in the breeders’ gene pool;
Amendment 1097 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 10 #
2023/0199(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) There is a need to support critical technologies in the following fields: deep and digital technologies, clean technologies, and biotechnologies (including the respective critical raw materials value chains), in particular projects, companies and sectors with a critical role for EU’s competitiveness and resilience and its value chains, as well as technologies, which can be utilized in replacing critical non-renewable materials with renewable materials. By way of example, deep technologies and digital technologies should include microelectronics, high-performance computing, quantum technologies (i.e., computing, communication and sensing technologies), cloud computing, edge computing, and artificial intelligence, cybersecurity technologies, robotics, 5G and advanced connectivity and virtual realities, including actions related to deep and digital technologies for the development of defence and aerospace applications. Clean technologies should include, among others, renewable energy; electricity and heat storage; heat pumps; electricity grid; renewable fuels of non- biological origin; sustainable alternative fuels; electrolysers and fuel cells; carbon capture, utilisation and storage; energy efficiency; hydrogen and its related infrastructure; smart energy solutions; technologies vital to sustainability such as water purification and desalination; advanced materials such as nanomaterials, composites and future clean construction materials, and technologies for the sustainable extraction and processing of critical raw materials. Biotechnology should be considered to include technologies such as biomolecules and its applications, pharmaceuticals and medical technologies vital for health security, crop biotechnology, and industrial biotechnology, such as for waste disposal, and biomanufacturing. The Commission may issue guidance to further specify the scope of the technologies in these three fields considered to be critical in accordance with this Regulation, in order to promote a common interpretation of the projects, companies and sectors to be supported under the respective programmes in light of the common strategic objective. Moreover, technologies in any of these three fields which are subjects of an Important Project of Common European Interest (IPCEI) approved by the Commission pursuant to Article 107(3), point (b) TFEU should be deemed to be critical, and individual projects within the scope of such an IPCEI should be eligible for funding, in accordance with the respective programme rules, to the extent that the identified funding gap and the eligible costs have not yet been completely covered.
Amendment 13 #
2023/0199(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) There is a need to support critical technologies in the following fields: deep and digital technologies, clean technologies, and biotechnologies (including the respective critical raw materials value chains), in particular projects, companies and sectors with a critical role for EU’s competitiveness and resilience and its value chains. By way of example, deep technologies and digital technologies should include microelectronics, high-performance computing, quantum technologies (i.e., computing, communication and sensing technologies), cloud computing, edge computing, and artificial intelligence, cybersecurity technologies, robotics, 5G and advanced connectivity and virtual realities, including actions related to deep and digital technologies for the development of defence and aerospace applications. Clean technologies should include, among others, renewable energy; electricity and heat storage; heat pumps; electricity grid; renewable fuels of non- biological origin; sustainable alternative fuels; electrolysers and fuel cells; carbon capture, utilisation and storage; energy efficiency; hydrogen and its related infrastructure; smart energy solutions; technologies vital to sustainability such as water purification and desalination; advanced materials such as nanomaterials, composites and future clean construction materials, and technologies for the sustainable extraction and processing of critical raw materials, including sustainable recovery, recycling and other processing. Biotechnology should be considered to include technologies such as biomolecules and its applications, pharmaceuticals and medical technologies vital for health security, crop biotechnology, and industrial biotechnology, such as for waste disposal, and biomanufacturing. The Commission may issue guidance to further specify the scope of the technologies in these three fields considered to be critical in accordance with this Regulation, in order to promote a common interpretation of the projects, companies and sectors to be supported under the respective programmes in light of the common strategic objective. Moreover, technologies in any of these three fields which are subjects of an Important Project of Common European Interest (IPCEI) approved by the Commission pursuant to Article 107(3), point (b) TFEU should be deemed to be critical, and individual projects within the scope of such an IPCEI should be eligible for funding, in accordance with the respective programme rules, to the extent that the identified funding gap and the eligible costs have not yet been completely covered.
Amendment 45 #
2023/0199(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In order to extend support possibilities for investments aimed at strengthening industrial development and reinforcement of value chains in strategic sectors, the scope of support from the ERDF should be extended by providing for new specific objectives under the ERDFintervention fields, without prejudice to the rules on eligibility of expenditure and climate spending as set out in Regulation (EU) 2021/106055 and Regulation (EU) 2021/105856 . In strategic sectors, it should also be possible to support productive investments in enterprises other than SMEs, which can make a significant contribution to the development of less developed and transition regions, as well as in more developed regions of Member States with a GDP per capita below the EU average. Managing authorities are encouraged to promote the collaboration between large enterprises and local SMEs, supply chains, innovation and technology ecosystems. This would allow reinforcing Europe’s overall capacity to strengthen its position in those sectors through providing access to all Member States for such investments, thus counteracting the risk of increasing disparities. _________________ 55 Regulation (EU) 2021/1060 laying down common provisions (OJ L 231, 30.6.2021, p. 159). 56 Regulation (EU) 2021/1058 on the European Regional Development Fund and on the Cohesion Fund (OJ L 224, 24.6.2021, p. 31).
Amendment 53 #
2023/0199(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) In order to help accelerate investments and provide immediate liquidity for investments supporting the STEP objectives under the ERDF, the ESF+59 and the JTF, an additional amount of exceptional pre-financing should be provided in the form of a one-off payment with respect to the priorities dedicated to investments supporting the STEP objectives. The additional pre- financing should apply to the whole of the JTF allocation given the need to accelerate its implementation and the strong links of the JTF to support Member States towards the STEP objectives. The rules applying for those amounts of exceptional pre- financing should be consistent with the rules applicable to pre-financing set out in Regulation (EU) 2021/1060. Moreover, to further incentivise the uptake of such investments and ensure its faster implementation, the possibility for an increased EU financing rate of 100% for the STEP prioritieinvestments should be available. When implementing the new STEP objectives, managing authorities are encouraged to apply certain social criteria or promote social positive outcomes, such as creating apprenticeships and jobs for young disadvantaged persons, in particular young persons not in employment, education or training, applying the social award criteria in the Directives on public procurement when a project is implemented by a body subject to public procurement, and paying the applicable wages as agreed through collective bargaining. _________________ 59 Regulation (EU) 2021/1057 establishing the European Social Fund Plus (ESF+) (OJ L 231, 30.6.2021, p. 21).
Amendment 54 #
2023/0199(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The regulatory framework for the implementation of the 2014-2020 programmes has been adapted over the past years to provide Member States and regions with additional with additional flexibility in terms of implementation rules and more liquidity to tackle the effects of the COVID-19 pandemic and the war or aggression against Ukraine. These measures, introduced at the end of the programming period, require sufficient time and administrative resources to be fully exploited and implemented; also at a time where Member States will focus resources on revising the 2021-2027 operational programmes linked to the STEP objectives. With a view to alleviate the administrative burden on programme authorities and to prevent possible loss of funds at closure for purely administrative reasons, the deadlines for the administrative closure of the programmes under the 2014-2020 period should be extended in Regulation (EU) No 1303/201361 and Regulation (EU) No 223/201462 . More specifically, the deadline for the submission of that final payment application should be extended by 12 months. Furthermore, the deadline for the submission of the closure documents should also be extended by 12 months. Therefore, Member States may submit the final payment application for each programme any time by 31 July 2025 and the closure documents any time by 15 February 2026. In the context of this amendment, it is appropriate to clarify that distribution of food and material bought until the end of the eligibility period (end- 2023) may continue after that date. In order to ensure a sound implementation of the EU budget and respect for the payment ceilings, payments to be made in 2025 following the interim payment applications submitted by the certifying authority after 31 October 2024 should be capped at 1 % of the financial appropriations from resources under the Multiannual Financial Framework per programme. Amounts due exceeding the ceiling of 1% of programme appropriations per fund for 2025 would not be paid in 2025 nor in subsequent years but only used for the clearance of pre-financing. Unused amounts shall be decommitted in accordance with the general rules for decommitment at closure. _________________ 61 Regulation (EU) 1303/2013 laying down common provisions (OJ L 347, 20.12.2013, p. 320). 62 Regulation (EU) 223/2014 on the Fund for European Aid on the Most Deprived (OJ L 72, 12.3.2014, p. 1).
Amendment 71 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a – point iii a (new)
Article 2 – paragraph 1 – point a – point iii a (new)
(iiia) low-carbon technologies
Amendment 104 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 1
Article 10 – paragraph 1 – point 1
Regulation (EU) 2021/1058
Article 3 – paragraph 1 – point a – point vi (new)
Article 3 – paragraph 1 – point a – point vi (new)
Amendment 105 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 2
Article 10 – paragraph 1 – point 2
Regulation (EU) 2021/1058
Article 3 – paragraph 1 – point b – point ix (new)
Article 3 – paragraph 1 – point b – point ix (new)
Amendment 107 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 3
Article 10 – paragraph 1 – point 3
Regulation (EU) 2021/1058
Article 3 – paragraph 1 a (new) – subparagraph 1
Article 3 – paragraph 1 a (new) – subparagraph 1
Amendment 110 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 3
Article 10 – paragraph 1 – point 3
Regulation (EU) 2021/1058
Article 3 – paragraph 1 a (new) – subparagraph 2
Article 3 – paragraph 1 a (new) – subparagraph 2
The Commission shall pay 30 % of the ERDF allocation to that priority as set out in the decisinvestments contributing to the STEP objectives referred to in Article 2 of Regulation .../.. [STEP Regulation] approvs set out ing the revised programme amendment as exceptional one-off pre- financing in addition to the yearly pre- financing for the programme provided for in Article 90(1) and (2) of Regulation (EU) 2021/1060 or in Article 51(2), (3) and (4) of Regulation (EU) 2021/1059. The exceptional pre-financing shall be paid by 31 December 2024, provided the Commission has adopted the decision approving the programme amendmentand shall not require a decision of the Commission amending the programme. The amendment shall be approved by the monitoring committee in advance. The Member State shall notify the revised programme to the Commission by 31 October 2024.
Amendment 118 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 3
Article 10 – paragraph 1 – point 3
Regulation (EU) 2021/1058
Article 3 – paragraph 1 a (new) – subparagraph 7
Article 3 – paragraph 1 a (new) – subparagraph 7
By way of derogation from Article 112 of Regulation (EU) 2021/1060, the maximum co-financing rates for dedicated priorities established to support the STEP objectivesinvestments contributing to the STEP objectives referred to in Article 2 of Regulation .../... [STEP Regulation] shall be increased to 100 %.
Amendment 125 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 4
Article 10 – paragraph 1 – point 4
Regulation (EU) 2021/1058
Article 5 – paragraph 2 – point e (new) – subparagraph 1
Article 5 – paragraph 2 – point e (new) – subparagraph 1
‘(e) when they contribute to the specificSTEP objective under PO 1 set out in Article 3(1), first subparagraph, point (a)(vi) or to thes referred to in Article 2 of Regulation .../...[STEP Regulation] under specific objectives under PO 21 set out in point (b)(ix) of that subparagraph,Article (3) 1, specific objectives under PO 2 in less developed and transition regions, as well as more developed regions in Member States whose average GDP per capita is below the EU average of the EU- 27 measured in purchasing power standards (PPS) and calculated on the basis of Union figures for the period 2015-2017.
Amendment 129 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 5
Article 10 – paragraph 1 – point 5
Regulation (EU) 2021/1058
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. In order to contribute to the specific objectives under PO 1 set out in Article 3(1), first subparagraph, point (a)(vi) and under PO 2 set out in point (b)(ix) of that subparagraphand under PO 2, the ERDF shall also support training, life-long learning, reskilling and education activities.
Amendment 139 #
2023/0199(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point 3
Article 11 – paragraph 1 – point 3
Regulation (EU) 2021/1056
Article 10 – paragraph 4 (new) – subparagraph 1
Article 10 – paragraph 4 (new) – subparagraph 1
The Commission shall pay 30% of the JTF allocation, including amounts transferred in line with Article 27 of Regulation EU 2021/1060, to a programme as set out in the decision approving therevised programme as exceptional one- off pre-financing in addition to the yearly pre-financing for the programme provided for in Article 90(1) and (2) of Regulation (EU) 2021/1060. The exceptional pre- financing shall be paid as from [entry into force of this Regulation] and shall not require a decision of the Commission amending the programme. The amendment shall be approved by the monitoring committee in advance. The Member State shall notify the revised programme to the Commission.
Amendment 142 #
2023/0199(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point 3
Article 11 – paragraph 1 – point 3
Regulation (EU) 2021/1056
Article 10 – paragraph 4 (new) – subparagraph 6
Article 10 – paragraph 4 (new) – subparagraph 6
By way of derogation from Article 112 of Regulation (EU) 2021/1060, the maximum co-financing rates for dedicated priorities established to support the STEP objectivesinvestments contributing to STEP objectives referred to in Article 2 of Regulation .../...[STEP Regulation] shall be increased to 100 %.
Amendment 144 #
2023/0199(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point 1
Article 12 – paragraph 1 – point 1
Regulation (EU) 2021/1057
Article 12 a (new) – paragraph 1
Article 12 a (new) – paragraph 1
In addition to the pre-financing for the programme provided for in Article 90(1) and (2) of Regulation (EU) 2021/1060, where the Commission approvesaccording to an amendment of a programme including one or more priorities dedicated to operations supported by the ESF+ contributing to the STEP objectives referred to in Article 2 of Regulation .../...66 [STEP Regulation], it shall make an exceptional pre-financing of 30% on the basis of the allocation to those priorities. The exceptional pre-financing shall be paid by 31 December 2024, provided the Commission has adopted the decision approving the programme amendmentand shall not require a decision of the Commission amending the programme. The amendment shall be approved by the monitoring committee in advance. The Member State shall notify the revised programme to the Commission by 31 October 2024. _________________ 66 Regulation …/… of the European Parliament and of the Council … [insert full title and OJ reference].
Amendment 151 #
2023/0199(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point 1
Article 14 – paragraph 1 – point 1
Regulation (EU) No 1303/2013
Article 135 – paragraph 6 (new) – subparagraph 2
Article 135 – paragraph 6 (new) – subparagraph 2
Amounts from resources other than REACT-EU reimbursed by the Commission as interim payments in 2025 following the interim payment applications submitted by the certifying authority after 31 October 2024 shall not exceed 1 % of the total financial appropriations to the programme concerned by Fund, REACT-EU resources excluded. Amounts that would be due to be paid by the Commission in 2025 exceeding this percentage shall not be paid and shall be used exclusively for the clearing of pre- financing at closure.
Amendment 159 #
2023/0199(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point 2
Article 14 – paragraph 1 – point 2
Amendments to Regulation (EU) No 1303/2013 [CPR]
Article 14 – paragraph 2
By way of derogation from the deadline set out in the first subparagraph, Member States may submit a final implementation report for the operational programme according to Article 141 and the documents referred to under points (a), (b) and (c) for the final accounting year by 15 February 2026.
Amendment 167 #
2023/0199(COD)
Proposal for a regulation
Article 10 – Paragraph 1 – Point 6
Article 10 – Paragraph 1 – Point 6
Regulation (EU) 2021/1058
Annex 1 – Table 1
Annex 1 – Table 1
Amendment 168 #
2023/0199(COD)
Proposal for a regulation
Article 10 – Paragraph 1 – Point 7
Article 10 – Paragraph 1 – Point 7
Regulation (EU) 2021/1058
Annex 1 – Table 1
Annex 1 – Table 1
Amendment 169 #
2023/0199(COD)
Proposal for a regulation
Article 10 – Paragraph 1 – Point 8
Article 10 – Paragraph 1 – Point 8
Regulation (EU) 2021/1058
Annex 2 – Table 1
Annex 2 – Table 1
Amendment 170 #
2023/0199(COD)
Proposal for a regulation
Article 10 – Paragraph 1 – Point 9
Article 10 – Paragraph 1 – Point 9
Regulation (EU) 2021/1058
Annex 2 – Table 1
Annex 2 – Table 1
Amendment 172 #
2023/0199(COD)
Proposal for a regulation
Article 13 – Paragraph 1 – Point 4
Article 13 – Paragraph 1 – Point 4
Regulation (EU) 2021/1060
Annex 1 – Table 1
Annex 1 – Table 1
Amendment 173 #
2023/0199(COD)
Proposal for a regulation
Article 13 – Paragraph 1 – Point 5
Article 13 – Paragraph 1 – Point 5
Regulation (EU) 2021/1060
Annex 1 – Table 6
Annex 1 – Table 6
(5) In Annex I, Table 6, the following row is added: 11 Contributing to 0% 0% skills and jobs in deep and digital technologies, clean technologies, biotechnologies (contributing to the STEP objectives referred to in Article 2 of Regulation ... /. ..[STEP Regulation]).
Amendment 144 #
2023/0132(COD)
Proposal for a directive
Recital 2
Recital 2
(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post- authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal treatments, inappropriate or highly burdensome treatments or treatments addressing subpopulations of a disease only. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.
Amendment 150 #
2023/0132(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 153 #
2023/0132(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3 b) With the financial support from the Horizon Europe programme, the Union should participate to the establishment of a sustainable network of centres of excellence complementing each other to enable transnational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of any diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks.
Amendment 225 #
2023/0132(COD)
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases, antibiotics and generic and biosimilar medicinal products. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 236 #
2023/0132(COD)
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ and 'quality of life' following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004], consult relevant stakeholders including representatives from patient's organisations, healthcare professionals and industry and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 262 #
2023/0132(COD)
Proposal for a directive
Recital 58
Recital 58
(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. In addition, the timelines set by Directive 89/105/EEC should be respected during the negotiations between Member States and marketing authoriation holder to ensure a fast and timely patient's access to medicines.
Amendment 287 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry ofn day-one of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The entry of generic, biosimilar, hybrid and bio-hybrid into the Union market on day-one is necessary to increase competition, improve patient's access to affordable medicines and reduce the pressure on national healthcare systems. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment and to obtain pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 346 #
2023/0132(COD)
Proposal for a directive
Recital 93
Recital 93
(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance as well as for the raw and initial materials employed in the production of cell and gene therapies, such as cytokines, culture media, reagents, plasmids, and viral vectors.
Amendment 359 #
2023/0132(COD)
Proposal for a directive
Recital 123 a (new)
Recital 123 a (new)
(123 a)Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.
Amendment 363 #
2023/0132(COD)
Proposal for a directive
Recital 128
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. Based on the findings from hospital pilots, the obligation to provide a paper leaflet should be lifted for medicinal products not intended for self- administration by the patient.
Amendment 367 #
2023/0132(COD)
Proposal for a directive
Recital 130
Recital 130
(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi- language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self- administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.
Amendment 419 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner and a hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).
Amendment 430 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 2 a (new)
Article 2 – paragraph 2 a (new)
2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.
Amendment 434 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to thegood pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).
Amendment 443 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety, quality and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.
Amendment 447 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 5
Article 2 – paragraph 5
5. If a hospital exemption approval is revoked due to safety, quality, or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.
Amendment 456 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety, quality and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data in the form of an EU-wide registry.
Amendment 460 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)
(a a) the data to be collected by Member States, including a description of the use of hospital exemption, the number of patients treated, the clinical and quality of life outcomes used to measure efficacy and safety of the advance therapy medicinal products prepared under the hospital exemption;
Amendment 461 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)
Article 2 – paragraph 7 – subparagraph 1 – point a a (new)
(a a) the data collection by Member States should cover the application of the hospital exemption, details of the patient group treated including patient counts, and the outcomes related to clinical efficacy and safety, as well as quality of life assessments.
Amendment 465 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.
Amendment 466 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for harmonised implementation of preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.
Amendment 514 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
(30 a) platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established, and which is prepared in a separate document by the owner of the platform technology. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to
Amendment 551 #
2023/0132(COD)
Proposal for a directive
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. The marketing authorisation application shall include the particulars and documentation listed in Annex I, submitted in accordance with Annex II. Where justified for therapeutic purposes, a marketing authorisation may be granted for a medicinal product for which an active substance master file, an additional quality master file and/or a platform technology master file exists and is referred to in the application.
Amendment 574 #
2023/0132(COD)
Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
Where justified for therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted for a medicinal product comprised of a fixed component and a variable component that is pre-defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients (‘platform technology’).
Amendment 677 #
2023/0132(COD)
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 1 a (new)
Article 26 – paragraph 1 – subparagraph 1 a (new)
Marketing authorisation applicants may, instead of submitting the relevant data on the quality, safety and/or efficacy of a medicinal product required in accordance with Annex II, rely on an additional platform technology master file or a platform technology master file certificate granted by the Agency in accordance with this Article (‘platform technology master file certificate’).
Amendment 678 #
2023/0132(COD)
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance, preparation or other material present or used in the manufacture of a medicinal product including cell and gene therapies;
Amendment 763 #
2023/0132(COD)
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 October 2005 to avoid restricting patients' access to existing treatments;
Amendment 1255 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 1263 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities conducted to generate data for an application, forare undertaken in order to:
Amendment 1273 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtain a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and forand its subsequent variations;
Amendment 1281 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) undertake health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 1295 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtain pricing and reimbursement. listing;
Amendment 1305 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) comply with all other regulatory or administrative requirement in the Union or in third countries;
Amendment 1310 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) enable public and private procurement of medicinal products for the supply after expiry of the relevant patents or supplementary protection certificate;
Amendment 1314 #
2023/0132(COD)
(a a) the subsequent practical requirements linked to such activities.
Amendment 1322 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) thThose activities conducted exclusively for the purposes set out in point (a), may cover the submission of the application for a marketing authorisation andfalling within the first subparagraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 1333 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market in a Member State of the medicinal products resulting from such activitiesmanufactured for the purposes mentioned above, while the relevant patent rights or supplementary protection certificates are in force in that Member State.
Amendment 1345 #
2023/0132(COD)
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Amendment 1383 #
2023/0132(COD)
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or healthcare professionals.
Amendment 1545 #
2023/0132(COD)
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients' access to existing treatments.
Amendment 1555 #
2023/0132(COD)
Proposal for a directive
Article 196 – paragraph 1 – point f
Article 196 – paragraph 1 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments.
Amendment 1565 #
2023/0132(COD)
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies, including real world data, to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder.
Amendment 204 #
2023/0131(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creatingaiming to create an attractive environment for research, development and production of medicines in the Union, along with a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while ensuring security of supply and addressing environmental concerns.
Amendment 212 #
2023/0131(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States and the Parliament have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring patient access and availability of medicinal products in all Member States.
Amendment 243 #
2023/0131(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product such as an advanced therapy medicinal products (ATMPs). Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies. For Advanced Therapy Medicinal Products (ATMPs), the European Medicines Agency's (EMA) working group dedicated to ATMPs should seek input from the Substances of Human Origin (SoHO) Coordination Board when dealing with cases that are not clearly defined.
Amendment 244 #
2023/0131(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) The Agency should be empowered to give scientific recommendations on whether a product under development, which could potentially fall under the mandatory scope of the centralised procedure, meets the scientific criteria to be a medicinal product such as advanced therapy medicinal products (ATMPs). Such an advisory mechanism would address, as early as possible, questions related to borderline cases with other areas such as substances of human origin, cosmetics or medical devices, which may arise as science develops. To ensure that recommendations given by the Agency take into account the views of equivalent advisory mechanisms in other legal frameworks, the Agency should consult the relevant advisory or regulatory bodies. The ad-hoc working group on Advanced Therapies should consult the SoHo Coordination Board on borderline cases.
Amendment 261 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals. The composition, responsibilities, operating methods, and areas of expertise of the Committees, Working Parties, and Working Groups, along with their work programs and suggestions, will be disclosed to the public and may be opened for stakeholder feedback.
Amendment 263 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. The model of rapporteurs remains unchanged. Representation of patients, their caregivers and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 265 #
2023/0131(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Scientific committees like the CAT have been instrumental to ensure expertise and capacity building in an emerging technological field. However, after more than 15 years, advanced therapy medicinal products are now more common. The full integration of their assessment in the work of the CHMP will facilitate the assessment of medicinal products within the same therapeutic class, independent of the technology on which they are based. It will also ensure that all biological medicinal products are assessed by the same committee. The ad-hoc working group on Advanced Therapy Medicinal Products (ATMPs) should provide guidance on the classification of ATMPs and borderline cases to the CHMP.
Amendment 269 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, industry, associations representing payers, academia, or other stakeholders, as relevant.
Amendment 270 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, academia, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 272 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients and their caregivers, healthcare professionals, industry, associations representing payers, or other stakeholders, as relevant.
Amendment 295 #
2023/0131(COD)
Proposal for a regulation
Recital 53 a (new)
Recital 53 a (new)
(53 a) The distinct properties of advanced therapy medicinal products (ATMPs) create substantial infrastructural and knowledge hurdles, along with systemic obstacles, making the 'release and continuous supply' of many ATMPs across all 27 Member States within a brief period challenging. It is essential to investigate alternative care options to ensure the availability of these therapies throughout the Member States, potentially utilizing frameworks for cross-border healthcare access, like Directive 2011/24/EU and Regulation (EC) No 883/2004.
Amendment 318 #
2023/0131(COD)
Proposal for a regulation
Recital 73
Recital 73
(73) To optimise the use of resources for both applicants for marketing authorisations and competent authorities assessing such applications, a single assessment of an active substance master file should be introduced. The outcome of the assessment should be issued through a certificate. To avoid duplication of assessment, the use of an active substance master file certificate should be mandatory for subsequent applications or marketing authorisations for medicinal products for human use containing that active substance from an active substance master file certification holder. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to extend the certification scheme to additional quality master files, e.g. in case of novel excipients, adjuvantsmaster files, such as quality master files for active substances other than chemical active substances or for other substances present or used in the manufacture of a medicinal product e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and, active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance and conjugates, or such as platform technology master files for platform technologies used in the manufacturing process of one or more medicinal products.
Amendment 353 #
2023/0131(COD)
Proposal for a regulation
Recital 79
Recital 79
(79) The creation of a voucher rewarding the development of priority antimicrobials through an additional year of regulatory data protection has the capacity, in combination with a set of push and pull incentives scheme, constitutes an alternative able to provide the needed financial support to developers of priority antimicrobials. However, in order to ensure that the financial reward which is ultimately borne by health systems is mostly absorbed by the developer of the priority antimicrobial and not the buyer of the voucher, the number of available vouchers on the market should be kept to a minimum. It is therefore necessary to establish strict conditions of granting, transfer and use of the voucher and to further give the possibility to the Commission to revoke the voucher under certain circumstances.
Amendment 362 #
2023/0131(COD)
Proposal for a regulation
Recital 80
Recital 80
(80) A transferable data exclusivity voucher and other push and pull incentives schemes to boost the development of priority antimicrobials should only be available to those antimicrobial products that bring a significant clinical benefit with respect to antimicrobial resistance, and which have the characteristics described in this Regulation. It is also necessary to ensure that an undertaking which receives this incentive is in turn capable to supply the medicinal product to patients across the Union in sufficient quantities and to provide information on all funding received for research related to its development in order to provide a full account of the direct financial support given to the medicinal product.
Amendment 389 #
2023/0131(COD)
Proposal for a regulation
Recital 88
Recital 88
(88) Regulation (EC) No 141/2000 of the European Parliament and of the Council55 has proved to be successful in boosting developments of orphan medicinal products in the Union; therefore an action at Union level remains preferable to uncoordinated measures by the Member States which may result in distortions of competition and barriers to intra-Union trade. The Union should not neglect or disregard the success of the Regulation since its entry into force in 2000, and build on its success driving and ensuring a similar degree of innovation under this Regulation. _________________ 55 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ L 18, 22.1.2000, p. 1).
Amendment 411 #
2023/0131(COD)
Proposal for a regulation
Recital 96 a (new)
Recital 96 a (new)
Amendment 433 #
2023/0131(COD)
Proposal for a regulation
Recital 105 a (new)
Recital 105 a (new)
(105 a)One of the overarching goals of this Regulation is to help meeting the medical needs of patients with rare diseases, to improve the affordability of orphan medicinal products and the patient access to orphan medicinal products across the Union, and to encourage innovation in areas of need. While other Union programmes and policies also contribute to these goals, people living with a rare disease continue to face common challenges that are many and multifactorial, including delayed diagnoses, lack of available transformative treatments, and difficulties to access treatments where they live, reflecting the fragmentation of the market across the Member States. The European added value to addressing the needs of people living with a rare disease being exceptionally high due to the rarity of patients, experts, data, and resources, it is appropriate for the Commission to develop, to complement this Regulation, a dedicated framework for rare diseases to bridge relevant legislation, policies and programmes, and support national strategies with a view to better meet the unmet needs of people living with rare diseases and their carers. This framework should be needs driven and goals based, and developped in consultation with the Member States and patient organisations as well as, where relevant, other interested parties.
Amendment 470 #
2023/0131(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment, including longer delays or interruptions in care or therapy, longer periods of hospitalisation, increased risks of exposure to falsified medicinal products, medication errors, adverse effects resulting from the substitution of unavailable medicinal products with alternative ones, significant psychological distress for patients and increased costs for healthcare systems. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.
Amendment 507 #
2023/0131(COD)
Proposal for a regulation
Recital 145
Recital 145
(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, including some advanced therapy medicinal products, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.
Amendment 508 #
2023/0131(COD)
Proposal for a regulation
Recital 145
Recital 145
(145) Experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, including some advanced therapy medicinal products, the procedure to achieve compliance with the requirements of Directives 2001/18/EC and 2009/41/EC as regards the environmental risk assessment and consent by the competent authority of a Member State is complex and can take a significant amount of time.
Amendment 521 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal product sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);
Amendment 549 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 11 a (new)
Article 2 – paragraph 2 – point 11 a (new)
(11 a) ‘demand’ means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;
Amendment 559 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12
Article 2 – paragraph 2 – point 12
(12) ‘shortage’ means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet the demand for that medicinal product in that Member State.or medical device at a national level, whatever the cause
Amendment 564 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 12 a (new)
Article 2 – paragraph 2 – point 12 a (new)
(12 a) ‘supply’ means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 599 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including with regard to the quality of life of a relevant patient population or subpopulation, of a life- threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 600 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment, including the improvement of quality of life of certain patient's groups, of a life-threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 668 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments;
Amendment 766 #
2023/0131(COD)
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 2
Article 26 – paragraph 4 – subparagraph 2
In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data.
Amendment 888 #
2023/0131(COD)
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article40a Push and pull incentives scheme to boost the development of priority antimicrobials 1. The Commission shall establish a Union push and pull incentives scheme to promote and urgently accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union level scheme. 2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding, which shall include i.a. the following incentives: (a) research grants under Union funds; (b) milestone prizes for novel antimicrobial developers; (c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales; 3. The Union push and pull incentives scheme shall be coordinated and managed by the Commission. 4. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of the Union push and pull incentives scheme. 5. By ... [7 years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council reviewing the application of the scheme laid down in this Article.
Amendment 1009 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency mayshall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil at least one of the following conditions:
Amendment 1010 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency mayshall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil the following conditions:
Amendment 1019 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point a a (new)
Article 60 – paragraph 1 – point a a (new)
(a a) are innovative Advanced Therapy Medicinal Products (ATMPs);
Amendment 1022 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products and are likely to address a high unmetlisted on the register of designated orphan medicinal need aproducts referred to in Aarticle 70(1); 67 (1) of this Regulation;
Amendment 1030 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point c
Article 60 – paragraph 1 – point c
(c) provide an exceptional therapeutic advancement or are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).
Amendment 1033 #
2023/0131(COD)
Proposal for a regulation
Article 60 – paragraph 1 – point c a (new)
Article 60 – paragraph 1 – point c a (new)
(c a) The Agency's working group on advanced therapy medicinal products is tasked with evaluating which products fulfill the criteria of innovative advanced therapy medicinal products as set out in point (b) of this article. The determinations made by the working group shall take into account the progressive development inherent to advanced therapy medicinal products.
Amendment 1041 #
2023/0131(COD)
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1
Article 61 – paragraph 1 – subparagraph 1
For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 4 (7), (29) and (30) of [revised Directive 2001/83/EC] and Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council71 . _________________ 71 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
Amendment 1043 #
2023/0131(COD)
Proposal for a regulation
Article 61 – paragraph 2 – subparagraph 1
Article 61 – paragraph 2 – subparagraph 1
When forming the recommendation referred to in paragraph 1, the Agency shall consult, where appropriate, relevant advisory or regulatory bodies established in other Union legal acts in related fields. In the case of products which are based on substances of human origin, the Agency shall consult the Substances of Human Origin (SoHO) Coordination Board as established in Regulation (EU) No [reference to be added after adoption cf. COM(2022)338 final], and classify all products that are significantly manipulated or utilized in a non- homologous manner, as either a medicinal product or an advanced therapy medicinal product, whichever is applicable.
Amendment 1098 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Article 68 – paragraph 1 – introductory part
1. The orphan medicine sponsor mayshall, prior to the submission of an application for marketing authorisation, request advice from the Agency on the following:
Amendment 1125 #
2023/0131(COD)
Proposal for a regulation
Article 70
Article 70
Amendment 1140 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningful reduction in disease morbidity or, mortality, severity or long term side effects for the relevant patient population.
Amendment 1152 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and, the authorities or, bodies and stakeholders referred to in Article 162.
Amendment 1158 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nine years for orphan medicinal products other than those referred to in points (b), (c) and (ca);
Amendment 1159 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nine years for orphan medicinal products other than those referred to in points (b), (c) and (ca);
Amendment 1182 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) twelven years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;where no satisfactory treatment has been approved in the Union for the indication in question.
Amendment 1192 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
Amendment 1194 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
(b a) twelve years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70 in the paediatric population;
Amendment 1251 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a), (b) and (ba), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
Amendment 1264 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 2 a (new)
Article 72 – paragraph 2 a (new)
2 a. The period of market exclusivity shall be prolonged by an additional 12 months for orphan medicinal products referred to in Article 71(2), points (a), (b), and (ba) if the orphan medicinal product is not authorised for the indication in question in any third country at the time of granting the authorisation.
Amendment 1282 #
2023/0131(COD)
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article 73a European Framework for Rare Diseases By (OP: 24 months after the date of entry into force of this Regulation), the Commission shall, following appropriate consultation with the Member States, patient organisations and, where relevant, other interested parties, propose a needs driven and goals based European Framework for Rare Diseases with a view to bridge relevant Union legislation, policies and programmes, and support national strategies to better meet the unmet needs of people living with rare diseases, and their carers.
Amendment 1399 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 1 – point a
Article 113 – paragraph 1 – point a
(a) it is not possible to adequately develop the medicinal product or category of products in compliance with the requirements applicable to medicinal products due to scientific or regulatory challenges arising from characteristics or methods related to the product;
Amendment 1408 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 2 – subparagraph 1
Article 113 – paragraph 2 – subparagraph 1
The regulatory sandbox shall set out a regulatory framework, including scientific requirements, for the development and, where appropriate clinical trials and placing on the market of a product referred to in paragraph 1 under the conditions set out in this Chapter. The regulatory sandbox may allow targeted derogations to this Regulation, [revised Directive 2001/83/EC] or Regulation (EC) 1394/2007 under the conditions set out in Article 114, while balancing patient safety and innovation in regulatory process.
Amendment 1418 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 3
Article 113 – paragraph 3
3. The Agency shall monitor the field of emerging medicinal products and may request information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients and mayshall engage with them in preliminary discussions.
Amendment 1430 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations, including, where relevant, of HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia. The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 1431 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 5
Article 113 – paragraph 5
5. The Agency shall be responsible for developing a sandbox plan based on data submitted by developers of eligible products and following appropriate consultations including, where relevant, HTA bodies, patients and their caregivers, clinicians, sponsors, developers and academia . The plan shall set out clinical, scientific and regulatory justification for a sandbox, including the identification of the requirements of this Regulation, [revised Directive 2001/83/EC] and Regulation (EC) 1394/2007 that cannot be complied with and a proposal for alternative or mitigation measures, where appropriate. The plan shall also include a proposed timeline for the duration of the sandbox. Where appropriate, the Agency shall also propose measures in order to mitigate any possible distortion of market conditions as a consequence of establishing a regulatory.
Amendment 96 #
2023/0124(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to safeguard the functioning of the internal market and to ensure that the objective of providing a high level of protection of health and the environment is achieved, it is necessary to establish that detergents and surfactants from third countries entering the Union market also comply with this Regulation. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those products. It is also necessary to lay down rules for importers to ensure that the detergents and surfactants they place on the market comply with those requirements and that the documentation drawn up by manufacturers and, where relevant, the CE marking areis available for inspection by the competent national authorities. Provision should also be made for importers to ensure that a product passport is available for those products.
Amendment 99 #
2023/0124(COD)
Proposal for a regulation
Recital 24
Recital 24
Amendment 130 #
2023/0124(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) It is crucial to make clear to both manufacturers and users that by creating the product passport for detergent or surfactant and, where relevant, by affixing the CE marking, the manufacturer declares that the detergent or surfactant is in conformity with all applicable requirements and that the manufacturer takes full responsibility thereof.
Amendment 155 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 24
Article 2 – paragraph 1 – point 24
Amendment 162 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34 – introductory part
Article 2 – paragraph 1 – point 34 – introductory part
(34) ‘batchmodel’ means a defined quantity of finished products that meets the following conditions:specific type of detergent or surfactant, which includes a product name and a unique formula, according to the Unique Formula Identifier (UFI).
Amendment 163 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34 – indent 1
Article 2 – paragraph 1 – point 34 – indent 1
Amendment 169 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34 – indent 2
Article 2 – paragraph 1 – point 34 – indent 2
Amendment 173 #
2023/0124(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 34 – indent 3
Article 2 – paragraph 1 – point 34 – indent 3
Amendment 206 #
2023/0124(COD)
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2 – point c
Article 7 – paragraph 2 – subparagraph 2 – point c
Amendment 224 #
2023/0124(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
Amendment 237 #
2023/0124(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
Amendment 251 #
2023/0124(COD)
Proposal for a regulation
Article 14
Article 14
Amendment 287 #
2023/0124(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) it shall correspond to a specific batchmodel of the detergent or surfactant;
Amendment 328 #
2023/0124(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point a
Article 25 – paragraph 1 – point a
Amendment 40 #
2023/0105(COD)
Proposal for a directive
Recital 3
Recital 3
(3) In light of the close link between the quality of honey and its origin and the need for the consumer not to be misled regarding the quality of the product, Directive 2001/110/EC lays down rules on the labelling of the origin where the honey has been harvested. In particular, Article 2(4) of that Directive requires the country or countries of origin where the honey has been harvested to be indicated on the label and provides that, if honey originates in more than one Member State or third country, the mandatory indication of the countries of origin may be replaced by one of the following, as appropriate: ‘blend of EU honeys’, ‘blend of non-EU honeys’, ‘blend of EU and non-EU honeys’. The different rules adopted on this basis by Member States may have misled consumers and may have hindered the functioning of the internal market. In the light of the Farm to Fork Strategy’s objective of strengthening consumers in making informed choices, including on the origin of their food, and in the interest to preserve the efficient functioning of the internal market throughout the Union through a harmonisation of the labelling rules, it is appropriate to revise the rules for honey origin labelling and provide that the country or countries of origin should be mentioned on the packaging. In light of the reduced size of the packs containing only a single portion of honey (breakfast packs) and the resulting technical difficulties, it is therefore appropriate to exempt those packs from the obligation of listing all individual countries of origin, where the honey originates in more than one country. To ensure the accuracy of the information on the country or countries of origin of honey that consumers are provided with, the placing on the market of honey should be conditional upon the accuracy of the composition of the product with its indicated country or countries of origin. To ensure the compliance of products with the requirements set out in this Directive, checks should be performed by competent authorities.
Amendment 48 #
2023/0105(COD)
Proposal for a directive
Recital 3
Recital 3
(3) In light of the close link between the quality of honey and its origin and the need for the consumer not to be misled regarding the quality of the product, Directive 2001/110/EC lays down rules on the labelling of the origin where the honey has been harvested. In particular, Article 2(4) of that Directive requires the country or countries of origin where the honey has been harvested to be indicated on the label and provides that, if honey originates in more than one Member State or third country, the mandatory indication of the countries of origin may be replaced by one of the following, as appropriate: ‘blend of EU honeys’, ‘blend of non-EU honeys’, ‘blend of EU and non-EU honeys’. The different rules adopted on this basis by Member States may have misled consumers and may have hindered the functioning of the internal market. In the light of the Farm to Fork Strategy’s objective of strengthening consumers in making informed choices, including on the origin of their food, and in the interest to preserve the efficient functioning of the internal market throughout the Union through a harmonisation of the labelling rules, it is appropriate to revise the rules for honey origin labelling and provide that the country or countries of origin should be mentioned on the packaging in descending order of their share in weight. In light of the reduced size of the packs containing only a single portion of honey (breakfast packs) and the resulting technical difficulties, it is therefore appropriate to exempt those packs from the obligation of listing all individual countries of origin, where the honey originates in more than one country. In order to increase transparency and to meet consumer expectations, the geographical origin of the honey should be indicated on the label in the same visual field as the indication of the product.
Amendment 52 #
2023/0105(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Following the "From the Hive" action carried out by the European Commission's Directorate-General for Health and Food Safety (DG SANTE), together with the national authorities of 18 countries belonging to the European Food Fraud Network, the European Anti- Fraud Office (OLAF) and the European Commission's Joint Research Centre (JRC), a very high percentage of imported honeys were found to be adulterated with cheap ingredients, such as sugar syrups and water, to artificially increase the product's volume. Directive 2001/110, amended by Directive 2014/63, empowers the European Commission to establish the most appropriate methods of analysis to ensure that honey marketed in the European Union complies with the requirements of the legislation. These methods are now obsolete, and there is an urgent need to update them regularly in the light of the latest scientific developments, in collaboration with the Commission's Joint Research Centre, in order to prevent fraudulent practices and to ensure a level-playing field between EU and non-EU operators.
Amendment 54 #
2023/0105(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) Following the "From the Hive" action carried out by the European Commission's Directorate-General for Health and Food Safety (DG SANTE), together with the national authorities of 18 countries belonging to the European Food Fraud Network, the European Anti- Fraud Office (OLAF) and the European Commission's Joint Research Centre (JRC), a very high percentage of imported honeys were found to be adulterated with cheap ingredients, such as sugar syrups and water, to artificially increase the product's volume. Directive 2001/110/EC empowers the European Commission to establish the most appropriate methods of analysis to ensure that honey marketed in the European Union complies with the requirements of the legislation. These methods are now obsolete, and there is an urgent need to update them regularly in the light of the latest scientific developments, in collaboration with the Commission's Joint Research Centre, in order to prevent fraudulent practices.
Amendment 62 #
2023/0105(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3b) It is also essential to improve traceability from the beekeeper to the consumer, with a minimum of compulsory, harmonised rules. At present, traceability rules do not make it possible to link the various operators who come into contact with the product, which encourages fraud. Given the difficulties involved in tracing the origin of honey, a specific traceability system needs to be set up for this sector, while limiting administrative burden for beekeepers to a minimum.
Amendment 63 #
2023/0105(COD)
Proposal for a directive
Recital 3 b (new)
Recital 3 b (new)
(3b) In addition to verifiability of the origin of honey thanks to the testing of its composition, the traceability of the product or batch should be ensured. At present, traceability rules do not make it possible to link the various operators who come into contact with the product, which encourages fraud. Given the difficulties involved in tracing the origin of honey, a specific traceability system needs to be set up for this sector.
Amendment 69 #
2023/0105(COD)
Proposal for a directive
Recital 3 c (new)
Recital 3 c (new)
(3c) To ensure accurate information for consumers and guarantee the traceability and verifiability of honey authenticity and honey origins, ultrafiltered honey, referred to in Directive 2001/110/EC as "filtered honey", should no longer be allowed to be marketed and labelled as "honey". Ultrafiltration refers to filtration processes using a filter mesh of a size under 100 µm thus removing the majority of the pollen from honey. Since pollen is the key element present in honey used to trace its origin when analysed, the absence of pollen in honey makes it almost impossible to verify the data provided regarding its country or countries of origin. Ultrafiltration thus alters honey by depriving it of one of its main components and characteristics, and prevents its traceability, thus enabling for fraud and misleading indications for consumers. If, when tested, a product marketed as honey presents little or no trace of pollen, it should be prohibited from being placed on the market as well as the batch it is part of, if applicable.
Amendment 70 #
2023/0105(COD)
Proposal for a directive
Recital 3 c (new)
Recital 3 c (new)
(3c) In order to avoid any ambiguity for the consumer and to ensure the traceability of honey, ultrafiltered honey, referred to in Directive 2001/110/EC as "filtered honey", should no longer be allowed to be marketed under the name of honey. While beekeepers commonly use wide-mesh honey sieves to remove any plant debris or pieces of wax, ultrafiltration removes much, if not almost all, of the pollen from honey. Pollen is the most important element present in honey on which analyses are based to verify its floral and geographical origin. The absence of pollen in honey by ultrafiltration therefore removes one of the essential components and prevents verification of the country or countries of origin.
Amendment 75 #
2023/0105(COD)
Proposal for a directive
Recital 3 d (new)
Recital 3 d (new)
(3d) Heat treatment above 40-50°C degrades the sensitive components of honey. However, the hydroxymethylfurfural (HMF) content and the diastase index can only be used to assess the gross degradation of honeys. A minimum threshold should be defined for the presence of invertase, a much more sensitive enzyme, which degrades rapidly at high temperatures. To ensure that consumers are properly informed, the term "virgin honey", referring to the absence of significant heat treatment, may be included on the label on the front of the commercial packaging of the honey if no heat treatment has degraded highly sensitive enzymes such as invertase, from harvesting to potting.
Amendment 76 #
2023/0105(COD)
Proposal for a directive
Recital 3 d (new)
Recital 3 d (new)
(3d) Considering the direct link between information of consumers and the reliability of the information indicated on honey, it is impossible to inform consumers unless the accuracy of the information on the label is guaranteed. Traceability and verifiability of the composition should therefore be ensured in order to guarantee the origin and the quality of honey, including in the case of honey contained in other products. Ensuring traceability and verifiability of the honey's country or countries of origin will also ensure a level-playing field between all operators by making sure that they all comply with the same obligations.
Amendment 78 #
2023/0105(COD)
Proposal for a directive
Recital 3 e (new)
Recital 3 e (new)
(3e) The commercialisation of honeys that are not naturally matured by bees, most of which are imported from third countries, distorts competition on the Union market. In most cases, this involves vacuum evaporation of the water contained in the honey, which results in a depletion of the aromas naturally present. The rapid and artificial evaporation of water from honey competes with the slow dehumidification process carried out naturally by bees in the hive. Artificial evaporation should therefore be prohibited.
Amendment 138 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 b (new)
Article 1 – paragraph 1 – point 1 b (new)
(1b) In Article 2, paragraph 2, subparagraph 1 is replaced by the following: "2. the product names referred to in Annex I, points 2 and 3, shall apply only to the products defined therein and shall be used in trade to designate them. These names may be replaced by the simple product name "honey", except in the case of filtered honey, comb honey, chunk honey or cut comb in honey and baker's honey. comb honey, honey with pieces of comb and industrial honey." Or. en (02001L0110)
Amendment 144 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Directive 2001/110/EC
Article 2 – paragraph 2 – point b a (new)
Article 2 – paragraph 2 – point b a (new)
In Article 2, paragraph 2, the following point ba is added: "(ba) except for honeys intended for industrial use, the term "virgin honey" may be included on the label on the front of the commercial packaging of the honey, provided that no heat treatment has degraded highly sensitive enzymes such as invertase, from harvesting to potting, and that the conditions referred to in Annex II, points 6 (diastase index and hydroxymethylfurfural content) and 7 (invertase index) are met."
Amendment 150 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Directive 2001/110/EC
Article 2 – paragraph 4 – point a
Article 2 – paragraph 4 – point a
(a) The country of origin where the honey has been harvested shall be indicated on the label. If the honey originates in more than one country, the countries of origin where the honey has been harvested shall be indicated on the label of packs. All countaining more than 25 g;ries of origin shall be written in full and listed in descending order of importance and their respective percentages shall be clearly indicated on the front-of-pack label of the product, close to the product's trade name. This shall also apply to products containing industrial honey, which shall indicate on their front-of-pack label the country or countries of origin of the honey they contain.
Amendment 171 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 Directive 2001/110/EC
Article 1 – paragraph 1 – point 2 Directive 2001/110/EC
(b) For the purpoExcept in the cases of Regulation (EU) No 1169/2011 and in particular Articles 12 to 15 thereof, the particulars to be indicated according to point (a) of this paragraph shall be considered as mandatory particulars in accordance with Article 9 of that Regulation.honey intended for industry, these names may be supplemented by indications relating to: - floral or vegetable origin, if the product comes entirely or essentially from the origin indicated and has the organoleptic, physico-chemical and microscopic characteristics thereof, - regional, territorial or topographical origin, if the product comes entirely from the origin indicated, - specific quality criteria.
Amendment 177 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
The following Article 2a is added : "Article 2a Honey and products containing honey placed on the Union market shall be part of a traceability system such as an identification code or a blockchain system. Competent authorities shall be able to trace the honey’s journey back to its country of origin. Operators placing honey and products containing honey on the market shall be able to trace it, via an identification number or blockchain system, to its previous operator and country of origin. This number shall be written on the product's label and/or documentation. This traceability system shall be supported by the traceability requirements established pursuant to Article 18 of Regulation (EC) No 178/2002."
Amendment 178 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 g (new)
Article 1 – paragraph 1 g (new)
Directive 2001/110/EC
Article 3
Article 3
Article 3 In the case of filtered honey and baker's honeis replaced by the following: "Article 3 In the case of honey intended for industry, bulk containers, packs and tradeaging and sales documentsation shall clearly indicate the full product name, as referred to in Annex I, point 2(b)(viii), and point 3. set out in point 3 of Annex I." Or. en (02001L0110)
Amendment 195 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 b (new)
Article 1 – paragraph 1 b (new)
Directive 2001/110/EC
Article 4 a (new)
Article 4 a (new)
The following Article 4a is added: "Article 4a A traceability system for honey shall be set up, complementing the horizontal rules already applicable to the agri-food sector in accordance with Article 18 of Regulation (EC) No 178/2002. The Commission is empowered to adopt, no later than 12 months after the entry into force of this Directive, a delegated act introducing a harmonised traceability system enabling competent authorities to trace the entire history of the honey produced and imported into the Union back to the harvesting beekeepers or, in the case of imported honey, to the operators."
Amendment 196 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
Annexes I and II are amended in accordance with Annex Ia to this Directive;
Amendment 202 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
Directive 2001/110/EC
Annex I – paragraph 2 – point b – point viii
Annex I – paragraph 2 – point b – point viii
Amendment 209 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 b (new)
Article 1 – paragraph 1 b (new)
Directive 2001/110/EC
Annex II – paragraph 2
Annex II – paragraph 2
In Annex II, paragraph 2 is replaced by the following: "When placed on the market as honey or used in any product intended for human consumption, honey shall not have added to it any food ingredient, including food additives, nor shall any other additions be made other than honey. Honey must, as far as possible, be free from organic or inorganic matters foreign to its composition. With the exception of point 3 of Annex I, it must not have any foreign tastes or odours, have begun to ferment, have an artificially changed acidity or have been heated in such a way that the natural enzymes have been either destroyed or significantly inactivated. , or have been exposed to vacuum evaporation. Honey, when marketed as such or used in any product intended for human consumption, must comply with the compositional characteristics set out in points 1 to 6. In addition, when marketed as "virgin honey" it must also comply with the compositional characteristics set out in point 6a." Or. en (02001L0110)
Amendment 210 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
In Annex II, paragraph 2 is replaced by the following: "When placed on the market as honey or used in any product intended for human consumption, honey shall not have added to it any food ingredient, including food additives, nor shall any other additions be made other than honey. Honey must, as far as possible, be free from organic or inorganic matters foreign to its composition. With the exception of point 3 of Annex I, iIt must not have any foreign tastes or odours, have begun to ferment, have an artificially changed acidity or have been heated in such a way that the natural enzymes have been either destroyed or significantly inactivated. , or have been exposed to vacuum evaporation. The category "products containing honey" therefore does not include honey blended with food ingredients or other additional ingredients." Or. en (02001L0110)
Amendment 217 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 c (new)
Article 1 – paragraph 1 c (new)
Directive 2001/110/EC
Annex II – paragraph 3
Annex II – paragraph 3
Amendment 218 #
2023/0105(COD)
Amendment 228 #
2023/0105(COD)
Proposal for a directive
Article 1 – paragraph 1 d (new)
Article 1 – paragraph 1 d (new)
Directive 2001/110/EC
Annex II – paragraph 6 a (new)
Annex II – paragraph 6 a (new)
In Annex II, the following paragraph 6a is added: "6a. Invertase index (Gontarski unit) for "virgin honeys". Determined after processing and blending. - generally, not less than 50 U/kg - honeys with a low natural enzyme content, not less than 25 U/kg."
Amendment 1 #
2023/0081(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Union has committed to the accelerated decarbonisation of its economy and ambitious deployment of renewable energy sources to achieve climate neutrality or net zero emissions (emissions after deduction of removals) by 2050. That objective is at the heart of the European Green Deal, the updated EU Industrial Strategy, and in line with the Union’s commitment to global climate action under the Paris Agreement31 . To reach the climate neutrality goal, Regulation (EU) 2021/1119 of the European Parliament and of the Council32 sets a binding Union climate target to reduce net greenhouse gas emissions by at least 55% by 2030 compared to 1990. The proposed “Fit for 55”33 package aims to deliver on the Union’s 2030 climate target and revises and updates Union legislation in this respect. , while respecting the principle set in Just Transition Mechanism, Regulation (EU) 2021/1056 of the European Parliament and of the Council34a, making sure that no person and no region is left behind in the climate transition. _________________ 31 Council Decision (EU) 2016/1841 of 5 October 2016 on the conclusion, on behalf of the European Union, of the Paris Agreement adopted under the United Nations Framework Convention on Climate Change OJ L 282, 19.10.2016, p. 4. 32 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). 33 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. 'Fit for 55': delivering the EU's 2030 Climate Target on the way to climate neutrality. COM(2021) 550, 14.7.2021. 34a Regulation (EU) 2021/1056 of the European Parliament and of the Council of 24 June 2021 establishing the Just Transition Fund.
Amendment 4 #
2023/0081(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) To fulfil those commitments, the Union must accelerate its pace of transition to clean energy, notably by increasing energy efficiency and the share of renewable energy sources and support sustainable circular bioeconomy technologies . This will contribute to achieving the EU targets of the European Pillar of Social Rights Action Plan for 2030 of an employment rate of at least 78% and participation in training of at least 60% of adults. It will also contribute to ensuring that the green transition is fair and equitable34 . _________________ 34 Council Recommendation on ensuring a fair transition towards climate neutrality, adopted on 16 June 2022 as part of the Fit for 55 package.
Amendment 6 #
2023/0081(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The net-zero transformation is already causing huge industrial, economic, and geopolitical shifts across the globe, which will become ever more pronounced as the world advances in its decarbonisation efforts. The road to net zero translates into strong opportunities for the expansion of Union’s net-zero industry, making use of the strength of the Single Market, by promoting investment in technologies in the field of renewable energy technologies , electricity and heat storage technologies, heat pumps, grid technologies, renewable fuels of non- biological origin technologies, electrolysers and fuel cells, fusion, small modular reactors and related best-in-class fuels, carbon capture, utilisation, and storage technologies, and energy-system related energy efficiency technologies and their supply chains, and sustainable circular bioeconomy technologies, allowing for the decarbonisation of our economic sectors, from energy supply to transport, buildings, and industry. A strong net zero industry within the European Union can help significantly in reaching the Union’s climate and energy targets effectively, as well as in supporting other Green Deal objectives, while creating jobs and growth.
Amendment 34 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘net-zero technologies’ means renewable energy technologies66 ; electricity and heat storage technologies; heat pumps; grid technologies; renewable fuels of non-biological origin technologies; sustainable alternative fuels technologies67 ; electrolysers and fuel cells; advanced technologies to produce energy from nuclear processes with minimal waste from the fuel cycle, small modular reactors, and related best-in-class fuels; carbon capture, utilisation, and storage technologies; and energy-system related energy efficiency and renewable bioenergy technologies. They refer to the final products, specific components and specific machinery, including technologies for circularity, primarily used for the production of those products. They shall have reached a technology readiness level of at least 8. _________________ 66 ‘renewable energy' means ‘renewable energy’ as defined in Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources 67 ‘sustainable alternative fuels’ means fuels covered by the Proposal for a Regulation of the European Parliament and of the Council on ensuring a level playing field for sustainable air transport, COM/2021/561 final and by the Proposal for a Regulation of the European Parliament and Council on the use of renewable and low-carbon fuels in maritime transport COM/2021/562 final.
Amendment 36 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘net-zero technologies’ means renewable energy technologies66 ; electricity and heat storage technologies; heat pumps; grid technologies; renewable fuels of non-biological origin technologies; sustainable alternative fuels technologies67 ; electrolysers and fuel cells; advanced technologies to produce energy from nuclear processes with minimal waste from theand their related fuel cycle, small modular reactors, and related best-in-class fuels; carbon capture, utilisation, and storage technologies; and energy-system related energy efficiency technologies. They refer to the final products, specific components and specific machinery primarily used for the production of those products. They shall have reached a technology readiness level of at least 8. _________________ 66 ‘renewable energy' means ‘renewable energy’ as defined in Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources 67 ‘sustainable alternative fuels’ means fuels covered by the Proposal for a Regulation of the European Parliament and of the Council on ensuring a level playing field for sustainable air transport, COM/2021/561 final and by the Proposal for a Regulation of the European Parliament and Council on the use of renewable and low-carbon fuels in maritime transport COM/2021/562 final.
Amendment 37 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) ‘component’ means a small part of a net-zero technology that is manufactured and traded by a company starting from processed materials and recycled components;
Amendment 57 #
2023/0081(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To achieve the 2030 objectives a particular focus is needed on some of the net-zero technologies, also in view their significant contribution towards the path to net zero by 2050. These technologies include solar photovoltaic and solar thermal technologies, onshore and offshore renewable technologies, battery/storage technologies, heat pumps and geothermal energy technologies, electrolysers and fuel cells including the technologies for low- carbon hydrogen, nuclear energy including fusion energy, sustainable biogas/biomethane, carbon capture and storage technologies and grid technologies. These technologies play a key role in the Union’s open strategic autonomy, ensuring that citizens have access to clean, affordable, secure energy. Given their role, these technologies should benefit from even faster permitting procedures, obtain the status of the highest national significance possible under national law and benefit from additional support to crowd-in investments.
Amendment 132 #
2023/0081(COD)
Proposal for a regulation
Annex I – subheading 1
Annex I – subheading 1
Strategic net-zero technologies Table: 1. Solar photovoltaic and solar thermal technologies 2. Onshore wind and offshore renewable technologies 3. Battery/storage technologies 4. Heat pumps and geothermal energy technologies 5. Electrolysers and fuel cells 6. Sustainable biogas/biomethane technologies 7. Carbon Capture, storage (CCS / BECCS) and carbon utilization (CCU) technologies 8. Grid technologies 9. Renewable bioenergy technologies (Complements the original annex list.)
Amendment 133 #
2023/0081(COD)
Proposal for a regulation
Annex I – subheading 1
Annex I – subheading 1
Strategic net-zero technologies 9. Nuclear technologies 10. Energy fusion technologies
Amendment 229 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘net-zero technologies’ means renewable energy technologies66 ; electricity and heat storage technologies; heat pumps; grid technologies; renewable fuels of non-biological origin technologies; sustainable alternative fuels technologies67 ; electrolysers and fuel cells including technologies for low-carbon hydrogen; advanced technologies to produce energy from nuclear processes with minimal waste from theand their related fuel cycle, small modular reactors, and related best-in-class fuels; carbon capture, utilisation, and storage technologies; and energy-system related energy efficiency technologies. They refer to the final products, specific components and specific machinery primarily used for the production of those products. They shall have reached a technology readiness level of at least 8. _________________ 66 ‘renewable energy' means ‘renewable energy’ as defined in Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources 67 ‘sustainable alternative fuels’ means fuels covered by the Proposal for a Regulation of the European Parliament and of the Council on ensuring a level playing field for sustainable air transport, COM/2021/561 final and by the Proposal for a Regulation of the European Parliament and Council on the use of renewable and low-carbon fuels in maritime transport COM/2021/562 final.
Amendment 754 #
2023/0081(COD)
Proposal for a regulation
Annex – row 8 a (new)
Annex – row 8 a (new)
(8a) Nuclear technologies including fusion energy
Amendment 41 #
2023/0079(COD)
Proposal for a regulation
Recital 25 c (new)
Recital 25 c (new)
(25c) It is essential to acknowledge the potential of mining, processing, and recycling projects to retain and increase value within regions, improve local skill sets, and combat depopulation, as they can serve as pivotal economic drivers, providing job opportunities, enhancing local capacities, and attracting populations, thus promoting regional development and long-term sustainability.
Amendment 78 #
2023/0079(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The general objective of this Regulation is to improve the functioning of the internal market by establishing a framework to ensure the Union's access to a secure and sustainable supply of critical raw materials. and the sustainable development of its regions
Amendment 135 #
2023/0079(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 1
Article 6 – paragraph 5 – subparagraph 1
Where the Member State together with local or regional authorities 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 141 #
2023/0079(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Member State together with regional and local authorities whose territory is concerned by a Strategic Project shall take measures to contribute to its timely and effective implementation.
Amendment 166 #
2023/0079(COD)
Proposal for a regulation
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. Member States, local and regional authorities may provide administrative support to Strategic Projects to facilitate their rapid and effective implementation, including by providing:
Amendment 189 #
2023/0079(COD)
Proposal for a regulation
Article 20 – paragraph 2 – introductory part
Article 20 – paragraph 2 – introductory part
2. Member States, in collaboration with local and regional authorities where necessary, shall identify key market operators along the critical raw materials value chain established in their territory and shall:
Amendment 199 #
2023/0079(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point b
Article 25 – paragraph 1 – point b
(b) increase the re-use of products and components with highhich contain critical raw materials recovery potential;
Amendment 68 #
2023/0042(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) While the review of this regulation forms part of efforts to meet the environmental objectives of decarbonising road transport in order to combat climate change, it should also take into account the significant industrial and social consequences of this process to ensure employment and accessible mobility for all.
Amendment 78 #
2023/0042(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The strengthened CO2 emission reduction requirements should incentivise an increasing share of zero-emission and low-emission vehicles being deployed on the Union market whilst providing benefits to users and citizens in terms of air quality and energy savings, as well as ensuring that innovation in the automotive value chain can be maintained. Zero-emission vehicles currently include battery electric vehicles, fuel-cell and other hydrogen-powered vehicles, and technological innovations are continuing. The automotive industry remains one of the pillars of the EU economy, contributing 7% of European GDP, providing 4.6 million jobs and remaining at the cutting edge of technological innovation with EUR 60 billion invested each year in research and development. The industry needs to be supported in its environmental and digital transition, as European manufacturers are now facing a triple bind, with tightened environmental regulations, increasing investment needs in innovation and heightened international competition. The strengthened CO2 emission reduction standards must become technology neutral in reaching the fleet-wide targets that they set. Zero and low-emission vehicles, which run on advanced biofuels or synthetic fuels as defined in Directive (EU) 2018/20011a. Zero-emission and low- emission vehicles currently include battery electric vehicles, fuel-cell and other hydrogen-powered vehicles, and technological innovations are continuing. __________________ 1a Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (recast).
Amendment 88 #
2023/0042(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Against that background, new strengthened CO2 emission reduction targets should be set for new heavy-duty vehicles for the period 2030 onwards, based on a life cycle analysis. Those targets should be set at a level that will deliver a strong signal to accelerate the uptake of zero-emission and low-emission vehicles on the Union market and to stimulate innovation in zero-emission technologies in a cost- efficient way and be consistent with the existence of the necessary enabling conditions, in particularly the deployment of charging and refuelling infrastructure across the Union.
Amendment 93 #
2023/0042(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) The principle of technological neutrality is fundamental to ensure there is efficiency and a plurality of solutions, to preserve and fasten innovation and development, including in disruptive technologies, and to allow market flexibility and a diverse range of social behaviours. It is thus important that we do not limit road transport to a single technology but rather encourage innovation and complementarities between efficient alternative technologies, such as the combined use of hybrid vehicles and low-carbon as well as CO2 neutral fuels. Furthermore, a ‘one size fits all’ approach at European level would be compromised by the wide economic, social, geographical and infrastructural diversity within and between Member States, whereas a mix of complementary technologies allows each region to implement the solutions it deems most appropriate to reduce its emissions.
Amendment 98 #
2023/0042(COD)
Proposal for a regulation
Recital 11 – paragraph 1
Recital 11 – paragraph 1
The updated New Industrial Strategy14 foresees the co-creation of green and digital transition pathways in partnership with industry, public authorities, social partners and other stakeholders. In this context, a transition pathway is being developed for the mobility ecosystem to accompany the transition of the automotive value chain. The pathway takes particular heed of small and medium-sized enterprizes in the automotive supply chain, of the consultation of social partners including by Member States, and also build on the European Skills Agenda with initiatives like the Pact for Skills to mobilise the private sector and other stakeholders to up-skill and re-skill Europe’s workforce in view of the green and digital transitions and on the Talent Booster Mechanism in the framework of the Harnessing Talents in EU regions initiative. The appropriate actions and incentives at the European and national level to boost the affordability of zero- emission vehicles are also being addressed in the pathway. This could, for example, include the possibility for Member States to use the proposed Social Climate Fund to assist micro-enterprises in the purchasing of zero-emission trucks and lorries. Particular attention should be also given to the impact that this transition will have on SMEs along the supply chain. __________________ 14 Commission Communication on Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery, COM(2021) 350 final of 5 May 2021.
Amendment 100 #
2023/0042(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union fleet-wide targets are to be complemented by the necessarydependent on the rapid roll-out of recharging and refuelling infrastructure as set out in the Commission Proposal for a regulation on the deployment of alternative fuel infrastructure16 . __________________ 16 Proposal for a Regulation of the European Parliament and of the Council on the deployment of alternative fuels infrastructure, and repealing Directive 2014/94/EU of the European Parliament and of the Council, 14.7.2021, COM/2021/559 final.
Amendment 105 #
2023/0042(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Manufacturers should be provided with sufficient flexibility in adapting their fleets over time in order to manage the transition towards zero-emission and low- emission vehicles in a cost-efficient manner, and i. The progressively more ambitious emission reduction targets have increased the costs of compliance for manufacturers. It is therefore appropriate to maintain the approach of decreasing target levels in five-year steps.
Amendment 117 #
2023/0042(COD)
Proposal for a regulation
Recital 17
Recital 17
Amendment 160 #
2023/0042(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The zero- and low-emission factor should last be applied for the reporting period of the year 2029, because it is no longer considered necessary after that time as an incentive39 to promote the market entrance of zero-emission vehicles in the heavy duty sector.
Amendment 179 #
2023/0042(COD)
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39a) For the swift decarbonisation of the transport sector, it is important to adopt a holistic approach and take into account the full-life cycle CO2 emissions of heavy duty vehicles place on the Union market. Looking exclusively at tailpipe emissions, only captures part of the CO2 emissions and is not in line with technological neutrality. Thus, the Commission should by 2026 develop a methodology for assessing the full life- cycle CO2 emission of heavy-duty vehicles.
Amendment 181 #
2023/0042(COD)
Proposal for a regulation
Recital 39 b (new)
Recital 39 b (new)
(39b) In order to speed-up the transition a mechanism, based on a carbon correction factor is introduced that reflects the CO2 intensity and the share of CO2 neutral fuels.
Amendment 182 #
2023/0042(COD)
Proposal for a regulation
Recital 39 c (new)
Recital 39 c (new)
(39c) a new definition of "CO2 neutral fuels" is introduced to allow for renewable fuels as defined in Directive 2018/2001, including biofuels, biogas, bioliquids, biomass fuels and renewable fuels of non-biological origin or recycled carbon fuels.
Amendment 234 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 a (new)
Article 3 – paragraph 1 – point 23 a (new)
(23a) "CO2 Neutral Fuels" means renewable fuels as defined in Directive 2018/20011a, including biofuels, bioliquids, biomass fuels and renewable fuels of non-biological origin or recycled carbon fuels;
Amendment 243 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 b (new)
Article 3 – paragraph 1 – point 23 b (new)
(23b) "Carbon Correction Factor" means a factor reflecting the CO2 intensity and share of CO2 neutral fuels;
Amendment 270 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point b
Article 3a – paragraph 1 – point b
(b) for all vehicle sub-groups for the reporting periods of the years 2030 to 2034 by 435 %,
Amendment 278 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
(c) for all vehicle sub-groups for the reporting periods of the years 2035 to 2039 by 655 %,
Amendment 301 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point d
Article 3a – paragraph 1 – point d
(d) for all vehicle sub-groups for the reporting periods of the years 2040 onwards by 980%.
Amendment 328 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
1. For vehicles referred to in point 4.2 of Annex I, manufacturers shall comply with the minimum shares of zero-emission vehicles in their fleet of new heavy-duty vehicles as laid down in point 4.3 of Annex I. For new urban buses the share of zero- emissions vehicles shall beaverage CO2 emissions shall be reduced by 80% as from the reporting period of the year 2030 and 100% as from the reporting period of the year 20305.;
Amendment 381 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 – point a
Article 1 – paragraph 1 – point 6 – point a
Regulation (EU) 2019/1242
Article 5 – paragraph 1 – subparagraph 1
Article 5 – paragraph 1 – subparagraph 1
Starting from 1 July 2020 and for each subsequent reporting period until the reporting period of the year 2029, the Commission shall determine for each manufacturer the zero- and low-emission factor for the preceding reporting period.
Amendment 453 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18
Article 1 – paragraph 1 – point 18
Regulation (EU) 2019/1242
Article 15 – paragraph 1
Article 15 – paragraph 1
The Commission shall, in 20287 and every year thereafter, review the effectiveness and impact of this Regulation and submit a report to the European Parliament and to the Council with the result of the review. The Commission shall in particular annually assess the deployment of charging and refuelling infrastructure for heavy duty vehicles across the Union.
Amendment 468 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18
Article 1 – paragraph 1 – point 18
Regulation (EU) 2019/1242
Article 15 – Paragraph 2a (new)
Article 15 – Paragraph 2a (new)
By 2026, the Commission shall publish a report developing a methodology to assess the life-cycle CO2 emissions of heavy-duty vehicles. The Commission is empowered to delegated acts to set out a methodology for the assessment of the life-cycle CO2 emissions of heavy duty vehicles placed on the Union market.
Amendment 482 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.3 – point 2.3.2 – paragraph 1
Annex I – point 2 – point 2.3 – point 2.3.2 – paragraph 1
Regulation (EU) 2019/1242
Annex I – Point 2.3 – Point 2.3.2 – Paragraph 1
Annex I – Point 2.3 – Point 2.3.2 – Paragraph 1
Reporting periods from 2025 to 2029onwards
Amendment 493 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.3 – point 2.3.3
Annex I – point 2 – point 2.3 – point 2.3.3
Regulation (EU) 2019/1242
Annex I – point 2 – point 2.3 – point 2.3.3
Annex I – point 2 – point 2.3 – point 2.3.3
Amendment 524 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 2 – subparagraph 2.1
Annex I – paragraph 2 – subparagraph 2.1
Amendment 552 #
2023/0042(COD)
Proposal for a regulation
ANNEX I – paragraph 4 – subparagraph 4.1. – table 4.2.
ANNEX I – paragraph 4 – subparagraph 4.1. – table 4.2.
4.2. Vehicle sub-groups included in the calculation of average specific CO2 emissions and specific emissions targets of manufacturers X = 2025 X= NO X = MCO2 X= MZE vehicle sub- sub-groups of sub-groups of sub-groups of transport of persons groups, subject transport of transport of vehicles, subject to zero-emissions to CO2 goods vehicles, persons vehicle targets according to Article emissions subject to CO2 vehicles, 3b targets emissions subject to CO2 according to targets emissions Article 3a according to targets paragraph 1 (a) Article 3a according to paragraphs Article 3a 1(b), 1(c) and paragraphs 1(d) and 1(b), 1(c) and paragraph 3 1(d) 4-UD, 4-RD, All vehicle sub- 32-C 31-L2, 32-C32, 31-LF, 31-L1, 31-L2DD, 31-DD3-LF, 33-LF,1, 4-LH, 5-RD, 5- groups referred 32-DD, 34-C2, 33-L1, 33-L2 32-C3, 32-DD, 33-DD, 35-FE, 39-FE LH, 9-RD, 9- to in points 34-C3, 34-DD, 33-L2, 34-C2, LH, 10-RD, 10- 1.1.1 and 1.1.3. LH 34-C3, 34-DD, LH
Amendment 563 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 4 – subparagraph 4.3. – table 4.3.1
Annex I – paragraph 4 – subparagraph 4.3. – table 4.3.1
4.3.1. The following CO2 emissions reduction targets rfsg and rfpsg pursuant to Article 3a shall apply to vehicles in the sub-group sg for different reporting periods: CO2 reduction targets rfsg and rfpsg groups sg Reporting period of the years Sub- 2025 – 2029 2030 – 2034 2035 – 2039 As from 2040 Medium lorries 53, 54 0 4320% 6455% 980% Heavy lorries > 7,4t 1s, 1, 2, 3 0 435% 64% 55% 980% Heavy lorries > 16 t 4-UD, 4-RD, 15% with 4x2 and 6x4 axle 4-LH, 5-RD, configurations 5-LH, 9-RD, 43 35% 64% 55% 980% 9-LH, 10-RD, 10-LH Heavy lorries > 16 t 11, 12, 16 0 0 with special axle 43 35% 6455% 980% configurations Coaches (rfsg) 32-C2, 32- 0 C3, 32-DD, 43% 20% 6455% 980% 34-C2, 34- C3, 34-DD Primary vehicles of 32-C2, 32- 0 0 coaches (rfpsg) C3, 32-DD, 43 20% 6455% 980% 34-C2, 34- C3, 34-DD Trailers 0 7,5% 7,5% 7,5% Semi-trailers 0 15% 15% 15%
Amendment 573 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 4 – subparagraph 4.3. – table 4.3.2
Annex I – paragraph 4 – subparagraph 4.3. – table 4.3.2
4.3.2. The following zero-emission vehicle targets zevMsg pursuant to Article 3b are applicable to vehicles in the sub-group sg for different reporting periods: Zero-emission vehicle mandates zevMsg Sub-groups Zero-emission vehicle mandates Reporting period of the years sg zevMsg before 2030 2030 – 2034 2035 – 2039 As from 2040 Urban heavy 31-LF, 31-L1, 31- 0 10 80% 100% 100% buses DD, 33-LF, 33- L1, 33-DD, 35- FE, 39-FE, 31-L2, 33-L2
Amendment 593 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 6 a (new)
Annex I – paragraph 6 a (new)
6 a. CALCULATION OF THE CARBON CORRECTION FACTOR (CCF) For each fuel or blend of fuels i, the CCFi shall be calculated according to the following method: 6.1. When the share of CO2 neutral fuels is 100%, CCFi = 1. 6.2. When the share of CO2 neutral fuels is 0%, CCFi = 0. 6.3. For blends of CO2 Neutral Fuels and conventional fuels, the CCFi shall be calculated according to the following formula: 𝑺𝑯𝑨𝑹𝑬𝑺𝒏;𝒊 𝑪𝑪𝑭𝒊 = 𝟏𝟎𝟎 Where: CCFi is the Carbon Correction Factor for a specific blend of CO2 neutral fuel i and conventional fuel. SHARESn;i is the percentage of CO2 neutral fuel i over the total consumption of fuel i, calculated from SHARES database.
Amendment 53 #
2022/2147(INI)
Motion for a resolution
Recital F
Recital F
F. whereas air and maritime transport are essential for ensuring territorial continuity and connecting the ORs both to the European mainland and with each other;
Amendment 68 #
2022/2147(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
Gb. whereas the ORs are in the front line when it comes to the effects of climate change and are particularly vulnerable in the face of increasingly frequent extreme weather events such as cyclones and floods, as well as volcanic eruptions;
Amendment 142 #
2022/2147(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. URecalls that young people make up a high proportion of the ORs' population and that, on average, half of the population of the six French ORs is under the age of 30; underlines the importance of young people for the revitalisation of traditional sectors in the ORs; calls for measures to attract young people into the primary sector;
Amendment 297 #
2022/2147(INI)
Motion for a resolution
Paragraph 35 a (new)
Paragraph 35 a (new)
35a. Proposes the creation of a research centre for tropical infectious diseases and medical conditions that are particularly common in the ORs, such as diabetes, obesity and certain cancers;
Amendment 324 #
2022/2147(INI)
Motion for a resolution
Paragraph 43
Paragraph 43
43. Welcomes the Commission’s announcement of the creation of a portal on all available EU funds, programmes and policy initiatives for the ORs, which responds to a request made by Parliament in its resolution of 14 September 2021; urges the Commission to create this portal without delay;
Amendment 3 #
2022/2104(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Highlights that the swift authorisation of sustainable feed additives and sustainable alternatives to pesticides plays an important role in reaching the ambitions of the Farm-to-Fork strategy; Stresses in that regard that sufficient capacity in terms of staff and their respective expertise is essential in order to prevent delays in application and assessment procedures for the approval of sustainable feed additives and sustainable alternatives to pesticides;
Amendment 21 #
2022/2059(INI)
Motion for a resolution
Recital E
Recital E
E. whereas the densquantity of waste has more than doubled in thirty years; whereas the improper management and treatment of waste from rivers and urban areas make the Mediterranean the area with the sixth largest accumulation of marine litter in the world;
Amendment 66 #
2022/2059(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Highlights the potential of all the Mediterranean regions for the development of onshore and offshore renewable energy sources and for a just and inclusive ecological transition;
Amendment 260 #
2022/2053(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Considers that carbon farming should be developed on the basis of a credible, fair, efficient and simple policy framework and sees this as a precondition for its success;
Amendment 308 #
2022/2053(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that carbon farming must be regulated in line with the current CAP and be seen as a complementary and additional topping-up option; underlines, however, that in the longer term carbon farming should be market-basede importance of maintaining consistency in all measures within EU policies, notably the CAP, to ensure that enabling conditions are created for the upscaling of carbon farming and to allow equal access for all farmers and foresters across Member states; calls for the integration of carbon farming into CAP National Strategic Plans (NSP) in line with Member States assessment and needs, to ensure that local natural conditions are adequately reflected, including innovative practices in crop and livestock production such as in animal nutrition and animal welfare;
Amendment 322 #
2022/2053(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Considers that addressing the knowledge gap, especially among farmers and foresters, is essential for creating an efficient certification framework for carbon removals via carbon farming; calls on the Member States to boost knowledge transfers through targeted training and education programmes, and access to dedicated advisory and extension services to increase the uptake of carbon farming by land managers, farmers and foresters; in this regard, recalls on Member States to ring-fence appropriate amount of resources for Advisory and Technical assistance in their Rural Development Plans 2023-2027 accordingly;
Amendment 424 #
2022/2053(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Believes that emissions reductions from agricultural activity should also benefit from objective measurement and certification;
Amendment 432 #
2022/2053(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Asks the Commission to engage with private actors, in particular retails and food processing industries, to make sure that the certification scheme triggers a price premium on the market, which would reward front runners and newcomers on an equal footing;
Amendment 3 #
2022/2046(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Reiterates its concern as regards the significant delay in the implementation of cohesion policy for the 2021-2027 period, as well as its call for the Commission and the Member States to speed up the adoption of the partnership agreements and programmes, without undermining their quality and while respecting the EU’s political priorities and the applicable principles; calls on the Member States to ensure that local authorities are included in the design and implementation of all programmes; reiterates the need for special consideration to be given to less-developed regions and island, islands, outermost regions and rural, remote and depopulated areas in this context;
Amendment 24 #
2022/2046(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls for a significant increase in the European Union Solidarity Fund (EUSF) budget, which would help regions to anticipate and mitigate the effects of climate change, and for the scope of the EUSF to be broadened, so that it can also support more climate-resilient restoration or construction of public and private infrastructure; stresses the importance of the social dimension of the green transition and the need to provide targeted support to the regions, industries, workers and households facing the biggest challenges;
Amendment 29 #
2022/2046(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Stresses the high potential of rural areas and the necessity to improve transport connectivity, high-speed broadband and the provision of services in order to help them meet challenges such as rural desertification, depopulation and ageing; asks, therefore, to increase the amount of resources at national level that are allocated to integrated territorial development in disadvantaged non-urban areas, suffering from natural, geographical or demographic handicaps; highlights the importance of synergies between different funding tools to channel an adequate level of funding towards rural areas through a multi-fund approach; reaffirms the importance of urban-rural linkages and of the development of strategies based on functional areas with the aim of preventing rural areas from shrinking;
Amendment 30 #
2022/2046(INI)
4 a. Stresses the role of urban areas in tackling the climate emergency, reiterates the need for further funding opportunities for cities to implement programmes locally; reminds that EUR 400 000 000 of the resources for the Investment for jobs and growth goal shall be allocated to the EuropeanUrban Initiative under direct or indirect management by the Commission as laid out in Regulation (EU) 2021/1058, calls for the European Urban Initiative to begiven a greater budget and scope, in order to support the delivery of the Urban Agenda in the next programming period;
Amendment 33 #
2022/2046(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Recalls that among the many inequalities exposed by the COVID-19 pandemic, the digital divide is a serious one; highlights the need to allocate sufficient funds for the development of digital skills; calls for digital inclusion to be recognised as a right for all generations and for a clear commitment to achieve universal internet connectivity;
Amendment 39 #
2022/2046(INI)
5 a. Welcomes the decision of the European Commission to maintain the general escape clause of the Stability and Growth Pact in 2023; suggests to envisage the possibility that public spending under cohesion policy by Member States and regional and local authorities as part of ESIF Funds should not be considered as national or equivalent structural expenditure as defined within the Stability and Growth Pact;
Amendment 20 #
2022/2032(INI)
Motion for a resolution
Recital C
Recital C
C. whereas cohesion policy, even though it is not a crisis instrument, helps to respond effectively to asymmetric shocks such as the current refugee crisis caused by the Russian invasion of Ukraine; whereas cohesion policy, in its nature and identity, is a long-term investment policy;
Amendment 31 #
2022/2032(INI)
Motion for a resolution
Recital G
Recital G
G. whereas infrastructure quality, provision of services, access to healthcare and transports and mobility solutions differs vastly between urban and rural regions;
Amendment 46 #
2022/2032(INI)
Motion for a resolution
Recital K
Recital K
K. whereas the regional innovation divide has grown and education and skills gaps between more and less developed regions are often wide; whereas skills endowments are concentrated especially in capital regions and a large urban-rural divide has emerged;
Amendment 49 #
2022/2032(INI)
Motion for a resolution
Recital L
Recital L
L. whereas disparities remain in the speed of the digital transition across Europe; whereas very high-speed connections are only accessible to two out of three city residents and one out of six rural residents;
Amendment 53 #
2022/2032(INI)
Motion for a resolution
Recital M
Recital M
M. whereas significant progress has been made in improving employment and social inclusion, but regional disparities remain larger than before the 2008 financial crisis; whereas cohesion policy should provide efficient responses for tackling poverty and social exclusion, creating employment and growth, promoting investment in education, health, research and innovation, fighting climate change and tackling demographic challenges; whereas cohesion policy can only fulfil all these tasks if it is embedded in solid funding;
Amendment 67 #
2022/2032(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Is convinced that cohesion policy can only continue to play its present role as a vector for investment and job creation, an instrument to reduce regional and intraregional disparities and a solidarity mechanism for all EU regions if it has solid and adequate funding; stresses that this implies providing at least for the same level of funding as in the 2021-2027 financial period, topped up with the Just Transition Fund (JTF) II budgetary resources; ; recalls that new challenges need fresh money and asks, when relevant, to top up cohesion policy with new budgetary resources to allow Member States and regional authorities to address the different challenges and crises affecting the European Union;
Amendment 109 #
2022/2032(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Maintains that an unallocated flexibiTakes note that, even though cohesion politcy reserve of 15 % of the total allocation for cohesion pois not a crisis instrument, a certain degree of agility and flexibilicty instrumentof its rules should be put in placemaintained to strengthen regions’ resilience and responsiveness, enabling them to address new and upcoming challenges and absorb asymmetric shocks; recalls that this new added value should contribute to preserving a strong cohesion policy in the post-2027 MFF and not making it vulnerable to budgetary cuts or weakening reforms;
Amendment 145 #
2022/2032(INI)
Motion for a resolution
Paragraph 8 – introductory part
Paragraph 8 – introductory part
8. Believes, thatTakes note of the recent changes applied to the co-financing rate for the ‘Investment in jobs and growth’ goal at the level of each priority should not be higher than:under the 2021-2027 programming period; invites the Commission to assess the impact of these changes and insists on the need to increase the co-financing rate, especially for transition and more developed regions;
Amendment 162 #
2022/2032(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Notes that ‘rust belts’ still exist in most Member States; believes that, to address the potentially negative impact of the transition of old industries such as steel and aluminium and to support the development of the regions affected,urges to support the industrial transition of these territories and address its potentially negative impact making use of the cohesion fund and the JTF II resources should be directed towardsand by creating smart specialisation strategies tailored to each of the regions in industrial transition, fostering innovation-led growth and ensuring the spread of growth benefits;
Amendment 8 #
2022/2023(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission to make social equity one ofand territorial cohesion the central points in the development of the Sustainable Urban Mobility Plans (SUMPs) provided for in the context of the TEN-T revision, as these have a greater impact on regional areas outside the RTEN-T nodes and include a greater number of municipalities, towns and functional areas;
Amendment 13 #
2022/2023(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Welcomes the Commission’s proposal to improve the 19 sustainable urban mobility indicators by 2022; calls on the Commission, furthermore, to prioritise the allocation of funds to municipalities and countricities, regions and Member States whose projects improve indicators and are in line with the SUMPs;
Amendment 33 #
2022/2008(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Welcomes the up-date of the New Industrial Strategy after one year into the Covid-19 pandemic; highlights the fact that the recovery prospects vary significantly amongst the industrial ecosystems and also amongst different regions of the European Union; underlines that the recovery process is endangered by the new energy crisis affecting different regions in very different ways requesting adapted regional and local recovery, resilience and development strategies;
Amendment 35 #
2022/2008(INI)
Draft opinion
Paragraph 6 b (new)
Paragraph 6 b (new)
6 b. Welcomes the new approach of the European Commission for reducing the strategic and industrial dependencies and working towards diversifying the international supply chains; underlines the important role of innovative SMEs in this process;
Amendment 37 #
2022/2008(INI)
Draft opinion
Paragraph 6 d (new)
Paragraph 6 d (new)
6 d. Highlights the need to better support the traditional industries and economic specificities of the regions on their way to the green and digital transition, encouraging the forming and growing of industrial hubs in order to help the regional development and reach the cohesion policy targets;
Amendment 38 #
2022/2008(INI)
Draft opinion
Paragraph 6 e (new)
Paragraph 6 e (new)
6 e. Underlines the need of better synergies between the European funds, prioritizing the innovation and the ecological approach, opening the eligibilities to all industries, including the food processing industry according to the regional specificities;
Amendment 39 #
2022/2008(INI)
Draft opinion
Paragraph 6 f (new)
Paragraph 6 f (new)
6 f. Highlights that the New Industrial Strategy should take into account the specificities of remote areas and outermost regions, analyse and come with solutions for the development of the local and traditional industries of these regions and integrating them in the European industrial ecosystem;
Amendment 41 #
2022/2008(INI)
6 h. Calls for taking into account the need for a common approach and a commonly approved strategy for challenging situations that might affect the industry in the future, keeping in mind that the unilateral measures taken by many Member States especially in the beginning of the Covid-19 pandemic affected the well functioning of the industry especially in cross-border regions where trans-border workers were not allowed to daily travel from one country to another;
Amendment 44 #
2022/2008(INI)
Draft opinion
Paragraph 6 k (new)
Paragraph 6 k (new)
6 k. Underlines the importance of supporting the local production of energy and the encouraging of domestic energy production which will lead to local and regional development, the completion of the European energy infrastructure and of a real Single Market in the field of energy;
Amendment 251 #
2022/0396(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In line with the waste hierarchy set out in Article 4(2) of Directive 2008/98/EC, and in line with life-cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packaging without increasing food waste and preserving food safety and hygiene standards. In addition, the measures aim at increasing the use of recycled content in packaging ensured either through mechanical or chemical recycling, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.
Amendment 268 #
2022/0396(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Packaging should be designed, manufactured and commercialised in such a way as to allow for its re-use or high- quality recycling, and to minimise its impact on the environment during its entire life-cycle and the life cycle of products, for which it was designed. In line with article 4, paragraph 2 of Directive 2008/98/EC establishing the Waste Hierarchy, derogations should be allowed if the life- cycle assessment shows a better environmental outcome on the generation and management of waste.
Amendment 331 #
2022/0396(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) In order to ensure a high level of human and animal health protection in accordance with requirements in Union legislation and to avoid any risk to the security of supply and to the safety of medicines and medical devices safety, it is appropriate to provide for the exclusion from the obligation of a minimum recycled content in plastic packaging for immediate packaging as defined in Article 1, point 23, of Directive 2001/83/EC and in Article 4, point 25, of Regulation (EU) 2019/6, as well as for contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 and for contact sensitive packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746. This exclusion should also apply to outer packaging of human and veterinary medicinal products as defined in Article 1, point 24, of Directive 2001/83/EC and in Article 4, point 26, of Regulation (EU) 2019/6 in cases where it has to comply with specific requirements to preserve the quality of the medicinal product. and for contact sensitive plastic packaging for food intended for infants and young children, food for special medical purposes and packaging for drinks and food typically used for young children covered by Regulation (EU) No 609/2013.
Amendment 338 #
2022/0396(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unit of packagingpackaging, where plastics is the predominant material, contains a certain minimum percentage of recycled content recovered from post- consumer plastic waste calculated as an average of the plastic packaging placed on the territory of a Member State. If such requirement poses a risk to food, human or animal safety, it should not apply to food contact plastic packaging.
Amendment 350 #
2022/0396(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure uniform conditions for the implementation of the rules on calculating and verifying, per unit of post-consumer plastic waste in packaging, the share of recycled content recovered from post-consumer plastic waste present and establishing the format for technical documentation, the Commission should be empowered to adopt implementing provisions, in accordance with Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council55. _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 370 #
2022/0396(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) For limited packaging applications made of biodegradable plastic polymers, there is a demonstrable environmental benefit of using compostable packaging, which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where appropriate waste collection schemes and waste treatment infrastructures are available in a Member State, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams or pose a risk for the quality or usability of compost in line with the requirements of the harmonised European standard 13432 on packaging recoverable through composting and biodegradation.
Amendment 398 #
2022/0396(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) In order to facilitate conformity assessment with requirements on packaging minimisation, it is necessary to provide presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and specify measurable design criteria, including where appropriate, maximum weight or empty space limits for specific packaging formats as well as by-default, standardised packaging designs that comply with the packaging minimisation requirement without compromising the requirements or safety needed for packaging materials in contact with food.
Amendment 403 #
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 while preserving food safety and food quality. 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.
Amendment 440 #
2022/0396(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) In order to ensure a high level of environmental protection in the internal market as well as a high level of food safety and hygiene, and facilitate the achievement of the packaging waste prevention targets, unnecessary or avoidable packaging should not be allowed to be placed on the market. Derogations should be allowed in case such packaging is necessary to ensure the quality, hygiene and food safety of the product or to avoid food waste and contamination risks. The list of such packaging formats is provided in Annex V of this Regulation. In order to adapt the list to the technical and scientific progress the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the list.
Amendment 450 #
2022/0396(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) To incentivise waste prevention, a new concept of ‘refill’ should be introduced. Refill should be considered as a specific waste prevention measure that counts towards and is necessary for meeting of the re-use and refill targets. However, containers owned by the consumer, performing a packaging function in the context of refill, such as reusable cups, mugs, bottles or boxes are not packaging in the sense of this Regulation. Only refill happening via a system for refill shall count towards the reuse and refill targets. Such system for refill can for example be a system for refill found in the premises of an economic operator or a product dispenser for home consumption.
Amendment 472 #
2022/0396(COD)
Proposal for a regulation
Recital 69
Recital 69
(69) Certain uses of single use transport packaging formats are not necessary, as there is a wide range of well-functioning reusable alternatives. In order to ensure that such alternatives are effectively used, it is appropriate to require economic operators, when transporting products between different sites of the same economic operator or between the economic operator and the linked or partner enterprises, to use only reusable transport packaging with respect to packaging formats such as pallets, foldable plastic boxes, plastic crates, intermediate bulk containers, both rigid and flexible, or drums. The same obligation should, for the same reasons, apply to economic operators transporting products within one Member State. In line with Article 4, paragraph 2 of Directive 2008/98/EC establishing the Waste hierarchy, derogations should be allowed for recyclable single use packaging in case it provides a better overall environmental outcome demonstrated by the life-cycle assessment.
Amendment 487 #
2022/0396(COD)
Proposal for a regulation
Recital 90
Recital 90
(90) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the waste generation by eliminating excessive packaging and restrict the uses of certain packaging formats, unless packaging is necessary to prevent food waste or to ensure consumer safety, extending the life span of packaging, re-designing products so that no packaging or less packaging can be used, including bulk sales, and by shifting from single use packaging to reusable packaging where environmental benefits have been demonstrated and do not call into question the benefits on food waste prevention or on consumer safety.
Amendment 587 #
2022/0396(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. This Regulation applies without prejudice to Union regulatory requirements for packaging such as those regarding safety, quality, the protection of health and the hygiene of the packed products, or to transport requirements, as well as without prejudice to the provisions of the Directive 2008/98/EC as regards the management of hazardous waste and as regards the requirements regarding the choice of options that deliver the best overall environmental outcome justified by life- cycle thinking provided for in paragraph 2 of Article 4 of Directive 2008/98/EC.
Amendment 608 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point f
Article 3 – paragraph 1 – point 1 – point f
(f) compostable tea or coffee bags necessary to contain a tea or coffee product and intended to be used and disposed of together with the product;
Amendment 638 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) ‘plastic packaging’ means a packaging that is wholly or predominantly made of plastic;
Amendment 646 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 22
Article 3 – paragraph 1 – point 22
(22) ‘re-use’ means any operation by which reusable packaging is used again for the same purpose for which it was conceived as part of a broader reuse system, with or without the support of auxiliary products, including refill- and dilutate-at-home solutions;
Amendment 665 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28
Article 3 – paragraph 1 – point 28
(28) ‘refill’ means an operation entailing a system for refill by which an end user fills its owna container, which fulfils the packaging function, with a product or several products offered by the final distributor in the context of a commercial transactionpurchased through a final distributor;
Amendment 714 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 34
Article 3 – paragraph 1 – point 34
(34) ‘integrated component’ means a packaging component that may be distinct from the main body of the packaging unit, and may be of a different material, but is integral to the packaging unit and its functioning and does not need to be separated from the main packaging unit in order to consume the product and is typically discarded at the same time as the packaging unit, although not necessarily in the same disposal routeis disposed together with the main body of the packaging;
Amendment 721 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 35
Article 3 – paragraph 1 – point 35
(35) ‘separate component’ means a packaging component that is distinct from the main body of the packaging unit, which maycan be of a different material, that needs to bemanually disassembled completely and permanently from the main packaging unit in order to access the product, and that is typically discarded prior to anbody of the packaging by the end consumer, and that is recommended to be disposed separately from the main body of the packaging unit;
Amendment 755 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘compostable packaging’ means packaging capable of undergoing physical, chemical, thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide, mineral salts, biomass and water, according to Article 47(4), and does not hinder the separate collection and the composting process or activity into which it is introduced in industrially controlled conditions and fulfills the requirements laid down in the harmonised European standards EN 13432;
Amendment 1021 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 7 – point a
Article 6 – paragraph 7 – point a
(a) the manner in which to express the result of the recyclability assessment, evaluated directly or through mass balance as material yield from waste input achieved in commercially operated and available recycling technology, in recyclability performance grades from A to E, as described in Table 3 of Annex II, based on the percentage of the packaging unit, in weight, which is recyclable according to paragraph 1;
Amendment 1091 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From 1 January 2030, the plastic part in packagingpackaging where plastics is the predominant material shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaging: either through mechanic or chemical recycling, calculated as an average of the plastic packaging placed on the territory of a Member State.
Amendment 1092 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From 1 January 2030, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packagingeither through mecanic or chemical recycling, calculated as an average of the plastic packaging placed on the territory of a Member State :
Amendment 1117 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) 310 % for contact sensitive plastic packaging made from polyethylene terephthalate (PET) as the major component;
Amendment 1153 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packagingpackaging where plastics is the predominant material shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packagingeither through mecanic or chemical recycling, calculated as an average of the plastic packaging placed on the territory of a Member State:
Amendment 1194 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2a. Economic operators shall be exempted from the obligation to meet the targets in paragraphs 1 and 2 if, during a calendar year, they comply with the definition of microenterprise in accordance with the rules set out in the Commission Recommendation 2003/361/EC
Amendment 1202 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 3 – point d a (new)
Article 7 – paragraph 3 – point d a (new)
(da) contact sensitive plastic packaging for food intended for infants and young children, food for special medical purposes and packaging for drinks and food typically used for young children as defined in Article 1, point (a), (b) and (c) of Regulation (EU) No 609/2013.
Amendment 1267 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. By 31 December 2026, the Commission is empowered to adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unit of plastic packaging, and the format for the technical documentation referred to in Annex VII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1344 #
2022/0396(COD)
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation], packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit and vegetables and very lightweight plastic carrier bags shall be compostable in industrially controlled conditions in bio-waste treatment facilities in line with the requirements of the harmonised European standard 13432 to avoid contamination risk or affect the quality of compost.
Amendment 1702 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Economic operators shall not place on the market packaging in the formats and for the purposes listed in Annex V, unless such packaging is in line with the requirements regarding the choice of options that deliver the best overall environmental outcome justified by life- cycle thinking provided for in paragraph 2 of Article 4 of Directive 2008/98/EC, as of 1 January 2030.
Amendment 1748 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend Annex V in order to adapt it to technical and scientific progress with the objective to reducing packaging waste and improve the best overall environmental outcome justified by life-cycle thinking provided for in paragraph 2 of Article 4 of Directive 2008/98/EC. When adopting those delegated acts, the Commission shall consider the potential of the restrictions on the use of specific packaging formats to reduce the packaging waste generated while ensuring an overall positive environmental impact, and shall take into account the availability of alternative packaging solutions that meet requirements set out in legislation applicable to contact sensitive packaging, as well as their capability to prevent microbiological contamination of the packaged product.
Amendment 1794 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. From 1 January 2030, economic operators making large household appliances listed in point 21 of Annex II to Directive 2012/19/EU available on the market for the first time within the territory of a Member State shall ensure that 90 % of those products are made available in reusable transport packaging within a system for re-use.
Amendment 1804 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 1834 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
Amendment 1866 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
Amendment 1910 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
Amendment 1977 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 8 – point b
Article 26 – paragraph 8 – point b
(b) from 1 January 2040, 530 % of such packaging used is reusable packaging within a system for re-use;
Amendment 2009 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 10 – introductory part
Article 26 – paragraph 10 – introductory part
10. Economic operators using grouped packaging in the form of boxes, excluding cardboard, used outside of sales packaging to group a certain number of products to create a stock-keeping unit or distribution shall ensure that:
Amendment 89 #
2022/0394(COD)
Proposal for a regulation
Title 1
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a Union certification framework for carbon removals and carbon farming
Amendment 90 #
2022/0394(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 43(2) and 192(1) thereof,
Amendment 113 #
2022/0394(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The aim of this Regulation is to develop a voluntary Union certification framework for carbon removals and carbon farming, with the view to incentivise the uptake of high- quality carbon removals and, in the case of carbon farming, biogenic emissions reduction, in full respect of the biodiversity and the zero-pollution objectives. It is a tool to support the achievement of the Union objectives under the Paris Agreement, notably the goal of collective climate neutrality by 2050 laid down in Regulation (EU) 2021/1119 of the European Parliament and of the Council24 . The Union also committed to generate negative emissions after 2050. An important instrument to enhance carbon removals in terrestrial ecosystems is Regulation (EU) 2018/841 of the European Parliament and of the Council25 , which is currently under review. The objective of the review is to set out a Union net removals target of 310 Mt CO2 eq by 2030, and to allocate respective targets to each Member State. In this regard, the planned revision of the Regulation should also look at how to incorporate the carbon removals achieved through carbon farming in the EU and national targets. Furthermore, in the case of biogenic emissions reduction, the Commission should consider how to include those in the ETS trading system. __________________ 24 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). 25 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1).
Amendment 124 #
2022/0394(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Union certification framework will support the development of carbon removal activities in the Union that result in an unambiguous net carbon removal benefit, while avoiding greenwashing. In the case of carbon farming, such certification framework should also encourage the uptake ofachieving biogenic emissions reduction together with carbon removal activitis, as these that generate co-benefits for biodiversity, therefore achievwo are intrinsically linked ing their nature restoration targets set out in Union law on nature restorational cycles. Biogenic emissions reduction will require their own methodology for accounting and certification, alongside carbon removals. . The Union certification framework will be instrumental in meeting the Union climate change mitigation objectives set in international agreements and in the Union legislation.
Amendment 129 #
2022/0394(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) The Union voluntary certification framework builds on and contributes to the ongoing public and private work regarding the certification of carbon removals.
Amendment 131 #
2022/0394(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to support operators willing to make additional efforts to increase carbon removals in a sustainable way, the Union certification framework should take into account the different types of carbon removal and carbon farming activities, their specificities and related environmental impacts. Therefore, this Regulation should provide clear definitions of carbon removal, carbon removal activities, and other elements of the Union certification frameworkfarming, carbon farming storage, biogenic emission reductions, carbon removal and carbon farming activities, and other elements of the Union certification framework and specify broad range of financing possibilities, either private or public.
Amendment 145 #
2022/0394(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) This Regulation should set out the requirements under which carbon removals and biogenic emission reduction should be eligible for certification under the Union certification framework. To this end, carbon removals should be quantified in an accurate and robust way; and they should be generated only by carbon removal activities that generate a net carbon removal benefit, are additional, aim to ensure long-term storage of carbon, and have a neutral impact or co-benefit on sustainability objectives. For the carbon removals and biogenic emissions reductions achieved through carbon farming, these should also be quantified in an accurate and robust way, with information provided through the LPIS database; they should also be additional and create co-benefits. Furthermore, carbon removals should be subject to independent third-party auditing in order to ensure the credibility and reliability of the certification process. Mandatory Union carbon pricing rules established through Directive 2003/87/EC of the European Parliament and of the Council26 are in place which regulate the treatment of emissions from activities covered by that Directive. This Regulation should be without prejudice to Directive 2003/87/EC, except in relation to the certification of removals of emissions from sustainable biomass which are zero-rated in accordance with Annex IV thereto. __________________ 26 Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32).
Amendment 157 #
2022/0394(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) A carbon removal and carbon farming activity should result in a net carbon removal benefit showing that it delivers a positive climate impact. The net carbon removal benefit should be computed following two steps. First, operators should quantify the amount of additional carbon removals that a carbon removal activity has generated in comparison to a baseline. Furthermore, in the case of carbon farming, operators should also quantify the biogenic emissions reductions set against the baseline. A standardised baseline reflecting the standard performance of comparable activities in similar social, economic, environmental and technological circumstances and geographical locations should be preferred because it ensures objectivity, minimises compliance and other administrative costs, and positively recognises the action of first movers who have already engaged in carbon removal activities. In the context of carbon farming, the use of available digital technologies, including electronic databases and geographic information systems, remote sensing, artificial intelligence and machine learning, and of electronic maps should be promoted to decrease the costs of establishing baselines and of monitoring carbon removal activities. However, where it is not possible to set such a standardised baseline, a project-specific baseline based on the operator’s individual performance may be used. In order to reflect the social, economic, environmental and technological developments and to encourage ambition over time in line with the Paris Agreement, baselines should be periodically updated.
Amendment 169 #
2022/0394(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The second step for quantifying the net carbon removal benefit should consist of subtracting any increase in greenhouse gas emissions related to the implementation of the carbon removal activity. Relevant greenhouse gas emissions that should be taken into consideration include direct emissions, such as those resulting from the use of more fertilisers, fuel or energy, or indirect emissions, such as those resulting from land use change, with consequent risks for food security due to displacement of agricultural production. A reduction in greenhouse gas emissions resulting from the implementation of the carbon removal activity should not be taken into account to quantify the net carbon removal benefit, but should be considered as a co-benefit towards the sustainability objective of climate change mitigation; by being reported on the certificates, decreases in greenhouse gas emissions (like the other sustainability co-benefits) can increase the value of the certified carbon removals. However, for carbon farming activities, the reduction of biogenic emissions shall be counted towards the net benefit of the activity, especially due to the interconnected nature of carbon and nitrogen cycles.
Amendment 173 #
2022/0394(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) A carbon removal activity delivers a net carbon removal benefit when the carbon removals above the baseline outweigh any increase in greenhouse gas emissions due to the implementation of the carbon removal activity. For instance, in the case of activities that deliver permanent carbon storage by injecting carbon underground, the amount of permanently stored carbon should outweigh the energy- related greenhouse gas emissions from the industrial process. In the case of carbon farming, the carbon captured by an afforestation activity or the carbon kept in the ground by a peatland re-wetting activity should outweigh the emissions from the machinery used to carry out the carbon removal activity or the indirect land use change emissions that can be caused by carbon leakage. Farmers, forest owners and managers should strive to achieve biogenic emission reductions rather, which shall be quantified and accounted for as part of the net removal benefit.
Amendment 182 #
2022/0394(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Carbon removals should be quantified in a relevant, accurate, complete, consistent and comparable manner. Uncertainties in the quantification should be duly reported and accounted in order to limit the risk of overestimating the quantity of carbon dioxide removed from the atmosphere. Carbon removals and biogenic emissions reductions generated by carbon farming should be quantified with a high level of accuracy to assure the highest quality and minimise uncertainties. Moreover, in order to incentivise synergies between Union climate and biodiversity objectives, enhanced monitoring of land needs to be required, thereby helping to protect and enhance the resilience of nature-based carbon removals throughout the Union. The satellite and on-site monitoring and reporting of emissions and removals need to closely reflect those approaches, and make the best use of advanced technologies available under Union programmes, such as Copernicus, making full use of already existing tools, and ensure consistency with the national greenhouse gas inventories.
Amendment 191 #
2022/0394(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) In order to ensure that the Union certification framework channels incentives toward carbon removals and biogenic emissions reductions that go beyond the standard practice, carbon removal and carbon farming activities should be additional. Therefore, these activities should go beyond statutory requirements, that is, operators should carry out activities that are not already imposed upon them by the applicable law. Moreover, carbon removal and carbon farming activities should take place due to the incentive effect provided by the certification. Such effect is present when the incentive created by the potential revenues, resulting from the certification, changes the behaviour of operators in such a way that they engage in the additional carbon removal activity to achieve additional carbon removals.
Amendment 195 #
2022/0394(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) A standardised baseline should reflect the statutory and market conditions in which the carbon removal or carbon farming activity takes place. If a carbon removal activity is imposed upon operators by the applicable law, or it does not need any incentives to take place, its performance will be reflected in the baseline. For this reason, a carbon removal activity that generates carbon removals in excess of such a baseline should be presumed to be additional. Hence, the use of a standardised baseline should simplify the demonstration of additionality for operators. Therefore, it should reduce the administrative burden of the certification process, which is particularly important in the case of small- scale land managers.
Amendment 200 #
2022/0394(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Atmospheric and biogenic carbon that is captured and stored through a carbon removal activity risks being released back into the atmosphere (e.g. reversal) due to natural or anthropogenic causes. Therefore, operators should take all relevant preventive measures to mitigate those risks and duly monitor that carbon continues to be stored over the monitoring period laid down for the relevant carbon removal activity. The validity of the certified carbon removals should depend on the expected duration of the storage and the different risks of reversal associated with the given carbon removal activity. Among other possibilities, activities that store carbon in geological formations provide enough certainties on the very long-term duration of several centuries for the stored carbon and can be considered as providing permanent storage of carbon. Carbon farming or carbon storage in products are more exposed to the risk of voluntary or involuntary release of carbon into the atmosphere. To account for this risk, the validity of the certified carbon removals generated by carbon farming and carbon storage in products should not be subject to an expiry date matching with the end of the relevant monitoring period. Thereafter, thebut should be further defined per carbon farming activity in the certification methodology. The risk of reversibility of carbon storage should be assumed to be released into the atmosphere, unless the economic operator proves the maintenance of the carbon stoccounted for in the discount rate set for the carbon farming activity. Moreover, in order not to discourage sequestration actions, which in the short term can account for significant amounts of carbon, short- term storage should be encouraged to stimulate farmers' transition and investments in sequestration practices. Various mechanisms exist to integragte through uninterrupted monitoring activitieshort-term storage into the carbon market and the associated risk which should be deployed such as reserve funds, insurance, rebate systems.
Amendment 217 #
2022/0394(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Carbon removal activities have a strong potential to deliver win-win solutions for sustainability, even if trade- offs cannot be excluded. Therefore, it is appropriate to establish minimum sustainability requirements to ensure that carbon removal activities have a neutral impact or generate co-benefits for the sustainability objectives of climate change mitigation and adaptation, the protection and restoration of biodiversity and ecosystems, the sustainable use and protection of water and marine resources, the transition to a circular economy, and pollution prevention and control. Those sustainability requirements should, as appropriate, and taking into consideration local conditions, build on the technical screening criteria for Do Not Significant Harm concerning forestry activities and underground permanent geological storage of CO2, laid down in Commission Delegated Regulation (EU) 2021/213928 , and on the sustainability criteria for forest and agriculture biomass raw material laid down in Article 29 of Dire. Carbon farming activities should contribute to at least one additional practivce (EU) 2018/2001 of the European Parliament and of the Council29 . Practices, such as forest monocultures, that produce harmful effects forset out, such as prevention and improvement of water quality, protection of biodiversity shouland not be eligible for certificationhers. __________________ 28 Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives (OJ L 442, 9.12.2021, p. 1). 29 Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82).
Amendment 226 #
2022/0394(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Farming practices that remove CO2 from the atmosphere contribute to the climate neutrality objective and should be rewarded, either via the Common Agricultural Policy (CAP) or other public or private initiatives. Specifically, this Regulation should take into account farming practices as referenced in the Communication on Sustainable Carbon Cycles30 . __________________ 30 Communication from the Commission, Sustainable Carbon Cycles, COM (20221) 800.
Amendment 236 #
2022/0394(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Operators or groups of operators may report co-benefits that contribute to the sustainability objectives beyond the minimum sustainability requirements. To this end, their reporting should comply with the certification methodologies tailored to the different carbon removal activities, developed by the Commission. Certification methodologies should, as much as possible, incentivise the generation of co-benefits for biodiversity going beyond the minimum sustainability requirements. These additional co-benefits will give more economic value to the certified carbon removals and will result in higher revenues for the operators. In the light of these considerations, it is appropriate for the Commission to prioritise the development of tailored certification methodologies on carbon farming activities that provide significant co-benefits for biodiversity.
Amendment 244 #
2022/0394(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) It is appropriate to develop detailed certification methodologies for the different carbon removal and carbon farming activities in order to apply, in a standardised, verifiable and comparable way, the quality criteria laid down in this Regulation. Those methodologies should ensure the robust and transparent certification of the net carbon removal benefit generated by the carbon removal activity, while avoiding disproportionate administrative burden for operators or group of operators, in particular for small farmers and forest holders. To this end, the Commission should be empowered to supplement this Regulation by adopting delegated acts establishing detailed certification methodologies for the different carbon removal activities. Those methodologies should be developed in close consultation with the Expert Group on Carbon Removals and all other interested actors. They need to be based on the best available scientific evidence, build upon existing public and private schemes and methodologies for carbon removal certification, and take into account any relevant standard and rules adopted at national and Union level. The development of these methodologies should include a call for evidence supporting the drafting of the methodologies and a call for feedback on the draft methodologies, providing all interested stakeholders the possibility to contribute.
Amendment 251 #
2022/0394(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to ensure a credible and reliable certification process, carbon removal and carbon farming activities should be subject to independent third- party auditing. In particular, carbon removal and carbon farming activities should be subject to an initial certification audit before their implementation, verifying their compliance with the quality criteria set out in this Regulation, including the correct quantification of the expected net carbon removal benefit. Carbon removal and carbon farming activities should also be subject to periodic re- certification audits to verify the compliance of the generated carbon removals. To this end, the Commission should be empowered to adopt implementing acts to set out the structure, technical details, maximum prices for certification audit, and the minimum information to be contained in the description of the carbon removal activity, and in the certification and re- certification audit reports.
Amendment 266 #
2022/0394(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) It is appropriate that carbon removal and carbon farming certificates underpin different end- uses, such as the compilation of national and corporate greenhouse gas inventories, including with regard to Regulation (EU) 2018/841 of the European Parliament and of the Council31 , the proof of climate- related and other environmental corporate claims (including on biodiversity), or the exchange of verified carbon removal units through voluntary carbon offsetting markets. To this end, the certificate should contain accurate and transparent information on the carbon removal activity, including the total removals and net carbon removal benefit and, in the case of carbon farming, biogenic emissions reduction, that comply with the quality criteria set out in this Regulation. The Commission should be also empowered to adopt delegated acts to further specify or amend Annex II which lists the minimum information to be contained in the certificates. __________________ 31 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1).
Amendment 272 #
2022/0394(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) To ensure an accurate, robust and transparent verification, certification bodies responsible for performing the certification of carbon removal activities should have the required competences and skills and should be accredited by national accreditation authorities pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council32 . For the purposes of carbon farming, these national accreditation authorities should be national paying agencies. To avoid possible conflicts of interest, the certification bodies should also be completely independent from the operator carrying out the carbon removal activity that is subject to the certification. In addition, Member States should contribute towards ensuring the correct implementation of the certification process by supervising the operation of certification bodies that are accredited by national accreditation authorities, and by informing the certification schemes about relevant non-conformity findings. __________________ 32 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
Amendment 318 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. The objective of this Regulation is to facilitate the deployment of carbon removals and carbon farming by operators or groups of operators. To that end, this Regulation establishes a voluntary Union framework for the certification of carbon removals by laying down:and carbon farming by laying down: (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
Amendment 347 #
2022/0394(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This voluntary Union framework for the certification of carbon removals and carbon farming does not apply to emissions falling within the scope of Directive 2003/87/EC, with the exception of the storage of carbon dioxide emissions from sustainable biomass that are zero- rated in accordance with Annex IV thereto.
Amendment 380 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
Amendment 395 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘monitoring period’ means a period, the duration of which is determined in accordance to the type of carbon removal or carbon farming activity, over which the storage of carbon is monitored by the operator;
Amendment 435 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point i
Article 2 – paragraph 1 – point i
(i) ‘carbon storage in products’ means a carbon removal or carbon farming activity that stores atmospheric and biogenic carbon in long- lasting products or materials;
Amendment 439 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point k
Article 2 – paragraph 1 – point k
(k) ‘certification scheme’ means a schemen initiative, composed of set of commitments, managed by a private or public organisation that oversees the certification of compliance of operators or group of operators with this Regulation;
Amendment 449 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o
Article 2 – paragraph 1 – point o
(o) ‘carbon removal unit’ means one tonne of certified net carbon removal benefit generated by a carbon removal or carbon farming activity and registered by a certification scheme.
Amendment 450 #
2022/0394(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o a (new)
Article 2 – paragraph 1 – point o a (new)
(oa) “biogenic emission reduction unit” means one tonne of CO2 or CO2 equivalent certified GHG emission reduction generated by carbon farming activity and registered by a certification scheme.
Amendment 534 #
2022/0394(COD)
Proposal for a regulation
Article 4 – paragraph 6
Article 4 – paragraph 6
6. By way of derogation from paragraph 5, where duly justified, tThe baseline may be based on the individual carbon removal performance of that activity.
Amendment 761 #
2022/0394(COD)
Proposal for a regulation
Article 9 – paragraph 5
Article 9 – paragraph 5
5. The Commission may adopt implementing acts to set out the structure, format, technical details of the comprehensive description of the carbon removal or carbon farming activity referred to in paragraph 1, and of the certification and re-certification audit reports referred to in paragraphs 2 and 3, as well as maximum price for certification audit set in relation to total net carbon removal benefit of operator or group of operators. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
Amendment 887 #
2022/0394(COD)
Proposal for a regulation
Annex I – paragraph 1 – point k a (new)
Annex I – paragraph 1 – point k a (new)
(ka) standard setting for the price point of emission offsets.
Amendment 181 #
2022/0365(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) This Regulation shall not apply to exhaust emissions from passenger cars and vans. These emissions shall continue to be regulated, and the provisions under Regulation (EC) No 715/2007 of the European Parliament and of the Council on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 6) and on access to vehicle repair and maintenance information shall apply. The requirements for the type approval procedures for light passenger vehicles and light commercial vehicles, as well as the test methodology, including the boundary conditions for testing, should remain those currently laid down in Regulation No 715/2007 of the European Parliament and of the Council on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 6) and on access to vehicle repair and maintenance information.
Amendment 182 #
2022/0365(COD)
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
Amendment 193 #
2022/0365(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The technical requirements for the type-approval of motor vehicles, engines and replacement parts with regard to emissions (‘emission type-approval’) are currently set out in two Regulations that apply to emission type-approval for light- duty and heavy-duty vehicles respectively, i.e. Regulation (EC) No 715/2007 of the European Parliament and of the Council (‘Euro 6’)44 and Regulation (EC) No 595/2009 of the European Parliament and of the Council (‘Euro VI’)45 . The reason for having two Regulations was that the emissions of heavy-duty vehicles were checked based on engine testing, while for light-duty vehicles the basis was whole vehicle testing. Since then, methodologies have been developed that allow testing of both light- and heavy-duty vehicles on the road. It is therefore no longer necessary to base type-approval on engine testing. _________________ 44 Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1). 45 Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (OJ L 188, 18.7.2009, p. 1).
Amendment 200 #
2022/0365(COD)
Proposal for a regulation
Recital 5
Recital 5
Amendment 206 #
2022/0365(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Furthermore, the current emission limits were adopted in 2007 for light-duty vehicles and for heavy-duty vehicles in 2009. Both emission limits were adopted on the basis of the then available technology. Since then, technology has advanced and the level of emissions achieved with a combination of current technologies is much lower than that achieved more than 15 years ago. That technological progress should be reflected in emission limits based on state-of-the- art existing technology and knowledge of pollution controls and for all relevant pollutants.
Amendment 213 #
2022/0365(COD)
Proposal for a regulation
Recital 7
Recital 7
Amendment 224 #
2022/0365(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In order to ensure that the emissions for both light and heavy duty vehicles are limited in real life, testing vehicles in real conditions of use with a minimumover a statistically relevant non-biased set of restrictions, boundaries and other driving requirements and not only in the laboratory is required.
Amendment 231 #
2022/0365(COD)
Proposal for a regulation
Recital 9
Recital 9
Amendment 271 #
2022/0365(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Sensors and other complex devices installed on vehicles are already used today to detect anomalies on emissions and trigge, store information and trigger the need for related repairs through the on-board diagnostic (OBD) system. The OBD system currently in use, however, does not detect accurately or timely the malfunctions and neither does it sufficiently and timely force repairs. As a result, it is possible that vehicles emit much more than they are allowed to do. The sensors used up to now for OBD can also be used to monitor and control the emission behaviour of the vehicles on a continuous basis via an on-board monitoring (OBM) system. The OBM will also warn the user to perform repairs of the engine or the pollution control systems when these are needed. It is therefore appropriate to require that such a system is installed and to regulate its technical requirements and the dashboard malfunction indicator (MI). Some sensors used up to now for OBD can also be used to monitor and control the emission behaviour of the vehicles and may help improve the functionality of OBD.
Amendment 278 #
2022/0365(COD)
Proposal for a regulation
Recital 17
Recital 17
Amendment 288 #
2022/0365(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) In case the CommissionThe decarbonisation of the transport sector requires a technologically open framework. The Commission should thus deliver on its promise to makes a proposal for registering after 2035 new light-dutynew vehicles running exclusively on CO2 neutral fuels outside the scope of the CO2 fleet standards, and in conformity with Union law and the Union’´s climate neutrality objective, t. This Regulation will need to be amended to include the possibility to type approve such vehiclesshould introduce the possibility for manufacturers to designate vehicles equipped with internal combustion engines running on CO2 neutral fuels, either exclusively or as a blend. For the purpose of the CO2 fleet standards for light and heavy duty vehicles, the CO2 tailpipe emissions from vehicles running exclusively on CO2 neutral fuels should be considered zero.
Amendment 289 #
2022/0365(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) In case the CommissionAny Regulation in the transport sector requires a technologically open framework. The Commission should thus deliver on its promise to makes a proposal for registering after 2035 new light-duty vehicles running exclusively on CO2 neutral fuels outside the scope of the CO2 fleet standards, and in conformity with Union law and the Union’s climate neutrality objective, this Regulation will need to be amended to include the possibility to type approve such vehiclesshould introduce the possibility for manufacturers to designate vehicles equipped with internal combustion engines running exclusively on CO2 neutral fuels. For the purpose of the CO2 fleet standards for light and heavy duty vehicles, the CO2 tailpipe emissions from these vehicles should be considered zero.
Amendment 295 #
2022/0365(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) This Regulation should provide for the type approval of new light and heavy duty vehicles that operate solely on CO2 neutral fuels, including synthetic fuels, outside the scope of the CO2 fleet standards. A specific vehicle category for its type approval should be established. Such vehicles using the internal combustion engine should be eligible for registration, even beyond 2035, in order to allow for strictly technologically neutral approach.
Amendment 296 #
2022/0365(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) Scientific and technological findings prove the sustainability of climate-friendly, CO2-neutral fuels. In order to ensure that no fossil fuels are used in vehicles powered by these fuels, the Commission should work out requirements and rules, in cooperation with manufacturers and suppliers, to find technical solutions (e.g. sensors in fuel tank) that are practical, affordable and suitable for the masses.
Amendment 301 #
2022/0365(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Emissions from vehicles sold by small volume manufacturers constitute an insignificant part of emissions in the Union. Some fFlexibility mayshould therefore be allowed in some of the requirements for such manufacturers. Small volume manufacturers should therefore be able to substitute certain tests during type- approval with declarations of compliance, while ultra-small volume manufacturers should be allowed to use laboratory tests based on random real-driving cycles in relation to what is also demanded through the CO2 regulations by delaying the application of Euro 7 until 2035.
Amendment 307 #
2022/0365(COD)
(21) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to obligations of manufacturers as part of type-approval and procedures, test and methodologies to be applied for declaration of conformity, conformity of production check, in-service conformity-check and environmental vehicle passport (EVP); options and designations of vehicles; requirements, tests, methods and corrective measures related to durability of vehicles, systems, components and separate technical units, as well as registration and communication capabilities of OBM systems, including for the purpose of periodic technical inspections and roadworthiness checks; requirements and information to be provided by manufacturers of multistage vehicles as well as procedures to determine the CO2 value for these multistage vehicles; technical elements, administrative and documentation requirements for emission type-approval, checks and inspections and market surveillance checks, as well as reporting obligations, in-service conformity and conformity of production checks; methods and tests to (i) measure exhaust emissions in the lab and on the road, including random and worst-casebut statistically relevant RDE test cycles, the use of portable emissions measurement systems for verifying real driving emissions, and idle emissions, (ii) determine the CO2 emissions, fuel and energy consumption, the electric range and engine power of a motor vehicle, (iii) provide specifications for gear shift indicator (GSI) (iv) determine the impact of O3, O4 trailers on the CO2 , fuel and energy consumption, electric range and engine power of a motor vehicle, (iv) measure crankcase emissions, evaporative emissions, and brake emissions, in full accordance with UN WFHVR (v) evaluate compliance with minimum performance requirements of battery durability in full accordance with UN WFHVR , (vi) assess the in-service conformity of engines and vehicles; compliance thresholds and performance requirements, as well as (vii) test and methods to ensure performanceroper functioning of sensors (for OBD and OBM); (viii) methods to ensure and assess security measures; specification and characteristics of driver warning systems and inducement methods and to assess their correct operation; (ix) methods to assess the correct operation, effectiveness, regeneration and durability of original and replacement pollution control systems; (x) methods to ensure and assess security measures including vulnerability analysis and tampering protection; (xi) methods to assess the correct functioning of types approved under specific EURO7 designations; (xii) criteria for emission type- approvals for small and ultra-small volume manufacturers; (xiii) checks and test procedures for multistage vehicles; (xiv) performance requirements for test equipment; (xv) specification of reference fuels; and (xvi) methods for assessing the absence of defeat devices and defeat strategies; (xvii) to measure tyre abrasion, as well as (xviii) EVP format, data and method of communication of the EVP data. in full accordance with UN WFHVR.Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council50 . The Commission should adopt the acts provided in this paragraph no later than one year from the date of entry in force of this Regulation or of the UN WFHVR. _________________ 50 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 323 #
2022/0365(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) It is important to grant Member States, national type-approval authorities and economic operators enough time to prepare for the application of the new rules introduced by this Regulation. The date of application should therefore be deferred. While for light duty vehicles the date of application should be as soon as technically possible, for heavy duty vehicles and trailers the date of application may be further delayed by two years, since the transition to zero-emission vehicles will be longer for heavy duty vehicles until the implementing and delegated acts have been subsequently delivered and adopted by the Commission and by granting four years lead time from then.
Amendment 332 #
2022/0365(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation exclusively establishes common technical requirements and administrative provisions for the emission type-approval and market surveillance of motor vehicles, systems, components and separate technical units, with regard to their CO2 and pollutant emissions, fuel and energy consumption and battery durabilitynon-exhaust emissions and other pollutants, such as particulates from vehicles’ tyres and brakes.
Amendment 335 #
2022/0365(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes common technical requirements and administrative provisions for the emission type-approval and market surveillance of motor vehicles, systems, components and separate technical units, with regard to their CO2 andnon- exhaust pollutant emissions, fuel and energy consumption and battery durability.
Amendment 337 #
2022/0365(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation lays down rules for the initial emission type approval, conformity of production, in-service conformity, market surveillance, the durability of pollution control systems and traction batteries, on-boardshall not apply to exhaust emission rules for light passenger vehicles and light commercial vehicles. For these rules, Regulation No 715/2007 of the European Parliament and of the Council on type approval of monitoring systems, security provisions to limit tampering and cybersecurity measures, vehicles with respect to emissions from light passenger and commercial vehicles (Euro 6) and theon accurate determination of CO2 emissions, electric range, fuel and energy consumption and energy efficiencess to vehicle repair and maintenance information shall apply independently.
Amendment 338 #
2022/0365(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation lays down rules for the initial emission type approval, conformity of production, in-service conformity, market surveillance, the durability of pollution control systems and traction batteries, on- board monitoring systems, security provisions to limit tampering and cybersecurity measures, and the accurate determination of CO2 emissions, electric range, fuel and energy consumption and energy efficiency.
Amendment 342 #
2022/0365(COD)
Proposal for a regulation
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2a. This Regulation shall not apply to the requirements for the type approval procedures for light passenger vehicles, light commercial vehicles, motor vehicles and engines with regard to emissions from heavy goods vehicles and buses, as well as the test methodology, including boundary conditions for testing. For these rules, Regulation No 715/2007 of the European Parliament and of the Council on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 6) and on access to vehicle repair and maintenance information and Regulation No 595/2009 of the European Parliament and of the Council on type approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information shall apply independently.
Amendment 356 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 7
Article 3 – paragraph 2 – point 7
(7) ‘exhaust emissions’ means the emission from the tailpipe of the motor vehicle or engine of all of the following: CO2, gaseous, solid, liquid compounds and crankcase emissions;
Amendment 384 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 37
Article 3 – paragraph 2 – point 37
(37) ‘on-board diagnostic system’ or ‘OBD’ means a system that can generate vehicle on-board diagnostic (OBD) information, as defined in Article 3, point 49, of Regulation (EU) 2018/858 and is capable of communicating that information via the OBD port and over the air;in the context of this Regulation, a system on-board the vehicle which has the capability of detecting malfunctions of the monitored emission control systems, identifying the likely area of a malfunction by means of fault codes stored in computer memory, and illumination of the Malfunction Indicator (MI) to notify the operator of the vehicle.
Amendment 392 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 38
Article 3 – paragraph 2 – point 38
(38) ‘on-board monitoring system’ or ‘OBM’ means a system on board a vehicle that is capable of detecting either emission exceedances or when a vehicle is in zero emission mode if applicable, and capable of indicatmonitoring emissions withing the occurrence of such exceedances by means of information stored in the vehicle,measurement tolerance and of communicating that information via the OBD port and over the air;
Amendment 393 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 38
Article 3 – paragraph 2 – point 38
(38) ‘on-board monitoring system’ or ‘OBM’ means a system on board a vehicle that is capable of detecting either emission exceedances or when a vehicle is in zero emission mode if applicable, and capable of indicating the occurrence of such exceedances by means of information stored in the vehicle, and of communicatof monitoring emissions under the consideration of OBM measurement tolerance and providing that information via the OBD port and over the air;
Amendment 410 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 42
Article 3 – paragraph 2 – point 42
(42) ‘real driving emissions’ or ‘RDE’ means the emissions of a vehicle under normal driving conditions and extended conditions as specified in Tables 1 and 2 of Annex III;maximum one of the extended conditions; RDE test shall be divided by the applicable conformity factor.
Amendment 416 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 42 a (new)
Article 3 – paragraph 2 – point 42 a (new)
(42a) In order to allow manufacturers to comply with the emission limits in the context of test procedures, the compliance criteria should be introduced by the Commission in two steps. During the first step, upon the request of the manufacturer, a temporary conformity factor should apply, while as a second step only the final conformity factor should be used. The final conformity factor should set during a transition period and include a margin expressing the additional measurement uncertainty. The Commission should continuously assess that conformity factor in light of technical progress and annually adjust it downwards on the basis of scientific evidence, the improved accuracy of the measuring procedure and technical progress. The conformity factor should be gradually lowered and cease to apply by 2035.
Amendment 417 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 44
Article 3 – paragraph 2 – point 44
(44) ‘tampering’ means the inactivation, or modification by the economic operators or independent operators, of the engine, vehiclepower train engine control units such as pollution control device and system, propulsion system, traction battery, odometer, OBFCM or OBD/OBM, including any software or other logical control elements of those systems and their data;for personal benefit.
Amendment 421 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 47 – introductory part
Article 3 – paragraph 2 – point 47 – introductory part
(47) ‘small volume manufacturer’ means a manufacturer of fewer than 10 000 new motor vehicles of category M1 or 22 000 new motor vehicles of category N1 or 5 000 new motor vehicles of category N2 or 5 000 new motor vehicles of category N3 or 2 000 new motor vehicles of category M2 or 2 000 new motor vehicles of category M3 registered in the Union perin the previous calendar year and which:
Amendment 426 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 48
Article 3 – paragraph 2 – point 48
(48) ‘ultra-small-volume manufacturer’ means a small volume manufacturer that produces fewer than 1 0500 new motor vehicles of category M1 or fewer than 1 01 500 new motor vehicles of category N1 or 1 500 new motor vehicles of category N2 or 1 500 new motor vehicles of category N3 or 500 new motor vehicles of category M2 or 500 new motor vehicles of category N1M3 registered in the Union in the previous calendar year;
Amendment 428 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 57 a (new)
Article 3 – paragraph 2 – point 57 a (new)
(57a) ‘ CO2 neutral fuel vehicle’ or ‘CNCEV’ means a light or heavy-duty vehicle equipped with a combustion engine running exclusively on CO2 neutral fuel, including synthetic fuels.
Amendment 456 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 71
Article 3 – paragraph 2 – point 71
Amendment 475 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 78 a (new)
Article 3 – paragraph 2 – point 78 a (new)
(78a) "CO2 neutral fuels" means fuel which produces no net-greenhouse gas emissions or carbon footprint; including biofuels, bioliquids, biomass fuels and renewable fuels of non-biological origin or recycled carbon fuels, including synthetic fuels.
Amendment 476 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 78 a (new)
Article 3 – paragraph 2 – point 78 a (new)
(78a) "CO2 neutral fuels" means renewable fuels as defined in Directive 2018/2001, including biofuels, bioliquids, biomass fuels and renewable fuels of non- biological origin or recycled carbon fuels.
Amendment 479 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 78 b (new)
Article 3 – paragraph 2 – point 78 b (new)
(78b) "carbon correction factor (CCF)" means a factor reflecting the CO2 intensity and share of CO2 neutral fuels;
Amendment 489 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Manufacturers shall design, construct and assemble vehicles to comply with this Regulation, including complying with the emission limits set out in Annex I under the testing conditions set out in Annex III and respecting the values declared in the certificate of conformity and in the type- approval documentation for the lifetime of the vehicle as set out in table 1 of Annex IV. These vehicles shall be designated as “Euro 7” vehicles.
Amendment 494 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Manufacturers shall design, construct and assemble vehicles to comply with this Regulation, including complying with the emission limits set out in Annex I aund respecting the values declared in the certificate of conformity and er the conditions set out in Annex III and respecting the type- approval documentation for the lifetime of the vehicle as set out in table 1 of Annex IV. These vehicles shall be designated as “Euro 7” vehicles.
Amendment 497 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1
Article 4 – paragraph 3 – subparagraph 1
When verifying compliance with the exhaust emission limits, where the testing is performed in maximum one of the extended driving conditions, the emissions shall be divided by the extended driving divider set out in Annex IIIthe relevant annexes in Regulation (EU) 2017/1151 and Regulation (EU) 582/2011. .
Amendment 506 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
Amendment 522 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point b
Article 4 – paragraph 6 – point b
(b) OBM systems capable of detectmonitoring emissions above the emission limits due to malfunctions, increased degradation or other situations that increase emissionswithin the measurement tolerance;
Amendment 524 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point b
Article 4 – paragraph 6 – point b
(b) OBM systems capable of detectmonitoring emissions above the emission limits due to malfunctions, increased degradation or other situations that increase emissionwithin the capability of OBM measurement tolerances;
Amendment 530 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point c
Article 4 – paragraph 6 – point c
(c) OBFCM device to monitor their real-world fuel and energy consumption and other relevant parameters such as payload/massintended for vehicle propulsion [MB1] and for vehicles of categories N2 and N3 which are needed to determine their real-world fuel and energy efficiency;
Amendment 532 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point d
Article 4 – paragraph 6 – point d
(d) SOHCE and SOCR monitors of the traction battery and emissionSOH monitors of tailpipe emission control systems;
Amendment 537 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point g
Article 4 – paragraph 6 – point g
(g) devices communicating vehicle generated data together with the approval number and type variant version used for compliance with this regulation and OBFCM data, for the purpose of periodic roadworthiness tests and technical roadside inspection over the air, and for the purposes of communicating with recharging infrastructure and stationary power systems capable of supporting smart and bidirectional charging functionalities.
Amendment 548 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 8
Article 4 – paragraph 8
8. The manufacturer shall take measures to prevent the possibility of exploiting vulnerabilities referred to in paragraph 7. When such a vulnerability is found, the manufacturer shall remove the vulnerability, by software update or any other appropriate means to the extent possible based on knowledge at the time of type approval.
Amendment 554 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 10
Article 4 – paragraph 10
Amendment 563 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 565 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 573 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 574 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 579 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 582 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
Amendment 592 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. Manufacturers may designate vehicles as "Euro 7CN vehicle" where those vehicles are equipped with internal combustion engines running on CO2 neutral fuels, as defined in Art. 3 (78a), either exclusively or as a blend. The tailpipe CO2 emissions from Euro 7CN vehicles running exclusively on CO2 neutral fuels are considered zero for the purpose of Regulation (EU) 2023/851 and [Revision of Regulation 2019/1242]. The tailpipe C02 emissions from Euro 7CN vehicles running on a blend of fossil and CO2 neutral fuels are calculated in accordance with the carbon correction factor, as defined in Art. 3 (78b), for the purpose of Regulation (EU) 2023/851 and [Revision of Regulation 2019/1242].
Amendment 593 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4a. Manufacturers may designate vehicles as "Euro 7CN vehicle" where those vehicles are equipped with internal combustion engines running on CO2 neutral fuels, as defined in Art. 3 (78a), either exclusively or as a blend. The tailpipe CO2 emissions from Euro 7CN vehicles running exclusively on CO2 neutral fuels are considered zero for the purpose of Regulation (EU) 2023/851 and [Revision of Regulation 2019/1242]. The tailpipe C02 emissions from Euro 7CN vehicles running on a blend of fossil and CO2 neutral fuels are calculated in accordance with the carbon correction factor, as defined in Art. 3 (78b), for the purpose of Regulation (EU) 2023/851 and [Revision of Regulation 2019/1242].
Amendment 609 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Manufacturers shall ensure that thes technological construction of the vehicles comply with the values regarding CO2 emissions, fuel and energy consumption and energy efficiency declared under the provisions of this Regulation for the lifetime of the vehicle as set out in Annex IV, Table 1 in case of standard use of this vehicles.
Amendment 613 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Manufacturers shall ensure that the functionality of OBFCM, OBD and OBM devices and anti- tampering measures installed in these vehicles comply with the provisions of this Regulationshall not be deactivated as long as the vehicle is in use.
Amendment 620 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – introductory part
Article 6 – paragraph 6 – introductory part
6. The OBM systems installed by the manufacturer in these vehicles shall be capable of all of the following:communicating via the OBD port, including for the purpose of roadworthiness tests and technical roadside inspections.
Amendment 623 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point a
Article 6 – paragraph 6 – point a
Amendment 626 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point a
Article 6 – paragraph 6 – point a
Amendment 628 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point b
Article 6 – paragraph 6 – point b
Amendment 629 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point b
Article 6 – paragraph 6 – point b
Amendment 637 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point c
Article 6 – paragraph 6 – point c
Amendment 650 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The OBFCM devices installed by the manufacturer in these vehicles shall be capable of communicating thelegally appropriate and necessary vehicle data they record via the OBD port and over the air.
Amendment 656 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. For vehicles, systems, components and separate technical units presenting a serious risk or non-compliance with the requirements laid down in this regulation, manufacturers shall immediatelybe instructed according to the process and timescales of implementing legislation to take the necessary corrective measures, including repairs or modifications of those vehicles, systems, components and separate technical units as appropriate, to ensure compliance with this regulation. Manufacturers or any other economic operator shall withdraw it from the market or recall it, as appropriate. The manufacturer shall immediately inform the type approval authority that granted the type-approval of the non-conformity with appropriate details.
Amendment 667 #
2022/0365(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The manufacturer shall provide the type-approval authority with a signed declaration of conformity as regards the RDE, CO2 ambient temperature correction, OBD, OBM, emission and battery durability, continuous or periodic regeneration, anti-tampering and crankcase requirements as specified in Annex V. The manufacturer shall provide to the type- approval authority a signed declaration of conformity on the use of adaptive controls and geofencing options when the manufacturer selects these options.
Amendment 675 #
2022/0365(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 681 #
2022/0365(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
Amendment 698 #
2022/0365(COD)
2. Ultra-small volume manufacturers shall complydemonstrate compliance with the emission limits set out in Annex I in laboratory tests based on random real-driving cycles for in-service conformity and market surveillance purposes.
Amendment 705 #
2022/0365(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
Amendment 707 #
2022/0365(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
Amendment 719 #
2022/0365(COD)
3. With effect from … [OP please insert the date = the date of entry into force of all implementing or delegated acts related to this Regulation], where a manufacturer so requests, the national approval authorities shall not refuse to grant EU emission type-approval or national emission type-approval for a new type of vehicle or engine, or prohibit the registration, sale or entry into service of a new vehicle complying with this regulation.
Amendment 724 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. With effect from 2 years after entry into force of this Regulation, national authorities shall, on grounds relating to CO2 and pollutant emissions, fuel and electric energy consumption or battery durability, in the case of new types of M1, N1 vehicles, refuse to grant EU emission type-approval or national emission type-approval which do not comply with this Regulation.
Amendment 727 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. With effect from 1 July 2025As from 4 years after the entry into force of all implementing or delegated acts mandated by this regulation for obtaining vehicle type approval , national authorities shall, in the case of new M1, N1 vehicles, refuse on grounds relating to CO2 and pollutant emissions, fuel and energy consumption or battery durability, to grant EC type approval or national type approval, in respect to new vehicle types which do not comply with this Regulation. As from 5 years after the entry into force of all implementing or delegated acts relevant to the vehicle category in question, national authorities shall, in the case of new M1, N1 vehicles which do not comply with this Regulation consider certificates of conformity to be no longer valid for the purposes of registration and shall, on grounds relating to CO2 and pollutant emissions, fuel and energy consumption or battery durability, prohibit the registration, sale or entry into service of such vehicles.
Amendment 741 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
Amendment 757 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Article 10 – paragraph 5 a (new)
5a. With effect from seven years after entry into force of this Regulation, national authorities shall, on grounds relating to CO2 and pollutant emissions, fuel and electric energy consumption or battery durability, in the case of new types of M1, N1 vehicle constructed by small volume manufacturers, refuse to grant EU emission type-approval or national emission type-approval which do not comply with this Regulation.
Amendment 768 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 6
Article 10 – paragraph 6
6. With effect from 1 July 20305, national authorities shall, in the case of new M1, N1 vehicles constructed by small volume manufacturers which do not comply with this Regulation consider certificates of conformity to be no longer valid for the purposes of registration and shall, on grounds relating to CO2 and pollutant emissions, fuel and energy consumption, energy efficiency or battery durability, prohibit the registration, sale or entry into service of such vehicles.
Amendment 779 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. With effect from 1 July 2025As of 5 years after the date of entry into force of the final implementing or delegated acts related to this Regulation, the sale or installation of a system, component or separate technical unit intended to be fitted on an M1, N1 vehicle approved under this Regulation, shall be prohibited if the system, component and separate technical unit is not of type approved in compliance with this Regulation.
Amendment 792 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. With effect from 1 July 2027As of 5 years after the date of entry into force of the final implementing or delegated acts related to this Regulation, the sale or installation of a system, component or separate technical unit intended to be fitted on an M2, M3, N2, N3 vehicle and new O3, O4 trailers approved under this Regulation, shall be prohibited if the system, component and separate technical unit is not type approved in compliance with this Regulation.
Amendment 861 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point a
Article 14 – paragraph 4 – subparagraph 1 – point a
(a) for vehicles under the scope of Regulation (EC) 715/2007, the methods to measure exhaust emissions in the lab and on the road, including random and worst-case RDE test cycles,measures against biased driving and misuse during RDE testing the use of portable emissions measurement systems for verifying real driving emissions, and idle emissions;
Amendment 865 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point a
Article 14 – paragraph 4 – subparagraph 1 – point a
(a) the methods to measure exhaust emissions in the lab and on the road, including random and worst-casemeasures to prevent biased driving during RDE test cyclesing, the use of portable emissions measurement systems for verifying real driving emissions, and idle emissions;
Amendment 874 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point b
Article 14 – paragraph 4 – subparagraph 1 – point b
(b) the methods to determine the CO2 emissions, fuel and energy consumption, zero-emission range, electric range and engine power of a motor vehicleor vehicles under the scope of Regulation (EC) 595/2009, to carry-over all laboratory and in-service conformity (ISC-PEMS) test procedures laid down in that Regulation and its subsequent amendments;
Amendment 897 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point j
Article 14 – paragraph 4 – subparagraph 1 – point j
(j) OBFCM device, OBD and OBM systems, including compliance thresholds, performance requirements and tests, methods to ensure performance of sensors and over the air communication of data recorded by these devices and systems;
Amendment 918 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point u
Article 14 – paragraph 4 – subparagraph 1 – point u
Amendment 930 #
2022/0365(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 933 #
2022/0365(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point a
Article 15 – paragraph 1 – point a
Amendment 937 #
2022/0365(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b
Article 15 – paragraph 1 – point b
Amendment 942 #
2022/0365(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point c
Article 15 – paragraph 1 – point c
Amendment 969 #
2022/0365(COD)
(ea) setting out requirements and rules, in cooperation with manufactures and suppliers, for technical devices in vehicles that recognize the exclusive use of CO2 neutral fuels in vehicles.
Amendment 1004 #
2022/0365(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
It shall apply as from 1 July 20254 years after the entry into force of all implementing or delegated acts mandated by this regulation for obtaining vehicle type approval, for M1, N1 vehicles and components and separate technical units for those vehicles and as from 1 July 20274 years after the entry into force of all implementing or delegated acts mandated by this regulation for obtaining vehicle type approval, for M2, M3, N2, N3 vehicles and components and separate technical units for those vehicles and O3, O4 trailers.
Amendment 1013 #
2022/0365(COD)
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
It shall apply from 1 July 20305 for M1, N1 vehicles constructed by small volume manufacturers. Notwithstanding paragraph 2, Article 11(3) shall apply from the entry into force of this regulation.
Amendment 1113 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 3 – Row 3
Annex I – Table 3 – Row 3
Euro 7 evaporative emission limits for petrol fuelled M1, N1 vehicles Pollutant emissions M1, N1 with maximum mass N1 with maximum mass up to 2650 kg equal or more than 2650 kg Refuelling emissions 0.05 g/L of fuel 0.05 g/L of fuel deleted
Amendment 313 #
2022/0347(COD)
Proposal for a directive
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Directive sets intermediate limit values, target values, average exposure reduction obligations, average exposure concentration objectives, critical levels, information thresholds, alert thresholds and long-term objectives (‘air quality standards’) to be met by the year 20340, and regularly reviewed thereafter in accordance with Article 3.
Amendment 344 #
2022/0347(COD)
Proposal for a directive
Article 3 – paragraph 2 – subparagraph 2
Article 3 – paragraph 2 – subparagraph 2
In order to achieve the objectives set in Article 1, the review shall assess whether this Directive needs to be revised with a view to ensuring alignment with the World Health Organization (WHO) Air Quality Guidelines and the latest scientific information.
Amendment 369 #
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) progress made in implementing other relevant Union legislation, in particular in the field of climate, transport and energy.
Amendment 373 #
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) a socio-economic cost-benefit analysis
Amendment 482 #
2022/0347(COD)
Proposal for a directive
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Member States shall endeavour to achieve and preserve the best ambient air quality and a high level of environmental and human health protection , in line with the air quality guidelines published by the WHO and below the assessment thresholds laid down in Annex II .
Amendment 493 #
2022/0347(COD)
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall ensure by taking all necessary measures not entailing disproportionate costs that the average exposure reduction obligations for PM2.5 and NO2 laid down in Section 5, Point B, of Annex I, are met throughout their territorial units at NUTS 1 level, where they exceed the average exposure concentration objectives set out in Section 5, Point C, of Annex I.
Amendment 529 #
2022/0347(COD)
Proposal for a directive
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
1. Where, in a given zone , conformity with the limit values for particulate matter (PM10 and PM2.5) or nitrogen dioxide cannot be achieved by the deadline specified in Table 1 of Section 1 of Annex I, because of site-specific dispersion characteristics, orographic boundary conditions, adverse climatic conditions or, transboundary contributions, socio- economic conditions or the need for disproportionate measures, a Member State may postpone - that deadline once by a maximum of 5 years for that particular zone , if the following conditions are met:
Amendment 556 #
2022/0347(COD)
Proposal for a directive
Article 19 – paragraph 1 – subparagraph 1
Article 19 – paragraph 1 – subparagraph 1
Where, in given zones the levels of pollutants in ambient air exceed any limit value , laid down in Section 1 of Annex I, , Member States shall establish air quality plans for those zones as soon as possible and no later than 2 years after the calendar year during which that exceedance of any limit value was recorded. Those air quality plans shall set out appropriate and proportionate measures to achieve the concerned limit value and to keep the exceedance period as short as possible, and in any case no longer than 3 years from the end of the calendar year in which the first exceedance was reported .
Amendment 769 #
2022/0347(COD)
Proposal for a directive
Annex I – Part 1 – paragraph 1
Annex I – Part 1 – paragraph 1
Table 1 – Limit values for the protection of human health to be attained by 1 January 20340
Amendment 135 #
2022/0216(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. When SoHOs qualify or are used in medicinal products regulated by EU legislations mentioned above, only the provisions of this Regulation related to donor protection should be applicable.The criteria that define when SoHOs or SOHO preparations becomareproducts regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In addition, this Regulation should apply without prejudice to Union legislation on genetically modified organisms. _________________ 19 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 20 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 21 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 22 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). 23 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
Amendment 137 #
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. Furthermore, if minimal processing is needed to restore applicability during a surgical procedure or the manipulation is done within a closed system, the Regulation should not apply as well. 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, 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 140 #
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 and (EU) No 536/2014, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, 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 151 #
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 result of the donation. This Regulation should therefore includeaddress 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 riske respective risk-classifications shall be defined in the respective guidelines.
Amendment 181 #
2022/0216(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, programmes 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 contribute 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 necessary to ensure that donors are not financially disadvantaged by their donation. Thus, compensation 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 198 #
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 and other relevant EU legislations. When SoHOs or SoHO preparations meet the criteria to be defined as a medicinal products or an advanced therapy medicinal product, the classification as medicinal product or as advanced therapy medicinal product should prevail. National authority 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. In case of doubt on the classification of a substance, product or activity as medicinal product, the Commission should consult the permanent panel composed of representatives of the European Medicine Agency and the SoHO Coordination Board (SCB) for advice and to implement the classification decision taken by the panel across all EU Member States.
Amendment 211 #
2022/0216(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. In case the standard treatment or control group is based on medcinal products, the studies are considered as clinical trials as defined and regulated by Regulation 536/2014. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation.
Amendment 225 #
2022/0216(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as ae of the means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the same level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 255 #
2022/0216(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Union. Member States are also urged to take steps to strongly encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 262 #
2022/0216(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) To ensure the capacity to better collect more plasma, Member States are encouraged to develop or strengthen their respective plasmapheresis programs. The Commission shall aid them through guidance and the exchange of best practices.
Amendment 275 #
2022/0216(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. In case a product could be classified both as SoHO or SoHO preparation and medicinal product, the classification as medicinal product should prevail.The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach, ensure high protection of public health, and facilitate SoHO innovation.
Amendment 285 #
2022/0216(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) The processing of personal data under this Regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council and in Regulation (EU) 2018/1725 of the European Parliament and of the Council . The Commission may also decide that information on SoHO donations are added to donors Electronic Health Records (EHRs).
Amendment 289 #
2022/0216(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should, once it is established, be granted within the framework of the European Health Data Space and otherwise be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 301 #
2022/0216(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to enable better access to health data in the interests of public health, Member States should entrust competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of such data. Furthermore, access to secondary data for reseach purposes should be made available via the European Health Data Space, once it is established.
Amendment 315 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) SoHO donor recruitment; except if the entity is not subject to further SoHO activites as listed in this paragraph.
Amendment 322 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. In cases of autologous use of SoHOs, with the exception of processes involving a substantial manipulation or application intended for a non- homologous use, where:
Amendment 327 #
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, on investigational medicinal products regulated by Regulation 536/2014, 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 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 336 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘substance of human origin’ (SoHO) means any substance collected from the human body in whatever manner, whether it contains cells or not and whether those cells are living or not. For the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU, medicinal products regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC and investigational medicinal products regulated by Regulation (EC) No 536/2014;
Amendment 365 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point b
Article 3 – paragraph 1 – point 12 – point b
(b) meets a pre-defined specification; and
Amendment 367 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c
Article 3 – paragraph 1 – point 12 – point c
(c) is intended for application to a recipient for a specific clinical indication or is intended for distribution for manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof; and
Amendment 369 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c a (new)
Article 3 – paragraph 1 – point 12 – point c a (new)
(c a) does not involve a substantial manipulation or is intended for a non- homologous application.
Amendment 379 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘processing’ means any operation involved in the handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging with the exception of activities requiring substantial manipulation;
Amendment 410 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘EU SoHO Platform’ means the digital platform established by the Commission to exchange information concerning SoHO activities which should be interoperable with existing and upcoming frameworks;
Amendment 442 #
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 lossexpenses and inconveniences associated with donation;
Amendment 504 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2 a (new)
Article 14 – paragraph 2 – subparagraph 2 a (new)
2 a.In deviation from paragraphs 1 and 2, the following procedure shall apply when a substance or product may possibly be considered a medicinal product: (a) The question shall automatically be referred to the EMA and the SCB and the full dossier shall be made available. (b) The EMA and the SCB shall establish a permanent panel for reviewing such questions.The panel shall, where relevant, also consult other authorities mentioned in paragraph 1, such as the Medical Devices Coordination Group. (c) The panel shall seek to reach an opinion by consensus.An opinion adopted by consensus shall be implemented by the competent authorities.If no consensus can be reached, the question shall be referred to the Commission for a decision in accordance with paragraph 4. The members of the panel shall be appointed by the EMA and the SCB based on their specific expertise, including for the EMA in particular expertise in the area of advanced therapy medicinal products. The EMA shall ensure the secretariat of the panel and collaborate with the SCB in maintaining the compendium.
Amendment 508 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State following the consultation referred to in paragraph 1, or on its own initiative, by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b), or in accordance with paragraph 2a (c).
Amendment 511 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40, or in the case of paragraph 2a, the EMA.
Amendment 514 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
Article 14 – paragraph 7 – subparagraph 1
The Commission may, by means of implementing acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3). The Commission may also lay down rules concerning the procedure referred to in paragraph 2a and the operation of the permanent panel in coherence with the specific provisions foreseen in Regulation (EC) 726/2004, Directive 2001/83/EC and Regulation (EU) 2017/745.
Amendment 596 #
2022/0216(COD)
Proposal for a regulation
Article 50 – paragraph 1
Article 50 – paragraph 1
1. SoHO establishments shall establish, maintain and update, as necessary, a quality management system achieving a high level of quality of SoHOs by followingtaking into account, in particular, the Good Practice Guidelines published by the EDQM and which are included in the technical guidelines referred to in Article 56(4), point (a), and Article 59(4), point (a).
Amendment 621 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point k
Article 53 – paragraph 1 – point k
(k) develop and implement a plan for monitoring the donor’s health after the donation in cases where the SoHO donations imply a significant risk to a donor as referred to in paragraph 3;
Amendment 636 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for lossexpenses and inconveniences related to their participation in donations, for example, through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit that ensures that allowances are financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.
Amendment 749 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. Member States shall make all reasonable efforts to promote public participation in SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. In so doing, they shall encourage the collection of SoHO with a strong public and non- profit sector involvement.
Amendment 785 #
2022/0216(COD)
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Article 62 a Public Service Obligation SoHO entities collecting or processing blood or blood components in a Member State are, within the limits of their responsibilities, obliged to ensure an appropriate and continuous supply of these SoHOs and SoHO preparations in that Member State in order to meet the needs of patients.
Amendment 807 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts, stakeholders and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, particularily the ones defining boardelines with other legislation, shall have an observer role.
Amendment 821 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point b a (new)
Article 68 – paragraph 1 – point b a (new)
(b a) participating in the permanent panel referred to in Article 14(2 a) and in the procedure referred to in that paragraph.
Amendment 511 #
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 such as parks, urban areas and urban areas covered by watercourse or water feature. 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. __________________ 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 583 #
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 is 2015–1-2017, as this was the three most recent years for which data was available at the time of the announcement of the Farm to Fork Strategy3 to take into account the achievements already made by European farmers. 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 620 #
2022/0196(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The EU Biodiversity Strategy for 2030 recognises the need for urgent action to protect biodiversity. There is evidence of a widespread reduction of species, in particular insects and pollinators, in the Union. Biodiversity loss is, amongst other factors, driven by the inappropriate use of plant protection products, while Member States actions under current Union policy instruments have not yet been able to stop this trend of biodiversity loss. It is therefore essential to ensure that plant protection products are used in such a way as to mitigate the risk of harmful effects of such products on wildlife, through a number of measures including training, inspection of application equipment in professional use and protection of the aquatic environment and sensitive areas.
Amendment 2177 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 6 – point b
Article 18 – paragraph 6 – point b
(b) if necessary for the protection of the general public and vulnerable groups, the obligation to display notices regarding use of plant protection products on the perimeter of the area to be treated, and any specific form such display is to take;
Amendment 2185 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 7
Article 18 – paragraph 7
7. AIf necessary for the protection of the general public and vulnerable groups, a professional user that has been granted a permit to use a plant protection product in a sensitive area shall display notices to that regard on the perimeter of the area to be treated in the form indicated in the permit.
Amendment 2188 #
2022/0196(COD)
Proposal for a regulation
Article 18 – paragraph 8
Article 18 – paragraph 8
Amendment 2753 #
2022/0196(COD)
Proposal for a regulation
Annex I – paragraph 1 – introductory part
Annex I – paragraph 1 – introductory part
This Regulation is the instrument used to achieve the pesticide reduction targets contained in the Farm to Fork Strategy by requiring each Member State to contribute to achieving by 2030 a 530 % Union-wide reduction of both the use and risk of chemical plant protection products (‘Union 2030 reduction target 1’) and the use of more hazardous plant protection products (‘Union 2030 reduction target 2’). This Regulation also regulates the contribution of each Member State to these Union targets. Each Member State contribution, set in the form of a national target, to Union 2030 reduction target 1 is referred to as a ‘national 2030 reduction target 1’, while a Member State contribution to Union 2030 reduction target 2 is referred to as a ‘national 2030 reduction target 2’. The methodology for calculating progress towards achieving these targets is set out below:
Amendment 190 #
Amendment 266 #
2022/0195(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Geo-political developments have further underlined the need to safeguard the resilience of food systems.62 Evidence shows that restoring agro-ecosystems has positive impacts on food productivity in the long-term, and that the restoration of nature acts as an insurance policy to ensure the EU’s long-term sustainability and resilience. Securing biodiversity and maintaining food production are intrinsically linked. Prime examples of such synergies are the sustainable management of fishing stocks for fisheries and the benefit of soil fertility and pollinators in agriculture. However, those synergies can only be optimised if food producers, such as farmers and fishers, are continuously involved and consulted in relation to the development of relevant measures. _________________ 62 Communication from the Commission to the European Parliament, the Council, the European, Economic and Social Committee and the Committee of the Regions, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final.
Amendment 295 #
2022/0195(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Directive 92/43/EEC aims to maintain and restore, at favourable conservation status, natural habitats and species of wild fauna and flora of Union interest. However, it does not set a deadline for achieving that goal. Similarly, Directive 2009/147/EC does not establish a deadline for theDirective 2009/147/EC aims to recovery of bird populations in the Union.
Amendment 297 #
2022/0195(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Deadlines should therefore be established for putting in place restoration measures within and beyond Natura 2000 sites, in order to gradually improve the condition of protected habitat types across the Union as well as to re-establish them until the favourable reference area needed to achieve favourable conservation status of those habitat types in the Union is reached. In order to give the necessary flexibility to Member States to put in place large scale restoration efforts, it is appropriate to group habitat types according to the ecosystem to which they belong and set the time-bound and quantified area-based targets for groups of habitat types. This will allow Member States to choose which habitats to restore first within the groupMember States should be further supported in taking measures to meet their obligations to improve the condition of protected habitat types across the Union to achieve favourable conservation status of those habitat types in the Union, as is their obligation under existing nature legislation such as Directive 92/43/EEC and Directive 2009/147/EC.
Amendment 309 #
2022/0195(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) In order to ensure that the restoration measures are efficient and that their results can be measured over time, it is essential that the areas that are subject to such restoration measures, with a view to improving the condition of habitats that fall within the scope of Annex I to Directive 92/43/EEC, to re-establish those habitats and to improve their connectivity, show a continuous improvement until good condition is reached. However, a continuous improvement should not be made legally binding, since Member States cannot always prevent there will be a year in which the conditions of habitats lowers, due to various natural circumstances.
Amendment 314 #
2022/0195(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) It is also essential that the areas that are subject to restoration measures with a view to improving the quality and quantity of the habitats of species that fall within the scope of Directive 92/43/EEC, as well as habitats of wild birds falling within the scope of Directive 2009/147/EC, show a continuous improvement to contribute to the achievement of a sufficient quantity and quality of the habitats of such species. However, a continuous improvement should not be made legally binding, since Member States cannot always prevent there will be a year in which the conditions of habitats lowers, due to various natural circumstances.
Amendment 331 #
2022/0195(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) It is important that Member States take measures with the aim to prevent that the areas covered by habitat types falling within the scope of this Regulation do not, deteriorate as compared to the current situation, considering the current restoration needs and the necessity not to further increase the restoration needs in the future. It is, however, appropriate to consider the possibility of force majeure, which may result in the deterioration of areas covered by those habitat types, as well as unavoidable habitat transformations which are directly caused by climate change, or as a result of a plan or project, or needs of overriding public interest, for which no less damaging alternative solutions are available, to be determined on a case by case basis, or of a plan or project authorised in accordance with Article 6(4) of Directive 92/43/EEC.
Amendment 399 #
2022/0195(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) Restoration measures need to be put in place to enhance the biodiversity of agricultural ecosystems across the Union, including in the areas not covered by habitat types that fall within the scope of Directive 92/43/EEC. In the absence of a common method for assessing the condition of agricultural ecosystems that would allow setting specific restoration targets for agricultural ecosystems, it is appropriate to set a general obligationupport Member States in taking measures to improve biodiversity in agricultural ecosystems and measure the fulfilment of that obligationprogress on the basis of existing indicators.
Amendment 539 #
2022/0195(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) the continuous, long-term and sustained recovery of biodiverse and, resilient natureand productive ecosystems across the Union’s land and sea areas through the restoration of ecosystems;
Amendment 546 #
2022/0195(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) achieving the Union’s overarching objectives concerning climate change mitigation and, climate change adaptation, energy security and food security, and moving towards a circular bio-economy;
Amendment 570 #
2022/0195(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation establishes a framework within which Member States shall put in place, without delay, effective and area-based restoration measures which together shall cover, by 2030, at least 20 % of habitats in bad condition of the Union’s land and sea areas and, by 2050, all ecosystems in need of restoration.
Amendment 581 #
2022/0195(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. This Regulation establishes a framework within which Member States shall put in place, without delay, effective and area-based restoration measures which together shallith the aim to jointly cover, by 2030, at least 20 % of the Union’s land and sea areas and, by 2050, all ecosystemhabitats in need of restoration.
Amendment 605 #
2022/0195(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘restoration’ means the process of actively or passively assisting the recovery of an ecosys habitat by taking measures that contributem towards or to good condition, of a habitat type to the highest level of condition attainable and to its favourable reference area and to its favourable reference area to meet a favourable status as defined in article 1(e) of Directive 92/43/EEC, of a habitat of a species to a sufficient quality and quantity, or of species populations to satisfactory levels, as a means of conserving or enhancing biodiversity and ecosystem resilience;
Amendment 622 #
2022/0195(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘good condition’ means a state where the key characteristics of an ecosystem, namely its physical, chemical, compositional, structural and functional state, and its landscape and seascape characteristics, reflect the high level of ecological integrity, stability and resilience necessary to ensure its long-term maintenance and delivery of a wide range of ecosystem services;
Amendment 637 #
2022/0195(COD)
(5) ‘favourable reference area’ means the total area of a habitat type in a given biogeographical region or marine region at national level that is considered the minimum necessary to ensure the long- term viability of the habitat type and its species, and all its significant ecological variations in its natural range, notably taking into account variations due to pressures of climate change, and which is composed of the area of the habitat type and, if that area is not sufficient, the area necessary for the re-establishment of the habitat type;
Amendment 644 #
2022/0195(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘sufficient quality of habitat’ means the quality of a habitat of a species which allows the ecological requirements of a species to be met at any stage of its biological cycle so that it is maintaining itself on a long-term basis as a viable component of its habitat in its natural range, while taking into account the proportionality of means to achieve this status, as well as possible trade-offs with competing species;
Amendment 654 #
2022/0195(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘sufficient quantity of habitat’ means the quantity of a habitat of a species which allows the ecological requirements of a species to be met at any stage of its biological cycle so that it is maintaining itself on a long-term basis as a viable component of its habitat in its dynamic natural range;
Amendment 704 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall put in place the restoration measures that are necessary to improve towards good condition areas of habitat types listed in Annex I which are not in good conditionunder existing designation within the Natura 2000 network and not in good condition, taking into account possible trade-offs due to the need to achieve a balanced provision of a wide variety of ecosystem services. Such measures shall be in place on at least 30 % of the area of each group of habitat types listed in Annex I that is not in good condition, as quantified in the national restoration plan referred to in Article 12, by 2030, on at least 60 % by 2040, and on at least 90 % by 2050.
Amendment 714 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall put in place the restoration measures that are necessary to improve to good condition areas of habitat types within the Natura 2000 areas listed in Annex I which are not in good condition. Such measures shall be in place on at least 30 % of the area of each group of habitat types within the Natura 2000 areas listed in Annex I that is not in good condition, as quantified in the national restoration plan referred to in Article 12, by 2030, on at least 60 % by 2040, and on at least 90 % by 2050.
Amendment 717 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall put in place the restoration measures that are necessary to improve to good condition areas of habitat types listed in Annex I which are not in good condition. Such measures shall be put in place on at least 30 % of the area of each group of habitat types listed in Annex I that is not in good condition, as quantified in the national restoration plan referred to in Article 12, by 2030, on at least 60 % by 2040, and on at least 90 % by 2050.
Amendment 728 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 735 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall put in place the restoration measures that are necessary to re-establish the habitat types listed in Annex I in areas not covered by those habitat types. Such measures shall be in place oin areas representing at least 30 % of the additional overall surface needed to reach the total favourable reference area of each group of habitat types listed in Annex I, as quantified in the national restoration plan referred to in Article 12, by 2030, at least 60 % of that surface by 2040, and 100 % of that surface by 2050.necessary to ensure fulfilment of the goals laid down in paragraph 1 of this Article;
Amendment 738 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall inside the Natura 2000 areas put in place the restoration measures that are necessary to re-establish the habitat types listed in Annex I in areas not covered by those habitat types. Such measures shall be in place on areas within the Natura 2000 areas representing at least 30 % of the additional overall surface needed to reach the total favourable reference area of each group of habitat types listed in Annex I, as quantified in the national restoration plan referred to in Article 12, by 2030, at least 60 % of that surface by 2040, and 100 % of that surface by 2050.
Amendment 743 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States shall, within Natura 2000 sites and other strictly protected areas, put in place the restoration measures for the terrestrial, coastal and freshwater habitats of the species listed in Annexes II, IV and V to Directive 92/43/EEC and of the terrestrial, coastal and freshwater habitats of wild birds covered by Directive 2009/147/EC that are necessary to improve the quality and quantity of those habitats, including by re-establishing them, and to enhance connectivity, until sufficient quality and quantity of those habitats is achieved. When designing the measures referred to in paragraphs 1, 2 and 3 of this Article, Member States shall, to the largest extent possible, plan the measures so as current and future economic activity in the areas can take place and spatial planning is not disproportionately hampered, in order to address current and future challenges such as climate change, food security, affordable housing and infrastructure development.
Amendment 749 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States shall put in place the restoration measures for the terrestrial, coastal and freshwater habitats of the species listed in Annexes II, IV and V to Directive 92/43/EEC and of the terrestrial, coastal and freshwater habitats of wild birds covered by Directive 2009/147/EC that are necessary to improve the quality and quantity of those habitats, within Natura 2000 sites and other strictly protected areas, including by re- establishing them, and to enhance connectivity, until sufficient quality and quantity of those habitats is achieved.
Amendment 758 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The determination of the most suitable areas for restoration measures in accordance with paragraphs 1, 2 and 3 of this Article shall be based on the best available knowledge and the latest scientific evidence of the condition of the habitat types listed in Annex I, measured by the structure and functions which are necessary for their long-term maintenance including their typical species, as referred to in Article 1(e) of Directive 92/43/EEC, and of the quality and quantity of the habitats of the species referred to in paragraph 3 of this Article. Areas where the habitat types listed in Annex I are in unknown condition shall be considered as not being in good conditionthe Member State concerned shall rectify that data gap in accordance with Article 11(1). When determining the most suitable areas referred to in paragraph 4, Member States shall take into account socio-economic aspects as well as ensuring that future spatial planning will not be disproportionately hampered. Member States shall also utilise the full potential of coordination and synergies of designating those areas within Natura 2000 sites and other strictly protected areas.
Amendment 769 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The determination of the most suitable areas for restoration measures in accordance with paragraphs 1, 2 and 3 of this Article shall be based on the best available knowledge and the latest scientific evidence of the condition of the habitat types listed in Annex I, measured by the structure and functions which are necessary for their long-term maintenance including their typical species, as referred to in Article 1(e) of Directive 92/43/EEC, and of the quality and quantity of the habitats of the species referred to in paragraph 3 of this Article. AFor areas where the habitat types listed in Annex I are in unknown condition shall be considered as not being in good condition, measures shall be taken to assess their condition and to identify if restoration measures are required.
Amendment 779 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. The restoration measures referred to in paragraphs 1 and 2 shall consider the need for improved connectivity between the habitat types listed in Annex I and take into account the ecological requirements of the species referred to in paragraph 3 that occur in those habitat types, as well as possible trade-offs between requirements of competing species and habitat types.
Amendment 787 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 6
Article 4 – paragraph 6
6. Member States shall ensure that the areas that are subject to restoration measures in accordance with paragraphs 1, 2 and 3 show a continuous improvement in the condition of the habitat types listed in Annex I untiltowards good condition is reached, and a continuous improvement of the quality of the habitats of the species referred to in paragraph 3, until the sufficient quality of those habitats is reached. Member States shall ensureput in place measures to prevent that areas in which good condition has been reached, and in which the sufficient quality of the habitats of the species has been reached, do not deteriorate, taking into account shifting climatic conditions and natural ranges due to ongoing climate change.
Amendment 799 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 7
Article 4 – paragraph 7
Amendment 803 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 7
Article 4 – paragraph 7
7. Member States shall ensure that areas where the habitat types listed in Annex I occur do not deterioratput in place measures to prevent that areas designated in the Natura 2000 network where the habitat types listed in Annex I occur do not deteriorate, taking into account shifting climatic conditions and natural ranges due to ongoing climate change.
Amendment 821 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 8
Article 4 – paragraph 8
Amendment 828 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 8 – introductory part
Article 4 – paragraph 8 – introductory part
8. Outside Natura 2000 sites, the non- fulfilment of the obligations set out in paragraphs 61, 2, 3 and 76 is justified if it is caused by:
Amendment 841 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 8 – point b
Article 4 – paragraph 8 – point b
(b) unavoidable habitat transformations which are directlyfor example caused by climate change, third countries, non-preventable pests and diseases, natural disasters; or
Amendment 883 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 9 – introductory part
Article 4 – paragraph 9 – introductory part
9. For Natura 2000 sites, the non- fulfilment of the obligations set out in paragraphs 61, 2, 3 and 76, is justified if it is caused by:
Amendment 902 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 9 – point b
Article 4 – paragraph 9 – point b
(b) unavoidable habitat transformations which are directlyfor example caused by climate change:, third countries, non-preventable pests and diseases, natural disasters; or
Amendment 904 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 9 – point b
Article 4 – paragraph 9 – point b
(b) unavoidable habitat transformations which are directly caused by climate change, including measures necessary for climate change adaptation: or
Amendment 932 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 10 – point a
Article 4 – paragraph 10 – point a
(a) an increase of habitat area in good condition for habitat types listed in Annex I until at least 90 % is in good condition and until the favourable reference area for each habitat type in each biogeographic region of their territory is reached, taking into account changes of natural range due to climate change;
Amendment 952 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall put in place the restoration measures that are necessary to improve to good condition areas of habitat types listed in Annex II which are not in good condition. Such measures shall be put in place on at least 30 % of the area of each group of habitat types listed in Annex II that is not in good condition, as quantified in the national restoration plan referred to in Article 12, by 2030, on at least 60 % by 2040, and on at least 90 % by 2050.
Amendment 974 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Member States shall put in place the restoration measures that are necessary to re-establish the habitat types listed in Annex II in areas not covered by those habitat types. Such measures shall be in place oin areas representing at least 30 % of the additional overall surface needed to reach the total favourable reference area of each group of habitat types, as quantified in the national restoration plan referred to in Article 12, by 2030, at least 60 % of that surface by 2040, and 100 % of that surface by 2050.necessary to ensure fulfilment of the goals laid down in paragraph 1 of this Article;
Amendment 986 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Member States shall, within Natura 2000 sites and other strictly protected areas, put in place the restoration measures for the marine habitats of species listed in Annex III and in Annexes II, IV and V to Directive 92/43/EEC and for the marine habitats of wild birds covered under Directive 2009/147/EC, that are necessary in order to improve the quality and quantity of those habitats, including by re- establishing them, and to enhance connectivity, until sufficient quality and quantity of those habitats is achieved. When designing the measures referred to in paragraphs 1, 2 and 3 of this Article, Member States shall, to the largest extent possible, plan the measures so that current and future economic activity in the areas can take place and spatial planning is not disproportionately hampered, in order to address current and future challenges such as climate change, food security, affordable housing and infrastructure development.
Amendment 993 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The determination of the most suitable areas for restoration measures in accordance with paragraphs 1, 2 and 3 shall be based on the best available knowledge and the latest scientific evidence of the condition of the habitat types listed in Annex II, measured by the structure and functions which are necessary for their long-term maintenance, including their typical species, referred to in Article 1(e) of Directive 92/43/EEC, and of the quality and quantity of the habitats of the species referred to in paragraph 3. Areas where the habitat types listed in Annex II are in unknown condition shall be considered as not being in good conditionthe Member State concerned shall rectify that data gap in accordance with Article 11(1). When determining the most suitable areas referred to in paragraph 4, Member States shall take into account socio-economic aspects as well as ensure that future spatial planning will not be disproportionately hampered. Member States shall also utilise the full potential of coordination and synergies of designating those areas within Natura 2000 sites and other strictly protected areas.
Amendment 1012 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Member States shall aim to ensure that the areas that are subject to restoration measures in accordance with paragraphs 1, 2 and 3 show a continuous improvement in the condition of the habitat types listed in Annex II until good condition is reached, and a continuous improvement of the quality of the habitats of the species referred to in paragraph 3 until the sufficient quality of those habitats is reached. Member States shall ensure that areas in which good condition has been reached and in which the sufficient quality of the habitats of the species has been reached do not deteriorattotal national area in good condition and the total amount of area with a sufficient quality of the habitats of the species referred to in paragraph 1, 2, and 3 do not decrease over time.
Amendment 1028 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
Amendment 1050 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 8 – introductory part
Article 5 – paragraph 8 – introductory part
8. Outside Natura 2000 sites, the non- fulfilment of the obligations set out in paragraphs 61, 2, 3 and 76 is justified if caused by:
Amendment 1062 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 8 – point b
Article 5 – paragraph 8 – point b
(b) unavoidable habitat transformations which are directlyfor example caused by climate change, third countries, non-preventable pests and diseases, natural disasters; or
Amendment 1071 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 8 – point c
Article 5 – paragraph 8 – point c
(c) a project of private or public overriding public interest for which no less damaging and beneficial social efficient alternative solutions are available, to be determas defined oin a case by case basis.the national restoration plan; or
Amendment 1098 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 9 – introductory part
Article 5 – paragraph 9 – introductory part
9. For Natura 2000 sites, the non- fulfilment of the obligation set out in paragraphs 61, 2, 3 and 76, is justified if caused by:
Amendment 1114 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 9 – point b
Article 5 – paragraph 9 – point b
(b) unavoidable habitat transformations which are directlyfor example caused by climate change:, third countries, non-preventable pests and diseases, natural disasters; or
Amendment 1134 #
2022/0195(COD)
Proposal for a regulation
Article 5 – paragraph 10
Article 5 – paragraph 10
Amendment 1168 #
2022/0195(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States shall ensure, in close cooperation with regional authorities, aim to prevent that there is noa net loss of urban green space, at national level, and of urban tree canopy cover by 2030, compared to 2021, in all cities and in towns and suburbs.
Amendment 1188 #
2022/0195(COD)
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. Member States shall ensure that , in close cooperation withe re is angional authorities, aim to increase in the total national area and quality of urban green space in cities and in towns and suburbs of at least 3 % of the total area ofand urban tree canopy cover in cities and ofin towns and suburbs in 2021, by 2040, and at least 5 % by 2050. In addition Member States shall ensuraim to increase:
Amendment 1193 #
2022/0195(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) a minimum of 10 %net gain of urban tree canopy cover in all cities and in towns and suburbs by 2050at national level; and
Amendment 1259 #
2022/0195(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States shall remove the barriers to longitudinal and lateral connectivity of surface waters identified under paragraph 1 of this Article, in accordance with the plan for their removal referred to in Article 12(2), point (f). When removing barriers, Member States shall primarily address obsolete barriers, which are those that are no longer needed for renewable energy generation, inland navigation, water supply or other uses.
Amendment 1288 #
2022/0195(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall by 2030 have put in place measures to reverse the decline of pollinator populations by 2030 and achieve thereafter an increasing trend of pollinator populations, measured every three years after 2030implementing the measures, until satisfactory levels are achieved, as set out in accordance with Article 11(3).
Amendment 1289 #
2022/0195(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Member States shall put in place measures to reverse the decline of pollinator populations by 2030 and to achieve thereafter an increasing trend of pollinator populations, measured every three years after 2030, until satisfactory levels are achieved, as set out in accordance with Article 11(3).
Amendment 1315 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall put in place the restoration measures necessary to enhance biodiversity in agricultural ecosystems, in addition to the areas that are subject to restoration measures under Article 4(1), (2) and (3), while duly taking into account effects on and trade-offs with food production, food security and food prices.
Amendment 1322 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – introductory part
Article 9 – paragraph 2 – introductory part
2. Member States shallestablish measures with the aim of achieveing an increasing trend at national level of each of the following indicators in agricultural ecosystems, as further specified in Annex IV, measured in the period from the date of entry into force of this Regulation until 31 December 2030, and every three years thereafter, until the satisfactory levels, identified in accordance with Article 11(3), are reached:
Amendment 1323 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – introductory part
Article 9 – paragraph 2 – introductory part
2. Member States shall put in place measures to achieve an increasing trend at national level of each of the following indicators in agricultural ecosystems, as further specified in Annex IV, measured in the period from the date of entry into force of this Regulation until 31 December 2030, and every three years thereafter, until the satisfactory levels, identified in accordance with Article 11(3), are reached:
Amendment 1358 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) share of agricultural landland in rural areas with high-diversity landscape features.
Amendment 1370 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. Member States shall put in place restoration measures to ensure thatachieve a positive trend in the common farmland bird index at national level based on the species specified in Annex V, indexed on … [OP please insert the date = the first day of the month following 12 months after the date of entry into force of this Regulation] = 100, reaches the following levels:.
Amendment 1374 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. Member States shall put in place restoration measures to ensurewith the aim that the common farmland bird index at national level based on the species specified in Annex V, indexed on … [OP please insert the date = the first day of the month following 12 months after the date of entry into force of this Regulation] = 100, reaches the following levels:
Amendment 1375 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point a
Article 9 – paragraph 3 – point a
Amendment 1381 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point b
Article 9 – paragraph 3 – point b
Amendment 1394 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – introductory part
Article 9 – paragraph 4 – subparagraph 1 – introductory part
For organic soils in agricultural use constituting drained peatlands, Member States shall put in place restoration measures. Those measures shall be in place on at least:, including where appropriate rewetting. Member States shall determine relevant areas based on best scientific knowledge and on a consultation of concerned stakeholders.
Amendment 1398 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – introductory part
Article 9 – paragraph 4 – subparagraph 1 – introductory part
For organic soils in agricultural use constituting drained peatlands, Member States shall put in place restoration measures, while ensuring synergies with agricultural production. Those measures shall be in place on at least:
Amendment 1406 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point a
Article 9 – paragraph 4 – subparagraph 1 – point a
Amendment 1422 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point b
Article 9 – paragraph 4 – subparagraph 1 – point b
Amendment 1441 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point c
Article 9 – paragraph 4 – subparagraph 1 – point c
Amendment 1462 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 3
Article 9 – paragraph 4 – subparagraph 3
In addition, Member States may put in place restoration measures to rewet organic soils that constitute drained peatlands under land uses other than agricultural use and peat extraction and count those rewetted areas as contributing, up to a maximum of 20%, to the achievement of the targets referred to in the first subparagraph, points (a), (b) and (c).
Amendment 1468 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
4a. the non-fulfilment of the obligations set out in this article is justified if it is caused by: (a) force majeure; (b) unavoidable habitat transformations which are for example caused by climate change, third countries, non-preventable pests and diseases; or (c) a project of overriding public interest, including those of a social or economic nature, for which no less damaging alternative solutions are available.
Amendment 1479 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Member States shall put in place the restoration measures necessary to enhance biodiversity of forestimprove the long-term resilience of forest ecosystems, their biodiversity and provision of a wide range of ecosystem services, in addition to the areas that are subject to restoration measures pursuant to Article 4(1), (2) and (3).
Amendment 1491 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – introductory part
Article 10 – paragraph 2 – introductory part
2. Member States shall achieve an increasing trend at national level of each of the following indicators in forest ecosystems, as further set out in Annex VI, that are locally relevant to assess the long-term resilience and based on best available scientific knowledge, measured in the period from the date of entry into force of this Regulation until 31 December 2030, and every three years thereafter, until the satisfactory levels identified in accordance with Article 11(3) are reached:.
Amendment 1501 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point a
Article 10 – paragraph 2 – point a
Amendment 1507 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
Amendment 1515 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point c
Article 10 – paragraph 2 – point c
Amendment 1521 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point d
Article 10 – paragraph 2 – point d
Amendment 1531 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point e
Article 10 – paragraph 2 – point e
Amendment 1539 #
2022/0195(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point f
Article 10 – paragraph 2 – point f
Amendment 1588 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall prepare national restoration plans and carry out the preparatory monitoring and, research needed and due consultation of all relevant stakeholders to identify the restoration measures that are necessary and achievable by appropriate means to meet the targets and obligations set out in Articles 4 to 10, taking into account the latest scientific evidence.
Amendment 1610 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 2 – point a – point iii
Article 11 – paragraph 2 – point a – point iii
(iii) the favourable reference area taking into account the documented losses over at least the last 70 years and scientifically justified period of time, the projected changes to environmental conditions due to climate change;
Amendment 1622 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 2 – point a – point iv
Article 11 – paragraph 2 – point a – point iv
(iv) the areas most suitable for the re- establishment of habitat types in view of ongoing and projected changes to environmental conditions due to climate change and considering the long-term balance of the provision of a locally relevant range of ecosystem services ;
Amendment 1628 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 2 – point b
Article 11 – paragraph 2 – point b
(b) the sufficient quality and quantity of the habitats of the species required for achieving their favourable conservation status, taking into account the areas most suitable for re-establishment of those habitats, and the connectivity needed between habitats in order for the species populations to thrive, as well as ongoing and projected changes to environmental conditions due to climate change and possible trade-offs with regard to requirements of competing species and habitat types.
Amendment 1655 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Member States shall set, by 2030 at the latest, satisfactory levels for each of the indicators referred to in Articles 8(1), 9(2) and 10(2), through an open and effective process and assessment, based on the latest scientific evidence, consultation of relevant stakeholders and, if available, the framework referred to in Article 17(9).
Amendment 1669 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Member States shall put in place methodology and guidelines to identify and map the agricultural and forest areas in need of restoration, in particular the areas that, due to intensification or other management factors, are in need of enhanced connectivity and landscape diversity.
Amendment 1673 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 5 – introductory part
Article 11 – paragraph 5 – introductory part
5. Member States shall identify synergies and trade-offs with climate change mitigation, climate change adaptation and disaster prevention, disaster prevention and other socio-economic ecosystem services, notably food production and other productive functions contributing to the circular bio-economy, and prioritise restoration measures accordingly. Member States shall also take into account:
Amendment 1674 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 5 – introductory part
Article 11 – paragraph 5 – introductory part
5. Member States shall identify synergies and potential conflicts with food production and ensuring food security, as well as synergies and potential conflicts with climate change mitigation, climate change adaptation and disaster prevention and prioritise restoration measures accordingly. Member States shall also take into account:
Amendment 1684 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 5 – point c a (new)
Article 11 – paragraph 5 – point c a (new)
(ca) bio-economy and circular economy strategies on EU and national level.
Amendment 1718 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 7 – point g a (new)
Article 11 – paragraph 7 – point g a (new)
(ga) national forest programmes or national forest strategies.
Amendment 1735 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 8
Article 11 – paragraph 8
8. Member States shall, when preparing the national restoration plans, make use ofconsider the different examples of restoration measures listed in Annex VII, depending on specific national and local conditions, and the latest scientific evidence.
Amendment 1742 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 9
Article 11 – paragraph 9
9. Member States shall, when preparing the national restoration plans, aim at optimising the ecological, economic and social functions of ecosystems, while fully respecting ownership rights, as well as their contribution to the sustainable development of the relevant regions and communities.
Amendment 1761 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 11
Article 11 – paragraph 11
11. Member States shall ensure that the preparation of the restoration plan is open, inclusive and effective, that affected stakeholders are consulted from an early stage throughout the process and that the public is given early and effective opportunities to participate in its elaboration. Consultations shall comply with the requirements set out in Articles 4 to 10 of Directive 2001/42/EC.
Amendment 1800 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
(c) an indication of the measures to ensurehat aim to prevent that the areas covered by the habitat types listed in Annexes I and II do not deteriorate in the areas in which good condition has been reached and that an indication of the measures aim to prevent that the habitats of the species referred to in Articles 4(3) and 5(3) do not deteriorate in the areas in which the sufficient quality of the habitats of the species has been reached, in accordance with Articles 4(6) and 5(6);
Amendment 1803 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point c
Article 12 – paragraph 2 – point c
(c) an indication of the measures to ensureprevent that the areas covered by the habitat types listed in Annexes I and II do not deteriorate in the areas in which good condition has been reached and that the habitats of the species referred to in Articles 4(3) and 5(3) do not deteriorate in the areas in which the sufficient quality of the habitats of the species has been reached, in accordance with Articles 4(6) and 5(6);
Amendment 1808 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
(d) an indication of the measures to ensureprevent that the areas covered by habitat types listed in Annexes I and II do not deteriorate, in accordance with Article 4(7) and Article 5(7);
Amendment 1809 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point d
Article 12 – paragraph 2 – point d
(d) an indication of the measures to ensurehat aim to prevent that the areas covered by habitat types listed in Annexes I and II do not deteriorate, in accordance with Article 4(7) and Article 5(7) on a national level;
Amendment 1828 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point j
Article 12 – paragraph 2 – point j
(j) the estimated co-benefits for or trade-offs with climate change mitigation and relevant ecosystem services, notably food production and other ecosystem services contributing to a circular bio- economy, associated with the restoration measures over time, as well as wider socio- economic benefits or trade-offs of those measures;
Amendment 1830 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point j
Article 12 – paragraph 2 – point j
(j) the estimated co-benefits for climate change mitigation and food production associated with the restoration measures over time, as well as wider socio- economic benefits of those measures;
Amendment 1841 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point l
Article 12 – paragraph 2 – point l
(l) the estimated financing needs and identified funding outside the Common Agricultural Policy, including where applicable market-based solutions, for the implementation of the restoration measures, which shall include the description of the support to stakeholders affected by restoration measures or other new obligations arising from this Regulation, and the means of intended financing, public or private, including (co-) financing with Union funding instruments;
Amendment 1849 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point l a (new)
Article 12 – paragraph 2 – point l a (new)
(la) a description of existing and possible additional programmes which contribute to the development of business models that contribute to the goals of this regulation, including for the fisheries, aquaculture and agriculture sectors;
Amendment 1862 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point n
Article 12 – paragraph 2 – point n
(n) a summary of the process for preparing and establishing the national restoration plan, including information on public participation and of how the needs of local communities, landowners and stakeholders have been considered and how property rights have been respected;
Amendment 1867 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point o a (new)
Article 12 – paragraph 2 – point o a (new)
(oa) the estimated financing needs for the implementation of the restoration measures, which shall include the description of the support to stakeholders and in particularly private landowners affected by restoration measures or other new obligations arising from this Regulation, and the means of intended financing, public or private, including (co-) financing with Union funding instruments as well as a description on how the national plans will respect the private property rights according to national regulation and secure full compensation for economical or property disadvantages and losses;
Amendment 1892 #
2022/0195(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
Member States shall submit a draft of the national restoration plan referred to in Articles 11 and 12 to the Commission by… [OP please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation]. The Commission may grant, upon the request of a Member State, extension of the time limit for submission of the draft national restoration plan. Such a request shall duly justify the delay and clearly outline what the additional time is needed for. The approval of such a request shall neither hamper the effectiveness of the Commission to assess the synergies between different Member States' national restoration plans nor risk the achievement of the targets set in this Regulation.
Amendment 1944 #
2022/0195(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Member States shall review their national restoration plan at least once every 10 years, in accordance with Articles 11 and 12, taking into account progress made in the implementation of the plans, the best available scientific evidence as well as available knowledge of changes or expected changes in environmental conditions, including those due to climate change. The Member States shall in particular review the favourable reference areas needed to achieve the objectives of this Regulation, taking into account the best available scientific knowledge and challenges in spatial planning.
Amendment 1982 #
2022/0195(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. Member States shall ensure that members of the public, affected businesses and landowners, in accordance with national law, that have a sufficientlegitimate interest or that maintain the impairment of a right, have access to a review procedure before a court of law, or an independent and impartial body established by law, to challenge the substantive or procedural legality of the national restoration plans and any failures to act of the competent authorities, regardless of the role members of the public have played during the process for preparing and establishing the national restoration plan.
Amendment 2060 #
2022/0195(COD)
Proposal for a regulation
Article 17 – paragraph 9 – subparagraph 1 – introductory part
Article 17 – paragraph 9 – subparagraph 1 – introductory part
The Commission may adopt implementingdelegated acts to:
Amendment 2322 #
2022/0195(COD)
Proposal for a regulation
Annex VII – point 16
Annex VII – point 16
(16) Increase the agricultural area subject to agro-ecological management approaches such as organic agriculture or agro-forestry, regenerative farming, carbon farming, non-tillage farming, multicropping and crop rotation, integrated pest and nutrient management.
Amendment 26 #
2022/0164(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Due to the direct links between a sustainable recovery, building the Union’s resilience and the Union’s energy security, and its role for a just and inclusive transition, the Recovery and Resilience Facility iand the European Structural and Investment Funds are well-suited instruments to contribute to the Union’s response to these newly emerging challenges.
Amendment 31 #
2022/0164(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The Versailles Declaration of 10-11 March 2022 of the Heads of States and Governments invited the Commission to propose by the end of May a REPowerEU plan to phase out the dependency on Russian fossil fuel imports, which was subsequently reiterated in the European Council Conclusions of 24-25 March 2022. This should be done well before 2030 in a way that is consistent with the EU’s Green Deal and the climate objectives for 2030 and 2050 enshrined in the European Climate Law. Regulation (EU) 2021/241 should therefore be amended to enhance its ability to support reforms and investments dedicated to diversifying energy supplies, in particular fossil fuels, thereby strengthening the strategic autonomy of the Union alongside an open economy. Support should also be given to reforms and investments increasing the energy efficiency of the Member States’ economies, further investments in renewable energies, interconnections between Member States and supporting the most vulnerable households and SMEs suffering the consequences of the increase of energy prices.
Amendment 36 #
2022/0164(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) To maximise complementarity, consistency and coherence of policies and actions taken by the Union and Member States to foster independence and security of the Union’s energy supply, these energy-related reforms and investments should be established through a dedicated ‘REPowerEU chapter’ of the recovery and resilience plans and specific investments of the European Structural and Investment Funds within 2014-2020 and 2021-2027 programming period.
Amendment 71 #
2022/0164(COD)
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17 a) In order to provide an immediate response to the impact of the crisis, expenditure for operations for fostering energy crisis response capacities and support for vulnerable households and SMEs should be eligible as of 1 February 2022.
Amendment 72 #
2022/0164(COD)
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17 b) In order to provide additional flexibility to Member States for the reallocation of resources with a view to providing tailor-made responses to the energy crisis, The European Commision should asses the possibility to allow financial transfers under the Investment for growth and jobs goal between the ERDF, the ESF and the Cohesion Fund for both programmimng periods. Furthermore, transfer possibilities between categories of regions should also be exceptionally increased for Member States.
Amendment 73 #
2022/0164(COD)
Proposal for a regulation
Recital 17 c (new)
Recital 17 c (new)
(17 c) In order to ensure the fast implementation of projects furthering the "RepowerEU-Objectives" and to provide support to vulnerable households and SMEs suffering the consequences of the rise in enegy prices, co-financing rate of up to 100% should be possible under both programming periods.
Amendment 76 #
2022/0164(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) Regulation (EU)2021/1755 should also be amended to allow a possibility to transfer unused resources of the Brexit Adjustment Reserve for the achievements of the REPowerEU objectives.
Amendment 102 #
2022/0164(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2021/241
Article 21b a (new)
Article 21b a (new)
Amendment 164 #
2022/0164(COD)
Proposal for a regulation
Article 5 a (new)
Article 5 a (new)
Regulation (EU) 2021/1755
Article 8 a (new)
Article 8 a (new)
Amendment 11 #
2022/0162(COD)
Proposal for a regulation
Recital 134
Recital 134
(134) In order to improve governance and quality of interoperable digital public services, the Member States, the Union institutions, the executive agencies and the Union bodies, such as those referred to in Articles 70 and 71 should follow and apply to the greatest possible extent the European Interoperability Framework.
Amendment 15 #
2022/0162(COD)
Proposal for a regulation
Recital 161
Recital 161
(161) In order to ensure the absence of professional conflicting interests that may affect or risk affecting the capacity to perform the contract in an independent, impartial and objective manner, it is necessary to clarify the obligations of the contracting authority and of the candidates or tenderers. On the one hand, the candidates, tenderers, and, where appropriate, entities on whose capacity they rely as well as envisaged subcontractors should declare the absence of such conflicting interests, and to provide related information where requested. On the other hand, the contracting authority should assess the existence of such professional conflicting interests when declared or on the basis of additional information without interfering or delaying the evaluation of the project. Where such professional conflicting interests are established, this should lead to rejection from the award.
Amendment 16 #
2022/0162(COD)
Proposal for a regulation
Recital 165
Recital 165
(165) It is necessary to simplify the rules governing dynamic purchasing systems reducing the time consuming procedures, including the resolving of the appeals, to enable contracting authorities to take full advantage of the possibilities afforded by that purchasing method. In particular, the systems should be operated in the form of a restricted procedure, thus allowing for any economic operator that submits a request to participate and meets the exclusion and selection criteria to take part in procurement procedures carried out through the dynamic purchasing system over its period of validity, which should not be limited to four years. Tenders may also be presented in the form of an electronic catalogue particularly for off- the-shelf products or services generally available on the market. Moreover, in order to reduce the administrative burden given the dynamic nature of the systems, the requirement to appoint an opening and evaluation committee should be waived for specific procurements under a dynamic purchasing system. Considering the progress in digitalisation of procurement procedures, it should be clarified that public openings for open procedures may be organised remotely via video conferences.
Amendment 17 #
2022/0162(COD)
Proposal for a regulation
Recital 178
Recital 178
(178) Experience gained has shown that it is necessary to clarify in which cases a modification is considered altering the subject matter of the contract and the selection criteria.
Amendment 201 #
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 action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it. The implementation cost for connecting healthcare professionals to the EHDS should not be carried by healthcare professionals alone. To this end, Member States should ensure that EU financial incentives as well as national ressources are evenly and fairly distributed.
Amendment 220 #
2022/0140(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data until a relevant health professional validates the information, which would then be marked as confirmed by a health professional. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.
Amendment 232 #
2022/0140(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported but the restrictions on information should be easily identifiable by health professionals in the EHR in order to take due regard to the fact that the information is incomplete, when treating the patient. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.
Amendment 316 #
2022/0140(COD)
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36 a) The uptake of real-world data and real-world evidence, including patient reported outcomes, for evidence-based regulatory and policy purposes as well as for research, health technology assessment and clinical objectives should be encouraged. Real-world data and real- world evidence have the potential to complement randomised clinical trial data and is particularly relevant when assessing safety and medicinal effectiveness of innovative products, such as, but not limited to Advanced Therapies Medicinal Products (ATMPs), particularly in the rare disease domain.
Amendment 349 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders in the context of secondary use of electronic health data 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 should be provided by the level of confidentiality protection in accordance with TRIPS and Directive (EU) 2016/943. 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 353 #
2022/0140(COD)
Proposal for a regulation
Recital 40 a (new)
Recital 40 a (new)
(40 a) Clinical trials are of utmost importance for fostering innovation within Europe in the benefit of European patients. In order to incentivise continuous European leadership in this domain, the sharing of the clinical trials data through the EHDS for secondary use should not compromise the scientific integrity of and investment in these clinical trials, in line with Regulation (EU) 536/2014.
Amendment 367 #
2022/0140(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) The establishment of one or more health data access bodies, supporting access to electronic health data in Member States, is an essential component for promoting the secondary use of health- related data. Member States should therefore establish one or more health data access body, for instance to reflect their constitutional, organisational and administrative structure. However, one of these health data access bodies should be designated as a coordinator in case there are more than one data access body. Where a Member State establishes several bodies, it should lay down rules at national level to ensure the coordinated participation of those bodies in the EHDS Board. That Member State should in particular designate one health data access body to function as a single contact point for the effective participation of those bodies, and ensure swift and smooth cooperation with other health data access bodies, the EHDS Board and the Commission. Health data access bodies may vary in terms of organisation and size (spanning from a dedicated full-fledged organization to a unit or department in an existing organization) but should have the same functions, responsibilities and capabilities. Health data access bodies should not be influenced in their decisions on access to electronic data for secondary use. However, their independence should not mean that the health data access body cannot be subject to control or monitoring mechanisms regarding its financial expenditure or to judicial review. Each health data access body should be provided with the financial, technical and human resources, premises and infrastructure necessary for the effective performance of its tasks, including those related to cooperation with other health data access bodies throughout the Union. Given the central role of the health data access bodies in the context of secondary use of electronic health data, and especially the decision-making on granting or refusing a health data permit and preparing the data to make it available to health data users, their members and staff should have the necessary qualifications, experience and skills, in particular in the area of ethics, cybersecurity, protection of intellectual property and trade secrets, healthcare, scientific research, artificial intelligence and other relevant areas, as well as the protection of personal data and specifically data concerning health. In addition, the decision-making process regarding the granting or refusal of the health data permit should involve ethical considerations. Each health data access body should have a separate, public annual budget, which may be part of the overall state or national budget. In order to enable better access to health data and complementing Article 7(3) of Regulation […] of the European Parliament and of the Council [Data Governance Act COM/2020/767 final], Member States should entrust health data access bodies with powers to take decisions on access to and secondary use of health data. This could consist in allocating new tasks to the competent bodies designated by Member States under Article 7(1) of Regulation […] [Data Governance Act COM/2020/767 final] or in designating existing or new sectoral bodies responsible for such tasks in relation to access to health data.
Amendment 372 #
2022/0140(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) The health data access bodies should monitor the application of Chapter IV of this Regulation and contribute to its consistent application throughout the Union. For that purpose, the health data access bodies should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation. The health data access bodies should also cooperate with stakeholders, including patient organisations. Since the secondary use of health data involves the processing of personal data concerning health, the relevant provisions of Regulation (EU) 2016/679 apply and the supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 should be tasked with enforcing these rules. Moreover, given that health data are sensitive data and in a duty of loyal cooperation, the health data access bodies should inform the data protection authorities of any issues related to the data processing for secondary use, including penalties. In addition to the tasks necessary to ensure effective secondary use of health data, the health data access body should strive to expand the availability of additional health datasets, support the development of AI in health and promote the development of common standards. They should apply tested state-of-the-art techniques that ensure electronic health data is processed in a manner that preserves the privacy of the information contained in the data for which secondary use is allowed, including techniques for pseudonymisation, anonymisation, generalisation, suppression and randomisation of personal data. In this regard, health data access bodies should cooperate across borders and converge on common definitions and techniques. Health data access bodies can prepare datasets to the data user requirement linked to the issued data permit. This includes rules for anonymization of microdata sets.
Amendment 375 #
2022/0140(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Considering the administrative burden for health data access bodies toHealth data access bodies should comply with the obligations laid down in Article 14 paragraphs (1), (2), (3) and (4) of Regulation (EU) 2016/679 and inform the natural persons whose data are used in data projects within a secure processing environment, t. The exceptions provided for in Article 14(5) of Regulation (EU) 2016/679 shouldmay apply. TWherefore such exceptions are applied, health data access bodies should provide general information concerning the conditions for the secondary use of their health data containing the information items listed in Article 14(1) and, where necessary to ensure fair and transparent processing, Article 14(2) of Regulation (EU) 2016/679, e.g. information on the purpose and the data categories processed, allowing natural persons to understand whether their data are being made available for secondary use pursuant to data permits. Exceptions from this rule should be made when the results of the research could assist in the treatment of the natural person concerned. In this case, the data user should inform the health data access body, which should inform the data subject or his health professionalhealth professional of the data subject concerned. Natural persons should be able to access the results of different research projects on the website of the health data access body, ideally in an easily searchable manner. The list of the data permits should also be made public. In order to promote transparency in their operation, each health data access body should publish an annual activity report providing an overview of its activities.
Amendment 400 #
2022/0140(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, the use of anonymised electronic health data which is devoid of any personal data should be made available when possible and if the data user asks it. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the relevant health professional of the concerned natural person(s). Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 449 #
2022/0140(COD)
Proposal for a regulation
Recital 64 a (new)
Recital 64 a (new)
(64 a) Re-identification of natural persons should be considered a particularly serious breach of this Regulation. Member States should consider criminalising re-identification as well as disclosure of de-anonymised health data by health data users to serve as a deterrent measure.
Amendment 455 #
2022/0140(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) In order to promote the consistent application of this Regulation, a European Health Data Space Board (EHDS Board) should be set up. The Commission should participate in its activities and chair it. It. The EHDS Board should contribute to the consistent application of this Regulation throughout the Union, including by helping Member State to coordinate the use of electronic health data for healthcare, certification, but also concerning the secondary use of electronic health data. Given that, at national level, digital health authorities dealing with the primary use of electronic health data may be different to the health data access bodies dealing with the secondary use of electronic health data, the functions are different and there is a need for distinct cooperation in each of these areas, the EHDS Board should be able to set up subgroups dealing with these two functions, as well as other subgroups, as needed. An advisory forum should be set up to advise the EHDS Board it in the fulfilment of its tasks by providing stakeholder input in matters pertaining to this Regulation. The advisory forum should be composed of representatives of patients, health professionals, industry, scientific researchers and academia, have a balanced composition and represent the views of different relevant stakeholders. Commercial and non-commercial interests should be balanced. For an efficient working method, the digital health authorities and health data access bodies should create networks and links at national level with different other bodies and authorities, but also at Union level. Such bodies could comprise data protection authorities, cybersecurity, eID and standardisation bodies, as well as bodies and expert groups under Regulations […], […], […] and […] [Data Governance Act, Data Act, AI Act and Cybersecurity Act].
Amendment 467 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, interoperable common standards and, practices, and infrastructures and a governance framework for the primary and secondary use of electronic health data.
Amendment 472 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthens the rights of natural persons in relation to the availability, sharing and control of their electronic health data;
Amendment 481 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 3 – point a
Article 1 – paragraph 3 – point a
(a) manufacturers and suppliers of EHR systems and products claiming interoperability with EHR systems, including medical devices, high-risk AI systems and wellness applications placed on the market and put into service in the Union and the users of such products;
Amendment 526 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) ‘secondary use of electronic health data’ means: (i) the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may includewhich was personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;for purposes set out in Chapter IV of this Regulation, thereby constituting further processing within the meaning of Regulation (EU) 2016/679; or (ii) the processing of electronic health data which does not fall under (i) and was originally collected for the purposes set out in Chapter IV of this Regulation.
Amendment 583 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point z
Article 2 – paragraph 2 – point z
(z) ‘health data user’ means a natural or legal person who has lawful access toas well as Union institutions, bodies, offices and agencies, who has been granted access, in accordance with this Regulation, to one or more of the categories of personal or non- personal electronic health data for secondary use;
Amendment 602 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) ‘ real world evidence’ (RWE) means data that are collected outside the constraints of conventional randomised clinical trials.
Amendment 606 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae b (new)
Article 2 – paragraph 2 – point ae b (new)
(ae b) ‘real-world data’ (RWD) means routinely collected data relating to patient health status or the delivery of healthcare from a variety of sources other than traditional clinical trials.
Amendment 618 #
2022/0140(COD)
Proposal for a regulation
Article -3 (new)
Article -3 (new)
Article -3 Scope For the purpose of this Chapter, health data holder shall be understood only as data holder from health sector providing healthcare.
Amendment 652 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 5 a (new)
Article 3 – paragraph 5 a (new)
5 a. In addition to the electronic services referred to in paragraph 5 point (a), Member States shall also establish easily accessible support services for natural persons with adequately trained staff dedicated to assist them with exercising their rights referred to in this Article.
Amendment 656 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Natural persons may insert their electronic health data in their own EHR or in that of natural persons whose health information they can access, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative until a relevant health professional validates the information, which would then be marked as confirmed by a healthcare professional.
Amendment 667 #
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 sectorsector and providing healthcare to transmit their electronic health data to aor only specific part of health data identified by the requesting natural persons or necessary for the purpose at stake to a health 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 671 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 1 a (new)
Article 3 – paragraph 8 – subparagraph 1 a (new)
When a natural person makes the request for transmission, the health data holder shall have the obligation to comply with it, in accordance with Articles 6(1) and 9(2) point (a) of the Regulation (EU) 2016/679.
Amendment 679 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of selected health professionals to all or a specific part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms. Such restriction shall be easily identifiable in the EHR. When restricting the information, natural persons shall be made aware that restricting access may impact the provision of healthcare provied to them. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, including the conditions of medical liability, respecting the rules provided for by Article 18 (2) and (3) of the Regulation (EU) 2016/679 concerning the right to restriction of data processing. The Commission shall establish guidelines regarding medical liability when diagnosing and treating patients based on incomplete information.
Amendment 694 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcareproviding healthcare, including pursuant to Article 4(4) of this Regulation. The information shall be provided immediately and free of charge through electronic health data access services and stored for at least 3 years.
Amendment 700 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 10 a (new)
Article 3 – paragraph 10 a (new)
10 a. Natural persons shall have the possibility to choose whether to receive notifications about which health professional and when have accessed their personal electronic health data, as well as the periodicity of such notifications. There should be an automatic notification for situations when a health professional accesses the personal electronic health data of a natural person for the first time.
Amendment 701 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 11
Article 3 – paragraph 11
Amendment 726 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2 a. Notwithstanding the national rules established pursuant to paragraph 2, natural persons shall be able to easily give acces to their electronic health data to a selected health professional through the health data access services, if they wish so.
Amendment 730 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of chargeshall have access to electronic health data through health professional access services for the sole purpose of providing healthcare treatment, including relevant administration, and only through recognised electronic identification and authentication means, free of charge. The electronic health data in the electronic health records shall be structured in a user-friendly manner to allow for an easy use by health professionals.
Amendment 743 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Where access to electronic health data has been restricted by the natural person, pursuant to Article 3(9), the healthcare provider or health professionals shall not be informed of the content of the restricted electronic health data without prior authorisationexplicit consent as defined in Article 9(2)(a) of Regulation (EU) 2016/679 by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data, in line with Article 6(1)(d) of of Regulation (EU) 2016/679. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.
Amendment 789 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. For the purpose of paragraph 1, the Commission shall consult and cooperate with relevant stakeholders, including patients’ representatives, healthcare providers, health professionals, industry associations, national competence centres, as well as other Union and national authorities with competence in relevant areas, to encourage and contribute to the elaboration and adoption of a European electronic health record exchange format.
Amendment 793 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3 a. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are available in the language of the patient and the treating health professional.
Amendment 827 #
2022/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Where a Member State acceptenables the provision of telemedicine services, it shall, under the same conditions and in a non- discriminatory manner, accept the provision of the services of the same type by healthcare providers located in other Member States.
Amendment 854 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k
Article 10 – paragraph 2 – point k
(k) offer, in compliance with national legislation, telemedicine services and ensure that such services are easy to use, accessible to different groups of natural persons and health professionals, including natural persons with disabilities, dounder the same notn- discriminateory conditions and offer the possibility of choosing between in person and digital services;
Amendment 860 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point m
Article 10 – paragraph 2 – point m
(m) cooperate with other relevant entities and bodies at national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives through relevant associations, including patients’ representatives of patients, healthcare providers, health professionals, industry associations;
Amendment 879 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Each Member State shall ensure that each digital health authority is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers. Digital health authorities and their members and staff shall have the qualifications, experience and skills required to carry out their duties and exercise their powers.
Amendment 888 #
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 wiand consult with essential health stakeholders’ representatives, including patients’ representatives, health professionals and healthcare providers. Members of the digital health authority shall avoid any conflicts of interest.
Amendment 1086 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Article 29 – paragraph 3 a (new)
3 a. Where a finding of a market surveillance authortiy, or a serious incident it is informed of, concerns personal data protection, the market surveillance authority shall, without undue delay, inform and cooperate with the relevant supervisory authorities under Regulation (EU) 2016/679.
Amendment 1101 #
2022/0140(COD)
Proposal for a regulation
Article -31 (new)
Article -31 (new)
Article -31 Interoperability of wellness applications with EHR systems 1. Manufacturers of wellness applications may claim interoperability with an EHR system, after relevant conditions are met. When this is the case, the users of such wellness applications shall be duly informed about such interoperability and its effects. 2. The interoperability of wellness applications with EHR systems shall not mean automatic sharing or transmission of all or part of the health data from the wellness application with the EHR system. The sharing or transmission of such data shall only be possible pursuant to and in line with Article 3(6) of this Regulation and interoperability shall be limited exclusively to this end. The manufacturers of wellness applications claiming interoperability with an EHR system shall ensure that the user is able to choose which part of health data from the wellness application they want to insert in the EHR system. 3. Wellness applications shall not be able to access the information in EHRs nor extract any information from it.
Amendment 1110 #
2022/0140(COD)
6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device and in the case of software a digital label. 2D barcodes may also be used to display the label.
Amendment 1125 #
2022/0140(COD)
Proposal for a regulation
Article -33 (new)
Article -33 (new)
Article -33 Scope This Chapter shall apply to situations of secondary use of electronic health data where a health data user seeks access to such data, as referred to in Article 33, from one or more health data holders as defined in Article 2 (y) of this Regulation.
Amendment 1126 #
2022/0140(COD)
Proposal for a regulation
Article -33 a (new)
Article -33 a (new)
Article -33 a Rights of natural persons in relation to the secondary use of electronic health data Natural persons shall have the right to opt-out from sharing their electronic health data for secondary use. A mechanism shall be put in place to allow natural persons the flexibility to determine the categories of electronic health data and/or purposes from which they wish to opt out. Such mechanism shall be easily accessible, comprehensible and actionable.
Amendment 1127 #
2022/0140(COD)
Proposal for a regulation
Article 33 – title
Article 33 – title
Minimum categories of electronic health data for secondary use
Amendment 1176 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
(f) person generated electronic health data, including from medical devices, wellness applications or other digital health applications;
Amendment 1188 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from clinical trialsfully concluded or terminated clinical trials, in accordance with Regulation 536/2014;
Amendment 1224 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 3
Article 33 – paragraph 3
3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, including real-world data and real-world evidence, collected by entities and bodies in the health or care sectors, including public and private providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.
Amendment 1235 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailing protected intellectual property and trade secrets from private enterprisehealth data holders shall be made available for secondary use. Where such data is made available for secondary use, all technical and organisational measures necessary to preserve the confidentiality of IP rights and confidentiality of trade secrets shall be taken by the health data access body and in consultation with the data holder. This regulation is without prejudice to existing relevant Union legislation, including Directive 2004/48/EC, Directive 2001/29/EC, Directive (EU) 2016/943 and Directive (EU) 2019/790.
Amendment 1247 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 4 d (new)
Article 33 – paragraph 4 d (new)
4 d. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific technical and organisational measures necessary to preserve the confidentiality of such data.
Amendment 1302 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates, including optmising patient pathway;
Amendment 1310 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) higher education or, continuing proffessional development or higher education teaching activities in health or care sectors;
Amendment 1313 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point e
Article 34 – paragraph 1 – point e
(e) scientific research related to health or care sectorsdemonstrably linked to health or care sectors, such as prevention, early detection, diagnosis, treatment, rehabilitation or healthcare management, including fundamental, exploratory or applied healthcare research;
Amendment 1324 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services demonstrably contributing to public health or social security, or ensuring high levels of quality and safety of health or care, of medicinal products or of medical devices, including scientific research into their efficiency and efficacy and post-market safety monitoring;
Amendment 1350 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point h
Article 34 – paragraph 1 – point h
(h) improving delivery of care, optimising patient pathway and providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.
Amendment 1367 #
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 effective, proportionate and dissuasive sanctions:
Amendment 1371 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point a
Article 35 – paragraph 1 – point a
(a) taking decisions detrimental to a natural person or a group of natural persons based on their electronic health data; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;
Amendment 1389 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
Amendment 1418 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
Any other misuse of electronic health data, including its use for permissible purposes other than those specified in the data permit or data request, shall also be prohibited and subject to effective, proportionate and dissuasive sanctions.
Amendment 1427 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 1 a (new)
Article 36 – paragraph 1 a (new)
1 a. Each health data access body shall contribute to the consistent application of this Regulation throughout the Union. For that purpose, the health data access bodies shall cooperate with each other and with the supervisory authorities under Regulation (EU) 2016/679 as well as with the Commission and where relevant with the EDPB and the EDPS.
Amendment 1434 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Member States shall ensure that each health data access body is provided with adequathe human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers, including those related to the participation in the EHDS Board.
Amendment 1477 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point f
Article 37 – paragraph 1 – point f
(f) take all measures necessary to preserve IP rights and the confidentiality of IP rights and of trade secrets;
Amendment 1537 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 4 a (new)
Article 37 – paragraph 4 a (new)
4 a. The EDPB shall provide health data acces bodies with specific guidelines and minimum standards of anonymisation and pseudonymisation for the purposes in this Regulation in order to ensure the same level of quality of anonymisation and pseudonymisation across Member States. The guidelines shall be based on state-of- the-art technology in this regard, which in turn shall be used by the health data access bodies when carrying out their task of anonymisation or pseudonymisation of electronic health data. The guidelines shall be regularly updated, in line with technological progress in this field.
Amendment 1540 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – introductory part
Article 38 – paragraph 1 – introductory part
1. Health data access bodies shall make publicly available and easily searchable and accessible the conditions under which electronic health data is made available for secondary use, with information concerning:
Amendment 1547 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – point d
Article 38 – paragraph 1 – point d
(d) the arrangementmodalities for natural persons to exercise their rights in accordance with Chapter III of Regulation (EU) 2016/679;
Amendment 1556 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. Health data access bodies shall not be obliged to provide the specific information undercomply with the obligations laid down in Article 14(1) to (4) of Regulation (EU) 2016/679. Natural persons shall have the possibility to choose whether to receive notifications when their data are being used for secondary purpose, as well as the periodicity of such notifications.Where, with regards to obligations laid down in Article 14(1) to (4) of Regulation (EU) 2016/679 to eaca health ndatural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issueda access body decides to make use of the exception laid down in Article 14(5), point (b), of the same Regulation, it shall make sure to make the information as referred to in Article 14(1) to (4) of Regulation (EU) 2016/679 publicly available on its website in an aggregated form, allowing natural persons to understand whether their data are being made available for secondary use pursuant to Article 46data permits.
Amendment 1564 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Where a health data access body is informed by a health data user of a clinically significant finding that may impact onnfluence the health status of a natural person, as referred to in Article 41a(5) of this Regulation, the health data access body mayshall inform the natural person and his or , where applicable, the treating health professional of the natural person concerned about that finding. Where relevant, ther treating health professional about that findingshall take due regard to the expressed wish of the natural person not to be informed.
Amendment 1662 #
2022/0140(COD)
3. Where health data access bodies find that a data user or data holder does not comply with the requirements of this Chapter, they shall immediately notify the data user or data holder of those findings and shall give it the opportunity to state its views within 2 months.4 weeks. Where the finding of non-compliance concerns personal electronic health data, the health data access body shall immediately inform supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of this finding to ensure application and enforcement of this Regulation and relevant provisions of the aforementioned Regulations, including penalties;
Amendment 1667 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 4
Article 43 – paragraph 4
4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non- compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, tThe health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data within the EHDS for a period of up to 5 years.
Amendment 1686 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission mayshall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1707 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. Where the purpose of the data user’sdata user has demonstrated that the purpose of processing cannot be achieved with anonymised data, taking into account the information provided by the data userin line with Article 46(1c), 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 appropriatconsidered a particularly serious breach of this Regulation and shall be subject to effective, proportionate and dissuasive penalties.
Amendment 1727 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point -a (new)
Article 45 – paragraph 2 – point -a (new)
(-a) the applicant´s identity, description of professional functions and operations, including the identity of the concrete persons who will have access to electronic health data, if a data permit is granted;
Amendment 1732 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point a
Article 45 – paragraph 2 – point a
(a) a detailed plan and explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 34(1) access is sought;
Amendment 1736 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point a a (new)
Article 45 – paragraph 2 – point a a (new)
(a a) a declaration that the applicant has sufficient experience to manage the intended uses of the data requested, consistent with ethical practice and applicable laws and regulations;
Amendment 1740 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point a b (new)
Article 45 – paragraph 2 – point a b (new)
(a b) a detailed explanation of the expected benefits related to the use;
Amendment 1741 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point b
Article 45 – paragraph 2 – point b
(b) a description of the requested electronic health data, their timeframe, format and data sources, where possible, including geographical coverage where data is requested from several Member States;
Amendment 1744 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point c
Article 45 – paragraph 2 – point c
(c) an indication whether electronic health data shouldneed to be made available in an an pseudonymised format;
Amendment 1746 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point e
Article 45 – paragraph 2 – point e
(e) a description of the safeguards planned to prevent any other use or misuse of the electronic health data, including attempts to re-identify natural persons whose data are part of the dataset;
Amendment 1754 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h a (new)
Article 45 – paragraph 2 – point h a (new)
(h a) where applicable, information on the assessment of ethical aspects of the processing and evidence of ethics approval obtained by the competent ethics committee in line with national law;
Amendment 1759 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h b (new)
Article 45 – paragraph 2 – point h b (new)
(h b) a declaration that the intended uses of the data requested do not pose a risk of stigmatisation or dignitary harm to both individuals and the groups implicated in the dataset requested;
Amendment 1814 #
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](EU) 2022/868, the health data access body may extend the period for responding to a data access application by 2a maximum of 3 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 1884 #
2022/0140(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. When carrying out those tasks under Article 37 (1), points (b) and (c), tby the European Medicines Agency (EMA), European Centre for Disease Prevention and Control (ECDC) and Health Emergency Preparedness and Response Authority (HERA) to access the electronic health data under this Chapter. The health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]EMA, ECDC, or HERA about the availability of data within 2 months of 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 by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.
Amendment 1914 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 4
Article 50 – paragraph 4
4. The Commission shall, by means of implementing acts, provide for the technical, information security, confidentiality, data protection and interoperability requirements for the secure processing environments, in consultation with ENISA. Those implementing acts shall be adopted in accordance with the advisoryexamination procedure referred to in Article 68(2a).
Amendment 1960 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 a (new)
Article 52 – paragraph 13 – subparagraph 1 a (new)
Amendment 1986 #
2022/0140(COD)
Proposal for a regulation
Article 59 a (new)
Article 59 a (new)
Article 59 a Digital health literacy and digital health access 1. In order to ensure successful implementation of the EHDS, Member States shall put in place educational programmes aimed at increasing digital health literacy and relevant competences and skills. Those programmes shall be tailored to the needs of specific groups, including patients and health professionals, and shall be developed and reviewed, and where necessary updated, on a regular basis in consultation and cooperation with relevant experts and stakeholders. 2. Member States shall measure, on a regular basis, the digital health literacy of health professionals, patients as well as persons in general. 3. Member States shall organise awareness-raising campaigns to ensure that all specific groups are informed about the importance of digital health literacy as well as educational programmes available to them pursuant to paragraph 1. 4. Member States as well as the Commission shall take all the necessary measures to ensure that natural persons, and specifically patients and health professionals, are informed about the EHDS, its primary and secondary components, functionalities and conditions as well as their rights within EHDS. 5. Member States shall ensure that all natural persons have access to the infrastructure necessary for the effective management of their electronic health data, both within primary and secondary use.
Amendment 2022 #
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 th: (a) one high level representatives of digital health authorities andof all the Member States; and (b) one high level representative of health data access bodies of all the Member States. OtWhere a Member State has designated several health data access bodies, the coordinating health data access body shall be part of the EHDS Board; and (c) EDPB and EDPS. The EHDS Board shall be aided by an advisory forum as referred to in Article 65a. EMA, ECDC, ENISA shall be invited by the Board to join the meeting where the issues discussed are of relevance to their respective mandates or tasks. 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 role.
Amendment 2044 #
2022/0140(COD)
Proposal for a regulation
Article 64 a (new)
Article 64 a (new)
Article 64a Advisory forum 1. An advisory forum shall be established by the EHDS Board to advise it in the fulfilment of its tasks by providing stakeholder input in matters pertaining to this Regulation. 2. EMA, ECDC, JRC shall be permanent members of the advisory forum. 3. The advisory forum shall be composed of representatives of patients, health professionals, industry, scientific researchers and academia. The advisory forum shall have a balanced composition and represent the views of different relevant stakeholders. The composition of the advisory forum shall be balanced between commercial and non-commercial interests and, within the commercial interests, it shall be balanced between large companies, SMEs and start-ups. Focus on primary and secondary use of electronic health data shall also be balanced. 4. Members of the advisory forum shall be appointed by the Commission following a public call for interest and a transparent selection procedure, in consultation with the European Parliament. 5. The term of office of the members of the advisory forum shall be two years and it shall not be renewable more than twice consecutively. 6. The advisory forum may establish standing or temporary subgroups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation. 7. The advisory forum shall draw up its rules of procedure and elect two co- Chairs from among its members, one of them being from its permanent members. Their term of office shall be two years, renewable once. 8. The advisory forum shall hold regular meetings. The advisory forum can invite relevant experts and other relevant stakeholders to its meetings. The Chair of the EHDS Board may attend, ex officio, the meetings of the advisory forum. 9. In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations or written contributions. 10. The advisory forum shall prepare an annual report of its activities. That report shall be made publicly available.
Amendment 2088 #
2022/0140(COD)
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate and dissuasive. Specific attention shall be given to penalties for serious breaches of this Regulation, as referred to in Article 41a(3) and Article 44(3). Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them. 2. Penalties referred to in paragraph 1 shall be without prejudice to the penalties established pursuant to Regulation (EU) 2016/679 and Regulation (EU) 2018/1725. 3. The Commission shall provide Member States with guidelines and recommendations on the types and levels of penalties in order to prevent forum shopping and ensure fair enforcement, especially in cross-border cases. 4. Member States are encouraged to consider criminalising re-identification of anonymised data.
Amendment 2098 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. After 5 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, including the need to extend interoperability possibilities between EHR systems and electronic health data access services other than those established by the Member States, the possibility to expand the access to MyHealth@EU infrastructure to third countries and international organisations, the implementation and use by natural persons of the opt-out mechanism in secondary use as referred to in Article - 33a, the use and implementation of the right referred to in Article 3(9), the implementation of Articles 33 and 34 as well as the application of fees as referred to in Article 42, 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 2106 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1 a (new)
Article 70 – paragraph 1 a (new)
1a. After 2 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of the Union funding made available for the setting up of the European Health Data Space as well as an evaluation of funding allocated to this end by Member States, and where appropriate, consider further measures in this regard.
Amendment 31 #
2022/0105(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The reporting requirements should apply at ‘installation level’ in order to implement synergies between the Portal and databases on environmental pressures from industrial installations, including those covered by Directive 2010/75/EU, and to ensure coherence with, and support to, the implementof data and their subsequent publication in the Portal should apply at 'facility level' in order to provide clear, simple and comparable information tof that Directivee public.
Amendment 72 #
2022/0105(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) When adopting delegated acts, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert levelthe level of the relevant specialists and industrial sectors, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making58 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 58 OJ L 123, 12.5.2016, p. 1.
Amendment 85 #
2022/0105(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 16 a (new)
Article 2 – paragraph 1 – point 16 a (new)
(16 a) ‘facility’ means one or more installations on the same site that are operated by the same natural or legal person;
Amendment 89 #
2022/0105(COD)
Proposal for a regulation
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
1. TExcept in cases where the data is considered confidential as specified in Article 10, the Portal shall include data on:
Amendment 109 #
2022/0105(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) installationfacility, including the installationfacility's parent company where applicable, and its geographical location, including the river basin;
Amendment 114 #
2022/0105(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point i
Article 4 – paragraph 1 – point i
(i) installationfacility owner or operator.
Amendment 128 #
2022/0105(COD)
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. The operator of each installationfacility that undertakes one or more of the activities specified in Annex I, which meet the applicable capacity thresholds specified in that Annex, shall report annually, to its competent authority, the following data, unless that data is already available to the competent authority and except in cases where the data is considered confidential as specified in Article 10:
Amendment 149 #
2022/0105(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Operators shall obtain the data referred to in paragraph 1 by means of measurement. Where measurement is not practicable, operators shall use calculation. Where neither measurement nor calculation is practicable, opusing the best available information, which may include monitoring data, emission factors, mass balance equations, indirect monitoring or other calculations, engineering judgments and other methods in line with Article 8(1) and in accordance with internators may obtain the data by estimationionally approved methodologies, where these are available.
Amendment 171 #
2022/0105(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
When data is considered confidential by a Member Staten operator in accordance with Article 4(2) of Directive 2003/4/EC, the report referred to in Article 6(2) of this Regulation for the reporting year concerned shall indicate separately for each installationfacility which data cannot be made publicreported and provide the reasons for this.
Amendment 177 #
2022/0105(COD)
Proposal for a regulation
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
The Commission, assisted by the Agency, and after consultation with the E-PRTR expert group, shall draw up and periodically update guidance supporting the implementation of this Regulation, addressing at least the following:
Amendment 179 #
2022/0105(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) the data to be reported and an indicative sector-specific sub-list of air and water pollutants based on their significance and relevance;
Amendment 196 #
2022/0105(COD)
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experspecialists designated by each Member State and from industrial sectors in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 158 #
2022/0104(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Rearing of pigs, and poultry and cattle, while contributing to food security, cause significant pollutant emissions into the air and water. In order to reduce such pollutant emissions, including ammonia, methane, nitrates and greenhouse gas emissions and thereby improve air, water and soil quality, it is necessary to lower the threshold above which industrial-scale pigs and poultry installations are included within the scope of Directive 2010/75/EU and to include also cattle farming within that scope. Relevant BAT requirements take into consideration the nature, size, density and complexity of these installations, including the specificities of pasture based cattle rearing systems, where animals are only seasonally reared in indoor installations, and the range of environmental impacts they may have. The proportionality requirements in BATs aim to incentivise farmers to implement the necessary transition towards increasingly environmentally friendly agricultural practices.
Amendment 233 #
2022/0104(COD)
Proposal for a directive
Recital 29
Recital 29
(29) In order to ensure that Directive 2010/75/EU continues meeting its objectives to prevent or reduce emissions of pollutants and achieve a high level of protection of human health and the environment, while not adversely affecting sustainable European farming, based on the principles of respecting animal welfare, healthy and sustainable food production and promotion of small-scale and family farming, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to supplement that Directive in order to establish operating rules containing requirements for activities relating to industrial-scale rearing of poultry, and pigs and cattle, and to amend Annexes I and Ia to. Small-scale extensive farming, small-scale family farming and organic farming should be excluded from the scope of thatis Directive by adding an agro-industrial activity to ensure that it meets its objec. General definitions of small-scale extensive farming, small-scale family farming and organic farming should be laid down in this Directive, and detailed national definitions should be established, reflecting national and regional particularitives to prevent or reduce pollutants emissions and achieve a high level of protection of human health and the environment. In the preparation of the operating rules, the Commission should also ensure that sustainable forms of industrial-scale farming, respecting animal welfare principles and local traditions in sustainable farming, will benefit from either a registration regime or simplified administrative procedures. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 201677 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. __________________ 77 Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making; OJ L 123, 12.5.2016, p. 1–14.
Amendment 250 #
2022/0104(COD)
Proposal for a directive
Recital 32 a (new)
Recital 32 a (new)
(32a) Similar safeguards as presented in recital 32 for energy sector should be properly applied to other sectors, for exceptional circumstances seriously affecting supply chains that could make impossible the compliance of emission limit values for limited time periods.
Amendment 306 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Directive 2010/75 (EU)
Article 3 – paragraph 1 – point 12
Article 3 – paragraph 1 – point 12
(12) ‘BAT conclusions’ means a document containing the parts of a BAT reference document laying down the conclusions on best available techniques, their description, information to assess their applicability, the emission levels associated with the best available techniques, the environmental performance levels associated with the best available techniques, the minimum content of an environmental management system including benchmarks associated with the best available techniques, associated monitoring, emission levels associated with emerging techniques, environmental performance levels associated with emerging techniques, associated consumption levels and, where appropriate, relevant site remediation measures;;
Amendment 317 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2010/75 (EU)
Article 3 – paragraph 1 – point 13 a
Article 3 – paragraph 1 – point 13 a
(13a) ‘environmental performance levels associated with the best available techniques’ means the range of environmental performance levels, except emission levels, obtained under normal operating conditions using a BAT or a combination of BATs, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions;.
Amendment 324 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c a (new)
Article 1 – paragraph 1 – point 3 – point c a (new)
Directive 2010/75/EU
Article 3 – paragraph 1 – point 13 a a (new)
Article 3 – paragraph 1 – point 13 a a (new)
(ca) In Article 3, paragraph 1, point 13a a (new) is inserted: (13aa) "Innovative techniques" means techniques including emerging techniques, that should be at least at the level of technology demonstrated in relevant environment (industrially relevant environment in the case of key enabling technologies) or system prototype demonstration in operation environment;
Amendment 325 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c b (new)
Article 1 – paragraph 1 – point 3 – point c b (new)
Directive 2010/75/EU
Article 3 – paragraph 1 – point 13 a b (new)
Article 3 – paragraph 1 – point 13 a b (new)
(cb) In Article 3, paragraph 1, point 13a b (new) is inserted: (13ab) "Deep industrial transformation" means adoption of completely different process routes and/or primary process techniques that facilitate a significant reduction of emissions. Secondary, or 'end-of-pipe' techniques would not qualify as 'deep transformation'
Amendment 336 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point e
Article 1 – paragraph 1 – point 3 – point e
Directive 2010/75/EU
Article 3 – paragraph 1 – point 23 b
Article 3 – paragraph 1 – point 23 b
Amendment 350 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point e a (new)
Article 1 – paragraph 1 – point 3 – point e a (new)
Directive 2010/75/EU
Article 3 – paragraph 1 – point 23 c a (new)
Article 3 – paragraph 1 – point 23 c a (new)
(ea) In Article 3, paragraph 1, point 23c a (new) is inserted: (23ca) ‘Industrial-scale livestock rearing’ means rearing of poultry and pigs, which does not fall under the definitions laid down in points 23cc(new)) to (23d);
Amendment 365 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75 (EU)
Article 3 – paragraph 1 – point 50
Article 3 – paragraph 1 – point 50
(50) ‘emission levels associated with emerging techniques’ means the expected range of emission levels obtained under normal operating conditions using an emerging technique or a combination of emerging techniques, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions;
Amendment 368 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75 (EU)
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘environmental performance levels associated with emerging techniques’ means the expected range of environmental performance levels, except emission levels, obtained under normal operating conditions using an emerging technique or a combination of emerging techniques, as described in BAT conclusions, expressed as an average over a given period of time, under specified reference conditions;
Amendment 383 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75 (EU)
Article 3 – paragraph 1 – point 53 – introductory part
Article 3 – paragraph 1 – point 53 – introductory part
(53) ‘‘benchmarks’ means the indicative range of environmental performance levels, which are under the control of the operator, associated with best available techniques, other than emission levels, and may include:
Amendment 399 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point f
Article 1 – paragraph 1 – point 3 – point f
Directive 2010/75/EU
Article 3 – point 53 – point f
Article 3 – point 53 – point f
(f) other levels obtained under specified reference conditions as described in BAT conclusions, expressed as an average over a given period of time, obtained under specified reference conditions.
Amendment 498 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive 2010/75/EU
Article 9 – paragraph 2
Article 9 – paragraph 2
Amendment 508 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Directive 2010/75/EU
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
Amendment 525 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Directive 2010/75 (EU)
Article 11 – paragraph 1 – point f b
Article 11 – paragraph 1 – point f b
Amendment 607 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9 – point b
Article 1 – paragraph 1 – point 9 – point b
Directive 2010/75 (EU)
Article 13 – paragraph 2 – subparagraph 2
Article 13 – paragraph 2 – subparagraph 2
Without prejudice to Union competition law, information considered as confidential business information or commercially sensitive information shall only be shared with the Commission and with the following individuals having signed a confidentiality and non-disclosure agreement: civil servants and other public employees representing Member States or Union agencies, and representatives of non-governmental organisations promoting the protection of human health or the environment. The exchange of information considered as confidential business information or sensitive commercial information shall remain limited to what is required to draw up, review and, where necessary, update BAT reference documents, and such confidential business information or sensitive commercial information shall not be used for other purposes..
Amendment 692 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10 a (new)
Article 1 – paragraph 1 – point 10 a (new)
Directive 2010/75/EU
Article 14 – paragraph 3
Article 14 – paragraph 3
(10a) Article 14 paragraph 3 is amended as follows: BAT conclusions shall be the reference for setting the permit conditions. The techniques listed and described in BAT conclusions are not exhaustive. Other techniques may be used to ensure at least an equivalent level of environmental protection. Or. en (DIRECTIVE 2010/75/EU)
Amendment 732 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2010/75 (EU)
Article 14a – paragraph 2 – point a – point iii
Article 14a – paragraph 2 – point a – point iii
Amendment 750 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2010/75 (EU)
Article 14a – paragraph 2 – point b
Article 14a – paragraph 2 – point b
(d) a chemicals inventory of the relevant hazardous substances present in the installation as such, as constituents of other substances or as part of mixtures, a risk assessment of the impact of such substances on human health and the environment and an analysis of the possibilities to substitute them with safer alternativesor a reference to existing company documents containing this information, such as that included as part of a REACH registration or required by Council Directive 89/391/EEC;
Amendment 768 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive 2010/75 (EU)
Article 14a – paragraph 3 a (new)
Article 14a – paragraph 3 a (new)
3a. Information that is subject to mandatory reporting under other relevant Union legislation shall not be required under the EMS. Where such reporting is not public or reporting is required at company level, rather than installation level, a reference to the non-confidential parts of the respective reports shall be included in reporting under the EMS.
Amendment 793 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Amendment 835 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 3a
Article 15 – paragraph 3a
3a. The competent authority shall set indicative environmental performance limit values that ensure that, under normal operating conditions, such performance limits values do not exceed the environmental performance levels associated with BATs as laid down in the decisions on BAT conclusions referred to in Article 13(5).
Amendment 846 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75 (EU)
Article 15 – paragraph 4 – subparagraph 1 – introductory part
Article 15 – paragraph 4 – subparagraph 1 – introductory part
By way of derogation from paragraph 3 and 3a, and without prejudice to Article 18, the competent authority mayshall, in specific cases, set less strict emission limit values or environmental performance limit values (EPLVs). Such a derogation may apply onshall apply where an assessment shows that the achievement of emission levels or EPLVs associated with the best available techniques as described in BAT conclusions would lead to disproportionately higher costs compared to the environmental benefits due to:
Amendment 860 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75 (EU)
Article 15 – paragraph 4 – subparagraph 1 – point b a (new)
Article 15 – paragraph 4 – subparagraph 1 – point b a (new)
(ba) investment cycle related to the sustainability transition of the operator's group.
Amendment 877 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75 (EU)
Article 15 – paragraph 4 – subparagraph 4
Article 15 – paragraph 4 – subparagraph 4
Derogations referred to in this paragraph shall respect the principles set out in Annex II. The competent authority shall in any case ensure that no significant pollution is caused and that a high level of protection of the environment as a whole is achieved. Derogations shall not be granted where they mayin case it is proven that the specific contribution of the installation puts at risk compliance with environmental quality standards referred to in Article 18.
Amendment 904 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Directive 2010/75/EU
Article 15a – paragraph 1
Article 15a – paragraph 1
1. For the purpose of assessing compliance with emission limit values in accordance with Article 14(1), point (h), the correction made to measurements to determine the validated average emission values shall not exceed the measurement uncertainty of the measuring method. Uncertainty in emission measurements includes all sources of uncertainty based on the types of instrument (QAL1), calibration effect (QAL2) and operational effects (QAL3).
Amendment 907 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13
Article 1 – paragraph 1 – point 13
Directive 2010/75/EU
Article 15a – paragraph 2
Article 15a – paragraph 2
Amendment 922 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive 2010/75/EU
Article 16 – paragraph 3
Article 16 – paragraph 3
3. Where a derogation referred to in Article 15(4) has been granted, Member States shall, where justified, ensure that the operator monitors the concentration of the pollutants concerned by the derogation which are present in the receiving environment. The results of the monitoring shall be transmitted to the competent authority. Where relevant, monitoring and measuring methods for each concerned pollutant set out in other relevant Union legislation shall be used for the purpose of the monitoring referred to in this paragraph.
Amendment 941 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Directive 2010/75/EU
Article 18 – paragraph 1
Article 18 – paragraph 1
Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shallmay be included in the permit with a view to reducing the specific contribution of the installation to the pollution occurring in the relevant area without prejudice to other measures which may be taken to comply with environmental quality standards.
Amendment 948 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Directive 2010/75/EU
Article 18 – paragraph 2
Article 18 – paragraph 2
Where stricter conditions have been included in the permit in accordance with the first paragraph, regular monitoring of the concentration of relevant pollutants in the receiving environment resulting from operations of the installations concerned shallmay be required from the operator, and the results of such monitoring shall be transmitted to the competent authority. Where monitoring and measurement methods for the concerned pollutants are set out in other relevant Union legislation, such methods shall be used for the purpose of the monitoring referred to in this paragraph..
Amendment 960 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 d (new)
Article 1 – paragraph 1 – point 15 d (new)
Directive 2010/75/EU
Article 21– paragraph 3 a (new)
Article 21– paragraph 3 a (new)
(15d) In Article 21, paragraph 3a (new) is inserted as follows: 3a. By way of derogation from paragraph 3 and within 8 years of publications of Decision of BAT conclusions, the competent authority shall, in case undertakings implementing deep industrial transformation towards EU objectives on a clean, circular and climate neutral economy, exempt the operator to the reconsideration and updating the permit conditions for the activities concerned until the transformation is completed.
Amendment 967 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Directive 2010/75/EU
Article 21 – paragraph 5 – point c
Article 21 – paragraph 5 – point c
(c) where it is necessary to comply with an environmental quality standard referred to in Article 18 and the specific contribution of the installation is proven, including in the case of a new or revised quality standard or where the status of the receiving environment requires a revision of the permit in order to achieve compliance with plans and programmes set under Union legislation.
Amendment 995 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 17 – point b – point i
Article 1 – paragraph 1 – point 17 – point b – point i
Directive 2010/75 (EU)
Article 24 – paragraph 2 – introductory part
Article 24 – paragraph 2 – introductory part
2. When a decision on granting, reconsideration or updating of a permit has been taken, the competent authority shall make available to the public, including systematically via the Internet, free of charge and without restricting access to registered users, in relation to points (a), (b) and (f), the following non-confidential information:
Amendment 1010 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 17 – point c
Article 1 – paragraph 1 – point 17 – point c
Directive 2010/75/EU
Article 24 – paragraph 3 – point c a (new)
Article 24 – paragraph 3 – point c a (new)
(ca) upon request of the operator, competent authority shall not publish sensitive information relevant for the operator.
Amendment 1055 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 b – paragraph 1
Article 27 b – paragraph 1
Without prejudice to Article 18, the competent authority may grant temporary derogations from the requirements set out in Article 15(2) and (3) and from the principles set out in Article 11, points (a) and (b), for the testing of emerging or innovative techniques for a total period of time not exceeding 248 months. The competent authority may grant an extension of those temporary derogations. An initial extension period shall not exceed 12 months.
Amendment 1061 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75/EU
Article 27 c – paragraph 1
Article 27 c – paragraph 1
By way of derogation from Article 215(3), the competent authority may, when an operator chooses that option, set emission limit values that ensure that, within 6 years of publication of a decision on BAT conclusions in accordance with Article 13(5) relating to the main activity of an installation, emissions shall not, under normal operating conditions, exceed expected emission levels associated with emerging techniques as laid down in the decisions on BAT conclusions. Where the time period referred to in the first paragraph has elapsed and where the operator cannot comply with the emission limit values set by way of derogation from Article 15(3), the competent authority shall ensure that within a period of maximum 4 years following the expiry of the time period referred to in the first paragraph: (a) the permit conditions for the installation concerned are reconsidered and, if necessary, updated to ensure compliance with this Directive, in particular, with Article 15(3) and (4), where applicable; (b) the installation complies with those amended permit conditions. For the time period in between the expiry of the time period referred to in the first paragraph and the reconsideration and updating of the permit conditions, the competent authority shall apply the derogation principles referred to in Article 15(4)
Amendment 1093 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75 (EU)
Article 27 d – paragraph 1 – subparagraph 1
Article 27 d – paragraph 1 – subparagraph 1
Member States shallmay require that by 30 June 2030 the operator includes in its environmental management system referred to in Article 14a an indicative transformation plan for each installation carrying out any activity listed in points 1, 2, 3, 4, 6.1 a, and 6.1 b of Annex I. The transformation plan shall contain information on how the installation will transform itself, an indicative integrated transformation plan for all installations covered by the same permit in case two or more installations are covered by the same permit in accordance with Article 4(2), or a consolidated transformation plan at corporate level, for all undertakings in the group. Where a corporate identity has not developed an indicative consolidated transformation plan at corporate level, the development of transformation plans for each installation shall be mandatory. The transformation plan shall contain non- confidential information on how the corporate entity would transform its installations during the 2030-2050 period in order to contribute to the emergence of a sustainable, clean, circular and climate- neutral economy by 2050, using the format referred to in paragraph 4.
Amendment 1119 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75 (EU)
Article 27 d – paragraph 1 – subparagraph 2 a (new)
Article 27 d – paragraph 1 – subparagraph 2 a (new)
By way of derogation from the first subparagraph, installations that are operated by undertakings covered by [OJ please insert the reference number for 2021/0104 (COD)1a] carrying out any activity listed in Annex I, may use the description of the undertakings’ business model and strategy adopted under Article 19a of Directive 2013/34/EU instead of the consolidated corporate-level transformation plan indicated in the first subparagraph of this paragraph. __________________ 1aProposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2013/34/EU, Directive 2004/109/EC, Directive 2006/43/EC and Regulation (EU) No 537/2014, as regards corporate sustainability reporting, COM(2021)189
Amendment 1137 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75 (EU)
Article 27 d – paragraph 2 – subparagraph 1
Article 27 d – paragraph 2 – subparagraph 1
Member States shallmay require that, as part of the review of the permit conditions pursuant to Article 21(3) following the publication of decisions on BAT conclusions after 1 January 2030, the operator includes in its environmental management system referred to in Article 14a an indicative transformation plan for each installation carrying out any activity listed in Annex I that is not referred to in paragraph 1as set out in paragraph 1 of this Article. The transformation plan shall contain information on how the installation will transform itself during the 2030-2050 period in order to contribute to the emergence of a sustainable, clean, circular and climate-neutral economy by 2050, using the format referred to in paragraph 4.
Amendment 1165 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive 2010/75 (EU)
Article 27 d – paragraph 3
Article 27 d – paragraph 3
3. The operator shall make a summary of its transformation plan as well as the non-confidential results of the assessment referred to in paragraphs 1 and 2 public, as part of the publication of its environmental management system.
Amendment 1260 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70b – paragraph 1
Article 70b – paragraph 1
Amendment 1414 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70i – paragraph 1 – subparagraph 2
Article 70i – paragraph 1 – subparagraph 2
The operating rules shall take into account inter alia the nature, type, size and density of these installations and the specificities of pasture based cattle rearing, their animal welfare policies, and other aspects of syustems, where animals are only seasonally reared in indoor installationsainable animal rearing.
Amendment 1501 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 31
Article 1 – paragraph 1 – point 31
Directive 2010/75/EU
Article 79 – paragraph 2
Article 79 – paragraph 2
2. The penalties referred to in paragraph 1 shall include fines proportionate to the naturnover of the legal person or to the income of the natural person having committed the infringemente and severity of the violation concerned, and not exceed the level necessary for fines to be effective and dissuasive. The level of the fines shall be calculated in such a way as to make sure that they effectively deprive the person responsible for the violation of the economic benefits derived from that violation. The level of the fines shall be gradually increased for repeated infringements. In the case of a violation committed by a legal person, the maximum amount of such fines shall be at least 8 % of the operator’s annual turnover in the Member State concerned of the same nature.
Amendment 1552 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 32
Article 1 – paragraph 1 – point 32
Directive 2010/75/EU
Article 79a – paragraph 4
Article 79a – paragraph 4
Amendment 1597 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 2 – point 2.3 – point a b
Annex I – paragraph 3 – subparagraph 2 – point 2.3 – point a b
Amendment 1604 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point b
Annex I – paragraph 1 – point b
Directive 2010/75/EU
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point b
Annex I – paragraph 1 – subparagraph 2 – point 2.3 – point b
(b) operation of smitheries with hammers the energy of which exceeds 20 50 kilojoule per hammer;
Amendment 1614 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point c
Annex I – paragraph 1 – point c
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 2 – point 2.7
Annex I – paragraph 3 – subparagraph 2 – point 2.7
2.7. Manufacture of lithium-ion batteries (inexcluding assembling battery cells and battery packs), with a production capacity of 3,5 GWh or more per year.;
Amendment 1623 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point e
Annex I – paragraph 1 – point e
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 3 – point 3.6 – introductory part
Annex I – paragraph 3 – subparagraph 3 – point 3.6 – introductory part
3.6. Extraction and treatment (operations such as comminution, size control, beneficiation and upgrading) of the following non-energy minerals:processes for non- energy minerals that have a high or significant environmental impact, such as extraction through chemical processing, based on an exhaustive list to be established by the Commission by means of delegated acts.
Amendment 1625 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point e
Annex I – paragraph 1 – point e
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 3 – point 3.6 – point a
Annex I – paragraph 3 – subparagraph 3 – point 3.6 – point a
Amendment 1628 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point e
Annex I – paragraph 1 – point e
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 3 – point 3.6 – point b
Annex I – paragraph 3 – subparagraph 3 – point 3.6 – point b
Amendment 1663 #
2022/0104(COD)
Proposal for a directive
Annex II
Annex II
1. Rearing of cattle, pigs or poultry in installations of 1450 livestock units (LSU) or more, excluding rearing carried out in the context of small scale family farming and organic farming as defined in this Directive.
Amendment 1684 #
2022/0104(COD)
Proposal for a directive
Annex II
Annex II
Directive 2010/75/EU
Annex Ia – paragraph 2
Annex Ia – paragraph 2
Rearing of any mix of the following animals: cattle, pigs, poultry, in installations of 1450 LSU or more.
Amendment 10 #
2022/0100(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Regulation (EC) No 1005/2009 of the European Parliament and of the Council18 ensures, inter alia, that the Union complies with the Protocol. The Commission in its evaluation of Regulation (EC) No 1005/200919 concluded that the control measures established under that Regulation remain, in general, fit-for- purpose, are efficient and have significantly contributed to the recovery of the stratospheric ozone layer and to reduce climate warming. __________________ 18 Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer (OJ L 286, 16.09.2009, p.1). 19 Evaluation of Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer, SWD(2019) 407 final of 26 November 2019.
Amendment 154 #
2022/0100(COD)
Proposal for a regulation
Article 27 – paragraph 5 – subparagraph 1
Article 27 – paragraph 5 – subparagraph 1
In cases of unlawful production, import, export, placing on the market, or use of ozone depleting substances listed in Annex I or of products and equipment containing those substances or whose functioning relies upon those substances and which are without prejudice to Directive 2008/99/EC or national law, Member States shall envisage maximum administrative fines of at least fivesix times the market value of the concerned substances or products and equipment concerned. In case of a repeated infringement within a five-year period, the Member States shall envisage maximum administrative fines of at least eightten times the market value of the concerned substances or products and equipment concerned.
Amendment 166 #
2022/0100(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
By 1 January 20330, the Commission shall publishresent a report on the implementation of this Regulationto the European Parliament and to the Council on the implementation of this Regulation. The Commission shall assess in particular the availability of alternatives to ozone depleting substances for which a derogation is granted under Articles 6, 7, 8 and 9. The Commission shall also assess the impact of this Regulation on the fight against the illegal trade of ozone depleting substances. Following the presentation of this report and the assessments requested, the Commission may, if appropriate, submit a legislative proposal.
Amendment 124 #
2022/0099(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) It is important that this Regulation ensures that the Union complies with its international obligations under the Kigali Amendment to the Protocol in the long- term, in particular, with regards to the reduction of consumption and production of HFCs, reporting and licensing requirements, in particular by introducing a phase-down for production and adding reduction steps for the placing of HFCs on the market for the time after 2030. However to achieve the climate target in energy sector, there might be a rising need of HFCs, in particular in light of the new target established by RePower to deploy 60 million new heat pumps by 2030. It is therefore of outermost importance that this Regulation takes into account the new target as well as the need to further invest in electrification and to expand power grid.
Amendment 126 #
2022/0099(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6 a) Future legislative proposals including the revision of REACH and the potential phase-out of PFAS shall take into account the strict phasing out of HFCs under this Regulation and avoid putting at risk the development of alternative and innovative solutions that could help to fight the climate crisis.
Amendment 165 #
2022/0099(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) Metered Dose Inhalers (MDIs) are life-saving medicines for patients suffering from asthma and chronic obstructive pulmonary disease. To avoid any shortages and ensure a smooth transition to safe, accessible and affordable alternatives, the European Commission, the European Medicine Agency and the Health Emergency Preparedness and Response Authority together with patient associations and healthcare professionals' organisations shall work closely together.
Amendment 168 #
2022/0099(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Considering the market value of the allocated quota, it is appropriate to claim a price for its allocation. This avoids a further fragmentation of the market to the detriment of those undertakings that are in need of the HFC supply and already dependent on HFC trade in the declining market. It is assumed that undertakings that decide not to claim and pay any quota, for which they would be entitled in the year(s) prior to the calculation of reference values, have decided to leave the market and thus they do not get a new reference value. The revenue should be used to cover administrative costs. Any remaining revenue should be allocated to Horizon Europe Fund to incentivise the development of alternatives to HFCs.
Amendment 183 #
2022/0099(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) In implementing this Regulation, tThe Commission should establish a so- called Consultation Forum to ensure a balanced participation of Member States’ representatives and representatives of civil society, including environmentalfacilitate the implementation of this Regulation. The Consultation Forum shall ensure a balanced participation of Member States’ representatives and of all relevant stakeholders including representatives of environmental organisations, patient associations and healthcare professionals' organisations, representatives of manufacturers, operators and certified persons.
Amendment 192 #
2022/0099(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to amend certain non- essential elements of this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (‘TFEU’) should be delegated to the Commission in respect of the establishment of a list of products and equipment for which the recovery of gases or their destruction is technically and economically feasible and the specification of the technologies to be applied; labelling requirements; the exclusion from quota requirements of HFCs in accordance with decisions of the Parties to the Protocol; concerning the amounts due for the allocation of quota and the mechanism to allocate remaining quotas; additional measures for the monitoring of substances and of products and equipment placed under temporary storage and customs procedures; the rules applicable to the release for free circulation of products and equipment imported from and exported to any entity not covered by the Protocol; the update of global warming potentials of listed substances. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level and that twith the Consultation Forum. Those consultations should be conducted in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making38 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 38 OJ L 123, 12.5.2016, p. 1.
Amendment 197 #
2022/0099(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation applies to the fluorinated greenhouse gases listed in Annexes I, II and III, whether alone or in a mixture.
Amendment 199 #
2022/0099(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3 a) 'Fluorinated greenhouse gas' means the hydrofluorocarbons, perfluorocarbons, sulphur hexafluoride and other greenhouse gases that contain fluorine, listed in Annex I, II and III or mixtures containing any of those substances;
Amendment 343 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The placing on the market of products and equipment, including parts thereof, listed in Annex IV, with an exemption for military equipment, shall be prohibited from the date specified in that Annex, differentiating, where applicable, according to the type or global warming potential of the gas contained.
Amendment 357 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 2 a (new)
Article 11 – paragraph 2 a (new)
2 a. The prohibition set out in paragraph 1, first subparagraph shall not apply to spare parts needed for the repairing and maintenance of existing installations.
Amendment 363 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1 – introductory part
Article 11 – paragraph 4 – subparagraph 1 – introductory part
Following a substantiated request by a competent authority of a Member State and taking into account the objectives of this Regulation, the Commission may, exceptionally, by means of implementing acts, authorise an exemption for up to four eight years to allow the placing on the market of products and equipment listed in Annex IV, including parts thereof, containing fluorinated greenhouse gases or whose functioning relies upon those gases, where it is demonstrated that:
Amendment 373 #
2022/0099(COD)
Proposal for a regulation
Article 11 – paragraph 5 – subparagraph 1
Article 11 – paragraph 5 – subparagraph 1
Only undertakings that hold a certificate required under Article 10(1), point (a) or the training attestation required under Article 10(2), or undertakings that employ persons holding such a certificate or a training attestation shall be allowed to purchase fluorinated greenhouse gases listed in Annex I or Annex II, Section 1, and spare parts for the purpose of carrying out the installation, servicing, maintenance or repair of the equipment containing those gases, or whose functioning relies upon those gases, referred to in Article 5(2), points (a) to (g), and Article 10(2). The prohibition set out in paragraph 1, first subparagraph shall not cover spare parts that are needed for repair and maintenance of existing installations.
Amendment 415 #
2022/0099(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The use of desflurane as inhalation anaesthetic is prohibited as from 1 January 20269, except when such use is strictly required and no other anaesthetic can be used on medical grounds. The user shall provide evidence, upon request, on the medical justification to the competent authority of the Member State and the Commission.
Amendment 432 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point e a (new)
Article 16 – paragraph 2 – point e a (new)
(e a) supplied directly by a producer or an importer for medical use if the usage is of medical necessity and if no other suitable alternative is available.
Amendment 439 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 2 – point e b (new)
Article 16 – paragraph 2 – point e b (new)
(e b) supplied directly by a producer or an importer to repair existing installations.
Amendment 444 #
2022/0099(COD)
Proposal for a regulation
Article 16 – paragraph 4 – subparagraph 1 – introductory part
Article 16 – paragraph 4 – subparagraph 1 – introductory part
Following a substantiated request by a competent authority of a Member State and taking into account the objectives of this Regulation, the Commission may, exceptionally by means of implementing acts, authorise an exemption for up to foureight years to exclude from the quota requirement laid down in paragraph 1 hydrofluorocarbons for use in specific applications, or specific categories of products or equipment, where it is demonstrated in the request that:
Amendment 463 #
2022/0099(COD)
Proposal for a regulation
Article 17 – paragraph 5 – subparagraph 1
Article 17 – paragraph 5 – subparagraph 1
The allocation of quotas is subject to the payment of the amount due which equals to threfive euro for each tonne of CO2 equivalent of quota to be allocated. Importers and producers shall be notified via the F-gas Portal of the total amount due for its calculated maximum quota allocation for the following calendar year and of the deadline for completing the payment. The Commission may, by means of implementing acts, determine the modalities and the detailed arrangements for the payment of the amount due. Those implementing acts shall be adopted in accordance with the examination procedure referred to in 34(2).
Amendment 479 #
2022/0099(COD)
Proposal for a regulation
Article 17 – paragraph 7
Article 17 – paragraph 7
7. The revenue generated from the quota allocation amount shall constitute external assigned revenue in accordance with Article 21(5) of Regulation (EU, Euratom) No 2018/1046. That revenue shall be assigned to the LIFE programme and to Heading 7 of the multiannual financial framework (European Public Administration), to cover the costs of external staff working on the management of the quota allocation, IT services, and licensing systems for the purpose of implementation of this Regulation and for ensuring compliance with the Protocol. Any revenue remaining after covering these costs shall be entered into the general budget of the Unionallocated to Horizon Europe Fund.
Amendment 537 #
2022/0099(COD)
Proposal for a regulation
Article 31 – paragraph 5 – subparagraph 1
Article 31 – paragraph 5 – subparagraph 1
In cases of unlawful production, import, export, placing on the market, or use of fluorinated greenhouse gases or of products and equipment containing those gases or whose functioning relies on those gases, Member States shall envisage maximum administrative fines of at least fivesix times the market value of the concerned gases or products and equipment concerned. In case of a repeated infringement within a five- year period, the Member States shall envisage maximum administrative fines of at least eightten times the value of the gases or products and equipment concerned.
Amendment 543 #
2022/0099(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
The Commission shall establish a Consultation Forum for providing advice and expertise in relation to the implementation of this Regulation. The Consultation Forum shall ensure a balanced participation of representatives of Member States and of all relevant stakeholders including environmental organisations, patient associations and healthcare professionals organisations, representative of manufacturers, operators and certified persons. The rules of procedure of the Consultation Forum shall be established by the Commission and shall be published.
Amendment 627 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 17
Annex IV – point 17
(17) Plug-in room and other self-contained air-conditioning and heat pump 1 January equipment that contain fluorinated greenhouse gases with GWP of 150 20257 or more.
Amendment 636 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 18
Annex IV – point 18
(18) Stationary split air-conditioning and split heat pump equipment : (a) Single split systems containing less than 3 kg of fluorinated greenhouse gases listed in Annex I, that contain, or whose 1 January 1 January greenhouse gases listed in Annex I, that contain, or whose 2025 functioning relies upon, fluorinated greenhouse gases listed in 2025 Annex I with GWP of 750 or more; (b) Split systems of a rated capacity of up to and including 12 kW containing, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 150 or more, except when required to meet safety standards; 1 January (c) Split systems of a rated capacity of more than 12 kW containing, 20279 containing, or whose functioning relies upon, fluorinated greenhouse gases with GWP of 750 or more, except when required to meet safety standards.
Amendment 650 #
2022/0099(COD)
Proposal for a regulation
Annex IV – point 23
Annex IV – point 23
(a) medium voltage switchgear for primary and secondary distribution up to 24 kV, with insulating or breaking medium using, or (23) Installation and whose functioning relies upon, gases with replacement of the 1 January GWP of 10 or more, or with GWP of 2000 following electricalmore than 1000 or more, unless 2026 or more than 2000, unless evidence is switchgear:2026 evidence is provided that no suitable alternative is alternative is available based on technical grounds within (23) Installation and grounds within the lower GWP ranges replacement of referred to above; the following (b) medium voltage switchgear for primary and electrical secondary distribution from more than 24 switchgear: kV and up to 52 kV, with insulating or breaking medium using, or whose 1 January functioning relies upon gases with GWP of 1 January 10 or more, or with GWP of more than 2030 2more than 1000, unless evidence is provided that no provided that no suitable alternative is available based on available based on technical grounds within the lower GWP the lower GWP ranges referred to above; (c) high voltage switchgear from 52 and up to 145 kV and up to 50 kA short circuit current with insulating or breaking medium using, or whose functioning relies upon gases with 1 January GWP of 10 or more, or with GWP of 2028 1 January GWP of more than 21000, unless evidence is 2028 is provided that no suitable alternative is available based on technical grounds within the lower GWP ranges referred to above; (d) high voltage switchgear of more than 145 kV or more than 50 kA short circuit current with insulating or breaking medium using, or whose functioning relies upon gases with 1 January GWP of 10 or more, or with GWP of 2031 1 January GWP of more than 21000, unless evidence is 2031 is provided that no suitable alternative is available based on technical grounds within the lower GWP ranges referred to above.
Amendment 678 #
2022/0099(COD)
Proposal for a regulation
Annex VII – point 1
Annex VII – point 1
Maximum Quantity Years in tonnes CO2 equivalent 2024 – 2026 415 701 077 2027 – 2029 17 688 36030 850 539 2030 – 2032 9 132 09717 688 360 2033 – 2035 8 445 7139 132 097 2036 – 2038 6 782 265 2039 – 2041 4 6 136 73238 941 2042 – 2044 5 491 193 247 259 2045 – 2047 4 845 6661 623 629 2048 onwards-2049 811 814 4 2050 133 0
Amendment 126 #
2022/0095(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) In order to create an effective and future-proof regulatory framework, it is necessary to allow for the setting of ecodesign requirements on all physical goods placed on the market or put into service, including components and intermediate products. This should allow the Commissions to take into account the broadest range of products possible when prioritising the establishment of ecodesign requirements and thereby maximise their effectiveness. Where needed, specific exemptions should be made when setting ecodesign requirements, for example for products with a particular purpose that could not be fulfilled when complying with ecodesign requirements or for second- hand products and new or second-hand components, originally designed or manufactured before the entry into force of this Regulation or of the relevant delegated act. In addition, exemptions should be made at the level of the framework for those products for which it is already clear that ecodesign requirements would not be suitable or where other frameworks provide for the setting of such requirements, as is for example the case for batteries, toys and packaging. This should be the case for food and feed as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council44 , medicinal products for human use as defined in Directive 2001/83/EC of the European Parliament and of the Council45 , veterinary medicinal products as defined in Regulation (EU) 2019/6 of the European Parliament and of the Council46 , living plants, animals and micro-organisms, products of human origin, and products of plants and animals relating directly to their future reproduction. __________________ 44 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). 45 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 46 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).
Amendment 137 #
2022/0095(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to allow the Commission to set requirements as appropriate to the product groups covered, ecodesign requirements should include performance and information requirements. Those requirements should be used to improve product aspects relevant for environmental sustainability, such as energy efficiency, durability, reparability and, reusability, refurbishment as well as carbon and environmental footprints. Ecodesign requirements should be transparent, objective, proportionate and in compliance with international trade rules.
Amendment 143 #
2022/0095(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) To avoid duplication of efforts and regulatory burden, consistency should be ensured between this Regulation and requirements set in or pursuant to other Union legislation, especially products, chemicals and waste legislation51 , including legislation on packaging and packaging waste. However, the existence of empowerments under other Union legislation to set requirements with the same or similar effects as requirements under this Regulation does not limit the empowerments included in this Regulation, unless specified in this Regulation. __________________ 51 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the implementation of the circular economy package - options to address the interface between chemical, product and waste legislation (COM(2018) 32 final).
Amendment 181 #
2022/0095(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Information on the presence of substances of concern in products, and their safety determined through a proper risk-assessment, is a key element to identify and promote products that are sustainable. The chemical composition of products determines largely their functionalities and impacts, as well as the possibilities for their re-use or for recovery once they become waste. The Chemicals Strategy for Sustainability64 calls for minimising the presence of substances of concern in products, and ensuring the availability of information on chemical content and safe use, by introducing information requirements and tracking the presence of substances of concern throughout the life cycle of materials and products. Regulation (EC) No 1272/2008 of the European Parliament and of the Council65 and other existing chemicals legislation such as Regulation (EC) No 1223/2009 already ensure communication on hazards to health or the environment posed by certain substances of concern on their own or in a mixture. Users of substances and mixtures should also be informed about pertinent sustainability- related information not primarily related to hazards to health or the environment. Furthermore, users of products other than substances or mixtures, and managers of waste from such products, should also receive sustainability-related information, including information primarily related to chemicals’ hazardssafety to health or the environment based on the result of the risk-assessment. Therefore, this Regulation should allow for the setting of requirements related to the tracking and communication of sustainability information, including the presence of substances of concern and their safe use in products throughout their life cycle, including with a view to their decontamination and recovery when they become waste. Such a framework should aim to progressively cover all substances of concern in all products listed in working plans setting out the product groups the Commission intends to tacklTo limit administrative burden, actors should only be required to deliver data once. __________________ 64 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Chemicals Strategy for Sustainability Towards a Toxic-Free Environment COM(2020)667 final. 65 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 187 #
2022/0095(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Information on the presence of substances of concern in products is a key element to identify and promote products that are sustainable. The chemical composition of products determines largely their functionalities and impacts, as well as the possibilities for their re-use or for recovery once they become waste. The Chemicals Strategy for Sustainability64 calls for minimising the presence of substances of concern in products, and ensuring the availability of information on chemical content and safe use, by introducing information requirements and tracking the presence of substances of concern throughout the life cycle of materials and products. Regulation (EC) No 1272/2008 of the European Parliament and of the Council65 and other existing chemicals legislation such as Regulation (EC) No 1223/2009 already ensure communication on hazards to health or the environment posed by certain substances of concern on their own or in a mixture. Users of substances and mixtures should also be informed about pertinent sustainability- related information not primarily related to hazards to health or the environment. Furthermore, users of products other than substances or mixtures, and managers of waste from such products, should also receive relevant sustainability-related information, including information primarily related to chemicals’ hazards to health or the environment. Therefore, this Regulation should allow for the setting of requirements related to the tracking and communication of sustainability information, including the presence of substances of concern in products throughout their life cycle, including with a view to their decontamination and recovery when they become waste. Such a framework should aim to progressively cover all substances of concern in all products listed in working plans setting out the product groups the Commission intends to tackle. __________________ 64 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Chemicals Strategy for Sustainability Towards a Toxic-Free Environment COM(2020)667 final. 65 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
Amendment 205 #
2022/0095(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To drive consumers towards more sustainable choices, labels should, when required by the delegated acts adopted pursuant to this Regulation, provide clear and understandable information allowing for the effective comparison of products, for instance by indicating classes of performance. Specifically for consumers, physical labels can be an additional source of information at the place of sale. They can provide a quick visual basis for consumers to distinguish between products based on their performance in relation to a specific product parameter or set of product parameters. They should, where appropriate, also allow for the accessing of additional information by bearing specific references like website addresses, dynamic QR codes, links to online labels or any appropriate consumer-oriented means. The Commission should set out in the relevant delegated act the most effective way of displaying such labels, including in the case of online distance selling, taking into account the implications for customers and economic operators and the characteristics of the products concerned. The Commission may also require the label to be printed on the packaging of the product.
Amendment 215 #
2022/0095(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) In order to encourageallow self- regulation as a valid alternative to regulatory approaches, this Regulation should, in continuation of Directive 2009/125/EC, include the possibility for industry to submit self-regulation measures that are aligned with and reflective of the objectives of this Regulation. The Commission should assess the self- regulation measures proposed by industry, along with the information and evidence submitted by the signatories, including in light of the international trade commitments of the Union and the need to ensure coherence with Union law. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt and update an act listing the self-regulation measures considered as valid alternatives to a delegated act setting ecodesign requirements. It is also appropriate, for instance in view of relevant market or technological developments within the product group concerned, that the Commission be able to request a revised version of the self-regulation measure whenever considered necessary. Once a self-regulation measure is listed in an implementing act, there is a legitimate expectation for economic operators that the Commission will not adopt a delegated act establishing ecodesign requirements for this specific product group. However, it is not excluded that the Commission may adopt horizontal ecodesign requirements also applying to the products covered by a recognised self-regulation measure for the product aspects not addressed by that self- regulation measure. Where the Commission considers that a self- regulation measure no longer fulfils the criteria set in this Regulation, it should remove that self-regulation from the implementing act listing the recognised self-regulation measures. Consequently, ecodesign requirements may then be established for the product groups previously addressed by the self-regulation measure, in accordance with this Regulation.
Amendment 219 #
2022/0095(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) Micro, small and medium-sized enterprises (SMEs) could greatly benefit from an increase in the demand for sustainable products but could also face costs and difficulties with some of the requirements. The Member States and the Commission should, in their respective areas of responsibility, provide adequate information, ensure targeted and specialised training, and provide specific assistance and support, including financial, to SMEs active in the manufacturing of products for which ecodesign requirements are set, including existing funding and financing tools. Those actions should, for example, cover the calculation of a scientifically robust and verifiable life-cycle based standard, such as the product environmental footprint, and the technical implementation of the product passport, and could facilitate SMEs' access to relevant digital tools, software and databases. Member States actions should be taken in respect of applicable State aid rules.
Amendment 238 #
2022/0095(COD)
Proposal for a regulation
Recital 57 a (new)
Recital 57 a (new)
(57a) The second-hand sector plays a specific role in promoting sustainable consumption patterns and in the development of new circular business models. Due to the specifities of those sectors, the role of second-hand economic operators along the value chain and related obligations must be distinguished from those applying to manufacturers, authorized representatives, importers, distributers, or dealers of new products. Therefore, this Regulation should further lay down rules applicable to second hand- economic operators.
Amendment 273 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 – point f
Article 1 – paragraph 1 – subparagraph 1 – point f
(f) recycled and by-product content in products;
Amendment 276 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 – point g
Article 1 – paragraph 1 – subparagraph 1 – point g
(g) product remanufacturing and recycling;
Amendment 280 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 – point g a (new)
Article 1 – paragraph 1 – subparagraph 1 – point g a (new)
(ga) product recyclability;
Amendment 317 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 18
Article 2 – paragraph 1 – point 18
(18) ‘refurbishment’ means preparing or modifyingtesting, and where necessary performing repair and maintenance, as well as deleting data connected to the previous use, including personal data, in case of electronic devices, by a professional, on an object that is waste or a second-hand product to restore its performance or functionality within the intended use, range of performance and maintenance originally conceived at the design stage, or to meet applicable technical standards or regulatory requirements, with before making it available on the market. Refurbishment may also include improving the raesult of making a fully functionalthetics of the product;
Amendment 327 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 20 b (new)
Article 2 – paragraph 1 – point 20 b (new)
(20b) 'recyclability' means the ability of a product to be recycled when it reaches its end-of-life stage, by using recycling techniques commercially available within the EU;
Amendment 352 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point a
Article 2 – paragraph 1 – point 28 – point a
(a) meets the criteria laid down in Article 57 and is identifiimpedes the re-use and recycling of materials in the product in which it is present, based ion accordance with Article 59(1) of Regulation (EC) No 1907/2006commercially available recycling technologies; or
Amendment 426 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 46 a (new)
Article 2 – paragraph 1 – point 46 a (new)
(46a) 'second-hand economic operator' means any economic operator or undertaking who makes available on the market second-hand products or components, whether prepared for reuse, checked, cleaned, repaired, refurbished, or without any action undertaken on the product;
Amendment 450 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
In addition, the definitions of ‘waste’, ‘hazardous waste’, ‘re-use’, ‘recovery’, ‘preparing for re-use’ and ‘recycling’ in Article 3, points (1), (2), (13), (15), (16) and (17), and by-products in Article 5 of Directive 2008/98/EC of the European Parliament and of the Council83 shall apply. __________________ 83 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
Amendment 470 #
2022/0095(COD)
Proposal for a regulation
Article 3 – paragraph 5 a (new)
Article 3 – paragraph 5 a (new)
5a. In order to promote re-use and to stimulate circular business models in line with the waste hierarchy, second-hand goods placed on the market shall be exempted from the obligations as laid down in Article 3, point (1).
Amendment 477 #
2022/0095(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
When establishing ecodesign requirements in delegated acts referred to in the first subparagraph, the Commission shall provide economic operators with sufficient transition time, with special consideration for the needs of SMEs. The Commission shall also supplement this Regulation by specifying the applicable conformity assessment procedures from among the modules set out in Annex IV to this Regulation and Annex II to Decision No 768/2008/EC, with the adaptations necessary in view of the product or ecodesign requirements concerned, in accordance with Article 36.
Amendment 493 #
2022/0095(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point e
Article 4 – paragraph 3 – point e
(e) requiring the use of verified online tools to calculate the performance of a product in relation to a product parameter referred to in Annex I, in accordance with Article 32(2);
Amendment 495 #
2022/0095(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point h
Article 4 – paragraph 3 – point h
(h) establishing relevant requirements applicable to public contracts, including implementation, monitoring and reporting of those requirements by Member States. Those requirements shall be based on the product parameters referred to in Annex I and established in accordance with Article 58.
Amendment 507 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point e a (new)
Article 5 – paragraph 1 – point e a (new)
(ea) recyclability
Amendment 522 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point j
Article 5 – paragraph 1 – point j
(j) recycled and by-product content;
Amendment 526 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point k
Article 5 – paragraph 1 – point k
(k) possibility of remanufacturing and recycling;
Amendment 549 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 3 – point b a (new)
Article 5 – paragraph 3 – point b a (new)
(ba) Following the 'repair as produced' principle as introduced in Directive No 2011/65/EU85a, the following products shall be exempted from ecodesign requirements to be set out in the Delegated Acts pursuant to Article 4: (a) spare parts for products that were placed on the market before the date of application of the delegated act; (b) products that are intended to be a part of more complex products that were placed on the market before the date of application of the delegated act. __________________ 85a Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
Amendment 566 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 4 – point a – point ii
Article 5 – paragraph 4 – point a – point ii
(ii) relevant Union legislation, including the extent to which it addresses the relevant product aspects listed in paragraph 1, with a view to ensure harmonisation and avoid conflicting or duplicating requirements in relation to existing legislation;
Amendment 578 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 4 – point a – point v a (new)
Article 5 – paragraph 4 – point a – point v a (new)
(va) the outcomes of relevant consultations, including the views expressed in the Ecodesign Forum.
Amendment 604 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 5 – point d
Article 5 – paragraph 5 – point d
(d) there shall be no disproportionate negative impact on the competitiveness of economic actors, at least ofin particular for SMEs;
Amendment 616 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5a. there shall be a transition time between the entering into force of an ecodesign requirement and its application, which shall be proportionate to the significance and complexity of the requirements set out.
Amendment 647 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point a
Article 7 – paragraph 2 – point a
(a) include, as a minimum, requirements related to the product passport referred to in Chapter III and requirements related to substances of concern referred to in paragraph 5 only when such substances are physically present within the product; and
Amendment 676 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – introductory part
Article 7 – paragraph 5 – subparagraph 1 – introductory part
The information requirements referred to in paragraph 1 shall enable the tracking of allrelevant substances of concern throughout the life cycle ofincluded in products, unless such tracking is already enabled by another delegated act adopted pursuant to Article 4 covering the products concerned, and shall include at least the following:
Amendment 678 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – introductory part
Article 7 – paragraph 5 – subparagraph 1 – introductory part
The information requirements referred to in paragraph 1 shall enable the tracking of all relevant substances of concern throughout the life cycle of products, unless such tracking is already enabled by another delegated act adopted pursuant to Article 4 covering the products concerned, and shall include at least the following:
Amendment 684 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – point b
Article 7 – paragraph 5 – subparagraph 1 – point b
(b) the location of the substances of concern within the product, where relevant;
Amendment 757 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point f
Article 8 – paragraph 2 – point f
(f) the actors that shall have access to information in the product passport and to what information they shall have access on a need-to-know basis, including customers, end-users, manufacturers, importers and distributors, dealers, repairers, refurbishers, remanufacturers, recyclers, competent national authorities, public interest organisations and the Commission, or any organisation acting on their behalf;
Amendment 768 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 2 – point g
Article 8 – paragraph 2 – point g
(g) the actors that may introduce or update the information in the product passport, including where needed the creation of a new product passport, and what information they may introduce or update, including manufacturers, repairers, refurbishers, maintenance professionals, remanufacturers, recyclers, competent national authorities, and the Commission, or any organisation acting on their behalf;
Amendment 782 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) ensure that actors along the value chain, in particular consumers, economic operators and competent national authorities, can access relevant product information relevant to themon a need-to-know basis;
Amendment 801 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point c c (new)
Article 8 – paragraph 3 – point c c (new)
(cc) where applicable, protect confidential business information and ensure information is shared in a secure way.
Amendment 807 #
2022/0095(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. The Commission shall ensure a sufficient transition time from the moment the information requirements to be adopted pursuant to Article 4 are finalised, in order for economic operators to gather, verify and upload any relevant information. Any changes to the information requirements to be adopted pursuant to Article 4 shall be accompanied by a sufficient transition time, with prolonged transition times for SMEs.
Amendment 818 #
2022/0095(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point d
Article 9 – paragraph 1 – subparagraph 1 – point d
(d) all information included in the product passport shall be based on open, standards, developed with an inter-operable format and shall be machine-readable, structured, and searchable, in accordance with the essential requirements set out in Article 10 and in respect of confidential business information;
Amendment 823 #
2022/0095(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point f
Article 9 – paragraph 1 – subparagraph 1 – point f
(f) the access to information included in the product passport shall be regulated in accordance with the essential requirements set out in Article 10 and the specific access rights at product group level shall be identified in the applicable delegated act adopted pursuant to Article 4, in consideration of confidential business information.
Amendment 827 #
2022/0095(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 – point f a (new)
Article 9 – paragraph 1 – subparagraph 1 – point f a (new)
(fa) where relevant, it shall rely on existing EU databases, such as the SCIP and EPREL databases.
Amendment 861 #
2022/0095(COD)
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 3 a (new)
Article 12 – paragraph 1 – subparagraph 3 a (new)
Economic operators, in particular SMEs, shall be provided with sufficient transition time to gather, verify and upload the requested data into the applicable IT tool.
Amendment 917 #
2022/0095(COD)
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1 – introductory part
Article 18 – paragraph 2 – subparagraph 1 – introductory part
The submitted self-regulation measure shall contain the following information:
Amendment 919 #
2022/0095(COD)
Proposal for a regulation
Article 18 – paragraph 3 – subparagraph 1 – introductory part
Article 18 – paragraph 3 – subparagraph 1 – introductory part
The Commission shall assess the propossubmitted self-regulation measure, and, where necessary, shall seek scientific advice from Union decentralised agencies. On the basis of that assessment, it shall establishthe Commission shall verify whether it is a valid alternative to a delegated act adopted pursuant to Article 4 where the following criteria are fulfilled:
Amendment 921 #
2022/0095(COD)
Proposal for a regulation
Article 18 – paragraph 3 – subparagraph 1 – point a
Article 18 – paragraph 3 – subparagraph 1 – point a
(a) the self-regulation measure contributes to improving the environmental sustainability of products in line with the objectives of this Regulation and ensuring the free movement in the internal market quickly or at a lesser expense than a delegated act adopted pursuant to Article 4;
Amendment 931 #
2022/0095(COD)
Proposal for a regulation
Article 18 – paragraph 4
Article 18 – paragraph 4
4. The Commission may at any point in time request the signatories of a self- regulation measure to submit a revised and updated version of that measure in view of relevant market or technological developments within the product group concerned or where it has reason to believe, based on substantiated claims, that the criteria set out in paragraph 3 are no longer fulfilled. Signatories shall have the possibility to withdraw from or maintain part of the self-regulation measure in response to this request.
Amendment 936 #
2022/0095(COD)
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Where the Commission considers, based on information received pursuant to paragraphs 4 or 5, that a self-regulation measure no longer fulfils the criteria set out in paragraph 3, it shall provide its signatories with a reasonable timeframe within which to take corrective measures, before deciding whether to delete it from the list referred to in that paragraph. In such cases, the Commission may decide to adopt ecodesign requirements applicable to the product covered by that self-regulation measure.
Amendment 960 #
2022/0095(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 – introductory part
Article 20 – paragraph 1 – subparagraph 1 – introductory part
Amendment 1111 #
2022/0095(COD)
Proposal for a regulation
Annex I – paragraph 1 – point h
Annex I – paragraph 1 – point h
(h) use or content of recycled materials and by-products;
Amendment 94 #
2022/0094(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) In order to contribute to the objectives of the European Green Deal and the Circular Economy Action Plan, and to ensure safe construction products, safety being one of the goals to be pursued in the legislation based on Article 114 of the Treaty on the Functioning of the European Union (TFEU), inherent product requirements related to safety, functionality and protection of environment, including climate, are necessary. When setting these requirements, the Commission should take into account their potential contribution to achieving Union climate, environmental and energy efficiency objectives. These requirements do not merely relate to the performance of construction products. Contrary to its predecessor Directive 89/106/EC, Regulation (EU) No. 305/2011 does not provide for the possibility to establish such inherent product requirements. However, certain harmonised standards for construction products contain such inherent product requirements which can relate to environment, to safety or simply to the good functioning of the product. These standards demonstrate that there is a practical need for such requirements on safety, the environment or simply the functioning of products. Article 114 TFEU as the legal base of this Regulation also imposes the pursuit of a high level of protection of the environment, health and human safety. Thus, this Regulation should (re-)introduce or validate inherent product requirements. Whilst these requirements need to be laid down by the legislator, there is a need for specifying them for the more than 30 product families, each with several categories. Hence, 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 specify the requirements for the respective construction product family or category. The European Commission shall consult European standardisation organisations and relevant stakeholders prior the adoption of the delegated acts.
Amendment 98 #
2022/0094(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) In particular, in the case of energy- related products included in ecodesign working plans which are also construction products and for intermediary products, with the exception of cement, priority for the setting of sustainability requirements will be given to the [ESPR] with the exception for cement for which such requirements shall be defined by this Regulation. This should be the case for instance for heaters, boilers, heat pumps, water and space heating appliances, fans, cooling and ventilating systems and photovoltaic products, excluding building- integrated photovoltaic panels. This Regulation may still intervene in a complementary manner where needed, mainly in relation to safety aspects also taking account of other Union legislation on products such as on gas appliances, low voltage, and machinery. For other products, in order to avoid unnecessary burden for economic operators, the need may arise in future to determine the conditions under which the fulfilment of obligations under other Union law also fulfils certain obligations under this Regulation. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to determine such conditions.
Amendment 108 #
2022/0094(COD)
Proposal for a regulation
Recital 47
Recital 47
Amendment 120 #
2022/0094(COD)
Proposal for a regulation
Article 2 – paragraph 3 – point d
Article 2 – paragraph 3 – point d
Amendment 150 #
2022/0094(COD)
Proposal for a regulation
Article 4 – paragraph 3 – subparagraph 1 (new)
Article 4 – paragraph 3 – subparagraph 1 (new)
The Commission shall consult European standardisation organisations and relevant stakeholders prior to the adoption of the delegated acts referred to paragraph 3.
Amendment 219 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
Amendment 223 #
2022/0094(COD)
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
Amendment 240 #
2022/0094(COD)
Proposal for a regulation
Article 83 – paragraph 1 – subparagraph 1
Article 83 – paragraph 1 – subparagraph 1
Where Member States provide incentives for a product category covered by a delegated act establishing performance classes in accordance with Article 4(4), point (a) or a “traffic-light-labelling” in accordance with Article 22(5), those incentives shall aim at the highest two populated classes / colour codes, or at higher classes / better colour codes.
Amendment 290 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – introductory part
Annex I – Part A – point 2 – paragraph 2 – introductory part
Harmonised technical specifications shall to the extent possible cover the following essential characteristics related to life cycle assessment defined in point (a) to (j):
Amendment 294 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point a
Annex I – Part A – point 2 – paragraph 2 – point a
(a) climate change effects (mandatory);
Amendment 320 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point k
Annex I – Part A – point 2 – paragraph 2 – point k
Amendment 322 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point l
Annex I – Part A – point 2 – paragraph 2 – point l
Amendment 324 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point m
Annex I – Part A – point 2 – paragraph 2 – point m
Amendment 326 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point n
Annex I – Part A – point 2 – paragraph 2 – point n
Amendment 328 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point o
Annex I – Part A – point 2 – paragraph 2 – point o
Amendment 329 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 2 – point p
Annex I – Part A – point 2 – paragraph 2 – point p
Amendment 333 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 3
Annex I – Part A – point 2 – paragraph 3
Harmonised technical specifications shall indicate that for the essential characteristic of climate change effectss defined under points (a) to (j) it is mandatory for the manufacturer to declare the performance of the product as set out in Articles 11(2) and 22(1).
Amendment 337 #
2022/0094(COD)
Proposal for a regulation
Annex I – Part A – point 2 – paragraph 4 a (new)
Annex I – Part A – point 2 – paragraph 4 a (new)
Harmonised technical specifications may include the following characteristics related to life-cycle assessment defined by point (a) to (f): (a) particulate matter; (b) ionizing radiation, human health; (c) eco-toxicity, freshwater; (d) human toxicity, cancer; (e) human toxicity, non-cancer; (f) land use related impacts.
Amendment 3 #
2021/2255(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the New European Bauhaus (NEB) initiative, which is intended to round offgive the European Green Deal a strong creative and cultural dimension and complement strategies for territorial, social and economic cohesion with its values of beautiful, sustainable and inclusive solutions, thereby improving quality of life for people in the EU;
Amendment 40 #
2021/2255(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Notes that the NEB encompasses many dimensions and policy areas, which may make it difficult for regional and local authorities to fully understand how to make the most of its opportunities; underlines the crucial role of local and regional authorities in implementing the NEB, as decentralised management allows for a better territorial approach; calls on the Commission, therefore, to provide specific and targeted information on projects, funding, technological and capacity- building opportunities as well as clear definitions of award criteria;
Amendment 48 #
2021/2255(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Underlines that the NEB, in order to be really impactful, visible and successful in the long term, requires fresh financial resources;
Amendment 2 #
2021/2254(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the Commission’s presentation of its long-term vision for rural areas; emphasises that the development of rural areas must be kept high on the EU agenda, as rural areas are active actors in the EU’s green and digital transition;
Amendment 23 #
2021/2254(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Highlights the importance to strengthen the bottom-up approach to rural and local development, which is a vehicle for social innovation and capacity building, empowering rural citizens to take ownership of their area's development through the design and implementation of strategy and projects;
Amendment 25 #
2021/2254(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Requestcalls that the Commission propose a single EU-wide definition of functional rural arearural areas are very diverse across Europe; highlights that the differences between each Member State and region must be taken into account when drawing up rural development plans;
Amendment 45 #
2021/2254(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Underlines the fact that the main objective of the long-term vision should be to fight depopulation, ageing and rural abandonment, including through investment in infrastructure, ensuring efficient connectivity, including broadband connections, and the provision of services, including digital, as well as economic diversification, job creation and innovative mobility solutions; underlines the role of SMEs in achieving these objectives;
Amendment 73 #
2021/2254(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Highlights the opportunities that the green transition and green economy can provide in terms of job opportunities, in increasing rural resilience to natural disasters, climate change and economic crises and in bringing renewed attention to rural areas;
Amendment 84 #
2021/2254(INI)
Draft opinion
Paragraph 10
Paragraph 10
10. Believes that connections between rural and urban areas must be addressed in a complementary manner in order to implement rural strategies and action plans accordingly; underlines the importance of partnerships across rural areas and remote areas in particular as well as cooperation between rural areas across national borders; emphasises the importance of fighting the digital divide between urban and rural areas, especially as regards high- speed broadband connectivity and the promotion of digital skills;
Amendment 90 #
2021/2254(INI)
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Underlines the importance of quality, affordable and safe public transports connecting rural areas; stresses the need for EU cohesion funds to support the improvement of connectivity and mobility solutions in rural areas;
Amendment 96 #
2021/2254(INI)
Draft opinion
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Underlines the need to strongly improve access to healthcare in rural areas through appropriate and, where necessary, itinerant medicine solutions and services, such as equipped buses offering citizens living in rural areas the possibility to undergo preventive screening tests or consultations;
Amendment 100 #
2021/2254(INI)
Draft opinion
Paragraph 12
Paragraph 12
12. Highlights the diversity of rural areas and the crucial importance of tailor- made territorial approaches in implementing the long-term vision, primarily in less developed, remote, sparsely populated areas and outermost regions.
Amendment 12 #
2021/2202(INI)
Motion for a resolution
Recital B
Recital B
B. whereas border regions, especially those with a low population density, tend to experience more unless favourable development conditions and are generally less economically successful than other regions within Member States, and whereas their economic potential is not being fully tapped;
Amendment 42 #
2021/2202(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Welcomes the progress the Commission has made thus far in implementing its 2017 action plan, in particular via the ‘b-solutions’ initiative – which has made it possible to provide legal and administrative support to authorities in border authoritieregions and to resolve 90 cases involving barriers to interaction – and via the support provided to improve access to employment, promote multilingualism in border areas and pool healthcare facilities;
Amendment 55 #
2021/2202(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Emphasises that the regulation on a European cross-border mechanism (ECBM)ECBM, as proposed by the Commission, would have contributed to removed more than 50 % of the barriers concerned, including those resulting from the lack of cross-border public transport, and limited access to employment, education, cultural and leisure services; with that in mind, deeply regrets the fact that the legislative procedure relating to the ECBM has been blocked by the Council;
Amendment 63 #
2021/2202(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Emphasises that alongside the damage caused by COVID-19, border regions are also having to dealconfronted with the consequences of Brexit, which are creating new barriers to free trade and causing serious disruption to cross-border trade between the EU and the UK, making life more difficult for businesses and citizens in border regions; welcomes, in that regard, the agreement reached on the Brexit Adjustment Reserve to provide financial and legal support to Member States and regions affected by Brexit;
Amendment 66 #
2021/2202(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Notes with interest that the public consultation on overcoming border obstacles conducted by the Commission in 2020 showed that the main problem experienced by people living in border areas wasere, among others, the lack of reliable cross-border public transport services, the lack of digital services and their limited cross-border interoperability, obstacles directly due to language differences, obstacles related to the legislative processes, and to economic disparities;
Amendment 93 #
2021/2202(INI)
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Recalls that natural catastrophes occurred in 2021 affected several border regions in Belgium, France, Luxembourg, the Netherlands, and Germany; notes that an enhanced cross-border cooperation in information sharing, exchange of best practices, and joint civil protection operations could ensure a more effective and prompt reaction;
Amendment 13 #
2021/2106(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Regrets that the absorption rate of European Structural and Investment Funds , which increased from 12% in 2019 to 15% in 2020 , is slower than expected with 45 % (EUR 209 billion) remaining to be absorbed and presents considerable disparities between Member States; acknowledges that the relaxation of the eligibility rules introduced for Covid-19 related expenditure resulted in a significant progress made in implementing financial instruments (FIs) supported by European Structural and Investment Funds (ESIF) in the 2014- 2020; welcomes that this accelerated implementation allows the EU to achieve the target set out in the Investment Plan for Europe to double the use of ESIF FIs in the programming period 2014-2020;
Amendment 19 #
2021/2106(DEC)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Acknowledges that, in order to react to the Covid-19 pandemic, the EU co-legislators introduced the relaxation of applicable rules to facilitate the use of ESI funds to provide liquidity, flexibility and simplification; welcomes the timely adoption of such measures allowing managing authorities to accelerate the deployment of Financial Instruments to support 365.000 SMEs across Europe during 2020; calls on the Commission to provide support to the Member States to minimise the risk that these exceptional measures could weaken the control systems and increase the risk of errors and irregularities;
Amendment 10 #
2021/2101(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the EU’s ambition is to pursue digital policies that empower people and businesses to achieve a sustainable and prosperous digital future in all regions;
Amendment 20 #
2021/2101(INI)
Motion for a resolution
Recital D
Recital D
D. whereas there is still a digital divide in the EU in terms of geography, age, gender, educational attainment, socio- economic status and income, which prevents some individuals and businesses from reaping the benefits of the digital transformation; whereas the digital divide plays an undeniable role in further alienating the so-called "places that don't matter" thus reinforcing the Union's territorial imbalances and contributing to the economic and political instability that derives from it;
Amendment 29 #
2021/2101(INI)
Motion for a resolution
Recital E
Recital E
E. whereas, in spite of the fact that the COVID-19 pandemic 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 andwhich offers a great potential to decentralize working places from urban to rural areas; whereas there aremain 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 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 38 #
2021/2101(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
F a. whereas the COVID-19 pandemic has heightened many of the already existing problems in rural areas and has emphasized the vulnerability of these regions, notably in terms of digital capacity, quality and delivery of health services, education, access to broadband, resilience of value chains, and digital skill competences;
Amendment 74 #
2021/2101(INI)
7. CallsHighlights the need to overcome the persisting digital divide between rural and urban areas, and to develop the potential offered by connectivity and digitalisation in rural areas through the development of a horizontal strategy; calls therefore on the Member States to use cohesion policy resources to roll out smart villages post-2020, which will contribute to the digitalisation of rural areas and the empowerment of rural communities;
Amendment 80 #
2021/2101(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Calls upon regions and Member States to increase funding for available and affordable high-quality network infrastructure, such as fibre and 5G, in areas where the market conditions are such that private investments will not be able to deliver such networks on their own; recalls the importance of having an adequate competition and State Aid framework that enables the deployment of high-speed broadband and 5G infrastructure in all cities regardless of their size;
Amendment 82 #
2021/2101(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Urges the Member States to usemake full use of the financial resources available to them through both the ERDF-CFuropean Structural and Investment funds and the NextGenerationEU recovery instrument to the fullest extent possible to give regions that arin order to provide lagging -behind regions the targeted support that they needrequire to overcome the digital divide; supports efforts to promote digitalization by strengthening thematic concentration in cohesion policy, while simultaneously promoting the use of financial instruments in cooperation with the EIB or other development banks;
Amendment 88 #
2021/2101(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Calls also for the full implementation of the Connecting Europe Facility (CEF), as the new CEF digital financing instrument along with greater cross-border digital connectivity, will play a vital role in closing economic, social, and territorial divides, offering many new opportunities to Europe's regions, including rural areas;
Amendment 91 #
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-CFuropean Structural and Investment funds should contribute to an inclusive digital society and to fostering the economic, social and territorial cohesion in all EU regions with a focus on less developed regions;
Amendment 113 #
2021/2101(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for a follow-up to the eGovernment action plan that will ensure the efficient digital transformation of public administrations and services in all Member States and establish measures to increase digital skills for public sector workers; underlines that this follow-up should incorporate the many lessons learned from the Covid-19 pandemic, where public administration services moved almost exclusively online;
Amendment 130 #
2021/2101(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Notes that e-Commerce has a great potential for rural SMEs and local producers as it increases their outreach and reduces barriers associated to being located in regions that face severe and permanent geographical or demographic challenges; calls upon regions and Member States to establish pilot projects and digitalization strategies to integrate e- Commerce in rural SME´s business models;
Amendment 131 #
2021/2101(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14 b. Recognizes the potential of digitalization to connect companies, especially SMEs, and highlights the positive impact of digitalization in the provision of social services such as smart transport solutions, eHealth, online banking services and tailored learning solutions for vulnerable students; recalls the importance of establishing digital skills education in parallel to ensure we don´t leave anyone behind;
Amendment 135 #
2021/2101(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes with concern that both start- ups and established SMEs struggle with a lack of skilled employees and highlights that the skills shortage is particularly acute for skills relating to digitalisation and new technologies, as 35 % of the labour force have low or no digital skills; believes that initiatives should be launched to support the SMEs facing specific challenges in training their workforces and attracting and retaining digital talent; considers important to establish hybrid learning models to render upskilling accessible to those with basic to none digital skills;
Amendment 140 #
2021/2101(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Stresses the need to fill the digital skills gaps across the EU so that all individuals and businesses can make the most of the digital transformation; calls for the progressive implementation of the Commission’s Digital Education Action Plan 2021-2027 for promoting better digitalisation skills, which would guarantee relevant education, training and job opportunities for everyone; highlights the crucial role of Member States and regional governments in supporting rural authorities in their efforts to shape and ensure digital inclusion, by protecting citizens’ data and empowering people and local businesses via access to data;
Amendment 47 #
2021/2100(INI)
Motion for a resolution
Recital G b (new)
Recital G b (new)
G b. whereas cross-border healthcare- related cooperation requires the support and involvement of a wide range of partners, medico-social institutions, health insurance entities and public authorities;
Amendment 51 #
2021/2100(INI)
Motion for a resolution
Recital G d (new)
Recital G d (new)
Gd. whereas a European Health Union should contribute to and foster closer cooperation, coordination and knowledge sharing on health between Member States and relevant stakeholders and increase the EU's capacity to combat cross-border health threats;
Amendment 53 #
2021/2100(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Considers that instruments such as those provided by the cohesion policy should be used in order to provide equal access to minimum quality standards of medical services across the European Union; calls on the Commission and Member States to work better together and pool their resources to achieve this goal;
Amendment 59 #
2021/2100(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Believes that the EU should develop a strategic and integrated approach when it comes to major diseases, by bringing together diverse resources from several funds, including cohesion funds; emphasises the need to replicate the model of Europe's Beating Cancer Plan for tackling other health problems such as mental health and cardiovascular diseases;
Amendment 60 #
2021/2100(INI)
Motion for a resolution
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Underlines the rise of mental illnesses and disorders, especially in the context of the Covid-19 pandemic; calls on the Commission to propose a new European Action Plan for Mental Health as soon as possible, using all the instruments available, including cohesion policy, in the form of a comprehensive plan with measures and targets to leave no one behind, on the model of Europe's Beating Cancer Plan;
Amendment 61 #
2021/2100(INI)
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Believes that the recovery from the Covid-19 pandemic is an opportunity to build stronger and more resilient health systems by using the instruments of the cohesion policy; supports the Commission in the creation of a well functioning European Health Union and to unlock the huge potential of health cooperation;
Amendment 79 #
2021/2100(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Underlines that the European Reference Networks could improve access to healthcare for rare and complex diseases; calls on the Commission and Member States to ensure ongoing support and better resources to the European Reference Networks (ERN) and national centres of expertise for rare and complex diseases, and to extend the ERN field of work to other fields such as severe burns and organ transplantation programmes; calls on the Commission to analyse the feasibility of establishing a dedicated fund, under the Cohesion Policy, to guarantee equitable access to approved therapies for rare diseases;
Amendment 97 #
2021/2100(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Emphasises that citizens in rural and remote 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 and access to vital drugs; 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;
Amendment 108 #
2021/2100(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Believes that, in order to overcome the major obstacles that exist in terms of equality of access to healthcare in rural areas, wide use should be made of advanced technologies, such as e-Health, robotic surgery or 3D printing, as an integral part of the ‘smart villages’ concept11 , with the goal of improving access to healthcare and increasing efficiency and quality; _________________ 11 https://enrd.ec.europa.eu/enrd-thematic- work/smart-and-competitive-rural- areas/smart-villages_en
Amendment 109 #
2021/2100(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Underlines the merits of a European approach in tackling the Covid- 19 pandemic, through joint acquisitions, stockpiles and other measures; calls for the continuation and development of this approach, using the instruments of the cohesion policy, for other joint EU acquisitions of medical equipment and treatments such as cancer-preventing vaccines like HPV, hepatitis B vaccines, emergency equipment, to improve affordability and access to treatments;
Amendment 134 #
2021/2100(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Encourages the use of NextGenerationEU funds and cohesion funds to radically upgrade the digital capabilities of healthcare systems; emphasizes the need for enhanced interoperability of IT systems, as this is the main pillar for facilitating cross- border provision of eHealth services and especially of telemedicine services;
Amendment 135 #
2021/2100(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16b. Calls on the Commission and the Member States to use the cohesion policy instruments in order to promote the digitalization of medication in European hospitals, including traceability systems, to reduce medication errors, to improve communication between care units and to simplify bureaucracy; calls for the implementation and development of the eHealth Digital Service Infrastructure (eHDSI), including a single European digital patient file, which ensures that citizens have rapid access to adequate medical services everywhere in the European Union;
Amendment 136 #
2021/2100(INI)
Motion for a resolution
Paragraph 16 c (new)
Paragraph 16 c (new)
16c. Calls on the Commission to establish a European lists of essential medicines and to ensure their availability and affordability through permanent stocks, joint price negotiations and joint procurement, using EU instruments, including those provided by the cohesion policy;
Amendment 160 #
2021/2100(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Calls on the Commission to ensure that the existing coordinating bodies will facilitate cross-border treatments based on Advanced therapy medicinal products (ATMP) and to ensure that patients across Europe enjoy equitable access to innovative therapies; calls on Member States to authorize these innovative treatments abroad in an effective and timely manner and to accelerate the reimbursement processes for patients;
Amendment 168 #
2021/2100(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission 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; calls on the Commission and Member States to better disseminate information about the access to cross-border healthcare;
Amendment 172 #
2021/2100(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to carry out a comprehensive study on the cooperation framework between insurance systems in the EU, looking at potential bottlenecks and shortcomings that patients looking for medical services in the territory of another Member State encounter, as well as administrative barriers that prevent citizens to benefit from cross-border healthcare, and to highlight how the cohesion policy instruments could be used to solve these potential problems;
Amendment 186 #
2021/2100(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls on the European Commission and Member States, in light of the COVID-19 pandemic, to support, jointly through cohesion policy and the EU4Health Programme, the development of response strategies, protocols and procedures at national and European levels to enable better cooperation in case of future public health emergencies;
Amendment 36 #
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 functional urban areas and mid-sized cities play a key role in providing social services and economic opportunities for rural and depopulated areas, while offering alternative urban solutions to big cities;
Amendment 47 #
2021/2075(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas many European cities are facing a record-breaking surge in energy prices that threatens to affect the post- pandemic economic recovery;
Amendment 60 #
2021/2075(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Acknowledges the social, economic, territorial, cultural and historical diversity of urban areas across the Union, draws attention to challenges such as segregation and poverty;
Amendment 69 #
2021/2075(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Underlines that overconcentration of the population 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, urban sprawl, and a significantwhile the density of cities has many advantages in terms of sustainable living, high concentration of the population in certain urban areas may also have repercussions on the affordability of housing, the level of pollution, the quality of life, the risk of poverty and social exclusion for certain segments of the population;
Amendment 160 #
2021/2075(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Calls for investment promoting sustainable urban mobility through environmentally friendly transport systems; highlights the need to promote and develop public transport systems in urban areas, and to adapt public transportation capacity to the growing demand of day-to-day job travel in or out of city centres;
Amendment 164 #
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; Recalls the importance of having an adequate competition and State Aid framework that enables the deployment of highspeed broadband and 5G infrastructure in all cities regardless of their size;
Amendment 172 #
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 newall generations and for a clear commitment to achieve universal internet connectivity for cities;
Amendment 174 #
2021/2075(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Highlights that libraries and cultural centers can support local communities and disadvantaged groups in facilitating digital inclusion, social inclusion, lifelong learning and pathways to employment;
Amendment 183 #
2021/2075(INI)
Motion for a resolution
Paragraph 16 b (new)
Paragraph 16 b (new)
16 b. Considers that existing urban primary health structures need to be strengthened physically and financially; notes that the shift in healthcare delivery shall also propel the arrival of digital innovation and improve the integration of care through up-to-date information channels to deliver more targeted, personalised, effective and efficient healthcare;
Amendment 205 #
2021/2075(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Recognizes the important role that urban areas play in the concrete implementation of programmes and projects derived from EU legislation;
Amendment 2 #
2021/2013(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
— having regard to the Commission communication of 5 May 2021 on Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe's recovery (COM(2021)350),
Amendment 222 #
2021/2013(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Highlights the fact that therapies such as homeopathy, physiotherapy and acupuncture can bring benefits to the patients in relation to the parallel effects of several diseases and their treatments such as cancer; stresses the importance to develop a holistic, integrative and patient- centric approach and to encourage the complementary use of these therapies;
Amendment 418 #
2021/2013(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Insists that a competitive EU pharmaceutical industry is strategic and more responsive to patients’ needs; points out that the industry needs a stable, flexible and agile regulatory environment; believes that it can thrive globally with a clear, robust and efficient intellectual property system; welcomes the initiative to build interoperable digital infrastructure for the European Health Data Space; calls on the Commission to develop guidance to promote the secondary use of data for research and to ensure fair, transparent and non-discriminatory access to data throughout Europe;
Amendment 447 #
2021/2013(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls for the Commission and Member States to use real-world data for regulatory decisions on medicines to complement evidence from randomised- controlled clinical trials;
Amendment 513 #
2021/2013(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the fact that gene and cell therapies, personalised medicine, nanotechnology, next-generation vaccines, e-health and the ‘Million plus genomes’ initiative have a transformative potential and can bring enormous benefits to patients and societies in relation to the prevention, diagnosis, treatment and post- treatment of all diseases; urges the Commission to ensure sufficient regulatory expertise to support dialogue with developers, to develop appropriate regulatory frameworks, to guide new business models without compromising safety standards and product efficacy, and to run information campaigns to raise awareness and encourage the use of these innovations; calls on Member States to authorize the use of these innovative treatments abroad in an effective and timely manner and to accelerate the reimbursement process for cross-border treatment of patients;
Amendment 537 #
2021/2013(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to fully implement the Clinical Trials Regulation9 ; welcomes the revision of pharmaceutical legislation to adapt it to cutting-edge products, scientific advances and technological transformation; supports clinical trials that are more patient- centred as well as a new framework for the design of innovative trials and the pilot project to adopt a framework for the reuse of off- patent medicines; welcomes the launch of a vaccine platform to monitor vaccine efficacy and safety, supported by an EU- wide clinical trials network; _________________ 9 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1.
Amendment 580 #
2021/2013(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls that the EU’s open strategic autonomy is linked to the constant and sufficient availability of medicines in all Member States; recognises the multiple drivers of shortages; stresses the importance to involve all stakeholders including manufacturers, wholesalers and pharmacists to prevent and manage medicines’ shortages; recommends, when shortages of medicine occur, to inform healthcare professionals and patients about available alternatives; calls on the Commission to develop an early warning system for drug shortages, based on a European information network on supply problems, to increase public-private collaboration and to monitor the obligation on the part of industry to provide early and transparent information on the availability of medicines, parallel trade activities, export bans and unexpected manufacturing or quality problems, while limiting the administrative burdens on stakeholders and safeguarding confidentiality; calls on the Commission to develop a mechanism to safeguard transparency in production and supply chains in the event of emergencies;
Amendment 122 #
2021/2006(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Underscores the need to revise EU climate and environmental legislation in a coherent manner; takes the view that the binding emissions reduction targets for Member States in the Effort Sharing Regulation5 should remain the main legislative tool to reduce methane emissions as part of overall greenhouse gas reductions, while the Industrial Emissions Directive6 and other legislation cshould serve as a complementary tool; taking into account the need to avoid unnecessary overlaps between the legislations; calls on the Commission to assess the consistency of the National Emission Reduction Commitments Directive with meeting the EU´s air quality objectives as well as the Union's 2030 climate goals and its objective of climate neutrality in 2050 at the latest, as enshrined in the European Climate Law, and to revise it accordingly as soon as possible; _________________ 5Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013. OJ L 156, 19.6.2018, p. 26. 6 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control). OJ L 334, 17.12.2010, p. 17.
Amendment 149 #
2021/2006(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Recognises the importance of and the need to support voluntary industry initiatives aimed at reducing methane emissions and considers that any regulatory initiatives should build upon best practices from existing voluntary actions and must be duly preceded by thorough impact assessments and involve all the stakeholders in order to ensure the feasibility and effectiveness of the proposed regulatory initiatives;
Amendment 234 #
2021/2006(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Welcomes the Commission’s initiatives on the utilisation and mitigation of methane from coal mines; expresses its strong support for mandatory MRV for coal mine methane emissions, including the requirement for companies that own closed sites or Member States (for abandoned mines where no existing owner is liable) to adopt the same MRV and LDAR measures as for operating sites; stresses that measures and activities to improve available datasets should follow the planned revision of E-PRTR;
Amendment 259 #
2021/2006(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that technologies and practices to limit methane emissions from agriculture are developing at a fast pace; calls on the Commission to ensure that proven effective and cost-efficient innovations are quickly implemented in the EU and integrated into EU agriculture policies taking into account national specificities, national strategic plans and the need to ensure sufficient financial support;
Amendment 219 #
2021/0423(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 13 a (new)
Article 2 – paragraph 1 – point 13 a (new)
(13 a) ‘quantification’ means operations to determine the quantity of methane emissions, based on direct measurements, engineering calculations, simulations, models, or estimation through generic or specific emission factors.
Amendment 398 #
2021/0423(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. By … [24 months from the date of entry into force of this Regulation], operators shall also submit a report to the competent authorities containing direct measurementsquantification of source-level methane emissions for operated assets. Reporting at such level may involve the use of source- level measurement and sampling as the basis for establishing specific emission factors used for emissions estimationWhen emission factors are used, the quantification shall involve specific emission factors.
Amendment 415 #
2021/0423(COD)
Proposal for a regulation
Article 12 – paragraph 3 – subparagraph 1
Article 12 – paragraph 3 – subparagraph 1
By … [36 months from the date of entry into force of this Regulation] and by 30 March every year thereafter, operators shall submit a report to the competent authorities containing direct measurementsquantification of source-level methane emissions for operated assets referred to in paragraph 2, complemented by measurements of site- level methane emissions, thereby allowing assessment and verification of the source- level estimates aggregated by site. If the technologies for site-level measurement do not reach satisfactory technology readiness levels or market availability an operator can request the competent authority to postpone site-level measurements by one year.
Amendment 491 #
2021/0423(COD)
Proposal for a regulation
Article 12 – paragraph 8
Article 12 – paragraph 8
8. In the case of significant discrepancies between the emissions quantified using source-level methods and those resulting from site-level measurement, additional measurements shall be carried ouoperators shall provide reasoning for the discrepancy. If the discrepancy is not due to the technological limits of employed quantification methods, the competent authority may request an additional measurement within the same reporting period.
Amendment 592 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
Operators shall repair or replace all components found to be emitting 500 parts per million or more of methanemake a first attempt to repair all detected leaks no later than five days after detection.
Amendment 599 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 2
Article 14 – paragraph 4 – subparagraph 2
Amendment 610 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 3
Article 14 – paragraph 4 – subparagraph 3
Amendment 619 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4
Article 14 – paragraph 4 – subparagraph 4
Amendment 624 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 – point a (new)
Article 14 – paragraph 4 – subparagraph 4 – point a (new)
(a) safety to humans and objects in proximity,
Amendment 625 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 – point b (new)
Article 14 – paragraph 4 – subparagraph 4 – point b (new)
(b) significant deterioration of the gas supply,
Amendment 626 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 – point c (new)
Article 14 – paragraph 4 – subparagraph 4 – point c (new)
(c) continuity of supply to end consumers,
Amendment 627 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 – point d (new)
Article 14 – paragraph 4 – subparagraph 4 – point d (new)
(d) administrative authorizations,
Amendment 628 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 – point e (new)
Article 14 – paragraph 4 – subparagraph 4 – point e (new)
(e) accessibility to component,
Amendment 629 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 – point f (new)
Article 14 – paragraph 4 – subparagraph 4 – point f (new)
(f) availability of parts necessary for the repair.
Amendment 630 #
2021/0423(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 4 a (new)
Article 14 – paragraph 4 – subparagraph 4 a (new)
Where the emission abatement cost for a repair is higher than the limit set by ACER, the operators shall postpone the repair provided that they disclose to the competent authority the calculation details in the repair and monitoring schedule.
Amendment 778 #
2021/0423(COD)
Proposal for a regulation
Article 15 – paragraph 5 a (new)
Article 15 – paragraph 5 a (new)
5 a. Where implementing venting or flaring provisions leads to an abatement cost higher than the limit set by ACER, the operators shall minimize the vented emissions by other available more cost- efficient means and include the justification in the report according to Article 17.
Amendment 794 #
2021/0423(COD)
Proposal for a regulation
Article 15 – paragraph 5 b (new)
Article 15 – paragraph 5 b (new)
5 b. Where implementing venting or flaring provisions requires an approval of relevant authorities, permitting, procuring, and installing new equipment, operators shall proceed at the fastest possible schedule. The competent authorities may request the details of the schedule and request modifications.
Amendment 882 #
2021/0423(COD)
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. As regards surface coal mines, mine operators shall use deposit-specific coal mine methane emission factors to quantify emissions resulting from mining operations. Mine operators shall establish those emission factors on a quarterlyn annual basis, in accordance with appropriate scientific standards and take into account methane emissions from surrounding strata.
Amendment 60 #
2021/0420(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The core network has been identified on the basis of an objective planning methodology. That methodology has identified the most important urban nodes, ports and airports, as well as border crossing points. Wherever possible, tThose nodes are to be connected with multimodal links as long as they are economically viable and feasible by 2030. The methodology has ensured the interconnection of all Member States and the integration of the main islands into the core network.
Amendment 62 #
2021/0420(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) The TEN-T network should fully take into account the diversity of challenges facing EU regions including geographic or significant physical constraints, for example in outermost regions and other remote, insular, peripheral and mountainous regions or in sparsely populated areas, or for isolated or partially isolated networks. All regions should be included in the whole core network, extended core network and comprehensive network to ensure the territorial cohesion of our Union.
Amendment 66 #
2021/0420(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) Projects of common interest for which Union funding is sought should be the subject of a socio-economic cost- benefit analysis based on a recognised methodology, taking into account the relevant social, economic, climate-related and environmental benefits, territorial balance and costs as well as the life-cycle approach. The analysis of climate-related and environmental costs and benefits should be based on the environmental impact assessment carried out pursuant to Directive 2011/92/EU of the European Parliament and of the Council21 . _________________ 21 Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1).
Amendment 80 #
2021/0420(COD)
Proposal for a regulation
Recital 59
Recital 59
(59) A sufficient number of fast recharging points for light and heavy-duty vehicles accessible to the public should be deployed across the trans-European transport network. This aim should ensure full cross-border connectivity and allow electric vehicles to circulate throughout the Union. Distance-based targets for the trans- European transport network as defined in Regulation (EU) […] [on the deployment of alternative fuels infrastructure] are to ensure a minimum of sufficient coverage of electric recharging points along the Union’s main road networks including areas facing geographical and demographic challenges and outermost regions.
Amendment 85 #
2021/0420(COD)
Proposal for a regulation
Recital 66
Recital 66
(66) European Transport Corridors should help to develop the infrastructure of the trans-European transport network in such a way as to address bottlenecks, enhancsure cross-border connections and improve efficiency and sustainability. They should contribute to cohesion throughby improveding territorial cooperation through a bottom up approach that takes into account the needs of local communities, local and regional authorities. They should also address wider transport policy objectives and facilitate interoperability, modal integration and multimodal operations while respecting geographical approach. The corridor approach should be transparent and clear and the management of such corridors should not create additional administrative burdens or costs.
Amendment 88 #
2021/0420(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point f
Article 3 – paragraph 1 – point f
(f) 'urban node' means an urban area where elements of the transport infrastructure of the trans-European transport network, such as ports including passenger terminals, airports, railway stations, bus terminals, logistic platforms and facilities and freight terminals, located in and around the urban area, including their functional urban areas, are connected with other elements of that infrastructure and with the infrastructure for regional and local traffic;
Amendment 91 #
2021/0420(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point b – point ii
Article 4 – paragraph 2 – point b – point ii
(ii) reduction of infrastructure quality gaps between Member States by further developing interconnections and ensuring the effective connectivity of EU border regions;
Amendment 131 #
2021/0420(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
The provisions relating to railways, and in particular any requirement to connect airports and ports to railways as well as the provisions related to safe and secure parking and multimodal freight terminals shall not apply to Cyprus, Malta and outermost regions and Malta for as long as no railway system is established within their territory.
Amendment 18 #
2021/0340(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The proposed concentration limits in Annexes IV and V to Regulation (EU) 2019/1021 have been set applying the same methodology that was used to establish the concentration limits in previous amendments of Annexes IV and V to Regulation (EC) No 850/2004. The proposed concentration limits should achieve the objective of a high level of protection of human health and the environment associated to the destruction or irreversible transformation of the substances concerned. Those limits should also take into consideration the broader policy objective of achieving a climate- neutral and circular economy including the achievement of recycling targets, enshrined in the European Green Deal26 . _________________ 26 COM(2019) 640 final
Amendment 152 #
2021/0223(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) The revised national policy frameworks should include supporting actions for the development of the market as regards alternative fuels, including the deployment of the necessary infrastructure to be put into place, in close cooperation with regional and local authorities and with the industry concerned, while taking into account the needs of small and medium- sized enterprises. Additionally, the revised frameworks should describe the overall national framework for planning, permitting and procuring of such infrastructure, including the identified obstacles and actions to remove them so shat a faster rollout of infrastructure can be achieved. In sparsely populated areas, outermost regions and areas with low traffic density where demand for such infrastructure is low, securing a sufficiently comprehensive infrastructure may not be possible on market terms. Under State aid law, a Member State may provide investment aid and CEF funding for this purpose. The deployment of alternative fuels infrastructure must leave no one behind.
Amendment 171 #
2021/0223(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point b – indent 2 a (new)
Article 2 – paragraph 1 – point 3 – point b – indent 2 a (new)
- biomethane,biopropane, bioLPG, renewable Dimethyl Ether,
Amendment 172 #
2021/0223(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point b a (new)
Article 2 – paragraph 1 – point 3 – point b a (new)
(b a) alternative fossil fuels’ for a transitional phase blended with at least 50% of biomass fuels and biofuel,
Amendment 176 #
2021/0223(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 30
Article 2 – paragraph 1 – point 30
(30) ‘e-mobility service provider’ means a legal person who provides services in return for remuneration to an end user, includingparticularly the sale of a recharging service;
Amendment 181 #
2021/0223(COD)
Proposal for a regulation
Article 2 a (new)
Article 2 a (new)
Article 2 a ‘along the TEN-T network‘ means maximum radius of 10 km from the nearest exit on the respective TEN-T road,
Amendment 218 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. Member States shall take necessary measures to ensure a minimum coverage of publicly accessible recharging points dedicated to heavy-duty vehicles in their territory. To that end, Member States shall ensure that:
Amendment 220 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a – introductory part
Article 4 – paragraph 1 – point a – introductory part
(a) along the TEN-T core network, publicly accessible recharging pools dedicated to heavy-duty vehicles and meeting the following requirements are deployed in each direction of travel with a maximum distance of 6100 km in-between them:
Amendment 224 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a – point i
Article 4 – paragraph 1 – point a – point i
(i) by 31 December 20258, each recharging pool shall offer a power output of at least 14700 kW and include at least one recharging station with an individual power output of at least 350 kW;
Amendment 227 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a – point ii
Article 4 – paragraph 1 – point a – point ii
(ii) by 31 December 20303, each recharging pool shall offer a power output of at least 351400 kW and include at least two recharging stations with an individual power output of at least 350 kW;
Amendment 232 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b – point i
Article 4 – paragraph 1 – point b – point i
(i) by 31 December 20303, each recharging pool shall offer a power output of at least 14700 kW and include at least one recharging station with an individual power output of at least 350 kW;
Amendment 235 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b – point ii
Article 4 – paragraph 1 – point b – point ii
(ii) by 31 December 20358, each recharging pool shall offer a power output of at least 351400 kW and include at least two recharging stations with an individual power output of at least 350 kW;
Amendment 244 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) by 31 December 20258, in each urban node publicly accessible recharging points dedicated to heavy-duty vehicles providing an aggregated power output of at least 600 kW are deployed, provided by recharging stations with an individual power output of at least 150 kW;
Amendment 245 #
2021/0223(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e
Article 4 – paragraph 1 – point e
(e) by 31 December 20303, in each urban node publicly accessible recharging points dedicated to heavy-duty vehicles providing an aggregated power output of at least 1200 kW are deployed, provided by recharging stations with an individual power output of at least 150 kW.
Amendment 266 #
2021/0223(COD)
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1
Article 5 – paragraph 2 – subparagraph 1
From 1 January 2027 onwards, operators of recharging points shall ensure that all publicly accessible recharging stations with a power output equal to or more than 50 kW operated by them comply with the requirement in point (b) provided that those recharging stations are undergoing major renovation.
Amendment 316 #
2021/0223(COD)
Proposal for a regulation
Article 13 – paragraph 1 a (new)
Article 13 – paragraph 1 a (new)
1 a. When preparing a draft national policy framework, the Member States can deviate from mandatory national targets set out in Article 4 provided that it is based on comprehensive justification. Such deviation shall not be more than 15% of that targets.
Amendment 329 #
2021/0223(COD)
Proposal for a regulation
Article 13 – paragraph 7 a (new)
Article 13 – paragraph 7 a (new)
7 a. When a Member State decides to use possibility to deviate from mandatory national targets as set out in paragraph 1a, the Commission shall also assess the reasons that are behind such deviation and may ask a Member State for more clarification.
Amendment 53 #
2021/0218(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2 a) Renewable energy production often takes place at local level and depends on regional SMEs; Member States should therefore fully involve local and regional authorities when setting targets and supporting policy measures;
Amendment 60 #
2021/0218(COD)
Proposal for a directive
Recital 2 d (new)
Recital 2 d (new)
(2 d) Competent authorities should establish simplified rules and administrative procedures for small renewable energy producers and local energy communities in order to ensure that they do not face discriminatory administrative burdens.
Amendment 79 #
2021/0218(COD)
Proposal for a directive
Recital 5
Recital 5
(5) The rapid growth and increasing cost-competitiveness of renewable electricity production can be used to satisfy a growing share of energy demand, for instance using heat pumps for space heating or low-temperature industrial processes, electric vehicles for transport, or electric furnaces in certain industries. Renewable electricity can also be used to produce synthetic fuels for consumption in hard-to-decarbonise transport sectors such as aviation and maritime transport. A framework for electrification needs to enable robust and efficient coordination and expand market mechanisms to match both supply and demand in space and time, stimulate investments in flexibility, and help integrate large shares of variable renewable generation. This framework must also take into account existing regional disparities and the specific features of each region, and to support cost-effective solutions, ensuring a reduction in energy costs for Europe's people and businesses. Member States should therefore ensure that the deployment of renewable electricity continues to increase at an adequate pace to meet growing demand. For this, Member States should establish a framework that includes market-compatible mechanisms to tackle remaining barriers to have secure and adequate electricity systems fit for a high level of renewable energy, as well as storage facilities, fully integrated into the electricity system. In particular, this framework shall tackle remaining barriers, including non-financial ones such as insufficient digital and human resources of authorities to processand guidance to process more efficiently and cost-effectively a growing number of permitting applications. in a timely manner.
Amendment 103 #
2021/0218(COD)
Proposal for a directive
Recital 10 a (new)
Recital 10 a (new)
(10 a) Local and regional authorities are key actors when it comes to bringing Europe closer to its energy and climate objectives. Energy production at the local level is crucial to foster renewable energy production, reduce external energy dependence and decrease energy poverty rates.
Amendment 105 #
2021/0218(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Buildings have a large untapped potential to contribute effectively to the reduction in greenhouse gas emissions in the Union. The decarbonisation of heating and cooling in this sector through an increased share in production and use of renewable energy will be needed to meet the ambition set in the Climate Target Plan to achieve the Union objective of climate neutrality. However, progress on the use of renewables for heating and cooling has been stagnant in the last decade, largely relying on increased use of biomass. Without the establishment of targets to increase the production and use of renewable energy in buildings, there will be no ability to track progress and identify bottlenecks in the uptake of renewables. Furthermore, the creation of targets will provide a long-term signal to investors, including for the period immediately after 2030. This will complement obligations related to energy efficiency and the energy performance of buildings. Therefore, indicative targets for the use of renewable energy in buildings should be set to guide and incentivise Member States’ efforts to exploit the potential of using and producing renewable energy in buildings, encourage the development of and integration of technologies which produce renewable energy while providing certainty for investors and local level engagement. Finally, as renewable energy production often takes place at local and regional level and depends on local and regional SMEs, Member States need to fully involve local and regional authorities when setting targets and supporting policy measures.
Amendment 108 #
2021/0218(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Insufficient numbers of skilled workers, in particular installers and designers of renewable heating and cooling systems, slow down the replacement of fossil fuel heating systems by renewable energy based systems and is a major barrier to integrating renewables in buildings, industry and agriculture. Upskilling through training programmes for installers and designers on renewable heating and cooling and storage technologies should be managed at local and regional level; Member States should partner and cooperate with business, regional and educational authorities, social partners and renewable energy communities to anticipate the skills that will be needed. A sufficient number of high-quality training programmes and certification possibilities ensuring proper installation and reliable operation of a wide range of renewable heating and cooling systems should be made available and designed in a way to attract participation in such training programmes and certification systems. Member States should consider what actions should be taken to attract groups currently under-represented in the occupational areas in question and how to incentivise the promotion of new and improved skills, aiming to specifically support stable, local and high-quality employment in rural communities. The list of trained and certified installers should be made public to ensure consumer trust and easy access to tailored designer and installer skills guaranteeing proper installation and operation of renewable heating and cooling.
Amendment 119 #
2021/0218(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The Union’s renewable energy policy aims to contribute to achieving the climate change mitigation objectives of the European Union in terms of the reduction of greenhouse gas emissions. In the pursuit of this goal, it is essential to also contribute to wider environmental objectives, and in particular the prevention of biodiversity loss, which is negatively impacted by the indirect land use change associated to the production of certain high-indirect land- use change-risk biofuels, bioliquids and biomass fuels. Contributing to these climate and environmental objectives constitutes a deep and longstanding intergenerational concern for Union citizens and the Union legislator. As a consequence, the changes in the way the transport target is calculated should not affect the limits established on how to account toward that target certain fuels produced from food and feed crops on the one hand and high indirect land-use change-risk fuels on the other hand. In addition, in order not to create an incentive to use biofuels and biogas produced from food and feed crops in transport, Member States should continue to be able to choose whether count them or not towards the transport target. If they do not count them, they may reduce the greenhouse gas intensity reduction target accordingly, assuming that food and feed crop-based biofuels save 50% greenhouse gas emissions, which corresponds to the typical values set out in an annex to this Directive for the greenhouse gas emission savings of the most relevant production pathways of food and feed crop-based biofuels as well as the minimum savings threshold applying to most installations producing such biofuelsSustainable biofuels, bioliquids and biomass fuels that co-generate valuable protein for animal and human consumption, and are deforestation-free, should be a building block of the decarbonisation of transport, within a reasonable limit preventing unwanted negative impacts on the availability of food and feed resources. Member States should be put in an equal footing in their use of these sustainable biofuels, bioliquids and biomass fuels, to reach the higher level of emission savings, under common limit.
Amendment 121 #
2021/0218(COD)
Proposal for a directive
Recital 35
Recital 35
(35) To ensure higher environmental effectiveness of the Union sustainability and greenhouse emissions saving criteria for solid biomass fuels in installations producing heating, electricity and cooling, the minimum threshold for the applicability of such criteria should be lowered from the current 20 MW to 510 MW starting in 2027.
Amendment 125 #
2021/0218(COD)
Proposal for a directive
Recital 37
Recital 37
(37) In order to reduce the administrative burden for producers of renewable fuels and recycled carbon fuels and for Member States, where voluntary or national schemes have been recognised by the Commission through an implementing act as giving evidence or providing accurate data regarding the compliance with sustainability and greenhouse gas emissions saving criteria as well as other requirements set in this Directive, Member States should accept the results of the certification issued by such schemes within the scope of the Commission’s recognition. In order to reduce the burden on small installations, Member States should establish a simplified verification mechanism starting 1 January 2027 for installations of between 510 and 120MW.
Amendment 129 #
2021/0218(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The Union’s renewable energy policy aims to contribute to achieving the climate change mitigation objectives of the European Union in terms of the reduction of greenhouse gas emissions. In the pursuit of this goal, it is essential to also contribute to wider environmental objectives, and in particular the prevention of biodiversity loss, which is negatively impacted by the indirect land use change associated to the production of certain high-indirect land- use change-risk biofuels, bioliquids and biomass fuels. Contributing to these climate and environmental objectives constitutes a deep and longstanding intergenerational concern for Union citizens and the Union legislator. As a consequence, the changes in the way the transport target is calculated should not affect the limits established on how to account toward that target certain fuels produced from food and feed crops on the one hand and high indirect land-use change-risk fuels on the other hand. In addition, in order not to create an incentive to use biofuels and biogas produced from food and feed crops in transport, Member States should continue to be able to choose whether count them or not towards the transport target. If they do not count them, they may reduce the greenhouse gas intensity reduction target accordingly, assuming that food and feed crop-based biofuels save 50% greenhouse gas emissions, which corresponds to the typical values set out in an annex to this Directive for the greenhouse gas emission savings of the most relevant production pathways of food and feed crop-based biofuels as well as the minimum savings threshold applying to most installations producing such biofuelsSustainable biofuels, bioliquids and biomass fuels that co-generate valuable protein for animal and human consumption, and are deforestation-free, should be a building block of the decarbonisation of transport, within a reasonable limit preventing unwanted negative impacts on the availability of food and feed resources. Member States should be put in an equal footing in their use of these sustainable biofuels, bioliquids and biomass fuels, to reach the higher level of emission savings, under common limit.
Amendment 130 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – subparagraph 2 – point 1a
Article 2 – subparagraph 2 – point 1a
Amendment 143 #
2021/0218(COD)
Proposal for a directive
Recital 35
Recital 35
(35) To ensure higher environmental effectiveness of the Union sustainability and greenhouse emissions saving criteria for solid biomass fuels in installations producing heating, electricity and cooling, the minimum threshold for the applicability of such criteria should be lowered from the current 20 MW to 510 MW starting in 2027.
Amendment 149 #
2021/0218(COD)
Amendment 152 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 2 – point (a)(iii)
Article 3 – paragraph 3 – subparagraph 2 – point (a)(iii)
Amendment 159 #
2021/0218(COD)
Proposal for a directive
Recital 37
Recital 37
(37) In order to reduce the administrative burden for producers of renewable fuels and recycled carbon fuels and for Member States, where voluntary or national schemes have been recognised by the Commission through an implementing act as giving evidence or providing accurate data regarding the compliance with sustainability and greenhouse gas emissions saving criteria as well as other requirements set in this Directive, Member States should accept the results of the certification issued by such schemes within the scope of the Commission’s recognition. In order to reduce the burden on small installations, Member States should establish a simplified verification mechanism starting 1 January 2027 for installations of between 510 and 120MW.
Amendment 164 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 3
Article 3 – paragraph 3 – subparagraph 3
Amendment 168 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b Directive (EU) 2018/2001
Article 1 – paragraph 1 – point 2 – point b Directive (EU) 2018/2001
By 2026 the Commission shall present a report on the impact of the Member States’ support schemes for biomass, including on biodiversity and possible market distortions, and will assess the possibility for further limitations regarding support schemes to forest biomass.;
Amendment 177 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point a
Article 1 – paragraph 1 – point 4 – point a
Directive (EU) 2018/2001
Article 9 – paragraph 1 a
Article 9 – paragraph 1 a
1a. By 31 December 2025, each Member State shall agree to establish at least one joint project with one or more other Member States for the production of renewable energy. The drafting and implementation of this joint project should involve local and regional authorities of the territories concerned. The Commission shall be notified of such an agreement, including the date on which the project is expected to become operational. Projects financed by national contributions under the Union renewable energy financing mechanism established by Commission Implementing Regulation (EU) 2020/129425 shall be deemed to satisfy this obligation for the Member States involved.; _________________ 25 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).
Amendment 198 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 1a
Article 2 – paragraph 2 – point 1a
Amendment 203 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 18 – paragraph 3 – part 3
Article 18 – paragraph 3 – part 3
To achieve such sufficient numbers of installers and designers, Member States, in cooperation with local and regional authorities, shall ensure that sufficient training programmes leading to qualification or certification covering renewable heating and cooling technologies, storage technologies, and their latest innovative solutions, including infrastructure, are made available. Member States shall put in place measures to promote participation in such programmes, in particular by small and medium-sized enterprises and the self- employed. Member States may put in place voluntary agreements with the relevant technology providers and vendors to train sufficient numbers of installers, which may be based on estimates of sales, in the latest innovative solutions and technologies available on the market.
Amendment 213 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive (EU) 2018/2001
Article 22a – paragraph 1
Article 22a – paragraph 1
1. Member States shall endeavour to increase the share of renewable sources in the amount of energy sources used for final energy and non-energy purposes in the industry sector by an indicative average minimum annual increase of 1.1 percentage points by 2030.
Amendment 216 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Directive (EU) 2018/2001
Article 22a (new)
Article 22a (new)
Amendment 228 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – point (a)
Article 25 – paragraph 1 – point (a)
(a) the amount of renewable fuels and renewable electricity supplied to the transport sector leads to a greenhouse gas intensity reduction of at least 136 % by 2030, compared to the baseline set out in Article 27(1), point (b), in accordance with an indicative trajectory set by the Member State;
Amendment 234 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point a – point i
Article 1 – paragraph 1 – point 15 – point a – point i
Directive (EU) 2018/2011
Article 26 – paragraph 1 – subparagraph 1
Article 26 – paragraph 1 – subparagraph 1
For the calculation of a Member State's gross final consumption of energy from renewable sources referred to in Article 7 and of the greenhouse gas intensity reduction target referred to in Article 25(1), first subparagraph, point (a), the share of biofuels and bioliquids, as well as of biomass fuels consumed in transport, where produced from food and feed crops, shall be no more than one percentage point higher than the share of such fuels in the final consumption of energy in the transport sector in 2020 in that Member State, with a maximum of 7 % of final consumption of energy in the transport sector in that Member State.;
Amendment 235 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point a – point ii – introductory part
Article 1 – paragraph 1 – point 15 – point a – point ii – introductory part
(ii) the second, third and fourth subparagraph is replaced by the following:are deleted.
Amendment 236 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point a – point ii
Article 1 – paragraph 1 – point 15 – point a – point ii
Directive (EU) 2018/2001
Article 26 – paragraph 1 – subparagraph 4
Article 26 – paragraph 1 – subparagraph 4
Amendment 238 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point c
Article 1 – paragraph 1 – point 16 – point c
Directive (EU) 2018/2001
Article 27 point 1a
Article 27 point 1a
(c a) the share of biofuels and biogas for transport produced from grape marc and wine lees may be considered to be twice its energy content during a 6-years transitional period starting from the entry into force of the directive.
Amendment 256 #
2021/0218(COD)
Proposal for a directive
Article premier – paragraph 1 – point 18 a (new)
Article premier – paragraph 1 – point 18 a (new)
Directive (EU) 2018/2001
Article 29 point 13
Article 29 point 13
Amendment 259 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 20 – point d
Article 1 – paragraph 1 – point 20 – point d
Directive 2018/2001
Article 30 – paragraph 6 – subparagraph 4
Article 30 – paragraph 6 – subparagraph 4
For installations producing electricity heating and cooling with a total rated thermal input between 510 and 120 MW, starting 1 January 2027, Member States shall establish simplified national verification schemes to ensure the fulfillment of the sustainability and greenhouse gas emissions criteria set out in paragraphs (2) to (7) and (10) of Article 29.;
Amendment 262 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Amendment 263 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive (EU) 2018/2001
Article 31a – paragraph 1
Article 31a – paragraph 1
1. The Commission shall ensure that a Union database is set up to enable the tracing of liquid and gaseous renewable fuels, including the tracing of the feedstocks listed in Annex IX used in their production, and recycled carbon fuels.
Amendment 267 #
2021/0218(COD)
Proposal for a directive
Annex I – paragraph 1 – point 5 – point a
Annex I – paragraph 1 – point 5 – point a
6. For the purposes of the calculation referred to in point 1(a), greenhouse gas emissions savings from improved agriculture management, esca, such as shifting to reduced or zero- tillage, storing carbon in soil with biochar, improved crop/rotation, the use of cover crops, including crop residue management, and the use of organic soil improver (e.g. compost, manure fermentation digestate), shall be taken into account only if they do not risk to negatively affect biodiversity. Carbon in biomasses can be converted into biochar through pyrolysis, which can be stored by land application, thereby making it a negative missions technology. Here, the bonus for the improved agricultural and manure management is returned to the farmer responsible for the negative emissions when sustainability/environmental certificates are issued. Further, solid and verifiable evidence shall be provided that the soil carbon has increased or that it is reasonable to expect to have increased over the period in which the raw materials concerned were cultivated while taking into account the emissions where such practices lead to increased fertiliser and herbicide use37 .; _________________ 37 Measurements of soil carbon can constitute such evidence, e.g. by a first measurement in advance of the cultivation and subsequent ones at regular intervals several years apart. In such a case, before the second measurement is available, increase in soil carbon would be estimated on the basis of representative experiments or soil models. From the second measurement onwards, the measurements would constitute the basis for determining the existence of an increase in soil carbon and its magnitude.
Amendment 270 #
2021/0218(COD)
(a a) (a bis) In part A, the following alinea is inserted: (r) Intermediate and cover crops;
Amendment 271 #
2021/0218(COD)
Proposal for a directive
Annex I – paragraph 1 – point 8 a (new)
Annex I – paragraph 1 – point 8 a (new)
Directive (EU) 2018/2001
Annex IX – Part A – point g
Annex IX – Part A – point g
Amendment 281 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 2 – point a – point i
Article 3 – paragraph 3 – subparagraph 2 – point a – point i
Amendment 302 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 2 – point a – iii
Article 3 – paragraph 3 – subparagraph 2 – point a – iii
Amendment 845 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 20 – point d
Article 1 – paragraph 1 – point 20 – point d
Directive (EU) 2018/2001
Article 30 – paragraph 6 – subparagraph 4
Article 30 – paragraph 6 – subparagraph 4
For installations producing electricity heating and cooling with a total rated thermal input between 510 and 120 MW, starting 1 January 2027, Member States shall establish simplified national verification schemes to ensure the fulfillment of the sustainability and greenhouse gas emissions criteria set out in paragraphs (2) to (7) and (10) of Article 29.;
Amendment 863 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive (EU) 2018/2001
Article 31 – paragraph 2, 3 and 4
Article 31 – paragraph 2, 3 and 4
Amendment 871 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive (EU) 2018/2001
Article 31a – paragraph 1
Article 31a – paragraph 1
1. The Commission shall ensure that a Union database is set up to enable the tracing of liquid and gaseous renewable fuels, including the tracing of the feedstocks listed in Annex IX used in their production, and recycled carbon fuels.
Amendment 907 #
2021/0218(COD)
Proposal for a directive
Annex I – paragraph 1 – point 5 – point a
Annex I – paragraph 1 – point 5 – point a
Directive (EU) 2018/2001
Annex V – Part C – point 6
Annex V – Part C – point 6
6. For the purposes of the calculation referred to in point 1(a), greenhouse gas emissions savings from improved agriculture management, esca, such as shifting to reduced or zero-tillage, storing carbon in soil with biochar, improved crop/rotation, the use of cover crops, including crop residue management, and the use of organic soil improver (e.g. compost, manure fermentation digestate), shall be taken into account only if they do not risk to negatively affect biodiversity. Carbon in biomasses can be converted into biochar through pyrolysis, which can be stored by land application, thereby making it a negative missions technology. Here, the bonus for the improved agricultural and manure management is returned to the farmer responsible for the negative emissions when sustainability/environmental certificates are issued. Further, solid and verifiable evidence shall be provided that the soil carbon has increased or that it is reasonable to expect to have increased over the period in which the raw materials concerned were cultivated while taking into account the emissions where such practices lead to increased fertiliser and herbicide use37 .; _________________ 37Measurements of soil carbon can constitute such evidence, e.g. by a first measurement in advance of the cultivation and subsequent ones at regular intervals several years apart. In such a case, before the second measurement is available, increase in soil carbon would be estimated on the basis of representative experiments or soil models. From the second measurement onwards, the measurements would constitute the basis for determining the existence of an increase in soil carbon and its magnitude.
Amendment 935 #
2021/0218(COD)
Proposal for a directive
Annex I – paragraph 1 – point 8 – point a a (new)
Annex I – paragraph 1 – point 8 – point a a (new)
Directive (EU) 2018/2001
Annex IX – Part A – point (r)
Annex IX – Part A – point (r)
(aa) In part A, the following point r is inserted: (r) Intermediate and cover crops;
Amendment 169 #
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 198 #
2021/0214(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The CBAM seeks to gradually 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 and by ensuring that Union export products are not replaced by more carbon intensive products, which would undermine the objective of reducing global emissions. To ensure a gradual transition from the current system of free allowances to the CBAM, t while preserving Union competitiveness. The CBAM should be progressively phased in while free allowances in sectors covered by the CBAM are phased outgradually phased out after an assessment by the Commission has proven that this Regulation is effective in protection from the risk of carbon leakage for both imports and exports. The gradual phase-out of free allowance is essential to ensure a just transition for energy- intensive sectors. 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.
Amendment 216 #
2021/0214(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) While the surrendering of CBAM certificates for Union imports addresses the risk of carbon leakage on the Union market, it is essential to avoid also the risk that Union exports to global markets are replaced by more carbon intensive goods or by goods that are not subject to equivalent climate policy and carbon costs. To this purpose if the assessment of the effectiveness of the CBAM in tackling carbon leakage both on the internal market and global markets is positive, after the test period 2026-2028, in 2029 the Commission should present a report to the European Parliament and to the Council accompanied with a legislative proposal to address the carbon leakage risk on export markets . If the report concludes that the surrendering of CBAM certificates by importers is effective in addressing the carbon leakage risk on the Union market and that the free allocation rules related to Union domestic sales should be amended, the legislative proposal should ensure the maintenance of free allocation related to Union exports and provide the calculation methodology for determining this allocation.
Amendment 322 #
2021/0214(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) In order not to disproportionately hinder existing trade flows by CBAM obligations, we must do the utmost to reduce unnecessary administrative burden, for instance by recognition of third countries’ emission monitoring systems.
Amendment 426 #
2021/0214(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) Contracting Parties to the Treaty establishing the Energy Community45 or Parties to Association Agreements including Deep and Comprehensive Free Trade Areas are committed to decarbonisation processes that should eventually result in the adoption of carbon pricing mechanisms similar or equivalent to the EU ETS or in their participation in the EU ETS. to the EU ETS should benefit from CBAM exemption with regard to the goods originating in those countries provided that certain conditions are satisfied. Those third countries should develop a roadmap and commit to implement an effective system of monitoring, reporting and verification of greenhouse gas emissions, a carbon pricing mechanism similar to the EU ETS, and should commit to achieving carbon neutrality. That exemption should be withdrawn if there are reasons to believe that the country in question does not fulfil its commitments. The Union is committed to providing those third countries with financial support for the adoption of carbon pricing mechanisms similar to the EU ETS, the deployment of decarbonisation technologies, and the implementation of other measures aimed at achieving climate neutrality. __________________ 45 Council Decision 2006/500/EC of 29 May 2006 on the conclusion by the European Community of the Energy Community Treaty (OJ L 198, 20.7.2006, p. 15).
Amendment 463 #
2021/0214(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) The Commission should evaluate the application of this Regulation before the endstart of the transitional periodremoval of free allowances in ETS 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 . With regards to indirect emissions, the evaluation should take into account the exposure of Union producers to carbon costs passed on in electricity prices due to the functioning of the EU energy market. __________________ 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 502 #
2021/0214(COD)
Proposal for a regulation
Recital 54
Recital 54
(54) The Commission should strive to engage in an even handed manner and in line with the international obligations of the EU, with the third countries whose trade to the EU is affected by this Regulation, to explore possibilities for dialogue and cooperation with regard to the implementation of specific elements of the Mechanism set out this Regulation and related implementing acts. It should also explore possibilities for concluding agreements to take into account their carbon pricing mechanism, provided that they deliver equivalent GHG emissions reductions and carbon costs constraints.
Amendment 553 #
2021/0214(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – 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. The mechanism shall first prove to be effective to prevent the risk of carbon leakage both for imports into or exports from the customs territory of the Union, without prejudice to maintaining EU ETS allowances free of charge at benchmark level until a test period with actual surrendering obligation by declarants running until 2030.
Amendment 622 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 11 – point a (new)
Article 2 – paragraph 11 – point a (new)
(a) the third country is a party to the Treaty establishing the Energy Community and/or a party to Association Agreement, including a Deep and Comprehensive Free Trade Area with the Union;
Amendment 623 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 11 – point b (new)
Article 2 – paragraph 11 – point b (new)
(b) the third country has put in place an effective system of monitoring, reporting and verification of greenhouse gas emissions;
Amendment 624 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 11 – point c (new)
Article 2 – paragraph 11 – point c (new)
(c) the third country has submitted a roadmap to the Commission, containing a timetable for the adoption of measures to implement the conditions set out in points (d), (e), and (f);
Amendment 626 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 11– point e (new)
Article 2 – paragraph 11– point e (new)
(e) the third country has committed to climate neutrality and has accordingly formally formulated and communicated, where applicable, to the United Nations Framework Convention on Climate Change a long-term low greenhouse gas emissions development strategy aligned with that objective, and has implemented that obligation in its domestic legislation;
Amendment 627 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 11 – point f (new)
Article 2 – paragraph 11 – point f (new)
(f) the third country has, when implementing the roadmap pursuant to point (c), demonstrated substantial progress towards the alignment of domestic law with Union law in the field of climate action on the basis of that roadmap. The implementation of an emission trading system by 1 January 2030 is conditional upon third country’s receipt of the financial, institutional, and expert support from the Union.
Amendment 628 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 12
Article 2 – paragraph 12
12. The Union, may conclude agreements with third countries with a view to take account of carbon pricing mechanisms in these countries in the application of Article 9A third country satisfying the conditions set out in paragraph 11, points (a) to (f), shall be listed in Annex II, Section C, of this Regulation, and shall submit two reports on the fulfilment of the conditions pursuant to paragraph 7, points (a) to (f), one before 1 July 2025 and another before 1 July 2029. By 31 December 2025 and by 31 December 2029, the Commission shall assess, notably on the basis of the roadmap pursuant to paragraph 11, point (c), and the reports received from the third country, whether that third country continues to respect the conditions set out in paragraph 11.
Amendment 633 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 12 a (new)
Article 2 – paragraph 12 a (new)
12a. A third country listed in Annex II, Section C of this Regulation, shall be removed from that list if the Commission has reasons to consider that the country has not shown sufficient progress to comply with one of the requirements listed in paragraph 11, points (a) to (f), or if the country has taken action incompatible with the objectives set out in the Union climate and environmental legislation.
Amendment 634 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 12 b (new)
Article 2 – paragraph 12 b (new)
12b. The Commission is empowered to adopt delegated acts in accordance with Article 28 to amend the lists in Annex II, Sections A, B or C, depending on whether the conditions in paragraphs 5, 7, 9, 11 or 13 are satisfied.
Amendment 635 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 12 c (new)
Article 2 – paragraph 12 c (new)
12c. The Union may conclude agreements with third countries with a view to take account of carbon pricing mechanisms in these countries.
Amendment 746 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The authorised declarant shall keep records of the documentation, certified by an independent person, verifier accredited pursuant to article 18 and in line with the competences established in Article 8 (1) concerning the verification of embedded emissions. The accredited verifier is required to demonstrate that the declared embedded emissions were subject to a carbon price in the country of origin of the goods and keep evidence of the proof of the actual payment for that carbon price which should not have been subject to an export rebate or any other form of compensation on exportation.
Amendment 773 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The Commission shall, upon request by a register the information on operators of an installations located in a third country, register the information on that operator and on itsies and those installations in a central database referred to in Article 14(4).
Amendment 791 #
2021/0214(COD)
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. The operator may, at any timefter 10 years, ask to be deregistered from the database.
Amendment 990 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
2. Practices of circumvention include situations where a change in the pattern of trade in relation to goods included in the scope of this Regulation, whether slightly modified or not, stems from a practice, process or work has insufficient due cause or economic justification other than avoiding obligations as laid down in this Regulation and consist in replacing those goods with slightly modified products, which are not included in the list of goods in Annex I but belong to a sector included in the scope of this Regulation. or undermining their effects, including on overall GHG emissions and on prices of the like products.
Amendment 1014 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2a. The practice, processor work referred to in the first subparagraph include, inter alia: (a) the slight modification of the product concerned to make it fall under customs codes which are normally not subject to the obligations of this Regulation, provided that the modification does not alter its essential characteristics; (b) false declarations as to the identity of the producer of the product concerned or of the nature of the product concerned or the production process involved in making it; (c) the consignment of the product concerned via third countries to which no or more favourable obligations apply; (d) the reorganisation by exporters or producers of their patterns and channels of sales in order to eventually avoid obligations as laid down in this Regulation, or undermine their effects, including on overall GHG emissions and on prices of the like products, for instance via practices of resource shuffling. For the purposes of this sub-point, resource shuffling shall be defined as any practice, process or work that that have insufficient due cause or economic justification other than avoiding obligations as laid down in this Regulation, or undermining their effects, without delivering environmental benefits on global GHG emissions; (e) in the circumstances indicated in paragraph 2, the assembly of parts by an assembly operation in the Union or a third country; (f) Any other measure to eventually avoid 6 or evade obligations as laid down in this Regulation, or undermine their effects, including on overall GHG.
Amendment 1030 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 3
Article 27 – paragraph 3
3. A Member State or any party affected or benefitted by the situations described in paragraph 2 may notify the Commission if it is confronted, over a two- month period compared with the same period in the preceding year with a significant decrease in the volume of imporFollowing a complaint from an interested party or on its own initiative, the Commission may decide, following an investigation, to extend goods included in the scope of this Regulation and an increase of volume of imports of slightly modified products, which are not included in the list of goods in Annex I. The Commission shall continually monitor any significant change of pattern of trade of goods and slightly modified products at Union levelobligations laid down in this Regulation, in whatever way is necessary to prevent future circumvention of the Mechanism, when circumvention of the measures in force is taking place.
Amendment 1041 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. The notificatDecisions referred to in the third paragraph 3 shall state the reasons on which it is based and shall include relevant data and statistics regarding the goods and products referred to in paragraph 2be subject to the appeal procedure as set out in Article 30.
Amendment 1049 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 5
Article 27 – paragraph 5
5. Where the Commission, taking into account the relevant data, reports and statistics, including when provided by the customs authorities of Member States, has sufficient reasons to believe that the circumstances referred to in paragraph 3 are occurring in one or more Member States, it is empowered to adopt delegated acts in accordance with Article 28 to supplement the scope of this Regulation in ordInvestigations shall be initiated pursuant to this Article on the initiative of the Commission or at the request of a Member State or of any interested party on the basis of sufficient evidence regarding the factors set out in the second paragraph. Initiations shall be made by means of a Commission regulation which shall also instruct customs authorities of Member States to subject imports to registration. The Commission shall provide information to the Member States once an interested party or a Member State has submitted a request justifying the initiation of an investigation and the Commission has completed its analysis thereof, or where to include slightly modified products for anti-circumvention purposeshe Commission has itself determined that there is a need to initiate an investigation.
Amendment 1062 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 5 a (new)
Article 27 – paragraph 5 a (new)
5a. Investigations shall be carried out by the Commission. The Commission may be assisted by customs authorities and the investigation shall be concluded in due time.
Amendment 1067 #
2021/0214(COD)
Proposal for a regulation
Article 27 – paragraph 5 b (new)
Article 27 – paragraph 5 b (new)
5b. The Commission Decision finding circumvention shall impose a penalty pursuant to article 26 on an Authorised Declarant involved in the circumvention and, if appropriate, the operator of the installation located in the third country that is linked to the Authorised Declarant. Where appropriate, the penalty shall also entail the withdrawal of import authorisation and be extended to the operator.
Amendment 1093 #
2021/0214(COD)
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 2(10), 2(114), 18(3) and 27(5) shall be conferred on the Commission for an indeterminate period of time.
Amendment 1098 #
2021/0214(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. The delegation of power referred to in Articles 2(10), 2(114), 18(3) and 27(5) may be revoked at any time by the European Parliament or by the Council.
Amendment 1103 #
2021/0214(COD)
Proposal for a regulation
Article 28 – paragraph 7
Article 28 – paragraph 7
7. A delegated act adopted pursuant to Articles 2(10), 2(114), 18(3) and 27(5) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 1116 #
2021/0214(COD)
Proposal for a regulation
Article 30 – paragraph 1
Article 30 – paragraph 1
1. The Commission shall collect, in consultation with relevant stakeholders, the information necessary with a view to extending the scope of this Regulation to indirect emissions and goods other than those listed in Annex I, and develop methods of calculating embedded emissions based on environmental footprint methods.
Amendment 1134 #
2021/0214(COD)
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
2. Before the endstart of the transitional periodremoval of free allowances under ETS, 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, and assess if the conditions are in place for the effective implementation of a CBAM before phasing out free allocation. The report shall contain, in addition, the assessment of the rules to be applied in the testing period established pursuing to article 30bis and 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.
Amendment 1189 #
2021/0214(COD)
Proposal for a regulation
Article 30 a (new)
Article 30 a (new)
Article 30 a The Commission shall monitor and evaluate the mechanism’s effectiveness with regard to the risk of carbon leakage before phasing out free allocation to sectors at risk of carbon leakage covered by this regulation. To this end, the Commission shall, after consultation of the sectors subject to this regulation, present a report to the European Parliament and the Council evaluating: - the first three years (2026-2028) of the surrendering obligation pursuant to article 22; - the risk of carbon leakage on export markets. Only if the evaluation is clearly positive, the report shall be accompanied by a legislative proposal phasing out free allocation to sectors subject to this regulation, as set out in Article 10.a.1of Directive 2003/87/EC, and implementing a solution to address the risk of carbon leakage on export market.
Amendment 1259 #
2021/0214(COD)
Proposal for a regulation
Annex II – Part 2 a (new)
Annex II – Part 2 a (new)
Section C - Countries outside the scope of this Regulation who are committed to decarbonisation processes that should result in the adoption of emission trading system similar to the EU ETS [Currently empty]
Amendment 276 #
2021/0211(COD)
Proposal for a directive
Recital 29
Recital 29
Amendment 835 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11 – point a
Article 1 – paragraph 1 – point 11 – point a
Directive 2003/87/EC
Article 10 – paragraph 1 – subparagraph 3a
Article 10 – paragraph 1 – subparagraph 3a
In addition, at least 2,5 % of the total quantity of allowances between [year following the entry into force of the Directive] and 2030 shall be auctioned for the Modernisation Fund. The beneficiary Member States for this amount of allowances shall be the Member States with a GDP per capita at market prices below 65 % of the Union average during the period 2016 to 2018. The funds corresponding to this quantity of allowances shall be distributed in accordance with Part B of Annex IIb.
Amendment 931 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a – point i
Article 1 – paragraph 1 – point 12 – point a – point i
Directive 2003/87/EC
Article 10a – paragraph 1 – subparagraph 2a
Article 10a – paragraph 1 – subparagraph 2a
Amendment 962 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a – point i
Article 1 – paragraph 1 – point 12 – point a – point i
Amendment 1000 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2003/87/EC
Article 10a – paragraph 1a – subparagraph 1
Article 10a – paragraph 1a – subparagraph 1
Amendment 1023 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2003/87/EC
Article 10a – paragraph 1a – subparagraph 2
Article 10a – paragraph 1a – subparagraph 2
Amendment 1051 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2003/87/EC
Article 10a – paragraph 1a – subparagraph 3
Article 10a – paragraph 1a – subparagraph 3
Amendment 1062 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive 2003/87/EC
Article 10 – paragraph 1a – subparagraph 4
Article 10 – paragraph 1a – subparagraph 4
Amendment 1246 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14 – point a
Article 1 – paragraph 1 – point 14 – point a
Directive 2003/87/EC
Article 10d – paragraph 1 – subparagraph 2
Article 10d – paragraph 1 – subparagraph 2
The investments supported shall be consistent with the aims of this Directive, as well as the objectives of the Communication from the Commission of 11 December 2019 on The European Green Deal (*) and Regulation (EU) 2021/1119 of the European Parliament and of the Council (**) and the long-term objectives as expressed in the Paris Agreement. No support from the Modernisation Fund shall be provided to energy generation facilities that use solid fossil fuels.”;
Amendment 1386 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19 a (new)
Article 1 – paragraph 1 – point 19 a (new)
Directive 2003/87/EC
Article 29 a
Article 29 a
(19a) Article 29a is replaced by the following: Article 29a “Article 29a Measures in the event of excessive price 1. Iffluctuations fluctuations “1. Where, for more than sixthree consecutive months, the allowance prverage price of allowance in the auctions carried out in accordance with the act adopted under Article 10(4) is more than three1.4 times the average price of allowances during the twosix preceding yearconsecutive months oin the European carbon market, the Commission shall immediately convene a meeting of the Committee esauctions for the allowances covered by this Chapter, the Commission shall, as a matter of urgency, adopt a decision to release 50 million allowances covered by this Chapter from the Market Stabilished by Aty Reserve in accordance with article 91(7) of Decision No 280/2004/EC. 2. If the price evolution referred to in paragraph 1 does not correspond to changing market fundamentals, one of the following measures may be adopted, taking into account the degree of price evolution: (a) States to bring forward the auctioning of a part of the quantity to be auctioned; (b) States to auction up to 25 % of the remaining allowances in the new entrants reserve. Those measures shall be adopted in accordance with(EU) 2015/1814 equally distributed within auctions during a period of three months. 2. Where, for more than three consecutive months, the average price of allowance in the auctions carried out in accordance with the act adopted under Article 10(4) is more than 2.1 times the average price of allowance during the six preceding consecutive months in the auctions for the allowances covered by this Chapter, the Commission shall, as a matter of urgency, adopt a decision to release 150 million allowances covered by this Chapter from the Market Stability Reserve in accordance with article 1(7) of Decision (EU) 2015/1814 equally distributed within auctions during a period of three management procedure referred to in Article 23(4). 3. Any measure shall take utmost account of thonths. a measure which allows Member a measure which allows Member 3. When measures pursuant to paragraph 1 or 2 of this article areports submitted by the Commission to the European Parliament adopted, similar measures pursuant to paragraphs 1 or 2 shall not be adopted earlier thand to the Council pursuant to Article 29, as well as any other relevant information provided by Member States. 4. The arrangements for the applichree months thereafter. 4. When measures pursuant to paragraph 1 or 2 of this Article are adopted, the amount of allowances subsequently released from the Market Stability Reserve shall not be included in the calculations of these provisions shall be laid down in the acts referred to in Article 10(4). otal number of allowances in circulation in accordance with Article 1(4) of Decision (EU) 2015/1814 in that respective calendar year or if not possible for the following calculation.”
Amendment 1502 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2003/87/EC
Article 30 h – paragraph 1
Article 30 h – paragraph 1
1. Where, for more than three consecutive months, the average price of allowance in the auctions carried out in accordance with the act adopted under Article 10(4) is more than twice1.4 times the average price of allowance during the six preceding consecutive months in the auctions for the allowances covered by this Chapter, the Commission shall, as a matter of urgency, adopt a decision to release 50 million allowances covered by this Chapter from the Market Stability Reserve in accordance with Article 1a(7) of Decision (EU) 2015/1814. Where fewer than 50 million allowances are in the reserve, all allowances in the reserve shall be released under this paragraph.
Amendment 1510 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2003/87/EC
Article 30 h – paragraph 2
Article 30 h – paragraph 2
2. Where, for more than three consecutive months, the average price of allowance in the auctions carried out in accordance with the act adopted under Article 10(4) is more than three2.1 times the average price of allowance during the six preceding consecutive months in the auctions for the allowances covered by this Chapter, the Commission shall, as a matter of urgency, adopt a decision to release 150 million allowances covered by this Chapter from the Market Stability Reserve in accordance with Article 1a(7) of Decision (EU) 2015/1814. Where fewer than 150 million allowances are in the reserve, all allowances in the reserve shall be released under this paragraph.
Amendment 1516 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2003/87/EC
Article 30 h – paragraph 2 a (new)
Article 30 h – paragraph 2 a (new)
2a. Where measures pursuant to paragraph 1 or 2 of this Article are adopted, similar measures pursuant to paragraph 1 or 2 shall not be adopted earlier than three months thereafter.
Amendment 1521 #
2021/0211(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2003/87/EC
Article 30 h – paragraph 2 b (new)
Article 30 h – paragraph 2 b (new)
2b. When measures pursuant to paragraph 1 or 2 of this Article are adopted, the amount of allowances subsequently released from the Market Stability Reserve shall not be included in the calculations of total number of allowances in circulation in accordance with Article 1a(4) of Decision (EU) 2015/1814 in that respective calendar year or if not possible for the following calculation.
Amendment 1539 #
2021/0211(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 1 – point a
Article 2 – paragraph 1 – point 1 – point a
Decision (EU) 2015/1814
Article 1 – paragraph 4
Article 1 – paragraph 4
The total number of allowances in circulation in a given year shall be the cumulative number of allowances issued and not put in reserve in the period since 1 January 2008, including the number that were issued pursuant to Article 13(2) of Directive 2003/87/EC as in force until 18 March 2018 in that period and entitlements to use international credits exercised by installations under the EU ETS in respect of emissions up to 31 December of that given year, minus the cumulative tonnes of verified emissions from installations under the EU ETS between 1 January 2008 and 31 December of that same given year, any allowances cancelled in accordance with Article 12(4) of Directive 2003/87/EC.; The total number of allowances in circulation in a given year shall not take into account the amount of allowances held by entities that is not used to cover obligations under the EU ETS. The Commission is empowered to adopt implementing act to determine the number of allowances according to the previous sentence in accordance with the examination procedure referred to in Article 22a(2).
Amendment 80 #
2021/0206(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A Social Climate Fund (‘the Fund’) should therefore be established to provide funds to the Member States to support their policies to address the social impacts of the emissions trading for buildings and road transport on vulnerable households, vulnerable micro-enterprises and, vulnerable transport users and workers in affected sectors. This should be achieved notably through temporary income support and measures and investments intended to reduce reliance on fossil fuels through increased energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transport including attractive and safe active mobility, and public transport to the benefit of vulnerable households, vulnerable micro-enterprises and vulnerable transport users and to update the workers qualification in affected sectors.
Amendment 93 #
2021/0206(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12 a) Particular attention needs to be paid to tenants in the private rental market. Those tenants include vulnerable households in energy poverty and lower middle-income ones, that are significantly affected by the price impacts of increased heating costs or by higher rental prices following renovation, but are not in a position to renovate the building they occupy. As part of their Social Climate Plans, Member States should therefore develop, in consultation with landlords, specific measures and investments to support vulnerable tenants on the private rental market in order to make renovation measures and contribute to the Union’s climate targets.
Amendment 94 #
2021/0206(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The Porto Declaration of 8 May 2021 reaffirmed the European Council’s pledge to work towards a social Europe ensuring a fair transition, and its determination to continue deepening the concrete implementation of the European Pillar of Social Rights at EU and national level, with due regard for respective competences and the principles of subsidiarity and proportionality.
Amendment 96 #
2021/0206(COD)
Proposal for a regulation
Recital 12 b (new)
Recital 12 b (new)
(12 b) Mobility poverty represents an equally concerning challenge for the Union. Addressing this issue is becoming more pressing as a result of the increasing phase-out requirements for combustion engine vehicles, high fuel prices, or high dependencies on transport availability, accessibility and costs to go to work or for daily mobility needs due to living in rural, insular, outermost regions, mountainous, remote and less accessible areas or for less developed regions or territories, including less developed peri-urban areas.
Amendment 103 #
2021/0206(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Ensuring that the measures and investments are particularly targeted towards energy poor or vulnerable households, vulnerable micro-enterprises and, vulnerable transport users and workers in affected sectors is key for a just transition towards climate neutrality. Support measures to promote reductions in greenhouse gas emissions should help Member States to address the social impacts arising from the emissions trading for the sectors of buildings and road transport.
Amendment 103 #
2021/0206(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A Social Climate Fund (‘the Fund’) should therefore be established to provide funds to the Member States to support their policies to address the social impacts of the emissions trading for buildings and road transport on vulnerable households, vulnerable micro-enterprises and vulnerable transport users. This should be achieved notably through temporary income support and measures and investments intended to reduce reliance on fossil fuels through increased energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transport to the benefit of vulnerable households, vulnerable micro-enterprises and vulnerable transport users.
Amendment 109 #
2021/0206(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) For that purpose, each Member State should prepare together with the relevant stakeholders listed in Article 8.1 of Regulation (EU) 2021/1060 such as social partners, regional and local authorities and submit to the Commission a Social Climate Plan (‘the Plan’). Those Plans should pursue two objectives. Firstly, they should provide vulnerable households, vulnerable micro-enterprises and vulnerable transport users the necessary resources to finance and carry out investments in energy efficiency, decarbonisation of heating and cooling, in zero- and low-emission vehicles and mobility. Secondly, they should mitigate the impact of the increase in the cost of fossil fuels on the most vulnerable and thereby prevent energy and transport poverty during the transition period until such investments have been implemented. The Plans should have an investment component promoting the long-term solution of reduce fossil fuels reliance and could envisage other measures, including temporary direct income support to mitigate adverse income effects in the shorter term.
Amendment 110 #
2021/0206(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Pending the impact of those investments on reducing costs and emissions, well targeted direct income support for the most vulnerable would help the just transition. Such support should be understood to be a temporary measure accompanying the decarbonisation of the housing and transport sectors. It would not be permanent as it does not address the root causes of energy and transportmobility poverty. Such support shcould only concern direct impacts of the inclusion of building and road transport into the scope of Directive 2003/87/EC, not electricity or heating costs related to the inclusion of power and heat production in the scope of that Directive. Eligibility for such direct income support should be limited in timbe considered as a means of enabling the most vulnerable households, microenterprises and businesses to meet their essential socio- economic needs. Eligibility for such direct income support should be limited in time, but harmonised with the phasing in of the relevant directives and regulations affecting vulnerable actors in the Fit for 55 package.
Amendment 118 #
2021/0206(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Member States, in consultation with the stakeholders listed in Article 8.1 of Regulation (EU) 2021/1060 (CPR) such as social partners, local and regional level authorities, are best placed to design and to implement Plans that are adapted and targeted to their local, regional and national circumstances as their existing policies in the relevant areas and planned use of other relevant EU funds. In that manner, the broad diversity of situations, the specific knowledge of local and regional governments, research and innovation and industrial relations and social dialogue structures, as well as national traditions, can best be respected and contribute to the effectiveness and efficiency of the overall support to the vulnerable.
Amendment 132 #
2021/0206(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The increase in the price for fossil fuels may disproportionally affect vulnerable households, vulnerable micro- enterprises and vulnerable transport users who spend a larger part of their incomes on energy and transport, who, in certain regions, including in rural, insular, mountainous, remote and less accessible areas or for less developed regions or territories, including the outermost regions and less developed peri-urban areas, do not have access to alternative, affordable mobility and transport solutions and who may lack the financial capacity to invest into the reduction of fossil fuel consumption.
Amendment 146 #
2021/0206(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19 a) Renewable energy communities and citizen energy communities can help Member States to achieve the objectives of this Regulation via a bottom-up approach initiated by citizens, as those communities empower and engage consumers and enable certain groups of household customers, both living in urban and in rural, insular, mountainous, remote and less accessible areas or for less developed regions or territories, including less developed peri-urban areas, to advance energy efficiency in households, support the use of renewable energy and at the same time contribute to fighting energy poverty. For this purpose, Member States should promote the role of renewable energy communities and citizen energy communities and regard them as eligible beneficiaries of the Fund.
Amendment 152 #
2021/0206(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Member States should submit their Plans together with the update of their integrated national energy and climate plans in accordance with Article 14 of Regulation (EU) 2018/1999 of the European Parliament and of the Council35 after the consultation with stakeholders listed in Article 8.1 of Regulation (EU)2021/1060 such as social partners, local and regional level authorities. The Plans should include the measures to be financed, their estimated costs and the national contribution. They should also include key milestones and targets to assess the effective implementation of the measures. _________________ 35 Regulation (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 159 #
2021/0206(COD)
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22 a) In order to reduce administrative burden , the Member States at the appropriate territorial level, and the Commission shall implement the budget of the Fund under shared management. In doing so, the Commission and Member States shall respect the principles of sound financial management, transparency and non-discrimination and shall ensure the visibility of the Union action . The Union and Member States should refrain from imposing unnecessary rules resulting in excessive administrative burden for beneficiaries.
Amendment 163 #
2021/0206(COD)
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Mobility poverty has no clear Union-level or national definitions are available. However, the problem is becoming more pressing to address as a result of the increasing phase-out requirements for combustion engine vehicles, high fuel prices, or high dependencies on transport availability, accessibility and costs to go to work or for daily mobility needs due to living in rural, insular, outermost regions, mountainous, remote and less accessible areas or for less developed regions or territories, including less developed peri-urban areas.
Amendment 164 #
2021/0206(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The financial envelope of the Fund should, in principle, be commensurate to amounts corresponding to 25% of the expected revenues from the inclusion of buildings and road transport into the scope of Directive 2003/87/EC in the period 2026-2032. Pursuant to Council Decision (EU, Euratom) 2020/205341 , Member States should make those revenues available to the Union budget as own resources. Member States are to finance 50% of the total costs of their Plan themselves. For this purpose, as well as for investment and measures to accelerate and alleviate the required transition for citizens negatively affected, Member States should inter alia use their expected revenues from emissions trading for buildings and road transport under Directive 2003/87/EC for that purpose. Moreover, the financial envelope should be reinforced by using additional revenues from a higher carbon price generated by the extension of the scope of Directive2003/87/EC to buildings and road transport. In the event of a higher carbon price, additional revenues should automatically finance the Fund. _________________ 41 Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1).
Amendment 165 #
2021/0206(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) To ensure that financial support provided by the Fund can reach vulnerable households, vulnerable micro- enterprises, vulnerable transport users in the initial years of the entry into force of the Fund, Member States, upon a request submitted together with the Social Climate Plan, can receive an amount of up to 13% of their financial allocation in the form of pre-financing within two months after the adoption by the Commission of the legal commitments.
Amendment 168 #
2021/0206(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to facilitate the preparation of the Social Climate Plan and to ensure transparent rules for monitoring and evaluation, 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 in respect of setting out the template based on which Member States shall prepare their Social Climate Plans and the common indicators for reporting on the progress and for the purpose of monitoring and evaluation of the implementation of the Plans. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 177 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
The measures and investments supported by the Fund shall benefit households, micro-enterprises and transport users, which are vulnerable and particularly affected by the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC, especially households in energy poverty and citizens without public transport alternative to individual cars (in remote and rural areas)in mobility poverty.
Amendment 179 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
(12) ‘vulnerable small and micro- enterprises’ means small and micro- enterprises that are significantly affected by the transition towards climate neutrality, especially the price impacts of the inclusion of buildings intorevised Directive 2021/0213 and the potential extension of the scope of Directive 2003/87/EC to buildings and road transport and lack the means to renovate the building they occupy or to purchase zero and low-emission vehicles;
Amendment 190 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 13
Article 2 – paragraph 1 – point 13
(13) ‘vulnerable transport users’ means transport users, including from lower middle-income households, that are significantly affected by the price impacts of the inclusion of road transport into the scope of Directive 2003/87/ECtransition towards climate neutrality, at risk of mobility poverty, especially because of the price impacts of the revised Directive 2021/0213 and the potential inclusion of road transport and lack the means to purchase zero- and low- emission vehicles or to switch to alternative sustainable modes of transport, including public transport, particularly in rural and remote areas.
Amendment 210 #
2021/0206(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) For that purpose, each Member State should prepare together with the relevant stakeholders listed in Article 8.1 of Regulation (EU) 2021/1060 such as the social partners, regional and local authorities and submit to the Commission a Social Climate Plan (‘the Plan’). Those Plans should contribute to the implementation of the principles of the European Pillar of Social Rights and the achievement of the United Nations Sustainable Development Goals while ensuring that no one is left behind as well as pursue two objectives. Firstly, they should provide vulnerable households, vulnerable micro-enterprises and vulnerable transport users the necessary resources to finance and carry out investments in energy efficiency, decarbonisation of heating and cooling, in zero- and low-emission vehicles and mobility. Secondly, they should mitigate the impact of the increase in the cost of fossil fuels on the most vulnerable and thereby prevent energy and transport poverty during the transition period until such investments have been implemented. The Plans should have an investment component promoting the long-term solution of reduce fossil fuels reliance and could envisage other measures, including temporary direct income support to mitigate adverse income effects in the shorter term.
Amendment 211 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b a (new)
Article 3 – paragraph 3 – point b a (new)
(b a) finance measures and investments to ensure workers reskilling and upskilling in affected sectors.
Amendment 214 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10 a) 'citizen energy community' means citizen energy community as defined in Article 2, point (11) of Directive (EU) 2019/944 of the European Parliament and of the Council1a; _________________ 1a Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU Text with EEA relevance
Amendment 216 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 b (new)
Article 2 – paragraph 1 – point 10 b (new)
(10 b) ‘renewable energy community’ means renewable energy community as defined in point (16) of Article 2 of Directive (EU) 2018/2001 of the European Union and of the Council1a. _________________ 1a Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources
Amendment 218 #
2021/0206(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
Amendment 230 #
2021/0206(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Member States, in consultation with the stakeholders listed in Article 8.1 of Regulation (EU) 2021/1060 (CPR) such as social partners, local and regional level authorities, are best placed to design and to implement Plans that are adapted and targeted to their local, regional and national circumstances as their existing policies in the relevant areas and planned use of other relevant EU funds. In that manner, the broad diversity of situations, the specific knowledge of local and regional governments, research and innovation and industrial relations and social dialogue structures, as well as national traditions, can best be respected and contribute to the effectiveness and efficiency of the overall support to the vulnerable.
Amendment 240 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Each Member State shall prepare, in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation (EU) 2021/1060 such as social partners, local and regional authorities and submit to the Commission a Social Climate Plan (‘the Plan’) together with the update to the integrated national energy and climate plan referred to in Article 14(2) of Regulation (EU) 2018/1999 in accordance with the procedure and timeline laid down in that Article. The Plan shall contain a coherent set of measures and investments to address the impact of carbon pricing on vulnerable households, vulnerable micro-enterprises and vulnerable transport users in order to ensure affordable heating, cooling and mobility while accompanying and accelerating necessary measures to meet the climate targets of the Union.
Amendment 255 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point c
Article 5 – paragraph 2 – point c
(c) zero- and low-emission mobility and transport, taking into account the carbon footprint of vehicles throughout their life cycle;
Amendment 259 #
2021/0206(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Pending the impact of those investments on reducing costs and emissions, well targeted direct income support for the most vulnerable would help the just transition. Such support should be understood to be a temporary measure accompanying the decarbonisation of the housing and transport sectors. It would not be permanent as it does not address the root causes of energy and transport poverty. Such support should omainly concern direct impacts of the inclusion of building and road transport into the scope of Directive 2003/87/EC, not electricity or heating costs related to the inclusion of power and heat production in the scope of that Directive. Eligibility fSuch direct income support should decrease in time as the investments in energy efficiency, in building renovation and in zero- and low-emission mobility and transport should have paid off. Such direct income support should be limited in timeto 40% of the total estimated costs of the Plans for the period 2024-2027 and should be limited to 30% for the period 2028-2032.
Amendment 274 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) an estimate of the likely effects of that increase in prices on households, and in particular on incidence of energy poverty and mobility poverty, on micro- enterprises and on transport users, comprising in particular an estimate and the identification of vulnerable households, vulnerable micro- enterprises and vulnerable transport users; these impacts are to be analysed with a sufficient level of regional disaggregation, taking into account elements such as access to public transport and basic services and identifying the areas mostly affected, particularly territories which are remote such as outermost regions and rural;
Amendment 278 #
2021/0206(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Taking into account the importance of tackling climate change in line with Paris Agreement commitments, the commitment to the European Pillar of Social Rights and the commitment to the United Nations Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of the target that 30% of all expenditure under the 2021- 2027 multiannual financial framework should be spent on mainstreaming climate objectives and should contribute to the ambition of providing 10% of annual spending to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. For this purpose, the methodology set out in Annex II of Regulation (EU) 2021/1060 of the European Parliament and of the Council33 should be used to tag the expenditures of the Fund. The Fund should support activities that fully respect the climate and environmental standards and priorities of the Union and comply with the principle of ‘do no significant harm’ within the meaning of Article 17 of Regulation (EU) 2020/852 of the European Parliament and of the Council34 . Only such measures and investments should be included in the Plans. Direct income support measures should as a rule be considered as having an insignificant foreseeable impact on environmental objectives, and as such be considered compliant with the principle of ‘do no significant harm’. The Commission intends to issue technical guidance to the Member States well ahead of the preparation of the Plans. The guidance will explain how the measures and investments must comply with the principle of ‘do no significant harm’ within the meaning of Article 17 of Regulation (EU) 2020/852. The Commission intends to present in 2021 a proposal for a Council Recommendation on how to address the social aspects of the green transition. _________________ 33 Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). 34 Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
Amendment 284 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) where the Plan provides for measures referred to in Article 3(2), the criteria for the identification of eligible final recipients, the indication of the envisaged time limit for the measures in question and their justification on the basis of a quantitative estimate and a qualitative explanation of how the measures in the Plan are expected to reduce energy and transportmobility poverty and the vulnerability of households, micro-enterprises and transport users to an increase of road transport and heating fuel prices;
Amendment 289 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point i
Article 4 – paragraph 1 – point i
(i) the arrangements for the effective monitoring and implementation of the Plan by the Member State concerned, to be undertaken in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation (EU)2021/1060 such as social partners, local and regional authorities, in particular of the proposed milestones and targets, including indicators for the implementation of measures and investments, which, where relevant, shall be those available with the Statistical office of the European Union European Statistical Office and the European Energy Poverty Observatory as identified by Commission Recommendation 2020/156354 on energy poverty; _________________ 54 OJ L 357, 27.10.2020, p. 35.
Amendment 299 #
2021/0206(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Member States should submit their Plans together with the update of their integrated national energy and climate plans in accordance with Article 14 of Regulation (EU) 2018/1999 of the European Parliament and of the Council35 , after the consultation with stakeholders listed in Article 8.1 of Regulation (EU) 2021/1060 such as social partners, local and regional level authorities. The Plans should include the measures to be financed, their estimated costs and the national contribution. They should also include key milestones and targets to assess the effective implementation of the measures. _________________ 35 Regulation (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 299 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2 a. The Commission shall be empowered to adopt, within three months after the entry into force of this Regulation, a delegated act in accordance with Article 25 to supplement this Regulation in order to set out a template based on which Member States shall prepare their Social Climate Plan.
Amendment 314 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e
Article 5 – paragraph 2 – point e
(e) reductions in the number of vulnerable households, especially households in energy poverty and mobility poverty, of vulnerable micro-enterprises and of vulnerable transport users, including in rural and remote areas and outermost regions.
Amendment 333 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) support building renovations, especially for those occupying worst- performing buildings, with a special attention to tenants, including in the form of financial support or fiscal incentives such as deductibility of renovation costs from the rent, independently of the ownership of the buildings concerned, and support for renovation of social housing;
Amendment 335 #
2021/0206(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The financial envelope of the Fund should, in principle, be commensurate to amounts corresponding to 25% of the expected revenues from the inclusion of buildings and road transport into the scope of Directive 2003/87/EC in the period 2026-2032. Pursuant to Council Decision (EU, Euratom) 2020/205341 , Member States should make those revenues available to the Union budget as own resources. Member States are to finance 50% of the total costs of their Plan themselves. For this purpose, as well as for investment and measures to accelerate and alleviate the required transition for citizens negatively affected, Member States should inter alia use their expected revenues from emissions trading for buildings and road transport under Directive 2003/87/EC for that purpose. Moreover, the financial envelope should be reinforced by using additional revenues from a higher carbon price generated by the extension of the scope of Directive 2003/87/EC to buildings and road transport. In the event of a higher carbon price, additional revenues should automatically finance the Fund. _________________ 41 Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1).
Amendment 342 #
2021/0206(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) To ensure that financial support provided by the Fund can reach vulnerable households, vulnerable micro- enterprises, vulnerable transport users in the initial years of the entry into force of the Fund, Member States, upon a request submitted together with the Social Climate Plan, can receive an amount of up to 13% of their financial allocation in the form of pre-financing within two months after the adoption by the Commission of the legal commitments;
Amendment 361 #
2021/0206(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Member States may include into the estimated total costs financial support provided to public orentities, private entities and renewable- or citizen energy communities other than vulnerable households, vulnerable micro-enterprises and vulnerable transport uses, if those entities carry out measures and investments ultimately benefitting vulnerable households, vulnerable micro- enterprises and vulnerable transport users.
Amendment 363 #
2021/0206(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to facilitate the preparation of the Social Climate Plan and to ensure transparent rules for monitoring and evaluation, 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 in respect of setting out the template based on which Member States shall prepare their Social Climate Plans and the common indicators for reporting on the progress and for the purpose of monitoring and evaluation of the implementation of the Plans. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
Amendment 368 #
2021/0206(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The implementation of the Fund should be carried out in line with the principle of sound financial management, including the protection of the Union budget in the case of breaches of the principles of the rule of law, the effective prevention and prosecution of fraud, tax fraud, tax evasion, corruption and conflicts of interest.
Amendment 373 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2 a. Each year, the programmed baseline allocation in the EU budget should be reinforced in case there is any increase of the carbon price, as this raise would create additional burden on the vulnerable households and microenterprises as well as vulnerable transport users. Such annual reinforcements should correspond to the carbon price increase and be accommodated within the MFF by means of an automatic ‘upward adjustment’ of the ceiling of Heading 3 and the payment ceiling, the mechanism for which is to be provided for in the MFF regulation according to Article 312 TFEU.
Amendment 385 #
2021/0206(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
The FundMember States and the Commission shall be implemented by the Commission in direct management in accordance with the relevant rules adopted pursuant to Article 322 TFEU, in particular Regulation (EU, Euratom) 2018/1046 and Regulation (EU, Euratom) 2020/2092 of the European Parliament and of the Council59 . _________________ 59 Regulation (EU, Euratom) 2020/2092 of the European Parliament and of the Council of 16 December 2020 on a general regime of conditionality for the protection of the Union budget (OJ L 433I, 22.12.2020, p. 1) the budget of the Union allocated to the Funds under shared management in accordance with Article 63 of the Financial Regulation. Member States shall prepare and implement programmes at the appropriate territorial level in accordance with their institutional, legal and financial framework.
Amendment 392 #
2021/0206(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Amendment 395 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
The measures and investments supported by the Fund shall benefit households, micro-enterprises and transport users, which are vulnerable and particularly affected by the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC, especially households in energy poverty and citizens without public transport alternative to individual cars (in remote and rural areas)in mobility poverty.
Amendment 413 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 4
Article 1 – paragraph 4
The general objective of the Fund is to contribute to thea socially fair transition towards climate neutrality notably by addressing the social impacts of the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC. The specific objective of the Fund is to support vulnerable households, vulnerable micro- enterprises and vulnerable transport users through temporary direct income support and through measures and investments intended to increase energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transport with the objective to gradually phase out fossil fuels dependence.
Amendment 440 #
2021/0206(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Where a Social Climate Plan, including relevant milestones and targets, is no longer achievable, either in whole or in part, by the Member State concerned because of objective circumstances, in particular because of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EC, the Member State concerned may, in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation(EU) 2021/1060 such as social partners, local and regional authorities, submit to the Commission an amendment of its Plan to include the necessary and duly justified changes. Member States may request technical support for the preparation of such request.
Amendment 444 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘energy poverty’ means energy povertya household’s lack of access to essential energy services that underpin a decent standard of living and health, including adequate warmth, cooling, lighting, and energy to power appliances, in the relevant national context, existing social policy and other relevant policies as defined in point [(49)] of Article 2 of Directive (EU) [yyyy/nnn] of the of the European Parliament and of the Council50 ; _________________ 50 [Directive (EU) [yyyy/nnn] of the of the European Parliament and of the Council (OJ C […], […], p. […]).] [Proposal for recast of Directive 2012/27/EU on energy efficiency]
Amendment 447 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2 a (new)
Article 2 – paragraph 1 – point 2 a (new)
(2a) ‘mobility poverty’ means households that have a disproportionate share of mobility expenditure to their disposable income or a limited availability of affordable public or alternative modes of transport required to meet essential socio-economic needs, with a particular focus on households in rural, insular, outermost regions, mountainous, remote and less accessible areas or less developed regions or territories, including less developed (peri-)urban areas, caused by one or a combination of factors: high fuel prices, the phase-out of internal combustion engine cars, high costs for the replacement of internal combustion engine cars with zero-emission cars, high- costs or lack of availability of adequate, affordable public or alternative modes of transport;
Amendment 459 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
1. Each Member State concerned shall, on a biennial basis, and in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation(EU) 2021/1060 such as social partners, local and regional authorities, report to the Commission on the implementation of its Plan as part of its integrated national energy and climate progress report pursuant to Article 17 of Regulation (EU) 2018/1999 and in accordance with Article 28 thereof. The Member States concerned shall include in their progress report:
Amendment 468 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11
Article 2 – paragraph 1 – point 11
(11) ‘vulnerable households’ means households in energy poverty or households, including lower middle- income onehouseholds, that are significantly affected by the transition towards climate neutrality, especially the price impacts of the incluextension of buildings into the scope of Directive 2003/87/EC to buildings and road transport and lack the means to renovate the building they occupy;
Amendment 470 #
2021/0206(COD)
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. The power to adopt delegated acts referred to in Article 4(2a) and Article 23(4) shall be conferred on the Commission for an indeterminate period of time.
Amendment 479 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
(12) ‘vulnerable micro-enterprises’ means micro-enterprises that are significantly affected by the transition towards climate neutrality, especially the price impacts of the incluextension of buildings into the scope of Directive 2003/87/EC to buildings and road transport and lack the means to renovate the building they occupy or to purchase zero- and low-emission vehicles;
Amendment 500 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 13
Article 2 – paragraph 1 – point 13
(13) ‘vulnerable transport users’ means transport users, including from lower middle-income households, that are significantly affected by the price impacts of the inclusion of road transport intotransition towards climate neutrality and at risk of mobility poverty, especially because of the price impacts of the extension of the scope of Directive 2003/87/EC to road transport and lack the means to purchase zero- and low- emission vehicles or to switch to alternative sustainable modes of transport, including public transport, particularly in rural and remote areas and outermost regions.
Amendment 516 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Each Member State shall prepare, in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation (EU) 2021/1060 such as social partners, local and regional authorities and submit to the Commission a Social Climate Plan (‘the Plan’) together with the update to the integrated national energy and climate plan referred to in Article 14(2) of Regulation (EU) 2018/1999 in accordance with the procedure and timeline laid down in that Article. The Plan shall contain a coherent set of measures and investments to address the impact of the transition towards climate neutrality, especially energy and mobility poverty including the impact of carbon pricing on vulnerable households, vulnerable micro-enterprises and vulnerable transport users in order to ensure affordable heating, cooling and mobility while accompanying and accelerating necessary measures to meet the climate targets of the Union.
Amendment 535 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Plan may include national measures providing temporary direct income support to vulnerable households and households that are vulnerable transport users to reduce the impact of the increase in the price of fossil fuels and especially resulting from the inclusion of buildings and road transport into the scope of Directive 2003/87/EC.
Amendment 581 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a a (new)
Article 4 – paragraph 1 – point a a (new)
(aa) detailed quantitative and qualitative information on energy and mobility poverty concerning the following: a mapping of vulnerable households, vulnerable micro-enterprises and vulnerable transport users identified at the start of the Plan, on the basis of the definition in Article 2;
Amendment 599 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) an estimate of the likely effects of that increase in prices on households, and in particular on incidence of energy poverty and mobility poverty, on micro- enterprises and on transport users, comprising in particular an estimate and the identification of vulnerable households, vulnerable micro- enterprises and vulnerable transport users; these impacts are to be analysed with a sufficient level of regional disaggregation, taking into account elements such as access to public transport and basic services and identifying the areas mostly affected, particularly territories which are remote such as outermost regions and rural;
Amendment 602 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) indicative national targets and objectives to reduce the number of vulnerable households, vulnerable micro- enterprises and vulnerable transport users over the duration of the Plan, including an indicative timetable with intermediary targets and objectives;
Amendment 609 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) where the Plan provides for measures referred to in Article 3(2), the criteria for the identification of eligible final recipients, the indication of the envisaged time limit for the measures in question and their justification on the basis of a quantitative estimate and a qualitative explanation of how the measures in the Plan are expected to reduce energy and transportmobility poverty and the vulnerability of households, micro-enterprises and transport users to an increase of road transport and heating fuel prices;
Amendment 632 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point i
Article 4 – paragraph 1 – point i
(i) the arrangements for the effective monitoring and implementation of the Plan by the Member State concerned, to be undertaken in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation (EU)2021/1060 such as social partners, local and regional authorities, in particular of the proposed milestones and targets, including indicators for the implementation of measures and investments, which, where relevant, shall be those available with the Statistical office of the European Union European Statistical Office and the European Energy Poverty Observatory as identified by Commission Recommendation 2020/156354 on energy poverty; _________________ 54 OJ L 357, 27.10.2020, p. 35.
Amendment 645 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. The Commission shall be empowered to adopt, within three months after the entry into force of this Regulation, a delegated act in accordance with Article 25 to supplement this Regulation in order to set out a template based on which Member States shall prepare their Social Climate Plan.
Amendment 668 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point d
Article 5 – paragraph 2 – point d
(d) greenhouse gas emissions reductions and gradually ending the fossil fuel dependence;
Amendment 675 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e
Article 5 – paragraph 2 – point e
(e) reductions in the number of vulnerable households, especially households in energy poverty and mobility poverty, of vulnerable micro-enterprises and of vulnerable transport users, including in rural and remote areas and outermost regions.
Amendment 695 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. The Fund shall only support micro-enterprises that respect applicable working conditions resulting from relevant national labour law or collective agreements.
Amendment 711 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States may include the costs of measures providing temporary direct income support to vulnerable households and vulnerable households that are transport users to absorb the increase in road transport and heating fuel prices. Such support shall decrease over time and be limited to the direct impact of the emission trading for buildings and road transport. Eligibility for such direct income support shall cease within the time limits identified under Article 4(1) point (d). Such direct income support shall be limited to 40% of the total estimated costs of the Plans for the period 2024-2027 and shall be limited to 30% for the period 2028-2032.
Amendment 726 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) support building renovations, especially for those occupying worst- performing buildings, with a special attention to tenants, including in the form of financial support or fiscal incentives such as deductibility of renovation costs from the rent, independently of the ownership of the buildings concerned and support for renovation of social housing;
Amendment 738 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) contribute to the decarbonisation, including the electrification, of heating and cooling of, and cooking in, buildings and the integration of energy from renewable sources that contribute to the achievements of energy savings including subsidies and zero-interest loans to invest in products and services to increase the energy efficiency of buildings and to integrate renewable energy sources in buildings;
Amendment 782 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) support public and private entities in developing and providing affordable zero- and low-emission mobility and transport services and the uptake of attractive active mobility options for rural, insular, mountainous, remote and less accessible areas, including the outermost regions or for less developed regions or territories, including less developed peri- urban areas.
Amendment 819 #
2021/0206(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Member States may include into the estimated total costs financial support provided to public or private entities, strictly excluding financial intermediaries, other than vulnerable households, vulnerable micro-enterprises and vulnerable transport uses, if those entities carry out measures and investments ultimately benefitting vulnerable households, vulnerable micro- enterprises and vulnerable transport users. Such entities shall comply with the requirements on visibility set out in Article 22a.
Amendment 845 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The financial envelope for the implementation of the Fund for the period 2028-2032 shall be EUR 48 500 000 000 in current prices, subject to the availability of the amounts under the annual ceilings of the applicable multiannual financial framework referred to in Article 312 TFEU.
Amendment 851 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. Each year, the programmed baseline allocation in the EU budget should be reinforced in case there is any increase of the carbon price, as this raise would create additional burden on the vulnerable households and microenterprises as well as vulnerable transport users. Such annual reinforcements should correspond to the carbon price increase and be accommodated within the MFF by means of an automatic ‘upward adjustment’ of the ceiling of Heading 3 and the payment ceiling, the mechanism for which is to be provided for in the MFF regulation according to Article 312 TFEU.
Amendment 886 #
2021/0206(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Support under the Fund shall be additional to the support provided under other Union and national funds, programmes and instruments. Measures and investments supported under the Fund may receive support from other Union funds, programmes and instruments provided that such support does not cover the same cost.
Amendment 898 #
2021/0206(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Amendment 930 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point i
Article 15 – paragraph 2 – point a – point i
(i) whether the Plan represents a response to the social impact on and challenges faced by vulnerable households, vulnerable micro-enterprises and vulnerable transport users in the Member State concerned from establishthe transition towards climate neutrality, especially from extending the emission trading system forto buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EC, especially households in energy poverty and mobility poverty, duly taking into account the challenges identified in the assessments of the Commission of the update of the concerned Member State’s integrated national energy and climate plan and of its progress pursuant to Article 9(3), and Articles 13 and 29 of Regulation (EU) 2018/1999, as well as in the Commission recommendations to Member States issued pursuant to Article 34 of Regulation (EU) 2018/1999 in view of the long-term objective of climate neutrality in the Union by 2050. This shall take into account the specific challenges and the financial allocation of the Member State concerned;
Amendment 940 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point ii a (new)
Article 15 – paragraph 2 – point a – point ii a (new)
(iia) whether the Plan is expected to ensure that no measure or investment included in the Plan does benefit micro- enterprises that do not respect applicable working conditions resulting from relevant national labour law and collective agreements;
Amendment 952 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b – point i
Article 15 – paragraph 2 – point b – point i
(i) whether the Plan is expected to have a lasting impact on the on the EU’s 2030 target, on climate neutrality and on the challenges addressed by that Plan and in particular on vulnerable households, vulnerable micro- enterprises and vulnerable transport users, especially households in energy poverty and mobility poverty, in the Member State concerned;
Amendment 978 #
2021/0206(COD)
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. On the basis of the assessment in accordance with Article 15, the Commission shall decide on the Plan of a Member State, by means of an implementing act, within sixthree months from the date of the submission of that Plan pursuant to Article 3(1) of this Regulation.
Amendment 980 #
2021/0206(COD)
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 – point b
Article 16 – paragraph 1 – subparagraph 1 – point b
(b) the Union financial allocation allocated in accordance with Articles 13 and 13a of this Regulation to be paid in pre-financing and instalments once the Member State has satisfactorily fulfilled the relevant milestones and targets identified in relation to the implementation of the Plan, which shall be subject, for the period 2028-2032, to the availability of the amounts referred to in Article 9(2) of this Regulation under the annual ceilings of the multiannual financial framework referred to in Article 312 TFEU;
Amendment 992 #
2021/0206(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Where a Social Climate Plan, including relevant milestones and targets, is no longer achievable, either in whole or in part, by the Member State concerned because of objective circumstances, in particular because of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EC, the Member State concerned may, in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation (EU) 2021/1060 such as social partners, local and regional authorities, submit to the Commission an amendment of its Plan to include the necessary and duly justified changes. Member States may request technical support for the preparation of such request.
Amendment 1009 #
2021/0206(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. After the Commission has adopted a decision as referred to in Article 16, it shall in due time conclude an agreement with the Member State concerned constituting an individual legal commitment within the meaning of Regulation (EU, Euratom) 2018/1046 covering the period 20254-2027. That agreement may be concluded at the earliest one year before the year of the start of the auctions under Chapter IVa of Directive 2003/87/EC.
Amendment 1028 #
2021/0206(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. In implementing the Fund, the Member States, as beneficiaries of funds under the Fund, shall take all the appropriate measures to protect the financial interests of the Union and to ensure that the use of funds in relation to measures and investments supported by the Fund complies with the applicable Union and national law, in particular regarding the protection of the Union budget in the case of breaches of the principles of the rule of law, the prevention, detection and correction of fraud, corruption and conflicts of interests. To this effect, the Member States shall provide an effective and efficient internal control system as further detailed in Annex III and the recovery of amounts wrongly paid or incorrectly used. Member States may rely on their regular national budget management systems.
Amendment 1030 #
2021/0206(COD)
Proposal for a regulation
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
1a. In implementing the Fund, the Commission shall take all the appropriate measures in accordance with Regulation (EU, Euratom) 2020/2092 to ensure the protection of funds in relation to measures and investments supported by the Fund in the case of breaches of the principles of the rule of law in the Member States. The Commission shall provide, to that effect, an effective and efficient internal control system and the recovery of amounts wrongly paid or incorrectly used.
Amendment 1047 #
2021/0206(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 1051 #
2021/0206(COD)
Proposal for a regulation
Article 22 a (new)
Article 22 a (new)
Article 22 a Visibility of Union funding 1. Each Member State and each intermediary entities benefiting from support under Article 8 shall ensure: (a) the visibility for final beneficiaries of Union support in all activities relating to operations supported by the Fund including by displaying the emblem of the Union and an appropriate funding statement that reads “funded by the European Union - Social Climate Fund” on documents and communication material; (b) communication to Union citizens of the role and achievements of the Fund through a single EU website portal in all official Member States languages, providing access to all programmes involving that Member State; (c) a short description of the operation, proportionate to the level of support, including its aims and results, and highlighting the financial support from the Union to be provided on their official website and social media sites, where such sites exist; (c) the display for operations involving physical investment or equipment durable plaques or billboards clearly visible to the final beneficiaries and the public, that present the emblem of the Union, as soon as the physical implementation of operations involving physical investment starts or purchased equipment is installed; (d) communication for operations involving financial instruments, including for temporary direct income support in accordance with Article 6(1), the amount of support from the Fund to the final recipients.
Amendment 1054 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
1. Each Member State concerned shall, on a biennial basis, and in consultation with the relevant stakeholders listed in Article 8, paragraph 1 of Regulation (EU) 2021/1060 such as social partners, local and regional authorities, report to the Commission on the implementation of its Plan as part of its integrated national energy and climate progress report pursuant to Article 17 of Regulation (EU) 2018/1999 and in accordance with Article 28 thereof. The Member States concerned shall include in their progress report:
Amendment 1058 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) detailed quantitative information on the number of households in energand micro- enterprises in energy poverty and mobility poverty;
Amendment 1063 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) when applicable, detailed information on progress towards the national indicative targets and objectives to reduce the number of households in energand micro-enterprises in energy poverty and mobility poverty;
Amendment 1088 #
2021/0206(COD)
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. By 1 July 20287, the Commission shall provide the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions with an evaluation report on the implementation and functioning of the Fund.
Amendment 1103 #
2021/0206(COD)
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. The power to adopt delegated acts referred to in Article 4(2a) and 23(4) shall be conferred on the Commission for an indeterminate period of time.
Amendment 344 #
2021/0203(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) energy systems while taking into account the impact on security of supply and affordability, and
Amendment 349 #
2021/0203(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) non-energy sectors, where those sectors have an impact on energy consumption, security of supply, affordability and energy efficiency.
Amendment 385 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 2 – point d – point iv a (new)
Article 4 – paragraph 2 – subparagraph 2 – point d – point iv a (new)
(iva) the share of industry in GDP;
Amendment 387 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 2 – point d – point iv b (new)
Article 4 – paragraph 2 – subparagraph 2 – point d – point iv b (new)
(ivb) availability of energy infrastructures.
Amendment 402 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. Where the Commission concludes, on the basis of its assessment pursuant to Article 29(1) and (3) of Regulation (EU) 2018/1999, that insufficient progress has been made towards meeting the energy efficiency contributions, Member States that are above their indicative trajectories referred to in paragraph 2 of this Article shall ensure that additional measures are implemented within onetwo years following the date of reception of the Commission's assessment in order to ensure getting back on track to reach their energy efficiency contributions. Those additional measures shall include, but shall not be limited to, the following measures:
Amendment 450 #
2021/0203(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Where public bodies occupy a building that they do not own, they shall exercise their contractual rights to the extent possible and encourage the building owner to renovate the building to a nearly zero-energy buildingcost-optimal levels in accordance with Aarticle 97 of Directive 2010/31/EU. When concluding a new contract for occupying a building they do not own, public bodies shall aim for that building to fall into the top two energy efficiency classes on the energy performance certificate.
Amendment 487 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 1 – point c
Article 8 – paragraph 1 – point c
(c) new savings each year from 1 January 2024 to 31 December 2030 of 1,5 % of annual final energy consumption, averaged over the three-year period prior to 1 January 2020.
Amendment 548 #
2021/0203(COD)
Proposal for a directive
Article 11 – paragraph 2 – subparagraph 1
Article 11 – paragraph 2 – subparagraph 1
The results of the energy audits including the recommendations from these audits shall be transmitted to the management of the enterprise. Member States shall ensure that the results and the implemented recommendations are published in the enterprise’s annual report, where applicable.
Amendment 603 #
2021/0203(COD)
2. Member States shall ensure that the public isand relevant stakeholders are given the opportunity to participate in the preparation of heating and cooling plans, the comprehensive assessment and the policies and measures.
Amendment 635 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point a
Article 24 – paragraph 1 – point a
a. until 31 December 2025, a system using at least 50% renewable and low- carbon energy, 50% waste heat, 75% cogenerated heat or 50% of a combination of such energy and heat;
Amendment 641 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point b
Article 24 – paragraph 1 – point b
b. from 1 January 2026, a new or refurbished system using at least 50% renewable and low-carbon energy, 50% waste heat, 80% of high-efficiency cogenerated heat or at least a combination of such thermal energy going into the network where the share of renewable energy is at least 5% and the total share of renewable energy, waste heat or high- efficiency cogenerated heat is at least 50%;
Amendment 653 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point c
Article 24 – paragraph 1 – point c
c. from 1 January 2035, a new or refurbished system using at least 50% renewable and low-carbon energy and waste heat, where the share of renewable energy is at least 20%;
Amendment 661 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point d
Article 24 – paragraph 1 – point d
d. from 1 January 2045, a new or refurbished system using at least 75 % renewable and low-carbon energy and waste heat, where the share of renewable energy is at least 40%;
Amendment 669 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point e
Article 24 – paragraph 1 – point e
e. from 1 January 2050, a new or refurbished system using only renewable energy and waste heat, where the share of renewable energy is at least 60%.
Amendment 729 #
2021/0203(COD)
Proposal for a directive
Annex I – point 2 – introductory part
Annex I – point 2 – introductory part
2. The following indicative formula represents the objective criteria reflecting the factors listed in points (d) (i) to (iva) of Article 4(2), each used for defining the level of national-specific ambition in % (Target) and having the same weight in the formula (0,25):
Amendment 731 #
2021/0203(COD)
Proposal for a directive
Annex I – point 2 – point d a (new)
Annex I – point 2 – point d a (new)
da) the share of industry in GDP ("Findustry")
Amendment 735 #
2021/0203(COD)
Proposal for a directive
Annex I – point 6 a (new)
Annex I – point 6 a (new)
6a. Findustry shall be calculated for each Member State based on its three- year average share of industry (except construction) on the gross value added to the Union’s three-year average over 2017- 2019 period
Amendment 142 #
2021/0201(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to contribute to the increased ambition to reduce greenhouse gas net emissions from at least 40 % to at least 55 % below 1990 levels, binding annual targets for net greenhouse gas removals should be set out for each Member State in the land use, land use change and forestry sector in the period from 2026 to 2030 (in analogy to the annual emission allocations set out in Regulation (EU) 2018/842 of the European Parliament and of the Council32 ), resulting in a target of 310 millions of tonnes CO2 equivalent of net removals for the Union as a whole in 2030. The methodology used to establish the national targets for 2030 should take into account the average greenhouse gas emissions and removals from the years 20168, 20179 and 201820, reported by each Member State, and reflect the current mitigation performance of the land use, land use change and forestry sector, and each Member State’s share of the managed land area in the Union, taking into account the capacity of that Member State to improve its performance in the sector via land management practices or changes in land use that benefit the climate and biodiversity. __________________ 32Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26).
Amendment 159 #
2021/0201(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The bindingcative annual targets for net greenhouse gas removals should be determined for each Member State by a linear trajectory. The trajectory should start in 2022, on the average of greenhouse gas emissions reported by that Member State during 2021, 2022 and 2023 and end in 2030 on the target set out for that Member State. For Member States that improve their methodology of calculating the emissions and removals, a concept of technical correction should be introduced. A technical correction should be added to the target of that Member State corresponding to the effect of the change in methodology on the targets and the efforts of the Member State to achieve them, in order to respect environmental integrity.
Amendment 183 #
2021/0201(COD)
Proposal for a regulation
Recital 8
Recital 8
Amendment 268 #
2021/0201(COD)
Proposal for a regulation
Recital 13
Recital 13
Amendment 331 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 2018/841
Article 1 – paragraph 1 – point e
Article 1 – paragraph 1 – point e
Amendment 365 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) 2018/841
Article 2 – paragraph 3
Article 2 – paragraph 3
Amendment 396 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/841
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
2. The 2030 Union target for net greenhouse gas removals is 310 million tonnes CO2 equivalent as a sum of the Member States targets established in accordance with paragraph 3 of this Article, and shall be based on the average of its greenhouse gas inventory data for the years 20168, 20179 and 201820.
Amendment 438 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/841
Article 4 – paragraph 4
Article 4 – paragraph 4
Amendment 614 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EU) 2018/841
Article 13 c – paragraph 1
Article 13 c – paragraph 1
Amendment 621 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EU) 2018/841
Article 13 c – paragraph 2
Article 13 c – paragraph 2
Amendment 656 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Regulation (EU) 2018/841
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
Amendment 670 #
2021/0201(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18
Article 1 – paragraph 1 – point 18
Regulation (EU) 2018/841
Article 17 – paragraph 2 – subparagraph 2
Article 17 – paragraph 2 – subparagraph 2
Following the report, the Commission shall make legislative proposals where it deems it appropriate. In particular, the proposals shall set out annual targets and governance aiming towards the 2035 climate-neutrality target as laid down in Article 4(4), additional Union policies and measures, and a post-2035 framework, including in the scope of the Regulation greenhouse gas emissions and removals from additional sectors, such as the marine and freshwater environment.;
Amendment 686 #
2021/0201(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
Regulation (EU) 2018/1999
Article 4 – paragraph 1 – point a – point 1 – point ii
Article 4 – paragraph 1 – point a – point 1 – point ii
the Member State’s commitments and national targets for net greenhouse gas removals pursuant to Article 4(1) and (2) of Regulation (EU) 2018/841 and its contributions aim towards reaching the Union objective of reducing greenhouse gas emissions to net zero by 2035 and achieving negative emissions thereafter pursuant to Article 4(4) of that Regulation;;
Amendment 697 #
2021/0201(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3 – point a
Article 2 – paragraph 1 – point 3 – point a
Regulation (EU) 2018/1999
Article 38 – paragraph 1 a
Article 38 – paragraph 1 a
In 2025, the Commission shall carry out a comprehensive review of the national inventory data submitted by Member States pursuant to Article 26(4) of this Regulation, in order to determine the indicative annual targets of net greenhouse gas emissions reduction of the Member States pursuant to Article 4(3) of Regulation (EU) 2018/841 and in order to determine the annual emission allocations of the Member States pursuant to Article 4(3) of Regulation (EU) 2018/842;
Amendment 52 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) do not exceed, in the years 2023, 2024 and 2025 to2030, the limit defined by a linear trajectory starting in 2022 at the annual emission allocation for that Member State, as set out pursuant to paragraph 3 of this Article for that year, and ending in 2030 at the limit set for that Member State in column 2 of Annex I to this Regulation;
Amendment 53 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 2 – point c
Article 4 – paragraph 2 – point c
Amendment 55 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 3 – subparagraph 3
Article 4 – paragraph 3 – subparagraph 3
For the years 2023, 2024 and 2025 to 2030, it shall determine the annual emission allocations based on the value for the 2005 greenhouse gas emissions of each Member State indicated pursuant to the second subparagraph and the reviewed values of the national inventory data for the years 2016, 2017 and 2018 referred to in the second subparagraph.
Amendment 56 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 3 – subparagraph 4
Article 4 – paragraph 3 – subparagraph 4
Amendment 189 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 2 – point (b)
Article 4 – paragraph 2 – point (b)
(b) do not exceed, in the years 2023, 2024 and 2025, to 2030 the limit defined by a linear trajectory starting in 2022 at the annual emission allocation for that Member State, as set out pursuant to paragraph 3 of this Article for that year, and ending in 2030 at the limit set for that Member State in column 2 of Annex I to this Regulation;
Amendment 213 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 3 – subparagraph 3
Article 4 – paragraph 3 – subparagraph 3
For the years 2023, 2024 and 2025 to 2030, it shall determine the annual emission allocations based on the value for the 2005 greenhouse gas emissions of each Member State indicated pursuant to the second subparagraph and the reviewed values of the national inventory data for the years 2016, 2017 and 2018 referred to in the second subparagraph.
Amendment 221 #
2021/0200(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EU) 2018/842
Article 4 – paragraph 3 – subparagraph 4
Article 4 – paragraph 3 – subparagraph 4
Amendment 83 #
2021/0197(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) This regulation forms part of efforts to meet the Union's wider objective to reduce emissions from passenger cars and light commercial vehicles. With the increasing use of zero- and low-emission vehicles, emission sources will move upstream in the automotive chain. By focusing exclusively on vehicle exhaust emissions, this legislation will therefore become progressively less effective in reducing emissions at EU level. In these circumstances, the Commission needs to come up with, by 31 December 2023 at the latest, a harmonised methodology for reporting the carbon balance of the life- cycle of such vehicles (‘Well-to-Wheels’) in order to obtain an overall view of their environmental impacts and thus ensure consistency of the means brought to bear in pursuit of the Union’s climate objectives. This regulation should be reviewed in 2027 to incorporate this extended carbon accounting as a new indicator for the reduction of emissions from the sector which is better able to reflect the true carbon balance of passenger cars and light commercial vehicles.
Amendment 87 #
2021/0197(COD)
Proposal for a regulation
Recital 7 b (new)
Recital 7 b (new)
(7b) While the review of this regulation forms part of efforts to meet the environmental objectives of decarbonising road transport in order to combat climate change, it should also take into account the significant industrial and social consequences of this process to ensure employment and accessible mobility for all.
Amendment 101 #
2021/0197(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The strengthened CO2 emission reduction requirements should incentivise an increasing share of zero-emission and low-emission vehicles being deployed on the Union market whilst providing benefits to consumers and citizens in terms of air quality and energy savings, as well as ensuring that innovation in the automotive value chain can be maintained. The automotive industry remains one of the pillars of the EU economy, contributing 7% of European GDP, providing 4.6 million jobs and remaining at the cutting edge of technological innovation with EUR 60 billion invested each year in research and development. The industry needs to be supported in its environmental and digital transition, as European manufacturers are now facing a triple bind, with tightened environmental regulations, increasing investment needs in innovation and heightened international competition. Within the global context, also the EU automotive chain must be a leading actor in the on- going transition towards zero-emissioncarbon-neutral mobility. The strengthened CO2 emission reduction standards armust become technology neutral in reaching the fleet- wide targets that they set. Different technologies are and remain available to reach the zero-emission fleet wide target. Zero-emission vehicles currently include battery electric vehicles, fuel-cell and other hydrogen powered vehicles, and technological innovations are continuing. Zero and low-emission vehicles, which run on advanced biofuels or synthetic fuels as defined in Directive (EU) 2018/20011a, which is currently under review, which also include well performing plug-in hybrid electric vehicles, can continue to play a role in the transition pathway.
Amendment 109 #
2021/0197(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) While battery-powered electric vehicles have great potential to decarbonise the fleet and should be encouraged, they do not justify abandoning the principle of technological neutrality, and should rather be used in concert with other efficient technologies. It is important to stress that no technology is ‘zero emission’ or has no environmental impact, including this type of vehicle (given the battery’s carbon footprint, the higher weight of vehicles, the origin of the electricity, the extraction of raw materials). In this respect, the risk of supply tensions should be assessed and addressed in order to meet European demand in a context of increased international pressure to extract the resources needed to manufacture batteries, with projections for battery production increasing twentyfold by 2050. Moreover, the impacts on electricity networks (in terms of decarbonisation, availability, performance and standardisation) or on the rollout of recharging infrastructures (network size correlated with autonomy, high private and public investment requirements) must be considered.
Amendment 110 #
2021/0197(COD)
Proposal for a regulation
Recital 9 b (new)
Recital 9 b (new)
(9b) The principle of technological neutrality is fundamental to ensure there is efficiency and a plurality of solutions, to preserve and fasten innovation and development, including in disruptive technologies, and to allow market flexibility and a diverse range of social behaviours. It is thus important that we do not limit road transport to a single technology but rather encourage innovation and complementarities between efficient alternative technologies, such as the combined use of hybrid vehicles and low-carbon fuels. Furthermore, a ‘one size fits all’ approach at European level would be compromised by the wide economic, social, geographical and infrastructural diversity within and between Member States, whereas a mix of complementary technologies allows each region to implement the solutions it deems most appropriate to reduce its emissions.
Amendment 117 #
2021/0197(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Against that background, new strengthened CO2 emission reduction targets should be set for both new passenger cars and new light commercial vehicles for the period 2030 onwards. Those targets should be set at a level that will deliver a strong signal to accelerate the uptake of zero- and low-emission vehicles on the Union market and to stimulate innovation in zero- and low-emission technologies in a cost- efficient way.
Amendment 125 #
2021/0197(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The targets in the revised CO2 performance standards should be accompanied by a European strategy to address the challenges posed by the scale- up of the manufacturing of zero- and low- emission vehicles and associated technologies, as well as the need for up- and re-skilling of workers in the sector and the economic diversification and reconversion of activities. Particular attention should be given to the impact that this transition will have on SMEs along the supply chain. Where appropriate, financial support should be considerallocated at the level of the EU and Member States to crowd in private investment, including via the European Social Fund Plus, the Just Transition Fund, the Innovation Fund, the European Regional Development Fund, the Cohesion Fund, the Recovery and Resilience Facility and other instruments of the Multiannual Financial Framework and the Next Generation EU, in line with State aid rules. The revised environmental and energy state aid rules will enable Member States to support business to decarbonize their production processes and adopt greener technologies in the context of the New Industrial Strategy.
Amendment 134 #
2021/0197(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) To achieve the necessary transition, it is essential to set up accompanying measures targeting the most affected actors in the automotive value chain across the EU, focusing on small and medium sized suppliers. To accompany the implementation of the updated CO2emissions reduction targets, a dedicated transition fund for the automotive sector should be created to help mitigate the negative effects on employment and local economies
Amendment 148 #
2021/0197(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The updated New Industrial Strategy26 foresees the co-creation of green and digital transition pathways in partnership with industry, public authorities, social partners and other stakeholders. In this context, a transition pathway should be developed for the mobility ecosystem to accompany the transition of the automotive value chain. The pathway should take particular heed of SMEs in the automotive supply chain, of the consultation of social partners including by Member States, and also build on the European Skills Agenda with initiatives like the Pact for Skills to mobilise the private sector and other stakeholders to up-skill and re-skill Europe’s workforce in view of the green and digital transitions. The appropriate actions and incentives at European and national level to boost the affordability of zero - and low-emission vehicles should also be addressed in the pathway. The progress made on this comprehensive transition pathway for the mobility ecosystem should be monitored every two years as part of a progress report to be submitted by the Commission, looking inter alia at the progress in the deployment of zero- emission vehicles, their price developments, deployment of alternative fuels development and infrastructure roll- out as required under the Alternative Fuels Infrastructure Regulation, the potential of innovative technologies to reach climate neutral mobility, international competitiveness, investments in the automotive value chain, up-skilling and re- skilling of workers and reconversion of activities. The progress report will also build on the two-year progress reports that Member States submit under the Alternative Fuels Infrastructure Regulation. The Commission should consult social partners in the preparation of the progress report, including the results in the social dialogue. Innovations in the automotive supply chain are continuing. Innovative technologies such as the production of electro-fuels with air capture, if further developed, could offer prospects for affordable climate neutral mobility. The Commission should therefore keep track of progress in the state of innovation in the sector as part of its progress report. _________________ 26 Commission Communication - Updating the 2020 New Industrial Strategy: Building a stronger Single Market for Europe’s recovery, COM(2021) 350 final of 5 May 2021
Amendment 163 #
2021/0197(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The rollout of sufficient charging and refuelling infrastructure for alternative fuels is an essential prerequisite for the development of the market for zero- and low-emission vehicles and, therefore, for the success of this Regulation; thus, any increase in this regulation’s emission-reduction targets, including on interim objectives, should go hand-in-hand with an increase in rollout targets set as part of the revision of the Directive on the deployment of alternative fuels infrastructure; in this connection, it is vital that investment in its deployment should be continued and increased. The Member States should be provided with sufficient support and help to achieve this objective due to their significant investment needs in a decade in which their tax losses and transfers of tax revenues towards alternative fuels will increase. In this context, it is important to underline that the issue of refuelling is intrinsically linked to the very autonomy of vehicles, that, the more the latter increases, the less frequent refuelling will need to be – and that the Commission should therefore take account of technological developments, in particular with regard to the autonomy of batteries, which affect the deployment of infrastructure.
Amendment 174 #
2021/0197(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Manufacturers should be provided with sufficient flexibility in adapting their fleets over time in order to manage the transition towards zero- and low-emission vehicles in a cost-efficient manner, and it is theref. The progressively more ambitious emission reduction targets have increased the costs of compliance for manufacturers. It is therefore all the more appropriate to maintain the approach of decreasing target levels in five-year steps.
Amendment 179 #
2021/0197(COD)
Proposal for a regulation
Recital 15
Recital 15
Amendment 205 #
2021/0197(COD)
Proposal for a regulation
Recital 21
Recital 21
Amendment 236 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point -a a (new)
Article 1 – paragraph 1 – point 1 – point -a a (new)
Regulation (EU) 2019/631
Article 1 – paragraph 4 – point a
Article 1 – paragraph 4 – point a
(-aa) in paragraph 4, point (a) is replaced by the following: "(a) for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021determined in accordance with point 6.1.1 of Part A of Annex I; as set in Regulation (EU) 2019/631;" Or. en (02019R0631)
Amendment 241 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point -a b (new)
Article 1 – paragraph 1 – point 1 – point -a b (new)
Regulation (EU) 2019/631
Article – paragraph 4 – point b
Article – paragraph 4 – point b
(-ab) paragraph 4, point (b) is replaced by the following: "(b) for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021determined in accordance with point 6.1.1 of Part A of Annex I; as set in Regulation (EU) 2019/631;" Or. en (02019R0631)
Amendment 256 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point a – point i
Article 1 – paragraph 1 – point 1 – point a – point i
Regulation (EU) 2019/631
Article 1 – paragraph 5 – point a
Article 1 – paragraph 5 – point a
(i) in point (a), the figure “37,5 %” is replaced by ‘550 %’,
Amendment 271 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Regulation (EU) 2019/631
Article 1 – paragraph 5 a (new)
Article 1 – paragraph 5 a (new)
Amendment 289 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point c
Article 1 – paragraph 1 – point 1 – point c
Regulation (EU) 2019/631
Article 1 – paragraph 6
Article 1 – paragraph 6
Amendment 299 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point d
Article 1 – paragraph 1 – point 1 – point d
Regulation (EU) 2019/631
Article 1 – paragraph 7
Article 1 – paragraph 7
Amendment 301 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point d
Article 1 – paragraph 1 – point 1 – point d
Regulation (EU) 2019/631
Article 1 – paragraph 7
Article 1 – paragraph 7
(d) paragraph 7 is replaced by the following: ‘7. From 1 January 2030, the following zero- and low-emission vehicles' benchmarks shall apply in accordance with points 6.3 of Parts A and B of Annex I, respectively: (a) a benchmark equal to a 40% share of the fleet of new passenger cars and; (b) a benchmark equal to a 35 % share of the fleet of new light commercial vehicles.’
Amendment 310 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point a a (new)
Article 1 – paragraph 1 – point 3 – point a a (new)
Regulation (EU) 2019/631
Article 3 – paragraph 1 – point a a (new)
Article 3 – paragraph 1 – point a a (new)
(aa) the following point is inserted: ‘(aa) ‘plug-in hybrid electric vehicle’ (PHEV): a vehicle powered by a combination of an electric motor with a rechargeable battery and an internal combustion engine, which may operate together or separately.’
Amendment 333 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Regulation (EU) 2019/631
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
(4a) In Article 4, the following paragraph is added: '3a. New vehicles equipped with hydrogen combustion engines are defined as zero- emission vehicles, meaning zero-gram CO2 tailpipe emissions under WLTP.'
Amendment 346 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EU) 2019/631
Article 8 a (new)
Article 8 a (new)
(5a) The following Article is inserted "Article 8a Creation of a dedicated fund for the most affected actors in the automotive value chain across the EU By [6months entry into force of this Regulation], the Commission shall set up a dedicated transition fund for the automotive sector to help mitigate the negative effects on employment and local economies. The fund shall provide financial support to the most affected actors in the automotive value chain across the EU, focusing on small and medium sized suppliers."
Amendment 356 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2019/631
Article 10 – paragraph 2
Article 10 – paragraph 2
Amendment 372 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 a (new)
Article 1 – paragraph 1 – point 6 a (new)
Regulation (EU) 2019/631
Article 11a (new)
Article 11a (new)
Amendment 377 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 a (new)
Article 1 – paragraph 1 – point 6 a (new)
Regulation (EU) 2019/631
Article 12 – paragraph 3 – subparagraph 3 (new)
Article 12 – paragraph 3 – subparagraph 3 (new)
(6a) In Article 12, paragraph 3, the following subparagraph is added: In addition, the Commission shall in particular assess the use of fuel and energy consumption data referred to in paragraph 1 for Off-Vehicle Charging Hybrid Electric Vehicles (OVC-HEVs). Using that data, the Commission shall adopt delegated acts in accordance with Article 17 to adapt the utility factors used for OVC-HEVs, in order to ensure that their emissions are representative of real- world driving from 2030 onwards.
Amendment 379 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 a (new)
Article 1 – paragraph 1 – point 6 a (new)
Regulation (EU) 2019/631
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
(6a) In Article 12, the following paragraph is inserted: ‘3a. ‘The Commission shall draw up, no later than 31 December 2023, a common Union methodology for the assessment and the consistent data reporting of the full life-cycle CO2 emissions of fuels and energy consumed by vehicles on the EU market.’
Amendment 385 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2019/631
Article 14a – paragraph 1
Article 14a – paragraph 1
By 31 December 2025, and every two years thereafter, the Commission shall report on the progress towards zero emission road mobility. The report shall in particular monitor and assess the need for possible additional measures to facilitate the transition, including through financial means. climate neutral road mobility. The report shall assess and ascertain whether this regulation needs to be modified to take a more holistic and comprehensive approach to emissions, on the basis of the methodologies set out in Articles 7(10) and 12(3a). The report shall in particular monitor and assess the need for possible additional measures to facilitate the transition, including through financial means. In the reporting, the Commission shall consider all factors that contribute to a cost-efficient progress towards climate neutrality by 2050, including the following: a) the cost of zero- and low-emission vehicles; b) consumer take-up of zero- and low- emission vehicles; c) the specific characteristics of light commercial vehicles; d) progress in achieving a sufficient roll- out of recharging and refuelling infrastructure for alternative fuels including, but not limited to; progress in achieving the targets as required under the Alternative Fuels Infrastructure Regulation and the Energy Performance of Buildings Directive; e) the potential contribution of innovation technologies and sustainable alternative fuels, including synthetic fuels, to reach climate neutral mobility; f) the contribution of emissions trading in road transport; g) the functioning of the incentive mechanism for zero- and low-emission vehicles; h) the impact on consumers, particularly those on low and medium incomes; i) progress in social dialogue as well as aspects to further facilitate an economically viable and socially fair transition, taking into account employment and competitiveness, towards affordable climate neutral road mobility. For each of the factors listed above, the Commission shall issue an assessment of its effectiveness, taking into account expected progress, in enabling the 2030 and 2035 fleet average CO2 targets to be met.
Amendment 405 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EU) 2019/631
Article 14 a – paragraph 2
Article 14 a – paragraph 2
In the reporting, the Commission shall consider all factors that contribute to a cost-efficient progress towards climate neutrality by 2050. This includes the deployment of zero- and low-emission vehicles, the transition from a purely exhaust-emissions-based to a holistic life- cycle-analysis-based approach to emissions, the threshold of grammes of CO2 used for defining what constitutes a low-emission vehicle and, if necessary, the revision thereof, progress in achieving the targets for the roll-out of recharging and refuelling infrastructure as required under the Alternative Fuels Infrastructure Regulation, the potential contribution of innovation technologies and sustainable alternative fuels to reach climate neutral mobility, impact on consumers, progress in social dialogue as well as aspects to further facilitate an economically viable and socially fair transition towards zero emissionclimate- neutral road mobility.;
Amendment 422 #
2021/0197(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 10 – point a
Article 1 – paragraph 1 – point 10 – point a
Regulation (EU) 2019/631
Article 15 – paragraph 1 – subparagraph 1
Article 15 – paragraph 1 – subparagraph 1
1. The Commission shall, in 20287, review the effectiveness and impact of this Regulation, building on the two yearly reporting, and submit a report to the European Parliament and to the Council with the result of the review.
Amendment 454 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point a
Annex I – paragraph 1 – point 1 – point a
Regulation (EU) 2019/631
Annex I – Part A – point 6.1
Annex I – Part A – point 6.1
EU fleet-wide targets for 2025 onwardsand 2030’,
Amendment 473 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point b
Annex I – paragraph 1 – point 1 – point b
Regulation (EU) 2019/631
Annex I – Part A – point 6.1.2
Annex I – Part A – point 6.1.2
EU fleet-wide target for 2030 to 2034onwards
Amendment 478 #
2021/0197(COD)
Amendment 499 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point e
Annex I – paragraph 1 – point 1 – point e
Regulation (EU) 2019/631
Annex 1 – Part A – point 6.2.2
Annex 1 – Part A – point 6.2.2
Amendment 509 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
6.3.1 Specific emissions targets for 2025 to 2029:deleted
Amendment 512 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation (EU) 2019/631
Annex I – Part A – point 6.3.1 – subparagraph 2
Annex I – Part A – point 6.3.1 – subparagraph 2
specific emissions reference target is the specific emissions reference target of CO2 determined in accordance with point 6.2.1 for the period 2025 to 2029 and point 6.2.2 for 2030 onwards;
Amendment 520 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation (EU) 2019/631
Annex I – Part A – point 6.3.1 – subparagraph 5
Annex I – Part A – point 6.3.1 – subparagraph 5
x is 15 % in the years 2025 to 2029 and 40% from 2030 onwards..
Amendment 531 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation (EU) 2019/631
Annex I – Part A – point 6.3.2
Annex I – Part A – point 6.3.2
6.3.2 Specific emissions targets for 2030 to 2034onwards
Amendment 540 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 1 – point f
Annex I – paragraph 1 – point 1 – point f
Regulation (EU) 2019/631
Annex I – Part A – point 6.3.3
Annex I – Part A – point 6.3.3
Amendment 556 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point a
Annex I – paragraph 1 – point 2 – point a
Regulation (EU) 2019/631
Annex I – Part B – point 6.1
Annex I – Part B – point 6.1
The EU fleet-wide targets for 2025 onwardsand 2030
Amendment 569 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point b
Annex I – paragraph 1 – point 2 – point b
Regulation (EU) 2019/631
Annex I – Part B – point 6.1.2
Annex I – Part B – point 6.1.2
The EU fleet-wide targets for 2030 to 2034onwards
Amendment 570 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point c
Annex I – paragraph 1 – point 2 – point c
Regulation (EU) 2019/631
Annex I – Part B – point 6.1.3
Annex I – Part B – point 6.1.3
Amendment 587 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point d
Annex I – paragraph 1 – point 2 – point d
Regulation 2019/631
Annex I – Part B – point 6.2.2
Annex I – Part B – point 6.2.2
Amendment 598 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point e
Annex I – paragraph 1 – point 2 – point e
Regulation (EU) 2019/631
Annex I – Part B – point 6.2.3
Annex I – Part B – point 6.2.3
Amendment 611 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point e a (new)
Annex I – paragraph 1 – point 2 – point e a (new)
Regulation (EU) 2019/613
Annex I – Part A – point 6.3.1
Annex I – Part A – point 6.3.1
(ea) point 6.3.1 of Annex I part B is replaced by the following: 6.3.1 Specific emissions targets for 2025 to 2029 The specific emissions target = (specific emissions reference target – (øtargets – EU fleet-wide target2025)correction) · ZLEV factor where: specific emissions reference target is the specific emissions reference target for the manufacturer determined in accordance with point 6.2.1; øtargets EU fleet-wide target2025correction = (øtarget – EU fleet-wide target2021) · (1- reduction factor2025) øtargetis the average, weighted on the number of new light commercial vehicles of each individual manufacturer, of all the specific emissions reference targets determined in accordance with point 6.2.1; by 31 October 2024 and every second year thereafter, the figures Øtarget for new light commercial vehicles in the preceding two calendar years starting with 2022 and 2023. The new respective Øtarget shall apply from 1 January of the calendar year following the date of the adjustment; ZLEV factor is (1 + y – x), unless this sum is larger than 1,05 or lower than 1,0 in which case the ZLEV factor shall be set to 1,05 or 1,0, as the case may be; where: y is the share of zero- and low-emission vehicles in the manufacturer's fleet of new light commercial vehiclepassenger cars calculated as the total number of new zero- and low- emission vehicles, where each of them is counted as ZLEVspecific in accordance with the following formula, divided by the total number of new light commercial vehiclepassenger cars registered in the relevant calendar year: ZLEVspecific = 1 − (𝑠𝑝𝑒𝑐𝑖𝑓𝑖𝑐 𝑒𝑚𝑖𝑠𝑠𝑖𝑜𝑛𝑠 50 𝑜𝑓𝐶𝑂2 ) ZLEVspecific = 1 – ( specific emissions of CO2 50 ) x is 15 %.%
Amendment 623 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point f Regulation (EU) 2019/631
Annex I – paragraph 1 – point 2 – point f Regulation (EU) 2019/631
6.3.2. Specific emissions targets for 2030 to 2034onwards
Amendment 642 #
2021/0197(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 2 – point g
Annex I – paragraph 1 – point 2 – point g
Regulation (EU) 2019/631
Annex I – part B – point 6.3.3
Annex I – part B – point 6.3.3
Amendment 14 #
2020/2276(INI)
Motion for a resolution
Recital B
Recital B
B. whereas coastal and maritime tourism has been hit particularly hard by the socioeconomic crisis caused by the COVID-19 pandemic, even though it is a major source of employment for the Atlantic regions;
Amendment 17 #
2020/2276(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the European Atlantic area extends off the African coast to encompass Madeira, the Azores and the Canary Islands, and across the Atlantic to take in the Netherlands Antilles, the French Antilles, French Guiana and Saint Pierre and Miquelon, and whereas the Atlantic strategy should address all these regions while remaining open toenabling a close cooperation with third countries and their regions;
Amendment 26 #
2020/2276(INI)
Motion for a resolution
Recital J a (new)
Recital J a (new)
Amendment 56 #
2020/2276(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses that greater synergies are needed between the different European Funds and Programmes, particularly with directly managed programmes, as well as with national and regional programmes, to support a sustainable, robust and competitive blue economy in the Atlantic regions;
Amendment 81 #
2020/2276(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Hopes that the strategy will encourage joint planning and development of the sectors of the blue economy in the Atlantic area, with environmental and climate policies as central pillars, thus contributing towards the achievement of the Union's decarbonisation objectives and promoting renewable offshore power generation technologies, while fighting against marine litter;
Amendment 279 #
2020/2273(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that a clear definition of strict protection needs to be established in agreement between Member States and the Commission leaving Member States enough flexibility to take into account specificities of their natural conditions and national legislations
Amendment 513 #
2020/2273(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Expresses its support for the 2030 targets of bringing at least 25 % of agricultural land under organic farm management, which should become the norm in the long term, and ensuring that at least 10 % of agricultural land consists of high-diversity landscape features provided that food self-sufficiency and stability of the EU are not jeopardised and food imports from non-EU countries are not increased, which will be reduced in the EU as a result of organic farming, which should be implemented at farm level, targets which should both be incorporated into EU legislation; considers it imperative that farmers receive support and training in the transition towards agroecological practices;
Amendment 704 #
2020/2273(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission to urgently present a proposal for an EU legal framework based on mandatory due diligence that ensures sustainable and deforestation-free value chains which should also apply to third countries;
Amendment 787 #
2020/2273(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Welcomes the Commission’s targets of reducing the use of more hazardous and chemical pesticides by 50 %, the use of fertilisers by at least 20 % and nutrient losses by at least 50 % by 2030, which should be made binding taking into account the differences between Member States, which should be made binding including in relation to imports to the EU; considers that the derogation envisaged in Article 53(1) of Regulation (EC) No 1107/2009 should be clarified and must only be applied for health and environmental reasons;
Amendment 189 #
2020/2260(INI)
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas the Farm to Fork Strategy should consider all three pillars of sustainability (economic, social and environmental) when translating the targets into legislation;
Amendment 314 #
2020/2260(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the European model of a multifunctional sustainable agricultural sector, driven by family farms, continues to ensure food security, quality food production, local supply chains, good agriculture practices, high environmental standards and vibrant rural areas throughout the EU;
Amendment 439 #
2020/2260(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. recognises that EU’s agriculture has reduced GHG emissions by 22% in the period 1990 -2016, while in the same period the GHG emissions from agriculture have increased by 6% in the USA, by 24% in China and India and by 47% in Brazil;
Amendment 453 #
2020/2260(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas antimicrobial resistance may also have impacts on human health;
Amendment 461 #
2020/2260(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. recognises that EU’s agriculture has reduced the use of antibiotic burden by 35% in the period 2011 - 2018 and that the share of the veterinary burden represents 1/3 of the AMR burden in EU, while the remaining 2/3 of AMR burden is related to human antibiotics use;
Amendment 565 #
2020/2260(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the announcement of an impact-assessed proposal for a legislative framework for sustainable food systems; invites the Commission to use this proposal to set out a holistic common food policy aimed at reducing the environmental and climate footprint of the EU food system in order to make Europe the first climate- neutral continent by 2050 and strengthen its resilience to ensure food security in the face of climate change and biodiversity loss, leading a global transition towards sustainability from farm to fork, based on the principle of a multifunctional agricultural sector while ensuring consistency between policies by taking into account the existing legislation in order to enable all actors in the European food system to develop long-term plans based on realistic and transparent objectives; suggests that the respective base lines and progress achieved in each Member State be taken into account setting more ambitious targets for those Member States who have not made sufficient reductions of the use of chemical pesticides, antimicrobials and fertilisers until now, while promoting the exchange of know-how and best practices between Member States; stresses the need to include the entire food and beverage chains including processing, marketing, distribution and retail; asks the Commission to conduct a cumulative impact assessment of the farm to fork strategy that can help in deciding on the best policy options for the way forward;
Amendment 677 #
2020/2260(INI)
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Underlines that no single farming model can fulfil the various requirements for sustainable production as all models have their specific strengths and weaknesses with regard to the different pillars of sustainability, particularly climate and environmental performance including land-use; calls for a multi- model approach that focuses on exploiting the strengths of different farming models and further improving their weaknesses;
Amendment 827 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Welcomes the Commission´s proposal to reduce nutrient losses; stresses that a strategy to reduce nutrient losses should focus primarily on enabling farmers to increase efficiency of nutrient management and highlights the importance of innovative technologies and solutions such as precision and smart farming and plant nutrition advisory services and management support; further calls for the strategy to consider the climate and environmental impact of different fertilisers;
Amendment 841 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Welcomes the Commission's plan to reduce the overall sales of antimicrobials for farmed animals and in aquaculture by 50% in 2030; recalls the importance of a One Health approach;
Amendment 870 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 d (new)
Paragraph 3 d (new)
Amendment 871 #
2020/2260(INI)
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Acknowledges the substantial efforts made to reduce the use of antimicrobials for treating animals as highlighted in the 2019 European Court of Auditors report on AMR, further enhanced by the new EU Regulations on Veterinary Medicinal Products and Medicated Feed, contributing to the global effort to reduce antibiotic resistance; underlines that the EU must ensure the treatment of animals with antimicrobials remains possible when needed, in order to ensure that animal health and welfare is protected at all times;
Amendment 913 #
2020/2260(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Emphasises the importance of recognising the significant impact of agriculture and especially some animal production practices on greenhouse gas (GHG) emissions and land use; stresses the need to enhance natural carbon sinks and reduce agricultural emissions of carbon dioxide, methane and nitrous oxide, in particular in the feed and livestock sectors; calls for regulatory measures and targets to ensure progressive reductions in all GHG emissions in these sectors, while not degrading the quality and nutrient value of European soils and while ensuring that imports from third countries not compliant with the Strategy conditions and objectives will be subject to the EU Carbon Border Adjustment Mechanism or similar EU adjustment mechanisms to ensure fair competition for EU producers;
Amendment 1079 #
2020/2260(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Welcomes the notion of rewarding carbon sequestration in soils; stresses, however, that intensive and industrial agriculture and farming models with negative Highlights the enormous potential of agriculture and forestry to contribute to carbon sequestration and thus achieving climate neutrality; welcomes the notion of rewarding carbon sequestration in soils under a new carbon farming initiative; invites the Commission to present several options including carbon market approaches; stresses, that all practices that reduce the climate-impacts on biodiversity should not receive climate ff farming should be taken into account in a robust accoundting orframework and be incentivised; calls for the proposals to be in line with the environmental objectives and the ‘do no harm’ principle of the Green Deal;
Amendment 1181 #
2020/2260(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights the enormous potential of new varieties to contribute to various targets of the strategy by improving crop resilience, thus reducing plant protection product input, by improving efficient nutrient intake, thus reducing fertiliser input and water consumption, as well as by facilitating mitigation of crop production to different pressures resulting from climate change; stresses the importance of access to new breeding techniques in order to accelerate breeding of new varieties; recalls that achieving any ambitious input reduction target requires access to effective tools beyond merely increasing efficiency of input application; urges the Commission to propose a forward-looking regulatory framework without delay;
Amendment 1391 #
2020/2260(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its deep concern about the emergence of zoonoticinfectious diseases that are transferred from animals to humans (anthropozoonoses), such as Q fever, avian influenza and the new strain of influenza A (H1N1), which is exacerbated by anthropogenic climate change, the destruction of biodiversity, environmental degradation and our current food production systempose a major threat to livestock health and in many cases (zoonotic diseases) pose a threat of transmission to the human population which due to its current way of life is extremely predisposed to sharing new pathogens;
Amendment 1660 #
2020/2260(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls for measures to reduce the burden that highly processed foods with high salt, sugar and fat content place on public health; regrets that the introduction of nutrient profiles is greatly delayed and stresses that a robust set of nutrient profiles must be developed to restrict or prohibit the use of false nutritional claims on highly processed foods high in fats, sugars and/or salt; calls for a mandatory EU-wide front-of-pack nutrition labelling system based on independent sciencerecognises the cost burden that would arise from these requirements to small and medium-size producers and their ability to compete with large manufacturers, therefore invites the Commission to propose a simplified scheme for SMEs participation;
Amendment 1890 #
2020/2260(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Highlights the recognition in the strategy that Europeans’ diets are not in line with recommendations for healthy eating, and that a population-wide shift in consumption patterns is needed towards more healthy and plant-based foods and less red and processed meat, sugars, salt, and fats, which will also benefit the environment; emphasises that EU-widenational guidelines for sustainable and healthy diets would bring clarity to consumers on what constitutes a healthy and sustainable diet and informin a specific geography and contribute to Member States’ own efforts to integrate sustainability elements in national dietary advice; calls on the Commission to develop such guidelines and specific actions to effectively promote healthy pbalant-based dietced diets respecting national dietary specifics and traditions;
Amendment 1985 #
2020/2260(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Calls for a revision of public and private procurement legislation, including minimum mandatory criteria in schools and other publicpublic and private institutions to encourage organic and local food productionsourcing and to promote more healthysustainable diets by creating a food environment that enables consumers to maketch their healthy choices with availability of supply;
Amendment 2008 #
2020/2260(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Underlines that binding reduction targets for environmental footprint of food products and food waste in trade and retail are needed to comprehensively achieve objectives of this strategy;
Amendment 2122 #
2020/2260(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Underlines the importance EU funding for research and innovation as a key driver in accelerating the transition to a more sustainable, healthy and inclusive European food system while facilitating investments needed to encourage agro- ecologicalsustainable practices in both social and technological innovation, and the crucial role of farm advisory services in ensuring the transfer of knowledge to the farming community, drawing on the existing specialised training systems for farmers in Member States; encourages the agri-food sector to actively use the funding earmarked for the sector in Horizon Europe in this regard;
Amendment 2141 #
2020/2260(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Stresses that innovation is the main driver of resilient growth, of efficient and resource-friendly sustainable farming and of increasing its productivity and profitability; insists that the Strategy should be built on a strong European commitment to the promotion of research and development of innovative solutions and technologies in key areas such as digitalisation, precision farming, new breeding techniques, feed additives, as well as safer effective and efficient means of plant protection, fertilisation and veterinary medicines;
Amendment 2228 #
2020/2260(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Recalls the global responsibility of European food systems and their key role in setting global standards for food safety, environmental protection and animal welfare; calls on the Commission and the Member States to ensure that all food and feed products imported to the EU fully meet relevant EU regulations and standards, standards, and binding objectives arising from this Strategy and to provide development assistance to support primary producers from developing countries in meeting those standards; welcomes the Commission’s intention to take the environmental impacts of requested import tolerances into account;
Amendment 28 #
2020/2140(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Welcomes efforts to simplify requirements to be made of project managers and management authorities in the Member States under the 2021-2027 programming period of the Common Provisions Regulation; underlines that the key to solving this issue is through simpler national eligibility rules which might help reduce, first of all, the administrative burden and second of all, the source of error, thereby ensuring a high level of transparency; urges wider use of Simplified Cost Options, which ECA also considers a great relief for applicants and for control; points out that there is a need for an improvement of the audit working methods put in place at the national level.
Amendment 33 #
2020/2140(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Acknowledges that COVID-19 crisis has provided a new and unexpected challenge that the EU and its Member States need to respond determinedly and provide solutions at the EU and national level; welcomes the increasing financial flexibility in cohesion spending which enables Member States to use the funds to finance crisis-related projects; underlines the necessity of fostering the continuity and deeper cooperation of all stakeholders relevant to cohesion policy, mainly SMEs, municipalities and regions, which will struggle with unemployment and healthcare in the coming months;
Amendment 41 #
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. Underlines that the increasing shift from performance to compliance hinders the cohesion objectives and generates unnecessary spending.
Amendment 46 #
2020/2140(DEC)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Points out that concerning fraud, both the Commission and the Member States are responsible for addressing fraud in Cohesion spending. They need to step up their efforts to prevent and detect fraud, in cooperation with EPPO and the anti-fraud office (OLAF).
Amendment 60 #
2020/2091(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recognises that while the EU Ambient Air Quality (AAQ) Directives have been effective in setting common EU air quality standards and facilitating the exchange of information on air quality, they have failed to effectively reduce air pollution and to curb its adverse effects; draws attention to the fact that a high number of Member States still do not comply with current air quality standards and have not taken enough action to improve air quality and keep exceedances to a minimumdespite the fact that Member States have established and implemented a number of air improving measures; recognises the fact that air pollution has no boundaries and that there is a significant exchange of air pollutants between Member States and also between EU and non-EU countries as noted in the Second Clean Air Outlook; points out that Member States are not able to take any actions regarding emission sources outside their territory; encourages the Commission to take into account the complex nature of air pollution (e.g. the secondary particulate matters formation, global and EU transfer of air pollution) when designing new air quality policy to ensure that appropriate measures are taken on appropriate level;
Amendment 73 #
2020/2091(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that AAQ Directives are based on air quality standards that are now 15 to 20 years old, and that some of them are much weaker than current World Health Organization (WHO) guidelines and the levels suggested by the latest scientific evidence on human health impacts; welcomes the commitment made in the European Green Deal to revise air quality standards and align them more closely with WHO standards; stresses the fact that revised air quality standard must be based on a feasibility study and accompanied by a specific set of measures needed for their achievement;
Amendment 93 #
2020/2091(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Stresses the need to guarantee that air quality is being measured by the Member States in appropriate locations and at emissions sources, in order to avoid underestimation of air pollution; calls on the Member StatesCommission to improve their monitoring networks, and on the Commission to enforce the obligations of the Directive in this regard, including by providingpose clearer provisions regarding the monitoring network and provide additional support to Member States in setting up monitoring stations, the training and hiring of experts, and ensuring greater accuracy in inspection, control and monitoring;
Amendment 106 #
2020/2091(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Acknowledges the fact that Member States have established an air quality monitoring network based on common criteria defined by the AAQ Directives, with more than 4 000 monitoring stations and 16 000 sampling points; points out that site location provisions involve multiple criteria and offer a degree of flexibility which can make verification more difficult, and which often generate data that does not provide information on where the highest concentrations of air pollutants occur; urges the Commission to review and establish new mandatory rules for locating monitoring stations and sampling points; stresses that air quality modelling can complement and substitute sampling points therefore the AAQD should incorporate air quality modelling more clearly into the air quality assessment process;
Amendment 112 #
2020/2091(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that the AAQ Directives do not focus on reducing emissions in places where people suffer most from air pollution, or where concentrations are highest, and that concrete action in this area is needed; nNotes that lower socio- economic groups are more exposed to air pollution because they are more likely to live close to sources of heavy pollution, both outdoor, such as traffic and industrial areas, and indoor, such as the combustion of low-quality solid fuels for domestic heating; underlinecalls ion this regard the need to better reflect human exposure to air pollution in EU law, and urges the Commission to include new indicators e Commission to offer additional financial support specifically aimed at low income citizens to improve their wellbein g air quality indices, snd help to reduche asir populallution density around monitoring stations and sampling pointin their communities;
Amendment 133 #
2020/2091(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that confinement measures to control the spread of pandemic led to a drastic decrease in emissions and air pollution (except of household heating) , thus clearly showing the impact of human activities on the environment; notes with regret that continuous exposure to air pollution may worsen the impact of respiratory viruses such as COVID-19; underlines that fighting air pollution must be at the core of the EU recovery plan, and that mandatory and effectively enforced air quality requirements are key to guaranteeing citizens’ health and improving their resilience against future health threats;
Amendment 151 #
2020/2091(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Welcomes the announcement of the Commission’s Zero Pollution Action Plan; emphasises that air pollution is a burden that requires a holistic approach; alerts that any new measures will be worthless if air quality is not properly prioritised and mainstreamed in all EU policies, including EU emission source legislation, such as on climate, energy, transport, industry, agriculture and waste, while ensuring better synergies between all policy areas; calls on the Commission and the Member States to cooperate more closely in all areas and at all levels in order to help local authorities achieve cleaner air;
Amendment 166 #
2020/2091(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Urges the Commission and the Member States to strengthen all emissions legislation; underlines that reducing emissions at source is the only effective way to guarantee clean air; alerts that most Member States will not comply with their 2020 and 2030 emissions reduction commitments established under the NEC directive; stresses the need for stringent measures to reduce transport emissions, particularly road and maritime transport, aviation, industrial installations, agriculture and energy production and the need to incorporate the EU air quality and emission standards into the trade policy to prevent transfer of emissions outside EU which would further exacerbate the effect of transboundary air pollution on the EU air quality while reducing the competitiveness of the EU companies;
Amendment 199 #
2020/2091(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. RPoints out that the Commission does not analyse nor give any feedback to the AQPs, especially their measures, reported by Member States; notes that proper and critical feedback to the reported AQPs could help Member States to design better AQPs with more effective measures and it could prevent noncompliance with air quality standards; regrets the fact that the AAQ Directive neither requires Member States to report on the implementation of AQPs to the Commission nor to update them when new measures are adopted or when the progress is insufficient; calls on the Commission to establish a yearly reporting obligation for the implementation of AQPs;
Amendment 208 #
2020/2091(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Alerts that as of October 2019, 32 infringement procedures against 20 Member States remained pending; considers that persistent exceedances of air quality standards by Member States indicate their lack of commitment to adopting more effective measures, and the ineffectiveness of the current enforcement procedure; urges the Commission to review the current enforcement procedure for the AAQ Directives;
Amendment 220 #
2020/2091(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Stresses that information on the possible health effects of air pollution provided by Member States is scarce, unclear and not easily accessible for the public; calls on the Commission and Member States to launch public information campaigns on topics such as different types of air pollutants and their impact on human health or current local levels of air pollution, and to publish rankings of the best and least progress made by air quality zones;
Amendment 64 #
2020/2087(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Points out that it is vital that aid and funds be sent every more rapidly to affected regions, and that links with the Union Civil Protection Mechanism (UCPM) and the ERDF climate-change adaptation component are essential in order to create a comprehensive package; insists that synergies with these and other relevant EU funding instruments should be used flexibly and to their fullest extent;
Amendment 68 #
2020/2087(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Points out that, according to the United Nations Office for Disaster Risk Reduction, (UNDRR) over the last 20 years (2000- 2019), 7 348there were 7,348 major natural disasters thave been recorded worldwide at a cost of around USD 3 000 billion, compared to 3 656 disasters between 1980 and 1999t claimed 1.23 million lives, affected 4.2 billion people and resulted in $2.97 trillion in global economic losses;
Amendment 71 #
2020/2087(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
Amendment 77 #
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 that the least developed and most fragile territories, such as islands, are often the most affected by the impact of climate change;
Amendment 84 #
2020/2087(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Considers it vital to improve disaster risk prevention and management in Europe; recommendstakes note of overviews of natural and man-made disaster risks that the EU faces based on reports prepared by the Commission and, in this regard, thatasks Member States to consider that they put in place, together with the Commission, disaster management plans for accurate and rapid damage assessment;
Amendment 88 #
2020/2087(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission to continue its work ton simplifying the EUSF and speed up the application procedure for Member States and to speed up the final disbursement of the Union contribution;
Amendment 110 #
2020/2087(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights that the use of the EUSF has encouraged policy learning in national and local authorities, leading them to assess their broader disaster risk management measures; Draws particular attention to the situation of local authorities which have little experience in EU-funded projects and calls on the Commission to provide them with increased operational support, in particular administrative support;
Amendment 111 #
2020/2087(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to consider adapting the EUSF as far as possible to the regions that are the most vulnerable to natural, ecological and health disasters, particularly the ORs, islands, mountainous regions, regions that are prone to intense seismic or volcanic activity and those that are sparsely populated;
Amendment 118 #
2020/2087(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Points out that in its revised proposal of 27 May 2020 on the MFF 2021-2027 the Commission provided for a maximum annual budget of EUR 1 billion for the EUSF (in 2018 prices) and therefore notes with concernnotes that under the agreement on the new MFF, the EUSF has been merged with the Emergency Aid Reserve (EAR) into a new ‘Solidarity and Emergency Aid Reserve’ (SEAR) package, with an overall annual budgetary allocation of EUR 1.2 billion;
Amendment 125 #
2020/2087(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Welcomes the fact that the revised EUSF adopted in April 2020 has increased the level of advance payments from 10% to 25% of the amount of the financial contribution anticipated and the maximum amount of the advances from EUR 30 million to EUR 100 million; points out, however, that for countries facing major disasters, the effectiveness of the Fund is directly linked to the level of advance payments and is of the view that it should be much higher, amounting to at least 33%;
Amendment 132 #
2020/2087(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes with regret that it takes on average one year for the entire grant to reach the beneficiary and that the Fund cannot therefore, under the current conditions, claim to act as an instrument for rapid intervention; calls on the Commission to expedite payment procedures and to explore ways of simplifying, as much as possible, the administrative procedures required to access aid, in order to relieve disaster- stricken regions or countries from unnecessary administrative burdens;
Amendment 135 #
2020/2087(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Believes that, in the future, the EUSF budget will have to be increased in order to make it a real tool for EU solidarityit is important that the level of the EUSF budget and allocation of funding is monitored and, if necessary, adjusted;
Amendment 148 #
2020/2087(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Takes the view that this broadening of the scope of the EUSF requires a larger budgetclose monitoring and evaluation;
Amendment 5 #
2020/2076(INI)
Draft opinion
Recital A
Recital A
A. whereas a domestic industry is a motor of growth, innovation and social well-beingprosperity within the EU;
Amendment 11 #
2020/2076(INI)
Draft opinion
Recital B
Recital B
B. whereas the EU’s SMEs play a crucial role in the EU industry and have traditionally generated a high share of the EU’s employment, and in so doing havtherefore ensureding social and economic well-being and prosperity all over the EU territory;
Amendment 15 #
2020/2076(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas the COVID-19 crisis has led to disruptions in value chains and shown the vulnerabilities in key European strategic industrial sectors;
Amendment 16 #
2020/2076(INI)
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 17 #
2020/2076(INI)
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas regions are the place where innovative and industrial ecosystems can grow and develop, and make the links between industry, SMEs, research centres, innovation stakeholders and local communities;
Amendment 18 #
2020/2076(INI)
Draft opinion
Recital B c (new)
Recital B c (new)
Bc. whereas local specificities are both inevitable and desirable to develop the strength of the European industry;
Amendment 19 #
2020/2076(INI)
Draft opinion
Recital B d (new)
Recital B d (new)
Bd. whereas the COVID-19 crisis has demonstrated the potential across all European regions to provide concrete and innovative answers to societal challenges;
Amendment 20 #
2020/2076(INI)
Draft opinion
Recital B e (new)
Recital B e (new)
Be. whereas the changing nature of geopolitical tensions and the recent COVID-19 crisis have led to disruptions in value chains and shown the vulnerabilities in key European strategic industrial sectors;
Amendment 21 #
2020/2076(INI)
Draft opinion
Recital B f (new)
Recital B f (new)
Bf. whereas the effects of industry relocation tend to be localised, hitting specific regions disproportionately;
Amendment 29 #
2020/2076(INI)
Draft opinion
Recital B
Recital B
B. whereas non-EUthe competitors often take advantage ofiveness of European industry has been negatively impacted by unfair international competition and global distortions; whereas non-EU companies often are subject to less stringenct climate and environmental regulations and lower labour costs in their respective countries;
Amendment 33 #
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, and the transition to a digital economy , bringing citizens, cities and regions together, and allowing for a just transitionin particular in those regions undergoing the process for a just transition, so that no one is left behind;
Amendment 44 #
2020/2076(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Notes that investment in innovative means of productionResearch and Innovation and deployment of innovative technologies, means of production and upskilling workers particularly in SMEs should foster cohesion amongst all EU regions, allowing them to accomplish fair, resilient and inclusive economic growth, allowing them to transition and innovate to access market opportunities;
Amendment 61 #
2020/2076(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses the importance of the Union maintaining a secure supply of critical materials and minerals, pharmaceutical ingredients, medicines and medical equipment; calls for the strengthening of European value chains to reduce dependence from third countries in key strategic areas;
Amendment 68 #
2020/2076(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights the potential of circular economy in reducing energy and resource consumption, and in increasing capacity and a reliable supply of recycled materials that are critical for green energy and digital technologies;
Amendment 72 #
2020/2076(INI)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Underlines the potential of circular bioeconomy and the forest-based industry in promoting a competitive and sustainable industry; encourages Member States to promote investments and public procurement in renewable, recyclable, bio-based products;
Amendment 75 #
2020/2076(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Reiterates that theprivate and public sectors hasve an important new role to play in facilitating a just transition by promoting a green and fair energy transition, green and , blue, digital and sustainablue investments, the circular economy, as well as climate adaptation and risk prevention in all EU regions, in particular in Outermost regions;
Amendment 75 #
2020/2076(INI)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Notes the contribution of the chemical industry to many strategic value chains and to producing carbon-neutral, resource-efficient and circular technologies and solutions; calls for a sustainable chemicals policy, aligned with the Industrial Strategy;
Amendment 80 #
2020/2076(INI)
Draft opinion
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Underlines the importance of green mobility in creating new jobs, boosting European industry, and reducing emissions from the transport sector; calls for a large scale strategy and increased investments for the rollout of a wide EV- charging infrastructure network of fast, reliable and compatible charging stations for electric vehicles;
Amendment 81 #
2020/2076(INI)
Draft opinion
Paragraph 1 h (new)
Paragraph 1 h (new)
1h. Notes the role played by battery technologies in the decarbonisation of mobility and energy systems; welcomes the European Battery Alliance and the Strategic Action Plan on Batteries; calls for the promotion and stimulation of battery production in Europe, as well as for the creation of a coherent and supportive regulatory framework for sustainable batteries, in line with the principles of circular economy, the wider EU decarbonisation objectives and the need to reduce dependence on raw and critical materials and metals from third countries;
Amendment 82 #
2020/2076(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that a priority of the New Industrial Strategy for Europe should be to support regions in the diversification of existing industries, upgrading industrial capacity, as well as in stimulating investment and innovation to re-develop and strengthen the resilience of local and regional economies; welcomes the focus put by the European Commission on industrial and innovative regional ecosystems, and asks that the EU industrial strategy enables full involvement of regions and regional stakeholders in its governance and implementation;
Amendment 82 #
2020/2076(INI)
Draft opinion
Paragraph 1 i (new)
Paragraph 1 i (new)
1i. Notes that renewable and low- carbon hydrogen can contribute to reducing greenhouse gas emissions, to the recovery of the EU economy and to paving the way for climate neutrality in 2050 by supporting hard-to-decarbonise sectors; welcomes the launch of the Clean Hydrogen Alliance; notes the potential for EU leadership in clean hydrogen; calls for strategic investments for the production and use of clean hydrogen, for the creation of an enabling network of infrastructure and for research and innovation;
Amendment 83 #
2020/2076(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4b. Recalls that a place-based industrial policy allows for a tailored approach that enables to develop existing advantages, specialties and capabilities, creates an industrial policy based on the existing comparative advantages and strives to support enterprises to move towards high-technology sectors, typical of Industry 4.0; reminds that a place based approach fosters additional elements such as collaboration, adaptability, resource management capability and facilitates the interaction of different local and regional elements;
Amendment 87 #
2020/2076(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. NWelcomes the Recovery Fund and the Next Generation EU instrument to develop strong Cohesion and Industrial policies; 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 developmentand climate-resilient development; recognizes the role of ESIF in European regions to develop skills and build capacities for smart specialization, circular economy, entrepreneurship and transition to industry 4.0;
Amendment 94 #
2020/2076(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Highlights the importance of creating a simplified and coherent funding landscape, from R&D to market uptake, at EU, national and regional levels, particularly in respect to ESI funds, through simplification, harmonization and complementarity of the regulations and rules of the different funding instruments; encourages synergies between EU, national, regional and private funding for financing industry-led innovation projects, namely to support further exploitation and cross fertilization using smart specialization principles as a guide to coordinate, enhance efficiency and avoid duplication;
Amendment 95 #
2020/2076(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Warns that parts of EU energy and industry sector are under serious existential risks and accents that negative social impacts of the EU green politics are progressing faster than the EU tools to mitigate these negative impacts;
Amendment 108 #
2020/2076(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Urges the Commission to set strong mechanisms to mitigate the negative economic and social effects to European regions resulting from industry relocation;
Amendment 112 #
2020/2076(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Considers that ESIF financial support should prioritise investments in new or transformed industrial production in carbon-intensive regions in order to facilitate achieving the goals of a just transition; Stresses that Cohesion Policy operational programmes should be developed in line with the new Industrial Strategy for Europe by combining grants with financial instruments in order to fill in the investment gap.
Amendment 148 #
2020/2076(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Acknowledges the importance of the Just Transition Mechanism to support the most affected regions and workers in the transition towards a climate neutral economy and to alleviate the socio- economic impact of the transition; welcomes the proposal for an increased budget for the Just Transition Fund;
Amendment 158 #
2020/2076(INI)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls for a predictable intellectual property framework as this is key toAcknowledges that a strong framework of intellectual property rights is a crucial factor underpinning European competitiveness; calls for the strengthening and effective enforcement of this framework as this is key to competitiveness, to upholding technological autonomy, incentivising investments and the promotion ofng sustainable innovative solutions contributing, in particular, to reducing GHG1 emissions; __________________ 1; Greenhouse gas emissions
Amendment 162 #
2020/2076(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission to preserve a vibrant research-based pharmaceutical industry; insists that the measures proposed in the Commission's upcoming Pharmaceutical Strategy should be aligned with the Industrial Strategy and focused on ensuring that Europe remains an innovator and world leader in the manufacturing of medicines and active ingredients;
Amendment 180 #
2020/2076(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls for better coordinatedion between FTAs4 to foster consistency between trade,provisions and the EU's industrial policy; urges the swift modernisation of EU regulations on product safety and a more resilient customs, and market surveillance and industrial policies; calls for prioritising the implementation of, in particular, the EU regulations on product safety for imported productspolicy; insists that custom controls throughout the EU follow the same standards, by means of a direct unified customs control mechanism, in coordination with Member States and in full compliance with the principle of subsidiarity; __________________ 4 Free Trade Agreements
Amendment 8 #
2020/2074(INI)
Motion for a resolution
Citation 17 a (new)
Citation 17 a (new)
Amendment 11 #
2020/2074(INI)
– having regard to the Commission proposal for a regulation of the European Parliament and of the Council of 28 May 2020 on the public sector loan facility under the Just Transition Mechanism (COM(2020)0453),
Amendment 50 #
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 societyall stakeholders in society, particularly the private sector, social partners and citizens, together with elected officials, including local and regional authorities, and must be backed by robust and inclusive social measures to ensure a fair transition that supports job retention and creation, particularly green and blue jobs;
Amendment 63 #
2020/2074(INI)
Motion for a resolution
Recital K
Recital K
K. whereas regional environment strategies should serve the pursuit of full employment and social progressbalance ecology and economy while supporting the pursuit of full employment and progress in order to better tackle the effects of climate change and fight the loss of biodiversity;
Amendment 81 #
2020/2074(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Underlines the importance of tackling climate change in line with the Union’s commitments undertaken under the European Green Deal to implementing the Paris Agreement and the SDGs, taking into consideration social and, economic and territorial aspects to ensure a fairjust transition for all territories and their citizens;
Amendment 86 #
2020/2074(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Welcomes the Commission’s proposal on the European Climate Law, which enshrines the 2050 climate neutrality target to be reached collectively by the EU into Union legislation, including the intermediate targets for 2030 and 2040, while taking into account the EU competitiveness, national circumstances and principles of solidarity and fairness;
Amendment 91 #
2020/2074(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Emphasises the need for local and regional authorities to make a clear political commitment to achieving the climate targets; and translating them into local actions that respect the constraints and emphasise the assets of each territory;
Amendment 98 #
2020/2074(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Highlights the crucial role for Cohesion Policy, as with other policies, particularly environmental, agricultural, fisheries or cultural policies, in fighting climate change and achieving climate neutrality by 2050 at the latest and the intermediate target by 2030, as well as the role of local and regional authorities in mitigating and adapting to climate change, in particular through a far-reaching reform of investment policies;
Amendment 117 #
2020/2074(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that sustainability and the transition to an economy that is safe, climate neutral, climate resilient, more resource efficient and circular, circular and socially balanced are crucial to ensuring the long- term competitiveness of the Union economy;
Amendment 142 #
2020/2074(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Underlines the key role of local and regional authorities in achieving a fair transition to a climate-neutral economy for all, with social and, economic and territorial cohesion at its core;
Amendment 162 #
2020/2074(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Welcomes the proposal to top upagreement reached in trilogue on the Just Transition Fund; regrets the fact, however, that the top-up amount proposed by the Commission has been cut under the Council agreement on Next Generation EU; underlines that these cuts would jeopardise the fund’s core objectivecalls on the Member States to programme the funds as quickly as possible and calls on the Member States concerned to give special consideration to the outermost regions in the distribution of funds;
Amendment 169 #
2020/2074(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Points out that, under Article 349 of the TFEU, the outermost regions benefit from special rules allowing the adoption of tailor-made measures that take account of their specificities; calls for the necessary financial resources to be allocated to those regions so that they can achieve a green transition that balances economy and ecology, and can adapt to the effects of climate change from which they particularly suffer due to their vulnerability;
Amendment 181 #
2020/2074(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Highlights the need to capitalise on the outcome of initiatives such as New Energy Solutions Optimised for Islands (NESOI) and Clean Energy for EU Islands (CE4EUI), which also includes islands that have the status of Overseas Countries and Territories (OCTs) forming part of the European family, to ensure a functional transition between the 2014- 2020 and 2021-2027 programming periods; welcomes the Memorandum of Split, which recognises the leading role for island communities in the energy transition;
Amendment 218 #
2020/2074(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for a greater role for Cohesion Policy in supporting risk prevention efforts to adapt to the present and future impacts of climate change at regional and local levels, with a particular focus on the outermost regions given that they are significantly affected by climate change and are exposed to natural disasters such as cyclones, volcanic eruptions and drought, as well as flooding and rising water levels;
Amendment 4 #
2020/2071(INI)
Motion for a resolution
Citation 7 b (new)
Citation 7 b (new)
- having regard to the Council Conclusions of 8 June 2010 on ‘Equity and Health in All Policies: Solidarity in Health’,
Amendment 27 #
2020/2071(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the increase in global demand has aggravated shortages of medicines in the EU, undermining health services in the Member States and exposing patients to considerable risks; whereas in France, 1 450 cases of unavailability of medicines were noted in 2019 compared to 44 cases in 2008; whereas in the Netherlands, the number of drug stock-out cases almost doubled in 2019, with 1,492 cases recorded, compared to 769 in 2018; whereas in the Czech Republic, 2,208 products suffered from a supply disruption in 2019, compared to 1,630 in 2018 and 19 in 2008; whereas the Member States have a duty to find swift and effective solutions through closer European integration;
Amendment 41 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the Charter of Fundamental Rights of the European Union recognises the fundamental right of citizens to health and medical treatment;
Amendment 59 #
2020/2071(INI)
Motion for a resolution
Recital A f (new)
Recital A f (new)
Af. whereas the entry of generics and biosimilars into the market is an important mechanism for increasing competition, reducing prices and ensuring the sustainability of healthcare systems; whereas their market entry should not be delayed;
Amendment 60 #
2020/2071(INI)
Motion for a resolution
Recital A g (new)
Recital A g (new)
Ag. whereas the COVID-19 crisis has exacerbated the EU’s long-existing structural problems related to the supply of medicines, and the dependency on third-country import for medicines and medical materials;
Amendment 63 #
2020/2071(INI)
Motion for a resolution
Recital B
Recital B
B. whereas medicines to treat cancer, infections and disorders of the nervous system account for more than half of those in short supply; whereas injectable specialties appear to be the most vulnerable to the risk of shortage due to the complexity of their manufacturing process;
Amendment 114 #
2020/2071(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the consequence of growing demand coupled with price suppression is the concentration of active pharmaceutical ingredients supply, a reduction in the number of chemicals manufacturers and a lack of alternative solutions should problems arise;
Amendment 123 #
2020/2071(INI)
Motion for a resolution
Recital E
Recital E
E. whereas stocks of ‘strategic’ medicinmedicinal products of major therapeutic interest are inadequatecurrently insufficient, with chemicals that are cheap and easy to produce and matureolder, yet essential medicines being in particularly short supply; whereas pharmaceutical firms operate on a just-in- time basis;
Amendment 160 #
2020/2071(INI)
Motion for a resolution
Recital G
Recital G
G. whereas, in the absence of a regulatory authority, stockpiling in some Member States is leading to a market imbalance and could, in the event of a health crisis, question the principle of solidarity;
Amendment 209 #
2020/2071(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses the importance of putting the patient at the centre when addressing the problem of medicines shortages and the geostrategic imperative that the Union regain its sovereignty and independence with regard to health care and secure its supply of medicines and medical equipment;
Amendment 246 #
2020/2071(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses the need for health policies to focus on patients’ health and interests and for closer cooperation between Member States;
Amendment 259 #
2020/2071(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls that medicines shortages have a direct impact on patients' health, safety and the continuation of their treatment; stresses that for patients, the consequences of drug shortages include: progression of the disease and / or worsening of symptoms due to delay in treatment, avoidable transmission of infectious diseases, increased risk of exposure to falsified medicines and significant psychological distress for patients and their families;
Amendment 261 #
2020/2071(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU);
Amendment 264 #
2020/2071(INI)
Motion for a resolution
Paragraph 3 e (new)
Paragraph 3 e (new)
3e. Calls for the launch of a Joint Action on the prevention of shortage of medicines which would be funded by the future Health Program; considers that this Joint Action would allow an exchange of good practices between the Member States and the development of common prevention measures;
Amendment 278 #
2020/2071(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicinesmedicinal products of major therapeutic interest ; calls on the Commission to map out potential production sites in the EU and their production capacity; suggests that the Commission also draw up a map of the production sites established in third countries;
Amendment 284 #
2020/2071(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needednecessary actions to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicinesmedicines including those which can not be substituted; calls on the Commission to map out potential production sites in the EU;
Amendment 295 #
2020/2071(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission and the Member States to set up a Task Force responsible for ensuring a constant inventory of the origin and production capacities of manufacturers in terms of active pharmaceuticals ingredients (APIs) and finished medicines,; considers that this independent body could establish and manage a database to prevent and steer European actions to avoid tensions or shortages on medicinal products of major therapeutic interest; stresses that this Task Force could ultimately assess the specific needs of medicinal products of major therapeutic interest of each Member State;
Amendment 307 #
2020/2071(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating tomake recommendations on ways to improve the availability and accessibility of medicines and to propose solutions to reduce manufacturers’ dependence on third countries in its next pharmaceutical and industrial strategies;
Amendment 315 #
2020/2071(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission to address in its next pharmaceutical and industrial strategies issues relating to the availability and accessibility of medicines and manufacturers’ dependence on third countries; shortage mitigation strategies should be included and health economic analysis should be considered;
Amendment 325 #
2020/2071(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe;
Amendment 339 #
2020/2071(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversificationorder to diversify resources and encourage the development of innovative production technologies capable of enhancing the responsiveness of production lines, in particular the continuous manufacturing process;
Amendment 341 #
2020/2071(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentivesincentives to support the diversification of supply in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification;
Amendment 365 #
2020/2071(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Stresses that the pharmaceutical sector remains an important industrial pillar as well as a driving force in terms of job creation;
Amendment 434 #
2020/2071(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importancemedicinal products of major therapeutic interest for health care; stresses the key contribution that can be made by new technologies, digitalization and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 471 #
2020/2071(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls for strengthening of the European Medicines Market to speed up patient access to medicines, make care more affordable, maximise savings in national health budgets and avoid administrative burdens for generic and biosimilar companies ;
Amendment 475 #
2020/2071(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Points out that generic and biosimilar medicines enable increased competition, reduced prices and savings for healthcare systems, thus helping to improve access to medicines for patients
Amendment 479 #
2020/2071(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Deplores the litigation cases aiming to delay generic entry; calls on the Commission to ensure that the end of the innovator's period of commercial exclusivity is respected;
Amendment 481 #
2020/2071(INI)
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Stresses that the added value and economic impact of biosimilar medicines on the sustainability of healthcare systems should be analysed, their market entry should not be delayed, and, where necessary, measures to support their introduction to the market should be examined;
Amendment 508 #
2020/2071(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supplysupply disruptions;
Amendment 514 #
2020/2071(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Welcomes the recent creation green lanes, set up to facilitate the transport of all goods, in order to allow the smooth running of the transport not only of medicines but also of raw materials, intermediate products and related materials, including packaging;
Amendment 518 #
2020/2071(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12c. Calls for the introduction of a specific statute for certain mature medicines which would be accompanied by incentives for manufacturers to maintain their marketing on the European market and ensure diversification of European production;
Amendment 519 #
2020/2071(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks, diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production;
Amendment 520 #
2020/2071(INI)
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12e. Underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;
Amendment 579 #
2020/2071(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls for the adoption of common definitions of 'supply disruption' and 'stock-out' of medicines as well as a grid of criteria for assessing the risk associated with each of these situations;
Amendment 581 #
2020/2071(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Calls for the adoption of a common definition of 'medicinal products of major therapeutic interest' with reference to their usefulness in public health, the absence of an alternative and the fragility of the production chain;
Amendment 617 #
2020/2071(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issued at European level in an effort to counter shortages during time of crisis, as has been done following the onset of the COVID-19 virus, with simplified procedures in the interests of improved response times;
Amendment 640 #
2020/2071(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital monitoring platform for sharingreporting and notifying harmonised information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipm, including manufacturers, wholesalers and pharmacists regarding shortages of medicines and medical equipment; such a platform should be efficient, user-friendly and transparent; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of problems, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 659 #
2020/2071(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Recommends the development of a catalogue of shortages in all the Member States which would allow the EMA to easily update its public catalogue of shortages assessed by its Committee for Medicinal Products for Human Use (CHMP) and / or its Committee for the pharmacovigilance risk assessment (PRAC);
Amendment 683 #
2020/2071(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Considers it essential to improve early communication with healthcare professionals and patients on medicine availability through the use of innovative digital tools providing real-time data on the availability, location, quantity and price of a given medicine, in compliance with data protection legislation; recommends the inclusion of information for healthcare professionals on available alternative;
Amendment 688 #
2020/2071(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Recalls that misinformation can lead to inappropriate use of medicines and the creation of unnecessary stockpiling;
Amendment 697 #
2020/2071(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic product information noticeleaflet to be drawn up in all the Union languages for everyall the Member States where the medicine on the EUis marketed, in order to facilitate salesthe moving of medicines between Member Statwithin the Single Market to prevent and mitigate shortages; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 710 #
2020/2071(INI)
Motion for a resolution
Subheading 3 a (new)
Subheading 3 a (new)
Preventing and responding to shortages in the event of health crises
Amendment 711 #
2020/2071(INI)
Motion for a resolution
Paragraph 20 b (new)
Paragraph 20 b (new)
Amendment 722 #
2020/2071(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to create a European strategic reserve of medicinal products of major interest, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; believes that the EMA could be the European regulatory authority responsible of this strategic reserve in order to prevent shortages of these medicines;
Amendment 726 #
2020/2071(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Stresses that its resolution of 17 April 2020 calls for the creation of a European Health Reaction Mechanism (EHRM) to respond to all types of health crises, to ensure operational coordination at European level, to restore European sovereignty over products health and to strengthen European cooperation in research and innovation; considers that this mechanism could monitor the constitution and the triggering of the strategic reserve of medicines and ensure its proper functioning within the Union;
Amendment 728 #
2020/2071(INI)
Motion for a resolution
Paragraph 21 c (new)
Paragraph 21 c (new)
21c. Recalls that its resolution also calls for the competences, budget and staffing of EMA to be substantially increased in order to allow it to coordinate medical responses in times of crisis; considers it essential that EMA has solid governance to meet future challenges such as monitoring and responding to shortages in coordination with the Member States; underlines that, in the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers; hopes that the reinforcement of the staff of EMA will enable it to carry out inspections of production sites established in third countries;
Amendment 730 #
2020/2071(INI)
Motion for a resolution
Paragraph 21 e (new)
Paragraph 21 e (new)
21e. Considers that in the event of a health crisis the closure of borders and customs controls cannot constitute an obstacle to cross-border movement of medicinal products of major interest within the Union; calls on the Commission and the Member States to set up secure and rapid procedures for checking products at the border during a health crisis in compliance with EU law;
Amendment 736 #
2020/2071(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages;
Amendment 3 #
2020/2040(INI)
Motion for a resolution
Citation 17
Citation 17
Amendment 5 #
2020/2040(INI)
Motion for a resolution
Citation 21
Citation 21
Amendment 21 #
2020/2040(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
A a. whereas Cohesion Policy addresses disparities between various regions and the backwardness of the least favoured regions with a view to achieving economic, social and territorial cohesion, of which the achievement of gender equality is an essential part;
Amendment 26 #
2020/2040(INI)
Motion for a resolution
Recital B
Recital B
B. whereas cohesion policy is asnot only vital to economic growth and social cohesion but is also an important policy tool to support gender equality;
Amendment 33 #
2020/2040(INI)
Motion for a resolution
Recital C
Recital C
C. whereas promoting gender equality is importantkey to reduceing regional economic and social disparities and for ensuringes the long-term sustainable development of regions;
Amendment 47 #
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 usefuessential for promoting gender equality;
Amendment 54 #
2020/2040(INI)
G. whereas preliminary studies suggest that the COVID-19 pandemic has exacerbated existing inequalities, bythe full economic, employment and social consequences of the pandemic are still unknown; whereas preliminary studies suggest that the COVID-19 pandemic has exacerbated existing inequalities between men and women, including an increase in unpaid care work and an increase in gender- based violence, whereas the public health crisis has a disproportionately impacting women and marginalised groups on women and girls and in particular women and girls from marginalised groups, which Cohesion Policy should take into account;
Amendment 63 #
2020/2040(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
H a. whereas small and medium- sized enterprises are the backbone of regional economies, whereas the promotion of equality, work-life balance, inclusive hiring and equal pay will enable gender equality in SMEs;
Amendment 131 #
2020/2040(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Points at the relevant role of Cohesion Funds in securing investment in care services; requests the Commission to propose a Care Deal for Europe aimed at supporting a transition towards a care economy in which Cohesion Policy should play a fundamental role;
Amendment 134 #
2020/2040(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. SRecognizes that innovation is a key element to boost growth and jobs in Europe and tailor-made strategies can enable each region to identify and develop its own competitive advantages; stresses that cohesion policy needs to support equal access to training for women in order to bridge the digital gender gap and to support the green and digital transitions;
Amendment 170 #
2020/2040(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Calls for the integration of a strong partnership principle in operational programmes under cohesion policy which will allow recipients, such as regions, cities and people shaping investment to meet their local needs, while ensuring that the importance of gender equality is promoted and addressed in all operational programmes;
Amendment 171 #
2020/2040(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18 b. Believes that cohesion policy should contribute to the widely existing urban inequalities by better integrating women in policy planning for regional and urban development to design gender- inclusive cities and communities that work for all; underlines that gender- sensitive urban planning can ensure a fairer and more equal access to urban goods; regions and local governments have a key role to play in the promotion of social inclusion, and gender sensitive territorial planning can contribute to making advancements in this process;
Amendment 175 #
2020/2040(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Underlines that a gender impact assessment shcould be a mandatory part of Member States’ evaluations on how the funds are spent and whether compliance with gender equality targets is respected;
Amendment 179 #
2020/2040(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Calls on the Commission and Member States to ensure that during the mid term review of the post-2020 cohesion policy, that an evaluation on the use of the resources is carried out to assess their effectiveness, efficiency, impact and, where applicable, inclusiveness and non- discrimination, including from a gender perspective;
Amendment 32 #
2020/2039(INI)
Motion for a resolution
Recital C
Recital C
C. whereas, although the EU population has seen substantial growth in previous decades, the growth rate is now falling and the population is expected to decrease in the longer term; whereas Europe will account for less than 4 % of the world’s population by 2070, and long- term demographic trends in European regions indicate lower birth rates and ageing societies; except in some outermost regions and particularly in Mayotte, where a population increase of 38% is forecast by 2050 compared to 2010 levels, alongside a corresponding increase of 26% for French Guiana1 a. _________________ 1aSources: INSEE (French National Institute of Statistics and Economic Studies), United Nations
Amendment 40 #
2020/2039(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas78% of European population lives in urban areas or functional urban areas, causing an uneven distribution of population throughout European regions
Amendment 41 #
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; whereas the COVID-19 pandemic has unveiled the fragility our healthcare systems, especially in connection with an aging population
Amendment 62 #
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 rural areas and areas facing natural or other specific constraints (ANC) ;
Amendment 63 #
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 rural areas and also in the outermost regions;
Amendment 67 #
2020/2039(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Observes that GDP per capita, income level, employment rate, fertility rate, socio economic factors, rural and urban divide, 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 patterns from eastern, southeastern and central regions to northern and northwestern regions mostly involve young, educated and skilled workers;
Amendment 71 #
2020/2039(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Points out that Europe is manifestly experiencing population ageing, affecting the dependency ratio and having negative effects on workforce growth, which is far behind the previous decade; warns of a visible decline of the labour force in eastern, southern and central European regions; regrets the COVID-19 pandemic has had a negative impact on the average life expectancy in Europe
Amendment 77 #
2020/2039(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Recognises the burden placed on women as principal caregivers in formal and informal settings, as well as its social value, especially during the COVID-19 crisis; whereas 80% of all care provided across the EU is provided by (unpaid) informal carers, 75% of whom are women; therefore points out the crucial role of cohesion policy in securing investments in care services, to improve working conditions in this sector and to support a transition towards a care economy;
Amendment 80 #
2020/2039(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Underlines that the ongoing COVID-19 crisis has exposed strong disparities in the quality and access to healthcare services; Notes that the combination of ageing population and limited healthcare infrastructure in rural areas facing demographic decline and low population density further exposes their population to health risks.
Amendment 83 #
2020/2039(INI)
Motion for a resolution
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Underlines that among the many inequalities exposed by the COVID-19 pandemic, the digital divide is a serious one, affecting in particular less developed regions, women, elderly people and people living in the Outermost regions and rural, remote and depopulated areas. Greater investment is needed in digitalisation, digital innovation and digital connectivity, which will enable a fair and equal transition towards a more digital economy and a digital online education system, accessible to all citizens, especially the most vulnerable in society;
Amendment 89 #
2020/2039(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes that in general rural, post- industrial 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; , which also leads to difficulties in accessing public services, such as housing, education, healthcare including access to vital drugs; points out that rural regions currently account for 28 % of Europe’s population but this is predicted to fall significantly in the future;
Amendment 95 #
2020/2039(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights that EU initiatives directed to rural areas such as cohesion and agricultural policies, should be further strengthened through promoting better coordination of policy initiatives that support youth employment, entrepreneurship, digitalisation and support for young and new farmers;
Amendment 99 #
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: poor infrastructure, including a lack of fast broadband internet and missing transport networks, fewer job opportunities, high level of youth unemployment, 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 138 #
2020/2039(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Stresses that local and regional 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 jobsterritorial approach to EU instruments, such as sustainable urban development, community-led local development strategies or Integrated Territorial Investments (ITIs) could be useful tool that can be used to maintain and create jobs, strengthen the attractiveness of the region, and increase accessibility to services at local level;
Amendment 150 #
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 providhelps shaping proper instruments promoting growth, integration, cooperation and innovation and tackling social challenges; insists also 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 capital investments;
Amendment 152 #
2020/2039(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Recalls the need for strategies aimed at reversing labour migration at EU and national level; calls on local and regional authorities to increase their attractiveness and 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;
Amendment 167 #
2020/2039(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Urges Member States and regional authorities to implement an integrated approach through Cohesion Policy Instruments to address demographic challenges and encourages the promotion of smart villages as a tool to attract and retain population; Recalls that the Recovery and Resilience Facility will provide large-scale 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 depopulation;
Amendment 171 #
2020/2039(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that the Recovery and Resilience Facility will provide large-scale 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 avoidthrough helping transformation to avoid, among other, the risk of depopulation;
Amendment 199 #
2020/2039(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the European Commission and Member States to include demographic challenges in their European and national development policies and long- term strategies for sustainable development correlated with the European Semester, thus ensuring proper financing for demographic issues;
Amendment 222 #
2020/2039(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls for more to be done to support regions facing significant population increases, such as Mayotte and French Guiana, by deploying adequate financial resources to guarantee the continuity of basic services in sufficient quantity and quality, particularly in the sectors of education, health and transport.
Amendment 232 #
2020/2039(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Highlights the role of cities and regions both in depopulated and overpopulated areas, reiterates the need for further funding opportunities directly available for cities and regions to implement programmes locally, calls for increasing the budget and broadening the scope of the European Urban Initiative;
Amendment 237 #
2020/2039(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Encourages policymakers at regional and national level to invest in the digital and knowledge economy, as well as in providing services and incentives, to maintain high-skilled workers and to develop research centres in the different regions in order to ensure the attractiveness of the depopulated areas to young talents and entrepreneurs;
Amendment 251 #
2020/2039(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Insists that investments should be focused on information and communication technology, 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 technologies among companies and schools in rural and isolated regions and regions in industrial transition; stresses the importance of an equal and parallel deployment of these technologies among regions to avoid further deepening the gap of attractiveness and digital divide
Amendment 261 #
2020/2039(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Calls on the Commission and the Member States to supporAcknowledges that ‘magnet cities’ since they primarily contribute to the building of regional ‘growth poles’; nevertheless, underlines that second-tier cities play a critical role in regional development, and calls onin this respect calls on the Commission and the Member States to put in practice strategies for the harmonised development of these cities;
Amendment 281 #
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 areas includes practical solution and means of support to address peripheries and 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 7 #
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 competitiveness of the European economy and other EU priorities such as social, economic and territorial cohesion and regional development, climate action, digitalisation, research and innovation, security and the management of migration, while acknowledging that the COVID-19 pandemic has provided a new and unexpected challenge that the EU and its Member States need to respond determinedly and provide solutions at the EU level;
Amendment 15 #
2020/1998(BUD)
Draft opinion
Paragraph 2
Paragraph 2
2. Reminds that cohesion is a shared competence between the EU and Member States and that as a mainas an effective 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 regionstheir regions; notes, however, that the regional differences in all Member States have not narrowed in the desired way; emphasizses in that context that programmes managed under European Structural and Investments (ESI) Funds support and contribute significantly to sustainable solutions for fair, sustainable and inclusive economic growth, investments and competitiveness, as well as high quality, safe and secure working and living conditions of the citizens, including equal opportunities, social justice and non-discrimination;
Amendment 24 #
2020/1998(BUD)
Draft opinion
Paragraph 3
Paragraph 3
3. Notes that the budget for the year 2021 startsis the first year of the new programming period 2021-2027 and that it should reflect the principles and priorities of an updated and reorientrevised Multiannual Financial Framework (MFF) and contribute effectively to the mitigation of the social and economic impact of the COVID-19 pandemic, while carefully considering available resources as well as budgetary rules and principles that will ensure realistic, immediate and satisfactory implementation;
Amendment 30 #
2020/1998(BUD)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Underlines that for timely and effective absorption of 2021 budget allocation, the necessary regulation and follow up documents must be adopted as soon as possible;
Amendment 36 #
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 be maintained also in MFF 2021-2027 in relation to COVID- 19 recovery measures;
Amendment 40 #
2020/1998(BUD)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the measures already approved by the European ParliamentTakes note of the recovery measures approved and welcomes the measures already approved such as the extension of the EU Solidarity Fund to cover public health emergencies that will make available almost EUR 800 million in 2020 and the Corona Response Investment Initiative (CRII and CRII+) that aim at providing €8 billion of liquidity to accelerate up to EUR 37 billion of European public investment in order to support citizens, regions and countries hit hard by the Coronavirus pandemic;
Amendment 41 #
2020/1998(BUD)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Underlines the necessity of fostering the continuity and development of the EU Space agency (including Galileo and EGNOS programmes) through financial support;
Amendment 61 #
2020/0380(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) On 1 February 2020, the United Kingdom of Great Britain and Northern Ireland (‘United Kingdom’) left the European Union and the European Atomic Energy Community (‘Euratom’) – hereafter referred together as the ‘Union’, entering a transition period. That time- limited period was agreed as part of the Withdrawal Agreement 11 and is to last untilended on 31 December 2020. During the transition period, the Union and the United Kingdom started formal negotiations on a future relationship. _________________ 11Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (‘Withdrawal Agreement’) (OJ L 29, 31.1.2020, p. 7).
Amendment 67 #
2020/0380(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Following tThe end of the transition period, has generated barriers to trade and to cross- border exchanges between the Union and the United Kingdom will be present. Band broad and far- reaching consequences for businesses, workers, citizens and public administrations are expected. Those consequences are unavoidable and stakeholders need to make sure that they are ready for them.
Amendment 77 #
2020/0380(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The Union is committed to mitigating the economic, social and territorial impact of the withdrawal of the United Kingdom from the Union and to show solidarity with all Member States and regions, especially the most affected ones in such exceptional circumstances.
Amendment 85 #
2020/0380(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) For the purposes of contributing to economic, social and territorial cohesion, it is appropriate that Member States, when designing support measures, focus in particular on the regions, areas and local communities, including those dependent on fishing activities in the United Kingdom waters, that are likely to be most negatively impacted by the withdrawal of the United Kingdom. Member States may have to take specific measures notably to support businesses and economic sectors adversely affected by the withdrawal. It is therefore appropriate to provide a non-exhaustive list of the type of measures that are most likely to achieve this objective, in particular SMEs, and economic sectors, including fisheries, agri-food and transport sectors, that are adversely affected by the withdrawal and which now face barriers to trade flows, an increase in administrative and custom procedures, and greater regulatory and financial burden. It is therefore appropriate to provide a non-exhaustive list of the type of measures that are most likely to achieve this objective. Relevant regional and local authorities, economic and social partners and civil society of the territories concerned shall be involved in the process of identification of the support measures in accordance with the partnership principle laid down in Article 6 of Regulation (EU) .../… [new CPR].
Amendment 105 #
2020/0380(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) In order to ensure reimbursement of administrative expenses linked to the implementation, management, monitoring, information, communication, control and auditing, the bodies responsible should be eligible for support from the Reserve, on a voluntary basis.
Amendment 109 #
2020/0380(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In order to take into account the immediate impact of the adverse consequences ofexpenses incurred in anticipating the withdrawal agreement of the United Kingdom from the Union on the Member States and their economies, the immediate impact of the adverse consequences of the withdrawal and the need to adopt mitigating measures, as appropriate, prior to the expiry of the transition period, the eligibility period for implementing such measures should start as from 1 Julanuary 202019 and be concentrated over a limited period of 30 monthslast until 31 December 2023.
Amendment 130 #
2020/0380(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Pursuant to paragraphs 22 and 23 of the Inter-institutional agreement for Better Law-Making of 13 April 201613 , there is a need to evaluate the Reserve on the basis of information collected through specific monitoring requirements, while avoiding overregulation and administrative burden, in particular on Member Statnational, regional and local authorities and final beneficiaries. These requirements, where appropriate, should include measurable indicators, as a basis for the evaluation of the Reserve. _________________ 13Interinstitutional Agreement between the European Parliament, the Council of the European Union and the European Commission on Better Law-Making (OJ L 123, 12.5.2016, p. 1).
Amendment 137 #
2020/0380(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) To ensure equal treatment of all Member States and consistency in the evaluation of the applications, the Commission should assess the applications in a package. It should look in particular into the eligibility and the accuracy of the expenditure declared, the direct link of the expenditure with measures taken to address the consequences of the withdrawal and the measures put in place by the Member State concerned to avoid double funding. Upon assessment of the applications for a financial contribution from the Reserve, the Commission should clear the pre- financing paid, and recover the unused amount. In order to concentrate the support on Member States most affected by the withdrawal, where the expenditure in the Member State concerned, accepted as eligible by the Commission, exceeds the amount paid as pre-financing and 0.06% of the nominal Gross National Income (GNI) for 2021 of the Member State concerned, it should be possible to allow for a further allocation from the Reserve to that Member Stata further allocation from the Reserve should be granted to Member States within the limits of the financial resources available. In order to ensure consistency with the pre-financing, the distribution method of the additional amount should also take into account the importance of trade within the limits ofUnited Kingdom in the financial resources availableternal market, based on reliable and official statistics. Given the extent of the expected economic shock, the possibility to use the amounts recovered from the pre-financing for the reimbursement of additional expenditure by Member States should be provided for.
Amendment 141 #
2020/0380(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The Commission should assist and support Member States in order to help their preparation of the measures, including on how to assess the direct link with the withdrawal of the United Kingdom from the Union.
Amendment 146 #
2020/0380(COD)
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) In order to reduce bureaucracy it is recommended to use existing techniques such as the simplified costs option to contribute to faster distribution of the financial resources
Amendment 156 #
2020/0380(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) The objectives of this Regulation are to maintain economic, social and territorial cohesion, to support employment and reintegration, including in the context of citizen's resettlement from the United Kingdom to the European Union and to provide a solidarity tool for Member States when dealing with the effects of the withdrawal of the United Kingdom from the Union which affects the Union as a whole though with different severity among regions and sectors. These objectives cannot be sufficiently achieved by the Member States alone but can rather, by reason of the scale and effects of the action, be better achieved at Union level. 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 158 #
2020/0380(COD)
(1) ‘reference period’ means the reference period referred to in Article 63(5), point (a), of the Financial Regulation, which shall be from 1 Julanuary 202019 to 31 December 20223;
Amendment 180 #
2020/0380(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point b
Article 4 – paragraph 3 – point b
(b) additional amounts of EUR 1 126 162 000 shall be made available in 20245 in accordance with Article 11.
Amendment 188 #
2020/0380(COD)
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. The financial contribution from the Reserve shall only support the public expenditure directly linked to measures specifically taken by Member States, regional and local authorities to contribute to the objectives referred to in Article 3, and may cover, in particular the following:
Amendment 205 #
2020/0380(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) measures to support employment, including through and reintegration, including in the context of citizens' resettlement from the United Kingdom to the European Union, through, inter alia, short-time work schemes, re- skilling and training in affected sectors;
Amendment 206 #
2020/0380(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) measures to support employment, job protection and job creation, including through short-time work schemes, up- skilling, re-skilling and training of workers in affected sectors;
Amendment 213 #
2020/0380(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point f
Article 5 – paragraph 1 – point f
(f) measures to facilitate regimes for certification and authorisation of products, to assist in meeting establishment requirements, to facilitate labelling and marking, for example for safety, health and environmental standards, as well as to assist in mutual recognition, including additional personnel and infrastructure, especially digital infrastructure;
Amendment 216 #
2020/0380(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point g a (new)
Article 5 – paragraph 1 – point g a (new)
(ga) technical assistance for the management, monitoring, information and communication, and control and auditing of the Reserve calculated as a flat rate at the amount of 3,5 % of the contribution from the Reserve for each Member State.
Amendment 256 #
2020/0380(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. By derogation from Article 12 of the Financial Regulation, unused commitment and payment appropriations under this Regulation shall be automatically carried over and may be used until 31 December 20256. The appropriations carried over shall be consumed first in the following financial year.
Amendment 266 #
2020/0380(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The Member States, in cooperation with regional and local authorities concerned and after consulting with the relevant economic and social partners and civil society of the territories concerned, shall submit an application to the Commission for a financial contribution from the Reserve by 30 September 20234. The Commission shall assess this application and establish whether additional amounts are due to Member States or any amounts should be recovered from the Member States in accordance with Article 11.
Amendment 276 #
2020/0380(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Where a Member State does not submit an application for a financial contribution from the Reserve by 30 September 20234, the Commission shall recover the total amount paid as pre- financing to that Member State.
Amendment 298 #
2020/0380(COD)
Proposal for a regulation
Article 11 – paragraph 3 – introductory part
Article 11 – paragraph 3 – introductory part
3. Where the accepted amount exceeds both the amount of pre-financing and 0.06% of the nominal GNI of 2021 of the Member State concerned, an additional amount shall be due to that Member State from the allocation referred to in Article 4(3), point (b), and any amounts carried over pursuant to Article 8(4). The allocation criteria for the additional amounts to be paid by the Commission to the Member States are set out in Annex Ia.
Amendment 304 #
2020/0380(COD)
Proposal for a regulation
Article 11 – paragraph 3 – subparagraph 1
Article 11 – paragraph 3 – subparagraph 1
In such a case, the Commission shall pay the amount exceeding the pre-financing paid to the Member State concerned or 0.06% of the nominal GNI of 2021, whichever is higher.
Amendment 316 #
2020/0380(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
Any amounts declared in the application for a financial contribution to the Commission by Member States shall be denominated in euro. Member States which have not adopted the euro as their currency shall convert the amounts in the application for financial contribution into euro using the monthly accounting exchange rates of the Commission in the month prior to the submission of the applicationduring which the expenditure is registered in the accounting systems of the Member State.
Amendment 321 #
2020/0380(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point f
Article 13 – paragraph 1 – point f
(f) preventing, detecting and correcting irregularities and fraud, and avoiding conflict of interest including through the use of a single data mining tool provided by the Commission;.
Amendment 329 #
2020/0380(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. By 30 June 20267, the Commissan independent evaluation shall be carryied out an evaluation to examine the effectiveness, efficiency, relevance, coherence and EU added value of the Reserve. The Commission may make use ofshall provide all relevant information already available in accordance with Article 128 of the Financial Regulation.
Amendment 56 #
2020/0360(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4 a) The target agreed in the conclusions of the March 2002 Barcelona European Council for Member States to have a level of electricity interconnections equivalent to at least 10 % of their installed production capacity has not yet been achieved. In its conclusions of 23 and 24 October 2014, the European Council endorsed an electricity interconnection target of at least 15 %. The communication of the Commission of 23 November 2017 on strengthening Europe's energy networks assesses progress towards achieving the 10 % interconnection target and suggests ways in which to operationalise the 15 % interconnection target for2030, provided that system benefits outweigh costs, while acknowledging that many Member States require significantly higher interconnection levels, in particular by taking into account the urgency indicators developed by the Interconnection expert group (ITEG).
Amendment 70 #
2020/0360(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Security of supply, as one main driver behind Regulation (EU) No 347/2013, has been significantly improved through projects of common interest. Moreover, the Commission’s climate target impact assessment27 expects the consumption of natural gas to be reduced significantly because its non-abated use is not compatible with carbon-neutrality. On the other hand, the consumption of biogas, renewable and low-carbon hydrogen and synthetic gaseous fuels will increase significantly towards 2050. Therefore, the natural gas infrastructure no longer needs support through the TEN-E policy should be technology neutral and based on life cycle emissions assessments to avoid future lock-in effects. The planning of energy infrastructure should reflect this changing gas landscape. _________________ 27 SWD(2020) 176 final
Amendment 95 #
2020/0360(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Following close consultations with all Member States and stakeholders, the Commission has identified 13 strategic trans-European energy infrastructure priorities, the implementation of which is essential for the achievement of the Union’s 2030 and 2050 energy and climate policy targets. Those priorities cover different geographic regions or thematic areas in the field of electricity transmission and storage, offshore grids for renewable energy, hydrogen transmission and storage, electrolysers, smart gas grids, smart electricity grids, and carbon dioxide transport and storage.
Amendment 99 #
2020/0360(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) A new Union list of project of common interest (‘Union list’) should be established every two years. Projects of common interest that are completed or that no longer fulfil the relevant criteria and requirements as set out in this Regulation should not appear on the next Union list. For that reason, existing projects of common interest that are to be included in the next Union list should be subject to the same selectionHowever PCI projects which have reached sufficient maturity (under construction or in permitting), are part of the national development strategic plans and are demonstrating steady and concrete procgress for the establishment of regional lists and for the establishment of the Union list applied to proposed projects. However t, as per their implementation plan, should be automatically re- confirmed in the future PCI lists until their commissioning without imposing reapplication by project promoters. The resulting administrative burden should be reduced as much as possible, for example by using to the extent possible information submitted previously, and by taking account of the annual reports of the project promoters. To that end, existing projects of common interest that have made significant progress should benefit from a streamlined inclusion process in the Union-wide ten- year network development plan.
Amendment 110 #
2020/0360(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) Grants for works related to projects of mutual interest should be available only for the investments located on the territory of the Union and only in case where at least twoone Member States contributes financially in a significant manner to the investment costs of the project in view of its benefits.
Amendment 132 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘smart gas grid’ means a gas network that makes use of innovative digital solutions to integrate in a cost efficient manner a plurality of low-carbon and renewable gas sources and their blends with methane in accordance with consumers’ needs and gas quality requirements in order to reduce the carbon footprint of the related gas consumption, enable an increased share of renewable and low-carbon gases, and create links with other energy carriers and sectors;
Amendment 135 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
Article 2 – paragraph 1 – point 9 a (new)
(9 a) “Repurposing” means the technical upgrade or modification of existing natural gas infrastructure for dedicated transmission of pure hydrogen;
Amendment 137 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 b (new)
Article 2 – paragraph 1 – point 9 b (new)
(9 b) “Retrofitting” means the technical upgrade or modification of existing natural gas infrastructure to enable or increase blending of hydrogen or biomethane with methane;
Amendment 153 #
2020/0360(COD)
Proposal for a regulation
Article 3 – paragraph 4 – introductory part
Article 3 – paragraph 4 – introductory part
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 of this Regulation amending annexes to this Regulation in order to establish the Union list of projects of common interest (‘Union list’), not excluding gas infrastructure where this solution clearly proves to bring a significant contribution to the decarbonisation of the energy system in the region, to the social and economic development of the area considering the cohesion targets of the Union, subject to the second paragraph of Article 172 of the Treaty on the Functioning of the European Union.
Amendment 181 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point f a (new)
Article 4 – paragraph 2 – point f a (new)
Amendment 219 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
3 a. Natural gas infrastructure shall be considered as projects of common interest and have access to Connecting Europe Facility under the category “smart gas grids” under the following criteria: (a) natural gas transmission pipeline projects which enables the transition from coal to natural gas, taking into account that the pipelines fulfil all necessary sustainability measures and technical requirements to transport 100% hydrogen and allow interconnection within coal regions of at least two Member States, based on the reference to the National Climate and Energy Plans including the scope of the TYNDPs.; (b) natural gas transmission pipeline projects provided that the pipelines can transport hydrogen based on the reference to the National Climate and Energy Plans including the scope of the TYNDPs;
Amendment 263 #
2020/0360(COD)
Proposal for a regulation
Article 11 – paragraph 12
Article 11 – paragraph 12
12. The consistent and interlinked model referred to in paragraph 11 shall cover at least the respective sectors’ interlinkages at all stages of infrastructure planning, specifically scenarios, and the infrastructure gaps identification therein in particular with respect to cross-border capacities within the scenarios, and projects assessment. The ENTSO-E and ENTSO G shall include in the interlinked model a roadmap for the future inclusion of other sectors relevant to the sound development of the electricity system and to the gas system and in accordance with the European, national and regional development strategies.
Amendment 276 #
2020/0360(COD)
(11) Security of supply, as one main driver behind Regulation (EU) No 347/2013, has been significantly improved through projects of common interest. Moreover, the Commission’s climate target impact assessment27 expects the consumption of natural gas to be reduced significantly because its non-abated use is not compatible with carbon-neutrality. On the other hand, the consumption of biogas, renewable and low-carbon hydrogen and synthetic gaseous fuels will increase significantly towards 2050. Therefore, the natural gas infrastructure no longer needs support through the TEN-E policyinfrastructure support through the TEN-E policy should be technology neutral and based on life cycle emissions assessments to avoid future lock-in effects. The planning of energy infrastructure should reflect this changing gas landscape. _________________ 27 SWD(2020) 176 final
Amendment 277 #
2020/0360(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1
Article 13 – paragraph 1 – subparagraph 1
When assessing the infrastructure gaps the ENTSO for Electricity and the ENTSO for Gas shall implement the energy efficiency first principle and consider with priority all relevant non-infrastructure related solutions to address the identified gaps. Where there are considerable gaps in the infrastructure the ENTSO E and ENTSO G shall consider the appropriate technical solution taking into account the specificity of the area, the differences between the degree of the pollution of the present energy solutions used in the region and the new proposed technology, national development strategies and the cohesion policy. Where using natural gas infrastructure is of ut most important for the region and the only efficient solution with a considerable contribution to the decarbonisation and the possibility to reconvert it to low carbon gases the projects shall be considered eligible.
Amendment 289 #
2020/0360(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The Commission’s communication on energy system integration underlines the need for integrated energy infrastructure planning across energy carriers, infrastructures, and consumption sectors. Such system integration starts from the point of departure of applying the energy efficiency first principle and taking a holistic approach in policy and beyond individual sectors. It also addresses the decarbonisation needs of the hard to abate sectors, such as parts of industry or certain modes of transport, where direct electrification is, currently, technically or economically challenging. Such investments include hydrogen and electrolysers, which are progressing towards commercial large-scale deployment. The Commission’s Hydrogen Strategy gives priority to hydrogen production from renewable electricity, which is the cleanest solution and is most compatible with the EU climate neutrality objective. In a transitional phase however, other forms of low-carbon hydrogen are needed to more rapidly replace existing hydrogen and kick-start an economy of scale.
Amendment 328 #
2020/0360(COD)
Proposal for a regulation
Annex I – Part 4 – point 12 – introductory part
Annex I – Part 4 – point 12 – introductory part
(12) Cross-border carbon dioxide network: development of carbon dioxide transport and storage infrastructure between Member States and with neighbouring third countries in view of the deployment of carbon dioxide capture and storage.
Amendment 341 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point a
Annex II – paragraph 1 – point 2 – point a
(a) any of the following equipment or installation aiming at enabling and facilitating the integration of renewable and low-carbon gases (including biomethane or hydrogen), synthetic methane or hydrogen) and their blends with methane into the network: digital systems and components integrating ICT, control systems and sensor technologies to enable the interactive and intelligent monitoring, metering, quality control and management of gas production, transmission, distribution, storage and consumption within a gas network. Furthermore, such projects may also include connections from renewable and low-carbon gases production facilities into transmission grid, equipment to enable reverse flows from the distribution to the transmission level and related necessary upgrades to the existing network. , such as upgrades of various gas infrastructure parts to retrofit network assets to be compatible to transport renewable and low-carbon gases in blends of methane and hydrogen. Hydrogen infrastructure as listed in points (a), (b), (c), and (d) may be used in the transitional period for the purposed of blending of hydrogen with methane until there is sufficient market demand to make pure hydrogen economically feasible.
Amendment 345 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point a
Annex II – paragraph 1 – point 3 – point a
(a) transmission pipelines for the transport of hydrogen including the repurposed natural gas infrastracture, giving access to multiple network users on a transparent and non-discriminatory basis, which mainly contains high-pressure hydrogen pipelines, excluding pipelines for the local distribution of hydrogen;
Amendment 355 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point d – paragraph 1
Annex II – paragraph 1 – point 3 – point d – paragraph 1
Any of the assets listed in points (a), (b), (c), and (d) may be newly constructed assets or assets convertrepurposed from natural gas dedicated to hydrogen, or a combination of the two. Hydrogen infrastructure as listed in point (a),(b), (c) and (d) may be used in a transitional period for the purpose of blends of hydrogen with methane or methane”
Amendment 369 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 1 – point 2
Annex III – Part 1 – point 2
(2) depending on the number of candidate projects for the Union list, regional infrastructure gaps and market developments, the Groups and the decision-making bodies of the Groups may split, merge or meet in different configurations, as necessary, to discuss matters common to all Groups or pertaining solely to particular regions. Such matters may include issues relevant to cross-regional consistency or the number of proposed projects included on the draft regional lists at risk of becoming unmanageable. To ensure a consistent development of the network, within their respective regional group, TSOs shall have the opportunity to coordinate with competent NRAs and competent Member States the opinion on projects not promoted by them but developed in their country creating the necessary synergies with the national development strategies and with the cohesion policy.
Amendment 377 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 2 – point 6
Annex III – Part 2 – point 6
(6) proposed carbon dioxide transport and storage projects falling under the category set out in point (5) of Annex II shall be presented as part of a plan, developed by at least two Member States, for the development of cross-border carbon dioxide transport and storage infrastructure, to be presented by the Member States concerned or entities designated by those Member States to the Commission.
Amendment 430 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘smart gas grid’ means a gas network that makes use of innovative digital solutions to integrate in a cost efficient manner a plurality of low-carbon and renewable gas sources and their blends with methane in accordance with consumers’ needs and gas quality requirements in order to reduce the carbon footprint of the related gas consumption, enable an increased share of renewable and low-carbon gases, and create links with other energy carriers and sectors;
Amendment 436 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
Article 2 – paragraph 1 – point 9 a (new)
(9a) “Repurposing” means the technical upgrade or modification of existing natural gas infrastructure for dedicated transmission of pure hydrogen;
Amendment 439 #
2020/0360(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 b (new)
Article 2 – paragraph 1 – point 9 b (new)
(9b) “Retrofitting” means the technical upgrade or modification of existing natural gas infrastructure to enable or increase blending of hydrogen or biomethane with methane;
Amendment 513 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 2 – point f a (new)
Article 4 – paragraph 2 – point f a (new)
(fa) The project ensures interoperability between natural gas and hydrogen transportation thanks to the development of natural gas transmission pipelines ready for the transportation of hydrogen and the setting of a date for the complete move from the transport of natural gas to the transport of hydrogen which should be aligned with National Climate and Energy Plans and support the objectives of the EU hydrogen strategy;
Amendment 524 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 – point b – point iii a (new)
Article 4 – paragraph 3 – point b – point iii a (new)
(iiia) sector integration, through the improvement of the interaction of different energy vectors or energy sectors, for instance through the increase of synergies in adjacent sectors, such as transport and mobility;
Amendment 581 #
2020/0360(COD)
Proposal for a regulation
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
3 a. Natural gas infrastructure shall be considered as projects of common interest and have access to Connecting Europe Facility under the category “smart gas grids” under the following criteria: (a) natural gas transmission pipeline projects which enables the transition from coal to natural gas, taking into account that the pipelines fulfil all necessary sustainability measures and technical requirements to transport 100% hydrogen and allow interconnection within coal regions of at least two Member States, based on the reference to the National Climate and Energy Plans including the scope of the TYNDPs.; (b) natural gas transmission pipeline projects provided that the pipelines can transport hydrogen based on the reference to the National Climate and Energy Plans including the scope of the TYNDPs
Amendment 821 #
2020/0360(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The integrated offshore network development plans shall be compatible with the latest Union-wide ten-Year Network Development Plans in order to ensure coherent development of onshore and offshore grid planning providing for an adequate and reliable transmission grid for transfer of electricity onshore as well as between coastal regions, regions inland, and landlocked Member States and to provide for a stable supply of electricity to centres of consumption or energy storage facilities.
Amendment 1004 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 2 – point a
Annex II – paragraph 1 – point 2 – point a
(a) any of the following equipment or installation aiming at enabling and facilitating the integration of renewable and low-carbon gases (including biomethane or hydrogen), synthetic methane or hydrogen) and their blends with methane into the network: digital systems and components integrating ICT, control systems and sensor technologies to enable the interactive and intelligent monitoring, metering, quality control and management of gas production, transmission, distribution, storage and consumption within a gas network. Furthermore, such projects may also include connections from renewable and low-carbon gases production facilities into the transmission grid, equipment to enable reverse flows from the distribution to the transmission level and related necessary upgrades to the existing network such as upgrades of various gas infrastructure parts to retrofit network assets to be compatible to transport renewable and low-carbon gases in blends of methane and hydrogen. Hydrogen infrastructure as listed in points (a), (b), (c), and (d) may be used during the transitional period for the purpose of blending of hydrogen with methane until there is sufficient market demand to make pure hydrogen economically feasible.
Amendment 1021 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point a
Annex II – paragraph 1 – point 3 – point a
(a) transmission pipelines for the transport of hydrogen including the repurposed natural gas infrastructure, giving access to multiple network users on a transparent and non-discriminatory basis, which mainly contains high-pressure hydrogen pipelines, excluding pipelines for the local distribution of hydrogen;
Amendment 1031 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point c a (new)
Annex II – paragraph 1 – point 3 – point c a (new)
(ca) storage facilities connected to the electricity networks that enable integration with electricity sectors, enabling the operations of the energy systems across multiple Energy carriers
Amendment 1035 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 3 – point d – paragraph 1
Annex II – paragraph 1 – point 3 – point d – paragraph 1
Any of the assets listed in points (a), (b), (c), and (d) may be newly constructed assets or assets convertrepurposed from natural gas dedicated to hydrogen, or a combination of the twoto hydrogen, or a combination of the two. Hydrogen infrastructure as listed in point (a), (b), (c) and (d) may be used in a transitional period for the purpose of blends of hydrogen with methane or methane.
Amendment 1050 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 4 – point a
Annex II – paragraph 1 – point 4 – point a
(a) electrolysers that: (i) have at least 100 MW capacity, (ii) the production complies with the life cycle greenhouse gas emissions savings requirement of 70 % relative to a fossil fuel comparator of 94g CO2e/MJ as set out in Article 25(2) and Annex V of Directive (EU) 2018/2001 of the European Parliament and of the Council.60 Life cycle greenhouse gas emissions savings are calculated using the methodology referred to in Article 28(5) of Directive (EU) 2018/2001 or, alternatively, using ISO 14067 or ISO 14064-1 taking into account the carbon intensity of the electricity in the country of production. Quantified life-cycle GHG emission savings are verified in line with Article 30 of Directive (EU) 2018/2001 where applicable, or by an independent third party, and (iii) have also a network-related function; _________________ 60 OJ L 328, 21.12.2018, p. 82.
Amendment 1064 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point b
Annex II – paragraph 1 – point 5 – point b
(b) facilities for liquefaction and buffer storage of carbon dioxide in view of its further transportation. This does not include infrastructure within a geological formation used for the permanent geological storage of carbon dioxide pursuant to Directive 2009/31/EC and associated surface and injection facilities;
Amendment 1066 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 – point b a (new)
Annex II – paragraph 1 – point 5 – point b a (new)
Amendment 1067 #
2020/0360(COD)
Proposal for a regulation
Annex II – paragraph 1 – point 5 a (new)
Annex II – paragraph 1 – point 5 a (new)
(5a) concerning district heating and cooling: district heating and cooling systems meeting the following criteria: (a) at least 1000 MW installed capacity for heating or 100 MW installed capacity for cooling, (b) existence of a district heating network for the transport of hot steam or water or a distribution network for the transport of chilled liquids in at least one of the following categories: low cooling temperature (5-25 degrees Celsius), low temperature (30-40 degrees Celsius), average temperature (40-90 degrees Celsius) or high temperature (from 100 degrees Celsius), (c) heat generators producing heat or waste heat that can be injected in the district heating network pursuant to the definition of ‘waste heat and cold’ of (EU) 2018/2001; ‘highly efficient cogeneration of (EU) 2012/27, geothermal energy, heat pumps or bioenergy;
Amendment 1073 #
2020/0360(COD)
Proposal for a regulation
Annex III – Part 1 – point 1 – introductory part
Annex III – Part 1 – point 1 – introductory part
(1) with regard to energy infrastructure falling under the competency of national regulatory authorities, each Group shall be composed of representatives of the Member States, national regulatory authorities, TSOs, DSOs, as well as the Commission, the Agency and the DSO- Entity and the ENTSO for Electricity or the ENTSO for Gas, as relevant.
Amendment 1123 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 1 – point g
Annex IV – point 1 – point g
(g) for smart gas grids, a project involves transmission system operators, transmission and distribution system operators or solely distribution system operators from at least two Member States. DProjects involving solely distribution system operators without the direct involvement of transmission system operators can be involved only with the support of the transmission system operators in the form of a letter of intent, of at least two Member States, that are closely associated to the project and ensure interoperability.
Amendment 1126 #
2020/0360(COD)
Proposal for a regulation
Annex IV – point 1 – point g a (new)
Annex IV – point 1 – point g a (new)
(ga) for district heating and cooling the project has at least 1000 Megawatt heat production capacity or 100 Megawatt cooling capacity
Amendment 1124 #
2020/0353(COD)
Proposal for a regulation
Article 60 – paragraph 1 – subparagraph 1 – point d
Article 60 – paragraph 1 – subparagraph 1 – point d
(d) the necessary safety instructions to handle waste batteries, including in relation to the risks associated with, and the handling of, batteries containing lithium; the risks and instructions of fire safety shall also be included;
Amendment 1128 #
2020/0353(COD)
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
2. Producers shall make available to distributors and operators referred to in Articles 50, 52 and 53 and other waste management operators carrying out repair, remanufacturing, preparing for re-use, treatment and recycling activities information regarding the safety and protective measures, including on occupational and fire safety, applicable to the storage and collection of waste batteries.
Amendment 1131 #
2020/0353(COD)
Proposal for a regulation
Article 60 – paragraph 3 – subparagraph 1 – point b
Article 60 – paragraph 3 – subparagraph 1 – point b
(b) the safety and protective measures, including on occupational safety and fire protection measures, applicable to the storage, transport, treatment and recycling processes for waste batteries.
Amendment 1315 #
2020/0353(COD)
Proposal for a regulation
Annex VI – Part A – paragraph 1 – point 8 a (new)
Annex VI – Part A – paragraph 1 – point 8 a (new)
8a. usable extinguishing agent
Amendment 119 #
2020/0321(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health from an early stage and in coordination with the national authorities, the industry and other entities of the pharmaceutical supply chain. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 227 #
2020/0321(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to ensure that sufficient resources, including appropriate staffing and adequate expertise, are available for the work provided for under this Regulation, expenditure of the Agency should be covered by the contribution from the Union to the Agency’s revenue.
Amendment 261 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is placed on the national market by a marketing authorisation holder, a manufacturer, a distributor, or any other actor in the distribution chain respectively;
Amendment 326 #
2020/0321(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders, representatives of healthcare professionals, patients and consumers to attend its meetings.
Amendment 379 #
2020/0321(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Immediately following the recognition of a public health emergency and after consultation of its working party, the industry and representatives of health professionals, the Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the public health emergency (‘the public health emergency critical medicines list’). The list shall be updated whenever necessary until the termination of the recognition of the public health emergency.
Amendment 425 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 434 #
2020/0321(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 545 #
2020/0321(COD)
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals;
Amendment 575 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The Emergency Task Force shall be composed of representatives of the Member States, of the scientific committees, working parties, and staff members of the Agency, the coordination group established in accordance with Article 27 of Directive 2001/83/EC, and the Clinical Trials Coordination and Advisory Group established in accordance with Article 85 of Regulation (EU) 536/2014.21 External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency. _________________ 21Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, OJ L 158, 27.5.2014, p. 1under Heads of Medicines Agencies. Each Member State may appoint one representative. A Member State may delegate its tasks in the Emergency Task Force to another Member State. External experts may be appointed and representatives of other Union bodies and agencies be invited on an ad hoc basis, as necessary. It shall be chaired by the Agency.
Amendment 581 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 591 #
2020/0321(COD)
Proposal for a regulation
Article 15 – paragraph 5
Article 15 – paragraph 5
5. When authorising a clinical trial application for which scientific advice has been given, Member States shall take that advice duly into account. The scientific advice provided by the Emergency Task Force and endorsed by the Committee for Medicinal Products for Human Use referred to in paragraph 2 shall have no binding force on the opinion of an independent Ethics Committee issued within authorisation of a clinical trial application.
Amendment 601 #
2020/0321(COD)
Proposal for a regulation
Article 16 – paragraph 7
Article 16 – paragraph 7
7. The Agency shall publish the recommendations provided pursuant to paragraph 3 and the opinions adopted pursuant to paragraph 4 including any updates on its web-portal.
Amendment 618 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of interventional clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies;
Amendment 641 #
2020/0321(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The Medical Devices Steering Group shall be chaired by the Agency. The Chair may invite third parties, including representatives of medical device interest groups, representatives of patients and healthcare professionals, to attend its meetings.
Amendment 695 #
2020/0321(COD)
Proposal for a regulation
Article 25 – paragraph 4 – point a
Article 25 – paragraph 4 – point a
(a) consider the need to provide for temporary exemptions at Member State level pursuant to Article 59(1) of Regulation (EU) 2017/745 or Article 54(1) of Regulation (EU) 2017/746 with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, while at the same time ensuring a high level of patient and product safety;
Amendment 699 #
2020/0321(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while at the same time ensuring a high level of patient and product safety;
Amendment 729 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, anonymised and aggregated sensitive personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements.
Amendment 225 #
2020/0310(COD)
Proposal for a directive
Recital 16
Recital 16
(16) In full respect of Article 153(5) of the Treaty on the Functioning of the European Union, this Directive neither aims to harmonise the level of minimum wages across the Union nor to establish an uniform mechanism for setting minimum wages. It does not interfere with the freedom of Member States to set statutory minimum wages or promote access to minimum wage protection provided by collective agreements, according to the traditions and specificities of each country and in full respect of national competences and social partners’ contractual freedom. This Directive does not impose an obligation on the Member States where minimum wage protection is ensured exclusively via collective agreements to introduce a statutory minimum wage nor to make the collective agreements universally applicable. Also, this Directive does not establish the level of pay, which falls within the contractual freedom of the social partners at national level and within the relevant competence of Member States. The purpose of this Directive is not to impose any obligation for Member States to take measures demanding the introduction of statutory minimum wages or measures implying that the social partners have an equivalent obligation. This Directive does not oblige Member States to grant access to minimum wage protection to all workers. Such an obligation would directly interfere with Article 153(5) of the Treaty on the Functioning of the European Union. Nothing in this Directive should be construed as creating rights for individuals.
Amendment 372 #
2020/0310(COD)
Proposal for a directive
Recital 29
Recital 29
(29) This Directive lays down minimum requirements, thus leaving untouched Member States' prerogative to introduce and maintain more favourable provisions. Rights acquired under the existing national legal framework in Sweden and Denmark should continue to apply, unless more favourable provisions are introduced by in accordance to the derogation in Article 1(3) and Article 16(2) of this Directive. The implementation of this Directive cannot be used to reduce existing rights for workers, nor can it constitute valid grounds for reducing the general level of protection afforded to workers in the field covered by this Directive.
Amendment 389 #
2020/0310(COD)
Proposal for a directive
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
1. With a view to improving working and living conditions in the Union, this Directive establishes a framework for the promotion of:
Amendment 409 #
2020/0310(COD)
Proposal for a directive
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) access of workers to minimum wage protection, in the form of wages set out byby promoting access to collective agreementsbargaining or in the form of a statutory minimum wage in Member States where it exists.
Amendment 421 #
2020/0310(COD)
Proposal for a directive
Article 1 – paragraph 3
Article 1 – paragraph 3
3. Nothing in this Directive shall be construed as imposing an obligation on the Member States where wage setting is ensured exclusivemainly via collective agreements to introduce a statutory minimum wage nor to make the collective agreements universally applicable or affect the contractual freedom of the social partners to negotiate, monitor and set wages through collective agreements. This Directive does not oblige Member States to grant access to minimum wage protection to all workers, nor shall it create any obligation on the Member States as regards the level or conditions for the setting of wages.
Amendment 573 #
2020/0310(COD)
Proposal for a directive
Article 5 – paragraph 2 – introductory part
Article 5 – paragraph 2 – introductory part
2. The national criteria referred to in paragraph 1 shall include at least the following elementwhose relevance and relative weight shall be decided by Member States in accordance with their prevailing national socio-economic conditions:
Amendment 863 #
2020/0310(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that, without prejudice to specific forms of redress and dispute resolution provided for, where applicable, in collective agreements, workers, including those whose employment relationship has ended, have access to effective and impartial dispute resolution and a right to redress, including adequate compensation, in the case of infringements of their rightsexisting national law or collective agreements provide for relating to statutory minimum wages or minimum wage protection provided by collective agreements and such rights have been infringed.
Amendment 880 #
2020/0310(COD)
Proposal for a directive
Article 11 – paragraph 2
Article 11 – paragraph 2
2. Member States shall take the measures necessary to protect workers, including those who are workers’ representatives, from any adverse treatment by the employer and from any adverse consequences resulting from a complaint lodged with the employer or resulting from any proceedings initiated with the aim of enforcing compliance with the rights relating to statutory minimum wages or minimum wage protection provided by collective agreements.provided for in existing national law or collective agreements relating to minimum wage protection
Amendment 305 #
2020/0300(COD)
Proposal for a decision
Article 2 – paragraph 2 – point a
Article 2 – paragraph 2 – point a
(a) irreversible and gradual reduction of greenhouse gas emissions and enhancement of removals by natural and other sinks in the Union to attain the 2030 greenhouse gas emission reduction target and achieve climate neutrality by 2050 as laid down in Regulation (EU) …/… while respecting the principle of technological neutrality32 ; __________________ 32 COM/2020/80 final.
Amendment 448 #
2020/0300(COD)
Proposal for a decision
Article 3 – paragraph 1 – point e
Article 3 – paragraph 1 – point e
(e) phasing out environmentally harmful subsidies at Union and national level, making the best use of market-based instruments and green budgeting tools, including those required to ensure a socially fair transition, and supporting businesses and other stakeholders in developing standardised natural capital accounting practices;
Amendment 596 #
2020/0300(COD)
Proposal for a decision
Article 4 – paragraph 4 a (new)
Article 4 – paragraph 4 a (new)
4a. The Commission shall present, where appropriate, by 31 March 2025 at the latest, a legislative proposal to add to the 8th EAP an Annex for the period after 2025 containing the list of clear actions necessary to achieve the priority objectives set out in Article 2(2) at Union and Member State Level and the respective timetable to deliver on these actions.
Amendment 599 #
2020/0300(COD)
Proposal for a decision
Article 5 – paragraph -1 (new)
Article 5 – paragraph -1 (new)
-1. By 31 March 2024, the Commission shall carry out a mid-term evaluation of the progress achieved towards the thematic priority objectives set out in Article 2(2), including the targets under the EGD, based on the most recent assessment referred to in Article 4(1), and submit a report to the European Parliament and to the Council. The mid-term evaluation of the 8th EAP shall include an assessment of the efficacy and efficiency of the progress of all environmental objectives at Union and Member State level with the aim of deploying this new approach in the context of monitoring progress towards the 8th EAP priority objectives for the period 2025-2030 and any subsequent Union Environment Action Programme.
Amendment 50 #
2020/0101(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) In accordance with Regulation [European Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the European Investment and Structural Funds should be carried out to address the unprecedented impact of the COVID-19 crisis. Such additional resources should be used to ensure compliance with the time limits provided for in Regulation [ERI]. Moreover, additional resources for economic, social and territorial cohesion should be made available through a revision of the multiannual financial framework for 2014- 2020.
Amendment 59 #
2020/0101(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) An additional exceptional amount of EUR 58 272 800 000 (in current prices) for budgetary commitment from the Structural Funds under the Investment for growth and jobs goal, for the years 2020, 2021 and 2022 as well as for the years 2023 and 2024, where justified by a Member State, should be made available to support Member States and regions most impacted in crisis repair in the context of the COVID-19 pandemic or preparing a green, digital and resilient recovery of the economy, with a view to deploying resources quickly to the real economy through the existing operational programmes. Resources for 2020 stem from an increase in the resources available for economic, social and territorial cohesion in the multiannual financial framework for 2014-2020 whereas resources for 2021 and 2022 and where applicable for 2023 and 2024, stem from the European Union Recovery Instrument. Part of the additional resources should be allocated to technical assistance at the initiative of the Commission. The Commission should set out the breakdown of the remaining additional resources for each Member State on the basis of an allocation method based on the latest available objective statistical data concerning Member States’ relative prosperity and the extent of the effect of the current crisis on their economies and societies. The allocation method should include a dedicated additional amount for the outermost regions given the specific vulnerability of their economies and societies. In order to reflect the evolving nature of the effects of the crisis, the breakdown should be revised in 2021 on the basis of the same allocation method using the latest statistical data available by 19 October 2021 to distribute the 2022, and where relevant the 2023 and 2024 tranches of the additional resources.
Amendment 78 #
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, staff and services for health services including residential care homes for elderly people, for providing support in the form of working capital or investment support to SMEs, and support to adapt to teleworking in operations contributing to the transition towards a digital and green economy, infrastructure providing basic services to citizens, including in Outermost Regions, rural and depopulated areas and areas affected by industrial transition, or economic support measures for those regions most dependent on sectors, such as tourism and culture, 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. 5); 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 93 #
2020/0101(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) For the ESF, Member States should primarily use the additional resources to support job maintenance, including taking into special consideration the needs of the Outermost Regions, rural and depopulated areas, and areas affected by industrial transition, including, but not exclusively, through short-time work schemes and support to self-employed, job creation, in particular for people in vulnerable situations and women bearing the brunt of the ensuing economic crisis, support to youth employment measures, education and training, transition towards a more digital and online education system, skills development and to enhance access to social services of general interest, including for children and people in vulnerable situations. It should be clarified that in the present exceptional circumstances support to short-time work schemes for employees and the self- employed in the context of the COVID-19 pandemic can be provided even when that support is not combined with active labour market measures, unless the latter are imposed by national law. Union support to those short-time work schemes should be limited in time.
Amendment 115 #
2020/0101(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to enable Member States to deploy the additional resources for crisis repair quickly in the context of the COVID-19 pandemic and preparing a green, digital and resilient recovery of the economy within the current programming period, it is justified to exempt, on an exceptional basis, Member States from the need to comply with ex ante conditionalities and requirements on the performance reserve and application of the performance framework, on thematic concentration, also in relation to the thresholds established for sustainable urban development for the ERDF, and requirements on preparation of a communication strategy for the additional resources. It is nevertheless necessary that Member States carry out at least one evaluation by 31 December 2024 or by 31 December 2026 where additional resources are made available for budgetary commitment in 2023 and 2024, to assess the effectiveness, efficiency and impact of the additional resources as well as how they contributed to achieving the goals of the new dedicated thematic objective. To facilitate the availability of comparable information at Union level, Member States are highly encouraged to make use of the programme-specific indicators made available by the Commission. In addition, while carrying out their responsibilities linked to information, communication and visibility, Member States and managing authorities should enhance the visibility of the exceptional measures and resources introduced by the Union, in particular by ensuring that potential beneficiaries, beneficiaries, participants, final recipients of financial instruments and the general public are aware of the existence, volume and additional support stemming from the additional resources.
Amendment 136 #
2020/0101(COD)
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The available resources should be eligible for incurred expenditure related to the COVID-19 crisis as of 1 February 2020, in order to guarantee that all COVID-19 related costs are covered under this instrument.
Amendment 153 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 2 – subparagraph 3
Article 92 b – paragraph 2 – subparagraph 3
The additional resources for 2021 and 2022 shall be made available from the addditional resources as set out in Article 92a. By way of derogation from the first subparagraph, and based on a reasoned request from a Member State, the additional resources may also be made available for budgetary commitment in 2023 and 2024. The additional resources set out in Article 92a shall also support administrative expenditure up to EUR 18 000 000 in current prices.
Amendment 156 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 4
Article 92 b – paragraph 4
4. The Commission shall adopt a decision, by means of implementing acts, setting out the breakdown of the additional resources as appropriations from the Structural Funds for 2020 and 2021 for each Member State in accordance with the criteria and methodology set out in Annex VIIa. That decision shall be revised in 2021 to set out the breakdown of the additional resources for 2022 based on data available by 19 October 2021. Where applicable, it shall also be revised in 2022 in relation to budgetary commitments in 2023 and 2024, based on the latest statistical data available. The revisions in 2021, and 2022 if applicable, shall ensure that operational programmes are not negatively impacted.
Amendment 178 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation No 1303/2013
Article 92 b – paragraph 8 – subparagraph 2
Article 92 b – paragraph 8 – subparagraph 2
Member States may allocate the additional resources either to one or more separate priority axes within an existing operational programme or programmes or to a new operational programme referred to in paragraph 11. By way of derogation from Article 26(1), the programme shall cover the period until 31 December 2022, or 31 December 2024 where the derogation referred to in paragraph 2 of this Article applies, subject to paragraph 4 abovof this Article.
Amendment 180 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 8 – subparagraph 2
Article 92 b – paragraph 8 – subparagraph 2
Amendment 183 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 8 – subparagraph 3
Article 92 b – paragraph 8 – subparagraph 3
For the ERDF, the additional resources shall primarily be used to support investments in products, staff and services for health services, including residential care homes for elderly people, and to provide support in the form of working capital or investment support to SMEs, investmentsupport to adapt to teleworking in operations contributing to the transition towards a digital and green economy, investments in infrastructure providing basic services to citizens, and including in the Outermost Regions, rural and depopulated areas and areas affected by industrial transition, or economic support measures infor those regions which are most dependent on sectors, such as tourism and culture, most affected by the crisis.
Amendment 211 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 9 – subparagraph 2
Article 92 b – paragraph 9 – subparagraph 2
The thematic objective referred to in the first subparagraph shall exclusively be available for the programming of the additional resources. By way of derogation from points (b), (c) and (d) of Article 96(1), it shall not be combined with other investment priorities.
Amendment 215 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 9 – subparagraph 5
Article 92 b – paragraph 9 – subparagraph 5
The revised financing plan set out in Article 96(2)(d) shall set out the allocation of the additional resources for the years 2020, 2021 and, where applicable, for 2022, 2023 and 2024, without identifying amounts for the performance reserve and with no breakdown per category of regions.
Amendment 239 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 12 – point d
Article 92 b – paragraph 12 – point d
Amendment 242 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92b – paragraph 12 – point e
Article 92b – paragraph 12 – point e
Amendment 244 #
2020/0101(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EU) No 1303/2013
Article 92 b – paragraph 12 a (new)
Article 92 b – paragraph 12 a (new)
12a. By way of derogation from Article 65(9), expenditure or operations supported under the thematic objective set out in paragraph 9 of this Article shall be eligible as of 1 February 2020.
Amendment 3 #
2020/0100(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Commission adopted a Communication on the European Green Deal on 11 December 20199 , drawing its roadmap towards a new growth policy for Europe and setting ambitious objectives to counter climate change and for environmental protection. In line with the objective to achieve the Union's 2030 climate and energy targets, and climate neutrality in the Union by 2050 in an effective and fair manner, the European Green Deal announced a Just Transition Mechanism to provide means for facing the climate challenge while leaving no one behind. The most vulnerable regions and people are the most exposed to the harmful effects of climate change and environmental degradation. At the same time, managing the transition requires significant structural changes. _________________ 9 COM(2019) 640 final.
Amendment 4 #
2020/0100(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The Commission adopted a Communication on the European Green Deal on 11 December 20199 , drawing its roadmap towards a new growth policy for Europe and setting ambitious objectives to counter climate change and for environmental protection. In line with the objective to achieve the Union's 2030 climate and energy targets, and climate neutrality in the Union by 2050 in an effective and fair manner, the European Green Deal announced a Just Transition Mechanism to provide means for facing the climate challenge while leaving no one behind. The most vulnerable regions and people are the most exposed to the harmful effects of climate change and environmental degradation. At the same time, managing the transition requires significant structural changes. _________________ 9 COM(2019) 640 final.
Amendment 10 #
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 by 2050 and with less capacity to deal with the transition challenges. _________________ 11 COM(2020) 22 final
Amendment 16 #
2020/0100(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to enhance the economic diversification of territoriesand modernisation of territories most negatively impacted by the climate transition, the Facility should cover a wide range of investments, on condition that they contribute to meet the development needs in the transition towards the Union’s 2030 climate and energy targets, and a climate neutral economy by 2050, as described in the territorial just transition plans. The investments supported may cover energy and transport infrastructure, district heating networks, green mobility, smart waste managementtechnology and infrastructures for clean, affordable and renewable energy and environmentally-friendly and decarbonised transport, district heating networks, green, smart and sustainable mobility, investments in research and innovation activities, including in universities and public research institutions, fostering the transfer of advanced and market-ready technologies, investments in digitalisation, digital innovation and digital connectivity, including digital and precision farming, smart waste management, greenhouse gas emission reduction, clean energy and energy efficiency measures including renovations and conversions of buildings, support to transition to a circular economy, land restoration and decontamination when the “polluters pays” principle cannot be applied, as well as up- and re-skilling, training and social infrastructure, including social housing. Infrastructure developments may also include solutions leading to their enhanced resilience to withstand disasters. Comprehensive investment approach should be favoured in particular for territories with important transition needs. Investments in other sectors could also be supported if they are consistent with the adopted territorial just transition plans. 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. Relevant local and regional authorities, economic and social partners and civil society of the territories concerned should be involved in the process of identification of the investments supported by the Facility in accordance with the partnership principle laid down in Article 6 of Regulation (EU) … /… [new CPR]. In order to help identify investments with a high positive environmental impact eligible under the Facility, the EU taxonomy on environmentally sustainable economic activities mayshould be used.
Amendment 23 #
2020/0100(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) In order to enhance the economic diversification of territories impacted by the transitionand modernisation of territories most negatively impacted by the transition to a climate-neutral economy, the Facility should cover a wide range of investments, on condition that they contribute to meet the development needs in the transition towards the Union’s 2030 climate and energy targets, and a climate neutral economy by 2050, as described in the territorial just transition plans. The investments supported may cover energy and transport infrastructure, district heating networks, green mobility, smart waste managementsustainable technology and infrastructures for clean, affordable and renewable energy and environmentally- friendly and decarbonised transport, district heating networks, green, smart and sustainable mobility, investments in research and innovation activities, including in universities and public research institutions, fostering the transfer of advanced and market-ready technologies, investments in digitalisation, smart waste management, greenhouse gas emission reduction, clean energy and energy efficiency measures including renovations and conversions of buildings, support to transition to a circular economy, land restoration and decontamination when the “polluters pays” principle cannot be applied, as well as up- and re-skilling, training and social infrastructure, including social housing. Infrastructure developments may also include solutions leading to their enhanced resilience to withstand disasters. Comprehensive investment approach should be favoured in particular for territories with important transition needs. Investments in other sectors could also be supported if they are consistent with the adopted territorial just transition plans. By supporting investments that do not generate sufficient revenues, the Facility aims at providing public sector entities with additional resources necessary to address the social, economic and environmental challenges resulting from the adjustment to climate transition. In order to help identify investments with a high positive environmental impact eligible under the Facility, the EU taxonomy on environmentally sustainable economic activities mayshall be used.
Amendment 36 #
2020/0100(COD)
(16) Since the grant component should reflect the divergent development needs of regions across Member States, such support should be modulated. Taking into account that public sector entities in less developed regions, as defined in Article 102(2) of Regulation [new CPR], in the outermost regions, as defined in Article 349 TFEU, and in rural, sparsely populated and depopulated areas generally experience lower public investment capacity, the grant rates applied to loans provided to such entities should be comparatively higher.
Amendment 48 #
2020/0100(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
The Facility shall provide support benefitting Union territories facing serious social, environmental and economic challenges deriving from the transition process towards the Union's 2030 climate and energy targets, and a climate-neutral economy of the Union by 2050.
Amendment 52 #
2020/0100(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
5. 'territorial just transition plan' means a plan established in accordance with Article 7 of Regulation [JTF Regulation], together with the relevant local and regional authorities of the territories concerned and in accordance with the partnership principle laid down in Article 6 of Regulation (EU) … /… [new CPR], and approved by the Commission;
Amendment 54 #
2020/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The general objective of the Facility is to address serious socio- economic challenges deriving from the transition process towards a climate-neutral economy for the benefit of the Union territories identified in the territorial just transition plans prepared by the Member States in accordance with Article 7 of Regulation [JTF Regulation] and to contribute to achieve the Union’s 2030 climate and energy targets, and climate neutrality by 2050, in line with Paris Agreement objectives.
Amendment 60 #
2020/0100(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The general objective of the Facility is to address serious socio- economic challenges deriving from the transition process towards a climate-neutral economy for the benefit of the Union territories identified in the territorial just transition plans prepared by the Member States in accordance with Article 7 of Regulation [JTF Regulation] and to contribute to the European Green Deals objectives, in particular the transition towards a climate-neutral economy by 2050.
Amendment 68 #
2020/0100(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. For grants awarded pursuant to calls for proposals launched no later than 31 December 20247, Union support awarded to eligible projects in a Member State shall not exceed the national shares set out in the decision to be adopted by the Commission pursuant to paragraph 4.
Amendment 69 #
2020/0100(COD)
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Access to resources Access to the Facility shall be conditional on the adoption of a national objective towards the achievement of climate neutrality by 2050 at the latest. For those Member States, which have not yet committed to a national target for climate neutrality, only 50% of their national allocation shall be released, while the remaining 50% shall be made available once they have adopted that target.
Amendment 71 #
2020/0100(COD)
2. For grants awarded pursuant to calls for proposals launched no later than 31 December 20247, Union support awarded to eligible projects in a Member State shall not exceed the national shares set out in the decision to be adopted by the Commission pursuant to paragraph 4.
Amendment 79 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point a
Article 8 – paragraph 1 – point a
(a) the projects achieve measurable impact in addressing serious social, economic or environmental challenges deriving from the transition process towards a climate-neutral economy, contribute to achieve the Union’s 2030 climate and energy targets, and climate neutrality by 2050, and benefit territories identified in a territorial just transition plan, even if they are not located in those territories;
Amendment 85 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
Amendment 86 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
Amendment 88 #
2020/0100(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b a (new)
Article 8 – paragraph 1 – point b a (new)
(b a) the projects aim at revitalization and resocialization of the territories associated with the return of people to the region;
Amendment 97 #
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 2 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 205% of the amount of the loan provided by the finance partner.
Amendment 103 #
2020/0100(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. The performance reporting system shall ensure that data regarding the indicators referred to in paragraph 1 are collected efficiently, effectively and in a timely fashion. Beneficiaries in cooperation with finance partners shall provide to the Commission the data regarding those indicators.
Amendment 28 #
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, lea and must use clear mechanisms at the Commission level in order to make sure that living no one is left behind. _________________ 19 Commission Communication - The European Green Deal, COM(2019) 640 final of 11 December 2019.
Amendment 51 #
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 mincrease resilience and reduce vulnerability of society toimise and decrees the velocity of the climate change.
Amendment 58 #
2020/0036(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Achieving climate neutrality should require a contribution from all economicthe public and private 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. In this context the regulatory framework of energy should be harmonised at the Union level and should incentivise the domestic and economic production and use of green energy. The digital transformation, technological innovation, and research and development are also important drivers for achieving the climate-neutrality objective.
Amendment 73 #
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, without jeopardizing the economic development of the European Union.
Amendment 82 #
2020/0036(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union should aim to achieve a balance between anthropogenic economy- wide emissions and removals, through natural and technological solutions, of greenhouse gases domestically within the Union by 2050. The Union-wide 2050 climate-neutrality objective should be pursued by all Member States collectively, and the Member States, t. The European Parliament, the Council and the Commission together with the Member States should take the necessary measures to enable its achievement. Measures at Union level will constitute an important part of the measures needed to achieve the objective taking into account the different starting position of each Member State in the energy transition as well as their capacity to finance the necessary investments required by the transition towards climate neutrality. Measures at Union level will constitute an important part of the measures needed to achieve the objective, but will be adapted to different areas according to the local and regional needs and local measurements of the green house gases emissions.
Amendment 101 #
2020/0036(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Adaptation is a key component of the long-term global response to climate change. Therefore, Member States and the Union should enhance their adaptive capacity, strengthen resilience and reduce vulnerability to climate change, as provided for in Article 7 of the Paris Agreement, as well as maximise the co- benefits with other environmental, development and cohesion policies and legislation. Member States should adopt comprehensive national adaptation strategies and plans.
Amendment 107 #
2020/0036(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In taking the relevant measures at Union and national level to achieve the climate-neutrality objective, Member States and the European Parliament, the Council and the Commission should take into account the contribution of the transition to climate neutrality to the well- being of citizens, the prosperity of society and the competitiveness of the economy; energy and food security and affordability; fairness and solidarity across and within Member States considering their economic capability and infrastructural development, national circumstances and the need for convergence over time; the need to make the transition just and socially fair; to leave no one behind; based on impact assessment and best available scientific evidence, in particular the findings reported by the IPCC; the need to integrate climate change related risks into investment and planning decisions; cost- effectiveness and technological neutrality in achieving greenhouse gas emissions reductions and removals and increasing resilience; progression over time in environmental integrity and level of ambition.
Amendment 125 #
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 measuring the impact for the EU as well as for each individual Member State 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. _________________ 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 130 #
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 considering the specificity of each area. 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 asses the need of technical support and know-how, cooperates with the Member State to establish the necessary measures and the time needed in order to close the gap between the expectations and actual reality. Should the Member State fail in achieving the goal the Commission could take the necessary measures in accordance with the Treaties. The Commission should also regularly assess relevant national measures, and issue recommendations and offer technical support where it finds that a Member State’s measures are inconsistent with the climate-neutrality objective or inadequate to enhance adaptive capacity, strengthen resilience and reduce vulnerability to climate change.
Amendment 140 #
2020/0036(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) As citizens and, communities and economic operators have a powerful role to play in driving the transformation towards climate neutrality forward, strong public and social engagement on climate action should be facilitated. The Commission should therefore engage with all parts of society to enable and empower them to take action towards a climate- neutral and climate- resilient society, including through launching a European Climate Pact. The European Union should empower the experts through European funding to find and implement innovative solutions in the economic and environmental challenges towards the climate neutrality.
Amendment 145 #
2020/0036(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) Innovative technical and natural solutions, like carbon capture and storage, reforestation and others, enhancing the removal of greenhouse gases, as the main way, to achieve the climate neutrality in a developed economy should be facilitated by the European Union through consistent and constant direct funding.
Amendment 151 #
2020/0036(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Union has been pursuing an ambitious policy on climate action and has put in place a regulatory framework to achieve its 2030 greenhouse gas emission reduction target based on the latest scientific understanding, technological openness and the transparency and efficiencies that markets provide. The legislation implementing this target consists, inter alia, of Directive 2003/87/EC of the European Parliament and of the Council26 , which establishes a system for greenhouse gas emission allowance trading within the Union, Regulation (EU) 2018/842 of the European Parliament and of the Council27 , which introduced national targets for reduction of greenhouse gas emissions by 2030, and Regulation (EU) 2018/841 of the European Parliament and of the Council28 , which requires Member States to balance greenhouse gas emissions and removals from land use, land use change and forestry. _________________ 26Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a system for greenhouse gas emission allowance trading within the Union and amending Council Directive 96/61/EC (OJ L 275 of 25 October 2003, p. 32). 27Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26). 28 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1).
Amendment 157 #
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 level is needed to effectively supplement and reinforce national and regional 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 170 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Union-wide emissions and removals of greenhouse gases regulated in Union law shall be balanced atin the latestEU as a whole by 2050, thus reducing emissions to net zero by that date.
Amendment 172 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. The relevant Union institutions and the Member States shall take the necessary measures at Union and national and regional level respectively, to enable the collective achievement of the climate- neutrality objective set out in paragraph 1, taking into account the importance of promoting fairness and solidarity among Member States, social and economic cohesion as well as the different starting position of each Member States in the transition towards climate neutrality. The offsetting instruments for Member States facing greater impact of the transition to a low carbon economy, such as the Modernisation Fund and Solidarity Provision in the EU ETS Directive (2008/87/EC), shall be significantly increased.
Amendment 190 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. By September 2020, the Commission shall review the Union’s 2030 target for climate referred to in Article 2(11) of Regulation (EU) 2018/1999 in light of the climate-neutrality objective set out in Article 2(1), and explore options for a new 2030 target of 50 to 55% emission reductions compared to 1990. Where the Commission considers that it is necessary to amend that target based on new solid scientific evidence, it shall make proposals to the European Parliament and to the Council as appropriate.
Amendment 191 #
2020/0036(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union should aim to achieve a balance between anthropogenic economy- wide emissions and removals, through natural and technological solutions, of greenhouse gases domestically within the Union by 2050. The Union-wide 2050 climate-neutrality objective should be pursued by all Member States collectively, and the Member States, t. The European Parliament, the Council and the Commission together with the Member States should take the necessary measures to enable its achievement taking into account the different starting position of each Member State in the energy transition as well as their capacity to finance the necessary investments required by the transition towards climate neutrality. Measures at Union level will constitute an important part of the measures needed to achieve the objective.
Amendment 197 #
2020/0036(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The Union should aim to achieve a balance between anthropogenic economy- wide emissions and removals, through a science-based and market-organised approach, based on knowledge and innovation, including openness towards natural and technological solutions, of greenhouse gases domestically within the Union by 2050. The Union-wide 2050 climate-neutrality objective should be pursued by all Member States collectively, and the Member States, the European Parliament, the Council and the Commission should take the necessary measures to enable its achievement. Measures at Union level will constitute an important part of the measures needed to achieve the objective.
Amendment 233 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point c
Article 3 – paragraph 3 – point c
(c) best available technology, while respecting the concept of technological neutrality and the need for research in or investments to mature new, promising technology in all sectors;
Amendment 246 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point e
Article 3 – paragraph 3 – point e
(e) fairness and solidarity social and economic cohesion between and within Member States ensuring the European instruments to support the cohesion policy;
Amendment 253 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point g
Article 3 – paragraph 3 – point g
(g) investment needs and opportunities including infrastructural development needs;
Amendment 254 #
2020/0036(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In taking the relevant measures at Union and national level to achieve the climate-neutrality objective, Member States and the European Parliament, the Council and the Commission should take into account the contribution of the transition to climate neutrality to the well- being of citizens, the prosperity of society and the competitiveness of the economy; energy and food security and affordability; fairness and solidarity across and within Member States considering their economic capability, national circumstances and the need for convergence over time; the need to make the transition just and socially fair; to leave no one behind; based on impact assessment and best available scientific evidence, in particular the findings reported by the IPCC; the need to integrate climate change related risks into investment and planning decisions; cost- effectiveness and technological neutrality in achieving greenhouse gas emissions reductions and removals and increasing resilience; progression over time in environmental integrity and level of ambition.
Amendment 267 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point j a (new)
Article 3 – paragraph 3 – point j a (new)
(ja) diverse starting positions of Member States and different impacts and costs that achieving climate neutrality objective will have on their economies and societies;
Amendment 270 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point j b (new)
Article 3 – paragraph 3 – point j b (new)
(jb) the right of each Member State to determine its own energy mix in accordance with article 194 paragraph 2 of TFEU.
Amendment 273 #
2020/0036(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The relevant Union institutions and the Member States shall ensure continuous progress in enhancing adaptive capacity, ensuring the transfer of knowhow when needed, strengthening resilience and reducing vulnerability to climate change in accordance with Article 7 of the Paris Agreement.
Amendment 276 #
2020/0036(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shall develop and implement adaptation realistic strategies and plans that include comprehensive risk management frameworks, based on the local and regional needs and real local measurements of the greenhouse gases emissions, robust climate and vulnerability baselines and progress assessments.
Amendment 287 #
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 measuring the impact for the EU as well as for each individual Member State, 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. _________________ 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 435 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. Union-wide emissions and removals of greenhouse gases regulated in Union law shall be balanced atin the latestEU as a whole by 2050, thus reducing emissions to net zero by that date.
Amendment 440 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 2
Article 2 – paragraph 2
2. The relevant Union institutions and the Member States shall take the necessary measures at Union and national level respectively, to enable the collective achievement of the climate-neutrality objective set out in paragraph 1, taking into account the importance of promoting fairness and solidarity among Member States. , social and economic cohesion as well as the different starting position of each Member States in the transition towards climate neutrality. The offsetting instruments for Member States facing greater impact of the transition to a low carbon economy, such as the Modernisation Fund and Solidarity Provision in the EU ETS Directive (2008/87/EC), shall be significantly increased.
Amendment 482 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. By September 2020, the Commission shall review the Union’s 2030 target for climate referred to in Article 2(11) of Regulation (EU) 2018/1999 in light of the climate-neutrality objective set out in Article 2(1), and explore options for a new 2030 target of 50 to 55% emission reductions compared to 1990. Where the Commission considers that it is necessary to amend that target, it shall make proposals to the European Parliament and to the Council as appropriate.
Amendment 504 #
2020/0036(COD)
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
4. By 30 June 2021, the Commission shall assess how the Union legislation implementing the Union’s 2030 target would need to be amended in order to enable the achievement of 50 to 55 % emission reductions compared to 1990 and to achieve the climate-neutrality-objective set out in Article 2(1), and consider taking the necessary measures, including the adoption of legislative proposals, in accordance with the Treaties.
Amendment 623 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point c
Article 3 – paragraph 3 – point c
(c) best available technology, while respecting the concept of technological neutrality and the need for research in or investments to mature new, promising technology in all sectors;
Amendment 659 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point e
Article 3 – paragraph 3 – point e
(e) fairness and, solidarity, social and economic cohesion between and within Member States;
Amendment 717 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point j a (new)
Article 3 – paragraph 3 – point j a (new)
(ja) diverse starting positions of Member States and different impacts and costs that achieving climate neutrality objective will have on their economies and societies;
Amendment 732 #
2020/0036(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point j b (new)
Article 3 – paragraph 3 – point j b (new)
(jb) the right of each Member State to determine its own energy mix in accordance with article 194 paragraph 2 of TFEU.
Amendment 158 #
2020/0006(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) This Regulation identifies types of investments for which expenditure may be supported by the JTF. All supported activities should be pursued in full respect of the climate and environmental priorities of the Union. The list of investments should include those that support local economies and are sustainable in the long- term, taking into account all the objectives of the Green Deal. The projects financed should contribute to a transition to a climate-neutral and circular economy. Investments in transitional energy sources such as natural gas shall be eligible for support if such investments lead to a substantial reduction of greenhouse gas emissions, and allow for the use of renewable gas as a sustainable alternative. For declining sectors, such as energy production based on coal, lignite, peat and oil shale or extraction activities for these solid fossil fuels, support should be linked to the phasing out of the activity and the corresponding reduction in the employment level. As regards transforming sectors with high greenhouse gas emission levels, support should promote new activities through the deployment of new technologies, new processes or products, leading to significant emission reduction, in line with the EU 2030 climate objectives and EU climate neutrality by 205013 while maintaining and enhancing employment and avoiding environmental degradation. Particular attention should also be given to activities enhancing innovation and research in advanced and sustainable technologies, as well as in the fields of digitalisation and connectivity, provided that such measures help mitigate the negative side effects of a transition towards, and contribute to, a climate- neutral and circular economy. _________________ 13 As set out in “A Clean Planet for all European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy”, Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee, the Committee of the Regions and the European Investment Bank - COM(2018) 773 final.
Amendment 361 #
2020/0006(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 – point d a (new)
Article 4 – paragraph 2 – subparagraph 1 – point d a (new)
(da) Investments related to production, processing and distribution of natural gas provided that it is used as a bridging technology replacing coal, lignite, peat or oil shale, and deliver significant reductions in green house gas emissions. These investments should allow for the use of renewable gas at a later stage.
Amendment 488 #
2020/0006(COD)
Proposal for a regulation
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) investment related to the production, processing, distribution, storage or combustion of solid fossil fuels;
Amendment 634 #
2020/0006(COD)
Proposal for a regulation
Annex I – paragraph 1 – point a – point i
Annex I – paragraph 1 – point a – point i
(i) greenhouse-gas emissions of industrial facilities in NUTS level 23 regions where the carbon intensity, as defined by the ratio of greenhouse gas emissions of industrial facilities as reported by Member States in accordance with Article 7 of Regulation (EC) No 166/2006 of the European Parliament and of the Council28 compared to the gross value added of the industry, exceeds by a factor of two the EU-27 average. Where that level is not exceeded in any NUTS level 23 regions in a given Member State, greenhouse-gas emissions of industrial facilities in the NUTS level 23 region with the highest carbon intensity is taken into account (weighting 49%), _________________ 28Regulation (EC) No 166/2006 of the European Parliament and of the Council of 18 January 2006 concerning the establishment of a European Pollutant Release and Transfer Register and amending Council Directives 91/689/EEC and 96/61/EC (OJ L 33, 4.2.2006, p. 1).
Amendment 648 #
2020/0006(COD)
Proposal for a regulation
Annex I – paragraph 1 – point a – point iii
Annex I – paragraph 1 – point a – point iii
(iii) employment in industry in the NUTS level 23 regions taken into account for the purposes of point (i) (weighting 25%),
Amendment 889 #
2020/0006(COD)
Amendment 893 #
2020/0006(COD)
Proposal for a regulation
Annex II – point 2 – point 2.3 – table
Annex II – point 2 – point 2.3 – table
Amendment 894 #
2020/0006(COD)
Proposal for a regulation
Annex II – point 2 – point 2.4 – table 2
Annex II – point 2 – point 2.4 – table 2
To fill in only if support is provided to productive investments other than SMEs: - an exhaustive list of such operations and enterprises and for each of thementerprises and a justification of the necessity of such support through a gap analysis demonstrating that the expected job losses would exceed the expected number of jobs created in the absence of this investment
Amendment 897 #
2020/0006(COD)
Proposal for a regulation
Annex II – point 2 – point 2.4 – table 3
Annex II – point 2 – point 2.4 – table 3
To fill in only if support is provided to investments to achieve the reduction of greenhouse gas emissions from activities listed in Annex I to Directive 2003/87/EC: - an exhaustive list of operations to be supported and a justification that they contribute to the transition to a climate- neutral economy and lead to substantial reductions in greenhouse gas emissions going below the relevant benchmarks used for free allocation under Directive 2003/87/EC and provided that they are necessary for the protection of a significant number of jobs
Amendment 46 #
2019/2712(RSP)
Paragraph 2 a (new)
2a. Recalls that the Paris Agreement acknowledges the « right to health » as a key human right in its preamble; underlines that Article 4.1 of the United Nations Framework Convention on Climate Change (UNFCCC) states that “all Member States should employ appropriate methods, for example impact assessments, formulated and determined nationally, with a view to minimising adverse effects on the economy, on public health and on the quality of environment, of projects or measures undertaken by them to mitigate or adapt to climate change”; considers that health should be included in national adaptation plans and national communications to the UNFCCC;
Amendment 379 #
2019/2156(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission to include bindensure implementation of existing targets for the protection and restoration of forest ecosystems, including native European forests, as part of the EU's future forest strategy;
Amendment 3 #
2019/2028(BUD)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Underlines that the outermost regions referred to in Article 349 of the TFEU benefit from specific measures, particularly in the context of the cohesion policy, with regard to the conditions for accessing much-needed and essential funds to promote sustainable development and therefore achieve the sustainable development goals (SDGs), in view of their economic and social situation, the high structural impact of their geographical remoteness and their specific exposure to the effects associated with climate change;
Amendment 27 #
2019/2028(BUD)
Draft opinion
Paragraph 8
Paragraph 8
8. Notes that the Structural Reform Support Programme funding will be financed using the Global Margin for Commitments; warns that increases should come at no expense to cohesion policy; recalls that new EU initiatives should be financed with new additional resources and not at the expense of long-standing EU policies;
Amendment 37 #
2019/2028(BUD)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Notes the proposal of the European Commission to dedicate 21% of the overall 2020 budget to tackle climate change and to ensure the decarbonisation of the European economy; underlines the need to ensure a just and fair transition to low-carbon economy by 2050;
Amendment 38 #
2019/2028(BUD)
Draft opinion
Paragraph 9 b (new)
Paragraph 9 b (new)
9 b. Points out that increased investments are needed in research and innovation to develop low-carbon technologies; calls on the Commission and the Council to allocate sufficient resources in the budget to implement the future Just Transition Fund to ensure the necessary support for coal and carbon intensive regions to facilitate a just and inclusive transition; recalls that the transition to low-carbon economy has led to the loss of 27.000 jobs between 2015 and 2020 in the coal industry and could reach 160.000 jobs by 2030;
Amendment 16 #
2019/0101(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Regulation (EU) 2016/64621 introduced the dates of application of the RDE test procedure, as well as the compliance criteria for RDE. The introduction of the dates of application for passenger vehicles and light-duty vehicles were chosen in a yearly sequence to guarantee timely planning of the manufacturer for each vehicle group. For that purpose, pollutant-specific conformity factors were used to take account of statistical and technical uncertainties of the measurements conducted by means of Portable Emission Measurement Systems (PEMS). A clear distinction should be made between the conformity factor (CF) and the error margin in order to reflect more accurately the separation of responsibilities between car manufacturers and the manufacturers of the PEMS. __________________ 21 Commission Regulation (EU) 2016/646 of 20 April 2016 amending Regulation (EC) No 692/2008 as regards emissions from light passenger and commercial vehicles (Euro 6) (OJ L 109, 26.04.2016, p.1).
Amendment 46 #
2019/0101(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) In order to assess more accurately the error margin, a standard procedure to assess RDE measurement uncertainty with regard to gaseous and particle emissions is necessary. It is essential therefore that the European Committee for Standardization (CEN) adopt as soon as possible standards for the PEMs devices. The Commission should duly take into account these standards.
Amendment 97 #
2019/0101(COD)
Proposal for a regulation
Annex – paragraph 1
Annex – paragraph 1
Regulation (EC) No 715/2007
Annex I – table 2a – row 2
Annex I – table 2a – row 2
CF 1,43 1 +error 1,5 - +error - - - pollutant- final (2) margin margin final (2) (margin (margin =[0,43]*) =[0,5]*) * To be revised downwards to the figure proposed in the JRC report as soon as this is published. (2) CF pollutant-final is the conformity factor used to determine compliance with the Euro 6 emission limits by taking into account the technical uncertainties linked with the use of the Portable Emission Measurement Systems (PEMS). It is expressed as 1 + error margin.