596 Amendments of Elisabetta DE BLASIS
Amendment 170 #
2023/2010(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Notes that the implementation process for almost all the SDGs is lagging and that two consecutive years of regression have been recorded for many indicators9 owing to the pandemic crisis and geopolitical crises; reaffirms the importance of each SDG and highlights the key challenges that persist for sustainable development, particularly in relation to poverty (SDG 1), hunger (SDG 2), health (SDG 3), education (SDG 4), clean and affordable energy (SDG 7), decent work and economic growth (SDG 8),climate change (SDG 13), oceans (SDG 14) and biodiversity (SDG 15); underlines the strategic role that SDG 10, on reducing inequality, and SDG 17, on partnerships for the goals, can play in the global implementation of the 2030 Agenda; _________________ 9 UN Sustainable Development Report 2022, ‘From Crisis to Sustainable Development: the SDGs as Roadmap to 2030 and Beyond’: SDGs as a roadmap to 2030 and beyond), https://resources.unsdsn.org/2022- sustainable-development-report.
Amendment 182 #
2023/2010(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Highlights the need to take into consideration all clean energy sources, including new-generation nuclear energy, with a view to achieving SDG 7 and energy sovereignty as soon as possible;
Amendment 184 #
2023/2010(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Calls for proper implementation of the SDGs not to undermine in any way the potential economic growth of the Member States or to promote a model of ‘sustainable degrowth’ to the detriment of people’s well-being;
Amendment 203 #
2023/2010(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Points out that joint action by the Member States of the European Union is essential for the implementation of the 2030 Agenda but is insufficient to meet the ambitious Sustainable Development Goals in their entirety; calls, therefore, for European diplomacy to promote the SDGs in 'less virtuous' countries that are still far from achieving the goals of the 2030 Agenda;
Amendment 285 #
2023/2010(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses, in this regard, that the EU and its Member States must avoid any potential negative spillover effects of their industrial policies at the expense of the Global South, which occur as a result of and must strive to ensure that all the otheir pamost economic and technological modelhighly industrialised countries outside the EU do likewise; advocates cooperation with global partners to turn any negative spillover effects into virtuous circles; calls for all major EU policies to be subject to a mandatory SDG check to provide more insight on and address any negative effects, and also to ensure that change in this area is measurable;
Amendment 291 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Points to the importance of universal international organisations in supporting a holistic approach to achieving the SDGs; calls on the EU Member States, in this regard, to work together to achieve an effective reform of international organisations, in particular the UN Security Council, so that they are more representative and in step with the times when it comes to responding effectively and immediately to international crises;
Amendment 345 #
2023/2010(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission to present the ‘beyond GDP’ dashboard without delay, as set out in the 8th environment action programme; points out that GDP is, in any event, currently the most reliable indicator of state welfare owing to its objective nature, and that it can therefore only be replaced by an equally reliable indicator;
Amendment 431 #
2023/2010(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Recognises the importance of domestic resources being mobilised in developing countries and draws attention to the fact that this is contingent on an enabling international environment; calls on the Commission and the Member States to take the initiative and push for the establishment of a UN intergovernmental commission for international cooperation on tax matters, in order to fight illicit financial outflows and close tax havens;
Amendment 465 #
2023/2010(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Reiterates that the SDGs are the only globally agreed and comprehensive set of goals on the great challenges ahead and the 2030 Agenda should therefore serve as a guiding light for navigating through the current uncertainties; highlights the opportunity that the SDGs provide to establish a true well-being economy centred on people, growth and the planet, and to work towards a sustainable world beyond 2030;
Amendment 281 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 2 – point c a (new)
Article 22 – paragraph 2 – point c a (new)
(c a) very persistent and very mobile (vPvM);
Amendment 283 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1
Article 22 – paragraph 2 – subparagraph 1
or d) are endocrine active agents.
Amendment 290 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. TWhen the ERA indicate a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 294 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The ERA for antimicrobialbiotics shall include an evaluation of the risk for antimicrobialbiotic resistance selection in the environment due to the entire manufacturing supply chain inside and outside theof the active substance or medicinal product within the European Union, use and disposal of the antimicrobial antibiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
Amendment 304 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.
Amendment 304 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.
Amendment 313 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified asto potentially harmfulcause a risk to the environment by risk-based prioritisation in accordance with paragraph 2. This programme shall be made publicly available by the Agency.
Amendment 313 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified asto potentially harmfulcause a risk to the environment by risk-based prioritisation in accordance with paragraph 2. This programme shall be made publicly available by the Agency.
Amendment 320 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products asthat potentially harmfulcause a risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.
Amendment 320 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products asthat potentially harmfulcause a risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.
Amendment 324 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The current marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.
Amendment 324 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The current marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.
Amendment 326 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.
Amendment 326 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.
Amendment 328 #
2023/0132(COD)
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.
Amendment 328 #
2023/0132(COD)
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.
Amendment 429 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be only made available electronically, it shall not preclude the marketing authorisation holder from providing the package leaflet in paper format in addition to the electronic format on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 429 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available in paper format or electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packaging of a medicinal product. If a Member State decides that the package leaflet shall be only made available electronically, it shall not preclude the marketing authorisation holder from providing the package leaflet in paper format in addition to the electronic format on a voluntary basis. If the package leaflet is only made available electronically, the patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patients.
Amendment 439 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.
Amendment 439 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. By derogation from paragraph 3, where the medicinal product is not intended to be delivered directly to the patient, the package leaflet may be made available electronically only.
Amendment 448 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 448 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the package leaflet and removing the obligation to include a package leaflet in paper format in the package. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = fivone years following 18 months after the date of entering into force of this Directive].
Amendment 457 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 457 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies at the latest by [1 year after publication of the text].
Amendment 460 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. After consultation with Member States and relevant stakeholders, the Agency shall implement a system providing public access to the electronic version of the package leaflet, the summary of product characteristics and the labelling on the database provided in Article 138 of [revised Regulation (EC) No 726/2004] The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].
Amendment 460 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 6 a (new)
Article 63 – paragraph 6 a (new)
6 a. After consultation with Member States and relevant stakeholders, the Agency shall implement a system providing public access to the electronic version of the package leaflet, the summary of product characteristics and the labelling on the database provided in Article 138 of [revised Regulation (EC) No 726/2004] The system shall be implemented by the Agency and used by all Member States at the latest by [30 months after publication].
Amendment 499 #
2023/0132(COD)
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, and during the duration period of the compulsory licencefor the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory license is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority on or before the date such suspension takes effect.
Amendment 499 #
2023/0132(COD)
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by the final decision of a relevant authority in the Union to a party to address a public health emergency, the data and market protection shall be suspended with regard to that party insofar as the compulsory licencse requires, and during the duration period of the compulsory licencefor the indication relevant to the public health emergency, only for the duration period of the compulsory licence and, where relevant, only in the Member State(s) where the compulsory license is granted. The marketing authorization holder of the medicinal product for which the data and market protection are suspended shall be notified by the relevant competent authority on or before the date such suspension takes effect.
Amendment 605 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 605 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A non-cumulative period of regulatory data protection period of four years shall be granted for a medicinal product with respect to a new therapeutic indicationoption, including a new indication, posology, pharmaceutical form, method or route of administration or any other way in which the medicinal product may be used, not previously authorised in the Union, provided that:
Amendment 611 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 611 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outevidence was provided in relation to the therapeutic indicaoption demonstrating that it is of significant clinical benefit, and
Amendment 616 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 616 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point b
Article 84 – paragraph 1 – point b
(b) the medicinal product is authorised in accordance with Articles 9 to 12 and has notdoes not fall in the same global marketing authorization as a medicinal product that has previously benefitted from data protection or market exclusivity, or 25 years have passed since the granting of the initial marketing authorisation of the medicinal product concerned.
Amendment 618 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be designated as a value added medicinal product.
Amendment 618 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 3
Article 84 – paragraph 3
3. During the data protection period referred to in paragraph 1, the marketing authorisation shall indicate that the medicinal product is an existing medicinal product authorised in the Union that has been authorised with an additional therapeutic indicationedicinal product shall be designated as a value added medicinal product.
Amendment 240 #
2023/0131(COD)
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for afor a marketing authorisation, made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency or alternatively incentives already introduced in other areas such as rare diseases.
Amendment 296 #
2023/0131(COD)
Proposal for a regulation
Article 63 – paragraph 2
Article 63 – paragraph 2
Amendment 299 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. The orphan medicineal product sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.
Amendment 301 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 2 – subparagraph 1 – introductory part
Article 64 – paragraph 2 – subparagraph 1 – introductory part
The application for the designation of the orphan medicine sponsoral product shall be accompanied by the following particulars and documentation:
Amendment 304 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The Agency shall verify the validity of the application and share its draft scientific conclusions with the applicant. The applicant shall be invited to provide their observations on the draft conclusions. The Agency shall, in consultation with the Member States, the Commission and interested parties, draw up detailed guidelines on the required procedure, format and content of applications for designation and for the transfer of the orphan designation pursuant to Article 65.
Amendment 305 #
2023/0131(COD)
Proposal for a regulation
Article 64 – paragraph 4 – subparagraph 1
Article 64 – paragraph 4 – subparagraph 1
The Agency shall adopt a decision granting or refusing the orphan designation based on the criteria referred to in Article 63(1) or in the relevant delegated acts adopted in accordance with Article 63(2) within 90 days of the receipt of a valid application. The application is considered valid if it includes all the particulars and documentation referred to in paragraph 2. Within the timelines for adoption of a decision foreseen in [subparagraph 1], the Agency shall transmit its scientific conclusions to the applicant. Within 30 days of receipt of the scientific conclusions, the sponsor may submit to the Agency a written request, citing detailed grounds, for a re-examination. Within 30 days following receipt of a request for re-examination, the Agency shall confirm or revise its previous scientific conclusions. Where the Agency considers it necessary, it may consult the Committee for Medicinal Products for Human Use or the appropriate working parties when re-examining the above mentioned scientific conclusions. If, within the 30-day period referred to in [6th subparagraph], the applicant does not request re-examination, the scientific conclusions shall become definitive. The Agency shall adopt a decision within a period not exceeding 10 days following the date on which the scientific conclusions have become definitive
Amendment 310 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
Amendment 313 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Amendment 317 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
Amendment 318 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 4
Article 66 – paragraph 4
4. An orphan designation ceases to be valid once an orphan medicine sponsor has obtained a marketing authorisation for the relevant medicinal product in accordance with Article 13(2). An orphan designation shall however remain valid in case the indication of the initial marketing authorisation addresses only a subset of the population affected by the designated orphan condition OR where the orphan medicinal product sponsor can provide evidence that studies supporting the use of the designated orphan medicinal product are planned or ongoing with respect to additional indications within the scope of the designated condition / orphan designation.
Amendment 344 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 356 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
(b) thirteen years for orphan medicinal products addressing a whigch unmet medicafulfil oneed as referred to in Article 70 of the following requirements ;
Amendment 360 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 479 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities and the Agency should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders in a centralised, digitalised and automated system. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority or the Agency. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entitiescreation of strategic reserves are taken. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 522 #
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 557 #
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 does not meet the demand for that medicinal product in that Member Statat a national level, regardless of the cause.
Amendment 568 #
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 1185 #
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;
Amendment 1466 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point a
Article 116 – paragraph 1 – point a
(a) its decision to permanently cease the marketing of a medicinal product in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1468 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point b
Article 116 – paragraph 1 – point b
(b) its request to permanently withdraw the marketing authorisation for that medicinal product authorised in that Member State no less than twelvesix months before the last supply of that medicinal product into the market of a given Member State by the marketing authorisation holder;
Amendment 1487 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 a (new)
Article 116 – paragraph 1 a (new)
1 a. The marketing authorisation holder of a medicinal product in possession of a centralised marketing or a national marketing authorisation shall notify the Agency of a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than three months before the start of such temporary disruption of supply or, if this is not possible, as soon as they become aware of such temporary disruption.The temporary disruption in supply of a medicinal product for which another pack size of that same product is available shall not need to be notified. The Agency shall make available the information to the concerned Member States to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1500 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for anycritical and strategic medicinal products placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1529 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency and to the competent authority in a Member State, to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.
Amendment 1656 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of the therapeutic indication and importance, the availability of appropriate alternatives, and vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 69 #
2023/0042(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The REPowerEU Communication13 outlined a plan to make the Union independent from Russian fossil fuels well before the end of this decade. The Communication highlights the importance, among others, of further increasing the efficiency and reducing fossil consumption in the transport sector, where electrification can be combined with the use of fossil-free renewable fuels, including hydrogen to replace fossil fuels. __________________ 13 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, REPowerEU Plan, COM(2022)230 final of 18.5.2022.
Amendment 74 #
2023/0042(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In order to contribute to the reduction in net greenhouse gas emissions of at least 55 % by 2030 compared to 1990 and in conformity with the energy efficiency first principle, it is necessary to strengthenassess the reduction requirements set out in Regulation (EU) 2019/1242 for heavy-duty vehicles, by an intensive use of carbon neutral fuels. A clear pathway also needs to be set for further reductions beyond 2030 to contribute to achieving the climate neutrality objective by 2050.
Amendment 77 #
2023/0042(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Strengthening CO2 emission reduction requirements for heavy-duty vehicles and rolling-out the necessary recharging and refuelling infrastructure will play a key role in reducing the emissions of the entire heavy-duty vehicles fleet to zero as soon as possible and by 2050 at the very latest, but it should also be complemented by other initiatives aiming at accelerating a modal shift from road to rail and increasing rail freight.
Amendment 82 #
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 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.
Amendment 84 #
2023/0042(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) Following consultation with stakeholders, at the latest one year after the entry into force of the regulation, the Commission should make a proposal for registering heavy-duty vehicles running exclusively on CO2 neutral fuels for compliance purposes in conformity with EU law and with the Union’s climate neutrality objective.
Amendment 92 #
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 consistent with the avy-duty vehicles for the period 2030 onwards. Those targets should be set at a level that will deliver a strong signal to accelerateailability of enabling conditions, namely sufficiently dense network of alternative fuels infrastructure, with the aim of promoting the uptake of zero-emission vehicles on the Union market and to stimulate innovation in zero-emission technologies in a cost- efficient way.
Amendment 109 #
2023/0042(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Due to the heterogeneous structure of the total truck fleet, it is not possible to fully predict whether for all niche uses, technological developments will be quick enough to ensure that zero-emission tailpipe technology isand that vehicles powered by carbon neutral fuels are a viable choice. This may include uses such as long-haul heavy- duty vehicles in specific territorial morphology and meteorological circumstances, coaches and lorries for critical security and safety applications that cannot be fulfilled by zero-emission tailpipe technologies. The vehicles in question should constitute a limin adequated share of the entire heavy-duty vehicle fleet, on the basis of typology of missions. In view of such considerations, some margin in the 204028 target should be left to accommodate developments in technology yet to occur. For this reason it is vital to consider the full life-cycle CO2 emissions from heavy-duty vehicles at Union level. Therefore, at the latest one year after the entry into force of the Regulation, the Commission should evaluate the possibility of developing a common Union methodology for the assessment and the consistent data reporting of the full life-cycle CO2 emissions of heavy-duty vehicles placed on the Union market. Where appropriate, the Commission should adopt follow-up measures, including legislative proposals.
Amendment 123 #
2023/0042(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) With the stricter Union fleet-wide targets from 2030 onwards, manufacturers will have to deploy significantly more zero-emission vehicles on the Union market. In that context, the incentive mechanism for zero- and low-emission vehicles (‘ZLEV’) would no longer serve its original purpose and would risk undermining the effectiveness of Regulation (EU) 2019/1242. The ZLEV incentive mechanism should therefore be removed as of 20340.
Amendment 139 #
2023/0042(COD)
Proposal for a regulation
Recital 21 – paragraph 5
Recital 21 – paragraph 5
Vocational vehicles, such as garbage trucks, tippers or concrete mixers, should continue to be exempted from the calculation of average specific CO2 emissions of manufacturers. On the other hand, zero-and-Low emission vocational vehicles could be used for the purpose of this Regulation and for the purpose of determining manufacturer's compliance with its specific CO2 emissions targets.
Amendment 143 #
2023/0042(COD)
Proposal for a regulation
Recital 23
Recital 23
Amendment 161 #
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 20239, because it is no longer considered necessary after that time as an incein order to contivnue to promote the market entrance of zero-emission vehicles in HDV sector.
Amendment 173 #
2023/0042(COD)
Proposal for a regulation
Recital 29
Recital 29
Amendment 175 #
2023/0042(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) Furthermore, in order to strengthen the development of new zero-emission technologies powered by carbon neutral fuels in specialized small- and medium- sized companies, it should also be possible to transfer zero-emission and vehicles powered by carbon neutral fuels between non-connected entities.
Amendment 188 #
2023/0042(COD)
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) This regulation aims to accelerate the transition towards carbon neutral mobility in a technologically neutral way. As a complement to the efforts towards an increasing availability of zero emission vehicles, a mechanism based on a carbon correction factor is introduced to duly account the contribution from the use of sustainable renewable transport fuels including biofuels, biomass fuels as well as RFNBOs when assessing the compliance with CO2 emissions reductions of newly registered heavy-duty vehicles.
Amendment 194 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EU) 2019/1242
Article 2 – paragraph 1 – subparagraph 1 – point b
Article 2 – paragraph 1 – subparagraph 1 – point b
(b) N1, which do not fall under Regulation (EU) 2019/631, N22 with a technically permissible maximum laden mass above 5 tons and N3;
Amendment 197 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EU) 2019/1242
Article 2 – paragraph 1 – subparagraph 1 – point c
Article 2 – paragraph 1 – subparagraph 1 – point c
(c) O3 and O4. It shall also apply, for the purposes of this Regulation, to zero-and-low emission vocational vehicles.
Amendment 209 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point g
Article 1 – paragraph 1 – point 3 – point g
Regulation (EU) 2019/1242
Article 3 – paragraph 3 – point g – point 11
Article 3 – paragraph 3 – point g – point 11
(a) a heavy-duty motor vehicle with not more than 51 g/(t∙km) or 51 g/(p∙km) of CO2 emissions as determined in accordance with Article 9 of Regulation (EU) 2017/2400 and vehicles powered by renewable fuels;
Amendment 229 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point i
Article 1 – paragraph 1 – point 3 – point i
Regulation (EU) 2019/1242
Article 3 – paragraph 1 – point 23 a (new)
Article 3 – paragraph 1 – point 23 a (new)
(23a) “CO2 Neutral Fuel” means a biofuel, biogas, biomass fuel, Renewable liquid and gaseous transport Fuel of Non Biological Origin (RFNBO) or a Recycled Carbon Fuel (RCF), as defined by Directive 2018/2001, where the emissions of the fuel in use e(u) can be taken to be net zero, meaning that the CO2 equivalent of the carbon incorporated in the chemical composition of the fuel in use e(u) is of biogenic origin, or has been avoided being emitted as CO2 into the atmosphere or has avoided its existing fate;
Amendment 235 #
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) ‘CO2 Neutral Fuel’ means a renewable and/or synthetic fuel as defined by Directive 2018/2001 including biofuel, biogas, biomass fuel, Renewable liquid and gaseous transport Fuel of Non Biological Origin – RFNBO or Recycled Carbon Fuel – RCF, where the emissions of the fuel in use (eu) can be taken to be net zero, meaning that the CO2 equivalent of the carbon incorporated in the chemical composition of the fuel in use eu is of biogenic origin and/or has been avoided being emitted as CO2 into the atmosphere or has been captured from ambient air or has avoided its existing fate. Other renewable and/or synthetic fuels not listed in Directive 2018/2001 can fulfil this definition provided that they meet the above criteria and the sustainability criteria of said Directive and associated delegated acts. A mixture of two or more CO2 Neutral Fuels is considered a CO2 Neutral Fuel;
Amendment 245 #
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 c (new)
Article 3 – paragraph 1 – point 23 c (new)
(23c) ‘Carbon Correction Factor (CCF)’ means a factor which applies a correction to the CO2 tailpipe emissions of vehicles for compliance assessment, to reflect the GHG emission intensity and the share of CO2 Neutral Fuels, as defined in paragraph 79 of this article;
Amendment 250 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point j
Article 1 – paragraph 1 – point 3 – point j
Regulation (EU) 2019/1242
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 258 #
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 4530 %, including vehicles 100% powered by carbon neutral fuels.
Amendment 273 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3a – paragraph 1 – point c
Article 3a – paragraph 1 – point c
(c) for all vehicle sub-groups for the reporting periods of the years 2035 to 2039 by 65 %,45%, including vehicles 100% powered by carbon neutral fuels.
Amendment 290 #
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 970%, including vehicles 100% powered by carbon neutral fuels.
Amendment 326 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EU) 2019/1242
Article 3b – paragraph 1
Article 3b – paragraph 1
1. For vehicles referred to in point 4.2 of Annex I, manufacturers shall comply with the minimum shares of zero-emission vehicles in their fleet of new heavy-duty vehicles as laid down in point 4.3 of Annex I. For new urban buses the share of zero- emissions vehicles shall be 80% as from the reporting period of the year 2030 and 100% as from the reporting period of the year 20305.;
Amendment 336 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
2. Member States may decide to exclude from the obligation under this Article a limited share of the urban buses registered in each reporting period, confirming that the purpose of the vehicle cannot be equally served by a zero-emission vehicle or vehicles powered by carbon neutral fuels and it is thus in the public interest to register a non- zero emission vehicle to fulfil that purpose, due to socio-economic cost-benefit in view of specific territorial morphology or meteorological circumstances.
Amendment 364 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EU) 2019/1242
Article 4 – paragraph 5 – point a
Article 4 – paragraph 5 – point a
(a) the data reported for the manufacturer’s new heavy-duty vehicles registered in the preceding reporting period including zero-and-low emission vocational vehicles; and;
Amendment 368 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EU) 2019/1242
Article 4 – paragraph 1 – point b a (new)
Article 4 – paragraph 1 – point b a (new)
(5a) Following consultation with stakeholders, at the latest one year after the entry into force of the regulation, the Commission shall make a proposal for registering heavy-duty vehicles running exclusively on CO2 neutral fuels for compliance purposes in conformity with EU law and with the Union’s climate neutrality objective;
Amendment 382 #
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 392 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 6 – point c
Article 1 – paragraph 1 – point 6 – point c
Regulation (EU) 2019/1242
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The zero-emission and low- emission factor shall reduce the average specific CO2 emissions of a manufacturer by a maximum of 3 10%. The contribution to that factor of the zero-emission vehicles of category N, other than those in vehicles sub-groups 4-UD, 4-RD, 4-LH, 5-RD, 5- LH, 9-RD, 9-LH, 10-RD, 10-LH, shall reduce the average specific CO2 emissions of a manufacturer by a maximum of 1,5 3%.;
Amendment 395 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2019/1242
Article 6a – paragraph 1 – point b
Article 6a – paragraph 1 – point b
Amendment 399 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2019/1242
Article 6a – paragraph 1 – subparagraph 1– point c
Article 6a – paragraph 1 – subparagraph 1– point c
(c) for transfers of zero-emission vehicles and vehicles powered by carbon neutral fuels between manufacturers not belonging to a group of connected manufacturers: the number of zero- emissions vehicles transferred to a manufacturer must not exceed 5 % of all its new heavy-duty vehicles registered in a given reporting period.
Amendment 412 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 9 – point d
Article 1 – paragraph 1 – point 9 – point d
Regulation (EU) 2019/1242
Article 7 – paragraph 1 – subparagraph 4
Article 7 – paragraph 1 – subparagraph 4
Emission credits and emission debts acquired in the reporting periods of the years 2025 to 2039 shall, where applicable, be carried over from one reporting period to the next reporting period. However, any remaining emission debts shall be cleared in the reporting periods of the year 2029, 2034 and 2039.;
Amendment 421 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point c
Article 1 – paragraph 1 – point 11 – point c
Regulation (EU) 2019/1242
Article 8 – paragraph 2 – point a
Article 8 – paragraph 2 – point a
(a) where, in any of the reporting periods of the years 2025 to 2028, 2030 to 2033, 2035 to 2038 the sum of the emission debts reduced by the sum of the emission credits exceeds the emission debt limit referred to in Article 7(1), third subparagraph;
Amendment 428 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point c
Article 1 – paragraph 1 – point 11 – point c
Regulation (EU) 2019/1242
Article 8 – paragraph 2 – point b
Article 8 – paragraph 2 – point b
Amendment 435 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 16
Article 1 – paragraph 1 – point 16
Regulation (EU) 2019/1242
Article 13 f – paragraph 4
Article 13 f – paragraph 4
4. The amounts of the administrative fines shall be considered as revenue for the general budget of the Union.’Social Climate Fund’s specific budgetary line for ‘support for goods and workers in the automotive sector’.
Amendment 450 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18
Article 1 – paragraph 1 – point 18
Regulation (EU) 2019/1242
Article 15
Article 15
The Commission shall, in 20287, 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. ’ In this report, the Commission shall assess in particular, but not limited to, the following elements: (a) registrations of zero-emission heavy- duty vehicles in Member States; (b) the deployment of charging and refuelling infrastructure suitable for heavy-duty vehicles in Member States along the entire European road and motorway network [REFERENCE TO XXX AFIR]; (c) the implementation of road user charges differentiated by CO2 emissions in Member States [REFERENCE TO XXX Eurovignette]; (d) the level of the average price of allowances under the new emissions trading system covering road transport [REFERENCE TO XXX ETS2]; (e) measures to support haulage companies in renewing their fleets of vehicles; (f) Based on the results of the above assessment and on the evidence of lack of any of the above conditions, the Commission should consider making a proposal to review the CO2 targets and waive the excess CO2 emissions premiums as set out in Article 8 of this Regulation.
Amendment 458 #
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, 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.
Amendment 463 #
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 2
Article 15 – paragraph 2
The report shall, where appropriate, be accompanied by a proposal for amending this Regulation. The Commission shall report to the European Parliament and to the Council on the state of the enabling conditions for the market adoption of zero-emission heavy-duty vehicles in the Union. In this report, the Commission shall assess in particular, but not limited to, the following elements: (a) registrations of zero-emission heavy- duty vehicles in Member States; (b) the deployment of charging and refuelling infrastructure suitable for heavy-duty vehicles in Member States [REFERENCE TO XXX AFIR]; (c) the implementation of road user charges differentiated by CO2 emissions in Member States [REFERENCE TO XXX Eurovignette]; (d) the level of the average price of allowances under the new the emissions trading system covering road transport [REFERENCE TO XXX ETS2]; (e) other measures that support the uptake of zero-emission heavy-duty vehicles. Based on the results of the above assessment and on the evidence of lack of any of the above of conditions, the CO2 targets should be reviewed and excess CO2 emissions premiums according to Art. 8 of this Regulation be waived.
Amendment 469 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 18 a (new)
Article 1 – paragraph 1 – point 18 a (new)
Regulation (EU) 2019/1242
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
(18a) At the latest one year after the entry into force of the regulation, the Commission shall evaluate the possibility of developing a common Union methodology for the assessment, and the consistent data reporting, of the full life- cycle CO2 emissions of new heavy-duty vehicles placed on the Union market. The Commission shall transmit that evaluation to the European Parliament and to the Council and complement it, where appropriate, by follow-up measures such as legislative proposals.
Amendment 471 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 19 – point a
Article 1 – paragraph 1 – point 19 – point a
Regulation (EU) 2019/1242
Article 17 – paragraph 2 – subparagraph 1
Article 17 – paragraph 2 – subparagraph 1
The power to adopt delegated acts referred to in Article 3b, Article 4 bis, Article 11(2), Article 13(4) second subparagraph, Article 13c(3), Article 13d(2), Article 13e(4), Article 13f(2) and Article 14(1) shall be conferred on the Commission for a period of five years from [OP, please insert the date of entry into force of this Regulation].;
Amendment 473 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 19 – point b
Article 1 – paragraph 1 – point 19 – point b
Regulation (EU) 2019/1242
Article 17 – paragraph 3 – subparagraph 1
Article 17 – paragraph 3 – subparagraph 1
The delegation of power referred to in Article 4bis, Article 11(2), Article 13(4) second subparagraph, Article 13c(3), Article 13d(2), Article 13e(4), Article 13f(2) and Article 14(1) may be revoked at any time by the European Parliament or by the Council.;
Amendment 475 #
2023/0042(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 19 – point c
Article 1 – paragraph 1 – point 19 – point c
Regulation (EU) 2019/1242
Article 17 – paragraph 6 – point c
Article 17 – paragraph 6 – point c
(c) in paragraph (6), “ Article 4 (bis), Article 11(2), the second subparagraph of Article 13(4) and Article 14(1)” is replaced by the following: “Article 11(2), Article 13(4) second subparagraph, Article 13c(3), Article 13d(2), Article 13f(2) and Article 14(1)”;
Amendment 484 #
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 – point 2.3
Annex I – point 2 – point 2.3
Reporting periods from 2025 to 2029onwards
Amendment 494 #
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
Annex I – point 2 – point 2.3
Amendment 498 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.4 – paragraph 5 – subparagraph 3
Annex I – point 2 – point 2.4 – paragraph 5 – subparagraph 3
Regulation (EU) 2019/1242
Annex I – point 2 – point 2.4
Annex I – point 2 – point 2.4
Vsg is the number of new heavy-duty vehicles of the manufacturer, including zero-and-low vocational vehicles in a subgroup sg;
Amendment 500 #
2023/0042(COD)
Proposal for a regulation
Annex I – point 2 – point 2.4 – paragraph 5 – subparagraph 4
Annex I – point 2 – point 2.4 – paragraph 5 – subparagraph 4
Regulation (EU) 2019/1242
Annex I – point 2 – point 2.4
Annex I – point 2 – point 2.4
V is the number of new heavy-duty vehicles of the manufacturer including zero-and-low vocational vehicles.
Amendment 526 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 2 – subparagraph 2.1
Annex I – paragraph 2 – subparagraph 2.1
2.1. Calculation of the specific CO2 emissions of a new heavy-duty vehicle The specific emissions in g/km of a new heavy-duty vehicle v attributed to a sub-group sg or of its primary vehicle shall be calculated in accordance with the following formula: 𝐶𝑂2𝑣 = ∑𝑊 𝑚𝑝 𝑚𝑝 𝑠𝑔,𝑚𝑝 × 𝐶𝑂2𝑣,𝑚𝑝 × (𝟏 ― 𝐂𝐂𝐅𝐢) 𝐶𝑂2p𝑣 = ∑𝑊 𝑚𝑝 𝑚𝑝 𝑠𝑔,𝑚𝑝 × 𝐶𝑂2p𝑣,𝑚𝑝 × (𝟏 ― 𝐂𝐂𝐅𝐢) Where, ∑𝑚𝑝 is the sum over all mission profiles mp listed in Table 2; sg is the sub-group to which the new heavy-duty vehicle v has been attributed according to Section 1 of this Annex; Wsg,mp, is the mission profile weight specified in points 2.1.1 to 2.1.3; CO2v,mp is the CO2 emissions in g/km of the new heavy-duty vehicle v determined for a mission profile mp, reported in accordance with Articles 13a and 13b and normalised pursuant to Annex III; CO2pv,mp is the CO2 emissions in g/km of the primary vehicle of the new heavy-duty vehicle v, determined for a mission profile mp, reported in accordance with Articles 13a and 13b; CCFi is the Carbon Correction Factor for the fuel or blend of fuels in use i, as defined in article 3 point (25) and calculated according to paragraph 7 of this Annex. For zero-emissions motor vehicles the values of CO2v,mp and CO2pv,mp shall be set to 0.
Amendment 532 #
2023/0042(COD)
Amendment 547 #
2023/0042(COD)
Proposal for a regulation
Paragraph 4 – subparagraph 4.1. – table 4.2.
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-C2, 32-C3, 31-LF, 31-L1, 31-L2, 31-DD, 33-LF, 33-L1, 4-LH, 5-RD, 5- groups referred 32-DD, 34-C2, 33-L1, 33-L2, 33-DD, 35-FE, 39-FE LH, 9-RD, 9- to in points 34-C3, 34-DD, LH, 10-RD, 10- 1.1.1 and 1.1.3. 31-L2, 33-L2 LH
Amendment 560 #
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 4315% 6450% 970% Heavy lorries > 7,4t 1s, 1, 2, 3 0 430% 6450% 970% Heavy lorries > 16 t 4-UD, 4-RD, 15% with 4x2 and 6x4 axle 4-LH, 5-RD, configurations 5-LH, 9-RD, 430% 6450% 970% 9-LH, 10-RD, 10-LH Heavy lorries > 16 t 11, 12, 16 0 with special axle 430% 6450% 970% configurations Coaches (rfsg) 32-C2, 32- 0 C3, 32-DD, 4315% 6450% 970% 34-C2, 34- C3, 34-DD Primary vehicles of 32-C2, 32- 0 coaches (rfpsg) C3, 32-DD, 43 15% 6450% 970% 34-C2, 34- C3, 34-DD Trailers 0 7,5% 7,5% 7,5% Semi-trailers 0 15% 15% 15%
Amendment 575 #
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 1080% 100% 100% buses DD, 33-LF, 33- L1, 33-DD, 35- FE, 39-FE, 31-L2, 33-L2
Amendment 585 #
2023/0042(COD)
Proposal for a regulation
Annex I – paragraph 6 a (new)
Annex I – paragraph 6 a (new)
Amendment 7 #
2022/2183(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas protection of biodiversity not only has natural value, but also represents the true added value of agricultural production in the European Union, and whereas investing in distinctiveness is a necessary condition for allowing agricultural undertakings to distinguish themselves in terms of the quality of their production and thus to face the globalised market by safeguarding, defending and creating local economic systems around food value;
Amendment 19 #
2022/2183(INI)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. whereas consumer demand is increasingly oriented towards food that can offer health guarantees, towards healthy and sustainable products and, in particular, towards products of clear origin that are obtained through traditional methods of agricultural production, and whereas the high quality, welfare, sustainability and environmental protection standards of European agricultural and agri-food production have been verified;
Amendment 58 #
2022/2183(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Supports the just transition to agro- ecologicalsustainable and organic farming; reiterates its support for the ambitions, targets andthat the goals of the farm to fork, biodiversity and zero-pollution strategies; welcomes their published and announced legislative proposals, including those must neither lead to a reduction or lowering of food safety, quality and supply standards in the EU nor have negative effects on farms; welcomes, where possible, their proposals related to the reduction in the use of pesticides and their associated risks and the setting of EU food waste reduction targets; stresses that these proposals must be supported by appropriate and comprehensive impact studies based on scientific evidence;
Amendment 70 #
2022/2183(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Reiterates the importance of supporting local production and the consumption of seasonal, local products from a short and verified supply chain that protects both small producers and, at the same time, consumers, reduces waste and losses, and is capable of providing healthy, certified, quality products with a reduced environmental footprint;
Amendment 101 #
2022/2183(INI)
Draft opinion
Paragraph 2
Paragraph 2
2. Calls for the strictreasonable application of the One Health principle in all policies that affect the availability and accessibility of food; stresses that food safety must never be jeopardised;
Amendment 115 #
2022/2183(INI)
Draft opinion
Paragraph 3
Paragraph 3
3. Highlights that the availability of plant proteins, if consumed directly, is more than sufficient to meet globala balanced diet, such as the Mediterranean diet, which involves consumption of quality food produced from sustainable agriculture and livestock farming, should be promotein needsd; acknowledges the positive impact that greater consumption of plant- based dietfoods haves on humans, animals, the planet and food security; stresses that reducing the number and density of farmed animalssustainable management of livestock farming can effectively combat the climate and biodiversity crises, decrease the risk of zoonotic diseases and contribute to food security in the short and long terms; deplores the placing on the market of ‘zero-’, ‘-free’, ‘enriched’ or ‘functional’ products, made by the multinational food companies using transformation processes involving assembly and handling activities that make these foods artificial products far removed from nature, with a greater environmental impact than traditional agricultural production methods;
Amendment 137 #
2022/2183(INI)
Draft opinion
Paragraph 4
Paragraph 4
Amendment 149 #
2022/2183(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Considers that it is necessary to raise the limits for the use of nitrogen fertilisers derived from animal manure, such as RENURE1 a, digestate and any other useful and verified alternatives, in line with the limits currently applicable to fertilisers; calls, further, on the Commission to consider a temporary exemption to bring down the cost of fertilisers and to review the Nitrates Directive and its limit of 170 kg/ha nitrogen per year; __________________ 1 a REcovered Nitrogen from manURE (RENURE).
Amendment 156 #
2022/2183(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Reiterates its position on new genomic breeding techniques1; regrets the biased naturepoints out that new genetic improvement targets can promote sustainability; calls, therefore, on the EU and the Member States to speed up research ofn the current impact assessment and callsuse of new cultivation techniques in order to increase yields and make crops more resilient to climate change and new pathogens, particularly in view onf the Commission to restart the process droughts and water shortages that are afflicting an inclusive mannerreasing number of EU Member States; __________________ 1 Resolution of 20 October 2021 on a farm to fork strategy for a fair, healthy and environmentally-friendly food system. OJ C 184, 5.5.2022, p. 2.
Amendment 160 #
2022/2183(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Underlines the importance of ensuring the security and diversity of seed and plant propagating material to provide stable yields and plant varieties adapted to the pressures of climate change, including traditional and locally-adapted varieties, and varieties suitable for organic production and low input farming systems, while ensuring transparency and freedom of choice for farmers and access to genetic resources and innovative plant breeding techniques in order to contribute to healthy seeds and protect plants against harmful pests and diseases and to help farmers tackle the growing risks caused by climate change, ensuring an incentive for open innovation through plant variation;
Amendment 166 #
2022/2183(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. Is concerned that the resumption of Ukrainian grain exports mainly benefits Western feed and livestock industries instead of alleviating pressures in the Global South2COVID-19 crisis and the current war in Ukraine have highlighted the risk to EU food security; reiterates the need to strengthen EU food security and sovereignty, to reduce dependence on third-country imports and to increase essential agricultural infrastructure, in particular transport and storage infrastructure to ensure the movement and supply of food and feed within the Union; stresses, further, the need to ensure that farmland is used primarily for the production of food and feed; __________________ 2 https://ruralsociologywageningen.nl/2022/ 11/11/crisis-and-capitalism-a-deep-dive- into-the-black-sea-grain-initiative-and- the-global-politics-of-food/
Amendment 173 #
2022/2183(INI)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Underlines that the food safety of imported products requires observance of conditions of reciprocity in trade agreements with third countries, and that the same safety guarantees should be demanded as for EU products;
Amendment 183 #
2022/2183(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Calls for a strategy to regionalise the supply chain of the most important commodities and to ensure the supply of local and sustainable animal and plant proteins;
Amendment 190 #
2022/2183(INI)
Draft opinion
Paragraph 8
Paragraph 8
8. Underscores the need for independent policymaking based on facts and values, and on the various impact studies conducted;
Amendment 199 #
2022/2183(INI)
Draft opinion
Paragraph 9
Paragraph 9
9. Considers it irresponsible that the EU continues to support environmentally harmful and cruel practices under the common agricultural policy and common fisheries policythat the EU should take the necessary measures to provide farmers and fishers with planning security, adequate financial resources and guarantees, also under the common agricultural policy and common fisheries policy, in order to maintain and, where necessary, increase food production in the EU.
Amendment 85 #
2022/2171(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Commission and the Member States to adopt measures to put an end to fast fashion; underlines the need to achieve a paradigm shift in the fashion industry to end overproduction and to make fast fashion go out of fashion, enhancing the strategic value of the supply chain, promoting as much as possible a sustainable production model opposed to the "fast-fashion" one, which combines creative capacity and production systems based on the quality of processes, materials and details;
Amendment 109 #
2022/2171(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses the need to introduce subsidises on taxation measures for products that meet ecological standards, thus enabling producers to sustain environmentally sustainable production processes while maintaining competitive price levels and supporting the value chain by promoting the reshoring of delocalised production in the EU.
Amendment 124 #
2022/2171(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls for a revision of criteria for awarding the Ecolabel to associate this label with products for which at least three economically significant processes have taken place in accordance with clear sustainability criteria defined at EU level.
Amendment 137 #
2022/2171(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Expresses concern that from a consumption point of view, over their life cycle, textiles have on average the fourth highest negative impact on the climate and the environment, after food, housing and mobility7 ; points out that in 2020, the textiles sector was responsible for the third highest impact on water and land use and the fifth highest impact on the use of raw materials and greenhouse gas emissions8 ;, encourages the use of recycled raw materials and supports the conversion of the disposal cost of textile waste into added value of the secondary raw material. __________________ 7 7 https://www.eea.europa.eu/publications/tex tiles-and-the-environment-the 8 https://www.eea.europa.eu/publications/tex tiles-and-the-environment-the
Amendment 142 #
2022/2171(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Stresses that textiles are the fourth biggest contributor to climate change from an EU consumption perspective, and that the industry’s emissions are only expected to increase9 ; calls for further legislation to fully decarbonise the industry, starting with more transparency on scope 3 emissions in textile supply chains; calls for ambitious science-based targets to be set by 2024 for the reduction of greenhouse gas emissions in the textiles sector, covering their entire lifecycle, in line with the Paris Agreement goal of keeping global warming to 1.5°C above pre-industrial temperatures; recalls that around 70 % of the emissions related to the Union’s textile consumption take place outside of the EU10 ; calls for more robust information and disclosure on the impacts on biodiversity;, calls for the development at European level of " Textile Hubs", i.e. innovative textile regeneration poles, made up of research centres and disposal plants, for the sorting and recovery of pre- and post- consumer waste, turning waste into value and creating new jobs in textile manufacturing districts. __________________ 9 https://ec.europa.eu/environment/circular- economy/pdf/new_circular_economy_actio n_plan.pdf 10 https://www.eea.europa.eu/publications/tex tiles-in-europes-circular-economy
Amendment 184 #
2022/2171(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the need to regulate all textile products under the Ecodesign Regulation, starting with garments and footwear as a priority;
Amendment 199 #
2022/2171(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls for the ecodesign requirements for textiles to set horizontal requirements swiftly, targeting a comprehensive group of products starting with garments and footwear, and later, when needed, to focus on differentiated requirements between different textile product groups;
Amendment 250 #
2022/2171(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Welcomes the intention of the Commission to set out harmonised EU rules on extended producer responsibility for textiles, with eco-modulation of fees as part of the revision of the Waste Framework Directive, and in particular that a significant proportion of the contributions made to extended producer responsibility schemes will be used for waste prevention and preparation for re-use measures; calls for adequately weight extended producer responsibility obligations to safeguard subcontractors and intermediate processors;
Amendment 305 #
2022/2171(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Highlights the potential of the digital product passport to support full value chain coverage as part of a coherent framework with corporate due diligence legislation on sustainability; provided that such an initiative does not lead to more bureaucracy for producers, enabling micro and SMEs to better communicate their sustainability, calls on the Commission to require companies to use the digital product passport to disclose and submit site information throughout their supply chains, as well as information on the use of materials and chemicals; calls for environmental information to be complemented by information on social aspects and labour and working conditions;
Amendment 327 #
2022/2171(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Highlights that negative environmental impacts and social impacts in supplier countries cannot be avoided through due diligence legislation alone; calls on the Commission to provide additional support for local actors in partner countries and to take additional legislative measures to address these impacts in countries outside the EU;, underlines the need of organising and implementing a better and harmonised surveillance of the internal market, with specific custom controls to prevent the import of counterfeit and/or unsafe textile products lacking the requirements expressly demanded to those who produce and operate within the EU, in order to safeguard the consumer and the environment.
Amendment 70 #
2022/0432(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. Iand in accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituentsubstances is to be generated under the same conditions as data on any other substance with more than one costituent, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individualthe substance with more than one constituents is not available, multi- constituent and where relevant data onindividual constituents is available, thesesubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituentsubstances. _________________ 39 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
Amendment 80 #
2022/0432(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) It is normally not possible to sufficiently assess theFor the assessment of endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi- constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi- constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those casboth whole substance data and data for the individual constituents of the substance with more than one constituent, impurity or additive should be used as the basis for hazard classification of those substances.
Amendment 94 #
2022/0432(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while readability of labels should be ensured by layadding down minimum font size and formatting requirementsmore examples of label in the Guidance on Labelling and Packaging.
Amendment 124 #
2022/0432(COD)
Proposal for a regulation
Recital 37
Recital 37
Amendment 134 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) 1272/2008
Article 2 – point 7a
Article 2 – point 7a
Amendment 151 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3
Article 5 – paragraph 3
A multi-constituent substance containing at least one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
Amendment 156 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
For the evaluation of multi-constituentthese substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classesand ‘hazardous to the aquatic environment’ referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3, and 4.1. and 4.2.3.1. of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance. , impurities and additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
Amendment 168 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 5
Article 5 – paragraph 3 – subparagraph 5
For the evaluation of multi-constituentthese substances pursuant to Chapter 2 in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I3 and 4.4 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance. , impurities or additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
Amendment 170 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 6
Article 5 – paragraph 3 – subparagraph 6
Amendment 176 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7
Article 5 – paragraph 3 – subparagraph 7
Amendment 216 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a
Article 1 – paragraph 1 – point 11 – point a
Regulation (EC) 1272/2008
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member States in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 29 paragraph 1)
Amendment 290 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Article 1 – paragraph 1 – point 30
Regulation (EC) 1272/2008
Article 61 – paragraph 7
Article 61 – paragraph 7
Substances and mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub- paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 1824 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation]. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 61 – paragraph 7))
Amendment 292 #
2022/0432(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Article 1 – paragraph 1 – point 30
Regulation (EC) 1272/2008
Article 61 – paragraph 7 a (new)
Article 61 – paragraph 7 a (new)
Amendment 300 #
2022/0432(COD)
Proposal for a regulation
Annex I – Paragraph 1 – point 2
Annex I – Paragraph 1 – point 2
Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3
Capacity of the Dimensions of the Dimensions of each Minimum font-size package label (in pictogram (in millimetres) for the millimetres) information required by Article 17 Not exceeding 3 If possible, at least Not smaller than 8pt litres: 52x74 10x10 If possible, at least 16x16 Greater than 3 At least 74x105 At least 23x23 12pt litres but not exceeding 50 litres: Greater than 50 At least 105x148 At least 32x32 16pt litres but not exceeding 500 litres: Greater than 500 At least 148x210 At least 46x46 20pt’; litres:
Amendment 301 #
2022/0432(COD)
Proposal for a regulation
Annex I – paragraph 1 – point 3
Annex I – paragraph 1 – point 3
Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5
Annex I – Part 1 – Section 1.2.1.5
Amendment 229 #
2022/0396(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Council underlined in its Conclusions of December 202038, that the revision of Directive 94/62/EC should update and establish more concrete, effective and easy to implement provisions to facilitate sustainable packaging in the internal market and minimise the complexity of packaging in order to foster economically feasible solutions, to improve the reusability and recyclability as well as minimise substances of concern in packaging materials, especially concerning food packaging materials, and to provide for labelling packaging in an easily understandable way to inform consumers about its recyclability and where its waste should be discarded to facilitate sorting and recycling. At the same time it noted that hygiene and food safety standards have to be respected. _________________ 38 https://data.consilium.europa.eu/doc/docu ment/ST-13852-2020-INIT/en/pdf
Amendment 232 #
2022/0396(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The European Parliament’s Resolution of 10 February 2021 on the New Circular Economy Action Plan39reiterated the objective of making all packaging reusable or recyclable in an economically viable way by 2030 and called on the Commission to present a legislative proposal including waste reduction measures and targets and ambitious essential requirements in the Packaging and Packaging Waste Directive to reduce excessive packaging, including in e-commerce, improve recyclability and minimise the complexity of packaging, increase recycled content, phase out hazardous and harmful substances, and promote re-use. In addition, it stressed that food safety or hygiene standards must not be compromised. _________________ 39 https://www.europarl.europa.eu/doceo/doc ument/TA-9-2021-0040_EN.html
Amendment 240 #
2022/0396(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) An item, which is an integral part of a product and is necessary to contain, support or preserve that product throughout its lifetime and where all elements are intended to be used, consumed or disposed of together, should not be considered as being packaging given that its functionality is intrinsically linked to it being part of the product. However, in light of the disposal behaviour of consumers regarding tea and coffee bags as well as coffee or tea system single-serve units, which in practice are disposed of together with the product residue leading to the contamination of compostable and recycling streams, those specific items should be treated as packaging. This is in line with the objective to increase the separate collection of bio-waste, as required by Article 22 of Directive 2008/98/EC of the European Parliament and of the Council41. Furthermore, to ensure coherence regarding end-of-life financial and operational obligations, also all coffee or tea system single-serve units necessary to contain coffee or tea should be treated as packaging. _________________ 41 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
Amendment 247 #
2022/0396(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In line with the waste hierarchy set out in Article 4(21) of Directive 2008/98/EC, and with the requirement set in paragraph 2 of Article 4 of the same Directive, which foresees that specific waste streams may depart from the hierarchy where this is in line with life- cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packagingand recycling of packaging while delivering the best environmental outcome. In addition, the measures aim at increasing the use of recycled content in packaging, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.
Amendment 290 #
2022/0396(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Designing packaging with the objective of its recycling, once it becomes packaging waste, is one the most efficient measures to improve the packaging circularity and raise packaging recycling rates and the use of recycled content in packaging, while ensuring marketing and consumer acceptance. Packaging design for recycling criteria have been established for a number of packaging formats under voluntary industry schemes or by some Member States for the purpose of the modulation of extended producer responsibility fees. In order to prevent barriers to the internal market and provide industry with a level playing field, and with the objective to promote the sustainability of packaging ensuring marketing and consumer acceptance, it is important to set mandatory requirements regarding the recyclability of packaging, by harmonising the criteria and the methodology for assessing packaging recyclability based on a design for recycling methodology at the Union level. In order to meet the objective set out in the CEAP that, by 2030, all packaging should be recyclable or reusable, in an economically viable manner, packaging recyclability performance grades should be established based on design for recycling criteria for packaging categories as listed in Annex II. However, packaging should comply with them only as of 1 January 2030 in order to give sufficient time to the economic operators to adapt.
Amendment 299 #
2022/0396(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) As design for recycling assessment in itself does not ensure that packaging is recycled in practice, it is necessary to establish a uniform methodology and criteria for assessing the recyclability of packaging in practice based on the state-of- the-art separate collection, sorting and recycling processes and infrastructure actually available in the Union. Related reporting from Member States and, where relevant, economic operators should support establishing the recyclability “at scale” thresholds and update, on this basis, the recyclability performance grades with respect to the specific packaging materials and categories. , preserving the added value conveyed to the final consumer with the packaging.
Amendment 306 #
2022/0396(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to establish harmonised rules on packaging design to ensure its recyclability while ensuring packaging performs all its functions and ensuring marketing and consumer acceptance, the power to adopt delegated acts should be delegated to the Commission to set out detailed criteria for packaging design for recycling per packaging materials and categories, as well as for the assessment of the packaging recyclability at scale including for categories of packaging not listed in this Regulation. In order to give economic operators and Member States sufficient time to collect and report the necessary data to establish the “at scale” recycling methodology, the manufacturers should ensure that packaging is recycled at scale as of 2035. That should ensure that packaging complies with the design for recycling criteria, and is also recycled in practice on the basis of the state of the art processes for separate collection, sorting and recycling.
Amendment 313 #
2022/0396(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to stimulate innovation in packaging, it is appropriate to allow that packaging, which presents innovative features resulting in significant improvement in the core function of packaging and has demonstrable environmental benefits, is given limited additional time of five years to comply withexempt from the recyclability requirements. The innovative features should be explained in the technical documentation accompanying the packaging.
Amendment 316 #
2022/0396(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) In order to protect human and animal health and safety, due to the nature of the packaged products and the related requirements, it is appropriate that the recyclability requirements should not apply to immediate packaging as defined in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council50and in Article 4(25) of Regulation (EU) 2019/6 of the European Parliament and of the Council51, which are in direct contact with the medicinal product, as well as contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council52andof in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council53.These exemptions should apply until 1 January 2035and contact sensitive packaging for foods covered by Regulation (EC) No 1935/2004 and Regulation (EU) No 609/2013. _________________ 50 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). 51 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). 52 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). 53 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
Amendment 332 #
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 and of contact sensitive packaging for foods covered by Regulation (EC) No 1935/2004 and Regulation (EU) No 609/2013. 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.
Amendment 336 #
2022/0396(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unit of packaging contains a certain minimum percentage of recycled content recovered from post- consumer plastic waste calculated as an average of the plastic packaging placed by a producer on the Union market. This provision should not apply to food or feed contact plastic packaging in those cases when the recycled content risks affecting human and animal health and/or compromising the organoleptic characteristics of products.
Amendment 368 #
2022/0396(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The bio-waste waste stream is oftencould be contaminated with conventional plastics and the material recycling streams are oftencould be contaminated with compostable plastics. This cross-contamination could leads to waste of traditional and compostable resources, lower quality secondary raw materials and should be prevented at source. As the proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, it is justified andTherefore, it is necessary to lay down clear and common rules on the use of compostableand disposal of plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human health. This is particularly the case when the use of compostable packaging helps collect or dispose of bio-wastelabeled as compostable, including the possibility to mandating applications. This is particularly the case when the use of compostable packaging helps collect or recycle of bio-waste. All plastic packaging labeled as compostable shouldn’t go into material recycling.
Amendment 373 #
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 packagingThere is a demonstrable environmental benefit of using compostable packaging for specific packaging applications (e.g., those strictly linked to food and food waste), 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 as required by Article 22 of Directive 2008/98, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging not labeled as compostable should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams.
Amendment 377 #
2022/0396(COD)
Proposal for a regulation
Recital 37
Recital 37
Amendment 381 #
2022/0396(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to facilitate conformity assessment with requirements on compostable packaging, it is necessary to provide for presumption of conformity for compostable packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council56for the purpose of expressing detailed technical specifications of those requirements and take into account, in line with the latest scientific and technological developments, the parameters, including compostquality of the output, proper processingtimes and admissible levels of contamination, which reflect the actual conditions in bio- waste treatment facilities, including anaerobic digestion processes. _________________ 56 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance (OJ L 316, 14.11.2012, p. 12).
Amendment 385 #
2022/0396(COD)
Proposal for a regulation
Recital 39
Recital 39
Amendment 388 #
2022/0396(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Packaging should be designed, where relevant for a given shape, so as to minimise its volume and weight while maintaining its ability to perform the packaging functions, including those referred to in Article 3 (1). The manufacturer of packaging should assess the packaging against the performance criteria, as listed in Annex IV of this Regulation. In view of the objective of this Regulation to reduce packaging and packaging waste generation and to improve circularity of packaging across the internal market, it is appropriate to further specify the existing criteria and to make them more stringent. The list of the packaging performance criteria, as listed in the existing harmonised standard EN 13428:200057, should therefore be modified. While marketing and consumer acceptance remain relevant for packaging designpresentation,design and differentiation functionality, they should not be part ofthe mainperformance criteria justifying on their own additional packaging weight and volume. However, this should not compromise product or packagingspecifications for craft and industrial products and food , beveragesand agricultural products that are registered aundprotected under theEU geographical indication protection schemeer or otherwiseprotected by Union intellectual property law orEU geographical indication protection schemes, including third country geographical indication/products that have been given distinctive recognition by the Union, as part of the Union’s objective to protect intellectual property,cultural heritage and traditional know- how.Traditional packaging associated with products that have been given distinctive recognition or are subject to geographical indications of origin protection shall nevertheless look to reduce packaging weight to the lowest weight possible whilst protecting the shape of the packaging in line with the overall ambitions of this proposal. On the other hand, recyclability, the use of recycled content, and re-use may justify additional packaging weight or volume, and should be added to the performance criteria. Packaging with double walls, false bottoms and other characteristics only aimed to increase the perceived product volume should not be placed on the market, as it does not meet the requirement for packaging minimisation. The same rule should apply to superfluous packaging not necessary for ensuring packaging functionality. _________________ 57 Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction.
Amendment 409 #
2022/0396(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) It is necessary to inform consumers and to enable them to appropriately dispose of packaging waste, including compostable lightweight and very lightweight plastic carrier bags. The most appropriate manner to do this is to establish a harmonised labelling system based on the material composition of packaging for sorting of waste, and to pair it with corresponding labels on waste receptacles. To this end, the Commission and the Member States should provide incentives, including economic ones, especially to micro- enterprises and SMEs.
Amendment 416 #
2022/0396(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) In order to inform end-users about reusability, availability of systems for re- use and location of collection points as regards reusable packaging, such packaging should bear a QR code or other data carrier that provides such information. The QR code should also facilitate tracking and the calculation of trips and rotations. In addition, reusable sales packaging should be clearly identified at the point of sale. To this end, the Commission and the Member States should provide incentives, including economic ones, especially to micro-enterprises and SMEs.
Amendment 436 #
2022/0396(COD)
Proposal for a regulation
Recital 61
Recital 61
Amendment 460 #
2022/0396(COD)
Proposal for a regulation
Recital 67
Recital 67
(67) In order to reduce the increasing proportion of packaging that is single use and the growing amounts of packaging waste generated, it is necessary to establish quantitative re-use and refill targets on packaging in sectors, which have been assessed as having the greatest potential for packaging waste reduction, namely food and beverages for take-away, large- white goods and some transport packaging. This was appraised based on factors such as existing systems for re-use, necessity of using packaging and the possibility of fulfilling the functional requirements in terms of containment, tidiness, health, hygiene and safety. Differences of the products and their production and distribution systems, were also taken into account. The setting of the targets is expected to support the innovation and increase the proportion of re-use and refill solutions. The use ofIn accordance with Article 4(2) of Directive 2008/98/EC, restriction shall not apply for single -use packaging for food and beverages filled and consumed within the premises in the HORECA sector should not be alloweddelivering a better overall environmental outcome justified by life cycle thinking, as well as a better overall economic and health impact.
Amendment 465 #
2022/0396(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) To increase their effectiveness and ensure the equal treatment of economic operators, the re-use and refill targets should be placed on the economic operators. In cases of targets for beverages, they should be additionally placed also on the manufacturers, as these actors are able to control the packaging formats used for the products they offer and decide based on thorough consideration of logistics, environmental, technical, industrial and consumer criteria. The targets should be calculated as a percentage of sales in reusable packaging within a system for re- use or through refill or, in case of transport packaging, as a percentage of uses. The targets should be material neutral. A detailed assessment should be carried out to ensure that reuse targets can be implemented in a safe, economically viable and environmentally sustainable way that would bring tangible benefits compared to recyclable alternatives. In order to ensure uniform conditions for the implementation of targets for re-use and refill, the power to adopt an implementing act in accordance with Article 291 of the Treaty on the methodology for their calculation, should be delegated to the Commission.
Amendment 484 #
2022/0396(COD)
Proposal for a regulation
Recital 78
Recital 78
(78) In order to ensure uniform conditions for the implementation of the recourse to common technical specifications, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to lay down, amend or repeal common technical specifications for the requirements on sustainability, labelling and systems for re- use, and to adopt test, measurement or calculation methods. That should be limited to those cases where technical standardization is unable to provide a concrete response to the purposes of this Regulation.
Amendment 495 #
2022/0396(COD)
Proposal for a regulation
Recital 91
Recital 91
(91) To achieve an ambitious and sustained reduction in the overall packaging waste generation, targets should be laid down for the reduction of packaging waste per capita to be achieved by 2030. Meeting a target of 5 % reduction in 2030 compared to 2018 should entail an overall absolute reduction of approximately 19 % on average acmaterial (plastics, wood, ferrosus the Union in 2030 compared to the 2030 baseline. Member States should reduce packaging waste generation by 10 %, compared to 2018, by 2035; this is estimated to reduce packaging waste by 29 % compared to the 2030 baseline. In order to ensure that the reduction efforts continue beyond 2030, a reduction target of 10 % from 2018, which would mean a reduction of 29 % compared to baseline, should be set for 2035 and, for 2040, a reduction target of 15 % from 2018, which means a reduction of 37 % compared to baseline should be establishedmetals, aluminium, glass and paper and cardboard) per capita to be achieved by 2040.
Amendment 503 #
2022/0396(COD)
Proposal for a regulation
Recital 91 a (new)
Recital 91 a (new)
(91a) Waste prevention through reduction at source by material should be a key guiding principle, as per the existing harmonised standard EN 13428:200030, whereby the substitution of one packaging material by another is not a basis for source reduction.
Amendment 516 #
2022/0396(COD)
Proposal for a regulation
Recital 98
Recital 98
(98) Regulation (EU) 2022/2065 of the European Parliament and of the Council66lays down rules on the traceability of traders, which more specifically contain obligations for providers of online platforms allowing consumers to conclude distance contracts with producers offering packaging to consumers located in the Union. In order to prevent free-riding from the extended producer responsibility obligations, it should be specified how such providers of online platforms should fulfil those obligations with regard to the registers of packaging producers established pursuant to this Regulation. In that context, providers of online platforms, falling within the scope of Section 4 of Chapter 3 of Regulation (EU) 2022/2065, allowing consumers to conclude distance contracts with producers should obtain from those producers information about their compliance with the extended producer responsibility rules set out in this Regulation. The rules on traceability of traders selling packaging online are subject to the enforcement rules set out in Regulation (EU) 2022/2065. As it can be difficult to supervise the concrete application of the obligations of the Regulation in the case of distance selling, particular attention should be paid to tools and control methods that ensure the proper implementation of the provisions. _________________ 66 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).
Amendment 529 #
2022/0396(COD)
Proposal for a regulation
Recital 103
Recital 103
(103) Deposit and return systems should be obligatory for single use plastic beverage bottles and metal beverage containers. Member States might also decide to include other packaging in these systems, in particular single use glass bottles, and should ensure that deposit and return systems for single-use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging, where technically and economically feasible. They should consider establishing deposit and return systems also for reusable packaging. In such situations, a Member State should be allowed, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Regulation.
Amendment 570 #
2022/0396(COD)
Proposal for a regulation
Recital 141 a (new)
Recital 141 a (new)
(141a) For the sake of clarity for food business operators, the nomenclature codes referred to food categories mentioned in Article 26 and Article 44 are taken from the Combined Nomenclature as defined in Article 1(2) of Council Regulation (EEC) No 2658/871 and as set out in Annex I thereto, which are valid at the time of publication of this Regulation and mutatis mutandis as amended by subsequent legislation.
Amendment 583 #
2022/0396(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation applies to all packaging, with the exception of packaging approved for the transport of dangerous goods regardless of the material used, and to all packaging waste, whether such waste is used in or originates from industry, other manufacturing, retail or distribution, offices, services or households.
Amendment 588 #
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 provided for in paragraph 2 of Article 4 of Directive 2008/98/EC.
Amendment 604 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point f
Article 3 – paragraph 1 – point 1 – point f
(f) permeable tea or coffee bagsingle- serve units necessary to contain a tea or coffee product and intended to be used and disposed of together with the product;
Amendment 616 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point g
Article 3 – paragraph 1 – point 1 – point g
(g) coffee or tea systemprotective beverage single-serve unit necessary to contain a coffee or tea product and intended to be used and disposed of together with the product;
Amendment 620 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1 a (new)
Article 3 – paragraph 1 – point 1 a (new)
(1a) 'recyclability' means the compatibility of packaging with the management and processing of waste, based on separate collection, sorting in separate streams, recycling at scale, and use of recycled materials to replace primary raw materials;
Amendment 634 #
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 packaging consisting of plastics as the predominant material.
Amendment 642 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 19
Article 3 – paragraph 1 – point 19
(19) ‘composite packaging’ means a unit of packaging made of two or more different materials, excluding materials used for labels, closures and sealing, which cannot be separated manually and therefore form a single integraloatings, linings, paints, inks, adhesives, closures and sealing which are considered as part of the weight of the main packaging material, which cannot be separated manually and therefore form a single integral unit, unless a given material constitutes an insignificant part of the packaging unit and in no case more than 15% of the total mass of the packaging unit;
Amendment 695 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32
Article 3 – paragraph 1 – point 32
(32) ‘recycled at scale’ means collected, sorted and recycled through installed state-of-the-art infrastructure and processes, covering at least 75 % of the Union populationthe existence of a clear pathway, including the development of sufficient capacity for the collected packaging waste to be directed towards defined and recognised waste streams through established industrial processes for reprocessing, including packaging waste exported from the Union that meets the requirements of Article 47(5);
Amendment 702 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32 a (new)
Article 3 – paragraph 1 – point 32 a (new)
(32a) 'high quality recycling’ means any recovery operation, as defined in Article 3, point (17), of Directive 2008/98/EC, that ensures that the distinct quality of the collected and sorted waste is preserved or recovered during that recovery operation, so that the resulting recycled materials are of sufficient quality to substitute primary raw materials with minimal loss of quantity, quality or function;
Amendment 716 #
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 route;is recommended to be disposed together with the main body of the packaging.
Amendment 723 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 35
Article 3 – paragraph 1 – point 35
(35) ‘separate component’ means a packaging component that is distinct from the main body of the packaging unit, which may be of a different material, that needs to becan be manually disassembled completely and permanently from the main packaging unit in order to access the product, and that is typically discarded prior to 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 733 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 38
Article 3 – paragraph 1 – point 38
Amendment 741 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 39 a (new)
Article 3 – paragraph 1 – point 39 a (new)
(39a) “recycled content in plastic packaging” is the amount of material contained in the packaging obtained from any recycling process of pre-consumer and post-consumer waste, whether to be recycled mechanically, physically or chemically.
Amendment 746 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 39 b (new)
Article 3 – paragraph 1 – point 39 b (new)
(39b) 'pre-consumer plastic waste' means plastic waste that is generated from production and converting of plastic material.
Amendment 783 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
The definitions of ‘substance of concern’ and ‘data carrier’ laid down in Article [2 points (28) and (30)] of Regulation [Ecodesign for sustainable products] shall apply;
Amendment 799 #
2022/0396(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
Amendment 812 #
2022/0396(COD)
Proposal for a regulation
Article 4 – paragraph 6 a (new)
Article 4 – paragraph 6 a (new)
6a. Any additional Member State information and labelling requirements that go beyond the requirements of this Regulation shall not be considered as mandatory but used on a voluntary basis.
Amendment 816 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Packaging shall be so manufactured that the presence and concentration of substances of concernthat meet the criteria in Article 57 and identified in accordance with Article 59(1) in a concentration above 0,1 % weight by weight (w/w) as laid down the Regulation (EC) No 1907/2006, as constituents of the packaging material or of any of the packaging components is minimised, including with regard to their presence in emissions and any outcomes of waste management, such as secondary raw materials, ashes or other material for final disposal.
Amendment 821 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Without prejudice toOther than the substances criteria laid down in Article 5(1), shall be applied the restrictions on chemicals set out in Annex XVII of Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food contact packaging in Regulation (EC) No 1935/2004, the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.
Amendment 843 #
2022/0396(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Recyclability requirements established in delegated acts adopted pursuant to Article 6(5)by CEN - European Committee for Standardization shall not restrict the presence of substances in packaging or packaging components for reasons relating primarily to chemical safety. They shall address, as appropriate, substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present, and shall, as appropriate, identify the specific substances concerned and their associated criteria and limitations.
Amendment 867 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. All packaging shall be recyclable from 1 January 2030.
Amendment 875 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) it is designed for recycling or, for compostable packaging, is compliant with point a), b) and c) of Annex III;
Amendment 894 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point d
Article 6 – paragraph 2 – subparagraph 1 – point d
(d) except for compostable plastics, it can be recycled so that the resulting secondary raw materials are of sufficient quality to substitute the primarya raw materials;
Amendment 910 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
Points (a) to (d) shall apply from 1 January 2030 and point (e) shall apply from 1 January 2035.
Amendment 934 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Recyclable packaging shall, from 1 January 2030, comply with the design for recycling criteria as laid down in the delegated actsCEN standards, where applicable, adopted pursuant to paragraph 4 and, from 1 January 2035, also with the recyclability at scale requirements laid down in the delegated actCEN standards adopted pursuant to paragraph 6. Where such packaging complies with those delegated actstandards, it shall be considered to comply with paragraph 2, points (a) and (e).
Amendment 953 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1
Article 6 – paragraph 4 – subparagraph 1
Amendment 974 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 2
Article 6 – paragraph 4 – subparagraph 2
The Commission is empowered to adopt delegated acts, in close cooperation with stakeholders, in accordance with Article 58 to amend Table 1 of Annex in order to adapt it to scientific and technical development in material and product design, collection, sorting and recycling infrastructure.
Amendment 1027 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 7 – point b
Article 6 – paragraph 7 – point b
(b) detailed design for recycling criteria including material specific requirements on the quality of recycling, where and when needed, for each packaging formaterial and category listed in Table 1 of Annex II;
Amendment 1042 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 8 – subparagraph 4 a (new)
Article 6 – paragraph 8 – subparagraph 4 a (new)
Small components (i.e., <50 mm in two dimensions) represent a particular challenge to current packaging material recycling facility capabilities. By way of derogation from paragraphs 2 and 3, such small components may be placed on the market until the Delegated Act establishing the Design for Recycling criteria is adopted. The Design for Recycling criteria to be established under the Delegated Act as referred to in paragraph 4 shall consider the requirements for small components and be compatible with the state of the art collection, sorting and recycling processes.
Amendment 1052 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 9 – subparagraph 2
Article 6 – paragraph 9 – subparagraph 2
Where use is made of this derogation, innovative packaging shall be accompanied by technical documentation, referred to in Annex VII, demonstrating its innovative nature and showing compliance with the definition in Article 3(347) of this Regulation.
Amendment 1057 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – introductory part
Article 6 – paragraph 10 – introductory part
10. Until 31 December 2034, tThis Article shall not apply to the following:
Amendment 1062 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point b
Article 6 – paragraph 10 – point b
(b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745;
Amendment 1065 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 – point c
Article 6 – paragraph 10 – point c
(c) contact sensitive plastic packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746.
Amendment 1074 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 10 a (new)
Article 6 – paragraph 10 a (new)
10a. outer packaging as defined in Article 1, point (24), of Directive 2001/83/EC and in Article 4, point (26), of Regulation (EU) 2019/6, in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product. Should the adoption of the delegated acts referred to in paragraphs 4 and 6 of this Article be delayed, a presumption of compliance with the points a) and e) of paragraph 2 shall apply to all packaging placed on the Union market until such delegated acts are adopted.
Amendment 1112 #
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 pre-consumer or post- consumer plastic waste, per unit of packaging:
Amendment 1116 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point a
Article 7 – paragraph 1 – point a
(a) 30 % for contact sensitive plastic packaging made from polyethylene terephthalate (PET) as the major component;
Amendment 1132 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – point b
Article 7 – paragraph 1 – point b
(b) 10 % for contact sensitive plastic packaging made from plastic materials other than PET, except single use plastic beverage bottles;
Amendment 1146 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 (new)
Article 7 – paragraph 1 – subparagraph 1 (new)
Targets per material shall be calculated as a percentage of the total number of units placed by a producer on the internal market.
Amendment 1175 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from pre-consumer or post- consumer plastic waste, per unit of packaging:
Amendment 1187 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1 (new)
Article 7 – paragraph 2 – subparagraph 1 (new)
Targets per material shall be calculated as a percentage of the total number of units placed by a producer on the internal market.
Amendment 1196 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 3 – point b
Article 7 – paragraph 3 – point b
(b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745;
Amendment 1198 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 3 – point c
Article 7 – paragraph 3 – point c
(c) contact sensitive plastic packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746;
Amendment 1213 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. Paragraphs 1 and 2 shall not apply to compostable plastic packaging. as well as to inks, adhesives, varnishes and coatings used on packaging. Compostable packaging can be placed on the market providing the presence of a minimum content of renewable raw material determined as percentage of carbon of biological origin present in packaging compared to the total carbon present therein and using for this purpose the current European standard on the subject based on radiocarbon methods EN 16640. Agricultural biomass used for the manufacture of compostable packaging complies with the criteria laid down in Article 29, paragraphs 2 to 5, of Directive (EU) 2018/2001. Forest biomass used for the manufacture compostable packaging complies with the criteria laid down in Article 29, paragraphs 6 and 7 of that Directive.
Amendment 1230 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 4 a (new)
Article 7 – paragraph 4 a (new)
4a. By 12 months from the entry into force of this Regulation, compostable packaging shall contain a minimum content of renewable raw material of at least 60%.
Amendment 1232 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 4 b (new)
Article 7 – paragraph 4 b (new)
4b. Paragraphs 1 and 2 shall not apply to innovative packaging as defined at article 3 para 37.
Amendment 1240 #
2022/0396(COD)
6. By 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be modulated based on the percentage of recycled content used in the packagingtaking into account the cost of packaging waste management and the revenues from sales of secondary materials.
Amendment 1246 #
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). The implementing acts can specify that calculation of recycled content from packaging covered by Regulation No 1935/2004 on materials and articles intended to come into contact with food is only included in the calculation of recycled content if the packaging application is also covered by Regulation No 1935/2004 on materials and articles intended to come into contact with food.
Amendment 1287 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 1
Article 7 – paragraph 9 – subparagraph 1
By 1 January 2028, the Commission shall assess the need for derogations from the minimum percentage laid down in paragraph 1, points b and d, for specific plastic packaging, or for the revision of the derogation established under paragraph 3 for specific plastic packaging.
Amendment 1309 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point a
Article 7 – paragraph 9 – subparagraph 2 – point a
(a) provide for derogations from the scope, timing or level of minimum percentage laid down in paragraph 1, points b and d, for specific plastic packaging, and, as appropriate,
Amendment 1312 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 9 – subparagraph 2 – point b
Article 7 – paragraph 9 – subparagraph 2 – point b
Amendment 1347 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By 2030 [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 and therefore allowed to be collected in bio-waste receptacles.
Amendment 1362 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. Compostable packaging can be placed on the market providing the presence of a minimum content of renewable raw material determined as percentage of carbon of biological origin present in packaging compared to the total carbon present therein and using for this purpose the current European standard on the subject based on radiocarbon methods EN 16640. Agricultural biomass used for the manufacture of compostable packaging complies with the criteria laid down in Article 29, paragraphs 2 to 5, of Directive (EU) 2018/2001. Forest biomass used for the manufacture compostable packaging complies with the criteria laid down in Article 29, paragraphs 6 and 7 of that Directive.
Amendment 1363 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Amendment 1372 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 2 a (new)
Article 8 – paragraph 2 a (new)
2a. Member States which have transposed Article 22 of Directive 2008/98 and have appropriate waste collection schemes and waste treatment infrastructure are empowered to require that lightweight plastic carrier bags shall be compostable in industrially controlled conditions. The same provision shall apply to compostable packaging formats.
Amendment 1378 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. By [OP: Please insert the date = 24 months from the date of entry into force of this Regulation], packaging, labeled as compostable, other than that referred to in paragraphs 1 and 2, including packaging made of biodegradshall comply with the criteria listed in Annex III. Packaging made with compostable material that is not labele plastic polymers,d as compostable shall allow material recycling without affecting the recyclability of other waste streams.
Amendment 1381 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. By [OP: please insert the date = 12 months from the entry into force of this Regulation] compostable packaging shall contain a minimum content of renewable raw material of at least 60%.
Amendment 1383 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. TAfter an assessment of the Expert Group, the Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend paragraphs 1 and 2 of this Article by addingdd other types of packaging to the types of packaging covered by those paragraphs 1 and 2 of this Article when it is justified and appropriate due to technological and regulatory developments impacting the disposal of compostable packaging and under the conditions set out in Annex III. A public register containing the lists of such applications should be established and updated by the Commission.
Amendment 1390 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. By 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be collected and managed by a dedicated extended producer responsibility scheme.
Amendment 1402 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. PBy 1 January 2030, packaging shall be designed so that its weight and volume is reduced to the minimum necessary for ensuring its functionalitys, as listed in the definition of packaging in Article 3(1), taking account of the material that the packaging is made of and its design, for a given material and a given shape.
Amendment 1422 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. PBy 1 January 2030, packaging not necessary to comply with any of the performance criteria set out in Annex IV and packaging with characteristics that are only aimed to increase the perceived volume of the product, including double walls, false bottoms, and unnecessary layers, shall not be placed on the market, unless the packaging design is subject to geographical indications of origin, shall not be placed on the market, unless the product or packaging design is subject to intellectual property protection or benefits from the Union's geographical indications of origin protection or have been given distinctive product recognition by the Union, in each case protected under Union legislation.
Amendment 1432 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1 – introductory part
Article 9 – paragraph 3 – subparagraph 1 – introductory part
Amendment 1437 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2
Article 9 – paragraph 3 – subparagraph 2
For the purpose of assessing the compliance with this paragraph, space filled by paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene, styrofoam chips or other filling materials shall be considered as empty space, unless required to protect and to transport the goods.
Amendment 1445 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point b
Article 9 – paragraph 4 – subparagraph 1 – point b
(b) the identification of the design requirements, including those related to intellectual property rights , which prevent further reduction of the packaging weight or volume, for each of these performance criteria;
Amendment 1465 #
2022/0396(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b
Article 10 – paragraph 1 – point b
Amendment 1498 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
Amendment 1530 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. From [OP: Please insert the date = 48 months after the date of entry into force of this Regul36 months after the adoption of the implementing act referred to in paragraph 5, information], on packaging shall bear a label on packaging reusability andreusability shall be marked on a label on packaging or shall be available through a QR code or other type of digital data carrier that provides further information on packaging reusability including the availability of a system for re-use and of collection points, and that facilitates the tracking of the packaging and the calculation of trips and rotations. In addition, reusable sales packaging shall be clearly identified and distinguished from single use packaging at the point of sale.
Amendment 1541 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1
Article 11 – paragraph 4 – subparagraph 1
Labels referred to in paragraphs 1 to 3 and the QR code or other type of digital data carrier referred to in paragraph 2 shall be placed, printed or engraved visibly, clearly legibly and indelibly on the packaging. Where this is not possible or not warranted on account of the nature and size of the packaging, information should be conveyed to consumers via digital means of communication (e.g., website, QR code) or they shall be affixed to the grouped packaging.
Amendment 1547 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 1 a (new)
Article 11 – paragraph 4 – subparagraph 1 a (new)
By way of derogation from paragraph 4, the information referred to in paragraph 1 to 3 may be provided by electronic means identified on the package or on a label attached thereto.In such cases, the following requirements apply: (a) no user data shall be collected or tracked; (b) the information shall not be displayed with other information intended for sales or marketing purposes.
Amendment 1550 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 4 – subparagraph 2
Article 11 – paragraph 4 – subparagraph 2
Where Union legislation requires information on the packaged product to be provided via a data carrier, a single data carrier shall be used for providing the information required for both the packaged product and the packaging. From [Please insert the date = 24 months after the entry into force of this Regulation] the Commission shall adopt guidance regarding provision of information by digital means.
Amendment 1557 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. By [OP: Please insert the date = 18 2 months after the date of entry into force of this Regulation], the Commission shall adopt implementing acts to establish a harmonised label and specifications for the labelling requirements and formats for the labelling of or the digital provision of information related to packaging referred to in paragraphs 1 to 3 and the labelling of waste receptacles referred to in Article 12. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1562 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 6
Article 11 – paragraph 6
6. By [OP: Please insert the date = 124 months after the date of entry into force of this Regulation], the Commission shall adopt implementing acts to establish the methodology for identifying the material composition of packaging referred to in paragraph 1 by means of digital marking technologies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1574 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8
Article 11 – paragraph 8
8. Packaging included in an extended producer responsibility scheme or covered by a deposit and return system other than that referred to in Article 44(1) mayshall be identified by means of a corresponding symbol throughout the territory in which that scheme or system applies. That symbol shall be clear and unambiguous and shall not mislead consumers or users as to the recyclability or reusability of the packagingharmonised symbol to be established via an implementing act by the Commission in accordance with the examination procedure referred to in Article 59 (3).
Amendment 1580 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8 a (new)
Article 11 – paragraph 8 a (new)
8a. Packaging referred to in paragraphs 1, 2 and 3, manufactured or imported before these deadlines, may be marketed until the stocks of the products are exhausted.
Amendment 1585 #
2022/0396(COD)
Proposal for a regulation
Article 11 – paragraph 8 b (new)
Article 11 – paragraph 8 b (new)
8b. This Article shall not apply to pharmaceutical packaging.
Amendment 1607 #
2022/0396(COD)
Proposal for a regulation
Article 13 – paragraph 6
Article 13 – paragraph 6
Amendment 1619 #
2022/0396(COD)
Proposal for a regulation
Article 13 – paragraph 9 a (new)
Article 13 – paragraph 9 a (new)
9a. Paragraphs 1 to 6 do not apply to custom made transport packaging for configurable devices and systems designed to be used in industrial and healthcare settings.
Amendment 1630 #
2022/0396(COD)
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
Amendment 1643 #
2022/0396(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point c
Article 17 – paragraph 2 – point c
(c) the manufacturer and the importer have complied with the requirements set out in Article 13(5) and (6) and Article 16(3) respectively.
Amendment 1666 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Economic operators who supply products to a final distributor or an end user in grouped packaging, transport packaging or e-commerce packaging, shall ensure that the empty space ratio is maximum 40 %inimised subject to the provisions within Part 1 and Part 2 of Annex IV.
Amendment 1684 #
2022/0396(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 2
Article 21 – paragraph 2 – subparagraph 2
Space filled by filling materials such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space, unless required to protect and to transport the goods.
Amendment 1697 #
2022/0396(COD)
Proposal for a regulation
Article 22
Article 22
Amendment 1750 #
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 improving the overall environmental outcomes in line with 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 non-recyclable 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 1780 #
Amendment 2162 #
Amendment 2217 #
2022/0396(COD)
Proposal for a regulation
Article 38 – paragraph 1 – introductory part
Article 38 – paragraph 1 – introductory part
1. Each Member State shall reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018the year of entry into force of this Regulation as reported to the Commission in accordance with Decision 2005/270/EC, for each of the specific materials contained in packaging waste listed in article 46, by
Amendment 2224 #
Amendment 2230 #
Amendment 2242 #
Amendment 2253 #
2022/0396(COD)
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
3. For the purpose of paragraph 2, Member States may use economic instruments and other measures to provide incentives for the application of the waste hierarchy, such as measures referred to in Annexes IV and IVa to Directive 2008/98/EC, or other appropriate instruments and measures, including incentives through extended producer responsibility schemes and requirements on producers or producer responsibility organisations to adopt waste prevention plans. Such measures shall be proportionate and non-discriminatory and be designed so as to avoid barriers to trade or distortions of competition in conformity with the Treaty and with Article 4 of this Regulation.
Amendment 2271 #
2022/0396(COD)
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. Producers shall be obliged to register in the register referred to in paragraph 1. They shall, to that end, submit an application for registration in each Member State where they make packaging available on the market for the first timethe home country. Where a producer has appointed a producer responsibility organisation as referred to in Article 41(1), the obligations set out in this Article shall be met by that organisation, unless otherwise specified by the Member State in which the register is established.
Amendment 2305 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 1 January 2030, Member States shall ensure that systems are set up to provide for the return and the separate collection of 90% of all packaging waste from the end users of each packaging format listed in Table 1 Annex II, in a given year, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling.
Amendment 2352 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 1 January 2030, Member States shall ensure that systems are set up to provide for the return and the separate collection of 90% of all packaging waste from the end users of each packaging format listed in Table 1 Annex II, in a given year, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling.
Amendment 2353 #
2022/0396(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. By 1 January 2030, Member States shall ensure that systems are set up to provide for the return and the separate collection of 90% of all packaging waste from the end users of each packaging format listed in Table 1 Annex II, in a given year, in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high quality recycling.
Amendment 2685 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 1 – row 11 a (new)
Annex II – Table 1 – row 11 a (new)
bottles and (11 a) Plastic PET - rigid flasks Opaque white
Amendment 2711 #
2022/0396(COD)
Proposal for a regulation
Annex II – Table 2 a (new)
Annex II – Table 2 a (new)
Indicative parameters that may be considered when developing design criteria for recycling under Article 6: 1. Additives 2. Labels 3. Closure systems and small parts 4. Adhesives 5. Printing inks 6. Colours 7. Material composition 8. Barriers / coatings 9. Ease of dismantling
Amendment 189 #
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 197 #
2022/0365(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) The type approval requirements for newly manufactured tyres C1, C2 and C3 are set in the General Safety Regulation ((EU) 2019/2144). Consequently, this Regulation complements those technical requirements – which remain the basis for new tyre type approval - with tyre abrasion requirements. The test method to measure tyre abrasion as well as tyre abrasion limits are being developed in the UN. In order to adopt such test method, relevant definitions, and tyre abrasion limits, this Regulation will have to be supplemented by secondary legislation along with the manufacturers’ obligations and relevant timeline for implementation as well as transitional period for tyres manufactured after a certain date according to Article 11 paragraph 3a (new).
Amendment 226 #
2022/0365(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) In order to ensure that the exhaust emissions for both light and heavy duty vehicles are limited in real life, testing vehicles in real conditions of use with a minimum set of restrictions, boundaries and other driving requirements and not only in the laboratory is required.
Amendment 233 #
2022/0365(COD)
Proposal for a regulation
Recital 9
Recital 9
Amendment 245 #
2022/0365(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Non-exhaust emissions consist of particles emitted by tyres and brakes of vehicles. Emissions from tyres is estimated to be the largest source of microplastics to the environment. As shown in the Impact Assessment, it is expected that by 2050, non-exhaust emissions will constitute up to 90% of all particles emitted by road transport, because exhaust particles will diminish due to vehicle electrification. Those non-exhaust emissions should therefore be measured and limited. The Commission should prepare a report on tyre abrasion by the end of 2024 to review the measurement methods and state-of-the- art in order to propose tyre abrasion limitsdeveloped in the UN with the view of ensuring consistency in the definition of tyre abrasion limits. In addition, the Report should include, to the extent possible, an impact assessment on tyre abrasion requirements, filling the gaps identified in this Regulation’s impact assessment.
Amendment 315 #
2022/0365(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to amend or supplement, as appropriate, 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 should be delegated to the Commission in respect of test conditions based on data collected when testing Euro 7 vehicles, brakes or tyres; test requirements, in particular taking into account technical progress and data collected when testing Euro 7 vehicles; introducing vehicle options and designations based on innovative technologies for manufacturers but also setting out brake particle emission limits and abrasion limits for tyre types in accordance with the test method and limits developed in the UN as well as minimum performance requirements of batteries and durability multipliers based on data collected when testing Euro 7 vehicles and setting out definitions and special rules for small volume manufacturers for vehicles of categories M2, M3, N2, N3, It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making51 . In particular, in order 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. _________________ 51 OJ L 123, 12.5.2016, p. 1.
Amendment 331 #
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 and pollutant emissions, fuel and energy consumption and battery durability. Technical requirements and administrative provisions established by this regulation for the emission type- approval and market surveillance of newly manufactured tyres, are to be considered together with the tyre technical requirements and administrative provisions of the General Safety Regulation (EU) 2019/2144.
Amendment 360 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 11
Article 3 – paragraph 2 – point 11
(11) ‘particulate matter’ or ‘PM’ means any material emitted from the tailpipe or the brakes and collected on a filter media according to the procedure described in this Regulation;
Amendment 364 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 14
Article 3 – paragraph 2 – point 14
(14) ‘’10 nm particle number above 10 nm’ or ‘PN10’ means the total number of solid particles emitted from the tailpipe or the brakes that have a diameter larger or equal thanmeasured according to the procedure described in this Regulation with a nominal cut-off at 10 nm;
Amendment 380 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 34
Article 3 – paragraph 2 – point 34
(34) ‘original pollution control systems’ means a pollution control system or an assembly of such systems covered by the type-approval granted for the vehicle concerned and fitted within the vehicle at the date of its first registration;
Amendment 385 #
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 395 #
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 omonitoring emissions under wthen 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 communicating that consideration of OBM measurement tolerances and providing information via the OBD port and over the air;
Amendment 436 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 62
Article 3 – paragraph 2 – point 62
(62) ‘power-to-mass-ratio’ means the ratio of rated power to the mass in running ordertechnically permissible maximum laden mass as defined in Annex XII of Regulation (EU) 2021/535;
Amendment 454 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 71
Article 3 – paragraph 2 – point 71
Amendment 467 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 77
Article 3 – paragraph 2 – point 77
Amendment 472 #
2022/0365(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point 78
Article 3 – paragraph 2 – point 78
Amendment 484 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Manufacturers shall ensure that the new vehicles they manufacture, which are sold, registered or put into service in the Union, are type approved in accordance with this Regulation. MAs from the specific application dates of this Regulation, manufacturers shall ensure that the new components or separate technical units, including engines, traction batteries, brake emission systems and replacement pollution control systems requiring type- approval which they manufacture and which are sold or put into service in the Union are type approved in accordance with this Regulation.
Amendment 492 #
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 in theer the conditions set out in Annex III and respecting 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 504 #
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 one extended driving conditions, the emissions shall be divided by the extended driving divider set out in Annex III.
Amendment 508 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Manufacturers shall design and construct components or separate technical units, currently only including engines, traction batteries, brake systems and replacement pollution control systems to comply with this Regulation, including complying with the emission limits set out in Annex I and the conditions set out in Annex III.
Amendment 520 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point a
Article 4 – paragraph 6 – point a
(a) OBD systems capable of detecting malfunctioning systems which lead to exhaust emission exceedances in order to facilitate repairs;
Amendment 525 #
2022/0365(COD)
Proposal for a regulation
Article 4 – paragraph 6 – point b
Article 4 – paragraph 6 – point b
(b) OBM systems capable of detecting emissions above the emission limits due to malfunctions, increased degradation or other situations that increase emissionmonitoring exhaust within the capability of OBM measurement tolerances;
Amendment 528 #
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 for vehicles of category N2 and N3 other relevant parameters such as payload/mass which are needed to determine their real-world fuel and energy efficiency;
Amendment 562 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 576 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 580 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. Manufacturers may designate vehicles of category M1 and N1 as “Euro 7A vehicle” where those vehicles are equipped with adaptive control functions. The use of adaptive control functions shall be demonstrated to the type-approval authorities during type- approval and verified during the lifetime of the vehicle as set out in table 1, Annex IV.
Amendment 586 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Manufacturers may designate vehicles of category M1 and N1 as “Euro 7G vehicle” where those vehicles are equipped with internal combustion engines with geofencing technologies. The manufacturer shall install a driver warning system on those vehicles to inform the user when the traction batteries are nearly empty and to stop the vehicle if not charged within 5 km from the first warning while on zero- emission mode. The application of such geofencing technologies may be verified during the lifetime of the vehicle.
Amendment 596 #
2022/0365(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Manufacturers may construct vehicles combining two or more ofof category M1 and N1 combining the characteristics referred to in paragraphs 1, 2 or 33 and 4 and designate them using a combination of symbols and letters such as “Euro 7+A”, “Euro 7+G”, “Euro 7+AG” oras “Euro 7AG” vehicles.
Amendment 608 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
Amendment 614 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Manufacturers shall ensure that OBFCM, OBD and OBM devices and anti- tampering measures installed in these vehicles comply with the provisions of this Regulationremain unchanged as long as the vehicle is in use.
Amendment 630 #
2022/0365(COD)
Proposal for a regulation
Article 6 – paragraph 6 – point b
Article 6 – paragraph 6 – point b
(b) communicating the data of the emission behaviour of the vehicle, including pollutant sensor and exhaust flow data, via the OBD port and over the air, including for the purpose of roadworthiness tests and technical roadside inspections55 ,56 or for the purpose of providing third-party services that assist the vehicle user in reducing emissions in use phase; _________________ 55 Directive 2014/47/ EU of the European Parliament and of the Council of 3 April 2014 on the technical roadside inspection of the roadworthiness of commercial vehicles circulating in the Union and repealing Directive 2000/30/EC (OJ L 127, 29.4.2014, p. 134). 56 Directive 2014/45/EU of the European Parliament and of the Council of 3 April 2014 on periodic roadworthiness tests for motor vehicles and their trailers and repealing Directive 2009/40/EC (OJ L 127, 29.4.2014, p. 129)
Amendment 645 #
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 including but not limited to the provision of third-party services to the vehicle user.
Amendment 676 #
2022/0365(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
Amendment 689 #
2022/0365(COD)
Article7a Specific provisions relating to vehicle tires abrasion 1. Tyre classification and definitions for the purposes of abrasion emission type approval shall follow the uniform provisions developed in the UN concerning the approval of tyres with regard to Tyre Abrasion emissions Type Approval and be included in this Regulation through an implementing act as per article 14 paragraph 3. 2. Any derogation to these requirements should be developed in the UN and included in this Regulation by delegated act as per Article 15.
Amendment 703 #
2022/0365(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
Amendment 708 #
2022/0365(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
Amendment 722 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. With effect from … [OP please insert the date = the date of entry into force of this Regulation]the publication of the implementing or delegated acts, 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 723 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
3a. Starting 24 months after the entry into force of this Regulation, and following the relevant timeline and specific provisions for components, and separate technical units, national authorities shall, on grounds relating to CO2 and pollutant emissions, fuel and electric energy consumption or battery durability, refuse to grant EU emission type-approval or national emission type- approval with regard to new types of M1 vehicles which do not comply with this Regulation.
Amendment 725 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 3 b (new)
Article 10 – paragraph 3 b (new)
3b. Starting 36 months after the entry into force of this Regulation, and following the relevant timeline and specific provisions for components, and separate technical units, national authorities shall, on grounds relating to CO2 and pollutant emissions, fuel and electric energy consumption or battery durability, refuse to grant EU emission type-approval or national emission type- approval with regard to new types of N1 vehicles which do not comply with this Regulation.
Amendment 732 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. With effect from 1 July 202536 months after entry into force of this Regulation, and following the relevant timeline and specific provisions for components, and separate technical units, 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 739 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 4 a (new)
Article 10 – paragraph 4 a (new)
4a. As of 48 months after entry into force of this Regulation, and following the relevant timeline and specific provisions for components, and separate technical units, national authorities shall, in the case of new N1 vehicles not complying 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 electric energy consumption or battery durability, prohibit the registration, sale or entry into service of such vehicles.
Amendment 746 #
2022/0365(COD)
5. With effect from 1 July 2027, national authorities shall, As of 48 months after entry into force of this Regulation, and following the case of new M2, M3, N2, N3 vehicles and new O3, O4 trailers, which do not comply with this Regulation consider certificates of conformity to be no longer valid for the purposes of registration andrelevant timeline and specific provisions for components, and separate technical units, national authorities shall, on grounds relating to CO2 and pollutant emissions, fuel and electric energy consumption, energy efficiency or battery durability, prohibit the registration, srefuse to grant EU emission type-approvale or entry into service of such vehiclesnational emission type-approval in the case of new types of M2, M3, N2, N3 vehicles and new O3, O4 trailers which do not comply with this Regulation.
Amendment 755 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Article 10 – paragraph 5 a (new)
5a. As of 60 months after entry into force of this Regulation, and following the relevant timeline and specific provisions for components, and separate technical units, national authorities shall, in the case of new M2, M3, N2, N3 vehicles and new O3, O4 trailers not complying 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 767 #
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 776 #
2022/0365(COD)
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. The Commission shall adopt implementing acts laying down the administrative and technical elements required for performing tests, checks and inspections for the purposes of verifying compliance with paragraph 1, as well as the technical elements required for market surveillance checks under paragraph 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17(2) and shall enter into force at least [3] years before the applicable dates in Article 10 (4) and (5).
Amendment 787 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. With effect from 1 July 202536 months after entry into force of 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 791 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 1 a (new)
Article 11 – paragraph 1 a (new)
Amendment 799 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. With effect from 1 July 202760 months after entry into force of 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 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 806 #
2022/0365(COD)
Proposal for a regulation
Article 11 – paragraph 3 a (new)
Article 11 – paragraph 3 a (new)
Amendment 834 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 3 – point e
Article 14 – paragraph 3 – point e
(e) anti-tampering, security and cybersecurity systems and security;
Amendment 837 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 3 – point g
Article 14 – paragraph 3 – point g
(g) brake system types and their replacement parts; specifically for the different vehicle categories that also take into account other on-vehicle systems that contribute to vehicle braking and braking of trailers;
Amendment 844 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 3 – point h
Article 14 – paragraph 3 – point h
(h) tyre types in respect to tyre abrasion as defined by the pertinent UN WP29 Regulation;
Amendment 860 #
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-casemeasures against biased driving and misuse during RDE test cyclesing, the use of portable emissions measurement systems for verifying real driving emissions, and idle emissions;
Amendment 869 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point a a (new)
Article 14 – paragraph 4 – subparagraph 1 – point a a (new)
(aa) for 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 878 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point g
Article 14 – paragraph 4 – subparagraph 1 – point g
(g) the methods to measure brake particle emissions, including methods for HDV, real driving brake particle emissions on the basis of the completed UNECE GTR for M1 and N1 vehicles and to carry out an expansive inter-laboratory test program to determine the baseline for M1 and N1 vehicle brake wear emissions from which proportional brake wear limits can be considered, a similar approach for HDV when an appropriate test method has first been developed at UNECE level and regenerative braking;
Amendment 888 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point h
Article 14 – paragraph 4 – subparagraph 1 – point h
(h) the methods to measure tyre abrasion in order to monitor tyre abrasion ratesrates in line with the relevant UN WP29 Regulation;
Amendment 894 #
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 906 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point r
Article 14 – paragraph 4 – subparagraph 1 – point r
(r) specifications of reference fuels for testing that include in the Fuel Quality Directive 98/70/EC an improved environmental specification for market fuels to enable exhaust pollutant reduction;
Amendment 912 #
2022/0365(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1 – point t
Article 14 – paragraph 4 – subparagraph 1 – point t
Amendment 931 #
2022/0365(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 950 #
2022/0365(COD)
Amendment 992 #
2022/0365(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
Regulation (EC) 715/2007 is repealed with effect from 1 July 20257.
Amendment 999 #
2022/0365(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
Regulation (EC) 595/2009 is repealed with effect from 1 July 20279.
Amendment 1008 #
2022/0365(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
It shall apply from 1 July 2025 for M1,24 months after entry into force of this Regulation for M1 vehicles, from 36 months after entry into force of this Regulation for N1 vehicles and components and separate technical units for those vehicles and from 1 July 202748 months after entry into force of this Regulation for M2, M3, N2, N3 vehicles and components and separate technical units for those vehicles and O3, O4 trailers.
Amendment 1017 #
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.
Amendment 1021 #
2022/0365(COD)
paragraph 6 of UN Global Technical Regulation 21
2 Measured in accordance with paragraph 5.3.2. of UN/ECE Regulation No 85 in the case of ICEVs and PEVs, or, in all other cases, measured in accordance with one of the test procedures laid down in
paragraph 6 of UN Global Technical Regulation 21
paragraph 6 of UN Global Technical Regulation 21
Euro 7 exhaust emission limits for M1, N1 vehicles with internal combustion engine Pollutant M1, N1 Only for N1 Emission Emission emissions vehicles vehicles with budget for all budget for all power to mass trips less than trips less than ratio1 less than 10 km for 10 km only for 3540 kW/t M1,N1 forN1 vehicles vehicles with power to mass ratio less than 3540 kW/t
Amendment 1028 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 1 – Row 3
Annex I – Table 1 – Row 3
Amendment 1034 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 1 – Row 4
Annex I – Table 1 – Row 4
Euro 7 exhaust emission limits for M1, N1 vehicles with internal combustion engine Pollutant Emission Emission emissions budget for all budget for all Only for N1 trips less than trips less than vehicles with 10 km for M1, 10 km only for M1, N1 vehicles power to mass N1 vehicles N1 vehicles with ratio256 less than power to mass 35 kW/t ratio less than 35 kW/t per km per km per trip per trip PM in mg 4.5 4.5 45 45 50
Amendment 1042 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 1 – Row 6
Annex I – Table 1 – Row 6
Euro 7 exhaust emission limits for M1, N1 vehicles with internal combustion engine Pollutant Emission Emission emissions budget for all budget for all Only for N1 trips less than trips less than vehicles with 10 km for M1, 10 km only for M1, N1 vehicles power to mass N1 vehicles N1 vehicles with ratio2930 less than power to mass 35 kW/t ratio less than 35 kW/t per km per km per trip per trip CO in mg 500 63740 5000 6300 7400
Amendment 1050 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 1 – Row 7
Annex I – Table 1 – Row 7
36 Measured in accordance with paragraph 5.3.2. of UN/ECE Regulation No 85 in the case of ICEVs and PEVs, or, in all other cases, measured in accordance with one of the test procedures laid down in paragraph 6 of UN Global Technical Regulation 21 37 Measured in accordance with paragraph 5.3.2. of UN/ECE Regulation No 85 in the case of ICEVs and PEVs, or, in all other cases, measured in accordance with one of the test procedures laid down in paragraph 6 of UN Global Technical Regulation 21 Euro 7 exhaust emission limits for M1, N1 vehicles with internal combustion engine Pollutant Emission Emission emissions budget for all budget for all Only for N1 trips less than trips less than vehicles with 10 km for M1, 10 km only for M1, N1 vehicles power to mass N1 vehicles N1 vehicles with ratio378 less than power to mass 35 kW/t ratio less than 35 kW/t per km per km per trip per trip THC in mg 100 1360 1000 13600
Amendment 1057 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 1 – Row 8
Annex I – Table 1 – Row 8
Euro 7 exhaust emission limits for M1, N1 vehicles with internal combustion engine Pollutant Emission Emission emissions Only for N1 budget for all budget for all Only for N1 trips less than trips less than vehicles with 10 km for M1, 10 km only for M1, N1 vehicles power to mass N1 vehicles N1 vehicles with ratio45 less than power to mass 35 kW/t vehicles with trips less than trips less than M1, N1 vehicles power to mass 10 km for M1, 10 km only for ratio46 less than N1 vehicles N1 vehicles with 35 kW/t power to mass ratio less than 45 Measured in accordance with paragraph 5.3.2. of UN/ECE Regulation No 85 in the case of ICEVs and PEVs, or, in all other cases, measured in accordance with one of the test procedures laid down in paragraph 6 of UN Global Technical Regulation 21 46 ratio less thanMeasured in accordance with paragraph 5.3.2. of UN/ECE Regulation No 85 in the case of ICEVs and PEVs, or, in all other cases, measured in accordance with one of the test procedures laid down in paragraph 6 of UN Global Technical Regulation 21 35 kW/t per km per km per trip per trip NMHC in mg 68 90 108 680 900 1080
Amendment 1064 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 1 – Row 9
Annex I – Table 1 – Row 9
Euro 7 exhaust emission limits for M1, N1 vehicles with internal combustion engine Pollutant Emission Emission emissions budget for all budget for all Only for N1 trips less than trips less than vehicles with 10 km for M1, 10 km only for M1, N1 vehicles power to mass N1 vehicles N1 vehicles with ratio512 less than power to mass 35 kW/t ratio less than 35 kW/t per km per km per trip per trip NH3 in mg 20 20 - 200 200 -
Amendment 1079 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 2
Annex I – Table 2
Amendment 1124 #
2022/0365(COD)
Proposal for a regulation
Annex I – Table 5
Annex I – Table 5
Amendment 1171 #
2022/0365(COD)
Proposal for a regulation
Annex II – Table 2 – Section I – Row 1
Annex II – Table 2 – Section I – Row 1
Euro 7 Minimum performance requirements (MPR) for battery durability for NM1 vehicles Battery energy based Start of life to 5 Vehicles more than Start of life to 8 years Vehicles up to MPR years or 1060 000 km 5 years or 100 000 additional lifetime whichever comes km, and up to first whichever comes first of 8 years or 160 000 kmfirst OVC-HEV 75% 65% PEV 75% 65%
Amendment 1203 #
2022/0365(COD)
Proposal for a regulation
Annex III – Table 1 – row 2
Annex III – Table 1 – row 2
Conditions for testing compliance of M1, N1 vehicles with exhaust emission limits with any market fuel and lubricant within the specifications issued by the manufacturer of the vehicle Parameter Normal driving Extended driving conditions* conditions - 1.6 (applies to measured Extended driving emissions only during the time divider when one of the conditions set Extended driving out in this column applies; and in divider the case two or more conditions are met, that partof the trip shall be excluded and set invalid)
Amendment 1218 #
2022/0365(COD)
Proposal for a regulation
Annex III – Table 1 – row 2
Annex III – Table 1 – row 2
Conditions for testing compliance of M1, N1 vehicles with exhaust emission limits with any market fuel and lubricant within the specifications issued by the manufacturer of the vehicle Parameter Normal driving Extended driving conditions* conditions Trip composition Any - - Biased and rare driving Biased and rare driving conditions are not conditions are not allowed allowed
Amendment 1228 #
2022/0365(COD)
Proposal for a regulation
Annex III – Table 2
Annex III – Table 2
Conditions for testing compliance of M1, N1 vehicles with exhaust emission limits with any market fuel and lubricant within the specifications issued by the manufacturer of the vehicle Parameter Normal driving conditions Extended driving for reference Ambient According to paragraph 4.2 of Annex 8 to conditions* - 2 (applies to measured Extended Driving emissions only during the time DividerCovering -7°C to temperature UN-ECE Regulation No.49-07 when one of the conditions set 38°C out According this column applies) Ambient -7°C to 35°C -10°C to -7°C or 35°C to 45°C temperature o paragraph 4.2 of Annex 8 to Maximum altitude 1 600 m From 1 600 to 1 800 m Not allowed 1700 meters UN-ECE Regulation No.49-07 Allowed according to Towing/aerodynami manufacturer specifications c modifications and up to the regulated speed Vehicle Payload Higher or equal than 10% Less than 10% Auxiliaries Possible as per normal use - Internal Combusparagraph 4.1 of Annex 8 to Vehicle payload ≥ 10% UN-ECE Regulation No.49-07 According to paragraph 4.5 of Annex 8 to Trip composition Any - Engine Loading at cold start Trip composition As per usual use Urban / rural / UN-ECE Regulation No.49-07 - 5 000 km for <16t TPMLM Between 3 000 km and 5 000 10 000 km for > 16t TPMLM km for <16t TPMLM motorway According to paragraph 3.2 of Annex 8 to Minimum mileage Between 3 000 km and 10 00025,000 km UN- km for > 16t TPMLMECE Regulation No.49-07
Amendment 1254 #
2022/0365(COD)
Proposal for a regulation
Annex III – Table 5
Annex III – Table 5
Amendment 201 #
2022/0347(COD)
Proposal for a directive
Recital 4
Recital 4
(4) The Zero Pollution Action Plan also sets out a vision for the year 2050, where air pollution is reduced to levels no longer considered harmful to health and natural ecosystems. To this end, a staged approach towards setting current and future EU air quality standards should be pursued, establishing intermediate air quality standards for the year 2030 and beyond, and developing a perspective for alignment with the WHO Air Quality Guidelines by the year 2050 at the latest based on a regular review mechanism to take into account the latest scientific understanding. Given the links between pollution reduction and decarbonisation, the long- term objective to achieve the zero pollution ambition should be pursued hand in hand with reduction of greenhouse gas emissions as set by Regulation (EU) 2021/1119 of the European Parliament and of the Council42. _________________ 42 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. 1–17).
Amendment 233 #
2022/0347(COD)
Proposal for a directive
Recital 15
Recital 15
(15) In order to protect human health and the environment as a whole, it is particularly important to combat emissions of pollutants at source and to identify and implement the most effective emission reduction measures at local, national and Union level , in particular when it comes to emissions from agriculture, industries, transport and energy generation . Therefore, emissions of harmful air pollutants should be avoided, prevented or reduced and appropriate standards set for ambient air quality taking into account relevant World Health Organization standards, guidelines and programmes. Since diffuse air emissions are the most difficult to combat, close cooperation at all levels of governance is needed to tackle pollution at its source.
Amendment 277 #
2022/0347(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Air quality plans should also be prepared ahead of 2030s soon as possible where there is a risk that Member States will not attain the limit values or ozone target value by that date in order to ensure that levels of pollutants are reduced accordingly.
Amendment 297 #
2022/0347(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Directive sets out a zero pollution objective for air quality, so that within the Union air quality is progressively improved to levels no longer considered harmful to human health and natural ecosystems, as defined by scientific evidence, thus contributing to a toxic-free environment at the latest by 2050. The objective must be pursued while safeguarding the social cohesion and sustainable growth of the Member States and ensuring that measures taken to achieve the objective do not jeopardise the social well-being and economic development of the Member States.
Amendment 306 #
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 objectivelimit values and average exposure reduction obligations (‘air quality standards’) to be met by the year 20340, and regularly reviewed thereafter in accordance with Article 3.
Amendment 319 #
2022/0347(COD)
Proposal for a directive
Article 1 – paragraph 3
Article 1 – paragraph 3
3. This Directive also sets target values, average exposure concentration objectives, critical levels, information thresholds, alert thresholds and long-term objectives. Furthermore, this Directive contributes to achieving: the Union’s pollution-reduction, biodiversity and ecosystem objectives in accordance with the 8th Environment Action Programme, as set out in Decision (EU) 2022/591 of the European Parliament and of the Council55. _________________ 55 Decision (EU) 2022/591 of the European Parliament and of the Council of 6 April 2022 on a General Union Environment Action Programme to 2030 (OJ L 114, 12.4.2022, p. 22).
Amendment 337 #
2022/0347(COD)
Proposal for a directive
Article 3 – paragraph 1
Article 3 – paragraph 1
1. By 31 December 202830, and every 5 years thereafter, and more often if substantial new scientific findings point to the need for it, the Commission shall review the scientific evidence related to air pollutants and their effects on human health and the environment relevant to achieving the objective set in Article 1 and present a report with the main findings to the European Parliament and to the Council.
Amendment 531 #
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, 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 544 #
2022/0347(COD)
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1 a. Where, in a given zone, conformity with the limit values for particulate matter (PM10 and PM2.5) 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, due to the complex characteristics of its secondary formation in the atmosphere which complicate the task of assessing the feasibility of complying with strict limit values, a Member State may postpone that deadline for that particular zone if the following conditions are met: a) an air quality plan is established in accordance with Article 19(4) and meeting the requirements listed in Article 19(5) to (7) for the zone to which the postponement would apply; b) the air quality plan referred in point (a) is supplemented by the information listed in Point B of Annex VIII related to the pollutants concerned and demonstrates how exceedance periods above the limit values will be kept as short as possible; c) the air quality plan referred to in point (a) outlines how additional funding, including via relevant national and Union funding programmes, will be mobilised to accelerate the improvement of air quality in the zone to which the postponement would apply.
Amendment 546 #
2022/0347(COD)
Proposal for a directive
Article 18 – paragraph 2 – subparagraph 1
Article 18 – paragraph 2 – subparagraph 1
Member States shall notify the Commission where, in their view, paragraph 1 is applicable, and shall communicate the air quality plan referred to in paragraph 1 and all relevant information necessary for the Commission to assess whether the invoked reason for postponement and the conditions set out in that paragraph are satisfied. In its assessment, the Commission shall take into account estimated effects on ambient air quality in Member States, at present and in the future, of measures that have been taken by Member States as well as estimated effects on ambient air quality of Union measures . The Commission shall also consider the administrative and economic effort that the above mentioned measures imply, as well as the possible lack of Union source-based regulations.
Amendment 590 #
2022/0347(COD)
Proposal for a directive
Article 19 – paragraph 4 – subparagraph 1
Article 19 – paragraph 4 – subparagraph 1
Where from [insert year 2 years after entry into force of this Directive], until 31 December 2029 in a zone or NUTS 1 territorial unit, the levels of pollutants are above any limit value to be attained by 1 January 20340 as laid down in Table 1 of Section 1 of Annex I, Member States shall establish an air quality plan for the concerned pollutant as soon as possible and no later than 2 years after the calendar year during which the exceedance of the was recorded to attain the respective limit values or ozone target value by the expiration of the attainment deadline.
Amendment 36 #
2022/0344(COD)
Proposal for a directive
Recital 1
Recital 1
(1) Chemical pollution of surface and groundwater poses a threat to the aquatic environment, with effects such as acute and chronic toxicity in aquatic organisms, accumulation of pollutants in the ecosystem and loss of habitats and biodiversity, as well as to human health. Setting environmental quality standards may helps to implement the zero pollution ambition for a toxic-free environment, provided that they are accompanied by gradual and concerted mitigation measures.
Amendment 54 #
2022/0344(COD)
Proposal for a directive
Recital 7
Recital 7
(7) A combination of source-control and end-of-pipe measures is required to effectively deal with most pollutants across their life cycle, including, as relevant, chemical design, authorisation or approval, control of emissions during manufacturing and use or other processes, and waste handling. The setting of new or stricter quality standards in water bodies therefore complements and is coherent with other Union legislation that addresses or could address the pollution problem at one or more of those stages, including Regulation (EC) No 1907/2006 of the European Parliament and of the Council49,Regulation (EC) No 1107/2009 of the European Parliament and of the Council50, Regulation (EU) No 528/2012 of the European Parliament and of the Council51, Regulation (EU) 2019/6 of the European Parliament and of the Council52, Directive 2001/83/EC of the European Parliament and of the Council53, Directive 2009/128/EC of the European Parliament and of the Council54, Directive 2010/75/EU of the European Parliament and of the Council55and Council Directive 91/271/EEC56, and specific measures should be provided for end users, who are likely to shoulder the heaviest burden as a result of the application of the directive. _________________ 49 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1). 50 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). 51 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). 52 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). 53 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). 54 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, p. 71). 55 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). 56 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).
Amendment 57 #
2022/0344(COD)
Proposal for a directive
Recital 8
Recital 8
(8) The new scientific knowledge points to a significant risk from several other pollutants found in water bodies, in addition to those already regulated. In groundwater, a particular problem has been identified through voluntary monitoring for per- and polyfluoroalkyl substances (PFAS) and pharmaceuticals. PFAS have been detected at more than 70% of the groundwater measuring points in the Union and existing national thresholds are clearly exceeded at a considerable number of locations, and pharmaceutical substances are also widely found. In surface waters, perfluorooctane sulfonic acid and its derivatives are already listed as priority substances, but other PFAS are now also recognised to pose a risk. Watch-list monitoring under Article 8b of Directive 2008/105/EC has confirmed a risk in surface waters from a number of pharmaceutical substances which should therefore be added to the priority substances list. These substances should be monitored whenever the risk assessment and the river basin risk management pertaining to the abstraction points, carried out in accordance with Article 8 of Directive (EU) 2020/2184, find that these substances are likely to be present in a specific water supply. Furthermore, the values should be applied only once technical guidelines for monitoring this parameter have been drawn up in accordance with Article 13(7) of Directive (EU) 2020/2184.
Amendment 69 #
2022/0344(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Considering the growing awareness of the relevance of mixtures and therefore of effect-based monitoring for determining chemical status, and considering that sufficiently robust effect-based monitoring methods already exist for estrogenic substances, Member States should apply such methods to assess the cumulative effects of estrogenic substances in surface waters over a period of at least two years. This will allow the comparison of effect- based results with the results obtained using the conventional methods for monitoring the three estrogenic substances listed in Annex I to Directive 2008/105/EC. That comparison will be used to assess whether effect-based monitoring methods may be used as reliable screening methods. Using suchThe assessments will employ only screening methods wouldhich have the advantage ofproven within the scientific community to be very reliable at delivering accurate data. This would allowing the effects of all estrogenic substances having similar effects to be covered, and not only those listed in Annex I to Directive 2008/105/EC. The definition of EQS in Directive 2000/60/EC should be modified to ensure that it may, in the future, also cover trigger values that might be set for assessing the results of effect- based monitoring. In order for the screening methods to prove their high degree of reliability in the scientific community, the methods must be put forward for and subjected to a public notice and consultation in line with the existing procedure for proposing amendments to EU directives.
Amendment 80 #
2022/0344(COD)
Proposal for a directive
Recital 21
Recital 21
(21) To ensure effective and coherent decision-making and develop synergies with the work carried out in the framework of other Union legislation on chemicals, the European Chemicals Agency (‘ECHA’), should be given a permanent and clearly circumscribed role in the prioritisation of substances to be included in the watch lists and in the lists of substances in Annexes I and II to Directive 2008/105/EC and Annexes I and II to Directive 2006/118/EC, and in the derivation of appropriate science-based quality standards. The Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) of ECHA, should facilitate the carrying out of certain tasks conferred on ECHA by providing opinions. ECHA should also ensure better coordination between various pieces of environmental law through increased transparency as regards pollutants on a watch list or the development of Union wide or national EQS or thresholds, by making relevant scientific reports publicly available. To this end, the ECHA should determine the appropriate, proportionate and cost- effective level and combination of product and process checks for both point and diffuse sources. The substances should also be classified as priorities for action on the basis of the risk identified by means of a simplified assessment procedure anchored in scientific principles.
Amendment 98 #
2022/0344(COD)
Proposal for a directive
Recital 34 a (new)
Recital 34 a (new)
(34a) This directive introduces new and more demanding technical and technological services for both analytics and sampling. For these services to be sustainable, the Commission will carry out an in-depth economic feasibility assessment, in order to quantify the economic, bureaucratic and administrative costs that will fall to the authorities responsible for monitoring, and to examine other possibilities offering better procurement and alternatives for recruitment and staff training.
Amendment 99 #
2022/0344(COD)
Proposal for a directive
Recital 34 b (new)
Recital 34 b (new)
(34b) Given the cross-border nature of many river basins, an expert scientific study will be required to consider setting common EQS at the European level for river basin-specific pollutants.
Amendment 100 #
2022/0344(COD)
Proposal for a directive
Recital 34 c (new)
Recital 34 c (new)
Amendment 101 #
2022/0344(COD)
Proposal for a directive
Recital 34 d (new)
Recital 34 d (new)
(34d) Given the significance of the reference analytical methods and effect- based methods referred to in this directive, common reference guidelines will need to be issued in this regard.
Amendment 103 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Directive 2000/60/EC
Article 1 – point e) – fourth indent
Article 1 – point e) – fourth indent
Amendment 105 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Directive 2000/60/EC
Article 2 – point 24)
Article 2 – point 24)
Amendment 106 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive 2000/60/EC
Article 2 – point 30)
Article 2 – point 30)
Amendment 116 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point c
Article 1 – paragraph 1 – point 2 – point c
Directive 2000/60/EC
Article 2 – point 30 a)
Article 2 – point 30 a)
Amendment 117 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point d
Article 1 – paragraph 1 – point 2 – point d
Amendment 129 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point a
Article 1 – paragraph 1 – point 4 – point a
Directive 2000/60/EC
Article 4 – paragraph 1 – point a) – point iv)
Article 4 – paragraph 1 – point a) – point iv)
(iv) Member States shall implement the necessary measures to progressively reduce pollution from priority substances and river basin specific pollutants, and to cease or phase out emissions, discharges and losses of priority hazardous substances., with the exception of those no longer used or produced in Europe;
Amendment 137 #
2022/0344(COD)
Amendment 145 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7 – point a
Article 1 – paragraph 1 – point 7 – point a
Directive 2000/60/EC
Article 10 – paragraph 2 – point a)
Article 10 – paragraph 2 – point a)
(a) emission controls based on best available techniques;, to be established by the Commission in a specific delegated regulation
Amendment 166 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive 2000/60/EC
Article 20 a – paragraph 2
Article 20 a – paragraph 2
2. The power to adopt delegated acts referred to in Article 20(1) shall be conferred on the Commission for an indeterminate period of time from [OP please insert the date = the date of entry into force of this Directive]36 months following the issue of the reference guidelines on effect-based methods.
Amendment 168 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15
Article 1 – paragraph 1 – point 15
Directive 2000/60/EC
Article 21 – paragraph 1
Article 21 – paragraph 1
1. The Commission shall be assisted by a committee. That committee on which the Member States shall be represented by experts in areas including the construction and management of flood defences and infrastructure, storage facilities and the use of water intended mainly for irrigation and environmental upkeep. It shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.
Amendment 171 #
2022/0344(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 19
Article 1 – paragraph 1 – point 19
Directive 2000/60/EC
Annex VIII
Annex VIII
Amendment 178 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point a Directive 2006/118/EC
Article 2 – paragraph 1 – point 4 – point a Directive 2006/118/EC
(c) threshold values established at Union level in accordance with Article 8(3) and listed in Part D of Annex II to this Directive.environmental quality standards set at European level for consistency among the Member States to prevent disparities in chemical classification;
Amendment 179 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point b
Article 2 – paragraph 1 – point 4 – point b
Directive 2006/118/EC
Article 3 – paragraph 2
Article 3 – paragraph 2
Amendment 180 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point c
Article 2 – paragraph 1 – point 4 – point c
Directive 2006/118/EC
Article 3 – paragraph 5
Article 3 – paragraph 5
Amendment 181 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 4 – point d
Article 2 – paragraph 1 – point 4 – point d
Directive 2006/118/EC
Article 3 – paragraph 6 – subparagraph 1
Article 3 – paragraph 6 – subparagraph 1
Amendment 184 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
Directive 2006/118/EC
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
Amendment 186 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 1
Article 6a – paragraph 1 – subparagraph 1
The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by ECHA, a watch list of substances for which Union-wide monitoring data are to be gathered by the Member States and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. The same analytical techniques and methods shall be set for all Member States for the sake of data comparability. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).
Amendment 196 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 6
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 4
Article 6a – paragraph 1 – subparagraph 4
ECHA shall prepare scientific reports to assist the Commission in selecting the substances for the watch list, taking into account key scientific knowledge and the following information:
Amendment 210 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
Directive 2006/118/EC
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 219 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 7
Article 2 – paragraph 1 – point 7
Directive 2006/118/EC
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The Commission is empowered to adopt delegated acts, in accordance with Article 8a, to amend Annex I to adapt it to technical and scientific progress by adding or removing groundwater pollutants and quality standards for those pollutants set out in that Annex and to amend Part B in orderPart B to adapt it to technical and scientific progress by adding pollutants or indicators for which Member States have to consider establishing national thresholds.
Amendment 235 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
Directive 2006/118/EC
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The Commission shall be assisted by a Ccommittee. That committee on which the Member States shall be represented by experts in areas including the construction and management of flood defences and infrastructure, storage facilities and the use of water intended mainly for irrigation, for environmental upkeep. It shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council*.
Amendment 237 #
2022/0344(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 11
Article 2 – paragraph 1 – point 11
Directive 2006/118/EC
Annex I
Annex I
Amendment 243 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 2 – point a Directive 2008/105/EC
Article 3 – paragraph 1 – point 2 – point a Directive 2008/105/EC
(iii) the substances numbered 5, 9, 13, 15, 17, 21, 23, 24, 28, 30, 34, 37, 41, 44 in Part A of Annex I, for which revised EQS are set, and the newly identified substances numbered 46 to 70 in Part A of Annex I, with effect from … [OP please insert the date = the first day of the36 months following 18 months after the date of entry into force of this Directive]the issue of the guidelines on the reference analytical methods, with the aim of preventing deterioration in the chemical status of surface water bodies and of achieving good surface water chemical status in relation to those substances.;
Amendment 257 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
Directive 2008/105/EC
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The Commission shall review, for the first time by … [OP: Please insert the date = six years after the date of entry into force of this Directive] and every six years thereafter, the list of priority substances and the corresponding EQS for those substances set out in Part A of Annex I and the list of pollutants set out in Part A of Annex II. To this end, the Commission should determine the appropriate, proportionate and cost-effective level and combination of product and process checks for both point and diffuse sources. The substances should also be classified as priorities for action on the basis of the risk identified by means of a simplified assessment procedure anchored in scientific principles.
Amendment 275 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
Directive 2008/105/EC
Article 8a – paragraph 3
Article 8a – paragraph 3
3. Member States shall, from … [OP please insert the date = the first day of the36 months following 18 months after the date of entry into force of this Directive], for a period of two yearthe issue of the guidelines on the reference analytical methods, monitor the presence of estrogenic substances in water bodies, using effect-based monitoring methods. They shall conduct the monitoring at least four times during each of the two years at locations where the three estrogenic hormones 7-Beta estradiol (E2), Estrone (E1) and Alpha-Ethinyl estradiol (EE2) listed in Part A to Annex I to this Directive, are being monitored using conventional analytical methods in accordance with Article 8 of Directive 2000/60/EC and Annex V to that Directive. Member States may use the network of monitoring sites identified for the surveillance monitoring of representative surface water bodies in accordance with point 1.3.1 of Annex V to Directive 2000/60/EC. To this end, the resources required to perform these activities need to be duly incorporated, and specific guidelines and reference analytical methods are essential. In addition, a training period should be factored in for staff at the national environmental agencies.
Amendment 276 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 1
Article 8b – paragraph 1 – subparagraph 1
The Commission is empowered to adopt implementing acts to establish, having regard to scientific reports prepared by ECHA, a watch list of substances for which it is necessary to gather Union wide monitoring data from the Member States and to lay down the formats to be used by the Member States for reporting the results of that monitoring and related information to the Commission. The monitoring activities are not expected to entail costs for farms. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 9(2).
Amendment 277 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 7 Directive 2008/105/EC
Article 3 – paragraph 1 – point 7 Directive 2008/105/EC
The watch list shall contain a maximum of 10 substances or groups of substances at any one time, and shall indicate the monitoring matrices and the possible methods of analysis for each substance. Those monitoring matrices and methods shall not entail excessive costs for the competent authorities. For these investigations, an in-depth assessment will nevertheless be required to estimate the costs associated with monitoring, the analytical methods, equipment upgrades and dedicated staff. The substances to be included in the watch list shall be selected from amongst the substances for which the information available indicates that they may pose a significant risk at Union level to, or via, the aquatic environment and for which monitoring data are insufficient. The watch list shall include substances of emerging concern.
Amendment 285 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 3
Article 8b – paragraph 1 – subparagraph 3
As soon as suitable monitoring, precise and EU-wide analytical methods for monitoring micro- plastics (including the types that will need to be sought) and selected antimicrobial resistance genes have been identified, those substances shall be included in the watch list.
Amendment 288 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 4 – introductory part
Article 8b – paragraph 1 – subparagraph 4 – introductory part
ECHA shall prepare scientific reports to assist the Commission in selecting the substances for the watch list, taking into account key scientific knowledge and the following information:
Amendment 290 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 4 – point e
Article 8b – paragraph 1 – subparagraph 4 – point e
(e) research projects and scientific publications, including information on trends and predictions based on modelling or other predictive assessments and data and information from remote sensing technologies, earth observation (Copernicus services), in-situ sensors and devices, or citizen science data, leveraging the opportunities offeprovided that the models or other predictive assessments, sensors and devices ared by artificial intelligence, advanced data analysis and processingroadly accepted by the scientific community as approaches with sound scientific foundations.
Amendment 297 #
2022/0344(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
Directive 2008/105/EC
Article 8d
Article 8d
Amendment 299 #
2022/0344(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [OP please insert the date = the first day of the month following 18 months aftermonth once 36 months have elapsed since the datissue of entry into forcethe guidelines ofn this Directivee reference analytical methods].
Amendment 306 #
2022/0344(COD)
Proposal for a directive
Annex II – paragraph 1 – point 2
Annex II – paragraph 1 – point 2
Directive 2000/60/EC
Annex VIII – point 13
Annex VIII – point 13
Amendment 310 #
2022/0344(COD)
Proposal for a directive
Annex III
Annex III
Directive 2006/118/EC
Annex I – Footnote 12 a (new)
Annex I – Footnote 12 a (new)
(12a) All references to the PFAS shall include their salts and the linear and branched structural isomers.
Amendment 311 #
2022/0344(COD)
Proposal for a directive
Annex III
Annex III
Directive 2006/118/EC
Annex I – Footnote 12 b (new)
Annex I – Footnote 12 b (new)
(12b) Given the different criteria for identifying metabolites in the Member States, provision will need to be made, before this directive enters into force, for a list of active substances together with the relevant and non-relevant metabolites and information on the associated risk.
Amendment 316 #
2022/0344(COD)
Proposal for a directive
Annex V – paragraph 1 – point 2
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I Part A – Table – Row 2 – Footnote 3
Annex I Part A – Table – Row 2 – Footnote 3
(3) This parameter is the EQS expressed as an annual average value (AA‑- EQS). Unless otherwise specified, it applies to the total concentration of all substances anisomers, including branched isomers.
Amendment 317 #
2022/0344(COD)
Proposal for a directive
Annex V – paragraph 1 – point 2
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I – Part A – Table – Row 9 – Footnote 10
Annex I – Part A – Table – Row 9 – Footnote 10
(10) No indicative parameter is provided for this group of substances. The indicative parameter(s) must be dey therefore need to be clearly identifined through the analytical methodand standardised at Member State level.
Amendment 246 #
2022/0195(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) It is appropriate to set an overarching objective for ecosystem restoration to foster economic and societal transformation, the creation of high-quality jobs and sustainable growth. Biodiverse ecosystems such as wetland, freshwater, forest as well as agricultural, sparsely vegetated, marine, coastal and urban ecosystems deliver, if in good condition, a range of essential ecosystem services, and the benefits of restoring degraded ecosystems to good condition in all land and sea areas far outweigh the costs of restoration. Those services contribute to a broad range of socio-economic benefits, depending on the economic, social, cultural, regional and local characteristics.
Amendment 270 #
2022/0195(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Geo-political developments have further underlined the need to safeguarprotect and enhance food security and the resilience of food systems.62 Evidence shows that restoring agro-degraded 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. _________________ 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 276 #
2022/0195(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) The restoration of ecosystems, coupled with efforts to reduce wildlife trade and, consumption and to promote sustainable management, will also help prevent and build up resilience to possible future communicable diseases with zoonotic potential, therefore decreasing the risks of outbreaks and pandemics, and contribute to support EU and global efforts to apply the One Health approach, which recognises the intrinsic connection between human health, animal health and healthy resilient nature.
Amendment 290 #
2022/0195(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Building on Directives 92/43/EEC and 2009/147/EC and in order to support the achievement of the objectives set out in those Directives, Member States should put in place restoration measures to ensure the recovery of protected habitats and species, including wild birds, across Union areas, also in areas that fall outside Natura 2000, always ensuring compliance with the principle of coexistence with agricultural activity.
Amendment 368 #
2022/0195(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) The EU Biodiversity Strategy for 2030 requires greater efforts to restore freshwater ecosystems and the natural functions of rivers. The restoration of freshwater ecosystems should include efforts to restore the natural longitudinal and lateral connectivity of rivers as well as their riparian areas and floodplains, including through the removal of barriers with a view to supporting the achievement of favourable conservation status for rivers, lakes and alluvial habitats and species living in those habitats protected by Directives 92/43/EEC and 2009/147/EC, and the achievement of one of the key objectives of the EU Biodiversity Strategy for 2030, namely, the restoration of at least 25 000 km of free-flowing rivers. When removing barriers, Member States should primarily address obsolete barriers, which are those that are no longer needed for renewable energy generation, inland navigation, water supply or other uses.
Amendment 428 #
2022/0195(COD)
Proposal for a regulation
Recital 55
Recital 55
(55) In order to reap the full biodiversity benefits, restoration and rewetting of areas of drained peatland shouldcan extend beyond the areas of wetlands habitat types listed in Annex I of Directive 92/43/EEC that are to be restored and re-established. Data about the extent of organic soils as well as their greenhouse gas emissions and removals are monitored and made available by LULUCF sector reporting in national greenhouse gas inventories by Member States, submitted to the UNFCCC. Restored and rewetted peatlands can continue to be used productively in alternative ways. For example, paludiculture, the practice of farming on wet peatlands, can include cultivation of various types of reeds, certain forms of timber, blueberry and cranberry cultivation, sphagnum farming, and grazing with water buffaloes. Such practices should be based on the principles of sustainable management and aimed at enhancing biodiversity so that they can have a high value both financially and ecologically. Paludiculture can also be beneficial to several species which are endangered in the Union and can also facilitate the connectivity of wetland areas and of associated species populations in the Union. Funding for measures to restore and rewet drained peatlands and to compensate possible losses of income can come from a wide range of sources, including expenditure under the Union budget and Union financing programmes.
Amendment 542 #
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 nature across the Union’s land and sea areas through the restoration of degraded ecosystems;
Amendment 580 #
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 up to 20 % of the Union’s land and sea areas and, by 2050, all ecosystems in need of restoration.
Amendment 595 #
2022/0195(COD)
(1a) ‘degraded ecosystems’ means an ecosystem that due to the loss of their natural conditions, have lost their production capacity, ability to produce important ecosystem services or ability to capture and store carbon dioxide;
Amendment 601 #
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 ecosystem towards or to good condition, of a habitat type to the highest level of condition attainable and to its favourable reference area, of a habitat of a species to a sufficient quality and quantity, or of species populations to satisfactory levels, as a means of cona state in which the ecosystem sufficiently produces important ecosystem servingces or enhancing biodiversity and ecosystem resiliencesufficiently hosts biological diversity;
Amendment 625 #
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 productivity;
Amendment 674 #
2022/0195(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘urban green space’ means all green urban areas; broad-leaved forests; coniferous forests; mixed forests; natural grasslands; moors and heathlands; transitional woodland-shrubs and sparsely vegetated areas - excluding areas used for agricultural purposes, as found within cities or towns and suburbs calculated on the basis of data provided by the Copernicus Land Monitoring Service as established by Regulation (EU) 2021/696 of the European Parliament and of the Council110 ; _________________ 110 Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU (OJ L 170, 12.5.2021, p. 69).
Amendment 685 #
2022/0195(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15 a (new)
Article 3 – paragraph 1 – point 15 a (new)
(15a) “force majeure”: 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 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 authorized in accordance with Article 6(4) of Directive 92/43/EEC.
Amendment 724 #
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 in place on at least 30 % of the area of each group of habitat typeoverall 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 731 #
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 on 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 809 #
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 inside Natura 2000 do not deteriorate.
Amendment 853 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 8 – point c
Article 4 – paragraph 8 – point c
(c) a project of overriding public interest for which no less damaging alternative solutions are available, to be determined on a case by case basis. , including measures to maintain food security and production of food and renewable resources;
Amendment 892 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 9 – point a
Article 4 – paragraph 9 – point a
(a) force majeure, including natural disasters;
Amendment 907 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 9 – point b
Article 4 – paragraph 9 – point b
(b) unavoidable habitat transformations or other circumstances which are directly caused by climate change: or
Amendment 933 #
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;
Amendment 942 #
2022/0195(COD)
Proposal for a regulation
Article 4 – paragraph 10 – point b
Article 4 – paragraph 10 – point b
(b) an increasing trend towards the sufficient quality and quantity of the terrestrial, coastal and freshwater habitats of the species referred to in Annexes II, IV and V to Directive 92/43/EEC and of the species covered by Directive 2009/147/EC.
Amendment 957 #
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 evaluated not in good condition based on the best available knowledge. Such measures shall be in place on at least 320 % of theeach area of each groups 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 981 #
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 estimated areas not covered by those habitat types, based on the best available knowledge. Such measures shall be in place on areas representing at least 320 % of the additional overall surface evaluated as needed to reach the total favourable reference area of each group of habitat types, based on the best available knowledge, 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 996 #
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 condition.
Amendment 1316 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Member States shall, taking into account social and economic requirements, 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).
Amendment 1326 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – introductory part
Article 9 – paragraph 2 – introductory part
2. Member States shall 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 20305, and every three years thereafter, until the satisfactory levels, identified in accordance with Article 11(3), are reached:
Amendment 1333 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point a
Article 9 – paragraph 2 – point a
Amendment 1343 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
Amendment 1356 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) share of agricultural land with high- diversity landscape features according to the CAP Strategic plan.
Amendment 1380 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point a
Article 9 – paragraph 3 – point a
(a) 110 by 20305, 120 by 20405 and 130 by 20505, for Member States listed in Annex V with historically more depleted populations of farmland birds;
Amendment 1401 #
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:
Amendment 1408 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point a
Article 9 – paragraph 4 – subparagraph 1 – point a
Amendment 1425 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point b
Article 9 – paragraph 4 – subparagraph 1 – point b
Amendment 1438 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 1 – point c
Article 9 – paragraph 4 – subparagraph 1 – point c
Amendment 1452 #
2022/0195(COD)
Proposal for a regulation
Article 9 – paragraph 4 – subparagraph 2
Article 9 – paragraph 4 – subparagraph 2
Amendment 1607 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 2 – point a – point ii
Article 11 – paragraph 2 – point a – point ii
(ii) the habitat area evaluated as not in good condition;
Amendment 1642 #
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 comprehensive assessment, based on the latest scientific evidence and, if available, the framework referred to in Article 17(9). When identifying the indicators referred to in Article 10(2) (a) and (b), Member States shall also consider phytosanitary safety criteria aimed at preventing the spread of harmful pathogens for the forest ecosystem species.
Amendment 1671 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 4
Article 11 – paragraph 4
4. Member States shall 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 1769 #
2022/0195(COD)
Proposal for a regulation
Article 11 – paragraph 11 a (new)
Article 11 – paragraph 11 a (new)
11a. The restoration plan is carried out in consultation and cooperation with representatives of owners and managers. Member States shall ensure that the preparation of the restoration plan complies with the principle of prior and informed consent and that no area is considered for restorations actions without its owner having the opportunity to express its view on the projects nor without the available financial means for adequate compensation.
Amendment 1777 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The national restoration plan shall cover the period up to 2050, with intermediate deadlines corresponding to the targets and obligations set out in Articles 4 to 130.
Amendment 1835 #
2022/0195(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point k – point iii a (new)
Article 12 – paragraph 2 – point k – point iii a (new)
(iiia) synergies, objectives and results of other National Plans foreseen by other policies, such as the CAP National Plans;
Amendment 1915 #
2022/0195(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. When assessing the draft national restoration plan, the Commission shall evaluate its compliance with Article 12, as well as its adequacy for meeting the targets and obligations set out in Articles 4 to 10, as well as the Union’s overarching objectives referred to in Article 1, the specific objectives referred to in Article 7(1) to restore at least 25 000 km of rivers into free-flowing rivers in the Union by 20305 and the 20305 objective of covering at least 10% of the Union’s agricultural area with high-diversity landscape features.
Amendment 2088 #
2022/0195(COD)
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 2
Article 18 – paragraph 2 – subparagraph 2
The first reports shall be submitted in June 20316, covering the period up to 20305.
Amendment 2120 #
2022/0195(COD)
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
Amendment 2129 #
2022/0195(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
Amendment 2139 #
2022/0195(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
Amendment 2147 #
2022/0195(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
Amendment 2174 #
2022/0195(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. The Commission shall evaluate the application of this Regulation by 31 December 203540.
Amendment 2188 #
2022/0195(COD)
Proposal for a regulation
Annex II – paragraph 2
Annex II – paragraph 2
Amendment 2189 #
2022/0195(COD)
Proposal for a regulation
Annex III – title
Annex III – title
MARINE SPECIES REFERRED TO IN ARTICLE 5(3) The list below includes the marine species listed in Annex II, IV and V of Directive 92/43/EEC and Directive 2009/147/EC.
Amendment 2332 #
2022/0195(COD)
Proposal for a regulation
Annex VII – point 24
Annex VII – point 24
(24) Minimise negative impacts of fishing activities on the marine ecosystem, for example by using gear with less impact on seabedas provided in Regulation (EU) No 1380/2013.
Amendment 161 #
2022/0140(COD)
Draft legislative resolution
Citation 8 a (new)
Citation 8 a (new)
— Having regard to the Commission's communication of 3 February 2021 on Europe's Beating Cancer Plan (COM(2021)0044),
Amendment 163 #
2022/0140(COD)
Draft legislative resolution
Citation 8 b (new)
Citation 8 b (new)
— Having regard to the EU's Framework Programme for Research and Innovation 2021-2027 (Horizon Europe) and the dedicated Horizon Europe Mission on Cancer,
Amendment 166 #
2022/0140(COD)
Draft legislative resolution
Citation 8 c (new)
Citation 8 c (new)
— Having regard to its resolution of 16 February 2022 on strenghtening Europe in the fight against cancer - towards a comprehensive and coordinated strategy (2020/2267(INI)), and the work of the Special Committee on Beating Cancer (BECA) in its mandate,
Amendment 218 #
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. Specifically relevant fields in the EHR should be clearly marked, such as patient ID, allergies, laboratory data, medical alerts, co- morbility and current medications. 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 288 #
2022/0140(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Furthermore, in accordance with the strenghtened role of the European Center for Diseases Control and Prevention (ECDC), Member States should ensure that the ECDC receives real-time and comparable data on vaccination, including vaccination coverage listed on the ECDC vaccine schedule and vaccine-preventable disease surveillance. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.
Amendment 320 #
2022/0140(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides ththis Regulation provides the appropriate and necessary safeguards. In addition, this Regulation should create a right for data users to process special categories of personal data referred to Article 9(1) of Regulation (EU)2016/679 subject to those same safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.
Amendment 528 #
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 the compatible further processing of electronic health data for purposes set out in Chapter IV of this Regulation, and, where such electronic health data is personal data, in accordance with Article 5(1)(b) of Regulation (EU) 2016/679. The data used may include 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;
Amendment 571 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point y
Article 2 – paragraph 2 – point y
(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation,o has the right or obligation to make available the relevant and appropriate data pursuant to the relevant requirements laid down in this Regulation. This should be in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or, in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;. This definition should be supported by Annex [xxx] with the following specifications: a) The definition of "data holder" shall not include all entities that have an obligation to share data for any purpose (e.g. an obligation to share data with regulators to ensure rugulatory compliance); b) The definition of "data holder" shall not include all entities which simply process data for technical reasons (e.g. if an entity only holds data transiently in order to process it on the instructions of others); c) In the context of a clinical trial, the sponsor of the clinical trial will always be the sole data holder of electronic clinical trial data. Where the sponsor is located outside of the EU, its EU legal representative will assume the role of data holder or other designated entity established within the Community.
Amendment 1031 #
2022/0140(COD)
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2), after consultation with the EHDS Board and other relevant stakeholders.
Amendment 1179 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point g
Article 33 – paragraph 1 – point g
(g) identification data related to health professionals involved in the treatment of a natural personresearch should be limited to data which are absolutely necessary;
Amendment 1185 #
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 completed clinical trials, in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;
Amendment 1190 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point j a (new)
Article 33 – paragraph 1 – point j a (new)
(j a) Data referred to in paragraph 1(j) should be made available in the format outlined in Annex IV in Regulation No 536/2014 or, if requested by the public sector, as defined in the Data Act Article 15 (a) or (b).
Amendment 1191 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point j b (new)
Article 33 – paragraph 1 – point j b (new)
(j b) Regarding electronic health data referred to in paragraph 1(j) of this Article, a summary of results of the clinical trial will be published and individual patient data may be shared, in accordance with Article 37(4) of Regulation (EU) No 536/2014.
Amendment 1406 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) Unfair commercial use or other unfair competitions, in accordance with Article 39 of TRIPS;
Amendment 1409 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e b (new)
Article 35 – paragraph 1 – point e b (new)
(e b) using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder's referenced product is under patent or regulatory data protection (including such use of data outside of the EU) or equivalent protected data of non- medicinal products, such as medical devices and software medical devices.
Amendment 1538 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 4 a (new)
Article 37 – paragraph 4 a (new)
4 a. Following open and public consultations, the Commission shall adopt guidelines on the functioning of the health data access bodies to ensure coherent processes among them.
Amendment 1688 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10 a (new)
Article 43 – paragraph 10 a (new)
10 a. Data holders lawfully protecting their IP rights and commercial property shall not be subject to fines while any disputes concerning the protection of industrial and commercial property are being resolved, in order to avoid conflicting obligations.
Amendment 1689 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10 b (new)
Article 43 – paragraph 10 b (new)
10 b. Data holders that breach the Regulation are subject to fines.
Amendment 1913 #
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 and interoperability requirements for the secure processing environments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The EHDS Board shall ensure consistent provision of the secure processing environment compliant with the technical information security and interoperability requirements and enforce compliance across the Member States.
Amendment 2000 #
2022/0140(COD)
Proposal for a regulation
Article 61 – paragraph 1
Article 61 – paragraph 1
1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.
Amendment 2105 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1 a (new)
Article 70 – paragraph 1 a (new)
1a. After two years from the entry into force of this Regulation, the Commission shall carry out an evaluation on the Union funding attributed to the setting up and working of the EHDS, notably as to the ability of Union bodies to carry out their tasks under this Regulation and of Member States to apply the Regulation in a uniform and coherent manner. The Commission shall 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 legislative proposals. Stakeholders shall be consulted in the preparation of the evaluation report.
Amendment 137 #
2022/0104(COD)
Proposal for a directive
Recital 2
Recital 2
(2) The European Green Deal announced a revision of Union measures to address pollution from large industrial installations, including reviewing the sectoral scope of the legislation and how to make it fully consistent with climate, energy and circular economy policies. In addition, the Zero Pollution Action Plan, the Circular Economy Action Plan and the Farm to Fork Strategy also call for reducing pollutant emissions at source, including sources not currently within the scope of Directive 2010/75/EU of the European Parliament and of the Council69 . Addressing pollution from certain agro- industrial activities thus requires their inclusion within the scope of that Directive. __________________ 69 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control); OJ L 334, 17.12.2010, p. 17-119.
Amendment 149 #
2022/0104(COD)
Proposal for a directive
Recital 4
Recital 4
(4) Rearing of pigs and, poultry cand cattle cause significant cause pollutant emissions into the soil, 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 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 that could be harmful to the environment. In addition to the targets set under the CAP, Directive (EU) 2016/2284 ('NEC')1a set targets to reduce emissions, including ammonia, from agriculture. Therefore, in order to avoid creating an administallations, and the range of environmental impacts they may have. The proportionality requirements in BATs aim to incenrative burden and unnecessary overlaps in the current legislativise farmers to implement the necessary transition towards increasingly environmentally friendly agricultural practicesramework, the current thresholds for pigs and poultry should remain unchanged.
Amendment 228 #
2022/0104(COD)
Proposal for a directive
Recital 27
Recital 27
(27) In light of the high number of rearing installationpig and poultry farms that should be included within the scope of Directive 2010/75/EU, and the relative simplicity of the processes and emissions patterns of such installationfarms, it is appropriate to set out specific simplified administrative procedures for issuing permits and for the operation of the relevant activities which are adapted to the sector, without prejudice to requirements related to public information and participation, monitoring and compliance.
Amendment 236 #
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, 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 rearing of poultry, pigs and cattle, and to amend Annexes I and Ia to that Directive by adding an agro-industrial activity to ensure that it meets its objectives to prevent or reduce pollutants emissions and achieve a high level of protection of human health and the environmentCommission shall establish operating rules containing requirements for activities relating to rearing of poultry and pigs. 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,of the European Parliament and the Council, they will 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 actthe operating rules. __________________ 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 243 #
2022/0104(COD)
Proposal for a directive
Recital 29 a (new)
Recital 29 a (new)
(29a) When establishing the operating rules, the Commission should ensure the exclusion of family farms, farms that are located in disadvantage areas, organic farms and all those farms that are taking actions in circular economy, reuse of livestock by-products and other sustainable practices towards an active reduction in livestock emissions and or improving the sustainability of their rearings.
Amendment 276 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2010/75/EU
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘installation’ means a stationary technical unit within which one or more activities listed in Annex I, in Annex Ia or in Part 1 of Annex VII are carried out, and any other directly associated activities on the same site which have a technical connection with the activities listed in those Annexes and which could have an effect on emissions and pollution;;
Amendment 307 #
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, emission levels associated with emerging techniques, environmental performance levels associated with emerging techniques, associated monitoring, associated consumption levels and, where appropriate, relevant site remediation measures;;
Amendment 319 #
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 358 #
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 48
Article 3 – paragraph 1 – point 48
(48) ‘industrial minerals’ means minerals used in industry for the production of semi-finished or finished products, with the exception of metalliferous ores, energy minerals, and minerals used for the production of construction minaterials and precious stones;
Amendment 360 #
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 371 #
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 382 #
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 503 #
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 507 #
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 a (new)
Article 9 – paragraph 2 a (new)
(7) In Article 9, paragraph 2 a (new) is added: 2a. For activities listed in Annex I to Directive 2003/87/EC, Member States may choose not to impose requirements relating to energy efficiency in respect of combustion units or other units emitting carbon dioxide on the site in case installations are covered by the obligation to conduct an energy audit or implement an energy management system pursuant to Article 8 of Directive 2012/27/EU or the operator implements equivalent measures.
Amendment 526 #
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 537 #
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 c
Article 11 – paragraph 1 – point f c
Amendment 568 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9 – point a
Article 1 – paragraph 1 – point 9 – point a
Directive 2010/75/EU
Article 13 – paragraph 1
Article 13 – paragraph 1
1. In order to draw up, review and, where necessary, update BAT reference documents, the Commission shall organise an exchange of information between Member States, the industries concerned, non-governmental organisations promoting environmental protection, the European Chemicals Agency and the Commission. The European Chemicals Agency will act as an observer of the process only providing scientific technical input for updating documents and will not have a role in the decision making process’.
Amendment 606 #
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 701 #
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
Article 14a
Amendment 711 #
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 1 – subparagraph 2a (new)
Article 14a – paragraph 1 – subparagraph 2a (new)
Implementation and adherence to an internationally accepted standardised system such as the European Union eco- management and audit scheme (EMAS) or the EN ISO 14001, can give higher credibility to the EMS especially when subject to a properly performed external verification.
Amendment 718 #
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 – introductory part
Article 14a – paragraph 2 – point a – introductory part
(a) indicative environmental policy objectives for the continuous improvement of the environmental performance and safety of the installation, which shall include measures to:
Amendment 743 #
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
(b) indicative objectives and performance indicators in relation to significant environmental aspects, which shall take into account benchmarks set out in the relevant BAT conclusions and the life- cycle environmental performance of the supply chain;
Amendment 745 #
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 c
Article 14a – paragraph 2 – point c
Amendment 749 #
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 d
Article 14a – paragraph 2 – point d
(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 alternativesused and manufactured in the installation;
Amendment 754 #
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 f
Article 14a – paragraph 2 – point f
Amendment 758 #
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 f a (new)
Article 14a – paragraph 2 – point f a (new)
(fa) The level of detail and the degree of formalisation of the EMS will generally be related to the nature, scale and complexity of the installation, and the range of environmental impacts it may have.
Amendment 764 #
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
Article 14a – paragraph 3
3. The relevant aspects of the EMS of an installation shall be made available on the Internet, free of charge and without restricting access to registered users.
Amendment 801 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 3 – subparagraph 1 – introductory part
Article 15 – paragraph 3 – subparagraph 1 – introductory part
The competent authority shall set the strictest possible emission limit values that are consistent with the lowest emissions achievable by applying BAT in the installation, and that ensure that, under normal operating conditions, emissions do not exceed the emission levels associated with the best available techniques (BAT- AELs) as laid down in the decisions on BAT conclusions referred to in Article 13(5). The emission limit values shall be based on an assessment by the operator of the whole range of BAT- AELs analysing the feasibility of meeting the strictest end of the BAT-AEL range and demonstrating the best performance the installation can achieve by applying BAT as described in BAT conclusions. The emission limit values shall be set through either of the following:lowest possible emission limit values that the installation can achieve at the highest expected emission state under normal operating conditions by applying BAT as described in BAT conclusion, and with an overall environmental approach, taking into account cross media effects as well as energy and other resource consumption such as water and raw materials.
Amendment 825 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Directive 2010/75/EU
Article 15 – paragraph 3 a
Article 15 – paragraph 3 a
Amendment 864 #
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 880 #
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 895 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
The Commission shall adopt an implementing act, to establish a standardised methodology for assessing the disproportionality between the costs of implementation of the BAT conclusions and the potential environmental benefits referred to in the first subparagraph and considering the investment cycle related to the sustainability transition of the operator’s group. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 75(2).
Amendment 899 #
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 a (new)
Article 15 – paragraph 4 a (new)
4a. By way of derogation from paragraph 3, in cases where an installation faces a sudden interruption in the supply of raw materials or fuels or a disruption of abatement technique’s elements, the competent authority shall establish less strict emission limit values, for a maximum of 3 months, which may be extended when the extraordinary circumstances persist, subject to a simplified assessment justifying the reasons and period for this temporary adjustment. Member States shall inform the Commission of any derogation granted under these circumstances. As soon as the supply conditions are restored then the derogation will no longer be valid. However, if the same circumstances keep prevailing, the adjustment of the emission limit values may be prolonged for another period of 6 months.
Amendment 938 #
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 shall 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 964 #
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 1008 #
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
Article 24 – paragraph 3 – point c
Amendment 1031 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Directive 2010/75/EU
Article 27 – paragraph 1
Article 27 – paragraph 1
Member States shall, where appropriate, encourage the development and application of emerging techniques, in particular where such techniques have been identified inby the BAT conclusions, the BAT reference documents or the findings of the innovation centre for industrial transformation and emissions referred to in Article 27ainnovation centre for industrial transformation and emissions (‘INCITE’) referred to in Article 27a and included the BAT reference documents. Member States may, where appropriate, encourage the application of emerging techniques where such techniques have been identified in the BAT conclusions.
Amendment 1050 #
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 techniquesinnovative techniques, including emerging techniques identified by the innovation centre for industrial transformation and emissions (‘INCITE’) referred to in Article 27a for a total period of time not exceeding 2436 months, subjected to extension depending on the Technology Readiness Levels of the specific technique.
Amendment 1064 #
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 15(3) and article 21 (3)(b), the competent authority may set emission limit values that ensure that, within 64 years of publication of athe date where the permit has been amended, emissions shall not, under normal operating conditions, exceed emission levels associated with emerging techniques as laid down in the decisions 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 emission levels associated with emerg. Where the time period referred 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 maximum period of 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 ing techniques as laid down in the decisions on BAT conclusions. he 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 1069 #
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 – number
Article 27 d – number
Amendment 1078 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Amendment 1083 #
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
Article 27 d – paragraph 1
Amendment 1089 #
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
Amendment 1109 #
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
Article 27 d – paragraph 1 – subparagraph 2
Amendment 1129 #
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
Amendment 1146 #
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 2
Article 27 d – paragraph 2 – subparagraph 2
Amendment 1155 #
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
Amendment 1174 #
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 4
Article 27 d – paragraph 4
Amendment 1231 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 24
Article 1 – paragraph 1 – point 24
Directive 2010/75/EU
Chapter VIa – title
Chapter VIa – title
SPECIAL PROVISIONS FOR INTENSIVE REARING OF POULTRY, AND PIGS AND CATTLE
Amendment 1244 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70a – paragraph 1
Article 70a – paragraph 1
Amendment 1248 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70a – paragraph 1a (new)
Article 70a – paragraph 1a (new)
By way of derogation from the first paragraph to this Article 70a, Member States can establish national rewarding systems in order to push farms toward more sustainability in term of emissions. This can result, among other things, in an increase of thresholds above which farms fall into the scope of this Directive for those farms that adopt sustainability and circular economy measures in order to lower their environmental impact in terms of emissions. In particular, farms that produce biogases for self-consumption in adjacent micro-installations and/or farms that confer manure to biogas installations or power plants, shall benefit from an increase in the thresholds for falling into the scope of this Directive.
Amendment 1263 #
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 1281 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70c – paragraph 1a (new)
Article 70c – paragraph 1a (new)
By way of derogation from the first paragraph to this Article, Member States may set a specific procedure for the registration of the installations only covered by this Chapter. The procedure for the registration shall be specified in a binding act and include at least a notification to the competent authority by the operators of the intention to operate its activity. Member States may use any similar pre existing procedure for the registration. They shall avoid administrative burden and additional costs for the operators. Member States shall issue the permits within six months from the date of the operator's application.
Amendment 1283 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70c – paragraph 1a (new)
Article 70c – paragraph 1a (new)
1a. Where the Member State considers that an operation or type of operation does not present genuine risks, it may provide for exemptions from authorisation and may provide simplified authorisations that may take the form of a simple notification.
Amendment 1347 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 25
Article 1 – paragraph 1 – point 25
Directive 2010/75/EU
Article 70f – paragraph 3 – subparagraph 2
Article 70f – paragraph 3 – subparagraph 2
Where non-compliance causes a significant degradation of local air, water or soil conditions, or where it poses, or risks to pose, a significant danger to human health, the operation of the installation shall be suspended by the competent authority until compliance is may be subject to binding measures tored stop the degradation.
Amendment 1389 #
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 1 – introductory part
Article 70i – paragraph 1 – subparagraph 1 – introductory part
Amendment 1422 #
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 2
Article 70i – paragraph 2
Amendment 1449 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 27
Article 1 – paragraph 1 – point 27
Directive 2010/75/EU
Article 74 – paragraph 1
Article 74 – paragraph 1
Amendment 1456 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 27
Article 1 – paragraph 1 – point 27
Directive 2010/75/UE
Article 74 – paragraph 2
Article 74 – paragraph 2
Amendment 1480 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 29
Article 1 – paragraph 1 – point 29
Directive 2010/75/EU
Article 76 – paragraph 2
Article 76 – paragraph 2
Amendment 1483 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 29
Article 1 – paragraph 1 – point 29
Directive 2010/75/EU
Article 76 – paragraph 3
Article 76 – paragraph 3
Amendment 1508 #
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 a (new)
Article 79 – paragraph 2 a (new)
2a. Since agricultural activity cannot be treated as an industrial activity, the provisions of this Directive can under no circumstances lead to penalties in the event of infringement of national implementing provisions by natural or legal persons carrying out an activity in the agricultural sector.
Amendment 1580 #
2022/0104(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 34
Article 1 – paragraph 1 – point 34
Directive 2010/75/EU
Annex Ia
Annex Ia
Amendment 1587 #
2022/0104(COD)
Proposal for a directive
Article 3 a (new)
Article 3 a (new)
Article 3 a Transitional provisions 1. In relation to installations carrying out activities referred to in Annex I, points 1.1, to 1.3, point 1.4 (except pyrolysis), point 2.1, point 2.2, point 2.3(a), point 2.3(b), point 2.3(c), points 2.4 to 2.6, points 3.1 to 3.5, points 4.1 to 4.6, point 5.1 to 5.6, point 5.3 (except anaerobic digestion), points 5.4 to 5.6, point 6.1, point 6.2 (except finishing of textile fibres), point 6.3, point 6.4, point 6.5 (except animal by products), point 6.7 which are in operation and hold a permit before [the first day of the month following 18 months after the date of entry into force of this Directive] or the operators of which have submitted a complete application for a permit before that date, provided that those installations are put into operation no later than [one year after the first day of the month following 18 months after the date of entry into force of this Directive], Member States shall apply the laws, regulations and administrative laws, regulations and administrative provisions adopted in accordance with Article 3(1) of the recast of Directive 2010/75/EU from [one year after the first day of the month following 18 months after the date of entry into force of this Directive]. 2. In relation to installations carrying out activities referred to in Annex I, point 1.4 for activities concerning pyrolysis, points 2.3(aa), point 2.3(ab), point 2.3 (bb), point 2.7, point 3.6, point 5.3 for activities concerning anaerobic digestion, point 6.2 for activities concerning finishing of textile fibres and point 6.5 for activities concerning animal by-products which are in operation before [the first day of the month following 18 months after the date of entry into force of this Directive], Member States shall apply the laws, regulations and administrative provisions adopted in accordance with this Directive from [two years after the first day of the month following 18 months after the date of entry into force of this Directive].
Amendment 1638 #
2022/0104(COD)
Proposal for a directive
Annex I – paragraph 1 – point h
Annex I – paragraph 1 – point h
Directive 2010/75/EU
Annex I – paragraph 3 – subparagraph 6 – point 6.2
Annex I – paragraph 3 – subparagraph 6 – point 6.2
6.2. Pre-treatment (operations such as washing, bleaching, mercerisation), dyeing or dyeing with integrated finishing of textile fibres or textiles where the treatment capacity exceeds 10 tonnes per day.;
Amendment 1658 #
2022/0104(COD)
Proposal for a directive
Annex II
Annex II
Directive 2010/75/EU
Annex Ia – paragraph 1
Annex Ia – paragraph 1
Amendment 1680 #
2022/0104(COD)
Proposal for a directive
Annex II
Annex II
Directive 2010/75/EU
Annex Ia – paragraph 2
Annex Ia – paragraph 2
Amendment 154 #
2022/0095(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Chemical safety is a recognised element of product sustainability. It is based on chemicals’ intrinsic hazards to health or the environment in combination with specific or generic exposure, and is addressed by chemicals legislation, such as Regulation (EC) No 1935/2004 of the European Parliament and of the Council58, Regulation (EC) No 1907/2006 of the European Parliament and of the Council59, Regulation (EC) No 1223/2009 of the European Parliament and of the Council60, Regulation (EU) 2017/745 of the European Parliament and of the Council61 and Directive 2009/48/EC of the European Parliament and of the Council62. This Regulation shouldmust not enable the restriction of substances based on chemical safety, as done under other Union legislation. Similarly, this Regulation should not enable the restriction of substances for reasons related to food safety. Union law on chemicals and food, however, does not allow addressing, through restrictions on certain substances, impacts on sustainability that are unrelated to chemical safety or food safety. To overcome this limitation, this Regulation should allow, under certain conditions, for the restriction, primarily for reasons other than chemical or food safety, of substances present in products or used that negatively affect products’ sustainability. Such restrictions should be assessed according their manufacturing processes which negatively affect products’ sustainabilityo proportionality criteria, taking into account the actual environmental impact of the substance in the finished product placed on the market, the availability of alternatives and the effectiveness of the product itself. This Regulation also should not result in the duplication or replacement of restrictions of substances covered by Directive 2011/65/EU of the European Parliament and of the Council63, which has as its objective the protection of human health and the environment, including the environmentally sound recovery and disposal of waste from electrical and electronic equipment. __________________ 58 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4). 59 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1). 60 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59). 61 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176). 62 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (OJ L 170, 30.6.2009, p. 1). 63 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 (OJ L 174, 1.7.2011, p. 88).
Amendment 165 #
2022/0095(COD)
Proposal for a regulation
Recital 23
Recital 23
Amendment 190 #
2022/0095(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) The information requirements set under this Regulation should include the requirement to make available a product passport. The product passport is an important tool for making information available to actors along the entire value chain and the availability of a product passport should significantly enhance end- to-end traceability of a product throughout its value chain. Among other things, the product passport should help consumers make informed choices by improving their access to product information relevant to them, allow economic operators other value chain actors such as repairers or recyclers to access relevant information, and enable competent national authorities to perform their duties. To this end, the product passport should not replace but complement non-digital forms of transmitting information, such as information in the product manual or on a label. In addition, it should be possible for the product passport to be used for information on other sustainability aspects applicable to the relevant product group pursuant to other Union legislation. The design of the digital product passport must also factor in ease of use for businesses, especially SMEs.
Amendment 209 #
2022/0095(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) To deliver in the most efficient way on the European Green Deal’s objectives and to address the most impactful products first, the Commission should carry out a prioritisation of products to be regulated under this Regulation and requirements that will apply to them. Based on the process followed for prioritisation under Directive 2009/125/EC, the Commission should adopt a working plan, covering at least 35 years, laying down a list of product groups for which it plans to adopt delegated acts as well as the product aspects for which it intends to adopt delegated acts of horizontal application. TIn prioritising, the Commission should consider in particular those product groups identified in this Regulation, and base its prioritisation on a set of criteria pertaining in particular to the delegated acts’ potential contribution to the Union climate, environmental and energy objectives and their potential for improving the product aspects selected without disproportionate costs to the public and economic operators. Considering their importance for meeting the Union’s energy objectives, the working plans should include an adequate share of actions related to energy-related products. Member States and stakeholders should also be consulted through the Ecodesign Forum. Due to the complementarities between this Regulation and Regulation (EU) 2017/1369 for energy-related products, the timelines for the working plan under this Regulation and the one provided for under Article 15 of Regulation (EU) 2017/1369 should be aligned.
Amendment 248 #
2022/0095(COD)
Proposal for a regulation
Recital 86
Recital 86
(86) In order to incentivise consumers to make sustainable choices, in particular when the more sustainable products are not affordable enough, mechanisms such as eco-vouchers and green taxation should be provided for. Incentives should also be provided for the repair, reuse and recovery of products already placed on the market. When Member States decide to make use of incentives to reward the best- performing products among those for which classes of performance have been set by delegated acts pursuant to this Regulation, they should do so by targeting those incentives at the highest two populated classes of performance, unless otherwise indicated by the relevant delegated act. However, Member States should not be able to prohibit the placing on the market of a product based on its class of performance. For the same reason, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to supplement this Regulation by further specifying which product parameters or related levels of performance Member States’ incentives concern in case no class of performance is determined in the applicable delegated act or where classes of performance are established in relation to more than one product parameter. The introduction of Member State incentives should be without prejudice to the application of the Union State aid rules.
Amendment 269 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1 – point d
Article 1 – paragraph 1 – subparagraph 1 – point d
(d) the presence of substances of concern in final products;
Amendment 293 #
2022/0095(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point g a (new)
Article 1 – paragraph 2 – point g a (new)
(ga) energy carriers within the meaning of Directive (EU) 2018/2001 and Directive 2009/30/EC.
Amendment 299 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘intermediateunfinished product’ or ‘semi-finished product’ means a product that requires further manufacturing or transformationprocessing such as mixing, coating or assembling to make it suitable for end- users;
Amendment 344 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 24
Article 2 – paragraph 1 – point 24
(24) ‘Product Environmental Footprint method’ means the life cycle assessment method to quantify the environmental impacts of products established by Recommendation (EU) 2021/2279 or on the basis of other internationally-recognised standards;
Amendment 360 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point b – indent 6
Article 2 – paragraph 1 – point 28 – point b – indent 6
— chronic hazard to the aquatic environment categories 1 to 42,
Amendment 363 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point b – indent 9
Article 2 – paragraph 1 – point 28 – point b – indent 9
Amendment 378 #
2022/0095(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 28 – point c
Article 2 – paragraph 1 – point 28 – point c
Amendment 476 #
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 grant economic operators sufficient time to adjust to the new requirements, taking into special consideration any impact on micro-enterprises and SMEs or on specific product groups mainly manufactured by 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 570 #
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, to ensure harmonisation and avoid duplication or overlaps of regulation;
Amendment 601 #
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 leastnd especially of micro-enterprises and of SMEs;
Amendment 611 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 5 – point f
Article 5 – paragraph 5 – point f
(f) there shall be no disproportionate administrative or financial burden on manufacturers or other economic actors.
Amendment 619 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 6 – introductory part
Article 5 – paragraph 6 – introductory part
6. The Commission shallmay, where appropriate, requireest supply chain actors, based on the specific characteristics of the product groups concerned, to:
Amendment 621 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 6 – point a
Article 5 – paragraph 6 – point a
(a) provide, upon request, manufacturers, notified bodies and competent national authorities with available information related to their supplies or services that is relevant in order to verify compliance with ecodesign requirements;
Amendment 624 #
2022/0095(COD)
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The Commission shall, where appropriate and based on the specific characteristics of the product groups concerned, identify appropriate means of verification for specific ecodesign requirements, including directly on the product or on the basis of the technical documentation. Verification procedures must not entail any additional administrative burdens for actors in the supply chain.
Amendment 675 #
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 substances of concern throughout the life cycle ofof relevance within 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 687 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1 – point b
Article 7 – paragraph 5 – subparagraph 1 – point b
(b) if relevant, the location of the substances of concern within the product;
Amendment 696 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 2 – point a
Article 7 – paragraph 5 – subparagraph 2 – point a
(a) establish which substances fall under the definition in Article 2(28), point (c), and are of relevance for the purposes of the product groups covered; the assessment of relevance should be based on horizontal criteria established in dialogue with stakeholders.
Amendment 704 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 2 – point b
Article 7 – paragraph 5 – subparagraph 2 – point b
(b) lay down deadlines for the entry into application of the information requirements referred to in the first subparagraph, using a step-by-step approach, with possible differentiation between substances; and
Amendment 709 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 2 – point c
Article 7 – paragraph 5 – subparagraph 2 – point c
Amendment 713 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 3
Article 7 – paragraph 5 – subparagraph 3
Amendment 719 #
2022/0095(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 4
Article 7 – paragraph 5 – subparagraph 4
Substances of concern falling under the definition in Article 2(28), point (a), shall not be exempted from the information requirement referred to in the first subparagraph if they are present in the relevant products, their main components or spare parts in a concentration above 0,1 % weight by weight.
Amendment 758 #
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, including customers, end-users, manufacturers, importers and distributors, dealers, repairers, including independent repairers, remanufacturers, recyclers, competent national authorities, public interest organisations and the Commission, or any organisation acting on their behalf;
Amendment 843 #
2022/0095(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b
Article 10 – paragraph 1 – point b
(b) consumers, economic operators, repairers, including independent repairers, collection and reuse operators, waste management operators and other relevant actors shall have free access, at no cost, to the product passport based on their respective access rights set out in the applicable delegated act adopted pursuant to Article 4;
Amendment 885 #
2022/0095(COD)
Proposal for a regulation
Article 16 – paragraph 2 – subparagraph 1
Article 16 – paragraph 2 – subparagraph 1
The Commission shall adopt and regularly update a working plan, covering a period of at least 35 years, setting out a list of product groups for which it intends to establish ecodesign requirements in accordance with this Regulation. That list shall include products aspects referred to in Article 5(1) for which the Commission intends to adopt horizontal ecodesign requirements established pursuant to Article 5(2), second subparagraph.
Amendment 923 #
2022/0095(COD)
Proposal for a regulation
Article 18 – paragraph 3 – subparagraph 1 – point b
Article 18 – paragraph 3 – subparagraph 1 – point b
(b) the market share in terms of volume of the signatories to the self-regulation measure in relation to the products covered by that measure is at least 850 % of units placed on the market or put into service;
Amendment 945 #
2022/0095(COD)
Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 3 – introductory part
Article 19 – paragraph 3 – subparagraph 3 – introductory part
In addition, without prejudice to applicable State aid rules, such measures mayshall include:
Amendment 948 #
2022/0095(COD)
Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 3 – point d a (new)
Article 19 – paragraph 3 – subparagraph 3 – point d a (new)
(da) Financial support to facilitate the participation of SMEs and their representatives in standardisation bodies and in the Ecodesign Forum referred to in Article 17.
Amendment 1061 #
2022/0095(COD)
Proposal for a regulation
Article 57 – paragraph 3 a (new)
Article 57 – paragraph 3 a (new)
3a. Member State incentives shall also relate to the promotion of the repair, re- use and recovery of products. Such incentives shall be aimed at consumers who use authorised or independent producers or repairers to carry out certain work to repair or recover goods instead of replacing them.
Amendment 1102 #
2022/0095(COD)
Proposal for a regulation
Annex I – paragraph 1 – point f
Annex I – paragraph 1 – point f
Amendment 1103 #
2022/0095(COD)
Proposal for a regulation
Annex I – paragraph 1 – point f
Annex I – paragraph 1 – point f
(f) use of substances, on their own, as constituents of substances or in mixtures, dur present ing the production process of products, or leading to their presence in products, including once these products become wasteend product that have a measurable negative effect on its sustainability;
Amendment 1109 #
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 as defined in other applicable European legislative specifications for products;