BETA

1584 Amendments of Ville NIINISTÖ

Amendment 5 #

2024/0016(CNS)

Proposal for a regulation
Recital 4
(4) Given that the Union’s most powerful world-class supercomputing capacity is found in the European High Performance Computing Joint Undertaking’s (the “Joint Undertaking”) facilities, it is those facilities that should be made available in order for the Commission’s initiative to become a reality. It is accordingly necessary to introduce a further objective to the existing six objectives of the Joint Undertaking that would cover the contribution made by its supercomputers to the new AI initiative of the Union, prioritizing fairness, transparency, trustworthiness, and ensuring positive societal impact.
2024/02/29
Committee: ITRE
Amendment 8 #

2024/0016(CNS)

Proposal for a regulation
Recital 5
(5) The new objective would allow the Joint Undertaking to perform activities in the domains of acquiring and operating AI- dedicated supercomputers or partitions of supercomputers to enable fast machine learning and training of trustworthy and ethical large AI foundation models. The Joint Undertaking should also be allowed to create a new access mode to its computing resources for AI startups and the wider scientific community active in AI and to develop dedicated AI applications optimized to run on its supercomputers, while safeguarding the basic principles of open acces, fairness and transparency. Those changes would enable the Joint Undertaking to offer tailored computing power and services to nurture large-scale AI training and development and uptake in the Union, which is not feasible under the current Regulation.
2024/02/29
Committee: ITRE
Amendment 21 #

2024/0016(CNS)

Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point a
Regulation (EU) 2021/1173
Article 2, point 3b
(3b) ‘Artificial Intelligence-dedicated supercomputer’ means a supercomputer that is primarily designed for training large scale, general-purpose artificial intelligence models and emerging artificial intelligence applications;
2024/02/29
Committee: ITRE
Amendment 23 #

2024/0016(CNS)

Proposal for a regulation
Article 1 – paragraph 1 – point 1 – point a
Regulation (EU) 2021/1173
Article 2, point 3c
(3c) ‘Artificial Intelligence Factory’ means a centralised or distributed entity providing an Artificial Intelligence supercomputing service infrastructure which is composed of an Artificial Intelligence-dedicated supercomputer or Artificial Intelligence partition of a supercomputer, an associated data centre, dedicated access and artificial intelligence- oriented supercomputing services andthat is openly and actively attracting and pooling talent to provide the competences required in using the supercomputers for Artificial Intelligence and respond to the needs and goals of the Union;;
2024/02/29
Committee: ITRE
Amendment 42 #

2024/0016(CNS)

Proposal for a regulation
Article 1 – paragraph 1 – point 3
Regulation (EU) 2021/1173
Article 4, paragraph 1, point h, subpoint (vii)
(vii) attracting, pooling and training talent through a transparent, equal opportunities and open process to develop their competences and skills in using the EuroHPC supercomputers for Artificial Intelligence;
2024/02/29
Committee: ITRE
Amendment 49 #

2024/0016(CNS)

Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EU) 2021/1173
Article 9, paragraph 5, point g, new subpoint (i a)
(i a) provision of an energy management plan that examines the availability of an adequate access to clean affordable energy, also through renewable power purchase agreements, and a strategy to increase energy- efficiency of the installations;
2024/02/29
Committee: ITRE
Amendment 8 #

2023/2111(INI)

Motion for a resolution
Citation 13
– having regard to the report of the European Technology and Innovation Platform on Deep Geothermal entitled ‘Vision for Deep Geothermal’,deleted
2023/10/18
Committee: ITRE
Amendment 9 #

2023/2111(INI)

Motion for a resolution
Citation 14
– having regard to the European Geothermal Energy Council’s Geothermal Market Report 2022 published on July 14, 2023,deleted
2023/10/18
Committee: ITRE
Amendment 10 #

2023/2111(INI)

Motion for a resolution
Citation 16 b (new)
– having regard to the European Commission study entitled “Geothermal plants and applications emissions: overview and analysis” from 20201a _________________ 1a Study on Geothermal plants and applications emissions: overview and analysis – Final report, Publications Office of the European Union, Luxembourg, 2020, ISBN 978-92-76- 04112-2, doi: 10.2777/755565,
2023/10/18
Committee: ITRE
Amendment 13 #

2023/2111(INI)

Motion for a resolution
Citation 16 a (new)
– having regard to the report of the Joint Research Centre from 2023 entitled “The heat pump wave: opportunities and challenges”1a _________________ 1a Toleikyte, A., Roca Reina, J.C., Volt, J., Carlsson, J., Lyons, L., Gasparella, A., Koolen, D., De Felice, M., Tarvydas, D., Czako, V., Koukoufikis, G., Kuokkanen, A. and Letout, S., The Heat Pump Wave: Opportunities and Challenges, Publications Office of the European Union, Luxembourg, 2023, doi:10.2760/27877, JRC134045
2023/10/18
Committee: ITRE
Amendment 16 #

2023/2111(INI)

Motion for a resolution
Citation 16 c (new)
– having regard to the European Commission 2023 study entitled “Overview of heating and cooling - Perceptions, markets and regulatory frameworks for decarbonisation”1a _________________ 1a Overview of heating and cooling - Perceptions, markets and regulatory frameworks for decarbonisation - Final Report, Publications Office of the European Union, Luxembourg, 2023, ISBN 978-92-76-61540-8, doi: 10.2833/962558,
2023/10/18
Committee: ITRE
Amendment 22 #

2023/2111(INI)

Motion for a resolution
Recital -A (new)
-A. Whereas geothermal energy is a valuable and local source of renewable energy that can provide, in a cost-effective way, dispatchable electricity, heat or a combination of both and has great potential for the power sector and for heat production;
2023/10/18
Committee: ITRE
Amendment 28 #

2023/2111(INI)

Motion for a resolution
Recital B
B. whereas heat pumps and geothermal energy technologies are categories deemedlisted as strategic net-zero technologies for Europe inin the annex of the Commission’s proposal of the Net Zero Industry Act;
2023/10/18
Committee: ITRE
Amendment 41 #

2023/2111(INI)

Motion for a resolution
Recital C a (new)
Ca. whereas geothermal energy can provide economic opportunities for Member States and be a source of quality jobs, creating jobs that require local knowledge and cannot be exported;
2023/10/18
Committee: ITRE
Amendment 45 #

2023/2111(INI)

Motion for a resolution
Recital C b (new)
Cb. whereas geothermal heating, cooling and power has already contributed to reduce imports of gas and other fossil energy imports from Russia and can play a role in the European Union’s future security of supply;
2023/10/18
Committee: ITRE
Amendment 73 #

2023/2111(INI)

Motion for a resolution
Paragraph 2
2. Welcomes the development of geothermal beyond power generation and heating and cooling; stresses that the process of extracting lithiumraw materials in an environmentally sustainable way from geothermal brines could help contribute secureing a sustainable and local supply of strategic critical raw materials like lithium supply;
2023/10/18
Committee: ITRE
Amendment 113 #

2023/2111(INI)

Motion for a resolution
Paragraph 7
7. Welcomes the growing awareness of and support for geothermal at national level; notes that some Member States have developed geothermal roadmaps, targets and dedicated policy measures; stresses the need to facilitate the exchange of information about these measures and data to support geothermal policies and to promote existing best practices; considers that this can be achieved through the establishment of a ‘geothermal alliance’;
2023/10/18
Committee: ITRE
Amendment 120 #

2023/2111(INI)

Motion for a resolution
Paragraph 7 a (new)
7a. Recalls that maintaining high environmental and transparency standards in geothermal projects, as well as avoiding conflicts of interest is important to include local communities;
2023/10/18
Committee: ITRE
Amendment 140 #

2023/2111(INI)

Motion for a resolution
Paragraph 8
8. Urges the Member States to explore methods of collecting different types of geological data from public and private entities with a view to organising, systematising and making it available to the public; notes that this should be achieved in compliance with confidentiality requirements and data protection rules, and, where necessary, include incentives and compensation for data sharing by private entities;
2023/10/18
Committee: ITRE
Amendment 158 #

2023/2111(INI)

Motion for a resolution
Paragraph 9
9. Stresses that for areas with insufficient subsurface data, governments can play a role in funding geothermal resource mapping and exploratory drilling; welcomes the fact that some Member States have already taken steps in this direction; calls for EU funding to support this data collection with a view to creating an EU-wide atlas of geothermal potential, in particular for surface geothermal projects;
2023/10/18
Committee: ITRE
Amendment 159 #

2023/2111(INI)

Motion for a resolution
Paragraph 10
10. Emphasises the geothermal potential of repurposed inactive oil and gas wells; calls on the Member States, in cooperation with oil and gas companiRegrets that the potential of repurposing existing oil and gas wells in depleted, abandoned or end-of-life hydrocarbon reservoirs for geothermal applications has not been explored; emphasises the geothermal potential of repurposed inactive oil and gas wells, especially for territories needing to transition from an energy mix heavily reliant on fossil energies; calls on the Member States, to produce publicly available maps of decommissioned wells with their specifications; calls as well for the early phase down of such still- functioning wells that would be suitable to be repurposed, without prejudice to liability requirements and obligations on the former operator;
2023/10/18
Committee: ITRE
Amendment 187 #

2023/2111(INI)

Motion for a resolution
Paragraph 14
14. Calls on the Commission to take appropriate steps to ensure that geothermal projects are better taken into account when using existing European funds and instruments; asks the Commission to consider setting up a dedicated geothermal fundcalls on Member States to make use of existing funding opportunities to support reskilling and upskilling of workers, in particular in, but not limited to, transition areas;
2023/10/18
Committee: ITRE
Amendment 202 #

2023/2111(INI)

Motion for a resolution
Paragraph 15
15. Notes that the requirements of mining laws designed for large-scale mining projects are difficult to uphold in much smaller-scalefaster permitting rules for geothermal, in compliance with existing EU environmental legislation, would facilitate the deployment of geothermal energy projects; calls on the Member States to review and simplify existing mining laws, where necessary, or to develop dedicated permitting rules for geothermal; asks the Commission to provide guidelines to ensure the requisite level of coherence across the European Union; asks the Commission to provide guidelines to ensure easier procedures across Member States, including to address the issue of streamlining processes across local, regional and national contexts and the possibility of differentiated procedures for surface geothermal and for deep geothermal energy;
2023/10/18
Committee: ITRE
Amendment 216 #

2023/2111(INI)

Motion for a resolution
Paragraph 16
16. Notes that permits for geothermal installations must be made extensible to cover the extraction of lithium or the production of hydrogen from existing capacity under the same lease;deleted
2023/10/18
Committee: ITRE
Amendment 240 #

2023/2111(INI)

Motion for a resolution
Paragraph 17
17. Expresses its concern over the reported backlogs and delays in the installation of GHPs, the drilling of wells and the granting of the requisite permissions due to a shortage of qualified staff; calls on Member States to adopt action plans to boost upskilling and reskilling of workers for geothermal technologies;
2023/10/18
Committee: ITRE
Amendment 262 #

2023/2111(INI)

Motion for a resolution
Paragraph 20
20. Regrets that the potential of depleted hydrocarbon reservoirs for geothermal applications is not being fully tapped;
2023/10/18
Committee: ITRE
Amendment 269 #

2023/2111(INI)

Motion for a resolution
Paragraph 21
21. Draws attention to existing repurposing projects in decommissioned mines, where applied cavern thermal energy storage technology is able to provide heating or cooling; notes the development of projects which plan to use oil reservoirs for energy storage; takes note of ongoing projects to repurpose decommissioned oil and gas wells for geothermal applications, thereby greatly reducing exploration risks and drilling costs, without prejudice to the liability requirements and obligations on the former operators;
2023/10/18
Committee: ITRE
Amendment 272 #

2023/2111(INI)

Motion for a resolution
Paragraph 22
22. Notes that many of these projects are implemented by the hydrocarbonfossil fuels industry, which sees them as an opportunity to be part of the energy transition, and that there is a need for the even stronger involvement of this industry in exploring the potential for geothermal; stresses that early assessment of resources, when the mines are still accessible, ensures the more efficient development of their alternative use, with due consideration on the liability regime to be applied;
2023/10/18
Committee: ITRE
Amendment 273 #

2023/2111(INI)

Motion for a resolution
Paragraph 22 a (new)
22a. Stresses that geothermal heating is provided locally, allowing local administrations to be more self-sufficient; highlights the relevance of geothermal heating to reducing dependency on energy imports from third countries and to the EU’s wider goals of increased strategic autonomy in the face of unstable energy supply;
2023/10/18
Committee: ITRE
Amendment 277 #

2023/2111(INI)

Motion for a resolution
Paragraph 23
23. CRecalls on the Member States to make use of existing European funding opportunities to support the re-skilling of the workforce in transition areas, with a view to capitalising on the jobs arising from geothermal projects; notes that oil and gas industry skills can be applied to the geothermal sectorimportance of a just transition towards a highly energy efficient and fully renewable based energy system and the need to fight every poverty; notes that geothermal energy will play a crucial role to substitute fossil fuels for many Member States, especially from Central and Eastern Europe, with existing district heating infrastructure;
2023/10/18
Committee: ITRE
Amendment 281 #

2023/2111(INI)

Motion for a resolution
Paragraph 23 a (new)
23a. Draws attention to geothermal heating’s role in the just energy transition across Europe as a source of decarbonised heating for communities with district heating networks; calls for EU, national and regional funds dedicated to the modernisation of existing networks to enable the deployment of this untapped source of heating;
2023/10/18
Committee: ITRE
Amendment 289 #

2023/2111(INI)

Motion for a resolution
Paragraph 25
25. Notes that public resistance remains a challenge for geothermal projects, particularly on the basis of environmental concerns such as the possible contamination of ground waters, gas emissions or water over-exploitation; expresses the opinion that, as well as the risk of possible damage on buildings linked to smaller earth quakes related to geothermal exploration; recalls the importance of maintaining high environmental, scientific and transparency standards can serve as an efficient way of overcoming distrustwhen exploiting geothermal energy as an efficient way of including communities and addressing possible concerns;
2023/10/18
Committee: ITRE
Amendment 173 #

2023/0205(COD)

Proposal for a regulation
Recital 10
(10) The sharing of the customer data in the scope of this Regulation should be based on the permission of the customer. The legal obligation on data holders to share customer data should be triggered once the customer has requested their data to be shared with a data user. This request can be submitted by a data user acting on behalf of the customer. Where the processing of personal data is involved, a data user should be able to demostrate they have a valid lawful basis for processing under article 6(1)(a) or (b) of Regulation (EU) 2016/679. The customers data can be processed for the agreed purposes in the context of the service provided. The processing of personal data must respect the principles of personal data protection, including lawfulness, fairness and transparency, purpose limitation and data minimisation. A customer has the right to withdraw the permission given to a data user at any time. When data processing is necessary for the performance of a contract, a customer should be able to withdraw permissions according to the contractual obligations to which the data subject is party. When personal data processing is based on consent, a data subject has the right to withdraw his or her consent at any time, as provided for in Regulation (EU) 2016/679.
2024/02/02
Committee: ECON
Amendment 191 #

2023/0205(COD)

Proposal for a regulation
Recital 22
(22) The permission dashboard should display the permissions given by a customer, including when personal data are shared based on consent or are necessary for the performance of a contract. The permission dashboard should warn a customer in a standard way of the risk of possible contractual consequences of the withdrawal of a permission, but the customer should remain responsible for managing such risk. should not encourage or influence the consumer to grant access in a way that materially distorts or impairs their ability to make a free and informed decision, as the customer should remain responsible for managing such risk. It is essential that consumers know exactly what they are giving their permission for and that their rights under the GDPR apply. This information should be provided to consumers in clear and understandable language. To allow consumers to effectively stay in control of their data, the deployment of dark patterns and pre- ticketed boxes in dashboards are prohibited for the purpose of providing permissions to data sharing.The permission dashboard should be used to manage existing permissions. Data holders should inform data users in real-time of any withdrawal of a permission. The permission dashboard should include a record of permissions that have been withdrawn or have expired for a period of up to two years to allow the customer to keep track of their permissions in an informed and impartial manner. Data users should inform data holders in real-time of new and re-established permissions granted by customers, including the duration of validity of the permission and a short summary of the purpose of the permission. The information provided on the permission dashboard is without prejudice to the information requirements under Regulation (EU) 2016/679.
2024/02/02
Committee: ECON
Amendment 203 #

2023/0205(COD)

Proposal for a regulation
Recital 25
(25) In order to enable the contractual and technical interaction necessary for implementing data access between multiple financial institutions, data holders and data users should be required to be part of financial data sharing schemes. These schemes should develop data and interface standards, joint standardised contractual frameworks governing access to specific datasets, and governance rules related to data sharing. In order to ensure that schemes function effectively, it is necessary to establish general principles for the governance of these schemes, including rules on inclusive governance and participation of data holders, data users and customers (to ensure balanced representation in schemes), transparency requirements, and a well-functioning appeal and review procedure (notably around the decision-making of schemes). Financial data sharing schemes must comply with Union rules in the area of consumer protection and data protection, privacy, and competition. The participants in such schemes are also encouraged to draw up codes of conduct similar toin accordance with those prepared by controllers and processors under Article 40 of Regulation (EU) 2016/679. While such schemes may build upon existing market initiatives, the requirements set out in this Regulation should be specific to financial data sharing schemes or parts thereof which market participants use to fulfil their obligations under this Regulation after the data of application of these obligations.
2024/02/02
Committee: ECON
Amendment 214 #

2023/0205(COD)

Proposal for a regulation
Recital 33
(33) In order to enable effective supervision and to eliminate the possibility of evading or circumventing supervision, financial information service providers must be either legally incorporated in the Union or in case they are incorporated in a third country appoint a legal representative in the Union. An effective supervision by the competent authorities is necessary for the enforcement of requirements under this Regulation to ensure integrity and stability of the financial system and to protect consumers. The requirement of legal incorporation of financial information service providers in the Union or the appointment of a legal representative in the Union does not amount to data localisation since this Regulation does not entail any further requirement on data processing including storage to be undertaken in Union.
2024/02/02
Committee: ECON
Amendment 220 #

2023/0205(COD)

Proposal for a regulation
Recital 48
(48) Regulation (EU) 2016/679 applies when personal data are processed. It provides for the rights of a data subject, including the right of access and right to port personal data. This Regulation is without prejudice to the rights of a data subject provided under Regulation (EU) 2016/679, including the right of access and right to data portability. This Regulation creates a legal obligation to share customer personal and non-personal data upon customer’s request and mandates the technical feasibility of access and sharing for all types of data within the scope of this Regulation. The granting of permission by a customer is without prejudice to the obligations of data users under Article 6 of(1)(a) or (b) of Regulation (EU) 2016/679. Permission should not be construed as ‘consent’ or ‘explicit consent’ or ‘necessity for the performance of a contract’ as defined in Regulation (EU) 2016/679. Personal data that are made available and shared with a data user should only be processed for services provided by a data user where there is a valid legal basis under Article 6(1) of Regulation (EU) 2016/679 and, when applicable, where the requirements of Article 9 of that Regulation on the processing of special categories of data are met. Processing of personal data in the context of this Regulation should be carried out in accordance with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, as well as, where applicable, with the ePrivacy Directive. In case of mixed datasets, where personal and non- personal data are inextricably linked, the protections in EU data protection legislation and in this Regulation concerning personal data shall be fully applicable.
2024/02/02
Committee: ECON
Amendment 225 #

2023/0205(COD)

Proposal for a regulation
Article 1 – paragraph 2 a (new)
This Regulation is without prejudice to Regulation (EU) 2016/679, Regulation (EU) 2018/1725, Directive 2002/58/EC, Directive (EU) 2019/2161, Directive 93/13/EEC, and Directive 2011/83. In the event of a conflict between this Regulation and Union law on the protection of personal data or privacy, or national legislation adopted in accordance with such Union law, the relevant Union or national law on the protection of personal data or privacy shall prevail.
2024/02/02
Committee: ECON
Amendment 226 #

2023/0205(COD)

Proposal for a regulation
Article 1 – paragraph 2 b (new)
This Regulation is without prejudice to Directive (EU) 2023/2225, Directive 2014/17/EU, Directive 2014/65/EU and Directive (EU) 2016/97.
2024/02/02
Committee: ECON
Amendment 227 #

2023/0205(COD)

Proposal for a regulation
Article 1 – paragraph 2 c (new)
This Regulation shall not affect the right of a customer to receive financial services and/or products without any additional costs from providers listed in article 2(2), shall they not avail themselves to the permission dashboard of article 8, or otherwise enable financial data sharing under the proposal. For the purposes of the implementation of this paragraph, the burden of proof shall lie with the data user.
2024/02/02
Committee: ECON
Amendment 254 #

2023/0205(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f
(f) data which forms part of a creditworthiness assessment of a firm which is collected as part of a loan application process or a request for a credit rating. Data collected as part of a creditworthiness assessment of consumers shall be excluded.
2024/02/02
Committee: ECON
Amendment 272 #

2023/0205(COD)

Proposal for a regulation
Article 2 – paragraph 3
3. This Regulation shall not apply to the entities referred to in Article 2(3), points (a) to (e), of Regulation (EU) 2022/2554. Any undertaking designated as a gatekeeper, pursuant to Article 3 of Regulation (EU) 2022/1925, shall not be an eligible data user for the purposes of this Regulation.
2024/02/02
Committee: ECON
Amendment 285 #

2023/0205(COD)

Proposal for a regulation
Article 2 – paragraph 4 a (new)
4 a. Only financially relevant information and data from the categories mentioned above shall be processed for the purposes of this Regulation. Special categories of data, under article 9(1) of Regulation (EU) 2016/679 shall not be processed for the purposes of this Regulation, unless it is strictly necessary to fulfil the service requested by the customer. Data that has been derived or inferred from data provided by a customer as a result of profiling shall not be processed for the categories of this Regulation. For the purposes of the implementation of this paragraph the burden of proof shall lie with the data user.
2024/02/02
Committee: ECON
Amendment 308 #

2023/0205(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 3
(3) ‘customer data’ means personal and non-personal data, excluding data resulting from profiling activities, that is collected, stored and otherwise processed by a financial institution as part of their normal course of business with customers which covers both data provided by a customer and data generated as a result of customer interaction with the financial institution;
2024/02/02
Committee: ECON
Amendment 323 #

2023/0205(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 7
(7) ‘financial information service provider’ means a data user that is authorised under Article 14 to access the customer data listed in Article 2(1) for the provision of financial information services and within the scope of Article 2(3);
2024/02/02
Committee: ECON
Amendment 328 #

2023/0205(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
(7 a) ‘financial information service’ means an online service providing consolidated information on one or more financial services products listed under Article 2(1) of this Regulation with a view to providing a customer with an overall view of their financial situation immediately at any given moment;
2024/02/02
Committee: ECON
Amendment 340 #

2023/0205(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point 29 a (new)
(29 a) ‘permission’ means the clear and unambiguous authorisation to a data user to access customer data, provided by customers themselves through a permission dashboard, based on which a data holder is required to make the requested data available for the specified purpose. For the purposes of this Regulation, the criteria of article 4(11) and the conditions in Article 7 of Regulation (EU) 679/2016 shall apply to permissions as well;
2024/02/02
Committee: ECON
Amendment 345 #

2023/0205(COD)

Proposal for a regulation
Article 4 – paragraph 1
The data holder shall, upon request from a customer submitted by electronic means or in an analogue format, make the data listed in Article 2(1) available to the customer without undue delay, free of charge, continuously and in real-time.
2024/02/02
Committee: ECON
Amendment 350 #

2023/0205(COD)

Proposal for a regulation
Article 5 – paragraph 1
1. The data holder shall, upon request from a customer submitted by electronic means, make available to a data user the customer data listed in Article 2(1) for the purposes for which the customer has granted permission to the data user and insofar as the data user demonstrates a valid legal basis under article 6(1)(a) or (b) of Regulation (EU) 2016/679. The customer data shall be made available to the data user without undue delay, continuously and in real-time.
2024/02/02
Committee: ECON
Amendment 361 #

2023/0205(COD)

Proposal for a regulation
Article 5 – paragraph 3 – point c
(c) request data users to demonstrate that they have a valid legal basis under article 6(1)(a) or (b) of Regulation (EU) 2016/679 and obtained the permission of the customer to access the customer data held by the data holder;
2024/02/02
Committee: ECON
Amendment 370 #

2023/0205(COD)

Proposal for a regulation
Article 6 – paragraph 2
2. A data user shall only accessrequest and access adequate, relevant and necessary customer data made available under Article 5(1) for the purposes and under the conditions for which the customer has granted its permission, and insofar as they demonstrate they have a valid legal basis under article 6(1)(a) or (b) of Regulation (EU) 2016/679. A data user shall delete customer data when it is no longer necessary for the purposes for which the permission has been granted by a customer.
2024/02/02
Committee: ECON
Amendment 374 #

2023/0205(COD)

Proposal for a regulation
Article 6 – paragraph 3
3. A customer mayshall be able to withdraw the permission it has granted to a data user at any time. When processing is necessary for the performance of a contract, a customer may withdraw the permission it has granted to make customer data available to a data user according to the contractual obligations to which it is subject.
2024/02/02
Committee: ECON
Amendment 380 #

2023/0205(COD)

Proposal for a regulation
Article 6 – paragraph 4 – point e
(e) not process customer data for advertising purposes, except for direct marketing in accordance with Union and national lawsubject to the prior consent of the consumer;
2024/02/02
Committee: ECON
Amendment 391 #

2023/0205(COD)

Proposal for a regulation
Article 6 – paragraph 4 a (new)
4 a. Data under this Regulation shall be stored on the territory of the Union.
2024/02/02
Committee: ECON
Amendment 394 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 2
2. In accordance with Article 160 of Regulation (EU) No 1093/2010, the European Banking Authority (EBA) shall develop guidelineregulatory technical standards on the implementation of paragraph 1 of this Article for products and services related to the credit score of the consumer, to mortgage credit agreements and to the provision of payment services for submission to the Commission by December 2025. Powers are delegated to the European Commission to adopt and, where necessary, amend regulatory technical standards on the implementation of paragraph 1 of this Aarticle for products and services related to the credit score of the consumer. Those regulatory technical standards shall be adopted in accordance with Articles 10 to 14 of regulation (EU) No 1093/2010.
2024/02/02
Committee: ECON
Amendment 400 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 3
3. In accordance with Article 160 of Regulation (EU) No 1094/2010, the European Insurance and Occupational Pensions Authority (EIOPA) shall develop guidelineregulatory technical standards on the implementation of paragraph 1 of this Article for products and services related to risk assessment and pricing of a consumer in the case of life, motor, home, health and sickness and basic insurance products, such as automobile and house or property insurance, for submission to the Commission by December 2025.
2024/02/02
Committee: ECON
Amendment 404 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 3 a (new)
3 a. In accordance with Article 10 of Regulation (EU) No 1094/2010, the European Securities and Markets Authority and the European Insurance and Occupational Pensions Authority shall develop regulatory technical standards on the implementation of paragraph 1 of this Article for products and services related to the suitability and appropriateness assessment required under Article 25 of Directive (EU) 2014/65/EU, Article 30 of Directive (EU) 2015/97, and Article 81(1) of Regulation (EU) 2023/1114 of a consumer for submission to the Commission by December 2025.
2024/02/02
Committee: ECON
Amendment 405 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 3 b (new)
3 b. Powers are delegated to the European Commission to adopt regulatory technical standards on the implementation of paragraph 2, 3 and 3a.
2024/02/02
Committee: ECON
Amendment 406 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 3 c (new)
3 c. For the purposes of paragraphs (2) and (3) of this article, regulatory technical standards shall address: (a) the limits of the combination of ‘customer data’ obtained pursuant to this Regulation with other types of personal data; (b) the explainability, transparency and bias avoidance safeguards needed to be installed when Artificial Intelligence tools and algorithms are being deployed, used or trained for any of the purposes mentioned in paragraphs (2), (3) and (3a) of this article; (c) the information provision obligations for financial institutions when a customer is presented with a personalised offer that is based on profiling or other types of automated processing of personal data; (d) how the ‘right to be forgotten’ of cancer survivors shall be applicable in relation to non-credit related insurance policies, including life and health insurance, in line with article 124 of the 2020/2267 (INI) Report of the European Parliament.This shall also be extended to other chronic diseases and conditions; (e) how data may be used to avoid excessive granularity that undermines the ‘risk sharing’ principle of insurance.
2024/02/02
Committee: ECON
Amendment 408 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 4
4. When preparing the guidelineregulatory technical standards referred to in paragraphs 2, 3 and 3a of this Article, EIOPA, ESMA, and EBA shall closely cooperate withformally consult the European Data Protection Board established by Regulation (EU) 2016/679.
2024/02/02
Committee: ECON
Amendment 410 #

2023/0205(COD)

Proposal for a regulation
Article 7 – paragraph 4 a (new)
4 a. Additional financial and human resources shall be provided to the European Banking Authority (EBA), the European Securities and Markets Authority (ESMA), and the European Insurance and Occupational Pensions Authority (EIOPA) for the fulfilment of their tasks under this Regulation.
2024/02/02
Committee: ECON
Amendment 417 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 2 – point a – introductory part
(a) provide the customer with an overview of each ongoing permission given to data users, in a format that is easy to understand, including:
2024/02/02
Committee: ECON
Amendment 419 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 2 – point a – point i
(i) the name and details of the data user to which access has been granted
2024/02/02
Committee: ECON
Amendment 420 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 2 – point a – point iii
(iii) a detailed description of the purpose of the permission;
2024/02/02
Committee: ECON
Amendment 421 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 2 – point a – point iv
(iv) the specific categories of data being shared;
2024/02/02
Committee: ECON
Amendment 425 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 2 – point b
(b) allow the customer to withdraw a permission given to a data user at any time;
2024/02/02
Committee: ECON
Amendment 427 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 2 – point c
(c) allow the customer to re-establish any permission withdrawn at any time;
2024/02/02
Committee: ECON
Amendment 428 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 3
3. The data holder shall ensure that the permission dashboard is easy to find in its user interface and that information displayed on the dashboard is clear, accurate and easily understandable for the customer and is in line with the European data protection and consumer legislative frameworks, notably Regulation (EU) 2016/679, Directive (EU) 2019/2161, Directive 93/13/EEC, and Directive 2011/83 EU.
2024/02/02
Committee: ECON
Amendment 429 #

2023/0205(COD)

Proposal for a regulation
Article 8 – paragraph 3 a (new)
3 a. The data holder shall ensure that the permission dashboard is not designed in a way that would encourage or unduly influence the customer to grant or withdraw permissions.This includes: (a) the procedure to withdraw consent shall not be made more difficult than the procedure to grant access; (b) providers of the dashboards shall not design, organise or operate their interfaces in a way that deceives or manipulates the recipients of their service or in a way that otherwise materially distorts or impairs the ability of the recipients of their service to make free and informed decisions.
2024/02/02
Committee: ECON
Amendment 465 #

2023/0205(COD)

Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) each of the parties listed in paragraph (a) above shall have fair and equal representation in the internal decision-making processes of the scheme as well as equal weight in any voting procedures; where a member is both a data holder and data user, its membership shall be counted equally towards both sides.
2024/02/02
Committee: ECON
Amendment 467 #

2023/0205(COD)

Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point e
(e) a financial data sharing scheme shall include a mechanism through which its rules can be amended, following an impact analysis and the agreement of the majority of each community of data holders and, data users and consumer associations respectively;
2024/02/02
Committee: ECON
Amendment 499 #

2023/0205(COD)

Proposal for a regulation
Article 10 – paragraph 6 – subparagraph 2 a (new)
Competent authorities shall undertake regular comprehensive reviews of data sharing schemes’ governance arrangements set out in Article 10(1). These reviews shall include a thorough and documented assessment whether the schemes’ arrangements are appropriate and credible for the purposes of ensuring the responsible treatment of customer data.
2024/02/02
Committee: ECON
Amendment 537 #

2023/0205(COD)

Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1 – point d a (new)
(d a) would be found in breach of Regulation (EU) 2016/679. Supervisory authorities established under article 51 of the same Regulation shall be the ones to notify that an infringement has been established.
2024/02/02
Committee: ECON
Amendment 539 #

2023/0205(COD)

Proposal for a regulation
Article 14 – paragraph 7 a (new)
7 a. An appropriate remuneration scheme shall be put in place in the financial data sharing schemes to enable consumer participation in their governance.
2024/02/02
Committee: ECON
Amendment 549 #

2023/0205(COD)

Proposal for a regulation
Article 18 a (new)
Article 18a Complaints Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the competent authorities of article 17 of this Regulation related to the provisions of this Regulation. Where the complaint concerns the rights of natural persons pursuant to Regulation (EU) 2016/679 the competent authority shall transmit the complaint to the supervisory authorities under Regulation (EU) 2016/679 and shall consult and cooperate with them in the handling of such complaints.
2024/02/02
Committee: ECON
Amendment 551 #

2023/0205(COD)

Proposal for a regulation
Article 20 – paragraph 3 – point f
(f) in the case of a natural person, maximum administrative fines of up to EUR 25 000 per infringement and up to a total of EUR 250 000 per year, or, in the Member States whose official currency is not the euro, the corresponding value in the official currency of that Member State on ... [OP please insert the date of entry into force of this Regulation].
2024/02/02
Committee: ECON
Amendment 553 #

2023/0205(COD)

Proposal for a regulation
Article 20 – paragraph 4 – subparagraph 1 – point a
(a) up to EUR 50 000 per infringement and up to a total of EUR 500 000 per year, or, in the Member States whose official currency is not the euro, the corresponding value in the official currency of that Member State on ... [OP please insert the date of entry into force of this Regulation];deleted
2024/02/02
Committee: ECON
Amendment 555 #

2023/0205(COD)

Proposal for a regulation
Article 20 – paragraph 4 – subparagraph 1 – point b
(b) 210% of the total worldwide annual turnover of the legal person of the preceding financial year, according to the last available financial statements approved by the management body;
2024/02/02
Committee: ECON
Amendment 557 #

2023/0205(COD)

Proposal for a regulation
Article 22 – paragraph 1 – point a
(a) the nature, gravity and the duration of the breach taking into account the nature scope or purpose of the processing concerned as well as the number of data subjects affected and the level of damage suffered by them;
2024/02/02
Committee: ECON
Amendment 558 #

2023/0205(COD)

Proposal for a regulation
Article 22 – paragraph 1 – point f a (new)
(f a) the categories of personal data affected by the infringement;
2024/02/02
Committee: ECON
Amendment 559 #

2023/0205(COD)

Proposal for a regulation
Article 22 – paragraph 1 – point k a (new)
(k a) the manner in which the infringement became known to the supervisory authority, in particular whether, and if so to what extent, the controller or processor notified the infringement;
2024/02/02
Committee: ECON
Amendment 572 #

2023/0205(COD)

Proposal for a regulation
Article 31 – paragraph 1 – point e a (new)
(e a) the impact the Regulation has had on financial inclusion and financial product and services simplicity;
2024/02/02
Committee: ECON
Amendment 576 #

2023/0205(COD)

Proposal for a regulation
Article 31 – paragraph 1 – point e b (new)
(e b) the impact of this Regulation on sustainable finance.
2024/02/02
Committee: ECON
Amendment 69 #

2023/0132(COD)

Proposal for a directive
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required tonecessary to ensure incentivisees for the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development are appropriately allocated and to prevent unintended extensions of data protection based on unclear interpretation of unmet medical need. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
2023/12/01
Committee: ITRE
Amendment 78 #

2023/0132(COD)

Proposal for a directive
Recital 52
(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.deleted
2023/12/01
Committee: ITRE
Amendment 86 #

2023/0132(COD)

Proposal for a directive
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.
2023/12/01
Committee: ITRE
Amendment 88 #

2023/0132(COD)

Proposal for a directive
Recital 55
(55) When applying the provisions on market launch incentives, mMarketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.
2023/12/01
Committee: ITRE
Amendment 92 #

2023/0132(COD)

Proposal for a directive
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territorrequest a market launch of a centrally for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place ldecentrally approved product at any time after the marketing authorisation is valid in their Member State. Subsequently, marketing authorisation holders have nine months to apply for a pricing and reimbursement in that Member State, 18 months where the marketing authorisation holder is a SME, an entitiy not engaged in economic activity or an entity with limited experience in the Union system. Alternative timelines may be agreed between the Member State and the marketing authorisation holder. Marketing authorisation holders have the right to launch a product in a Member State before beign proactively approached by that Member Stater.
2023/12/01
Committee: ITRE
Amendment 93 #

2023/0132(COD)

Proposal for a directive
Recital 57
(57) The issuing of documentation from the Member States as regards the prolongation of data protection for the purpose of supply of medicinal productsapplication for pricing and reimbursement in allthe Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the data protection period.
2023/12/01
Committee: ITRE
Amendment 95 #

2023/0132(COD)

Proposal for a directive
Recital 58
(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be tranparent and conducted in good faith.
2023/12/01
Committee: ITRE
Amendment 111 #

2023/0132(COD)

Proposal for a directive
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requiremeThe timely entry of generics and biosimilars onto the Union market is importants, necessarotably to obtain cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being consideredase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patient or SPC infringement. The application of this limited exemption is however fragmented across the Union ands in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies and, trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.
2023/12/01
Committee: ITRE
Amendment 115 #

2023/0132(COD)

Proposal for a directive
Recital 63 a (new)
(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State) of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
2023/12/01
Committee: ITRE
Amendment 118 #

2023/0132(COD)

Proposal for a directive
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct studactivities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that periodaforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
2023/12/01
Committee: ITRE
Amendment 124 #

2023/0132(COD)

Proposal for a directive
Recital 65 a (new)
(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anitcompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.
2023/12/01
Committee: ITRE
Amendment 134 #

2023/0132(COD)

Proposal for a directive
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or, they do not propose risk mitigation measures to sufficiently address the risks identified or the environmental risk is deemed unacceptable in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated wheneach time new data or knowledge about relevant risks become available.
2023/12/01
Committee: ITRE
Amendment 140 #

2023/0132(COD)

Proposal for a directive
Recital 72
(72) TLike every industrial sector, the production of medicines has a negative impact on the environment through CO2 emissions deriving from the medicines' global supply chains and through pharmaceutical effluents from the production, use and disposal. In addition, the emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobiaddressing manufacturing, use and disposal through monitoring, assessing and preventing the negative impact, addressing inefficiencies and developing greener pharmaceuticals, including manufacturings crucial to mitigate threats to public health.
2023/12/01
Committee: ITRE
Amendment 145 #

2023/0132(COD)

Proposal for a directive
Recital 74 a (new)
(74 a) In order to reduce duplication, optimise resources, reduce the use of animals in research, address current lack of understanding and resources on the individual and aggregated impact of pharmaceutical substances in the environment, and in line with the Aarhus Convention, all data related to the environmental risk assessment studies should be made publicly available and easily accessible in a database established by the Agency.
2023/12/01
Committee: ITRE
Amendment 155 #

2023/0132(COD)

Proposal for a directive
Recital 110
(110) The quality of medicinal products manufactured or available in the Union should be guaranteed by requiring that the active substances used in their composition comply with the principles of good manufacturing practice in relation to those medicinal products and that manufacturing is carried out in compliance with local environmental and occupational health and labour rights standards. It has proved necessary to reinforce the Union provisions on inspections and to compile a Union database of the results of those inspections.
2023/12/01
Committee: ITRE
Amendment 159 #

2023/0132(COD)

Proposal for a directive
Recital 127
(127) The use of electronic and technological possibilities other than paper package leaflets, which are complementary to the paper leaflet that is crucial for patients with limited digital health literacy can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal or better quality of information to all patients compared to the paper form of product information. Ensuring the protection of personal data pursuant to Regulation 2016/679 and prohibition of the identification, profiling or tracking of individuals is necessary in this regard.
2023/12/01
Committee: ITRE
Amendment 160 #

2023/0132(COD)

Proposal for a directive
Recital 128
(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, as an addition to the paper leaflet, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. The information in digital format should be easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.
2023/12/01
Committee: ITRE
Amendment 162 #

2023/0132(COD)

Proposal for a directive
Recital 129
(129) Where Member States decide that the package leaflet should be made available in principle only electronically, they should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patients. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.deleted
2023/12/01
Committee: ITRE
Amendment 166 #

2023/0132(COD)

Proposal for a directive
Recital 131
(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, tThe provisions of this Directive ensuare, without prejudice to the rules on the protection of confidential and personal data, and ensure transparency regarding any direct and indirect financial support received from any public authority or, public body, philantropic and other not-profit organisation including academia to carry out any activities for the research and development of medicinal products. In addition, when submitting a request for pricing and reimbursement, marketing authorisation holders should disclose, upon request, the company’s expenditure related to the research and development costs of the product.
2023/12/01
Committee: ITRE
Amendment 275 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 65, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
2023/12/01
Committee: ITRE
Amendment 277 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 1 a (new)
1 a. The ERA shall evaluate possible risks to the environment due to use and disposal of the medicinal product according to the requirements referred to in Annex II. With regard to risks resulting from manufacturing, the ERA shall provide information on discharges and emissions of the active substance and other environmentally relevant substances according to the requirements referred to in Annex II.
2023/12/01
Committee: ITRE
Amendment 287 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, to reduce discharges and emissions of the medicinal product to the environment and information on available techniques that will be used to reduce those discharges and emissions, in particular those occurring in manufacturing effluents before these effluents leave the manufacturing sites and to 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.
2023/12/01
Committee: ITRE
Amendment 292 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 4
4. The ERA for antimicrobialsFor antimicrobials and other substances which may cause antimicrobial resistance, including products with an antimicrobial mode of action, the ERA shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including by healthcare professionals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.
2023/12/01
Committee: ITRE
Amendment 300 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 5
5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, tThe Agency shall consult the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) and other stakeholders, including drinking water and wastewater operators, on the drafting of these scientific guidelines.
2023/12/01
Committee: ITRE
Amendment 301 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall include analytical techniques and explanations in the methodology on the ERA and 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 lead to a change of the conclusions of the ERA. The update shall include updates on the emissions of the medicinal product in manufacturing effluents and 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.
2023/12/01
Committee: ITRE
Amendment 307 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2
For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment. The ERA shall be updated when new information becomes available, every 5 years at the latest.
2023/12/01
Committee: ITRE
Amendment 308 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 7
7. For medicinal products referred to in Articles 9 to 12, the applicant may, where appropriate, refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines as referred to in the first paragraph.
2023/12/01
Committee: ITRE
Amendment 310 #

2023/0132(COD)

Proposal for a directive
Article 22 – paragraph 7 a (new)
7 a. In line with the Aarhus Convention1a, full environmental assessment studies and summaries with outcomes shall be made publicly available and proactively shared with drinking water and wastewater operators. The competent authorities shall include this information in their repository of medicinal products. _________________ 1a UN Convention on access to information, public participation in decision-making and access to justice in environmental matters, done at Aarhus, Denmark, on 25 June 1998.
2023/12/01
Committee: ITRE
Amendment 314 #

2023/0132(COD)

Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3012 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 Centre for Disease Prevention and Control (ECDC), 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 as potentially harmful to the environment in accordance with paragraph 2.
2023/12/01
Committee: ITRE
Amendment 319 #

2023/0132(COD)

Proposal for a directive
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency mayshall consult all relevant stakeholders and request from marketing authorisation holders the submission of relevant data or information.
2023/12/01
Committee: ITRE
Amendment 323 #

2023/0132(COD)

Proposal for a directive
Article 23 – paragraph 3
3. The 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 datafull data sets and summaries of conducted ERA studies submitted by the marketing authorisation holder, shall be made publicly available by the Agency and shall be proactively shared with drinking and wastewater operators.
2023/12/01
Committee: ITRE
Amendment 400 #

2023/0132(COD)

Proposal for a directive
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded body, philantropic or non-for profit organisation or fund in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
2023/12/01
Committee: ITRE
Amendment 404 #

2023/0132(COD)

Proposal for a directive
Article 57 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall declare all cases where the product was acquired at any stage of development from an entity not engaged in an economic activity (‘not-for-profit entity’) or a public-private research consortium.
2023/12/01
Committee: ITRE
Amendment 406 #

2023/0132(COD)

Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or, publicly funded body, philantropic or non-for profit organisation or fund that provided the financial support referred to in point (i);
2023/12/01
Committee: ITRE
Amendment 412 #

2023/0132(COD)

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)
(iii a) the percentage of total research and development costs covered by the financial support referred to in paragraph 1;
2023/12/01
Committee: ITRE
Amendment 414 #

2023/0132(COD)

Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)
(iii b) where applicable, information related to acquiring of product license from a not-for-profit-entity or a public- private consortium, including the amount of public funding invested prior to acquisition of the product, stage of development and name of the entity.
2023/12/01
Committee: ITRE
Amendment 416 #

2023/0132(COD)

Proposal for a directive
Article 57 a (new)
Article57a Responsibility to report on research and development costs In addition to the information listed in Article 57, the marketing authorisation holder shall, when submitting an application for reimbursement in a Member State for a nationally or centrally authorised product, declare upon request from the national competent authority responsible for pricing and reimbursement a detailed externally- audited reporting on the company’s expenditure related to the research and development cost of the medicinal product.
2023/12/01
Committee: ITRE
Amendment 417 #

2023/0132(COD)

Proposal for a directive
Article 58 – title
Traceability of substances used in the manufacture of medicinal products and manufacturing in the environmental impact assessment
2023/12/01
Committee: ITRE
Amendment 419 #

2023/0132(COD)

Proposal for a directive
Article 58 – paragraph 1
1. The marketing authorisation holder shall, when necessary, ensure the traceability of an active substance, starting material, excipient or any other substance intended or expected to be present in a medicinal product at all stages of manufacturing and distribution.
2023/12/01
Committee: ITRE
Amendment 420 #

2023/0132(COD)

Proposal for a directive
Article 58 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall include the manufacturing process of the substances referred to in paragraph 1 as an integral part of the environmental impact assessment referred to in Article 22 and in line with requirements set in Annex II.
2023/12/01
Committee: ITRE
Amendment 424 #

2023/0132(COD)

Proposal for a directive
Article 58 a (new)
Article 58a Obligation to launch products in Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, release and continuously supply into the supply chain the requested product in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member State no later than nine months from the date when the Member State made its request, or within 18 months from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); or (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. 2. The obligation laid down in paragraph 1 shall not prevent the marketing authorisation holder from submitting a pricing and reimbursement application in a Member State before receiving the request. 3. Following agreement between a Member State and a marketing authorisation holder, timelines other than those set out in paragraph 1 may apply. 4. For products authorised under [revised Regulation 726/2004], the marketing authorisation holder shall notify the Agency about the result of placing on the market of the products, in order to fulfil obligations set out in Article 138(2) of [revised Regulation 726/2004]. 5. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. 6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder.
2023/12/01
Committee: ITRE
Amendment 430 #

2023/0132(COD)

Proposal for a directive
Article 63 – paragraph 3
3. Member States may decide that tThe 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 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 shouldboth electronic and paper format. The printed copy of the package leaflet shall be included in the product's packaging. It shall be ensured that the information in digital format is easily accessible to all patients.
2023/12/01
Committee: ITRE
Amendment 446 #

2023/0132(COD)

Proposal for a directive
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. 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 = five years following 18 months after the date of entering into force of this Directive].
2023/12/01
Committee: ITRE
Amendment 467 #

2023/0132(COD)

Proposal for a directive
Article 63 – paragraph 7
7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data pursuant to Regulation 2016/679 and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes.
2023/12/01
Committee: ITRE
Amendment 482 #

2023/0132(COD)

Proposal for a directive
Article 67 – paragraph 6
6. Member States may, for the purposes of reimbursement, pharmacovigilance, pharmacoepidemiology or for data protection prolongation for market launchmonitoring of medicine shortages use the information contained in the repositories system referred to paragraph 2, second subparagraph, point (e).
2023/12/01
Committee: ITRE
Amendment 512 #

2023/0132(COD)

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
(a) 24 months, where the marketing authorisation holder demonstrates that the conditions referred to in Article 82(1) are fulfilled within two years, from the date when the marketing authorisation was granted or, within three years from that date for any of the following entities: (i) SMEs within the meaning of Commission Recommendation 2003/361/EC; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting of a marketing authorisation, have received not more than five centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest.deleted
2023/12/01
Committee: ITRE
Amendment 527 #

2023/0132(COD)

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;deleted
2023/12/01
Committee: ITRE
Amendment 532 #

2023/0132(COD)

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d
(d) 12six months, where the marketing authorisation holder obtains, during the data protection period, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies.
2023/12/01
Committee: ITRE
Amendment 539 #

2023/0132(COD)

Proposal for a directive
Article 81 – paragraph 2 – subparagraph 2
In the case of a conditional marketing authorisation granted in accordance with Article 19 of [revised Regulation (EC) No 726/2004] the prolongation referred to in the first subparagraph, point (b), shall only apply if, within fourthree years of the granting of the conditional marketing authorisation, the medicinal product has been granted a marketing authorisation in accordance with Article 19(7) of [revised Regulation (EC) No 726/2004.
2023/12/01
Committee: ITRE
Amendment 543 #

2023/0132(COD)

Proposal for a directive
Article 81 – paragraph 3
3. The Agency shall set the scientific guidelines referred to in paragraph 2, point (c), on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].deleted
2023/12/01
Committee: ITRE
Amendment 544 #

2023/0132(COD)

Proposal for a directive
Article 81 – paragraph 3 a (new)
3 a. All product-specific regulatory protection periods shall be made publicly available in the medicine repository on the website of the national competent authority and the Agency.
2023/12/01
Committee: ITRE
Amendment 548 #

2023/0132(COD)

Proposal for a directive
Article 82
[...]deleted
2023/12/01
Committee: ITRE
Amendment 579 #

2023/0132(COD)

Proposal for a directive
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union, medical service or SoHO preparation authorised in the Member State or the Union or other therapeutic option available for such disease, or, where despite medicinal products being authorised or therapeutic options available for such disease in the Union, the disease is associated with a remaining high morbidity or mortality; and
2023/12/01
Committee: ITRE
Amendment 596 #

2023/0132(COD)

Proposal for a directive
Article 83 – paragraph 2
2. Designated orphan medicinal products referred to in Article 67 of [revised Regulation (EC) No 726/2004] shall be considered as addressing an unmet medical need.deleted
2023/12/01
Committee: ITRE
Amendment 607 #

2023/0132(COD)

Proposal for a directive
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
2023/12/01
Committee: ITRE
Amendment 609 #

2023/0132(COD)

Proposal for a directive
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried outith an active-comparator were carried out by the marketing authorisation holder in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and
2023/12/01
Committee: ITRE
Amendment 623 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
2023/12/01
Committee: ITRE
Amendment 629 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, forfor the purpose of:
2023/12/01
Committee: ITRE
Amendment 635 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinalfor products and for subsequent variations;
2023/12/01
Committee: ITRE
Amendment 639 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
(ii) conducting health technology assessment as defined in Regulation (EU) 2021/2282;
2023/12/01
Committee: ITRE
Amendment 645 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
2023/12/01
Committee: ITRE
Amendment 649 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;
2023/12/01
Committee: ITRE
Amendment 653 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.
2023/12/01
Committee: ITRE
Amendment 663 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), mayshall cover the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
2023/12/01
Committee: ITRE
Amendment 668 #

2023/0132(COD)

Proposal for a directive
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.
2023/12/01
Committee: ITRE
Amendment 671 #

2023/0132(COD)

Proposal for a directive
Article 85 a (new)
Article 85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.
2023/12/01
Committee: ITRE
Amendment 691 #

2023/0132(COD)

Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point a a (new)
(a a) environmental impact assessment of the product’s manufacturing process;
2023/12/01
Committee: ITRE
Amendment 692 #

2023/0132(COD)

Proposal for a directive
Article 143 – paragraph 1 – subparagraph 2 – point b a (new)
(b a) proof that the product’s supply chain is diversified, identifying alternatives for each component;
2023/12/01
Committee: ITRE
Amendment 701 #

2023/0132(COD)

Proposal for a directive
Article 159 – paragraph 1 – subparagraph 1
At the request of a third country, the Commission shall assess whether that country’s regulatory framework applicable to active substances exported to the Union and the respective control and enforcement activities ensure a level of protection of public healthand worker's health and environment equivalent to that of the Union.
2023/12/01
Committee: ITRE
Amendment 702 #

2023/0132(COD)

Proposal for a directive
Article 159 – paragraph 2 – subparagraph 2 – point a
(a) the country’s rules for good manufacturing practice; including local environmental manufacturing standards, occupational health and labour rights standards;
2023/12/01
Committee: ITRE
Amendment 709 #

2023/0132(COD)

Proposal for a directive
Article 166 – paragraph 1 – point g – point v
(v) the batch number and serial number of the medicinal products, at least for medicinal products bearing the safety features referred to in Article 67;
2023/12/01
Committee: ITRE
Amendment 735 #

2023/0132(COD)

Proposal for a directive
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission mayshall suspend, revoke or vary a marketing authorisation if a serious risk to the environment or public health has been identified and not sufficiently addressed by the marketing authorisation holder.
2023/12/01
Committee: ITRE
Amendment 736 #

2023/0132(COD)

Proposal for a directive
Article 195 – paragraph 3
3. A marketing authorisation may also be suspended, revoked or varied where the particulars supporting the application as provided for in Articles 6, 9 to 14 or Annexes I to V are incorrect or have not been amended in accordance with Article 90, or where any conditions referred to in Articles 44, 45 and 87 have not been fulfilled or where the controls referred to in Article 191 have not been carried out.
2023/12/01
Committee: ITRE
Amendment 765 #

2023/0132(COD)

Proposal for a directive
Annex VI – paragraph 1 – point 8 a (new)
(8 a) for products containing substances classified based on Annex I of Regulation (EC) No 1272/2008 as persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM) or are endocrine active agents, a warning that improper use and disposal of the medicinal product, inter alia through toilets, contributes to deteriorating the aquatic environmen[A1] t. [A1]Justification: Patients, healthcare professionals and pharmacists must be informed of the impact on the aquatic environment of products containing PBT, vPvB, PMT and vPvM substances, as well as endocrine disruptors, so they dispose properly of products and can make informed choices between alternative treatments.
2023/12/01
Committee: ITRE
Amendment 50 #

2023/0131(COD)

Proposal for a regulation
Recital 29
(29) Legal entities that are not engaged in an economic activity such as universities, public bodies, research centres or not-for-profit organisations, represent an important source of research in unmet medical needs, research in different subpopulations, repurposing, optimisation and innovation and should also benefit from this support scheme. Whereas it should be possible to take account of the particular situation of these entities on an individual basis, such support can best be achieved by means of a dedicated support scheme, including administrative support and through the reduction, deferral and waiver of fees.
2023/11/30
Committee: ITRE
Amendment 62 #

2023/0131(COD)

Proposal for a regulation
Recital 41 a (new)
(41 a) Protecting global health is one of the priorities of the EU and under Article 178 of the Treaty, the Union should take into account the development policy aspects in any measure and promote the creation of conditions fit for human beings worldwide. To this end, this Regulation should particularly allow for the development of efficacious, safe, accessible, and affordable innovations to address global public health needs, including antimicrobial resistance, poverty-related and neglected diseases, widespread tropical disease and ensure high quality standards for medicinal products that are exported.
2023/11/30
Committee: ITRE
Amendment 65 #

2023/0131(COD)

Proposal for a regulation
Recital 45 a (new)
(45 a) Particular attention should be given to the gender balance of clinical trials so that women can fully and safely benefit from medicines throughout their life-course.
2023/11/30
Committee: ITRE
Amendment 67 #

2023/0131(COD)

Proposal for a regulation
Recital 51
(51) As a general rule a marketing authorisation should be granted for an unlimited time; howeverfor products other than generics should be granted for a period of five years in order to allow for the integration of real world evidence and re- assessment of the risk-benefit balance and in case of orphan medicines, also the related criteria related to population size and generated profit, once renewal may be decided only on justified grounds related to the safety of the medicinal producted, the marketing authorisation shall be valid for an unlimited period, unless the Agency decides on justified grounds related to the safety of the medicinal product to proceed with an additional five-year renewal period or revocation of the marketing authorisation.
2023/11/30
Committee: ITRE
Amendment 70 #

2023/0131(COD)

Proposal for a regulation
Recital 65
(65) In the preparation of scientific advice and in duly justified cases, the Agency should alsopromote an open discussion about latest scientific developments and the update of scientific guidelines and should be able to consult authorities established in other relevant Union legal acts or other public bodies established in the Union, as applicable. These may include experts in clinical trials, medical devices, substances of human origin or any other as required for the provision of the scientific advice in question.
2023/11/30
Committee: ITRE
Amendment 74 #

2023/0131(COD)

Proposal for a regulation
Recital 77
(77) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure; it is therefore necessary to consider new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs and not- for profit entities, which choose to invest in this area.
2023/11/30
Committee: ITRE
Amendment 76 #

2023/0131(COD)

Proposal for a regulation
Recital 78
(78) To be considered a ‘priority antimicrobial’, a medicinal product should represent a real advancement against antimicrobial resistance and should therefore bring forward non-clinical and clinical data that underpin a significant clinical benefit with respect to antimicrobial resistance. When assessing the conditions for antibiotics, the Agency shall take into account the prioritisation of pathogens as regards the risk of antimicrobial resistance provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high) or in case there is an equivalent list of priority pathogens adopted at Union level, the Agency should take such Union list into account as a priority. In order to address market failures for the development of antimicrobials, the priority focus should be on the research and development and subsequent production and fair distribution of new antimicrobials. However, addressing AMR will not be solved by R&D alone. To ensure prudent use of existing antibiotics, the Authority should also support the development and procurement of rapid diagnostic tools to ensure appropriate prescriptions.
2023/11/30
Committee: ITRE
Amendment 77 #

2023/0131(COD)

Proposal for a regulation
Recital 78 a (new)
(78 a) As the Commission’s study on bringing antimicrobial medical countermeasures to the market1a demonstrated, different kinds of push and pull incentives are needed to face this public health emergency. These tools may include market entry rewards, advance purchase agreements, milestone payments, innovation prizes, or subscription payments. In order to maximize the benefits from such public investments, the allocation of these financial and other incentives should respect the following principles and conditions of open science, affordability and EU-wide availability of developed products, delinking revenue from sale volumes of procured products, full transparency of all received funding and purchase agreements, gradient incentive scheme that rewards according to the innovation level, and the development of a stewardship and access plans. These principles and conditions should ensure that public money will be allocated with the objective of a rapid public return on investment for patients. _________________ 1a [1] https://op.europa.eu/en/publication- detail/-/publication/51b2c82c-c21b-11ed- 8912-01aa75ed71a1/language-en/format- PDF/source-282347876
2023/11/30
Committee: ITRE
Amendment 78 #

2023/0131(COD)

Proposal for a regulation
Recital 78 b (new)
(78 b) The principle of open science is pivotal to ensure rapid progress in the field of scientific research for priority antimicrobials. Over the past 30 years, the lack of sharing of results, failed trials and ongoing research has created bottlenecks for scientific development and contributes to the current market failure for the placing on the market of new antimicrobials. It is therefore of the utmost importance to have a paradigm shift towards open science, particularly in the area of publicly-funded research, to reduce duplication of research, allow for peer-verification of results and building further evidence based on most recent findings, as to making research and development funding efforts more efficient.
2023/11/30
Committee: ITRE
Amendment 79 #

2023/0131(COD)

Proposal for a regulation
Recital 79
(79) The creation of a voucher rewarding the development of priority antimicrobials through an additional year of regulatory data protection has the capacity to provide the needed financial support to developers of priority antimicrobials. However, in order to ensure that the financial reward which is ultimately borne by health systems is mostly absorbed by the developer of the priority antimicrobial and not the buyer of the voucher, the number of available vouchers on the market should be kept to a minimum. It is therefore necessary to establish strict conditions of granting, transfer and use of the voucher and to further give the possibility to the Commission to revoke the voucher under certain circumstances.deleted
2023/11/30
Committee: ITRE
Amendment 84 #

2023/0131(COD)

Proposal for a regulation
Recital 80
(80) A transferable data exclusivity voucher should only be available to those antimicrobial products that bring a significant clinical benefit with respect to antimicrobial resistance, and which have the characteristics described in this Regulation. It is also necessary to ensure that an undertaking which receives this incentive is in turn capable to supply the medicinal product to patients across the Union in sufficient quantities and to provide information on all funding received for research related to its development in order to provide a full account of the direct financial support given to the medicinal product.deleted
2023/11/30
Committee: ITRE
Amendment 86 #

2023/0131(COD)

Proposal for a regulation
Recital 81
(81) To ensure a high level of transparency and complete information on the economic effect of the transferable data exclusivity voucher, notably as regards the risk of overcompensation of investment, a developer of a priority antimicrobial is required to provide information on all direct financial support received for research related to the development of the priority antimicrobial. The declaration should include direct financial support received from any source worldwide.deleted
2023/11/30
Committee: ITRE
Amendment 89 #

2023/0131(COD)

Proposal for a regulation
Recital 82
(82) A transfer of a voucher for a priority antimicrobial may be conducted by sale. The value of the transaction which may be monetary or otherwise agreed between the buyer and the seller, shall be made public so as to inform regulators and the public. The identity of the holder of a voucher that has been granted and not yet used should be publicly known at all times so as to ensure a maximum level of transparency and trust.deleted
2023/11/30
Committee: ITRE
Amendment 90 #

2023/0131(COD)

Proposal for a regulation
Recital 83
(83) The provisions related to transferable data exclusivity vouchers shall be applicable for a specified period from the entry into force of this Regulation or until a maximum number of vouchers are granted by the Commission in order to limit the total cost of the measure to Member State health systems. The limited application of the measure will also provide the possibility to assess the effect of the measure in addressing the market failure in the development of new antimicrobials addressing antimicrobial resistance and assess the cost on national health systems. Such assessment will provide the necessary knowledge to decide whether to extend the application of the measure.deleted
2023/11/30
Committee: ITRE
Amendment 93 #

2023/0131(COD)

Proposal for a regulation
Recital 84
(84) The period of application of the provisions on transferable exclusivity vouchers for priority antimicrobials and the total number of vouchers may be extended by the Parliament and the Council upon proposal by the Commission on the basis of the experience acquired.deleted
2023/11/30
Committee: ITRE
Amendment 96 #

2023/0131(COD)

Proposal for a regulation
Recital 90
(90) Objective criteria for the orphan designation based on the prevalence of the life-threatening or chronically debilitating condition for which diagnosis, prevention or treatment is sought and the existence of no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Union should be maintained; a prevalence of not more than five affected persons per 10 000 is generally regarded as the appropriate threshold. The orphan designation criterion on the basis of return on investment has been abolished, since it has never been usednevertheless, products may still lose the orphan status in cases where the population criterion is no longer met or when sufficient profit was generated after five years on the market.
2023/11/30
Committee: ITRE
Amendment 97 #

2023/0131(COD)

Proposal for a regulation
Recital 90 a (new)
(90 a) The aim of intellectual property and regulatory incentives is to benefit society and promote innovation in areas of public health and unmet medical needs, such as rare diseases. It is of utmost importance that such incentives are not misused or abused, nor pose threats to affordability and patient access to treatments. In particular, the practice of artificially subdividing diseases to create subgroups of patients in order to fall under the orphan medicine prevalence criterion should be prohibited.
2023/11/30
Committee: ITRE
Amendment 102 #

2023/0131(COD)

Proposal for a regulation
Recital 100
(100) Orphan medicinal products addressing a high unmet medical need prevent, diagnose or treat conditions where either no other method of prevention, diagnosis or treatment exists or, if such method already exists, they would bring exceptional therapeutic advancement. In both cases, the criterion of meaningfusubstantial reduction in disease morbidity or mortality for the relevant patient population should ensure that only most effective medicinal products are covered. The Agency should draw up scientific guidelines on the category of ‘orphan medicinal products addressing a high unmet medical need’.
2023/11/30
Committee: ITRE
Amendment 104 #

2023/0131(COD)

Proposal for a regulation
Recital 102
(102) In order to incentivise research and development of orphan medicinal products addressing high unmet needs, to ensure market predictability and to ensure a fair distribution of incentives, a modulation of market exclusivity has been introduced; orphan medicinal products addressing high unmet medical needs benefit from the longest market exclusivity, while market exclusivity for well-established use orphan medicinal products, requiring less investment, is the shortest. In order to ensure increased predictability for developers, the possibility to review the eligibility criteria for market exclusivity after six years after the marketing authorisation has been abolished.
2023/11/30
Committee: ITRE
Amendment 106 #

2023/0131(COD)

Proposal for a regulation
Recital 103
(103) In order to encourage faster and wider access also to orphan medicinal products, an additional period of one yearsix months of market exclusivity is granted to orphan medicinal products for a Union market launch, with the exception of well- established use medicinal products.
2023/11/30
Committee: ITRE
Amendment 107 #

2023/0131(COD)

Proposal for a regulation
Recital 104
(104) To reward research into and development of new therapeutic indications, an additional period of one year of market exclusivity is provided for a new therapeutic indication (with a maximum of two indications).deleted
2023/11/30
Committee: ITRE
Amendment 115 #

2023/0131(COD)

Proposal for a regulation
Recital 132
(132) The Union and Member States have developed a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing medicinal products. This process focuses specifically on the added value of a medicinal product in comparison with other new or existing health technologies However, this evaluation should not be conducted in the context of the marketing authorisation, for which it is agreed that the fundamental criteria should be retained. It is useful in this respect to allow for the possibility of gathering information on the methods used by the Member States to determine the therapeutic benefit obtained by each new medicinal productTo ensure that medicine developers generate the right type of data for regulators throughout the market access pathway, the marketing authorisation applicants should submit, unless where duly justified and ethical, data from active-control clinical trials. This is important to avoid the unnecessary repetition of clinical studies, and to uphold high scientific standards and ethical principles at the point of marketing authorisation.
2023/11/30
Committee: ITRE
Amendment 119 #

2023/0131(COD)

Proposal for a regulation
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under regulatory supervision ensuring that appropriate safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case- by-case basis when drafting and reviewing legislation.deleted
2023/11/30
Committee: ITRE
Amendment 122 #

2023/0131(COD)

Proposal for a regulation
Recital 134
(134) In the area of medicinal products, a high level of protection of inter alia citizens, consumers, health, as well as legal certainty, a level playing field and fair competition always need to be ensured and existing levels of protection need to be respected.deleted
2023/11/30
Committee: ITRE
Amendment 124 #

2023/0131(COD)

Proposal for a regulation
Recital 135
(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed plan outlining the particularities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. Where appropriate, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.deleted
2023/11/30
Committee: ITRE
Amendment 135 #

2023/0131(COD)

Proposal for a regulation
Recital 138
(138) The national competent authorities 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. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to communicate the necessary information to patients, consumers, and healthcare professionals, including on estimated duration and available alternatives, and 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 and register such information in the European Shortages Monitoring Platform. . 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 patientimporters, manufacturers, suppliers, patient and consumer 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. 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 entities. _________________ 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).
2023/11/30
Committee: ITRE
Amendment 136 #

2023/0131(COD)

Proposal for a regulation
Recital 138 a (new)
(138 a)To facilitate appropriate communication between patients and consumers, on the one hand, and competent authorities on the other, Member States should collect data on the impact of shortages of medicinal products on patients and consumers, and share relevant information through the MSSG, in order to inform approaches to management of shortages of medicinal products. Marketing authorisation holders should set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market. Delegated 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 entities. The setting up of safety stocks of critical medicinal products should not hamper the availability and affordability of these products or harm the environment by inappropriate disposals at both European and global level. Given the global nature of pharmaceutical supply chains, the safety stocks should be proportionate and take into account the potential impacts on shortages in other Member States and third countries. In order to avoid any interruption of access to critical medicinal products, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.
2023/11/30
Committee: ITRE
Amendment 150 #

2023/0131(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point 10
(10) ‘regulatory sandbox’ means a regulatory framework during which it is possible to develop, validate and test in a controlled environment innovative or adapted regulatory solutions that facilitate the development and authorisation of innovative products which are likely to fall in the scope of this Regulation, pursuant to a specific plan and for a limited time under regulatory supervision.deleted
2023/11/30
Committee: ITRE
Amendment 236 #

2023/0131(COD)

Proposal for a regulation
Chapter III – title
III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’deleted
2023/11/30
Committee: ITRE
Amendment 237 #

2023/0131(COD)

Proposal for a regulation
Article 40
Article 40 Granting the right to a transferable data exclusivity voucher 1. Following a request by the applicant when applying for a marketing authorisation, 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. 2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product. 3. An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics: (a) it represents a new class of antimicrobials; (b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union; (c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection. In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level. 4. To be granted the voucher by the Commission, the applicant shall: (a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market; (b) provide information on all direct financial support received for research related to the development of the priority antimicrobial. Within 30 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.deleted
2023/11/30
Committee: ITRE
Amendment 266 #

2023/0131(COD)

Proposal for a regulation
Article 41
Article 41 Transfer and use of the voucher 1. A voucher may be used to extend the data protection for a period of 12 months of the priority antimicrobial or another medicinal product authorised in accordance with this Regulation of the same or different marketing authorisation holder. A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection. A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn. 2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection. 3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further. 4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.deleted
2023/11/30
Committee: ITRE
Amendment 272 #

2023/0131(COD)

Proposal for a regulation
Article 42
Article 42 Validity of the voucher 1. A voucher shall cease to be valid in the following cases: (a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product; (b) where it is not used within 5 years from the date it was granted. 2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. 3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83]. _________________ 69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).deleted
2023/11/30
Committee: ITRE
Amendment 273 #

2023/0131(COD)

Proposal for a regulation
Article 43
Article 43 Duration of application of Chapter III This Chapter shall apply until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.deleted
2023/11/30
Committee: ITRE
Amendment 324 #

2023/0131(COD)

Proposal for a regulation
Article 68 – paragraph 1 – point a
(a) the conduct of the various tests and trials necessary to demonstrate the quality, safety and, efficacy and environmental impact of the medicinal product, as referred to Article 138(1), second subparagraph, point (p);
2023/11/30
Committee: ITRE
Amendment 326 #

2023/0131(COD)

Proposal for a regulation
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and entities not engaged in economic activities provided for in framework programmes for research and technological development.
2023/11/30
Committee: ITRE
Amendment 335 #

2023/0131(COD)

Proposal for a regulation
Article 70 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such condition or where, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement; and
2023/11/30
Committee: ITRE
Amendment 338 #

2023/0131(COD)

Proposal for a regulation
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningfusubstantial reduction in disease morbidity or mortality for the relevant patient population.
2023/11/30
Committee: ITRE
Amendment 345 #

2023/0131(COD)

Proposal for a regulation
Article 71 – paragraph 2 – point a
(a) nineseven years for orphan medicinal products other than those referred to in points (b) and (c);
2023/11/30
Committee: ITRE
Amendment 354 #

2023/0131(COD)

Proposal for a regulation
Article 71 – paragraph 2 – point b
(b) teneight years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;
2023/11/30
Committee: ITRE
Amendment 359 #

2023/0131(COD)

Proposal for a regulation
Article 71 – paragraph 2 – point c
(c) five years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].deleted
2023/11/30
Committee: ITRE
Amendment 369 #

2023/0131(COD)

Proposal for a regulation
Article 71 – paragraph 4 – point c a (new)
(c a) a compulsory license has been granted in accordance with [Regulation on compulsory licensing for crisis management and amending Regulation (EC) 816/2006].
2023/11/30
Committee: ITRE
Amendment 370 #

2023/0131(COD)

Proposal for a regulation
Article 71 – paragraph 7
7. Where tThe Agency shall adopts scientific guidelines for the application of paragraphs 1 and 4, it shall consult the Commission.
2023/11/30
Committee: ITRE
Amendment 371 #

2023/0131(COD)

Proposal for a regulation
Article 72 – title
Prolongation and reduction of market exclusivity period
2023/11/30
Committee: ITRE
Amendment 375 #

2023/0131(COD)

Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
The periods of market exclusivity referred to in Article 71, paragraph 2, points (a) and (b), shall be prolonged by 12 months, where the orphan marketing authorisation holder can demonstrate that the conditions referred to in Article 81(2), point (a), and Article 82(1) [of revised Directive 2001/83/EC] are fulfilled.deleted
2023/11/30
Committee: ITRE
Amendment 379 #

2023/0131(COD)

Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 2
The procedures set out in Articles 82(2) to (5) [of revised Directive 2001/83/EC] shall accordingly apply to the prolongation of market exclusivity.deleted
2023/11/30
Committee: ITRE
Amendment 388 #

2023/0131(COD)

Proposal for a regulation
Article 72 – paragraph 2 – subparagraph 1
The period of market exclusivity shall be prolonged by an additional 126 months for orphan medicinal products referred to in Article 71(2), points (a) and (b), if at least two years before the end of the exclusivity period, the orphan marketing authorisation holder obtains a marketing authorisation for one or more new therapeutic indications for a different orphan condition.
2023/11/30
Committee: ITRE
Amendment 394 #

2023/0131(COD)

Proposal for a regulation
Article 72 – paragraph 4
4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraphs 1 and 2.deleted
2023/11/30
Committee: ITRE
Amendment 396 #

2023/0131(COD)

Proposal for a regulation
Article 72 – paragraph 4 a (new)
4 a. The market exclusivity period shall be reduced to five years if, at the end of the fifth year, it is established, in respect of the medicinal product concerned, that the criteria laid down in Article 63 are no longer met or where it is shown on the basis of available evidence that the product is sufficiently profitable not to justify maintenance of market exclusivity. The sponsor shall provide the Agency with the information necessary to re- assess the criteria laid down in Article 63 and the externally audited product-related profit margins for all authorised indications at least nine months before end of the fifth year.
2023/11/30
Committee: ITRE
Amendment 411 #

2023/0131(COD)

Proposal for a regulation
Chapter IX – title
IX REGULATORY SANDBOXdeleted
2023/11/30
Committee: ITRE
Amendment 412 #

2023/0131(COD)

Proposal for a regulation
Article 113
[...]deleted
2023/11/30
Committee: ITRE
Amendment 421 #

2023/0131(COD)

Proposal for a regulation
Article 114
Article 114 Products developed under a sandbox 1. When authorising a clinical trial application for products covered by a regulatory sandbox, Member States shall take the sandbox plan referred to in Article 113(1) into consideration. 2. A medicinal product developed as part of a regulatory sandbox may be placed on the market only when authorised in accordance with this Regulation. The initial validity of such authorisation shall not exceed the duration of the regulatory sandbox. The authorisation may be prolonged at the request of the marketing authorisation holder. 3. In duly justified cases, the marketing authorisation of a medicinal product developed under the regulatory sandbox may include derogations from the requirements set out in this Regulation and [revised Directive 2001/83/EC]. Those derogations may entail adapted, enhanced, waived or deferred requirements. Each derogation shall be limited to what is apt and strictly necessary to attain the objectives pursued, duly justified and specified in the conditions to the marketing authorisation. 4. For medicinal products developed as part of a regulatory sandbox for which a marketing authorisation has been granted in accordance with paragraph 2 and where appropriate paragraph 3, the summary of product characteristics and the package leaflet shall indicate that the medicinal product has been developed as part of a regulatory sandbox. 5. Without prejudice to Article 195 of [revised Directive 2001/83/EC], the Commission shall suspend a marketing authorisation granted in accordance with paragraph 2, where the regulatory sandbox has been suspended or revoked in accordance with Article 113(7). 6. The Commission shall immediately vary the marketing authorisation to take account of the mitigation measures taken in accordance with Article 115.deleted
2023/11/30
Committee: ITRE
Amendment 422 #

2023/0131(COD)

Proposal for a regulation
Article 115
Article 115 General sandbox provisions 1. The regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. In case of identification of risks to public health or safety concerns associated with the use of products covered by a sandbox, competent authorities shall take immediate and adequate temporary measures in order to suspend or restrict their use and inform the Commission in accordance with Article 113(2). Where such mitigation is not possible or proves to be ineffective, the development and testing process shall be suspended without delay until an effective mitigation takes place. 2. Participants in the regulatory sandbox, in particular the marketing authorisation holder of the medicinal product concerned, shall remain liable under applicable Union and Member States liability legislation for any harm inflicted on third parties as a result from the testing taking place in the sandbox. They shall inform the Agency without undue delay of any information which might entail the amendment of the regulatory sandbox or concerns the quality, safety or efficacy of products developed as part of a regulatory sandbox. 3. The modalities and the conditions of the operation of the regulatory sandboxes, including the eligibility criteria and the procedure for the application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173(2). 4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports shall be made publicly available by the Commission. 5. The Commission shall review the reports and put forward, as appropriate, legislative proposals with a view to update the regulatory framework referred to in Article 113(2) or delegated acts in accordance with Article 28 of [revised Directive 2001/83/EC].deleted
2023/11/30
Committee: ITRE
Amendment 432 #

2023/0131(COD)

Proposal for a regulation
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder and public authorities, where available, no less than six months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
2023/11/30
Committee: ITRE
Amendment 437 #

2023/0131(COD)

Proposal for a regulation
Article 117 – paragraph 1 a (new)
1 a. Shortage prevention plans shall be without delay submitted to the competent authority concerned defined in Article 116(1) and be made publicly available, upon request.
2023/11/30
Committee: ITRE
Amendment 447 #

2023/0131(COD)

Proposal for a regulation
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely mannerAll entities, including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or wholesale distributors, shall provide every three months, or more frequently as requested by the competent authority, stock level data reports indicating available quantities of all medicinal products in each of their warehouses.
2023/11/30
Committee: ITRE
Amendment 464 #

2023/0131(COD)

Proposal for a regulation
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP and include, among others, information on the duration, reasons and mitigation measures of medicine shortages. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems, including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive 2023/0132 (COD), and other relevant IT systems and databases, without duplication of reporting.
2023/11/30
Committee: ITRE
Amendment 479 #

2023/0131(COD)

Proposal for a regulation
Article 128 – paragraph 2 a (new)
2 a. The marketing authorisation holder shall set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market.
2023/11/30
Committee: ITRE
Amendment 480 #

2023/0131(COD)

Proposal for a regulation
Article 128 – paragraph 2 b (new)
2 b. By derogation from paragraph 2a, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.
2023/11/30
Committee: ITRE
Amendment 483 #

2023/0131(COD)

Proposal for a regulation
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timelby the deadline set by the Agency mannerd provide updates whenever necessary.
2023/11/30
Committee: ITRE
Amendment 525 #

2023/0131(COD)

Proposal for a regulation
Article 167 – paragraph 2
For the purposes of the first subparagraph, the Agency shall actively identify and implement cybersecurity best practices adopted within Union institutions, bodies, offices and agencitake measures to ensure its compliance with a high common level of cybersecurity within Union entities, identify and implement up- to-date cybersecurity best practices for preventing, detecting, mitigating, and responding to cyber attacks.
2023/11/30
Committee: ITRE
Amendment 534 #

2023/0131(COD)

Proposal for a regulation
Annex IV – Part V – paragraph 1 – point 2 – point d a (new)
(d a) For the purpose of reporting in accordance with Article 118, wholesale distributors shall provide regular stock level data reports indicating available quantities of all medicines in each of their warehouses.
2023/11/30
Committee: ITRE
Amendment 47 #

2023/0109(COD)

Proposal for a regulation
Recital 1
(1) The use of and dependence on information and communication technologies have become fundamental aspects and vulnerabilities in all sectors of economic activity as our public administrations, companies and citizens are more interconnected and interdependent across sectors and borders than ever before.
2023/09/22
Committee: ITRE
Amendment 49 #

2023/0109(COD)

Proposal for a regulation
Recital 2
(2) The magnitude, frequency and impact of cybersecurity incidents are increasing, including supply chain attacks aiming at cyberespionage, ransomware or disruption. They represent a major threat to the functioning of network and information systems. In view of the fast-evolving threat landscape, the threat of possible large-scale incidents causing significant disruption or damage to critical infrastructures demands heightened preparedness at all levels of the Union’s cybersecurity framework. That threat goes beyond Russia’s military aggression on Ukraine, and is likely to persist given the multiplicity of state- aligned, and criminal and hacktivist actors involved in current geopolitical tensions. Such incidents can impede the provision of public services and the pursuit of economic activities, including in critical or highly critical sectors, generate substantial financial losses, undermine user confidence, cause major damage to the economy of the Union, and could even have health or life-threatening consequences. Moreover, cybersecurity incidents are unpredictable, as they often emerge and evolve within very short periods of time, not contained within any specific geographical area, and occurring simultaneously or spreading instantly across many countries.
2023/09/22
Committee: ITRE
Amendment 64 #

2023/0109(COD)

Proposal for a regulation
Recital 21
(21) While the European Cyber Shield is a civilian project, the cyber defence community could benefit from stronger civilian detection and situational awareness capabilities developed for the protection of critical infrastructure. Cross-border SOCs, with the support of the Commission and the European Cybersecurity Competence Centre (‘ECCC’), and in cooperation with the High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’), should gradually develop dedicated access conditions and safeguards protocols and standards to allow for cooperation with the cyber defence community, including vetting and security conditions, respecting the civilian character of insitutions and the destination of funding, therefore using the funds available to the defence community . The development of the European Cyber Shield should be accompanied by a reflection enabling future collaboration with networks and platforms responsible for information sharing in the cyber defence community, in close cooperation with the High Representative and in full respect of rights and freedoms.
2023/09/22
Committee: ITRE
Amendment 114 #

2023/0109(COD)

Proposal for a regulation
Article 4 – paragraph 2
2. Following a call for expression of interest, National SOCs shallmay be selected by the European Cybersecurity Competence Centre (‘ECCC’) to participate in a joint procurement of tools and infrastructures with the ECCC. The ECCC may award grants to the selected National SOCs to fund the operation of those tools and infrastructures. The Union financial contribution shall cover up to 50% of the acquisition costs of the tools and infrastructures, and up to 50% of the operation costs, with the remaining costs to be covered by the Member State. Before launching the procedure for the acquisition of the tools and infrastructures, the ECCC and the National SOC shall conclude a hosting and usage agreement regulating the usage of the tools and infrastructures.
2023/09/22
Committee: ITRE
Amendment 119 #

2023/0109(COD)

Proposal for a regulation
Article 5 – paragraph 2
2. Following a call for expression of interest, a Hosting Consortium shallmay be selected by the ECCC to participate in a joint procurement of tools and infrastructures with the ECCC. The ECCC may award to the Hosting Consortium a grant to fund the operation of the tools and infrastructures. The Union financial contribution shall cover up to 75% of the acquisition costs of the tools and infrastructures, and up to 50% of the operation costs, with the remaining costs to be covered by the Hosting Consortium. Before launching the procedure for the acquisition of the tools and infrastructures, the ECCC and the Hosting Consortium shall conclude a hosting and usage agreement regulating the usage of the tools and infrastructures.
2023/09/22
Committee: ITRE
Amendment 151 #

2023/0109(COD)

Proposal for a regulation
Article 10 – paragraph 1 a (new)
1a. Following the triggering of the cyber emergency mechanism, the Commission shall report each year the assessment of both positive and negative working of the mechanism, including whether further cooperation or training requirements are needed.
2023/09/22
Committee: ITRE
Amendment 21 #

2023/0108(COD)

Proposal for a regulation
Recital 4 a (new)
(4 a) As the market and the educational systems offer variety of educational resources and formal trainings, it must be underlined that knowledge is also aquired in non-formal ways and skills can be demonstrated via degrees and certification but not exclusively. Especially in the curent fast evolving threat landscape, Member States and the beneficiaries of managed security services should take into account the highly skilled vulnerability researchers. Moreover entities and natural persons researching vulnerabilities may in some Member States be exposed to criminal and civil liability therefore Member States are encouraged to issue guidelines for non- prosecution of information security research and an exception for civil liability for those activities.
2023/09/21
Committee: ITRE
Amendment 37 #

2023/0108(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EU) 2019/881
Article 47 – paragraph 2
2. The Union rolling work programme shall in particular include a list of ICT products, ICT services and ICT processes or categories thereof, and managed security services, that are capable of benefiting from being included in the scope of a European cybersecurity certification scheme. Support measures to asses the needs for skilled employees, types of skills, existing training paths must be included along with measures to bridge any identified gaps.
2023/09/21
Committee: ITRE
Amendment 65 #

2023/0081(COD)

Proposal for a regulation
Recital 42
(42) To safeguard the level playing field and functioning of the internal market, a common Union framework should be created to collectively address this central challenge, including with a view to sharing the burden of the costs of such measures including via the proposed EU Sovereignty Fund. Several Union funding programmes, such as the Recovery and Resilience Facility, InvestEU, cohesion policy programmes or the Innovation Fund are also available to fund investments in net-zero technology manufacturing projects.
2023/06/20
Committee: ECON
Amendment 102 #

2023/0081(COD)

Proposal for a regulation
Article 14 – paragraph 1
1. The Commission and the Member States shall undertake activities to accelerate and crowd-in private investments in net-zero strategic projects. Such activities may, without prejudice to Article 107 and Article 108 of the TFEU, include providing and coordinating support to net-zero strategic projects facing difficulties in accessing finance. In order to prevent fragmentation of the Single Market, support mentioned in paragraph 1 of this Article shall also be made available from the EU Sovereignty Fund. The Commission shall draw on resources from the EU Sovereignty Fund with a special focus on facilitating investments in net-zero strategic projects ensuring the highest ecological and social standards possible. The amount of the financial envelope shall be drawn from the unallocated margins under the MFF ceilings or mobilised through the non- thematic MFF special instruments.
2023/06/20
Committee: ECON
Amendment 105 #

2023/0081(COD)

Proposal for a regulation
Article 14 – paragraph 1 a (new)
1 a. The support referred to in paragraph 1 shall be conditional on stringent environmental, social and labour commitments taken by the relevant project promoters, including in the form of decarbonisation plans, labour reskilling plans, commitment to effective social dialogue and collectively negotiated wages, high quality apprenticeships and decent working conditions.
2023/06/20
Committee: ECON
Amendment 108 #

2023/0081(COD)

Proposal for a regulation
Article 14 – paragraph 1 b (new)
1 b. The support mentioned in paragraph 1 may encompass (a) guarantees to decrease borrowing costs and reduce risk at an early stage of project development; (b) measures aimed at de-risking agreements with off-takers, including supporting off-takers established in the Union to sign off-take agreements with Net-Zero Strategic Projects.
2023/06/20
Committee: ECON
Amendment 114 #

2023/0081(COD)

Proposal for a regulation
Article 14 – paragraph 2 – point b a (new)
(b a) assistance to project promoters along the permit-granting process, in particular for small and medium-sized enterprises.
2023/06/20
Committee: ECON
Amendment 117 #

2023/0081(COD)

Proposal for a regulation
Article 14 – paragraph 2 a (new)
2 a. The European Commission may mobilise the InvestEU Advisory Hub to provide technical assistance to net-zero strategic projects in order to reinforce their technical, economic, environmental and social viability.
2023/06/20
Committee: ECON
Amendment 122 #

2023/0081(COD)

Proposal for a regulation
Article 15 – paragraph 1 a (new)
1 a. The Net-Zero Europe Platform shall, in particular, quantify financing needs and track disbursements by Member States, with an eye to mobilising resources from the EU Sovereignty Fund to ensure project promoters are not disadvantaged by an uneven availability of funds across Member States.
2023/06/20
Committee: ECON
Amendment 152 #

2023/0081(COD)

Proposal for a regulation
Article 20 – paragraph 2
2. The sustainability and resilience contribution shall each be given a weight between 15% andof at least 30% of the award criteria, without prejudice of the possibility to give a higher weighting to the criteria in Article 19(2), points (a) and (b), where applicable under Union legislation, and of any limit for non-price criteria set under State aid rules.
2023/06/20
Committee: ECON
Amendment 155 #

2023/0081(COD)

Proposal for a regulation
Article 20 – paragraph 2 a (new)
2 a. When cost differences are below 10%, the contracting authority or the contracting entity shall award the contract to the tender exhibiting the highest sustainability contribution.
2023/06/20
Committee: ECON
Amendment 160 #

2023/0081(COD)

Proposal for a regulation
Article 21 – paragraph 1
1. Without prejudice to Articles 107 and 108 of the Treaty and Article 4 of Directive 2018/200173 and in line with the Union’s international commitments, when deciding to set up schemes benefitting households or consumers which incentivise the purchase of strategic net-zero technology final products listed in the Annex, Member States, regional orand local authorities, bodies governed by public law orand associations formed by one or more such authorities or one or more such bodies governed by public law, shall design them in such a way as to promote the purchase by beneficiaries of strategic net-zero technology final products with a high sustainability, job quality, and resilience contribution as referred in Article 19(2), by providing additional proportionate financial compensation. __________________ 73 Directive 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources
2023/06/20
Committee: ECON
Amendment 164 #

2023/0081(COD)

Proposal for a regulation
Article 21 – paragraph 2
2. The additional financial compensation granted by authorities in accordance with paragraph 1, due to the application of the criteria referred to in Article 19(2) (b) (c) and (d) shall not exceed 25 % of the cost of the strategic net-zero technology final product for the consumer. The additional financial compensation shall be specifically addressed at consumers in energy poverty or at risk of energy poverty, as defined per Regulation (EU) 2023/955.
2023/06/20
Committee: ECON
Amendment 165 #

2023/0081(COD)

Proposal for a regulation
Article 21 – paragraph 3
3. When designing and implementing a scheme falling under paragraph 1, the authority shall base itself on an open, non- discriminatory and transparent process to assess the resilience and sustainability contribution of available products on the market. Any strategic net-zero technology final product shall be entitled to apply to join the scheme at any time. The authority shall specify a pass mark for products to be eligible to the additional financial compensation under the support scheme.
2023/06/20
Committee: ECON
Amendment 166 #

2023/0081(COD)

Proposal for a regulation
Article 21 – paragraph 4
4. Member States shall publish on a single free access website all information relating to schemes pursuant to Article 21(1) for each relevant strategic net-zero technology product.
2023/06/20
Committee: ECON
Amendment 1 #

2022/2079(INI)

Motion for a resolution
Citation 9
— having regard to the European Defence Fund 2021-2027, with its substantialdedicated budget for emerging disruptive technologies,
2022/12/08
Committee: ITRE
Amendment 3 #

2022/2079(INI)

Motion for a resolution
Citation 10 a (new)
— having regard to the Commission’s staff working document of 10 November 2022 entitled ‘First progress report on the implementation the Action Plan on synergies between civil, defence and space industries’ (SWD(2022)362),
2022/12/08
Committee: ITRE
Amendment 4 #

2022/2079(INI)

Motion for a resolution
Citation 10 b (new)
— having regard to its resolution of 7 June 2022 on the EEAS’s Climate Change and Defence Roadmap,
2022/12/08
Committee: ITRE
Amendment 10 #

2022/2079(INI)

Motion for a resolution
Recital A
A. whereas a strong and a technologically competitive defence sectorindustry is crucial for Europe’s security and prosperitydefence capabilities;
2022/12/08
Committee: ITRE
Amendment 13 #

2022/2079(INI)

Motion for a resolution
Recital B
B. whereas Russia’s war of aggression against Ukraine has shown that Europe needs to invest robustly in its defence and security technologies; in an efficient and collaborative manner; whereas Member States have set a 35% target for collaborative defence investments but have shown little and even decreasing political will to meet this target with only 11% in 2020 and a historic low of 8% in 2021;
2022/12/08
Committee: ITRE
Amendment 18 #

2022/2079(INI)

Motion for a resolution
Recital B a (new)
B a. Whereas there is an urgent need to establish a truly European defence equipment market, inter alia by consolidating industrial capacities, reducing industrial overcapacities, duplication and fragmentation and at the same time adapting the industrial basis, in particular its supply chains and skilled workforce, to the new security environment in Europe which demands to rapidly ramp up production capacities;
2022/12/08
Committee: ITRE
Amendment 21 #

2022/2079(INI)

Motion for a resolution
Recital C
C. whereas a steady and streliable supply of critical raw materials, technologies and components is vitalnecessary for Europe’s defence sector;
2022/12/08
Committee: ITRE
Amendment 24 #

2022/2079(INI)

Motion for a resolution
Recital D
D. whereas cutting-edge technologies and corresponding human capital, and in particular fast-evolving digital technologies and skills, are ever more important factors in sustaining and strengthening Europe’s security and defence industries;
2022/12/08
Committee: ITRE
Amendment 29 #

2022/2079(INI)

Motion for a resolution
Recital E
E. whereas the current fragmentation of and duplication in Europe’s defence sector and the European defence market leads to inefficient use of economic resources and reduced defence capabilities and amounts to collective losses of EUR 25 to 100 Billion according to the Commission;
2022/12/08
Committee: ITRE
Amendment 33 #

2022/2079(INI)

Motion for a resolution
Recital F
F. whereas some critical technologies which could be available for use in the defence sector originate in the civilian sector and could qualify for dual use if obstacles were removreciprocally, and boundary between defence and civilian applications is increasingly blurred;
2022/12/08
Committee: ITRE
Amendment 35 #

2022/2079(INI)

Motion for a resolution
Recital G
G. whereas open research and innovation involving academia, private enterprise and the public sector has the potential to accelerate the development of Europe’s cutting-edge technologies which have the potential to address market fragmentation provided that interoperability is ensured;
2022/12/08
Committee: ITRE
Amendment 40 #

2022/2079(INI)

Motion for a resolution
Recital G a (new)
G a. Whereas participating Member States of the European Defence Agency have dedicated more than EUR 25 Billion for R&D in defence over 2017-2020, of which only a small portion has been spent collaboratively;
2022/12/08
Committee: ITRE
Amendment 41 #

2022/2079(INI)

Motion for a resolution
Recital G b (new)
G b. Whereas deepening defence cooperation among Member States at Union level should go hand in hand with the strengthening of parliamentary oversight and control by both the European Parliament and national parliaments;
2022/12/08
Committee: ITRE
Amendment 48 #

2022/2079(INI)

Motion for a resolution
Paragraph 1
1. Welcomes the Commission’s roadmap for critical technologies for security and defence; emphasises the need for greater involvement of the European Union in coordinating and facilitating the development of security- and defence- related technology; underlines that the EU’s global technological competitiveness is highly dependent on innovation and the ability to deploy new technologies and train people rapidly;
2022/12/08
Committee: ITRE
Amendment 62 #

2022/2079(INI)

Motion for a resolution
Paragraph 3
3. Underlines that the worsening of the security situation in Europe after Russia’s illegal, unprovoked and unjustified war of aggression against Ukraine demands a stronger and better coordinated effort by the European Union and its Member States to invest in critical security and defence technologies; is concerned that the growing global demand for conventional weapon systems in the context of the war in Ukraine may have a negative effect on investments in the development of new technologies and to establish a truly European defence equipment market;
2022/12/08
Committee: ITRE
Amendment 65 #

2022/2079(INI)

Motion for a resolution
Paragraph 4
4. Welcomes the Commission’s setting up an observatory of critical technologies; calls on the Commission to fully integrate the findings of the observatory in its classified report to Member States on critical technologies and risks associated with strategic dependencies affecting security, space and defence; stresses the need for the Commission to further coordinate and facilitate cooperation between and resource pooling of the Member States in order to address the existing and future technology gaps; calls on the Commission to keep the European Parliament duly informed of the main outputs of this observatory; calls on the Commission to assess the opportunity of extending the scope of the Observatory to energy and mobility related industries;
2022/12/08
Committee: ITRE
Amendment 72 #

2022/2079(INI)

Motion for a resolution
Paragraph 5
5. Notes that the there is a risk of dependency for the supply of critical materials and of overstretched supply chains that may affect the EU’s capability to stay competitive in the field of critical technologies for security and defence; calls on the Commission to take the lead with a special research programme on new materials for critical technologies so as to minimise the EU’s dependency on third countries;deleted
2022/12/08
Committee: ITRE
Amendment 79 #

2022/2079(INI)

Motion for a resolution
Paragraph 6
6. Welcomes the creation of an EU defence innovation scheme (EUDIS) and the ongoing work with various tools relating to defence and new and dual-use technologies in order to help innovative start-ups and small and medium-sized enterprises overcome high technological, administrative, regulatory and market entry hurdles; calls on the Commission to encourage Member States, as the end users, to fully utilise cross-border innovation networks; calls on the Commission to duly consider the specific sensitivity of security and defence and the expected role and origin of private capital when setting up initiative under the EUDIS;
2022/12/08
Committee: ITRE
Amendment 94 #

2022/2079(INI)

Motion for a resolution
Paragraph 8
8. Is concerned about the lack of investment in new, disruptive technologies in the defence industry; calls on the Commission to establish the necessary cooperative tools and measures to encourage the defence industry to invest more in technological innovation in critical technologies for security and defence, in addition to producing existing weapon systems, in full compliance with and following the development of international law and the EU legislative framework, which prohibits the development of lethal autonomous weapons without meaningful human control over selection and engagement decisions when carrying out strikes against humans;
2022/12/08
Committee: ITRE
Amendment 100 #

2022/2079(INI)

Motion for a resolution
Paragraph 9
9. Stresses the need for closersignificant potential of cooperation between the Member States, and in particular their state-owned military industries, on capability development to boost innovation in critical technologies for security and defence; calls on the relevant EU bodies to act as catalysts and accelerators to encourage the Member States to coordinate their capability development programmes and calls on the Commission and Member States to consider an EU mechanism to pool national resources for R&;D in defence and security with a sound involvement of the European Parliament in the implementation;
2022/12/08
Committee: ITRE
Amendment 110 #

2022/2079(INI)

Motion for a resolution
Paragraph 10
10. Emphasises that EU financed and co-financed innovation and development in critical and disruptive defence technologies should leadbe strictly conditional to a higher degree of interoperability and common procurement of defence equipment by Member States once the technologies developed have reached an appropriate technological readiness level; stresses that it is equally important not to duplicate existing projects via the European level and underlines the importance to add an additional criterion that obliges EU- funded initiatives to reduce existing duplications in a significant manner; asks that the appropriate technological readiness level be defined by the Commission in cooperation with the Member States;
2022/12/08
Committee: ITRE
Amendment 119 #

2022/2079(INI)

Motion for a resolution
Paragraph 12
12. Is concerned about the insufficient level of financing for defence from the EU funds; recalls the fact that the European Defence Fund budget was cut by approximately 40 % relative to the Commission’s proposal for the multiannual financial framework (MFF) 2021-2027; calls on the Commission to explore exDeplores the historic low collaboration rate of Member States on defence investment which is of 8% for 2021; stresses the fact that neither the current, nor a revised MFF will be able to provide sufficient financial resources to boost defence collaboration at EU level at an appropriate level as the current security situation demands a quantum leap; urges the Member States to consider pooling considerable parts of their risting funding schemes and alternatinational defence budgets at EU levesl to increase the funding for critical technologies for security and defence under the current MFFjointly replenish depleted ammunition stocks and to jointly purchase weapon systems, including the most complex and expensive ones such as fighter jets, warships, and main battle tanks;
2022/12/08
Committee: ITRE
Amendment 129 #

2022/2079(INI)

Motion for a resolution
Paragraph 13
13. Emphasises the need for better dual use of existing civilian technologies, as well as dual-use innovation in the field of critical technologies for security and defence and the corresponding potential of furthering synergies between EU programmes; stresses the need for better knowledge sharing networks for existing and new technologies so as to enable potential end users and investors to make better use of technologies already on the market or invest in high-potential emerging technologies;
2022/12/08
Committee: ITRE
Amendment 133 #

2022/2079(INI)

Motion for a resolution
Paragraph 14
14. Encourages innovation based on increased resource efficiency, development of new materials, promotion of secondary raw materials and more sustainable public procurement, and the use of environmentally sustainable technology solutions; calls on the Commission to explore the way forward on sustainable security and defence technologies and how the EU’s security and defence industries and the EU’s resilience could benefit; in line with the EU’s Climate Change and Defence Roadmap and its resolution of 7 June 2022 on the very same topic, in particular reducing the dependence of EU’s security and defence to fossil fuels, and the vulnerability to climate change and corresponding need of adaptation to it;
2022/12/08
Committee: ITRE
Amendment 139 #

2022/2079(INI)

Motion for a resolution
Paragraph 14 a (new)
14 a. Underlines the need to increase investments in ‘green’ defence, in particular by dedicating a higher share of military and dual-technology innovation (equipment, energy, etc.) R&D funded from the EU budget to carbon-neutral fuels and propulsion systems for military aircraft, ships and other vehicles, in particular as regards future major weapons systems (e.g. the future combat air system (FCAS) and the European main battle tank (EMBT)) and others which are developed within the frameworks provided by the EU;
2022/12/08
Committee: ITRE
Amendment 141 #

2022/2079(INI)

Motion for a resolution
Paragraph 14 b (new)
14 b. Calls on DG DEFIS, the Member States, the EEAS and the EDA to adopt an approach incorporating energy, carbon and environmental footprint by design when implementing relevant EU funds; welcomes the fact that the EDF contributes to the integration of climate actions into EU policies; recalls that the research and development actions can be directed at solutions to improve efficiency, reduce the carbon footprint and achieve sustainable best practices; welcomes the relevant investment of EUR 133 million provided for in the first annual work programme, but notes that this represents only 11 % of the overall annual EDF budget;
2022/12/08
Committee: ITRE
Amendment 143 #

2022/2079(INI)

Motion for a resolution
Paragraph 15
15. Highlights that Russia’s war against Ukraine has repeatedly demonstrated the effectiveness of disruptive technologies that often come at relatively low cost while having a powerful impact on the battlefield against large weapon systems and formations; calls on the Commission to conduct a study on the lessons identified from the war in Ukraine with regard to critical technologies for security and defence;
2022/12/08
Committee: ITRE
Amendment 5 #

2022/2053(INI)

Draft opinion
Recital B
B. whereas the development and deployment at scale of carbon removal solutions is indispensable to climate neutrality and requires significant targeted support over the next decade for carbon captureevery tonne of fossil CO2 that is not emitted is the best contribution to achieving climate targets; whereas sustainably, safely and permanently storing CO2 from the atmosphere or from unavoidable emissions can contribute to climate neutrality only if the carbon is sourced from the atmosphere, stored out of the atmosphere permanently and considered net of all associated greenhouse gas emissions, butilisation and storage (CCUS); is a lesser sustainable solution than avoided emissions as safe, sustainable and permanent storage remains a major challenge;
2022/07/14
Committee: ITRE
Amendment 10 #

2022/2053(INI)

Draft opinion
Recital B a (new)
B a. whereas biogenic carbon flows are natural processes largely influenced by human interventions; whereas policies should differentiate between biogenic and fossil carbon cycles; whereas fossil carbon must be reduced to close-to-zero as soon as possible;
2022/07/14
Committee: ITRE
Amendment 22 #

2022/2053(INI)

Draft opinion
Paragraph 2
2. Reiteratecalls that the European Climate Law sets the goal of climate neutrality by 2050net-zero emissions by 2050 at the latest, and recognises the need to drastically reduce fossil carbon reliance;
2022/07/14
Committee: ITRE
Amendment 24 #

2022/2053(INI)

Draft opinion
Paragraph 2 a (new)
2 a. Reiterates1a its position to enhance net greenhouse gas removals by natural sinks to at least 310 million tonnes CO2 equivalent by 2030 while taking into account the ‘do no significant harm’ principle, and to supplement that target by additional measures and initiatives at Union level to support carbon farming; in this context recalls the importance of avoiding double counting in order to maintain the environmental integrity of the European climate policy framework; _________________ 1a From EP’s LULUCF position voted on 8 June https://www.europarl.europa.eu/doceo/doc ument/TA-9-2022-0233_EN.html
2022/07/14
Committee: ITRE
Amendment 27 #

2022/2053(INI)

Draft opinion
Paragraph 2 b (new)
2 b. Reiterates that progress made in one sector should not compensate for the lack of progress in other sectors and that the priority should be to stop the release of fossil emissions;
2022/07/14
Committee: ITRE
Amendment 28 #

2022/2053(INI)

Draft opinion
Paragraph 2 c (new)
2 c. Reiterates that removals of greenhouse gases by natural carbon sinks are fragile and potentially reversible and that the risk of reversal of removals by natural carbon sinks is further aggravated by climate change;
2022/07/14
Committee: ITRE
Amendment 29 #

2022/2053(INI)

Draft opinion
Paragraph 2 d (new)
2 d. Highlights that Climate science also shows that the climate response to emissions and removals is asymmetrical; meaning that one tonne of greenhouse gases emitted to the atmosphere cannot be compared to one tonne of greenhouse gases removed;
2022/07/14
Committee: ITRE
Amendment 32 #

2022/2053(INI)

Draft opinion
Paragraph 3
3. Reiterates the role of Horizon Europe missions and the European Innovation Council in researching breakthrough technologies; in researching new technologies, whilst ensuring the protection of the environment and high levels of human health protection2a; _________________ 2a Horizon Europe legal text Article 19 https://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:3202 1R0695&from=EN
2022/07/14
Committee: ITRE
Amendment 35 #

2022/2053(INI)

Draft opinion
Paragraph 4
4. Supports the increased size of the Innovation Fund for the deployment at scale of innovative low-carbon technologies to support industrial carbon removal and the possibility of carbon contracts for difference (CCfD) as a means of investment in innovative clean technologiConsiders that carbon capture and storage (CCS) can playa role for capturing and safely and permanently storing unavoidable emissions where no direct emissions reduction options are available; stresses that Carbon Capture and Utilisation (CCU) only contributes to temporarily avoid CO2 emissions being emitted in the atmosphere and that, unless those emissions are eventually safely and permanently stored, they are usually released later in the atmosphere, often on a very short timeframe, and therefore amount to delayed emissions which is not compatible with meeting the Union’s climate objectives;
2022/07/14
Committee: ITRE
Amendment 42 #

2022/2053(INI)

Draft opinion
Paragraph 5
5. Highlights the importance of European leadership and the need for a competitive CCUS market with financial incentivesin energy saving and energy efficiency measures, in electrifying our economy and boosting renewables which are the three pillars which would drastically reduce the need to permanently stored emissions through the use of CCS;
2022/07/14
Committee: ITRE
Amendment 46 #

2022/2053(INI)

Draft opinion
Paragraph 5 a (new)
5 a. Underlines that widespread deployment of CCS is contingent on availability and social acceptance of sustainable, safe and permanent storage facilities; stresses that post-injection environmental monitoring should be mandatory; strongly encourages the Commission to clarify the issue of liability if or when carbon removals are reversed and the resulting harm caused to human health (toxicological effects), the climate and environment or property including ground-water contamination and seismicity as well as the long-term effects on ecosystems;
2022/07/14
Committee: ITRE
Amendment 54 #

2022/2053(INI)

Draft opinion
Paragraph 5 b (new)
5 b. Stresses that CCS applied to fossil CO2installations cannot result in carbon dioxide removals, as carbon dioxide removals can only be achieved through the permanent storage of atmospheric (including biogenic) CO2;
2022/07/14
Committee: ITRE
Amendment 56 #

2022/2053(INI)

Draft opinion
Paragraph 5 c (new)
5 c. Stresses that CCU that results in the CO2 being emitted to the atmosphere at any point during the use or disposal of the product is not carbon dioxide removal but a delayed CO2 emission, regardless of the CO2 origin;
2022/07/14
Committee: ITRE
Amendment 59 #

2022/2053(INI)

Draft opinion
Paragraph 6
6. Calls on the Commission to propose a framework for carbon removal, with requirements onTakes note of the announcement made in the Commission communication on sustainable carbon cycles that each tonne of CO2 captured, transported, used and stored will be reported and accounted for by its fossil, biogenic or atmospheric origin; stresses that this monitoring, reporting and verification based on life- cycle considerations, framework, is a first step and that ist sufficiently flexible to accommodate new technologiehould be fully in place, operational and have demonstrated its effectiveness in delivering a highly transparent, science-based, robust and accountable accounting framework before the Commission presents further measures for regulating carbon sinks and carbon removals;
2022/07/14
Committee: ITRE
Amendment 66 #

2022/2053(INI)

Draft opinion
Paragraph 6 a (new)
6 a. Stresses that any carbon dioxide, which is only temporarily removed from the atmosphere, used and later released again amount to delayed emissions and has therefore no role to play in the economy-wide effort to reach net-zero GHG emissions by 2050 at the latest and negative emissions thereafter;
2022/07/14
Committee: ITRE
Amendment 74 #

2022/2053(INI)

Draft opinion
Paragraph 7
7. Calls on the Commission to present short-term actions to upscale carbon fEmphasises that marming, including ‘blue carbon’, as a business model that incentivises practices on naturale, coastal and freshwater ecosystems that increcan act ase carbon sequestration, and to foster a new industrial value chain for the sustainable capture, recycling, transportinks; encourages the Commission to collect further knowledge and data on the capacity of those ecosystems to capture and storage ofe carbon.;
2022/07/14
Committee: ITRE
Amendment 78 #

2022/2053(INI)

Draft opinion
Paragraph 7 a (new)
7 a. Calls on the Commission, in cooperation with industry sectors and stakeholders, including civil society organisations, involved in carbon removal practices and technologies to come forward with concrete solutions and initiatives aiming to replace fossil carbon with sustainable streams of recycled carbon;
2022/07/14
Committee: ITRE
Amendment 86 #

2022/0394(COD)

Proposal for a regulation
Title 1
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL establishing a Union certification framework for carbon removalsafe, sustainable and high quality carbon removals and carbon farming activities
2023/06/29
Committee: ENVI
Amendment 92 #

2022/0394(COD)

Proposal for a regulation
Recital 1
(1) Under the Paris Agreement adopted under the United Nations Framework Convention on Climate Change22 ('the Paris Agreement'), the international community has agreed to hold the increase in the global average temperature well below 2° C above pre-industrial levels and to pursue efforts to limit the temperature increase to 1.5° C above pre-industrial levels. That commitment has been reinforced with the adoption under the UNFCCC of the Glasgow Climate Pact on 13 November 2021, in which the Conference of the Parties to the UNFCCC, serving as the meeting of the Parties to the Paris Agreement, recognises that the impacts of climate change will be much lower at a temperature increase of 1,5 ºC, compared with 2 ºC, and resolves to pursue efforts to limit the temperature increase to 1,5 ºC. The Union and its Member States are Parties to the Paris Agreement and are strongly committed to its implementation by reduction of greenhouse gas emissions and increase in carbon removals. __________________ 22 Approved by Council Decision (EU) 2016/1841 of 5 October 2016 on the conclusion, on behalf of the European Union, of the Paris Agreement adopted under the United Framework Convention on Climate Change (OJ L 282, 19.10.2016, p. 1).
2023/06/29
Committee: ENVI
Amendment 96 #

2022/0394(COD)

Proposal for a regulation
Recital 2
(2) At a global scale, the latest reports23 by the International Panel on Climate Change (IPCC) points towards a decreasing likelihood of limiting global warming to 1.5 °C unless rapid and deepimmediate, deep and sustained cuts in global greenhouse gas (GHG) emissions across all sectors occur throughout the forthcomon-going decades and beyond. The IPCC report also clearly states that ‘the deployment of carbon dioxide removal to counterbalance hard-to-abate residual emissions is unavoidable if net- zero carbon dioxide (CO2) or GHG emissions are to be achieved’, while recognising that low demand scenarios can reduce the need for carbon capture and removal technologies. This will require the large-scale deployment of safe and sustainable activities for capturing CO2 from the atmosphere and durably storing it in geological reservoirs, terrestrial and marine ecosystems, or products. Today and with current policies, the Union is not on track to deliver the required carbon removals: carbon removals in terrestrial ecosystems have been decreasing in recent years, and. Despite significant past investment from the Union budget1a, no significant industrial carbon removals are currently taking place in the Union. __________________ 231a European Court of Auditors (2018). Special Report 2018/24, Demonstrating carbon capture and storage and innovative renewables at commercial stage in the EU: intended progress not achieved in the past decade. 23 IPCC AR6 Synthesis Report (2023), IPCC Working Group III (2022), Technical Summary. In: Climate Change 2022: Mitigation of Climate Change. Sixth Assessment Report (link).
2023/06/29
Committee: ENVI
Amendment 101 #

2022/0394(COD)

Proposal for a regulation
Recital 2 a (new)
(2a) The latest IPCC reports also stated that ‘large-scale land-based biological CDR may not prove as effective as expected, and its large-scale deployment may result in ecological and social impacts, suggesting it may not be a viable carbon removal strategy in the next 10-20 years’. In particular, the IPCC pointed to the large-scale deployment of BECCS, which ‘may push planetary boundaries for freshwater use, exacerbate land- system change, and significantly alter biosphere integrity and biogeochemical flows’. The IPCC report also clearly stated that overshooting 1.5°C would entail serious adverse impacts, some irreversible, and additional risks for human and natural systems, and that the larger the overshoot, the more challenging would be the return.
2023/06/29
Committee: ENVI
Amendment 106 #

2022/0394(COD)

Proposal for a regulation
Recital 2 b (new)
(2b) The potential for removals is nevertheless limited. Many removal activities are implemented on land, which competes for other uses such as food production, and have a saturation point for how much carbon they can absorb, such as soils saturated with organic matters.
2023/06/29
Committee: ENVI
Amendment 111 #

2022/0394(COD)

Proposal for a regulation
Recital 3
(3) The aim of this Regulation is to develop a voluntary Union certification framework for carbon removals, with the view to incentivise the uptake of safe, sustainable and high- quality carbon removals and carbon farming activities, in full respect of the biodiversity and the zero-pollution objectives. It is a tool to support the achievcomplement of the Union objectives under the Paris Agreement, notably the goal of collective climate neutrality by 2050 laid down in Regulation (EU) 2021/1119 of the European Parliament and of the Council24 . The Union also committed to generate negative emissions after 2050. An important instrument to enhance carbon removals immediate, deep and sustained reduction of GHG emissions by sources across all sectors that is needed to limit global warming terrestrial ecosystems iso 1,5°C. Regulation (EU) 2018/841 of the European Parliament and of the Council25 , which is currently under review. The objective of the review is to set out a Union net removals target of 310 Mt CO2 eq by 2030, and to allocate respective targets to each Member State. __________________ 24 Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1). 25 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1)as amended by Regulation (EU) 2023/839, the proposed Nature Restoration Law and the upcoming EU Soil Health Law are other important instruments to increase the amount of carbon stored in terrestrial ecosystems.
2023/06/29
Committee: ENVI
Amendment 120 #

2022/0394(COD)

Proposal for a regulation
Recital 4
(4) The Union certification framework will support the development of carbon removal and carbon farming activities in the Union that result in an unambiguous net carbon removal benefit, while avoiding greenwashing. In the case of carbon farming, such certification framework should also encouragesure that the uptake of carbon removal activities that generate co- benefits for biodiversity, therefore achieving the nature restoration targets set out in Union law on nature restoration. The Union certification framework will be instrumental in meeting the Union climate change mitigation objectives set in international agreements and in the Union legislation.
2023/06/29
Committee: ENVI
Amendment 133 #

2022/0394(COD)

Proposal for a regulation
Recital 5
(5) In order to support operators willing to make additional efforts to increase carbon removals in a sustainable way, the Union certification framework should take into account the different types of carbon removal and carbon farming activities, their specificities and related environmental impacts, including impacts in third countries caused by importing biomass or indirect land use changes. Therefore, this Regulation should provide clear definitions of carbon removal, and carbon removalfarming activities, and other elements of the Union certification framework.
2023/06/29
Committee: ENVI
Amendment 149 #

2022/0394(COD)

Proposal for a regulation
Recital 6
(6) This Regulation should set out the requirements under which carbon removal activities should be eligible for certification under the Union certification framework. To this end, carbon removal activities should be quantified in an accurate and robust robust and conservative way; and they should be generated only by carbon removal activities that generate a net carbon removal benefit, are additional, aim to ensure long-term storage of carbon over a timeframe equivalent to the time carbon stays in the atmosphere once emitted by sources, and have a neutral impact or co-benefit on sustainability objectives. Furthermore, carbon removal activities should be subject to independent third-party auditing in order to ensure the credibility and reliability of the certification process. Mandatory Union carbon pricing rules established through Directive 2003/87/EC of the European Parliament and of the Council26 are in place which regulate the treatment of emissions from activities covered by that Directive. This Regulation should be without prejudice to Directive 2003/87/EC, except in relation to the certification of removals of emissions from sustainable biomass which are zero- rated in accordance with Annex IV theretotherefore not apply to emissions falling within the scope of Directive 2003/87/EC, nor to emissions falling within the scope of Regulation (EU) 2018/842. __________________ 26 Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC (OJ L 275, 25.10.2003, p. 32).
2023/06/29
Committee: ENVI
Amendment 160 #

2022/0394(COD)

Proposal for a regulation
Recital 7
(7) A carbon removal activity should result in a net carbon removal benefit showing that it delivers a positive climate impact. The net carbon removal benefit should be computed following two steps. First, operators should quantify the amount of additional carbon removals that a carbon removal activity has generated in comparison to a baseline. A standardisedfirst-mover baseline reflecting the standardbest-in-class performance of comparable activities in similar social, economic, environmental and technological circumstances and geographical locations should be preferredapply because it ensures objectivhigh-quality, minimises compliance and other administrative costs, and positively recognises the action of first movers who have already engaged in carbon removal activities. In the context of carbon farmingHowever, twhe use of available digital technologies, including electronic databases and geographic information systems, remote sensing, artificial intelligence and machine learning, and of electronic maps should be promoted to decrease the costs of establishing baselines and of monitoring carbon removal activities. However, where it is not possible to set such a standardised baselinere it is not possible to set such a first-mover baseline because of the lack of existing comparable and representative activities, a project-specific baseline based on the operator’s individual performance may be used, as specified in the relevant certification methodology. In order to reflect the social, economic, environmental and technological developments and to encourage ambition over time in line with the Paris Agreement, baselines should be periodically updatedreviewed every five years, and updated accordingly in case of new robust scientific evidence, always in a conservative manner.
2023/06/29
Committee: ENVI
Amendment 167 #

2022/0394(COD)

Proposal for a regulation
Recital 8
(8) The second step for quantifying the net carbon removal benefit should consist of subtracting any increase in -greenhouse gas emissions related to the implementation of the carbon removal activity. Relevant greenhouse gas emissions that should be taken into consideration include direct emissions, such as those resulting from the use of more fertilisers, fuel, chemicals, materials or energy, or indirect emissions, such as those resulting from direct or indirect land use change, with consequent risks for food security due to displacement of agricultural production. A reduction in greenhouse gas emissions resulting from the implementation of the carbon removal activity should not be taken into account to quantify the net carbon removal benefit, but should be considered as a co- benefit towards the sustainability objective of climate change mitigation; by being reported on the certificates, decreases in greenhouse gas emissions (like the other sustainability co-benefits) can increase the value of the certifi, that took place within or outside the Union. In case the carbon removal activity uses biomass, all emissions related to biomass should be fully accounted for, and no biomass should be deemed carbon removneutrals.
2023/06/29
Committee: ENVI
Amendment 174 #

2022/0394(COD)

Proposal for a regulation
Recital 9
(9) A carbon removal activity delivers a net carbon removal benefit when the carbon removals above the baseline outweigh any increase in greenhouse gas emissions due to the implementation of the carbon removal activity. For instance, in the case of activities that deliver permanent carbon storage by injecting carbon underground, the amount of permanently stored carbon should outweigh the energy- related greenhouse gas emissions from the industrial process, including during the capture, transport and storage, as well as the average displaced emissions linked to competitive uses of renewable energy and waste heat. In the case of carbon farming, the carbon captured by an afforestation activity or the carbon kept in the ground by a peatland re- wetting activity should outweigh the emissions from the machinery used to carry out the carbon removal activity or the indirect land use change emissions that can be caused by carbon leakage.
2023/06/29
Committee: ENVI
Amendment 178 #

2022/0394(COD)

Proposal for a regulation
Recital 10
(10) Carbon removals should be quantified in a relevant, accuratconservative, complete, consistent and comparable manner. Uncertainties in the quantification should be duly reported and accounted in order to limit the risk of overestimating the quantity of carbon dioxide removed from the atmosphere. Carbon removals generated by carbon farming should be quantified with a high level of accuracy to assure the highest quality and minimise uncertainties. Moreover, in order to incentivise synergies between Union climate and biodiversity objectives, enhanced monitoring of land needs to be required, thereby helping to protect and enhance the resilience of nature-based carbon removals throughout the Union. The satellite and on-site monitoring and reporting of emissions and removals need to closely reflect those approaches, and make the best use of advanced technologies available under Union programmes, such as Copernicus, making full use of already existing tools, and ensure consistency with the national greenhouse gas inventories.
2023/06/29
Committee: ENVI
Amendment 186 #

2022/0394(COD)

Proposal for a regulation
Recital 10 a (new)
(10a) In the case of carbon farming activities, the absence of commonly agreed carbon measurement and monitoring approaches makes the quantification and the establishment of baselines more difficult. Moreover, those activities should be supported not only for their net carbon removal benefit, but also because they generate co-benefits for other environmental objectives, in particular biodiversity protection, ecosystem resilience and climate adaptation. At least in the first three years, it is therefore proposed that certification methodologies will be limited to carbon farming activities for which the best available and most recent scientific evidence recognises they are beneficial both for the climate and biodiversity. Certification methodologies should detail the requirements under which a practice can be certified. During this period, operators or group of operators should monitor the amount of carbon removed through the activity, and the evolution of the health of the ecosystem in which the activity takes place. Tier 3 methodologies should be used to quantify the amount of carbon removals generated by carbon farming, and enhanced monitoring of land should be required, thereby helping to protect and enhance the resilience of nature-based carbon removals throughout the Union. The satellite and on-site monitoring and reporting of emissions and removals need to closely reflect those approaches, and make the best use of advanced technologies available under Union programmes, such as Copernicus, making full use of already existing tools, and ensure consistency with the national greenhouse gas inventories. After the initial 3-year period, the Commission should assess whether the experience and information gathered during this period could be used to further quantify the net environmental benefit of those practices.
2023/06/29
Committee: ENVI
Amendment 187 #

2022/0394(COD)

Proposal for a regulation
Recital 11
(11) In order to ensure that the Union certification framework channels incentives toward carbon removalactivities that go beyond the standard practice, carbon removal activities should be additional. Therefore,operators or group of operators should demonstrate that theseir activities should go beyond statutory requirements, that is, operators should carry out activities that are not already imposed upon them by the applicable law. Moreover, carbon removal activities should take place due to the incentive effect provided by the certification. Such effect is present when the inare additional, in particular that they go beyond Union or national removals targets, or statutory requirements already imposed upon them by the applicable law, and that those activities become financially attractive only because of the monetisation of the generated cenrtive created by the potential revenues, resulting from the certification, changes the behaviour of operators in such a way that they engage in the additional carbon removal activity to achieve addificate. In the case of carbon farming activities, certification methodologies should ensure that only activities that are additional to the impact of the new national ctarbon removalsgets set out in Regulation (EU) 2023/839 are being certified.
2023/06/29
Committee: ENVI
Amendment 192 #

2022/0394(COD)

Proposal for a regulation
Recital 12
(12) A standardisedThe use of "best-in-class" baselines should reflect the statutory and market conditions in which the carbon removal activity takes place. If a carbon removal activity is imposed upon operators by the applicable law, or it does not need any incentives to take place, its performance will be reflected in the baseline. For this reason, a carbon removal activity that generatesimplify the demonstration of additionality for operators as carbon removals in excess of such a baselines should be presumed to be additional. Hence, the use of a standardised baseline should simplify the demonstration of additionality for operators. Therefore, it should reduce the administrative burden of the certification process, which is particularly important in the case of small-scale land managers. Possible perverse incentives for baseline inflation should be considered and addressed by the certification methodologies.
2023/06/29
Committee: ENVI
Amendment 204 #

2022/0394(COD)

Proposal for a regulation
Recital 13
(13) Atmospheric and biogenic carbon that is captured and stored through a carbon removal activity risks being released back into the atmosphere (e.g. reversal or leakage) due to natural or anthropogenic causes. Therefore, operators should take all relevant preventive measures to mitigate those risks and duly monitor that carbon continues to be stored over the monitoring period laid down for the relevant carbon removaltype of activity. The validity of the certified carbon removalcates should depend on the expected duration of the storage and the different risks of reversal associated with the given cactivity. Carbon removals activity. Activities that store carbon in geological formations provide enough certaintiesare expected to store carbon on the very long- term duration of several centuries for the stored carbon and can be considered as providing permanent storage of carbon. Carbon farming or carbon storage in product. They should be considered as providing permanent storage of carbon, while ensuring that a robust liability framework is in place to take account of the risks of leakages. On the other hand, carbon farming activities are more exposed to the risk of voluntary or involuntary release of carbon into the atmosphere. To account for this risk, the validity of the certified carbon removals generated by carbon farming and carbon storage in products should be subject to an expiry date matching with the end of the relevant expected storage and monitoring period. Thereafter, the carbon should be assumed to be released into the atmosphere, unless the economic operator proves the maintenance of the carbon storage through uninterrupted monitoring activities and a re-certification audit.
2023/06/29
Committee: ENVI
Amendment 209 #

2022/0394(COD)

Proposal for a regulation
Recital 14
(14) In addition to measures taken to minimise the risk of carbon release into the atmosphere during the monitoring period, appropriate liability mechanisms and corrective measures should be introduced to address cases of reversal. Such mechanisms could include e.g. discounting of carbon removal units, collective buffers or accounts of carbon removal units, and up-front insurance mechanism or leakage, in a way that there should be a liable party at any moment of time. In the case of carbon farming activities, and given the higher risk of reversal, certificates can only be generated after each re-certification audits, without prejudice to the possibility of providing advance payments to cover investment needs of the operators or group of operators. Since liability mechanisms in respect of geological storage and CO2 leakage, and relevant corrective measures have already been laid down by Directive 2003/87/EC and Directive 2009/31/EC of the European Parliament and of the Council27 , those liability mechanisms and corrective measures should apply to carbon removal activities in order to avoid double regulation. __________________ 27 Directive 2009/31/EC of the European Parliament and of the Council of 23 April 2009 on the geological storage of carbon dioxide and amending Council Directive 85/337/EEC, European Parliament and Council Directives 2000/60/EC, 2001/80/EC, 2004/35/EC, 2006/12/EC, 2008/1/EC and Regulation (EC) No 1013/2006 (OJ L 140, 5.6.2009, p. 114).
2023/06/29
Committee: ENVI
Amendment 214 #

2022/0394(COD)

Proposal for a regulation
Recital 15
(15) Carbon removalfarming activities have a strong potential to deliver win-win solutions for sustainability, even if trade- offs cannot be excluded. Therefore, it is appropriate to establishonly certify activities that meet minimum sustainability requirements to ensure that carbon removal activities have a neutral impact orthose activities generate co- benefits for the sustainability objectives of climate change mitigation and adaptation, the protection and restoration of biodiversity and ecosystems, the sustainable use and protection of water and marine resources, the transition to a circular economy, and pollution prevention and control. Those sustainability requirements should, as appropriate, and taking into consideration local conditions, build on the technical screening criteria for Do N, while providing that they do not Ssignificant Harm concerning forestry activities and underground permanent geological storage of CO2, laid down in Commission Delegated Regulation (EU) 2021/213928 , and on the sustainability criteria for forest and agriculture biomass raw material laid down in Article 29 of Directive (EU) 2018/2001 of the European Parliament and of the Council29 . Practices, such as forest monocultures, that produce harmful effects for biodiversity should not be eligible for certification. __________________ 28 Commission Delegated Regulation (EU) 2021/2139 of 4 June 2021 supplementing Regulation (EU) 2020/852 of the European Parliament and of the Council by establishing the technical screening criteria for determining the conditions under which an economic activity qualifies as contributing substantially to climate change mitigation or climate change adaptation and for determining whether that economic activity causes no significant harm to any of the other environmental objectives (OJ L 442, 9.12.2021, p. 1). 29 Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82)ly harm any of those objectives. Those sustainability requirements should be based on the latest available scientific evidence. Practices, such as forest monocultures, that produce harmful effects for biodiversity should not be eligible for certification.
2023/06/29
Committee: ENVI
Amendment 224 #

2022/0394(COD)

Proposal for a regulation
Recital 15 a (new)
(15a) Technologies for carbon removal activities are currently very intensive in energy, water and other materials. In order to obtain a certification under this framework, carbon removal activities should demonstrate that they have at least a neutral impact on the sustainability objectives of climate change mitigation and adaptation, the protection and restoration of biodiversity and ecosystems, the sustainable use and protection of water and marine resources, the transition to a circular economy, and pollution prevention and control. Carbon removal activities that are extensively relying on land use should demonstrate positive impacts on sustainability objectives.
2023/06/29
Committee: ENVI
Amendment 229 #

2022/0394(COD)

Proposal for a regulation
Recital 16
(16) Farming practices that remove CO2 from the atmosphere contribute to the climate neutralitywhile generating co- benefits for other sustainability objectives contribute to the Union's environmental objectives and should be rewarded, either via the Common Agricultural Policy (CAP) or other public or private initiatives. Specifically, this Regulation should take into account farming practices as referenced in the Communication on Sustainable Carbon Cycles30 . __________________ 30 Communication from the Commission, Sustainable Carbon Cycles, COM (20221) 800.
2023/06/29
Committee: ENVI
Amendment 241 #

2022/0394(COD)

Proposal for a regulation
Recital 17
(17) Operators or groups of operators may report additional co-benefits that contribute to the sustainability objectives beyond the minimum sustainability requirements. To this end, their reporting should comply with the certification methodologies tailored to the different carbon removaltypes of activities, developed by the Commission. Certification methodologies should, as much as possible, incentivise the generation of co-benefits for biodiversity going beyond the minimum sustainability requirements. These additional co-benefits will give more economic value to the certified carbon removals and will result in higher revenues for the operators. In the light of these considerations, it is appropriate for the Commission to prioritise the development of tailored certification methodologies on carbon farming activities that provide significant co-benefits for biodiversity.
2023/06/29
Committee: ENVI
Amendment 249 #

2022/0394(COD)

Proposal for a regulation
Recital 18
(18) It is appropriate to develop detailed certification methodologies for the different carbon removal or carbon farming activities in order to apply, in a standardised, verifiable and comparable way, the quality criteria laid down in this Regulation. Those methodologies should ensure the robust and transparent certification of the net carbon removal benefit generated by the carbon removal or carbon farming activity, while avoiding disproportionate administrative burden for operators or group of operators, in particular for small farmers and forest holders. To this end, the Commission should be empowered to supplement this Regulation by adopting delegated acts establishing detailed certification methodologies for the different carbon removal activities. Those methodologies should be developed in close consultation with the Expert GroupPlatform on Carbon Removals and all other interested actorCarbon Farming Activities. They need to be based on the best available scientific evidence, build upon existing public and private schemes and methodologies for carbon removal certifice open for a minimum four- week public consultation, and take into account any relevant standard and rules adopted at national and Un, Union or international level.
2023/06/29
Committee: ENVI
Amendment 252 #

2022/0394(COD)

Proposal for a regulation
Recital 19
(19) In order to ensure a credible and reliable certification process, carbon removal and carbon farming activities should be subject to independent third- party auditing. In particular, carbon removal and carbon farming activities should be subject to an initial certification audit before their implementation, verifying their compliance with the quality criteria set out in this Regulation, including the correctnservative quantification of the expected net carbon removal benefit. Carbon removal and carbon farming activities should also be subject to periodic re- certification audits to verify the compliance of the generated carbon removals. To this end, the Commission should be empowered to adopt implementing acts to set out the structure, technical details, and the minimum information to be contained in the description of the carbon removal activity, and in the certification and re- certification audit reports.
2023/06/29
Committee: ENVI
Amendment 257 #

2022/0394(COD)

Proposal for a regulation
Recital 20
(20) Providing land managers with improved knowledge, tools and methods for a better assessment and optimisation of the carbon removalfarming activities is key for cost- efficient implementation of mitigation actions and for securing their engagement in carbon farming. This is particularly relevant for Union small farmers or forest holders that often lack the know-how and the expertise required to implement carbon removalfarming activities and to comply with the required quality criteria and related certification methodologies. Therefore, it is appropriate to require that producer organisations facilitate the provision of relevant advisory services through technical advice to their members. The Common Agricultural Policy and national State aid can support financially the provision of advisory services, knowledge exchange, training, information actions or interactive innovation projects with farmers and foresters.
2023/06/29
Committee: ENVI
Amendment 261 #

2022/0394(COD)

Proposal for a regulation
Recital 21
(21) It is appropriate that carbon removal certificates underpin different end-uses, such as the compilation of national and corporateThe Union and its Member States should continue to develop, regularly update and report to the UNFCC their greenhouse gas inventories, inclu according wito the regard toules set out in Regulation (EU) 2018/841 of the European Parliament and of the Council31 , the proof of climate-rel1999. Certificates generated aund other environmental corporate claims (including on biodiversity), or the exchange of verified carbon removal units through voluntary carbon offsetting markets. To this end, the certificate should contain accurate and transparent information on the carbon removal activity, including the total removals and net carbon removal benefit that comply with the quality criteria set out in this Regulation. The Commission should be also empowered to adopt delegated acts to further specify or amend Annex II which lists the minimum information to be contained in the certificates. __________________ 31 Regulation (EU) 2018/841 of the European Parliament and of the Council of 30 May 2018 on the inclusion of greenhouse gas emissions and removals from land use, land use change and forestry in the 2030 climate and energy framework, and amending Regulation (EU) No 525/2013 and Decision No 529/2013/EU (OJ L 156, 19.6.2018, p. 1)er this framework should not be used for the purpose of developing greenhouse gas inventories. Moreover, this framework should not undermine the need for immediate, deep and sustained emissions reduction by sources across all sectors needed to limit global warming to 1.5°C. Therefore, carbon removal and carbon farming activities certified under this Union framework should not be used for, or claim to, offset, compensate or replace the reduction of anthropogenic greenhouse gas emissions by sources, neither in regulatory nor in voluntary frameworks.
2023/06/29
Committee: ENVI
Amendment 268 #

2022/0394(COD)

Proposal for a regulation
Recital 21 a (new)
(21a) Certificates may nevertheless be monetised, thereby giving a financial incentive to operators or groups of operators to carry on the carbon removal or carbon farming activities. Such financial incentives may include funding from legal or physical persons wishing to contribute to the achievement of environmental objectives (‘contribution claims’), funding from the Common Agricultural Policy, public procurements or other sources of public finance.
2023/06/29
Committee: ENVI
Amendment 269 #

2022/0394(COD)

Proposal for a regulation
Recital 21 b (new)
(21b) In the event of leakage or reversal, the relevant ‘contribution claims’ should be amended so as to reflect the reality of the situation.
2023/06/29
Committee: ENVI
Amendment 270 #

2022/0394(COD)

Proposal for a regulation
Recital 21 c (new)
(21c) Certificates should contain accurate and transparent information on the carbon removal or carbon farming activity, including the total removals and net carbon removal benefit that comply with the quality criteria set out in this Regulation, as well as provide information whether the certificate has been monetised, for which purpose and by whom. The Commission should be also empowered to adopt delegated acts to further specify or amend Annex II which lists the minimum information to be contained in the certificates.
2023/06/29
Committee: ENVI
Amendment 277 #

2022/0394(COD)

Proposal for a regulation
Recital 22
(22) To ensure an accurate, robust and transparent verification, certification bodies responsible for performing the certification of carbon removal and carbon farming activities should have the required competences and skills and should be accredited by national accreditation authorities pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council32 . To avoid possible conflicts of interest, the certification bodies should also be completely independent from the operator carrying out the carbon removal activity that is subject to the certification. In addition, Member States should contribute towards ensuring the correct implementation of the certification process by supervising the operation of certification bodies that are accredited by national accreditation authorities, and by informing the certification schemes about relevant non-conformity findings. __________________ 32 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
2023/06/29
Committee: ENVI
Amendment 281 #

2022/0394(COD)

Proposal for a regulation
Recital 23
(23) Certification schemes should be used by operators to demonstrate compliance with this Regulation. Therefore, certification schemes should operate on the basis of reliable and transparent rules and procedures and should ensure accuracy, reliability, integrity and non-repudiation of origin, and protection against fraud of information and of data submitted by operators. They should also ensure the correct accounting of the verified carbon removal unitsgenerated by a certified activity, notably by avoiding double counting. To this end, the Commission should be empowered to adopt implementing acts, including adequate standards of reliability, transparency, accounting and of independent auditing to be applied by certification schemes, so as to ensure the necessary legal certainty as regards the rules applicable to operators and to certification schemes. To ensure a cost- effective certification process, those technical harmonised rules on certification should also have the objective of reducing unnecessary administrative burden for operators, or group of operators, in particular for Small and Medium Enterprises (SMEs), including small farmers and foresters.
2023/06/29
Committee: ENVI
Amendment 289 #

2022/0394(COD)

Proposal for a regulation
Recital 26
(26) Certification schemesBy [insert the date 6 months after the date of entry into force of this Regulation], the Commission should establish and maintain interoperablea public Union registriesy in order to ensure transparency, trust and full traceability of carbon removal and carbon farming certificates, and to avoid the risk of fraud and double counting. Fraud may occur if more than one certificate is issued for the same carbon removal activity because the activity has been registered under two different certification schemes or has been registered twice under the same scheme. Fraud may also occur when the same certificate is used several times to make the same claim based on a carbon removal activity or a carbon removal unit. The registries should storecertificate or a carbon farming activity certificate. All information in the Union registry should be easy to navigate and search. Certification schemes should provide to the Commission all information required to be stored and made publicly available in electronic form in the Union registry. Such information includes the documents resulting from the certification process of carbon removals or carbon farming activities, including summaries of certification audits and re-certification audit reports, the certificates and updated certificates, and make them publicly available in electronic form. The registries should also record the certified carbon removal units that meet the Union quality criteria and the information included therein, as well as the current status of a certificate, for example whether active, retired or expired, a log of transactions, and make them publicly available in electronic form. Prior to the establishment of the Union public registry, certification schemes recognised by the Commission should maintain and store all the information required to be stored and made publicly available later on the Union registry. In order to ensure a level playing field within the single market, the Commission should be empowered to adopt implementing rules setting out standards and technical rules on the functioning and the inter-operability of thosethe minimum information to be made available by recognised certification schemes to the Union registriesy.
2023/06/29
Committee: ENVI
Amendment 297 #

2022/0394(COD)

Proposal for a regulation
Recital 27
(27) Certification schemes play an important role in providing evidence of compliance with the quality criteria for carbon removals. It is therefore appropriate for the Commission to require certification schemes to report regularly on their activity. Such reports should be made public, in full or where appropriate in an aggregated format, in order to increase transparency and scrutiny by citizens and independent third parties, and to improve supervision by the Commission. Furthermore, such reporting would provide the necessary information for the Commission to report on the operation of the certification schemes with a view to identifying best practices and submitting, if appropriate, a proposal to further promote such best practices. In order to ensure comparable and consistent reporting, the Commission should be empowered to adopt implementing acts setting out the technical details on the content and format of the reports drawn up by the certification schemes.
2023/06/29
Committee: ENVI
Amendment 299 #

2022/0394(COD)

Proposal for a regulation
Recital 28
(28) To enable operators to apply the quality criteria set out in this Regulation in a standardised and cost-effective way, while taking into account the specific characteristics of different carbon removal activities, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to supplement this Regulation by establishing detailed certification methodologies for different types of carbon removals and carbon farming activities. The Commission should also be able to amend Annex II listing the minimum information to be contained in the certificates. 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-Making34 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. Each draft delegated act should also be open for public consultation for a period of minimum four weeks. __________________ 34 OJ L 123, 12.5.2016, p. 1
2023/06/29
Committee: ENVI
Amendment 304 #

2022/0394(COD)

Proposal for a regulation
Recital 30
(30) The Commission should review the implementation of this Regulation 3 years following the entry into force of this Regulation, and subsequently not later than six months after the global stocktake agreed under Article 14 of the Paris Agreement.. Those reviews should take into account the relevant developments concerning the Union legislation, technological and scientific progress, market developments in the field of carbon removals and carbon farming activities, and food security including food availability and affordability, and should be informed by the results of the global stocktake of the Paris Agreement.
2023/06/29
Committee: ENVI
Amendment 308 #

2022/0394(COD)

Proposal for a regulation
Article 1 – title
Subject matter, scope and uscope
2023/06/29
Committee: ENVI
Amendment 311 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 1 – introductory part
1. The objective of this Regulation is to facilitate the deployment of carbon removals by operators or groups of operatorsenvironmentally sustainable, safe and secure permanent geological atmospheric carbon storage on the one hand, and increased carbon sequestration in biogenic carbon pools through land use activities in full respect of the biodiversity and zero-pollution objectives on the other hand, as a complement to the immediate, deep and irreversible reduction of GHG emissions by sources across all sectors needed to limit global warming to 1,5°C. To that end, this Regulation establishes a voluntary Union framework for the certification of carbon removals and carbon farming activities by laying down:
2023/06/29
Committee: ENVI
Amendment 323 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point a
(a) quality criteria for carbon removal and carbon farming activities that take place in the Union;
2023/06/29
Committee: ENVI
Amendment 326 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point b
(b) rules for the verification and certification of carbon removals and carbon farming activities;
2023/06/29
Committee: ENVI
Amendment 331 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point b a (new)
(ba) rules on the monitoring, validity, expiry and liability of carbon removals and carbon farming activities;
2023/06/29
Committee: ENVI
Amendment 335 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point c a (new)
(ca) rules for the use of the carbon removals certificates and carbon farming certificates.
2023/06/29
Committee: ENVI
Amendment 346 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 2
2. This voluntary Union framework for the certification of carbon removals and carbon farming activities does not apply to emissions falling within the scope of Directive 2003/87/EC, with the exception of the storage of carbon dioxide emissions from sustainable biomass that are zero-rated in accordance with Annex IV thereto and of Regulation (EU) 2018/842.
2023/06/29
Committee: ENVI
Amendment 352 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 2 a (new)
2a. Carbon removal and carbon farming activities certified under this Union framework shall not be used for or claim to offset, compensate or replace the reduction of anthropogenic greenhouse gas emissions by sources, neither in regulatory nor in voluntary frameworks.
2023/06/29
Committee: ENVI
Amendment 354 #

2022/0394(COD)

Proposal for a regulation
Article 1 – paragraph 2 b (new)
2b. This Regulation may apply to CO2 emissions captured within the Union but geologically stored in another Member of the European Economic Area, or in another neighbouring country, that applies the same legal requirements as the ones set out in Directive 2009/31/EC, pursuant to a legal agreement negotiated between that third country and the Union and ratified by both Parties according to their jurisdictional systems.
2023/06/29
Committee: ENVI
Amendment 356 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point a
(a) ‘carbon removal’ means either the storage of atmospheric or biogenic carbon within geological carbon pools, biogenic carbon pools, long-lasting products and materials, and the marine environment, or the reduction of carbon release from a biogenic carbon pool to the atmosphere;deleted
2023/06/02
Committee: ENVI
Amendment 369 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point b
(b) ‘carbon removal activity’ means one or more practices or processes carried out by an operator resulting in permanent carbon storage, enhancing carbon capture in a biogenic carbon pool, reducing the relewith net-negative GHG emissions over the entire life cycle of the activity, taking into account displacement effects due to competing use for energy and waste of carbon from a biogenic carbon pool to the atmosphere, or storing atmospheric or biogenic carbon in long- lasting products or materialsheat, as well as total GHG emissions arising from the transport and storage of CO2, and with minimum impact on natural resources, including water use, and which is not combined with Enhanced Hydrocarbon Recovery;
2023/06/02
Committee: ENVI
Amendment 379 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point c
(c) ‘biogenic carbon pool’ means above-ground biomass, below-ground biomass, litter, dead wood and soilliving biomass, litter, dead wood, dead organic matter, mineral soils and organic carbonsoils as set out in points (a) to (ef) of Part B of Annex I to Regulation 2018/841;
2023/06/02
Committee: ENVI
Amendment 381 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
(ca) ‘geological formation’ means as defined under Directive 2009/31/EC;
2023/06/02
Committee: ENVI
Amendment 384 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point d
(d) ‘operator’ means any legal or physical person who operates or controls a carbon removal activityor carbon farming activity, including cooperatives and local public authorities, or to whom decisive economic power over the technical functioning of the activity has been delegated;
2023/06/02
Committee: ENVI
Amendment 397 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point f
(f) ‘monitoring period’ means a period, the duration of which is determined in accordance to the type of carbon removal activitywith Article -9, over which the storage of carbon is monitored by the operator;
2023/06/02
Committee: ENVI
Amendment 405 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point g
(g) ‘permanent carbon storage’ means a carbon removal activity that, under normal circumstances and using appropriate management practices, injects and stores atmospheric or biogenic carbon for at least several centuries, including bioenergy with carbon capture and storage and direct air carbon capture and storage underground geological formations, in compliance with the rules set out in Directive 2009/31/EC;
2023/06/02
Committee: ENVI
Amendment 410 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point g a (new)
(ga) ‘leakage’ means any release of CO2 from the storage complex, as defined under Directive 2009/31/EC, and any release during the transportation of CO2;
2023/06/02
Committee: ENVI
Amendment 416 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point h
(h) ‘carbon farming’ means a carbon removal activity related to land management that results in the increase of carbon storage in living biomass, dead organic matter and soils by enhancing carbon capture and/or reducing the release of carbon to the atmosphereland use activity that results in the increase of carbon storage in biogenic carbon pools for at least one hundred years, including in the case of peatland rewetting when that activity only reduces the release of carbon to the atmosphere in the short term but leads to net removals in the medium to long term, while increasing the resilience of that activity to rising climate change impacts by demonstrating an enhancement of biodiversity as elaborated in Article 8c(3);
2023/06/02
Committee: ENVI
Amendment 427 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point h a (new)
(ha) ‘reversal’ means the voluntary or involuntary release of CO2 back into the atmosphere from biogenic carbon pools;
2023/06/02
Committee: ENVI
Amendment 429 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point i
(i) ‘carbon storage in products’ means a carbon removal activity that stores atmospheric and biogenic carbon in long-lasting products or materials;deleted
2023/06/02
Committee: ENVI
Amendment 437 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point i a (new)
(ia) ‘best-in-class comparable activity’ means the 5% best performing activity among a range of comparable activities in similar social, economic, environmental and technological circumstances and geographical locations, irrespective of their management practices;
2023/06/02
Committee: ENVI
Amendment 441 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point n
(n) ‘carbon removal certificate’ means a conformity statement issued by the certification body certifying that the carbon removal activity complies with this Regulation;
2023/06/02
Committee: ENVI
Amendment 442 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point n a (new)
(na) ‘carbon farming certificate’ means a conformity statement issued by the certification body certifying that the carbon farming activity complies with this Regulation;
2023/06/02
Committee: ENVI
Amendment 443 #

2022/0394(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point o
(o) ‘carbon removal unit’ means one tonne of certified net carbon removal benefit generated by a carbon removal activity and registered by a certification scheme.deleted
2023/06/02
Committee: ENVI
Amendment 469 #

2022/0394(COD)

Proposal for a regulation
Article 3 – paragraph 1 – introductory part
Carbon removals activities shall be eligible for certification under this Regulation where they meet bothall of the following conditions:
2023/06/02
Committee: ENVI
Amendment 471 #

2022/0394(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point -a (new)
(-a) they are not used for or claim to offset, compensate or replace the reduction of anthropogenic greenhouse gas emissions by sources, neither in regulatory nor in voluntary frameworks;
2023/06/02
Committee: ENVI
Amendment 474 #

2022/0394(COD)

Proposal for a regulation
Article 3 – paragraph 1 – point a
(a) they are generated from a carbon removal activity that compliescomply with the quality criteria set out in Articles 4 to 7;
2023/06/02
Committee: ENVI
Amendment 478 #

2022/0394(COD)

Proposal for a regulation
Article 3 – paragraph 1 a (new)
Carbon farming activities shall be eligible for certification under this Regulation when they meet all of the following conditions: (a) they are not used for or claim to offset, compensate or replace the reduction of anthropogenic greenhouse gas emissions by sources, neither in regulatory nor in voluntary frameworks; (b) they comply with the quality criteria set out in Articles 8a to 8e; (c) they are independently verified in accordance with Article 9.
2023/06/02
Committee: ENVI
Amendment 485 #

2022/0394(COD)

Proposal for a regulation
Chapter 2 – title
2 QUALITY CRITERIA FOR PERMANENT CARBON REMOVAL ACTIVITIES
2023/06/02
Committee: ENVI
Amendment 492 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 1
Net carbon removal benefit = CRbaseline – CRtotal – GHGincrease > 0total – GHGtotal – CRbaseline
2023/06/02
Committee: ENVI
Amendment 493 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2 – point a
(a) CRbaseline is the carbon removals under the baselineaverage total amount of CO2 removed from the atmosphere over the entire life cycle of best-in-class comparable activities;
2023/06/02
Committee: ENVI
Amendment 494 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2 – point b
(b) CRtotal is the total carbon removals of the carbon removalamount of CO2 removed from the atmosphere by the activity over the entire life cycle of the activity;
2023/06/02
Committee: ENVI
Amendment 496 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 1 – subparagraph 2 – point c
(c) GHGincrease is the increase intotal is all the direct and indirect greenhouse gas emissions, other than tver the entire life cycle of the activity, including greenhouse from biogenic carbon pools in the case of carbon farmigas emissions arising from the transport and storage of CO2, the use of fertilisers, fuels, chemicals, materials, biomass or energy, the displacement of energy and waste heat from competitive uses, as well as direct and indirect land use change, which are due to the implementation of the carbon removal activity. For the quantification of GHG emissions associated with the use of biomass, rigorous life-cycle assessments shall be applied to ensure that net- removals can only be accounted for once the total carbon debt payback period has expired.
2023/06/02
Committee: ENVI
Amendment 503 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 2
2. In the case of carbon farming, CRbaseline and CRtotal shall be understood as net greenhouse gas removals or emissions in accordance with the accounting rules laid down in Regulation (EU) 2018/841.deleted
2023/06/02
Committee: ENVI
Amendment 516 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 3
3. Quantities referred to in paragraph 1, points (a), (b) and (c), shall be designated with a negapositive sign (-+) if they are net greenhouse gas removals and with a positive sign (+) if they are net greenhouse gas emissions and can never be less than zero; they shall be expressed in tonnes of carbon dioxide equivalent.
2023/06/02
Committee: ENVI
Amendment 517 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 4
4. Carbon removals shall be quantified in a relevant, accurate, conservative, robust, complete, consistent, comparable and transparent manner. Uncertainties in the quantification of the net carbon removal benefit shall be duly reported and accounted for as part of the certification methodologies, in a manner that is conservative and proportionate, and in accordance with recognised statistical approaches. The degree of conservativeness shall be proportional to the level of uncertainty in the quantification of the net carbon removal benefit recognised by the latest available internationally recognised scientific evidence.
2023/06/02
Committee: ENVI
Amendment 530 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 5
5. The baseline shall correspond to the standard carbon removalaverage net greenhouse gas removals of the 5% best performance ofing comparable activities, in similar social, economic, environmental and technological circumstances and takeing into account the geographical context.
2023/06/02
Committee: ENVI
Amendment 535 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 6
6. By way of derogation from paragraph 5, where duly justified in the applicable certification methodology by the absence of enough comparable activities to be able to set a representative baseline, the baseline may be based on the individual carbon removal performance of that activity.
2023/06/02
Committee: ENVI
Amendment 544 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 7
7. TheEach baseline shall be periodically updatupdated at least every five years after it has been adopted. Possible reverse incentives for baseline inflation shall be considered and addressed.
2023/06/02
Committee: ENVI
Amendment 549 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 8
8. The quantification of the carbon removals shall account for uncertainties in accordance with recognised statistical approaches.deleted
2023/06/02
Committee: ENVI
Amendment 552 #

2022/0394(COD)

Proposal for a regulation
Article 4 – paragraph 9
9. To support the quantification of carbon removals generated by carbon farming, the operator or group of operators shall gather data on carbon removals and greenhouse gas emissions in a manner compatible with national greenhouse gas inventories under Regulation (EU) 2018/841 and Part 3 of Annex V to Regulation (EU) 2018/1999.deleted
2023/06/02
Committee: ENVI
Amendment 560 #

2022/0394(COD)

Proposal for a regulation
Article 5 – paragraph 1 – introductory part
1. A carbon removal activity shall be additional. To that end, the carbon removal activity shall meet bothall of the following criteria:
2023/06/02
Committee: ENVI
Amendment 565 #

2022/0394(COD)

Proposal for a regulation
Article 5 – paragraph 1 – point a
(a) it goes beyond any binding removals target set out at Union andor national levels, or statutory requirements set out at the level of the operator or group of operators;
2023/06/02
Committee: ENVI
Amendment 569 #

2022/0394(COD)

Proposal for a regulation
Article 5 – paragraph 1 – point b
(b) it takes place due to the incentive effectthe activity becomes financially attractive due to the monetisation of the certification.e;
2023/06/02
Committee: ENVI
Amendment 575 #

2022/0394(COD)

Proposal for a regulation
Article 5 – paragraph 1 – point b a (new)
(ba) it is not generated as a result of Union or national public funding.
2023/06/02
Committee: ENVI
Amendment 581 #

2022/0394(COD)

Proposal for a regulation
Article 5 – paragraph 2
2. Where the baseline is established pursuant to Article 4(5), additionality as referred to in paragraph 1 is considered to be complied with. Where the baseline is established pursuant to Article 4(6), additionality as referred to in paragraph 1, points (a) and (b), shall be demonstrated through specific testsAdditionality as referred to in paragraph 1, points (a), (b) and (c), shall be demonstrated through specific tests set out as part of the certification methodologies referred to in Article 8.
2023/06/02
Committee: ENVI
Amendment 588 #

2022/0394(COD)

Proposal for a regulation
Article 6 – title
Long-terMinimum storage duration
2023/06/02
Committee: ENVI
Amendment 593 #

2022/0394(COD)

Proposal for a regulation
Article 6 – paragraph 1
1. An operator or group of operators shall demonstrate that a carbon removal activity aims at ensuring the long-term storage of carbonensure the long-term storage of carbon via their activity during at least several centuries.
2023/06/02
Committee: ENVI
Amendment 598 #

2022/0394(COD)

Proposal for a regulation
Article 6 – paragraph 2
2. For the purposes of paragraph 1, an operator or group of operators shall comply with both of the following criteria: (a) they shall monitor and mitigate any risk of release of the stored carbon occurring during the monitoring period; (b) liability mechanisms in order to address any release of the stored carbon occurring during the monitoring period.deleted they shall be subject to appropriate
2023/06/02
Committee: ENVI
Amendment 615 #

2022/0394(COD)

Proposal for a regulation
Article 6 – paragraph 3
3. For carbon farming and carbon storage in productsAt the end of the monitoring period, and if no re-certification audits have been carried, the net carbon stored by a carbon removalremoval benefit generated by an activity during the entire life of that activity shall be considered released to the atmosphere at the end of the monitoring period.
2023/06/02
Committee: ENVI
Amendment 631 #

2022/0394(COD)

Proposal for a regulation
Article 7 – paragraph 1 – introductory part
1. A carbon removal activity shall have a neutral impact on or generate co- benefits for alldemonstrate it does no significant harm to any of the following sustainability objectives:
2023/06/02
Committee: ENVI
Amendment 654 #

2022/0394(COD)

Proposal for a regulation
Article 7 – paragraph 1 a (new)
1a. Carbon removal activities that are extensively relying on land use should demonstrate positive impacts on the sustainability objectives referred to in points (a) to (f) of paragraph 1.
2023/06/02
Committee: ENVI
Amendment 655 #

2022/0394(COD)

Proposal for a regulation
Article 7 – paragraph 1 b (new)
1b. A carbon removal activity shall not lead to land grabbing and land speculation, and respect the rights of local communities and indigenous people affected by those activities, both within and outside the Union.
2023/06/02
Committee: ENVI
Amendment 657 #

2022/0394(COD)

Proposal for a regulation
Article 7 – paragraph 2
2. For the purposes of paragraph 1, 1a carbon removal activity shall comply with minimum sustainability requirements laid down in the certification methodologies, set out inand 1b, the Commission shall set out in the relevant certification methodology minimum sustainability requirements for each type of activity, as part of the delegated acts adopted pursuant to Article 8.
2023/06/02
Committee: ENVI
Amendment 665 #

2022/0394(COD)

Proposal for a regulation
Article 7 – paragraph 2 a (new)
2a. The minimum sustainability requirements referred to in paragraph 2 shall take into account the impacts in third countries, in particular those caused by direct and indirect land use changes.
2023/06/02
Committee: ENVI
Amendment 680 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 1 a (new)
1a. The certification methodologies shall: (a) establish the baseline corresponding to the net greenhouse gas removals of the 5% best performing activities, in similar social, economic, environmental and technological circumstances; (b) specify the minimum sustainability requirements referred to in Article 7(2), and the rules for accounting additional co-benefits as referred to in Article 7(3); (c) be based on conclusive scientific evidence and the precautionary principle enshrined in Article 191 TFEU; (d) be easy to use and be set in a manner that facilitates the verification of their compliance.
2023/06/02
Committee: ENVI
Amendment 686 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 16 to establish the technical certification methodologies referred to in paragraph 1 for activities related to permanent carbon storage, carbon farming and carbon storage in produeach type of activity. Each certification methodology for each type of activity shall be subject to a separate delegated acts. Those certification methodologies shall include at least the elements set out in Annex I.
2023/06/02
Committee: ENVI
Amendment 692 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 2 a (new)
2a. Prior to the adoption and during the development of delegated acts, the Commission shall gather all necessary scientific expertise. For each draft delegated act, the Commission shall carry out a thorough impact assessment, and its final results shall be made public at the time of adoption of the related draft delegated act. The Commission shall ensure that stakeholders are able to provide feedback on each draft delegated act through a public consultation lasting at least four weeks.
2023/06/02
Committee: ENVI
Amendment 698 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 2 b (new)
2b. The Commission shall start by establishing certification methodologies for those activities which are the most mature, have the largest potential for generating net carbon removal benefits and that have the largest potential to provide co-benefits. The list of such activities is established under Annex IIb. Annex IIb shall be reviewed as part of the reviews referred to in Article 18(2).
2023/06/02
Committee: ENVI
Amendment 709 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 3 – point b
(b) the objective of minimising administrative burden for operators, particularly for small-scale carbon farming operators;
2023/06/02
Committee: ENVI
Amendment 718 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 3 a (new)
3a. Prior to adopting the delegated acts referred to in paragraph 2 of this Article, the Commission shall consult the Platform referred to in Article 14a regarding the technical certification methodologies referred to in paragraph 1 of this Article.
2023/06/02
Committee: ENVI
Amendment 721 #

2022/0394(COD)

Proposal for a regulation
Article 8 – paragraph 3 b (new)
3b. When the Commission does not follow the advice of the Platform when adopting the delegated acts referred to in paragraph 2 of this Article, it shall include a detailed justification of its choice in an Annex to the relevant delegated act.
2023/06/02
Committee: ENVI
Amendment 722 #

2022/0394(COD)

Proposal for a regulation
Article 8 a (new)
Article 8 a CHAPTER 2a QUALITY CRITERIA FOR CARBON FARMING ACTIVITIES Article 8a Carbon farming activities 1. The following practices shall be considered as carbon farming activities on agricultural land: (a) Peatland rewetting and maintenance, sustainable paludiculture; (b) Agroforestry, using site-and climate appropriate endemic species, in line with the Guidelines on Biodiversity- Friendly Afforestation, Reforestation and Tree Planting1a , taking into consideration dendrological range expansion due to climate change; (c) Unploughed, multi-species permanent pasture; (d) Conservation agriculture without herbicide use, with living roots all year round; (e) Carbon storage through sustainable manure management. 2. The practices that shall be considered as carbon farming activities on forested land are the ones in line with the Guidelines on Biodiversity-Friendly Afforestation, Reforestation and Tree Planting, allowing for the following: (a) Selective logging leading to a continuous cover; (b) Encouraging uneven-aged stands; (c) Species mixture in forest stands; (d) Prioritisation of site-and climate appropriate endemic species, no GM trees; (e) Natural regeneration or ecosystem restoration; (f) Wood from dead and dying trees retained, according to minimum science- based thresholds; (g) Forest edges maintained and shaped to help protecting biodiversity and water quality; (h) Peatland rewetting and maintenance, sustainable paludiculture. 3. The Commission is empowered to adopt delegated acts in accordance with Article 16 to establish the technical descriptions and boundaries of the activities referred to in paragraph 1 and 2. Those delegated acts shall be based on a solid body of peer reviewed scientific studies demonstrating the efficiency of these practices in terms of carbon storage. Practices that build on the intentional destruction of the existing carbon stock, or that increase the use of synthetic inputs, such as synthetic pesticides and fertilisers, and negatively affect the soil biota, for instance using heavy machinery that compacts the soils, shall not be eligible for certification. 4. When preparing those delegated acts, the Commission shall be free of political or business interference, and shall take into account the following elements: (a) the objectives of ensuring the robustness of carbon removals generated by carbon farming activities and recognising the protection and restoration of ecosystems; (b) the objective of minimising administrative burden for operators, particularly for small-scale carbon farming operators; (c) relevant Union and national law; (d) relevant Union and international certification methodologies and standards. 5. Prior to adopting the delegated acts referred to in paragraph 2 of this Article, the Commission shall consult the Platform referred to in Article 14a regarding the technical certification methodologies referred to in paragraph 1 of this Article. 6. When the Commission does not follow the advice of the Platform when adopting the delegated acts referred to in paragraph 2 of this Article, it shall include a detailed justification of its choice in an Annex to the relevant delegated act.
2023/06/02
Committee: ENVI
Amendment 724 #

2022/0394(COD)

Proposal for a regulation
Article 8 b (new)
Article 8 b Additionality 1. The net carbon removal benefit generated by an activity shall be additional. To that end, the carbon removal activity shall meet all of the following criteria: (a) it goes beyond any binding removals target set out at Union or national levels, or statutory requirements set out at the level of the operator or group of operators; (b) the activity becomes financially attractive due to the monetisation of the certificate; (c) it is not generated as a result of Union or national public funding. 2. Additionality as referred to in paragraph 1, points (a),(b) and (c), shall be demonstrated through specific tests set out as part of the certification methodologies.
2023/06/02
Committee: ENVI
Amendment 725 #

2022/0394(COD)

Proposal for a regulation
Article 8 c (new)
Article 8c Sustainability 1. A carbon farming activity shall generate co-benefits for all of the following sustainability objectives: (a) climate change mitigation; (b) climate change adaptation; (c) sustainable use and protection of water and marine resources; (d) transition to a circular economy, notably the closing of nutrients cycle; (e) prevention of soil degradation, soil restoration, improvement of soil fertility and of nutrient management and soil biota; (f) pollution prevention and control; (g) protection and restoration of biodiversity and ecosystems, conservation or restoration of habitats or species, including maintenance and creation of landscape features or non-productive areas. A carbon farming activity shall not significantly harm any of the sustainability objectives referred to in points (a) to (g) 2. A carbon removal activity shall not lead to land grabbing and land speculation, and respect the rights of local communities and indigenous people affected by those activities, both within and outside the Union. 3. For the purposes of paragraphs 1 and 2, a carbon farming activity shall comply with minimum sustainability requirements laid down in the certification methodologies, set out in the delegated acts adopted pursuant to Article 8e. 4. Where an operator or group of operators report co-benefits that contribute to the sustainability objectives referred to in paragraph 1 beyond the minimum sustainability requirements referred to in paragraph 2, they shall comply with the certification methodologies set out in delegated acts referred to in Article 8e. The certification methodologies shall incentivise as much as possible the generation of co-benefits going beyond the minimum sustainability requirements, in particular for the objective referred to in paragraph 1, point (g).
2023/06/02
Committee: ENVI
Amendment 726 #

2022/0394(COD)

Proposal for a regulation
Article 8 d (new)
Article 8d Monitoring methodologies 1. An operator or group of operators implementing activities referred to in Article 8a shall monitor the net carbon removal balance of those activities, which shall be quantified using the following formula: Net carbon removal balance = CRtotal - GHGtotal - CRbaseline where: (a) CRtotal is the total amount of CO2 removed from the atmosphere by the activity over the entire life cycle of the activity; (b) GHGtotal is all direct and indirect greenhouse gas emissions over the entire life cycle of the activity, including greenhouse gas emissions arising from the use of fertilisers, fuels, chemicals, materials, biomass or energy, as well as direct and indirect land use change, which are due to the implementation of the activity. For the quantification of GHG emissions associated with the use of biomass, rigorous life-cycle assessments shall be applied to ensure that net- removals can only be accounted for once the total carbon debt payback period has expired; (c) CRbaseline is the total amount of CO2 removed from the atmosphere over the entire life cycle of a best-in-class comparable activity. 2. In the context of paragraph 1, CRbaseline and CRtotal shall be understood as net greenhouse gas removals or emissions in accordance with the accounting rules laid down in Regulation (EU) 2018/841. 3. Quantities referred to in paragraph 1, points (a), (b) and (c), shall be designated with a positive sign (+) and can never be less than 0. They shall be expressed in tonnes of carbon dioxide equivalent. 4. The net carbon removal balance shall be quantified in a conservative, robust, complete, consistent, comparable and transparent manner. Uncertainties in the quantification of the net carbon removal balance shall be duly reported and accounted for as part of the monitoring methodologies, in a manner that is conservative and proportionate, and in accordance with recognised statistical approaches. The degree of conservativeness shall be proportional to the level of uncertainty in the quantification of the net carbon removal benefit recognised by the latest available internationally recognised scientific evidence. 5. CRbaseline shall correspond to the net greenhouse gas removals of comparable activities in similar social, economic, environmental and technological circumstances and take into account the geographical context, of the 5% best performing activities. 6. By way of derogation from paragraph 5, where duly justified in the applicable monitoring methodology by the absence of enough comparable activities to be able to set a representative baseline, the baseline may be based on the individual performance of that activity. 7. Each baseline shall be updated at least every 5 years after it has been adopted. Possible perverse incentives for baseline inflation shall be considered and addressed. 8. The Commission is empowered to adopt delegated acts in accordance with Article 16 to establish the monitoring methodologies for each type of activity referred to in Article 8a. Those monitoring methodologies shall use Tier 3 methodologies. 9. In the context of the report referred to in paragraph 2 of Article 18, the Commission may, where relevant, assess whether the data monitored and reported under this Article can be used to establish standardised baseline for carbon farming activities, and to quantify the net carbon removal benefit of those activities.
2023/06/02
Committee: ENVI
Amendment 727 #

2022/0394(COD)

Proposal for a regulation
Article 8 e (new)
Article 8e Certification methodologies 1. An operator or a group of operators shall apply the relevant certification methodologies to comply with the criteria laid down in Articles 8a to 8d. 1a. The certification methodologies shall: (a) establish the technical descriptions and boundaries of the activities referred to in paragraphs 1 and 2 of Article 8a, taking into account the geographical, geological and environmental context; (b) specify the minimum sustainability requirements referred to in Article 8b(1), and the rules for accounting additional co-benefits as referred to in Article 8b(3); (c) be based on conclusive scientific evidence and the precautionary principle enshrined in Article 191 TFEU; (d) be easy to use and be set in a manner that facilitates the verification of their compliance. 2. The Commission is empowered to adopt delegated acts in accordance with Article 16 to establish the technical certification methodologies referred to in paragraph 1 for each type of activity referred to in paragraphs 1 and 2 of Article 8a. Each certification methodology for each type of activity shall be subject to a separate delegated act. Those certification methodologies shall include at least the elements set out in Annex I. Prior to the adoption and during the development of delegated acts, the Commission shall gather all necessary scientific expertise. For each draft delegated act, the Commission shall carry out a thorough impact assessment, and its final results shall be made public at the time of adoption of the related draft delegated act. The Commission shall ensure that stakeholders are able to provide feedback on each draft delegated act through a public consultation lasting at least four weeks. 3. When preparing those delegated acts, the Commission shall be free of political or business interference, and shall take into account the following elements: (a) the objectives of ensuring the robustness of carbon removals generated by carbon farming activities, and recognising the protection and restoration of ecosystems; (b) the objective of minimising administrative burden for operators, particularly for small-scale operators; (c) relevant Union and national law; (d) relevant Union and international certification methodologies and standards. 4. Prior to adopting the delegated acts referred to in paragraph 2 of this Article, the Commission shall consult the Platform referred to in Article 14a regarding the technical certification methodologies referred to in paragraph 1 of this Article. 5. When the Commission does not follow the advice of the Platform when adopting the delegated acts referred to in paragraph 2 of this Article, it shall include a detailed justification of its choice in an Annex to the relevant delegated act.
2023/06/02
Committee: ENVI
Amendment 728 #

2022/0394(COD)

Proposal for a regulation
Chapter 3 – title
3MONITORING, CERTIFICATION AND LIABILITY
2023/06/02
Committee: ENVI
Amendment 729 #

2022/0394(COD)

Proposal for a regulation
Article -9 (new)
Article -9 Monitoring, validity and expiry, and liability 1. An operator or group of operators shall monitor and mitigate any risk of release of the stored carbon occurring during the monitoring period, which shall be set as follows: (a) for a carbon removal activity, the monitoring period and requirements shall be consistent with the provisions set out in Articles 13, 17 and 18 of Directive 2009/31/EC; (b) for a carbon farming activity, the monitoring period and requirements shall cover at least the entire duration over which the operator or group of operators declare the activity will increase carbon storage in biogenic carbon pools. 2. An operator or group of operators shall be subject to appropriate liability mechanisms, and designate a liable physical or legal person to be responsible for addressing any reversal or leakage at any point in time during the activity. For carbon removal activities, the liability mechanism shall be consistent with the liability mechanism set out in Directive 2009/31/EC. For carbon farming activities, the liable person shall in principle be the operator or the group of operators, except in case of contribution claims where the liable person shall be the personal or legal person making those claims. 3. The validity of a certificate shall expire: (a) for a carbon removal activity, at any point in case of leakage, unless it has been proven that the leakage has stopped due to the impact of the corrective measures referred to in paragraph 3; (b) for a carbon farming activity, at any point in case of reversal. 4. When the validity of a certificate expires, the operator or group of operators shall pay a financial compensation to society equivalent to the total amount of carbon considered released to the atmosphere multiplied by the estimated shadow carbon price of the year at which the leak or reversal takes place. The amounts of the financial compensations to society shall be considered as revenue for the general budget of the Union. The Commission shall determine, by means of implementing acts, the means for calculating and collecting the financial compensations to society. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17. When the certificate has been monetised for the purpose of compensation claims, the physical or legal person issuing such claims shall be responsible for paying the financial compensations to society.
2023/06/02
Committee: ENVI
Amendment 730 #

2022/0394(COD)

Proposal for a regulation
Article 9 – title
Certification of compliance and re- certification audits
2023/06/02
Committee: ENVI
Amendment 743 #

2022/0394(COD)

Proposal for a regulation
Article 9 – paragraph 1
1. To apply for a certification of compliance with this Regulation, an operator or a group of operators shall submit an application to a certification scheme. Upon acceptance of that application, the operator or a group of operators shall submit to a certification bodyThis application shall be made publicly available, and include a comprehensive description of the carbon removal activity, including the certification methodology applied to assess compliance with Articles 4 to 7 or with Articles 8a to 8d, the expected total carbon removals and net carbon removal benefit. Groups of operators shall also specify how advisory services on carbon removal activities are provided, in particular to small-scale carbon farming operators.
2023/06/02
Committee: ENVI
Amendment 747 #

2022/0394(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The certification bodyscheme shall conduct a certification audit toappoint an independent certification body which shall verify that the information submitted in accordance with paragraph 1 is accurate, reliable and protected against fraud, and to confirm compliance of the carbon removal activity with Articles 4 to 7. A or with Articles 8a result of that certification auditto 8d. When all the information provided by the operator or group of operators comply with the provisions set out in Articles 4 to 7 or in Articles 8a to 8d, the certification body shall issue a certification audit report, that includes a summary, and a certificate containing, as a minimum, the information set out in Annex II. The certification scheme shall control the certification audit report and the certificate, and make the summary ofall the information included in the certification audit report and the certificate publicly available in athe Union registry referred to in Article 12.
2023/06/02
Committee: ENVI
Amendment 753 #

2022/0394(COD)

Proposal for a regulation
Article 9 – paragraph 3
3. The same certification body shall carry out periodic re-certification audits to reconfirm compliance of the carbon removal activity with Articles 4 to 7 andor with Articles 8a to 8d, and in particular verify the generated net carbon removal benefit. Re-certification audits shall take place at least every 5 years for carbon farming activities, and at least every 10 years for carbon removal activities. As a result of that re-certification audit, the certification body shall issue a re- certification audit report, that includes a summary, and an updated certificate. The certification scheme shall control the re- certification audit report and the updated certificate, and make the summary of the re-certification audit report, the updated certificate and the certified carbon removal unitsm publicly available in athe Union registry referred to in Article 12.
2023/06/02
Committee: ENVI
Amendment 759 #

2022/0394(COD)

Proposal for a regulation
Article 9 – paragraph 4 a (new)
4a. Certification bodies shall be remunerated by the certification scheme. Certification schemes may require a fee to be paid by the operator or group of operators to cover the remuneration of certification bodies.
2023/06/02
Committee: ENVI
Amendment 765 #

2022/0394(COD)

Proposal for a regulation
Article 9 – paragraph 5
5. The Commission may adopt implementing acts to set out the structure, format, technical details of the comprehensive description of the carbon removal activity referred to in paragraph 1, and of the certification and re-certification audit reports referred to in paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
2023/06/02
Committee: ENVI
Amendment 776 #

2022/0394(COD)

Proposal for a regulation
Article 10 – paragraph 2 – point b
(b) legally and financially independent from the operators or from a group of operators, and carry out the activities required under this Regulation in the public interest.
2023/06/02
Committee: ENVI
Amendment 778 #

2022/0394(COD)

Proposal for a regulation
Article 10 – paragraph 4
4. Member States shall supervise the operation of certification bodies. Certification bodies shall submit, upon request by the national competent authorities, all relevant information necessary to supervise their operation, including date, time and location of the audits referred to in Article 9. Where Member States find issues of non- conformity, they shall inform the concerned certification body and the relevant certification scheme thereof without delay, and the corresponding information shall immediately be made publicly available through the Union registry referred to in Article 12.
2023/06/02
Committee: ENVI
Amendment 784 #

2022/0394(COD)

Proposal for a regulation
Article 11 – paragraph 2
2. Certification schemes shall operate on the basis of reliable and transparent rules and procedures, in particular with regard to internal management and monitoring, handling of complaints and appeals, stakeholder consultation, transparency and publication of information, appointment and training of certification bodies, addressing non- conformity issues, development and management of registries. Certificate schemes shall put in place easily accessible and free-of-charge complaint and appeal procedures, including allowing the possibility for third parties and civil society organisations to submit cases of suspicion of fraud or independent assessment of the rules and procedures of the certification schemes. Certification schemes shall provide the information on those rules and procedures to the Commission to be made publicly available in the Union registry referred to in Article 12.
2023/06/02
Committee: ENVI
Amendment 793 #

2022/0394(COD)

Proposal for a regulation
Article 11 – paragraph 3
3. Certification schemes shall verify if the information and data submitted by the operator or a group of operators for the certification of compliance pursuant to Article 9 were subject to independent auditing and if the certification of compliance wasand the re-certification audit reports were carried out in an accurate, and reliable, and cost-effective manner manner, and are protected against fraud.
2023/06/02
Committee: ENVI
Amendment 799 #

2022/0394(COD)

Proposal for a regulation
Article 11 – paragraph 4
4. Certification schemes shall publish in the Union registry referred to in Article 12, at least annually, a list of the appointed certification bodies, stating for each certification body by which entity or national public authority it was recognised and which entity or national public authority is monitoring it.
2023/06/02
Committee: ENVI
Amendment 809 #

2022/0394(COD)

Proposal for a regulation
Article 12 – title
RUnion registriesy
2023/06/02
Committee: ENVI
Amendment 811 #

2022/0394(COD)

Proposal for a regulation
Article 12 – paragraph 1
1. A certification schemeThe Commission shall establish and duly maintain a public registry ('Union registry') to make publicly accessible, in an easily accessible and searchable way, the information related to the certification process, including the certificates and updated certificates, and the information included therein, containing as a minimum the information set out in Annex IIA, the name of the certification body, the quantity of net carbon removal unbenefits certified in accordance with Article 9. Those registries shall use automated systems, including electronic templates, and shall be interoperable, and in case the certificate has been monetised, the reason it has been monetised, the price at which it has been monetised, and the final price paid to the operator or group of operators. The Union registry shall use automated systems, including electronic templates. Certification schemes shall be responsible for entering all the required information in the Union registry.
2023/06/02
Committee: ENVI
Amendment 822 #

2022/0394(COD)

Proposal for a regulation
Article 12 – paragraph 2
2. The Commission may adopt implementing acts setting out the structure, format, and technical details of the publicUnion registriy, and the rules, and ofprocedures for the recording, and holding or use of carbon removal unitf all the information contained in the certificates, as referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 17.
2023/06/02
Committee: ENVI
Amendment 830 #

2022/0394(COD)

Proposal for a regulation
Article 13 – paragraph 1
1. Only a certification scheme recognised by the Commission by means of a decision may be used by operators or group of operators to demonstrate compliance with this Regulation. Such decision shall be valid for a period of no more than 5 years. Such decision shall be made public in the central Union registry referred to in Article 12.
2023/06/02
Committee: ENVI
Amendment 835 #

2022/0394(COD)

Proposal for a regulation
Article 13 – paragraph 3
3. The Commission may repeal a decision recognising a certification scheme pursuant to paragraph 1 where the certification scheme fails to implement the standards and rules set out in the implementing acts referred to in Article 11(5). Where a Member State or a third party, including civil society organisations, raises concerns that a certification scheme does not operate in accordance with the standards and rules set out in the implementing acts referred to in Article 11(5) that constitute the basis for decisions under paragraph 1, the Commission shall immediately investigate the matter and take appropriate action, including repealing the relevant decision.
2023/06/02
Committee: ENVI
Amendment 842 #

2022/0394(COD)

Proposal for a regulation
Article 14 – paragraph 2
2. The Commission shall make those reports publicly available, in full or, where necessary to preserve the confidentiality of commercially sensitive information, in an aggregated form in the Union registry referred to in Article 12, in full or, only where absolutely necessary to preserve the confidentiality of commercially sensitive information, without those commercially sensitive information. The rest of the reports shall be made publicly available in full.
2023/06/02
Committee: ENVI
Amendment 847 #

2022/0394(COD)

Proposal for a regulation
Article 14 a (new)
Article 14a Platform on Carbon Removal and Carbon Farming Activities 1. The Commission shall establish a Platform on Carbon removal and Carbon farming Activities (the ‘Platform’). It shall be composed in a balanced manner of the following groups: (a) representatives of: (i) the European Environment Agency; (ii) the European Scientific Advisory Board on Climate Change established under Article 10a of Regulation (EC) No 401/2009 of the European Parliament and of the Council; (b) experts representing civil society with expertise in the areas covered by this Regulation; (c) experts representing relevant private stakeholders involved in the areas covered by this Regulation; (d) scientific experts appointed in a personal capacity who have proven and internationally recognised scientific expertise in the areas covered by this Regulation; (e) experts representing academia, including universities, research institutes and other scientific organisations. The number of representatives and experts referred to in points (a) to (e) shall be of equal number. 2. The Platform shall at minimum: (a) advise the Commission on the technical certification methodologies referred to in Article 8 and in Article 8e, as well as on the possible need to strengthen the environmental integrity of those in line with new internationally recognised scientific evidence; (b advise the Commission on addressing other sustainability objectives as those referred to in Article 7 and in Article 8c, including social and governance objectives; (c) advise the Commission on the minimum information included in the certificates referred to in Article 9, as well as on the rules and procedures related to audits and certification schemes, as well as on the possible need to update those; (d) advise the Commission on the possible need to develop further measures to improve data availability and quality. 3. The Platform shall be chaired by a representative of the European Environment Agency or of the European Scientific Advisory Board on Climate Change established under Article 10a of Regulation (EC) No 401/2009 elected by the members of the Platform. 4. The Platform shall be guided in its work by the best available and most recent scientific evidence, including the last reports of the IPCC, IPBES and other international bodies. It shall follow a fully transparent process. All its meetings shall be held publicly, and all its reports made publicly available.
2023/06/02
Committee: ENVI
Amendment 854 #

2022/0394(COD)

Proposal for a regulation
Article 15 – paragraph 1 a (new)
Prior to adopting the delegated acts referred to in the first sub-paragraph, the Commission shall consult the Platform referred to in Article 14a. When the Commission does not follow the advice of the Platform when adopting the delegated acts referred to in the first sub-paragraph, it shall include a detailed justification of its choice in an Annex to the relevant delegated act.
2023/06/02
Committee: ENVI
Amendment 861 #

2022/0394(COD)

Proposal for a regulation
Article 16 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making. Any draft delegated act shall be open for public consultation for a period of minimum four weeks.
2023/06/02
Committee: ENVI
Amendment 872 #

2022/0394(COD)

Proposal for a regulation
Article 18 – paragraph 2 a (new)
2a. In the context of the first report referred to in paragraph 2, the Commission shall, where relevant, assess the possible benefits and risks of enlarging the scope of permanent carbon storage as defined under this Regulation to in-situ mineralisation.
2023/06/02
Committee: ENVI
Amendment 878 #

2022/0394(COD)

Proposal for a regulation
Annex I – paragraph 1 – point a
(a) description of the carbon removal activity covered, including its monitoring period;
2023/06/02
Committee: ENVI
Amendment 880 #

2022/0394(COD)

Proposal for a regulation
Annex I – paragraph 1 – point g
(g) rules to carry out the specific additionality tests referred to in Article 5(2) and in Article 8b(2);
2023/06/02
Committee: ENVI
Amendment 881 #

2022/0394(COD)

Proposal for a regulation
Annex I – paragraph 1 – point h
(h) rules on monitoring and mitigation of any risk of release or leakage of the stored carbon referred to in Article 6(2), point (a-9(1);
2023/06/02
Committee: ENVI
Amendment 883 #

2022/0394(COD)

Proposal for a regulation
Annex I – paragraph 1 – point i
(i) rules on appropriate liability mechanisms referred to in Article 6(2), point (b-9(2);
2023/06/02
Committee: ENVI
Amendment 884 #

2022/0394(COD)

Proposal for a regulation
Annex I – paragraph 1 – point j
(j) rules on the minimum sustainability requirements referred to in Article 7(2) and in Article 8c(3);
2023/06/02
Committee: ENVI
Amendment 885 #

2022/0394(COD)

Proposal for a regulation
Annex I – paragraph 1 – point k
(k) rules on the monitoring and reporting of co-benefits referred to in Article 7(3) and in Article 8c(4).
2023/06/02
Committee: ENVI
Amendment 892 #

2022/0394(COD)

Proposal for a regulation
Annex I a (new)
ANNEX Ia Elements of the reporting methodologies referred to in Article 8c When adopting delegated acts pursuant to Article 8c(8), the reporting methodologies shall include at least the following elements: (a) description of the activity covered, including its monitoring period; (b) rules for identifying all carbon removal sinks and GHG emission sources referred to in Article 8c(1); (c) rules for calculating the carbon removals under the baseline referred to in Article 8c(1), point (c); (d) rules for calculating the total carbon removals referred to in Article 8c(1), point (a); (e) rules for calculating the total direct and indirect greenhouse gas emissions referred to in Article 8c(1), point (b); (f) rules to address uncertainties in the quantification of carbon removals referred to in Article 8c(4).
2023/06/02
Committee: ENVI
Amendment 898 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point a
(a) name and type of the carbon removal activity, including whether the activity constitutes a carbon removal or a carbon farming activity, the name and contact details of the operator or group of operators;
2023/06/02
Committee: ENVI
Amendment 901 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point b
(b) the location of the carbon removal activity, including geographically explicit location of the activity boundaries, respecting 1:5000 mapping scale requirements for the Member State;
2023/06/02
Committee: ENVI
Amendment 902 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point c
(c) start date and expected end date of the carbon removal activity;
2023/06/02
Committee: ENVI
Amendment 913 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point n
(n) duration of the monitoring perstorage medium and expected storage duratiodn of the carbon removal activity;
2023/06/02
Committee: ENVI
Amendment 914 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point n a (new)
(na) the monitoring period and requirement, the detailed liability mechanism and the liable legal of physical person, the amount of financial compensation to society in case of reversal or leakage as well as the possible agreement for the payment of the financial compensation to society between the operator or group of operator and the physical or legal personal making a contribution claim, as referred to in Article -9;
2023/06/02
Committee: ENVI
Amendment 919 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point o
(o) anyevidence that the activity meets the sustainability co-benefitobjectives referred to in Article 7(3) or in Article 8c ;
2023/06/02
Committee: ENVI
Amendment 920 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point o a (new)
(oa) disclosure of potential risks to any of the sustainability objectives referred to in Article 7(1) or in Article 8c(1);
2023/06/02
Committee: ENVI
Amendment 921 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point o b (new)
(ob) in case of reversal or leakage, the amount of total carbon released in the atmosphere from geological or biogenic carbon pools;
2023/06/02
Committee: ENVI
Amendment 922 #

2022/0394(COD)

Proposal for a regulation
Annex II – paragraph 1 – point o c (new)
(oc) any potential case of fraud or miscalculation revealed during re- certification audits;
2023/06/02
Committee: ENVI
Amendment 924 #

2022/0394(COD)

Proposal for a regulation
Annex II a (new)
ANNEX IIa Minimum information to be included in the Union registry referred to in Article 12 For each certified activity, the Union registry referred to in Article 12 shall include at least the following minimum information: (a) name and type of the activity, including whether the activity constitutes a carbon removal or a carbon farming activity, the name and contact details of the operator or group of operators; (b) effective start date and expected end date of the activity; (c) name of the certification scheme; (d) the Member State where the activity takes place; (e) the certification methodology for each carbon removal activity, in accordance with Article 8; (f) the expected net carbon removal benefit; (g) the current status of the certificate (active, withdrawn, expired); (h) in case the certificate has been monetised, for which reason has it been monetised, the price at which it has been monetised, and the final price paid to the operator: (i) in case the certificate has been monetised in the context of a contribution claim, the physical or legal person who has generated this claim; (j) for each activity, a link to all the other information included in the certification and audit re-certification reports. The Union registry referred to in Article 12 shall also include a list of all recognised certification schemes, their rules and procedures in accordance with Article 11(2), their annual activity reports in accordance with Article 14, the list of their appointed certification bodies, stating for each certification body by which entity or national public authority it was recognised and which entity or national public authority is monitoring it, in accordance with Article 11(4).
2023/06/02
Committee: ENVI
Amendment 926 #

2022/0394(COD)

Proposal for a regulation
Annex II b (new)
ANNEX IIb First practices for which certification methodologies should be developed according to Article 8(2) - Highly efficient Direct Air Carbon Capture and Storage using additional wind, solar or geothermal renewable energy capacities and minimising the use of natural resources, such as freshwater use, chemicals and materials.
2023/06/02
Committee: ENVI
Amendment 2 #

2022/0344(COD)

Proposal for a directive
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. A subset of specific PFAS as well PFAS total should therefore be added to the list of groundwater pollutants. 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. A subset of specific PFAS as well PFAS total should therefore be added to the list of priority substances. 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. Bisphenol A is being replaced by other bisphenols with similar properties. Bisphenols should therefore be added to the priority list.
2023/05/05
Committee: ITRE
Amendment 6 #

2022/0344(COD)

Proposal for a directive
Recital 12
(12) The evaluation of Union water legislation58 (the ‘evaluation’) concluded that the process for identifying and listing pollutants affecting surface and groundwater and setting or revising quality standards for them in the light of new scientific knowledge could be accelerated. If those tasks were to be carried out by the Commission, rather than in the framework of the ordinary legislative procedure as currently provided for in Articles 16 and 17 of Directive 2000/60/EC and Article 10 of Directive 2006/118/EC, the functioning of the surface and groundwater watch-list mechanisms, in particular in terms of timing and sequence of listing, monitoring and assessing results, could be improved, the links between the watch-list mechanism and the reviews of the lists of pollutants could be strengthened, and changes to the lists of pollutants could take account of scientific progress more swiftly. Therefore, and given the need to amend the lists of pollutants and their EQS promptly in the light of new scientific and technical knowledge, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex I to Directive 2008/105/EC with regard to the list of priority substances and corresponding EQS set out in Part A of that Annex and to amend Annex I to Directive 2006/118/EC with regard to the list of groundwater pollutants and quality standards set out in that Annex. In this context, the Commisison should take account of the results of the monitoring of substances on the surface and groundwater watch lists. As a consequence, Articles 16 and 17 of Directive 2000/60/EC and Annex X to that Directive, as well as Article 10 of Directive 2006/118/EC, should be deleted, while maintaining the need to take measures aiming at the cessation or phasing out of discharges, emissions and losses of priority hazardous substances. __________________ 58 Commission Staff Working Document Fitness check of the Water Framework Directive, Groundwater Directive, Environmental Quality Standards Directive and Floods Directive, SWD(2019) 439 final.
2023/05/05
Committee: ITRE
Amendment 7 #

2022/0344(COD)

Proposal for a directive
Recital 14 a (new)
(14 a) In order to ensure a harmonised approach and level playing field in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex I to Directive 2006/118/EC by setting a quality standard for PFAS total.
2023/05/05
Committee: ITRE
Amendment 17 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a a (new)
Directive 2006/118/EC
Article 6 – paragraph 2a (new)
(a a) in Article 6, the following paragraph 2a is inserted: 'Member States shall take all necessary measures to protect vulnerable sites, such as groundwater-dependent Natura 2000 sites, from pollution or drainage.'
2023/05/05
Committee: ITRE
Amendment 21 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4 – point a
Directive 2000/60/EC
Article 4 – paragraph 1 – point (a) – point (iv)
(iv) Member States shall implemenThe Commission shall adopt the necessary measures to progressively reduce pollution discharges, emissions and losses from priority substances, and river basin specific pollutants, and to cease or phase out emissions, discharges and losses of priority hazardous substances.; to cease or phase out emissions, discharges and losses of priority hazardous substances within an appropriate timeline and, in any case, not later than 20 years after a given priority substance is listed as hazardous in Part A of Annex I to Directive 2008/105/EC. That timeline shall apply without prejudice to the application of stricter timelines in any other applicable Union legislation. Member States shall implement such measures and take the necessary corresponding measures for river basin specific pollutants;
2023/05/05
Committee: ITRE
Amendment 32 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1– point (f)
(f) rResearch projects and scientific publications, including information on trends and predictionhe impact of material and thermal contaminants as well as impacts of aboveground and underground mines, quarries and tunnels on groundwater ecosystems and groundwater-dependent ecosystems and their biodiversity, on trends and forecasts based on modelling or other predictive assessments, and data ands well as information fromand data collected by remote sensing technologies, eEarth observation (Copernicus services), in- situ sensors and devices, or citizen science data, leveraging taking advantage of the opportunities offerpened by artificial intelligence, and advanced data analysis and processing;
2023/05/05
Committee: ITRE
Amendment 46 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 5
Directive 2008/105/EC
Article 8 – paragraph 3a (new)
3 a. By 12 January 2025, the Commission shall establish technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances under the parameter ‘PFAS Total’. By 12 January 2026, the Commission shall amend Annex I to set the quality standards for 'PFAS total'.
2023/05/05
Committee: ITRE
Amendment 49 #

2022/0344(COD)

Proposal for a directive
Recital 4
(4) Directive 2000/60/EC of the European Parliament and of the Council45establishes a framework for the protection of inland surface waters, transitional waters, coastal waters and groundwater. That framework involves the identification of priority substances amongst those that pose a significant risk to, or via, the aquatic environment at Union level. Directive 2008/105/EC of the European Parliament and of the Council46lays down Union-wide environmental quality standards (EQS) for the 45 priority substances listed in Annex X to Directive 2000/60/EC and eight other pollutants that were already regulated at Union level before Annex X was introduced by Decision No 2455/2001/EC of the European Parliament and of the Council47. Directive 2006/118/EC of the European Parliament and of the Council48lays down Union-wide groundwater quality standards for nitrates and for active substances in pesticides and criteria for establishing national threshold values for other groundwater pollutants. It also sets out a minimum list of 12 pollutants and their indicators for which Member States are required to consider establishingsuch national threshold values. The groundwater quality standards are set out in Annex I to Directive 2006/118/EC. _________________ 45 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1). 46 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84). 47 Decision No 2455/2001/EC of the European Parliament and of the Council of 20 November 2001 establishing the list of priority substances in the field of water policy and amending Directive 2000/60/EC (OJ L 331, 15.12.2001, p. 1). 48 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19).
2023/04/05
Committee: ENVI
Amendment 50 #

2022/0344(COD)

Proposal for a directive
Recital 4 a (new)
(4 a) Given the importance of groundwater as a drinking water source and given that groundwater ecosystems are more vulnerable to stressors than other freshwater ecosystems and lack the ability to recover from perturbations, a precautionary approach must be applied when setting groundwater threshold values to protect human health, groundwater ecosystems and groundwater-dependent ecosystems. In line with advice from the European Medicines Agency, an additional assessment factor of 10 should normally be applied when setting quality standards for groundwater as compared to surface water.
2023/04/05
Committee: ENVI
Amendment 51 #

2022/0344(COD)

Proposal for a directive
Recital 5
(5) Substances are considered for listing in Annex X to Directive 2000/60/EC or in Annex I or Annex II to Directive 2006/118/EC based on an assessment of the risk they pose to humans and the aquatic environment. The key components of that assessment are knowledge of the environmental concentrations of the substances, including information collected from watch-list monitoring, and of the (eco)toxicology of the substances, as well as of their persistence, bioaccumulation, toxicity, mobility, carcinogenicity, mutagenicity, reprotoxicity and endocrine disrupting potential.
2023/04/05
Committee: ENVI
Amendment 56 #

2022/0344(COD)

Proposal for a directive
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 cshould 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. _________________ 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).
2023/04/05
Committee: ENVI
Amendment 58 #

2022/0344(COD)

Proposal for a directive
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. A subset of specific PFAS as well as of PFAS total should therefore be aded to the list of groundwater pollutants. 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. A subset of specific PFAS as well as of PFAS total should therefore be added to the list of priority substances. 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. Bisphenol A is being replaced by other bisphenols with similar properties. Bisphenols should therefore be added to the priority list.
2023/04/05
Committee: ENVI
Amendment 68 #

2022/0344(COD)

Proposal for a directive
Recital 10 a (new)
(10 a) Concern has been expressed about the risk of sulfates and xanthates in the aquatic environment. Sulfates are already listed as a pollutant for groundwater, but little monitoring has taken place. Sulfates should therefore be included in the surface and ground water watch lists. Xanthates should be included in the surface water watch list.
2023/04/05
Committee: ENVI
Amendment 71 #

2022/0344(COD)

Proposal for a directive
Recital 12
(12) The evaluation of Union water legislation58(the ‘evaluation’) concluded that the process for identifying and listing pollutants affecting surface and groundwater and setting or revising quality standards for them in the light of new scientific knowledge could be accelerated. If those tasks were to be carried out by the Commission, rather than in the framework of the ordinary legislative procedure as currently provided for in Articles 16 and 17 of Directive 2000/60/EC and Article 10 of Directive 2006/118/EC, the functioning of the surface and groundwater watch-list mechanisms, in particular in terms of timing and sequence of listing, monitoring and assessing results, could be improved, the links between the watch-list mechanism and the reviews of the lists of pollutants could be strengthened, and changes to the lists of pollutants could take account of scientific progress more swiftly. Therefore, and given the need to amend the lists of pollutants and their EQS promptly in the light of new scientific and technical knowledge, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex I to Directive 2008/105/EC with regard to the list of priority substances and corresponding EQS set out in Part A of that Annex and to amend Annex I to Directive 2006/118/EC with regard to the list of groundwater pollutants and quality standards set out in that Annex. In this context, the Commisisionshould take account of the results of the monitoring of substances on the surface and groundwater watch lists. As a consequence, Articles 16 and 17 of Directive 2000/60/EC and Annex X to that Directive, as well as Article 10 of Directive 2006/118/EC, should be deleted, while maintaining the need to take measures aiming at the cessation or phasing out of discharges, emissions and losses of priority hazardous substances. _________________ 58 Commission Staff Working Document Fitness check of the Water Framework Directive, Groundwater Directive, Environmental Quality Standards Directive and Floods Directive, SWD(2019) 439 final.
2023/04/05
Committee: ENVI
Amendment 74 #

2022/0344(COD)

Proposal for a directive
Recital 14 a (new)
(14 a) In order to ensure a harmonised approach and level playing field in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Annex I to Directive 2006/118/EC by setting a quality standard for PFAS total.
2023/04/05
Committee: ENVI
Amendment 75 #

2022/0344(COD)

Proposal for a directive
Recital 15
(15) In order to ensure a harmonised approach and level playing field in the Union, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend Part B of Annex II to Directive 2006/118/EC by adapting the list of pollutants for which Member States have to consider establishing national threshold values.
2023/04/05
Committee: ENVI
Amendment 92 #

2022/0344(COD)

Proposal for a directive
Recital 28
(28) The empowerment in Article 8(3) of Directive 2000/60/EC which provides for the use of the regulatory procedure with scrutiny fulfils the criteria in Article 290(21) TFEU, since it concerns the adoption of technical specifications and standardised methods for analysis and monitoring of water status and therefore aims at ensuringuniform conditions for the harmonised implementation of that Directive. It should therefore be converted to an empowerment for the Commission to adopt implementing acts. In order to ensure comparability of data, the empowerment should also be extended to include the establishment of formats for reporting monitoring and status data in accordance with Article 8(4). The powers conferred on the Commission should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council62. _________________ 62 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)us rules supplementing it. It should therefore be converted to an empowerment for the Commission to adopt delegated acts.
2023/04/05
Committee: ENVI
Amendment 109 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Directive 2000/60/EC
Article 1 – point 30)
(30) ‘Priority substances’ means substances listed in Part A of Annex I to Directive 2008/105/EC, that is substances which present a significant risk to or via the aquatic environment in a high proportion ofseveral Member States.’;
2023/04/05
Committee: ENVI
Amendment 112 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 2 – point c
Directive 2000/60/EC
Article 2 – point 30 a)
(30a) ‘Priority hazardous substances’ means priority substances which are marked as ‘hazardous’ on the basis that they are recognised in scientific reports, in relevant Union legislation, or in relevant international agreements, as being toxic, persistent and liable to bio-accumulate, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile, or as giving rise to an equivalent level of concern, where this concern is relevant to the aquatic environment, and for which measures have to be taken pursuant to point (iv) of point (a) of paragraph 1 of Article 4.
2023/04/05
Committee: ENVI
Amendment 125 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4 – point a
Directive 2000/60/EC
Article 4 – paragraph 1 – point a) – point iv)
(iv) Member States shall implemenThe Commission shall adopt the necessary measures to progressively reduce pollution discharges, emissions and losses from priority substances, and river basin specific pollutants, and to cease or phase out emissions, discharges and losses of priority hazardous substances within an appropriate timeline and, in any case, not later than 20 years after a given priority substance is listed as hazardous in Part A of Annex I to Directive 2008/105/EC. That timeline shall apply without prejudice to the application of stricter timelines in any other applicable Union legislation. Member States shall implement such measures and take the necessary corresponding measures for river basin specific pollutancets.;
2023/04/05
Committee: ENVI
Amendment 134 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6 – point a
Directive 2000/60/EC
Article 8 – paragraph 3
3. The Commission is empowered to adopt implementingdelegated acts to set out technical specifications and standardised methods for analysis and monitoring of water status in accordance with Annex V and. The Commission is empowered to adopt implementing acts for establishing formats for reporting monitoring and status data in accordance with paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 21(2).;
2023/04/05
Committee: ENVI
Amendment 143 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6 – point b
Directive 2000/60/EC
Article 8 – paragraph 4
4. Member States shall ensure that the available individual monitoring data collected in accordance with point 1.3.4 and 2.4.3 of Annex V and the resulting status in accordance with Annex V are made available to the public and to the European Environment Agency (EEA) at least once a year electronically in a machine-readable format in accordance with Directive 2003/4/EC of the European Parliament and of the Council*, Directive 2007/2/EC of the European Parliament and of the Council** and Directive (EU) 2019/1024 of the European Parliament and of the Council***. For those purposes, Member States shall use the formats established in accordance with paragraph 3 of this Article.
2023/04/05
Committee: ENVI
Amendment 154 #

2022/0344(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 9
Directive 2000/60/EC
Article 12 – paragraph 2
The Commission shall respond to any notifications from Member States within a period of six months. Where the issue concerns failure to meet good chemical status, the Commission shall act in accordance with Article 7a of Directive 2008/105/EC. The Member States concerned shall cooperate to identify the sources of the issues referred to in paragraph 1 and the measures required for addressing those issues.
2023/04/05
Committee: ENVI
Amendment 176 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 2
Directive 2006/118/EC
Article 1 – paragraph 1 – point (ba) (new)
(b a) criteria for assessing the good ecological status of groundwater.
2023/04/05
Committee: ENVI
Amendment 185 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 5 a (new)
Directive 2006/118/EC
Article 6 – paragraph 2a (new)
(5 a) in Article 6, the following paragraph 2a is inserted: '2a. Member States shall take all necessary measures to protect vulnerable sites, such as groundwater-dependent Natura 2000 sites, from pollution or drainage.'
2023/04/05
Committee: ENVI
Amendment 189 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 2
The watch list shall contain a maximum oft least five substances or groups of substances 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. The substances to be included in the watch list shall be selected from amongst those 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. This watch list shall include substances of emerging concernselected from amongst those 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, and shall specify 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. This watch list shall include substances of emerging concern. The first watch list shall contain sulfates.
2023/04/05
Committee: ENVI
Amendment 197 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 4
ECHA shall prepare scientific reports to assist the Commission in selecting the substances and indicators for the watch list, taking into account the following information:
2023/04/05
Committee: ENVI
Amendment 200 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 1 – subparagraph 4 – point f
(f) rResearch projects and scientific publications, including information on trends and predictionhe impact of material and thermal contaminants as well as impacts of aboveground and underground mines, quarries and tunnels on groundwater ecosystems and groundwater-dependent ecosystems and their biodiversity, on trends and forecasts based on modelling or other predictive assessments, and data ands well as information fromand data collected by remote sensing technologies, eEarth observation (Copernicus services), in- situ sensors and devices, or citizen science data, leveragingtaking advantage of the opportunities offerpened by artificial intelligence, and advanced data analysis and processing;
2023/04/05
Committee: ENVI
Amendment 205 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 6
Directive 2006/118/EC
Article 6a – paragraph 3 – subparagraph 2
Each Member State shall select at least onetwo monitoring stations, plus the number of stations equal to its total area in km2 of groundwater bodies divided by 610 000 (rounded to the nearest integer).
2023/04/05
Committee: ENVI
Amendment 207 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 6 a (new)
Directive 2006/118/EC
Article 6aa (new)
(6 a) The following Article 6aa is inserted: 'Article 6aa Abstraction of groundwater for thermal use Groundwater may be abstracted for thermal use only if it does not adversely affect an existing groundwater ecosystem as a result of the abstraction and after re- injection. Competent authorities shall also take all necessary measures to progressively minimize anthropogenic inputs of heat, cold or contaminated surface water into groundwater in order to ensure the protection of groundwater ecosystems and of other aquatic and terrestrial ecosystems where these ecosystems, their biodiversity and their uses depend on the body of groundwater concerned. The measures required for this purpose shall be included in the program of measures pursuant to Article 11 of Directive 2000/60/EC. The EU Commission shall, not later than [OP: please insert the date = four years after the date of entry into force of this Directive] assess thermal impacts on groundwater to ensure the protection of groundwater ecosystems, as well as other aquatic ecosystems that depend on the body of groundwater concerned, to be accompanied, if appropriate, by a legislative proposal to the European Parliament and the Council.' .
2023/04/05
Committee: ENVI
Amendment 214 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8 – paragraph 1
1. The Commission shall review, for the first time by … [OP: please insert the date = sixfour years after the date of entry into force of this Directive] and every sixfour years thereafter, the list of pollutants set out in Annex I and the quality standards for those pollutants set out in that Annex, as well as the list of pollutants and indicators set out in Part B of Annex II.
2023/04/05
Committee: ENVI
Amendment 221 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 7
Directive 2006/118/EC
Article 8 – paragraph 2a (new)
2 a. By 12 January 2025, the Commission shall establish technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances under the parameter ‘PFAS Total’. By 12 January 2026, the Commission shall amend Annex I to set a quality standard for 'PFAS total'.
2023/04/05
Committee: ENVI
Amendment 231 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 7
Directive 2006/118/EC
Article 8 – paragraph 7
7. ECHA shall, every sixfour years, prepare and make publicly available a report, summarizing the findings of the review referred to in paragraphs 2 and 3. The first report shall be submitted to the Commission on … [OP: Please insert the date = fivthree years after the date of entry into force of this Directive].
2023/04/05
Committee: ENVI
Amendment 234 #

2022/0344(COD)

Proposal for a directive
Article 2 – paragraph 1 – point 8
Directive 2006/118/EC
Article 8a – paragraph 2
2. The power to adopt delegated acts referred to in Article 8(1), (2) and (2a) 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].
2023/04/05
Committee: ENVI
Amendment 245 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 3 – point a
Directive 2008/105/EC
Article 5 – paragraph 1 – subparagraph 2
The first subparagraph shall not apply to emissions, discharges and losses reported to the Commission electronically in accordance with Regulation (EU) .../… of the European Parliament and of the Council65. ; _________________ 65 +OP: Please insert in the text the number of the Regulation contained in document COM (2022) 157++ OP: Please insert in the text the number of the Regulation contained in document COM (2022) 157+++ OP: Please insert in the text the number of the Regulation contained in document COM (2022) 157deleted
2023/04/05
Committee: ENVI
Amendment 252 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 4 – introductory part
(4) In Article 7a(1), the first subparagraph is replaced by the is amended as followings:
2023/04/05
Committee: ENVI
Amendment 253 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 4
Directive 2008/105/EC
Article 7a – paragraph 1
1. For priority substances that fall within the scope of Regulation (EC) No 1907/2006, Regulation (EC) No 1107/2009, Regulation (EU) No 528/2012, Regulation (EU) 2019/6 of the European Parliament and of the Council*, or within the scope of Directive 2001/83/EC of the European Parliament and of the Council**, Directive 2009/128/EC of the European Parliament and of the Council*** or Directive 2010/75/EU, the Commission shall, as part of the report referred within six months after the European Environment Agency has made available the latest yearly monito ring data pursuant to Article 18(15) of Directive 2000/60/EC, assess whether the measures in place at Union and Member State level are sufficient to achieve the EQS for priority substances and the cessation or phasing-out objective for discharges, emissions and losses of priority hazardous substances in accordance with Article 4(1), point (a), of Directive 2000/60/EC.
2023/04/05
Committee: ENVI
Amendment 255 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 4 a (new)
Directive 2008/105/EC
Article 7a – paragraph 3
(4 a) Paragraph 3 is replaced by the following: "3. Where the results of the report show that additional measures at Union or Member State level are necessary in order to facilitate compliance with Directive 2000/60/EC in relation to a particular substance approved pursuant to Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012, Member States or the Commission shall apply Articles 21 or 44 of Regulation (EC) No 1107/2009 or Articles 15 or 48 of Regulation (EU) No 528/2012 to that substance, or products containing that substance. In the case of substances falling within the scope of Regulation (EC) No 1907/2006, the Commission shall initiate the procedure referred to in Articles 59, 61 or 69 of that Regulation. In applying the provisions of the Regulations referred to in the first and second subparagraphs, Member States and the Commission shall take into account any risk evaluations and socio-economic or cost-benefit analyses required under those Regulations, including as regards the availability of alternatives." Or. en (32008L0105)
2023/04/05
Committee: ENVI
Amendment 256 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 4 a (new)
Directive 2008/105/EC
Article 7a – paragraph 2
(4 a) Paragraph 2 is replaced by the following: "2. The Commission shall report to the European Parliament and to the Council on the outcome of the assessment referred to in paragraph 1 of this Article no later than six months after its annual assessment and shall accompany its report with any appropriate proposals including for control measures." Or. en (32008L0105)
2023/04/05
Committee: ENVI
Amendment 260 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 5
Directive 2008/105/EC
Article 8 – paragraph 1
1. The Commission shall review, for the first time by … [OP: Please insert the date = sixfour years after the date of entry into force of this Directive] and every sixfour 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.
2023/04/05
Committee: ENVI
Amendment 265 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 5
Directive 2008/105/EC
Article 8 – paragraph 3a (new)
3 a. By 12 January 2025, the Commission shall establish technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances under the parameter ‘PFAS Total’. By 12 January 2026, the Commission shall amend Annex I to set the quality standards for 'PFAS total'.
2023/04/05
Committee: ENVI
Amendment 266 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 5
Directive 2008/105/EC
Article 8 – paragraph 3b (new)
3 b. The Commission shall no later than [OP: Please insert the date = two years after the date of entry into force of this Directive] establish technical guidelines regarding methods of analysis for monitoring of 'Bisphenols Total’. The Commission shall no later than [OP: Please insert the date = three years after the date of entry into force of this Directive] amend Annex I to set the quality standards for ' Bisphenols total'.
2023/04/05
Committee: ENVI
Amendment 282 #

2022/0344(COD)

Proposal for a directive
Article 3 – paragraph 1 – point 7
Directive 2008/105/EC
Article 8b – paragraph 1 – subparagraph 2a (new)
2a. Sulfates and xanthates shall be included in the watch list, in order to gather monitoring data for the purpose of facilitating the determinataion of appropriate measures to address the risk posed by these substances.
2023/04/05
Committee: ENVI
Amendment 305 #

2022/0344(COD)

Proposal for a directive
Annex II – paragraph 1 – point 1
Directive 2000/60/EC
Annex VIII – point 10
10. Materials in suspension, including micro/nanoplastics., as well as materials giving rise to micro/nanoplastics;
2023/04/05
Committee: ENVI
Amendment 312 #

2022/0344(COD)

Proposal for a directive
Annex IV – paragraph 1 – point 1 a (new)
Directive 2006/118/EC
Annex II – Part B – title
(1 a) in part B, the title is replaced by the following: 'Minimum list of pollutants and their indicators for which Member States have to establish threshold values in accordance with Article 3'
2023/04/05
Committee: ENVI
Amendment 315 #

2022/0344(COD)

Proposal for a directive
Annex IV – paragraph 1 – point 2 a (new)
Directive 2006/118/EC
Annex II – Part B – point 3a (new)
(2 a) in Part B, the following new point 3a is added: '3a.Other indicators relevant to the quality of groundwater and to the better protection of groundwater ecosystems: Temperature Biology Surface water input.'
2023/04/05
Committee: ENVI
Amendment 318 #

2022/0344(COD)

Proposal for a directive
Annex VI
Directive 2008/105/EC
Annex II – Part A – point 10
10. Materials in suspension, including micro/nanoplastics, as well as materials giving rise to micro/nanoplastics;
2023/04/05
Committee: ENVI
Amendment 324 #

2022/0344(COD)

Proposal for a regulation
Annex III
Directive 2006/118/EC
Annex I – table – row 5a (new)
(1) (2) (3) (4) (5) (6) [Entr Name of Category of CAS number EU number (2) Quality Standard (3) y] No substance substances (1) [µg/l unless otherwise indicated] 3a PFAS - total Industrial not not applicable (7a) substances applicable ______________________ (7a) The quality standard will be set by the Commission by delegated act. Or. en JustificationThere is a total of more than 10 000 known PFAS substances. It is thus not enough to only set a quality standard for 24 PFAS - a quality standard should also be set for all PFAS. This is also the case in the drinking water directive. PFAS total should therefore already be included in Annex I. The actual quality standard should be set by the Commission via delegated act.
2023/04/04
Committee: ENVI
Amendment 325 #

2022/0344(COD)

Proposal for a regulation
Annex III
Directive 2006/118/EC
Annex I – table – row 6
4 Carbamazepin Pharmaceuticals 298-46-4 not applicable 0,025 e
2023/04/04
Committee: ENVI
Amendment 326 #

2022/0344(COD)

Proposal for a regulation
Annex III
6 Pharmaceutica Pharmaceuticals not not applicable 0,025 l active applicable substances – total (8)
2023/04/04
Committee: ENVI
Amendment 330 #

2022/0344(COD)

Proposal for a regulation
Annex III
Directive 2006/118/EC
Annex I – table – row 9
7 Non-relevant Pesticides not not applicable 0,1 (9) or 1 (10) orindividual) metabolites of applicable 2,5 or 5 (11) pesticides (individual) (nrMs) 0,5 (9) or 5 (10) or 12,5 (11) (total) (12) ______________________ (9) Applicable to ‘data-poor’ nrMs, i.e. nrMs for which no reliable experimental data on chronic or acute effects of the nrM are available on the taxonomic group confidently predicted to be the most sensitive. (10) Applicable to ‘data-fair’ nrMs, i.e. nrMs for which reliable experimental data on chronic or acute effects of the nrM are available on the taxonomic group confidently predicted to be the most sensitive, but where the data are insufficient to qualify the substances as ‘data-rich’. (11) Applicable to ‘data-rich’ nrMs, i.e. nrMs for which reliable experimental data, or equally reliable data obtained by alternative scientifically validated methods, are available on chronic or acute effects of the nrM on at least one species each of algae, of invertebrates, and of fish, allowing the most-sensitive taxonomic group to be confidently confirmed, and for which a QS can be calculated using a deterministic approach based on reliable chronic experimental toxicity data on that taxonomic group; Member States may apply for this purpose the latest guidance established in the framework of the Common Implementation Strategy for Directive 2000/60/EC (Guidance document No. 27, as updated). The QS of 2,5 for individual nrMs shall apply unless the QS calculated by the deterministic approach is higher, in which case a QS of 5 shall apply.0,5 (total) (12) (nrMs) ______________________ (12) ‘Total’ means the sum of all individual nrMs in each data category detected and quantified in the monitoring procedure.
2023/04/04
Committee: ENVI
Amendment 332 #

2022/0344(COD)

Proposal for a Directive
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I – table – row 5
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (3) Atra Her 191 217- 0,61 0,6 01 2,0 2,0 zine bici 2- 617- des 24-9 8
2023/04/04
Committee: ENVI
Amendment 337 #

2022/0344(COD)

Proposal for a Directive
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I – table – row 72 a new
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) 70a Bisp Ind not not * * * * hen ustri appl appl ols al icab icab che le le mic als ______________________ *The quality standards will be set by the Commission by delegated act.
2023/04/04
Committee: ENVI
Amendment 339 #

2022/0344(COD)

Proposal for a Directive
Annex V – paragraph 1 – point 2
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) 70b PFA Ind not not * * * * S - ustri appl appl total al icab icab che le le mic als ______________________ *The quality standards will be set by the Commission by delegated act.
2023/04/04
Committee: ENVI
Amendment 341 #

2022/0344(COD)

Proposal for a Directive
Annex V – paragraph 1 – point 2
Directive 2008/105/EC
Annex I – table – row 72 c new
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) 70c Pha Pha not not 0,25 0,02 rma rma appl appl 5 ceut ceut icab icab ical icals le le activ e subs tanc es - total
2023/04/04
Committee: ENVI
Amendment 121 #

2022/0278(COD)

Proposal for a regulation
Article 9 – paragraph 1 – introductory part
1. Where the Commission, taking into consideration the opinion provided by the advisory group, considers that the threat referred to in Article 3(2) is present, it shall activate the vigilance mode for a maximum duration of six months by means of an implement delegated act which shall be immediately applicable ing act. Such an implementingcordance with the procedure referred to in Article 43a. Such a delegated act shall contain the following:
2023/04/27
Committee: ITRE
Amendment 123 #

2022/0278(COD)

Proposal for a regulation
Article 9 – paragraph 1 – point a
(a) an assessment of the potential impact of the crisis, laying out why this crisis is of critical importance to the Union and its Member States, pointing out why this crisis is of systemic and vital importance for public security, public safety, public order or public health, and how this crisis would have a significant impact on the functioning of the Single Market;
2023/04/27
Committee: ITRE
Amendment 135 #

2022/0278(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The implementingdelegated act referred to in paragraph 1 shall be adopted in accordance with the examinationurgency procedure referred to in Article 41(2)3a.
2023/04/27
Committee: ITRE
Amendment 147 #

2022/0278(COD)

Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
The Commission may, among the goods of strategic importance listed in an implementing delegated act adopted pursuant to Article 9(1),, identify those for which it may be necessary to build a reserve in order to prepare for a Single Market emergency, taking into account the probability and impact of shortages on vital societal and vital economic activities. The Commission shall inform the Member States, the European Parliament and advisory board thereof.
2023/04/27
Committee: ITRE
Amendment 151 #

2022/0278(COD)

Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
The Commission mayshall require, by means of implementing acts, that the Member States provide information on the goods listed in an implementing delegated act adopted pursuant to Article 9(1), as regards all of the following:
2023/04/27
Committee: ITRE
Amendment 163 #

2022/0278(COD)

Proposal for a regulation
Article 12 – paragraph 3
3. Taking due account of stocks held or being built up by economic operators on their territory, Member States shall deploy their best efforts to build up strategic reserves of the goods of strategic importance identified in accordance with paragraph 1. The Commission shall provide support to Member States to coordinate and streamline their efforts.
2023/04/27
Committee: ITRE
Amendment 166 #

2022/0278(COD)

Proposal for a regulation
Article 12 – paragraph 4 – introductory part
4. Where the building of strategic reserves of goods of strategic importance identified pursuant to paragraph 1 can be rendered more effective by streamlining among Member States, the Commission mayshall draw up and regularly update, by means of implementing acts, a list of individual targets regarding the quantities and the deadlines for those strategic reserves that the Member States should maintain. When setting the individual targets for each Member State, the Commission shall take into account:
2023/04/27
Committee: ITRE
Amendment 174 #

2022/0278(COD)

Proposal for a regulation
Article 12 – paragraph 6 – subparagraph 2 – introductory part
Following such an assessment, where the Commission establishes, supported by objective datadata, which is objective, factual, measurable, substantiated, and not informed by bias, that
2023/04/27
Committee: ITRE
Amendment 193 #

2022/0278(COD)

Proposal for a regulation
Article 27 – paragraph 1
1. The Commission, informing the European Parliament, may invite one or more economic operators in crisis-relevant supply chains established in the Union to accept and prioritise certain orders for the production or supply of crisis-relevant goods (‘priority rated order’).
2023/04/27
Committee: ITRE
Amendment 197 #

2022/0278(COD)

Proposal for a regulation
Article 27 – paragraph 2
2. If an economic operator does not accept andor prioritise priority rated orders, the Commission may, at its own initiative or at the request of 14 Member States, assess the necessity and proportionality of resorting to priority rated orders in such cases, the Commission shall give the economic operator concerned as well as any parties demonstrably affected by the potential priority rated order, the opportunity to state their position within a reasonable time limit set by the Commission in light of the circumstances of the case. In exceptional circumstances, following such an assessment, the Commission may address an implementing act to the economic operator concerned, requiring it to either accept and prioritise the priority rated orders specified in the implementing act or explain in written why it is not possible or appropriate for that operator to do so. The Commission’s decision shall be based on objective data which is factual, measurable, substantiated and not informed by bias showing that such prioritisation is indispensable to ensure the maintenance of vital societal or vital economic activities in the Single Market.
2023/04/27
Committee: ITRE
Amendment 201 #

2022/0278(COD)

Proposal for a regulation
Article 27 – paragraph 4 – subparagraph 1
Where the economic operator to which the decision referred to in paragraph 2 is addressed declines to accept the requirement to accept andperform the prioritise they rated orders specified in the decision, it shall provide to the Commission, within 10 days from the notification of the decision, a reasoned explanation setting out duly justified reasons why it is not possible or appropriate, in light of the objectives of this provision, for it to comply with the requirement. Such reasons include the inability of the operator to perform the priority rated order on account of insufficient production capacity or a serious risk that accepting the order would entail particular hardship or economic burden for the operator, or other considerations of comparable gravity.
2023/04/27
Committee: ITRE
Amendment 206 #

2022/0278(COD)

Proposal for a regulation
Article 27 – paragraph 6
6. The Commission shall take the decision referred to in paragraph 2 in accordance with applicable Union law, including the principles of necessity and proportionality, and the Union’s obligations under international law. The decision shall in particular take into account the legitimate interests of the economic operator concerned and any available information concerning the cost and effort required for any change in production sequence. It shall state the legal basis for its adoption, fix the time limits within which the priority rated order is to be performed and, where applicable, specify the product and quantity. It shall state the fines provided for in Article 28 for failure to comply with the decision. The priority rated order shall be placed at a fair and reasonable price.
2023/04/27
Committee: ITRE
Amendment 211 #

2022/0278(COD)

Proposal for a regulation
Article 28 – paragraph 1 – introductory part
1. The Commission mayshall, by means of a decision, where deemed necessary and proportionate, impose fines:
2023/04/27
Committee: ITRE
Amendment 212 #

2022/0278(COD)

Proposal for a regulation
Article 28 – paragraph 1 – point a
(a) where a representative organisation of economic operators or an economic operator, intentionally or through gross negligence, supplies incorrect, incomplete or misleading information in response to a request made pursuant to Article 24, or does not supply the information within the prescribed time limit;
2023/04/27
Committee: ITRE
Amendment 214 #

2022/0278(COD)

Proposal for a regulation
Article 28 – paragraph 2
2. Fines imposed in the cases referred to in paragraph 1 (a) and (b) shall not exceed 200 000 EUR.deleted
2023/04/27
Committee: ITRE
Amendment 218 #

2022/0278(COD)

Proposal for a regulation
Article 28 – paragraph 3
3. Fines imposed in the cases referred to in paragraph 1 (c) shall not exceedbe lower than 1 % of the average daily turnover in the preceding business year for each working day of non-compliance with the obligation pursuant to Article 27 (priority rated orders) calculated from the date established in the decision not exceeding 1% of total turnover in the preceding business year.
2023/04/27
Committee: ITRE
Amendment 224 #

2022/0278(COD)

Proposal for a regulation
Article 34 – paragraph 1
1. TWhen respectively the vigilance mode or Single Market emergency mode has been activated pursuant to Article 9 or 14, two or more Member States may request that the Commission launch a procurement on behalf of the Member States that wish to be represented by the Commission (ʽparticipating Member Statesʼ), for the purchasing of goods and services of strategic importance listed in an implementing act adopted pursuant to Article 9(1) or crisis-relevant goods and services listed in an implementing act adopted pursuant to Article 14(5).
2023/04/27
Committee: ITRE
Amendment 227 #

2022/0278(COD)

Proposal for a regulation
Article 34 – paragraph 2
2. The Commission shall assess the utility, necessity and proportionality of the request. Where the Commission intends not to follow the request, it shall inform the Member States concerned and the advisory group referred to in Article 4 and give reasons for its refusal.
2023/04/27
Committee: ITRE
Amendment 229 #

2022/0278(COD)

Proposal for a regulation
Article 34 – paragraph 3
3. Where the Commission agrees to procure on behalf of the Member States, it shall draw up a proposal for a framework agreement to be concluded with the participating Member States allowing the Commission to procure on their behalf. This agreement shall lay down the detailed conditions, practical arrangements for this procedure as well as rules for decision- making, for the procurement on behalf of the participating Member States referred to in paragraph 1 and shall be made public.
2023/04/27
Committee: ITRE
Amendment 231 #

2022/0278(COD)

Proposal for a regulation
Article 35 – paragraph 1
1. The agreement [referred to in Article 34(3) shall establish a negotiating mandate, including on elements such as definition of technical specifications, award criteria and assessment of tenders received, for the Commission to act as a central purchasing body for relevant goods and services of strategic importance or crisis-relevant goods and services on behalf of the participating Member States through the conclusion of new contracts which shall be made public.
2023/04/27
Committee: ITRE
Amendment 235 #

2022/0278(COD)

Proposal for a regulation
Article 35 – paragraph 3
3. Representatives of the Commission or experts nominated by the Commission may carry out on-regular on-site visits, including not announced site visits at the locations of production facilities of relevant goods of strategic importance or crisis-relevant goods.
2023/04/27
Committee: ITRE
Amendment 237 #

2022/0278(COD)

Proposal for a regulation
Article 36 – paragraph 2
2. The contracts mayshall include a clause stating that a Member State which has not participated in the procurement procedure may become a party to the contract after it has been signed, laying out in detail the procedure for doing so and its effects.
2023/04/27
Committee: ITRE
Amendment 238 #

2022/0278(COD)

Proposal for a regulation
Article 36 a (new)
Article36a Publication of joint public procurement contracts 1. The Commission must ensure all joint procurement contracts are made available to the public and accessible on the Commission's website within 30 days after signing of the contract. Information disclosed for public scrutiny shall include: (a) the amount of public investment paid to the contractor, broke down by cost structure of the product; (b) price per unit of the product; (c) number of product units to be delivered per quarter; (d) number and locations of the product’s manufacturing sites; (e) arrangements related to product donations, intellectual property and technology transfer within the Union and with third countries; (f) product liability clauses and compensation for any damage caused by the product; (g) terms and conditions related to the breach of the contracts and their termination. The European Court of Auditors shall have full access to all relevant documents to provide accurate annual scrutiny of signed contracts and public investment.
2023/04/27
Committee: ITRE
Amendment 245 #

2022/0278(COD)

Proposal for a regulation
Article 41 – paragraph 1
The Commission and the Member States may set up interoperable digital open source tools or IT infrastructures supporting the objectives of this Regulation. Such tools or infrastructures may be developed outside the duration of the Single Market Emergency.
2023/04/27
Committee: ITRE
Amendment 249 #

2022/0278(COD)

Article43a Urgency procedure 1. Delegated acts adopted according to this Article shall enter into force without delay and shall apply as long as no objection is expressed. 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 3. Either the European Parliament or the Council may object to a delegated act. In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
2023/04/27
Committee: ITRE
Amendment 43 #

2022/0164(COD)

Proposal for a regulation
Recital 6
(6) The REPowerEU chapter should include new reforms and investments contributing to the REPowerEU aims. Furthermore, that chapter should contain an outline of other measures, financed from sources other than the Recovery and Resilience Facility, contributing to the energy-related objectives outlined in recital (3). The outline should cover measures whose implementation should take place between 1 February 2022 to 31 December 2026, the period during which the objectives set by this Regulation are to be achieved. As regards natural gas infrastructure, the investments and reforms of the REPowerEU chapters to diversify supply away from Russia should build on the needs currentlyto be identified through the assessment conducted and agreed by the European Network of Transmission System Operators for Gas (ENTSOG), established in the spirit of solidarity as regards security of supply and take into account the reinforced preparedness measures taken to adapt to new geopolitical threatsan open and robust consultation process involving all relevant stakeholders and prioritising green and energy efficient alternatives to building new gas infrastructure. Finally, the REPowerEU chapters should provide an explanation and a quantification of the effects of the combination of the reforms and investments financed by the Recovery and Resilience Facility and the other measures financed by other sources than the Recovery and Resilience Facility.
2022/09/08
Committee: ITRE
Amendment 80 #

2022/0164(COD)

Proposal for a regulation
Article 1 – paragraph 1 – point 6
Regulation (EU) 2021/241
Article 21c – paragraph 1 – point a
(a) improving energy infrastructure and facilities to meetof immediate security of supply needs for oil and gas, notablyand temporary use to meet security of supply needs, notably to reduce Union's energy imports and vulnerabilities during the nearest winter seasons of 2022-2023, to enable diversification of supply in the interest of the Union as a whole,
2022/09/08
Committee: ITRE
Amendment 19 #

2022/0160(COD)

Proposal for a directive
Recital 1
(1) In the context of the European Green Deal16 , Regulation (EU) 2021/1119 of the European Parliament and of the Council17 established the objective of the Union becoming climate neutral in 2050 at the latest, as well as the target of a at last 55% reduction in greenhouse gas emissions by 2030. This requires an energy transition in a manner that contributes to the sustainable economic,environmental and social development, prosperity and job creation in the EU. This requires an energy transition cantered on reducing energy and resource consumption and increased efficiency and significantly higher shares of renewable energy sources in an integrated energy system. _________________ 16 Communication from the Commission COM/2019/640 final, The European Green Deal. 17 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).
2022/09/29
Committee: ITRE
Amendment 21 #

2022/0160(COD)

Proposal for a directive
Recital 2
(2) Renewable energy plays a fundamental role in delivering on these objectives, given that the energy sector contributes today over 75% of total greenhouse gas emissions in the Union. By reducing those greenhouse gas emissions, renewable energy can also contributes to tackling environmental-related challenges such as biodiversity loss and to reducing land, water and air pollution in line with the objectives of the Zero-Pollution Action Plan as long as the renewable energy sources themselves do not exacerbate these challenges.
2022/09/29
Committee: ITRE
Amendment 25 #

2022/0160(COD)

Proposal for a directive
Recital 3
(3) Directive (EU) 2018/2001 of the European Parliament and of the Council18 sets a binding Union target to reach a share of at least 32 % of energy from renewable sources in the Union's gross final consumption of energy by 2030. Under the Climate Target Plan19 To achieve the objective of the European Green Deal and the 8th EAP and to make the legislation fit for 1.5°C, the share of renewable energy in gross final energy consumption would need to increase to 40%at least 56 % at least 45% energy efficiency by 2030 in order to achieve the Union’s greenhouse gas emissions reduction target20 . In this context, the Commission proposed in July 2021, as part of the package delivering on the European Green Deal, to double the share of renewable energy in the energy mix in 2030 compared to 2020, to reach at least 40%. The REPowerEU Communication21 outlined a plan to make the EU independent from Russian fossil fuels well before the end of this decade. The Communication foresees front-loading of wind and solar energy, increasing the average deployment rate as well as additional renewable energy capacity by 2030 to accommodate for higher production of renewable hydrogen. It also invited the co-legislators to consider a higher or earlier target for renewable energy. In this context, it is appropriate to increase the Union renewable energy target up to at least 45% in order to significantly accelerate the current pace of deployment of renewable energy, thereby speeding up the phase-out of EU’s dependence on fossil fuels and nuclear by increasing the availability of affordable, secure and, sustainable and renewable energy in the Union. _________________ 18 Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82). 19 Communication from the Commission COM(2020) 562 final of 17.9.2020, Stepping up Europe’s 2030 climate ambition Investing in a climate-neutral future for the benefit of our people. 20 Point 3 of the Communication from the Commission COM(2020) 562 21 REPowerEU: Joint European Action for more affordable, secure and sustainable energy, COM(2022) 108 final (“REPower EU Communication”).
2022/09/29
Committee: ITRE
Amendment 27 #

2022/0160(COD)

Proposal for a directive
Recital 3 a (new)
(3 a) Following the invasion of Ukraine by Russia, the case for a rapid energy transition has never been stronger and clearer. Russia provided more than 40% of the EU's total gas consumption, mostly used in the building sector, which is responsible for 40% of the EU’s total energy consumption. Since the invasion, the EU has sought suppliers from other third countries, yet the solution is replacing fossil fuels by increased energy efficiency and renewables deployment. With an accelerated roll out of heat pumps, the EU could save significant amounts of fossil fuel imports. Frontloading such investments, 10 million hydronic heat pumps by 2026 would further accelerate the reduction of EU dependence from external suppliers. According to REPowerEU, for 2022 alone an additional 12bcm of gas could be saved by every 10 million heat pumps installed. If the solar rooftop initiative of the RepowerEU communication is sufficiently covered by provisions in Energy performance of buildings directive (COM(2021) 802 final), a dedicated initiative for heat pump is still missing and therefore needed in this Directive.
2022/09/29
Committee: ITRE
Amendment 34 #

2022/0160(COD)

Proposal for a directive
Recital 7
(7) Some of the most common issues faced by renewable energy project developers relate to procedures established at national or regional level to assess the environmental impact of the proposed projectcomplex and protracted administrative, permitting and grid connection procedures established at national or regional level, lack of sufficient staffing of and technical expertise in permitting authorities. Therefore, it is appropriate to streamline certain environmental-related aspects of the permit- granting procedures and processes for renewable energy projects.
2022/09/29
Committee: ITRE
Amendment 35 #

2022/0160(COD)

Proposal for a directive
Recital 7 a (new)
(7 a) Citizens, local authorities and SMEs, acting as individual and collective self-consumers, and through renewable energy communities, are disproportionately impacted by complex, lengthy and opaque administrative procedures. This is often due to a lack of experience or expertise, financial and human resources to navigate permitting and grid connection processes in particular. There is a need to make it easier for non-professional and non- commercial market actors to successfully navigate obtaining relevant approvals. This should be facilitated by simplification where necessary, as well as dedicated windows where these actors do not have the same capacity as other professional well-resourced market participants. The integrated multilevel planning and mapping of renewable energy, should reflect the local planning and mapping carried out at local and regional level according to the provisions of the new article 15bb as well as identifying the estimated staff, training and technical needs of permit grantig authorities as well as the expected financing needs.
2022/09/29
Committee: ITRE
Amendment 36 #

2022/0160(COD)

Proposal for a directive
Recital 8
(8) A faster roll-out of renewable energy projects could be supported by strategic planning carried out by Member Statintegrated multilevel planning and mapping of renewable energy out by Member States in structured coordination with local and regional authorities. Member States, should identify the land and sea, surfaces, sub-surfaces, sea and inland water areas necessary for the installation of plants for the production of energy from renewable sources in order to meet at least their national contributions towards the revised 2030 renewable energy target set out in Article 3(1) of Directive (EU) 2018/2001, as well as their national long term strategies under the Regulation (EU) 2018/1999and the target of climate neutrality. Such areas should reflect their estimated trajectories and total planned installed capacity and should be identified by renewable energy technology set in the Member States’ updated national energy and climate plans pursuant to Article 14 of Regulation (EU) 2018/1999. The identification of the required land, surfaces, sub-surfaces, inland waters and sea areas should take into consideration the availability of the renewable energy resources and the potential offered by the different land and sea areas for renewable energy production of the different technologies, the projected energy demand, taking into account energy and system efficiency, overall and in the different regions of the Member State, and the availability of relevant heat and cooling network and grid infrastructure, energy storage and other flexibility tools bearing in mind the capacity needed to cater for the increasing amount of renewable energy, the potential of involving citizens actively in the energy system, acting as individual and collective self-consumers and through renewable energy communities, areas with other primary uses.
2022/09/29
Committee: ITRE
Amendment 41 #

2022/0160(COD)

Proposal for a directive
Recital 9
(9) Member States should designate as renewables go-to areas those areas that are particularly suitable to develop renewable energy projects, differentiating between technologies, and where the deployment of the specific type of renewable energy sources is not expected to have a significant environmental impactlow environmental impact, according to sensitivity mapping under Article 15b. Member States shall designate with priority, renewable go-to-areas as for instance artificial and built surfaces (rooftops, parking areas, waste sites etc.). In the designation of renewables go-to areas, Member States should avoid protected areas to the extent possible and consider restoration plans, restoration areas, bird and marine mammals migratory routes etc. Member States may designate renewable go-to areas specific for one or more types of renewable energy plants, except for biomass and hydropower plants, and should indicate the type or types of renewable energy that are suitable to be produced in each renewable go-to area.
2022/09/29
Committee: ITRE
Amendment 46 #

2022/0160(COD)

Proposal for a directive
Recital 10
(10) Directive 2001/42/EC of the European Parliament and of the Council22 establishes environmental assessments as an important tool for integrating environmental considerations into the preparation and adoption of plans and programmes. In order to designate renewables go-to areas, Member States should prepare a plan or plans encompassing the identification of areas and the applicable rules and mitigation measures for projects located in each go-torenewable area. Member States may prepare one single plan for all renewable go-to areas and technologies, or technology-specific plans identifying one or more renewable go-to areas. Each plan should be subject to anareas with each plan subject to a site and project specific environmental assessment carried out in accordance with the conditions set out in Directive 2001/42/EC in order to assess the impacts of each renewable technology on the relevant areas designated in such plan. Carrying out anHowever, such a strategic environmental assessment should not replace individual environmental impact assessment in accordance with Directive 2001/42/EC for this purpose would allow Member States to have a more integrats as required under inter alia the environmental Directive 2001/42/EC (impact assessment Directive) nor appropriate assessments as required aund efficient approach to planning and to take environmental considerations into account at an early phase of the planning process at a strategic level. This would contribute to ramping up the deployment of different renewable energy sources in a faster and streamlined manner whileer the Council Directive 92/43/EEC (Habitats Directive)1a and Directive 2009/147/EC Birds Directive1b for all projects potentially affecting Natura 2000 sites or protected habitats and/or species. These assessments will still need to be carried out, since not doing so would lead to the environmental impacts of a project in a renewable area, both inside and outside that area, not being assessed, would reduce the ability of authorities to mionimising the negative environmental impacts from these projector and evaluate infrastructure performance over time and its impact on biodiversity as well as undermining public participation rights. _________________ 221a Council Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment.92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206 22.7.1992, p. 7) 1b Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206 22.7.1992, p. 7) 24 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 020 26.1.2010, p. 7)
2022/09/29
Committee: ITRE
Amendment 52 #

2022/0160(COD)

(14) In the designated renewables go-to areas, renewable energy projects that comply with the rules and measures identified in the plan or plans prepared by Member States, should benefit from a presumption of not having significant effects on the environment. Therefore, there should be an exemption from the need to carry out a specific environmental impact assessment at project level in the sense of Directive 2011/92/EU of the European Parliament and of the Council24 , with the exception of projects which are likely to have significant effects on the environment in another Member State or where a Member State likely to be significantly affected so requests. The obligations under the UNECE Espoo Convention on environmental impact assessment in a transboundary context of 25 February 1991 should remain applicable for Member States where the project is likely to cause a significant transboundary impact in a third country. _________________ 24 Directive 2011/92/EU of the European parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment.deleted
2022/09/29
Committee: ITRE
Amendment 56 #

2022/0160(COD)

Proposal for a directive
Recital 15
(15) The designation of renewables areas and renewable go- to areas should allow renewable energy plants, their grid connection as well as co- located energy storage facilities located in these areas to benefit from predictability and streamlined administrative procedures. In particular, projects located in renewable go-tothese areas should benefit from accelerated administrative procedures, including a tacit agreement in case of a lack of response by the competent authority on an administrative step by the established deadline, unless the specific project is subject to an environmental impact assessment. These projects should also benefit from clearly delimited deadlines and legal certainty as regards the expected outcome of the procedure. Following the application for projects in a renewables go-to area, Member States should carry out a fast screening of such applications with the aim to identify if any of such projects is highly likely to give rise to significant unforeseen adverse effects in view of the environmental sensitivity of the geographic area where they are located that were not identified during the environmental assessment of the plan or plans designating renewables go-to areas carried out in accordance with Directive 2001/42/EC. All projects located in renewables go-to areas should be deemed approved at the end of such screening process. Only if Member States have clear evidence to consider that a specific project is highly likely to give rise to such significant unforeseen adverse effects, Member States should, after motivating such decision, subject such project to an environmental assessment in accordance with Directive 2011/92/EC and, where relevant, Directive 92/43/EEC25 . Given the need to accelerate the deployment of renewable energy sources, such assessment should be carried out within six months. _________________ 25 Council Directive 92/43/EEC of 21 May 1992 on the convervation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992) and should also benefit from clearly delimited deadlines and legal certainty as regards the expected outcome of the procedure.
2022/09/29
Committee: ITRE
Amendment 64 #

2022/0160(COD)

Proposal for a directive
Recital 16
(16) In view of the need to accelerate the deployment of renewable energy sources, the identification of renewables go-to areas and renewable areas should not prevent the ongoing and future installation of renewable energy projects in all areas available for renewable energy deployment. Such projects should remain subject to the obligation to carry out a dedicated environmental impact assessment in accordance with Directive 2001/92/EU and should be subject to the procedures foreseen for renewable energy projects located outside go-to areas. To speed up permitting at the scale necessary for the achievement of the renewable energy target set out in Directive (EU) 2018/2001, also the procedures applicable to projects outside of go-to areas should be simplified and streamlined with the introduction of clear maximum deadlines for all steps of the procedure, including dedicated environmental assessments per project, without foregoing the relevant obligations under existing legislation, including under the environmental impact assessment Directive as well as under the Birds and Habitats Directives.
2022/09/29
Committee: ITRE
Amendment 72 #

2022/0160(COD)

Proposal for a directive
Recital 21
(21) The installation of solar energy equipment, together with related co-located storagethermal or power energy storage, heating and cooling network and grid connection, in existing or future structures created for purposes different than solar energy production with the exclusion of artificial water surfaces, such as rooftops, parking areas, roads and railways, do not typically raise concerns related to competing uses of space or environmental impact. These installations therefore may benefit from shorter permit- granting procedures.
2022/09/29
Committee: ITRE
Amendment 75 #

2022/0160(COD)

Proposal for a directive
Recital 22
(22) Renewable energy sources are crucial to fight climate change, reduce energy prices, decrease the Union’s dependence on fossil fuels and ensure the Union’s security of supply. For the purposes of the relevant Union environmental legislation, in the necessary case-by-case assessments to ascertain whether a plant for the production of energy from renewable sources, its connection to the grid, the related grid itself or storage assets is of overriding public interest in a particular case, Member States should presume these plants and their related infrastructure as being of overriding public interest and serving public health and safety, except where there is clear evidence that these projects have major adverse effects on the environment which cannot be mitigated or compensated. Considering such plants as being of overriding public interest and serving public health and safety would allow such projects to benefit from a simplified assessment.deleted
2022/09/29
Committee: ITRE
Amendment 84 #

2022/0160(COD)

Proposal for a directive
Recital 30
(30) Since the objective of this Directive, namely reducing greenhouse gas emissions, energy dependency and energy prices, cannot be sufficiently achieved by the Member States but can rather, by reasons, of the scale of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiary as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.
2022/09/29
Committee: ITRE
Amendment 86 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 1
Directive 2018/2001
Article 2 – point 9a
(9a) ’renewables go-to area’ means a specific location, whether on land or sea,, surfaces, sub-surfaces, sea or inland water, where the installation of a type of renewable energy can be expected to have a low detrimental impact on ecosystems, including protected species and habitats, and which has been designated by a Member State according to article 15c and prioritised as particularly suitable for the swift installation of plants for the production of energy from a specific source of renewable energy sources, other than biomass combustionhydropowerplants and biomass combustion, processing and sourcing plants.
2022/09/29
Committee: ITRE
Amendment 97 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 2
Directive 2018/2001
Article 3–Paragraph 1
1. Member States shall collectively ensure that the share of energy from renewable sources in the Union’s gross final consumption of energy in 2030 is at least 456%.
2022/09/29
Committee: ITRE
Amendment 101 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 3
Directive 2018/2001
Article 15 – Paragraph 2a new
2a. Member States shall promote the testing of new renewable energy production, sharing and storage technologies in pilot projects in a real- world environment, for a limited period of time, in accordance with the applicable EU legislation, sustainability criteria and accompanied by appropriate safeguards to ensure the secure operation of the electricity and heat systems and avoid disproportionate impacts on the functioning of the internal market, under the supervision of a competent authority.
2022/09/29
Committee: ITRE
Amendment 104 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b –Title
Article 15bMapp Integrated multilevel mapping and planning of areas necessary for national contributions towards the 2030 RES target(s) and climate neutrality
2022/09/29
Committee: ITRE
Amendment 106 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph (–1)new
In view of achieving the targets set out by this Directive in the most cost and energy efficient way possible, Member States shall perform integrated multilevel mapping and planning for renewable energy resources deployment, in order to fully exploit the domestic potential and optimise the use of local renewable energy sources and the potentially available space, while respecting and implementing the energy efficiency first principle. To this end Member States shall put in place a process ensuring coordination among all the relevant national, regional and local authorities in the upstream planning of the mapping of the necessary areas complementing framework of article 11 of the Governance Regulation (EU) 2018/1999. The assessment shall cover the entire territory of the Member State.
2022/09/29
Committee: ITRE
Amendment 107 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 1
(1) By [12 years after the entry into force], Member States shall identify the land and sea areas necessary for the installation of plants for the production of energy from renewable sources that are required in order to meet their national contributions towards the 2030 renewable energy target in accordance with Article 3 of this Directive. Such areas shall be commensurate with the estimated trajectories and total planned installed capacity by renewable energy technology set in national energy and climate plans of Member States, as updated pursuant to Article 14 of Regulation (EU) 2018/1999. of the [Regulation for Nature Restoration] and no later than 3 years after the entry into force of this Directive, Member States shall perform integrated multilevel mapping and planning for renewable energy resources deployment and identify the installed capacity as well as land , surfaces, sub-surfaces, sea areas and inland water, necessary for the installation of plants for the production of energy from renewable sources and their related infrastructure, such as grid and storage facilites, including thermal storage, that are required to meet their national contributions towards the 2030 renewable energy target in accordance with Article 3 of this Directive, as well as relevant subtargets, and the target of climate neutrality in accordance with the European Climate Law [Regulation (EU) 2021/1119. Such areas shall be commensurate with the estimated trajectories and total planned installed capacity by renewable energy technology set in national energy and climate plans of Member States, as updated pursuant to Article 14 of Regulation (EU) 2018/1999, and set in national long term strategies pursuant to article 15 of Regulation (EU) 2018/1999, as part of the trajectory to move to 100% renewable energy by 2040. Identification of areas shall align with Member States’ obligations under environmental legislation, including under Directive 2008/56/EC, Directive 2000/60/EC, Directive 2009/147/EC, [the Regulation for Nature Restoration] and Directive 92/43/EEC. The assessment shall be part of the integrated national energy and climate plans referred to in Articles 3 and 14 of Regulation (EU) 2018/1999, and maritime spatial plans, including plans referred in Directive 2014/89/EU.’;
2022/09/29
Committee: ITRE
Amendment 116 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – letter a
(a) the availability of the renewable energy resources and the potential for renewable energy production of the different technologies in the land and sea, surfaces, subsurfaces, sea and inland water areas;
2022/09/29
Committee: ITRE
Amendment 118 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – point a a
(a a) information and data provided in the local renewable energy mapping and planning, developed according to article 15(ba) new;
2022/09/29
Committee: ITRE
Amendment 119 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4 Directive 2018/2001
(b) the projected energy demand, fully taking into account the expected energy efficiency and system flexibility gains, as well as for increased electrification of economic sectors, energy system integration and modelled on scenarios in line with the most recent scientific data and energy and climate legislations;
2022/09/29
Committee: ITRE
Amendment 122 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – point c
(c) the availability of relevant heating network, cooling and grid infrastructure, energy storage (power and thermal), and other flexibility tools, including via prosumers’ action, or the potential to create such grid infrastructure and storage.
2022/09/29
Committee: ITRE
Amendment 131 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – point c a (new)
(c a) the proximity to end-users and the energy density for decentralised renewable energy supply.
2022/09/29
Committee: ITRE
Amendment 135 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – – point c b (new)
(c b) information and data provided in the comprehensive assessments carried out pursuant to Article 14 of Directive 2012/27/EU and Article 23 of COM(2021) 558 final on Energy Efficiency Directive.
2022/09/29
Committee: ITRE
Amendment 137 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – point c c (new)
(c c) information and data provided in the context of the implementation of Directive 2014/89 establishing a framework for maritime spatial planning.
2022/09/29
Committee: ITRE
Amendment 139 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
(c d) the potential of involving citizens actively in the energy system as renewable self-consumers, collective self-consumers and renewable energy communities, [the latter which often face barriers accessing sites for renewable energy projects compared to professional project developers], as assessed in accordance with Article 21 and Article 22.
2022/09/29
Committee: ITRE
Amendment 142 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 – point c e (new)
(c e) the common needs of local communities, including households affected by energy poverty and vulnerability, and multiple local or regional administrative units or regions.
2022/09/29
Committee: ITRE
Amendment 143 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
(c f) land and sea areas with other primary uses, namely the existing Natura 2000 network, national protected areas and additional protected areas to be designated pursuant to the Union’s Commitment to protect 30% of its land and sea, all areas included in Member States’ Restoration Plans in line with their obligations under the [Nature Restoration Regulation], as well as areas included in the Member States’ Programmes of Measures in line with the Marine Strategy Framework Directive.
2022/09/29
Committee: ITRE
Amendment 145 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 a (new)
(2 a) By 1 year after the entry into force of this regulation, Member States shall carry out an assessment of the sensitivity of their protected species and habitats to planned energy production from renewable sources. These assessments shall be technology-specific and shall be used to determine land surfaces, sub- surfaces, sea and inland water areas where installations for the production of energy from renewable sources have low impacts on the environment. Assessments as set out in paragraph 1 shall align with Member States’ obligations under environmental legislation, including under Directive 2008/56/EC, Directive 2000/60/EC, Directive 2009/147/EC or Directive 92/43/EEC.
2022/09/29
Committee: ITRE
Amendment 147 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 2 b (new)
(2 b) When identifying areas referred to in paragraph 1, Member States shall identify: - the estimated staff, training, and technical needs of permit-granting authorities, including those involved in the environmental assessment processes, needed to ensure the implementation of the obligations arising from this Directive. - the expected financing needs for permitting authorities to enable the implementation of projected renewable energy installations, which shall include the description of the support to competent authorities and other stakeholders affected by new administrative obligations arising from this Directive and of the means of intended financing;and - the spatial planning policies and legal frameworks, such as distance rules for renewable energy installations, which negatively affect the implementation of the targets and the fulfilment of the obligations set out in this Directive. Member States shall ensure that competent local and regional authorities are involved in the process of the identification of areas referred to in paragraph 1, and offer technical, human and financial support to enable those authorities to take part in the process. Existing local and regional planning and mapping shall be incorporated.
2022/09/29
Committee: ITRE
Amendment 149 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4 Directive 2018/2001
(3) Member States shall favour multiple uses of the areas identified as a result of the obligation in paragraph 1, provided that the installation of renewable energy is compatible with the area existing uses and does not significantly undermine the achievement of their objectives.
2022/09/29
Committee: ITRE
Amendment 154 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 3 a (new)
(3 a) Member States shall encourage and support local and regional authorities to develop and implement trajectories or objectives for renewable energy produced by cities, renewables self-consumers, collective self-consumers and renewable energy communities
2022/09/29
Committee: ITRE
Amendment 160 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – paragraph 3 b (new)
(3 b) Before its adoption, the identification of the areas referred to in paragraph 1, shall be subject to an environmental assessment carried out in accordance with the conditions set out in Directive 2001/42/EC.
2022/09/29
Committee: ITRE
Amendment 162 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4
Directive 2018/2001
Article 15b – Paragraph 3c (new)
(3 c) Member States shall periodically review and update the identification of the areas referred to in paragraph 1, at least in the context of the update of the national energy and climate plans pursuant to Article 14of Regulation (EU) 2018/1999 and other relevant climate and energy legislation, including EED[xx/xxx], EPBD[xx/xxx],
2022/09/29
Committee: ITRE
Amendment 165 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 4 a (new)
Directive 2018/2001
Article 15b a (new)
(4 a) The following article 15ba is inserted; Article 15ba - Local renewable energy mapping and planning 1.In order to ensure a bottom-up approach for the development of the areas referred to in article 15b, Member States shall require regional and local authorities to conduct integrated local renewable energy mapping and planning at least in municipalities, respectively regions, having a total population higher than 10.000 and encourage smaller local municipalities to do the same on a voluntary bases.The plans shall be made public and submitted within the scope of the coordination process set out in paragraph 2.Those plans should at least: (a) include an assessment mapping out all the options to develop local sustainable renewable energy supply chains as well as identifying the local renewable energy supply and optimization options which are the most conducive to achieving a highly energy efficient and fully renewables based energy system in application of the energy efficiency first principle and from a local energy system integration perspective, and that contribute to long- term socio-economic development. b) include an assessment identifying land, surfaces, sub-surfaces, sea and inland water areas available for the installations of plants for the production of energy from renewable sources and their related infrastructure and energy storage (thermal and power) facilities expected to have low environmental impact, starting by first identify built and artificial environment. (c) forecast of the anticipated local demand increase in renewable electricity across sectors that needs to be matched with equivalent amounts of additional renewable capacities, the related infrastructure and energy storage (thermal and power) facilities and, when feasible, the demand response potential to facilitate the integration of growing share of renewable energy. (d) build on relevant data provided in the comprehensive assessments carried out pursuant to Article 14 of Directive 2019/1658 and Article 23 of COM(2021) 558 final on Energy Efficiency Directive. (e) be prepared with the involvement of all relevant regional or local stakeholders and ensure participation of the general public. (f) consider the common needs of local communities, including households affected by energy poverty and vulnerability, and multiple local or regional administrative units or regions. (g) exploit the entire potential of involving citizens actively in the energy system as renewable self-consumers, collective self- consumers or renewable energy communities, [the latter which often face barriers accessing sites for renewable energy projects compared to professional project developers], as assessed in accordance with Article 21(3) and Article22(4). (h) provide an assessment of synergistic effects of potential projects in order to avoid carrying out individual and fragmented evaluations in areas where multiple projects could be submitted; (i) include a methodology for monitoring the progress of implementation of policies and measures identified. 4.Each Member State shall ensure that the public is given the opportunity to participate in the preparation of the local and regional renewable energy plans and the assessments laid down in paragraph 3 as well as the resulting policies and measures.For this purpose, Member States shall develop recommendations supporting the regional and local authorities to implement policies and measures related to the development of integrated local renewable energy plans and mapping at regional and local level utilising the potential identified. 5.The plans developed under paragraph 3 shall be reviewed periodically at least in the context of the update of the national climate and energy plans years. 6.Member States shall support regional and local authorities to the utmost extent possible by any means including technical, human and financial support, for the development of renewable energy- related geographic information system (GIS) and other relevant tools, such as solar atlases or heat and cooling maps. 7. In accordance with Article 17 of the Governance Regulation (EU) 2018/1999, each Member State shall cover information on the progress in establishing and implementing this Article as part of its integrated national energy and climate plan.
2022/09/29
Committee: ITRE
Amendment 167 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 5
Directive 2018/2001
Article 15c – Paragraph 1
By [2 years after the entry into force], Member StatesWhen designating the areas referred to in Article 15b(1), Member States, in coordination with their local and regional authorities, shall adopt a plan or plans designating, within the areas referred to in Article 15b(1), renewables go-to areas for one or more types of renewable energy sources, that match the space requirements identified for each technology to reach the 2030 and 2040 targets for renewable energy , and related sectoral sub-taregts. In that plan or plans, Member States shall:
2022/09/29
Committee: ITRE
Amendment 192 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 5
Directive 2018/2001
Article 15c – Paragraph 3
(3) The plan or plans idesignating renewables go-to areasntifying land, surfaces, sub-surfaces, sea and inland water areas necessary for the installation of energy from renewable sources and designating renewables areas under 15b, 15ba and 15c shall be made publicly available and shall be reviewed periodically, at least in the context of the update of the national energy and climate plans pursuant to Article 14 of Regulation (EU) 2018/1999, and Directive 2014/89/EU.
2022/09/29
Committee: ITRE
Amendment 196 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 5
Directive 2018/2001
Article 15c – paragraph 3a (new)
(3 a) In order to enable citizens to reap the benefits of the energy transition and to exploit the potential of involving citizens actively in the energy system, Member States shall ensure the possibility municipalities and natural persons, acting as individual or jointly acting renewables self-consumers and through renewable energy communities to participate through financial ownership in renewable projects in the designated areas. Member States shall take appropriate measures to inform local communities at an early stage about new renewable projects and the procedures to participate in them.
2022/09/29
Committee: ITRE
Amendment 198 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 5 a (new)

Article 15ca (new)
(5 a) The following article 15ca (new) is inserted: ‘Article 15ca Public Participation' 1.Member States shall ensure that the preparation of the mappings and plans identifying the land, surfaces, sub- surfaces, inland water and sea areas necessary for the installation of plants for the production of energy from renewable sources and those designating renewables areas is open, inclusive and effective and that the public is given early and effective opportunities to participate in its elaboration, when all options are still open.To that end, Member States, and where relevant regional and local authorities, shall publish a proposal for the draft plans under Articles 15b(1), 15ba(3) and 15c(1), including the information referred to in Articles 15b(2)- (2b) 15c(1), as well as the outcomes of the environmental assessment and the appropriate assessments of Articles 15b(4) and 15c(2), above. 2.Member States, and where relevant regional and local authorities, shall identify the public affected or likely to be affected by, or having an interest in the plans, including natural or legal persons or their associations, organisations or groups, taking into account the objectives of this Directive and the potential impacts from its implementation on areas covered by other EU instruments. 3.Member States shall ensure that the public referred to in the previous paragraph is informed electronically and by public notices or by other appropriate means of: i. the draft proposal, where available; ii. any relevant environmental information held by the competent authority;and iii. practical arrangements for participation, including: (a) the administrative entity from which the relevant information may be obtained, (b) the administrative entity to which comments, opinions or questions may be submitted, and (c) reasonable time-frames allowing sufficient time for the public to be informed and to prepare and participate effectively in the environmental decision- making process. iv. opportunities for municipalities, residents, and the public concerned to participate in the implementation of the plans, both financially and non- financially, including through the establishment of renewable energy communities as covered by Articles 2(16) and 22 of this Directive. A time limit of at least eight weeks shall be set for receiving comments.Where meetings or hearings are organised, prior notice of at least four weeks shall be given. 5. In taking a decision on the plans, Member States shall take due account of the outcome of the public participation. Member States shall inform the public of the plans, including their text, and of the reasons and considerations upon which the decision is based, together with a summary of the results of the public consultation and how those results have been incorporated or otherwise addressed.
2022/09/29
Committee: ITRE
Amendment 203 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16 – Paragraph 1
(1) The permit-granting process shall cover all relevant administrative permits to build, repower and operate plants for the production of energy from renewable sources, co-located energy storage (power and thermal) facilities, as well as assets necessary for their connection to renewable heating networks, cooling infrastructure and the grid, including grid connection permits and environmental assessments where these are required. The permit-granting process shall comprise all procedures from the acknowledgment of the validity of the application in accordance with paragraph 2 to the notification of the final decision on the outcome of the procedure by the relevant authority or authorities.
2022/09/29
Committee: ITRE
Amendment 208 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16 – Paragraph 1a (new)
(1 a) Member States shall ensure that the financing of qualified staff, upskilling, and reskilling of their competent authorities at national, regional, and local level is proportionate with the implementation of the overall renewable energy needs established under Article 15b of this Directive, and with the planned installed renewable energy generation capacity as foreseen in their National Energy and Climate Plans updated pursuant to Article 14 of Regulation (EU) 2018/1999. Member States shall earmark all fees linked to the application and permit- granting processes for the above purpose of further financing qualified staff and improving the capacity of the relevant permitting authority.
2022/09/29
Committee: ITRE
Amendment 212 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16 – Paragraph 2
(2) No later than fourteen days for plants located in go-to areas and onetwo month for plants located outside of go-to areas, following the receipt of the application, the competent authority shall validate the application or, if the developer has not sent all the information required to process an application, request the developer to submit a complete application within fourteen daysone month from this request. If the developer does not submit a complete application within this deadline, the competent authority may reject the application in written form. In the event of a rejection, the competent authority shall justify its decision. The developer may resubmit a new application at any point in time following such rejection. The date of the acknowledgement of the validity of the application by the competent authority shall serve as the start of the permit- granting process. All applications deemed to be valid shall be made available to the public on the date of acknowledgement of their validity.
2022/09/29
Committee: ITRE
Amendment 220 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16 – Paragraph 3
(3) Member States shall set up or designate one or more contact points within its administration. Those contact points shall, upon request by the applicant, guide through and facilitate the entire administrative permit application and granting process. The applicant shall not be required to contact more than one contact point for the entire process. The contact point shall guide the applicant through the administrative permit application process, including the environmental related steps, in a transparent manner up to the delivery of one or several decisions by the responsible authorities at the end of the process, provide the applicant with all necessary information and involve, where appropriate, other administrative authorities. The contact point shall provide the public with information regarding their opportunities, and technical and practical aspects of installing renewables for self-consumption and in the context of renewable energy communities, as required by Article 18(6) of this Directive. The contact point, in coordination with relevant authorities, shall ensure fulfilment of the deadlines for the permit- granting procedures set out in this Directive. Applicants shall be allowed to submit all relevant documents in digital form. By [2 years from entry into force] Member States shall ensure that all procedures are carried out in electronic format.
2022/09/29
Committee: ITRE
Amendment 224 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16 – Paragraph 4
(4) The contact point shall make available a manual of procedures for developers of renewable energy production plants and shall provide that information also online, addressing distinctly also small-scale projects and, renewable energy communities, collective and individual renewables self- consumers projects, provide them with assistance and guide them through the administrative process of receiving support under renewables support schemes. The online information shall indicate the contact point relevant to the applicant's application. If a Member State has more than one contact point, the online information shall indicate the contact point relevant to the applicant's application.
2022/09/29
Committee: ITRE
Amendment 225 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16 – paragraph 4a (new)
(4 a) Member States shall ensure that administrative procedures, in particular permit granting and grid connections, provide for the provision of other technical assistance to renewable energy communities and renewable energy self- consumers, including through simplified procedures and dedicated application windows.
2022/09/29
Committee: ITRE
Amendment 227 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16– Paragraph 6a (new)
(6 a) Member States shall ensure that, in accordance with their national legal system, members of the public concerned who meet the conditions set out in the point (a) of this paragraph, including natural or legal persons or their associations, organisations or groups, have access to a review procedure before a court of law, or another independent and impartial body established by law, to challenge the substantive or procedural legality of decisions, acts and omissions that: - fail to comply with the legal obligations provided for in Articles 15b, 15c, 15d, 16a, and 16b of this Directive;or - are subject to Article 10 of Regulation (EU) 2018/1999. (a) Members of the public concerned shall be deemed to meet the conditions referred to in paragraph 6a where: (i) they have sufficient interest;or (ii) they maintain impairment of a right, where administrative procedural law of a Member State requires that as a precondition. What constitutes a sufficient interest shall be determined by Member States consistently with the objective of giving the members of the public concerned wide access to justice and in conformity with the ‘Aarhus Convention’.To that end, the interest of any non-governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed to have sufficient interest for the purposes of this paragraph. Member States shall ensure that practical information is made easily available to the public on access to administrative and judicial review procedures.’
2022/09/29
Committee: ITRE
Amendment 229 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 6
Directive 2018/2001
Article 16– Paragraph 7
(7) Member States shall ensure that administrative and judicial appeals in the context of a project for the development of renewable energy production plant or its related grid connection, including those related to environmental aspects shall be subject to the most expeditious administrative and judicial procedure that is available at the relevant national, regional and local level. non- renewable energy projects and energy infrastructure minimum approval times, where in place, cannot be shorter than those set for renewables
2022/09/29
Committee: ITRE
Amendment 237 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 7
Directive 2018/2001
Article 16 a – Paragraph 1
(1) Member States shall ensure that the permit-granting process referred to in Article 16(1) shall not exceed one year6 months for projects in renewables go-to areas. Where duly justified on the ground of extraordinary circumstances, that one-year6 months period may be extended by up to three months. In such a case, Member States shall clearly inform the developer about the extraordinary circumstances that justified the extension.
2022/09/29
Committee: ITRE
Amendment 243 #

2022/0160(COD)

(2) The permit-granting process for the repowering of plants and for new installations with an electrical capacity of less than 150 kW, co-located energy storage (power and thermal) facilities as well as their grid connection, located in renewables go-to areas shall not exceed sixthree months. Where duly justified on the ground of extraordinary circumstances, such as on grounds of overriding safety reasons where the repowering project impacts substantially on the grid or the original capacity, size or performance of the installation, that one yearthree month period may be extended by up to three months. Member States shall clearly inform the project developer about the extraordinary circumstances that justify the extension.
2022/09/29
Committee: ITRE
Amendment 263 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 16 a – Paragraph 6
(6) In the permit-granting process of the applications referred to in paragraphs 1 and 2, the lack of reply of the relevant administrative bodies within the established deadline shall result in the specific administrative steps to be considered as approved, except in those cases where the specific project is subject to an environmental impact assessment in accordance with paragraph 5. All resulting decisions will be publicly available.deleted
2022/09/29
Committee: ITRE
Amendment 282 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 9
Directive 2018/2001
Article 16 c – Title
Article 16cPermit-granting process for the installation Accelerated deployment of solar energy equipment in artificial structures
2022/09/29
Committee: ITRE
Amendment 286 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 9
Directive 2018/2001
Article 16 c – Paragraph 1
(1) Member States shall ensure that the permit-granting process referred to in Article 16(1) for the installation of solar energy equipment, including building- integrated solar installations, in existing or future artificial structures, with the exclusion of artificial water surfaces, shall not exceed three months, provided that the primary aim of such structures is not solar energy production. By derogation from Article 4(2) of Directive 2011/92/EU andAnnex II, points 3(a) and (b), alone or in conjunction with point 13(a) to that Directive, such inFor rooftop solar installations below 50 kW, Member States shall ensure simplified authorisation procedures are in place. Requirements for construction permits will be removed in case staillation of solar equipment shall be exempted from the requirement, if applicable, to carry out a dedicated environmental impact assessment under Article 2(1) of Directive 2011/92/EU in place. Member States shall also establish a roadmap to remove other barriers and to enhance the accelerated deployment of solar energy.
2022/09/29
Committee: ITRE
Amendment 288 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 9
Directive 2018/2001
Article 16 c – Paragraph 1a (new)
(1 a) Member States shall ensure that the installation of building-integrated solar is exempted from environmental impact assessment under article 2(1) of Directive 2011/92/EU and from building permitting.
2022/09/29
Committee: ITRE
Amendment 289 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 9 a (new)
Directive 2018/2001
Article 16 c a
(9 a) The following article 16ca is inserted: Article 16ca Accelerated deployment of heat pumps 1.In order to implement REPowerEU [COM(2022) 108], this Directive requires the roll out of at least [60] million new heat pumps, including [30] million hydronic heat pumps, by 2030 to reduce decisively the use of gas in the heating sector. 2.The deployment should be coupled whenever possible with smart energy system management and thermal storage, in order to lower peak electricity demand and to support energy system integration and overall system efficiency. 3.The deployment shall be made according to a binding national distribution key based on an assessment of: (i) the heat-pump potential broken down per Member States, (ii) the EU-wide analysis of individual heating systems that have reached or are close to reaching their technical lifetime.This analysis should be closely linked to the heat maps foreseen in Article 23 of COM(2021) 558 final on Energy Efficiency Directive, (iii) the local heating and cooling potential assessed according to Article 23 of COM(2021) 558 final on Energy Efficiency Directive; (iv) go-to areas and, when available renewable areas, as identified by the Member States according to articles 15b and 15c. The Commission shall accompany the deployment with concrete policies and measures to accelerate the roll-out of and heat pumps, such as: (i) measures to overcome any administrative and regulatory barriers, in particular to facilitate deployment in multi-occupancy buildings, (ii) measures to reduce the financial risks associated with the roll out of renewable heating systems, especially heat pumps, taking account of the variety and special needs of different target groups, including renewable self-consumers, vulnerable groups, jointly acting renewables self- consumers, renewable energy communities, SMEs and municipalities, (iii) a dedicated funding programme as well as channelling of existing funds to targeted emerging EU markets, (iv) measures to ensure the fast development of the required value chains skills, by mobilising universities, training bodies and job platforms. 4. Member States shall describe their policies and measures promoting the roll out of heat pumps in their integrated national energy and climate plans referred to in Articles 3 and 14 of Regulation (EU)2018/1999 and progress reports submitted pursuant to Article 17 of that Regulation.
2022/09/29
Committee: ITRE
Amendment 291 #

2022/0160(COD)

Proposal for a directive
Article 1 – paragraph 1 – point 10
Directive 2018/2001
Article 16 d
(10) The following Article 16d is inserted: ‘Article 16dOverriding public interest By [three months from entry into force], until climate neutrality is achieved, Member States shall ensure that, in the permit-granting process, the planning, construction and operation of plants for the production of energy from renewable sources, their connection to the grid and the related grid itself and storage assets are presumed as being in the overriding public interest and serving public health and safety when balancing legal interests in the individual cases for the purposes of Articles 6(4) and 16(1)(c) of Directive 92/43/EEC, Article 4(7) of Directive 2000/60/EC and Article 9(1)(a) of Directive 2009/147/EC.’deleted
2022/09/29
Committee: ITRE
Amendment 88 #

2022/0140(COD)

(53) For requests to access electronic health data from a single data holder in a single Member State and in order to alieviate the administrative burden for heath data access bodies of managing such request, the data user should be able to request this data directly from the data holder and the data holder should be able to issue a data permit while complying with all the requirements and safeguards linked to such request and permit. Multi- country requests and requests requiring combination of datasets from several data holders should always be channelled through health data access bodies. The data holder should report to the health data access bodies about any data permits or data requests they provide.deleted
2023/03/10
Committee: ITRE
Amendment 106 #

2022/0140(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concerning health and anonymised genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
2023/03/10
Committee: ITRE
Amendment 108 #

2022/0140(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point f
(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals using commonly accepted open standards and open data formats, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;
2023/03/10
Committee: ITRE
Amendment 109 #

2022/0140(COD)

(g) ‘European electronic health record exchange format’ means a structured, commonly used, open standard and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers;
2023/03/10
Committee: ITRE
Amendment 112 #

2022/0140(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point q – point i
(i) the death of a natural person or serious damage to a natural person’s health or rights;
2023/03/10
Committee: ITRE
Amendment 113 #

2022/0140(COD)

Proposal for a regulation
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, 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;deleted
2023/03/10
Committee: ITRE
Amendment 116 #

2022/0140(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point z
(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;
2023/03/10
Committee: ITRE
Amendment 118 #

2022/0140(COD)

Proposal for a regulation
Article 2 – paragraph 2 – point ad
(ad) ‘data quality’ means the degree to which characteristics of electronic health data are suitable for secondary use;
2023/03/10
Committee: ITRE
Amendment 133 #

2022/0140(COD)

Proposal for a regulation
Article 6 – paragraph 1 – introductory part
1. The Commission shall, by means of implementing acts, lay down the open technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format. The format shall include the following elements:
2023/03/10
Committee: ITRE
Amendment 137 #

2022/0140(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The Commission shall, by means of implementingdelegated acts, determine the requirements for the interoperable, cross- border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the secure transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
2023/03/10
Committee: ITRE
Amendment 138 #

2022/0140(COD)

Proposal for a regulation
Article 9 – paragraph 3
3. The Commission and the Member States shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).
2023/03/10
Committee: ITRE
Amendment 140 #

2022/0140(COD)

Proposal for a regulation
Article 9 – paragraph 4
4. The digital health authoritiMember States and the Commission shall implementdevelop a the cross- border identification and authentication mechanism at Union and Member States’ level, respectively, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final].
2023/03/10
Committee: ITRE
Amendment 145 #

2022/0140(COD)

Proposal for a regulation
Article 31 – paragraph 2 – point b
(b) reference to open common specifications to demonstrate compliance;
2023/03/10
Committee: ITRE
Amendment 150 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 1 – introductory part
1. Data holders shall make the following categories of electronic data available for secondary use upon request and only with consent from the data subject in the case of personal data, in accordance with the provisions of this Chapter:
2023/03/10
Committee: ITRE
Amendment 156 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 1 – point e
(e) anonymised human genetic, genomic and proteomic data;
2023/03/10
Committee: ITRE
Amendment 158 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 1 – point f
(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;
2023/03/10
Committee: ITRE
Amendment 166 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 1 – point n
(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;deleted
2023/03/10
Committee: ITRE
Amendment 175 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 3 a (new)
3a. When electronic health data is made available for secondary use through health data bodies, the beneficiary shall respect the principle of open science, and provide open access to research or processing results, following the principle “as open as possible, as closed as necessary”, in full respect of this regulation and other applicable laws. Derogations from the open access requirements, and open access practices should be closely monitored by the Commission and any exemption should be public.
2023/03/10
Committee: ITRE
Amendment 183 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 5
5. Where the consent of the natural person is required by national or Union law, health data access bodies shall rely on the obligations laid down in the respective legislation and this Chapter to provide access to electronic health data ensuring the primacy of the individual fundamental rights.
2023/03/10
Committee: ITRE
Amendment 188 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 7
7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.
2023/03/10
Committee: ITRE
Amendment 193 #

2022/0140(COD)

Proposal for a regulation
Article 33 – paragraph 8
8. Health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law or based on voluntary cooperation with the relevant data holders at national level, in particular to electronic health data held by private entities in the health sector and in accordance with the relevant security and privacy provisions.
2023/03/10
Committee: ITRE
Amendment 202 #

2022/0140(COD)

Proposal for a regulation
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services demonstrably contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
2023/03/10
Committee: ITRE
Amendment 206 #

2022/0140(COD)

Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Seeking or gaining access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 or made available according to this legislation for the following purposes shall be prohibited and subject to penalties :
2023/03/10
Committee: ITRE
Amendment 209 #

2022/0140(COD)

Proposal for a regulation
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
2023/03/10
Committee: ITRE
Amendment 210 #

2022/0140(COD)

Proposal for a regulation
Article 35 – paragraph 1 – point e
(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco products, or goods or services which are designed or modified in such a way that they contravene public order or morality or result in behavioural changes that reduce the freedom of choice or security of the natural persons.
2023/03/10
Committee: ITRE
Amendment 284 #

2022/0140(COD)

Proposal for a regulation
Article 46 – paragraph 1
1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the health data access body shallmay issue a data permit.
2023/03/10
Committee: ITRE
Amendment 286 #

2022/0140(COD)

Proposal for a regulation
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
2023/03/10
Committee: ITRE
Amendment 301 #

2022/0140(COD)

Proposal for a regulation
Article 48 – paragraph 1
By derogation from Article 46 of this Regulation, a data permit shall not be required toin the case of justified requests for access to the electronic health data under this Article by public sector bodies and Union institutions, bodies, offices and agencies that carry relevant activities under this Regulation. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe that cannot be longer than 2 additional months.
2023/03/10
Committee: ITRE
Amendment 304 #

2022/0140(COD)

Proposal for a regulation
Article 49
Access to electronic health data from a 1. access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shall be adressed to health data access bodies. 2. issue a data permit in accordance with Article 46 or provide an answer to a data request in accordance with Article 47. The data holder shall then provide access to the electronic health data in a secure processing environment in compliance with Article 50 and may charge fees in accordance with Article 42. 3. 51, the single data provider and the data user shall be deemed joint controllers. 4. shall inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this Article in order to enable the health data access body to fulfil its obligations under Article 37(1) and Article 39.rticle 49 deleted single data holder Where an applicant requests In such case, the data holder may By way of derogation from Article Within 3 months the data holder
2023/03/10
Committee: ITRE
Amendment 316 #

2022/0140(COD)

Proposal for a regulation
Article 61 – paragraph 1
1. Non-personal electronic data made 1. 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.
2023/03/10
Committee: ITRE
Amendment 321 #

2022/0140(COD)

Proposal for a regulation
Article 61 – paragraph 2
2. TheAdditional protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
2023/03/10
Committee: ITRE
Amendment 337 #

2022/0140(COD)

Proposal for a regulation
Article 69 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation, for all public and private stakeholders in particular for the non- respect of data access and usage provisions with intent or by negligence, and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.
2023/03/10
Committee: ITRE
Amendment 340 #

2022/0140(COD)

Proposal for a regulation
Annex II – point 2 – point 2.3
2.3. An EHR system that includes a functionality for entering structured personal electronic health data shall enable the entry of data structured in a structured way that supports the data sharing in a structured, commonly used, open and machine- readable format, enabling system to system communication.
2023/03/10
Committee: ITRE
Amendment 341 #

2022/0140(COD)

2.4. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised access, personal electronic health data sharing, or use of personal electronic health data for permitted purposes, in particular on the basis of commercial considerations and beyond security and legal safeguards requirements. .
2023/03/10
Committee: ITRE
Amendment 10 #

2021/2184(INI)

Motion for a resolution
Citation 15 a (new)
— having regard to the Paris Agreement as well as the Glasgow Climate Pact adopted under the United Nations Framework Convention on Climate Change,
2022/02/17
Committee: ECON
Amendment 23 #

2021/2184(INI)

Motion for a resolution
Recital A
A. whereas the bBanking uUnion (BU) currently consists of the Single Supervisory Mechanism (SSM) and the Single Resolution Mechanism (SRMremains incomplete as long as it lacks a European Deposit Insurance Scheme (EDIS);
2022/02/17
Committee: ECON
Amendment 53 #

2021/2184(INI)

Motion for a resolution
Recital C a (new)
C a. whereas the need remains to limit the damage due to failures within the current structure of the banking system, structural reforms aimed at reducing a priori the systemic risks due to interconnections and complexity, underpinning the 'too big to fail problem', would be much more effective;
2022/02/17
Committee: ECON
Amendment 65 #

2021/2184(INI)

Motion for a resolution
Recital E
E. whereas the role of the banking sector is crucial to the recovery and transition to a low-carbon economyneutral economy, in line with the objectives of the Paris Agreement and the European Green Deal;
2022/02/17
Committee: ECON
Amendment 87 #

2021/2184(INI)

Motion for a resolution
Recital G
G. whereas there is a need for effectiveprudential and anti-money laundering supervision is necessary and should be further strengthened;
2022/02/17
Committee: ECON
Amendment 99 #

2021/2184(INI)

Motion for a resolution
Recital I a (new)
I a. whereas the sovereign-bank doom loop has not been properly addressed yet
2022/02/17
Committee: ECON
Amendment 117 #

2021/2184(INI)

Motion for a resolution
Paragraph 2
2. Considers that the BU should be built in a friendly and attractive way, including fora complete and deeply integrated Banking Union would benefit all members of the Banking Union, while incentivising the accession of Member States outside the euro area;
2022/02/17
Committee: ECON
Amendment 132 #

2021/2184(INI)

Motion for a resolution
Paragraph 3 a (new)
3 a. Welcomes the ECB’s quick and substantial monetary policy response to the COVID-19 crisis, in a context of emergency; acknowledges the positive impact of this response on the economic situation of the euro area; welcomes the intention of the ECB to retain its support as long as it deems necessary to meet its mandate;
2022/02/17
Committee: ECON
Amendment 134 #

2021/2184(INI)

Motion for a resolution
Paragraph 3 b (new)
3 b. Regrets the fact that as long as fossil fuel companies benefit from very favourable financing conditions, the ECB targeted long-term refinancing operations are actively creating an implicit subsidy for the companies engaging in the most climate damaging activities;
2022/02/17
Committee: ECON
Amendment 142 #

2021/2184(INI)

Motion for a resolution
Paragraph 4
4. Recalls the key role of the EU banking sector in financing the recovery, resilience, and twin transition of the European economy;
2022/02/17
Committee: ECON
Amendment 155 #

2021/2184(INI)

Motion for a resolution
Paragraph 5
5. Notes that the EBA, the ECB and the SRB still see many problems in the banking system, such as high stocks of non-performing loans (NPLs), exposures to sectors which are sensitive to the COVID- 19 crisis, deficiencies in risk management, and discrepancies in the implementation of International Financial Reporting Standard 9 (IFRS 9); underlines with concern that these problems are likely to increase after the withdrawal of the emergency measures, such as payment moratoria and public guarantee schemes;
2022/02/17
Committee: ECON
Amendment 169 #

2021/2184(INI)

Motion for a resolution
Paragraph 6
6. Supports ongoing work on the implementation of the Basel III rules; stresses that the CRR and CRD review should fully reflect Basel III standards; emphasises that any consideration of EU banks' specificities shall be very limited and should not water down the new requirements on output floor, credit and operational risk; calls for the reflection of banks exposures to stranded assets in the capital requirements;
2022/02/17
Committee: ECON
Amendment 192 #

2021/2184(INI)

Motion for a resolution
Paragraph 8 a (new)
8 a. Regrets the failure to ensure full gender balance in EU financial institutions and bodies; reiterates the Parliament’s commitment not to take into account lists of candidates where the gender balance principle has not been respected; calls on the Commission, in view of the upcoming appointment of the new Chair of the Single Resolution Board, to submit a gender-balanced shortlist of candidates;
2022/02/17
Committee: ECON
Amendment 227 #

2021/2184(INI)

Motion for a resolution
Paragraph 11 a (new)
11 a. Is concerned about the excessive search for yield, which feeds the increasing appetite for leverage, complexity and opaqueness in financial markets; calls on banking supervision to closely monitor and tackle such risks;
2022/02/17
Committee: ECON
Amendment 229 #

2021/2184(INI)

Motion for a resolution
Paragraph 11 b (new)
11 b. Stresses that the temporary ban to dividend distributions was instrumental to safeguard banks’ capacity to absorb losses and lend to support the economy during the peak of the pandemic crisis; is concerned that the reintroduction of dividend distributions in September 2021 has been premature at a time where supervisors have little information on the actual level of credit risk because of the effect of the temporary relief measures; stresses that banks are still being financed in extremely favourable conditions because they finance the real economy and not for their own profit; calls on the Commission to look into the introduction of a legally binding dividend and buy- back ban as a supervisory tool during times of crisis in the context of the CRR;
2022/02/17
Committee: ECON
Amendment 233 #

2021/2184(INI)

Motion for a resolution
Paragraph 12
12. Notes that the transition to a low- carbon economy presents new challenges and risks related to the preference for sustainable investments; stresses the need for an in-depth analysis of the economic efficiency of sustainable investments in order to avoid a future bubble of green assets; calls for clear guidelines for banks based on economic data;deleted
2022/02/17
Committee: ECON
Amendment 245 #

2021/2184(INI)

Motion for a resolution
Paragraph 12 a (new)
12 a. Stresses the crucial role of the banking sector in channelling funding into sustainable investments and enabling the transition to a climate-neutral economy; underlines the importance of the Taxonomy Regulation for such an endeavour in that its implementation is consistent with the objectives of the Paris agreement and the European Green Deal; calls for the development of a social taxonomy that would spell out what constitutes a social investment, as has been done in the case of environmental investments;
2022/02/17
Committee: ECON
Amendment 247 #

2021/2184(INI)

Motion for a resolution
Paragraph 12 b (new)
12 b. Calls for the integration of climate and ecological risk in capital requirements; warns that financial institutions feed a vicious circle, aggravating climate change by financing fossil fuel related activities despite the recognition that climate change poses a major threat to financial stability; notes in this respect that companies with high exposures to fossil fuels frequently have high external credit ratings, even though they have significant exposures on their balance sheets that risk becoming stranded assets; calls, therefore, for the integration of climate risks in banks capital requirements by introducing a risk-based re-evaluation of the risk-weights attributed to fossil fuel exposures under the Capital Requirements Regulation that should differentiate between existing and new fossil fuels exposures;
2022/02/17
Committee: ECON
Amendment 249 #

2021/2184(INI)

Motion for a resolution
Paragraph 12 c (new)
12 c. Welcomes the Commission’s proposal for a Green Bond Standards (GBS) in that it requires that issuers must allocate 100% of the funds raised by their bond to economic activities that meet the EU Taxonomy requirements; stresses that the development of a uniform framework will significantly facilitate the ability to raise large-scale financing that will encourage economic activity contributing to the achievement of the European Green Deal; notes, however, that currently none of the bond instruments marketed as environmentally sustainable, totalling more than EUR 700 billion, provide any standardised information on the alignment of the use-of-proceeds with the EU taxonomy; calls therefore, for the transformation of the EU-GBS into a mandatory standard three years after the entry into force of the Regulation in line with the TEG recommendations;
2022/02/17
Committee: ECON
Amendment 250 #

2021/2184(INI)

Motion for a resolution
Paragraph 12 d (new)
12 d. Notes that 82% of the European debt-capital market provides no information on the instruments’ alignment with European environmental and climate policy goals; considers additional requirements indispensable for ensuring a level playing field in bond markets; is of the opinion that all types of bond instruments, not only those labelled as green, shall disclose their level of alignment with the EU Taxonomy;
2022/02/17
Committee: ECON
Amendment 251 #

2021/2184(INI)

Motion for a resolution
Paragraph 12 e (new)
12 e. Welcomes the revision of the Corporate Sustainability Reporting Directive as way to ensure consistency, comparability and reliability of sustainability information across the financial and non-financial sector; supports the extension of reporting standards to SMEs which constitutes an opportunity for such financial and non financial undertakings to demonstrate their commitment to the ecological and social sustainability and thereby ensure investor protection and feed into their competitive advantage;
2022/02/17
Committee: ECON
Amendment 252 #

2021/2184(INI)

Motion for a resolution
Paragraph 12 f (new)
12 f. Regrets that credit rating agencies do not properly and systematically include ESG risks in their rating methodologies; considers the lack of adequate integration of environmental and transition risks in credit rating models a significant methodological flaw; calls on the ESMA to make full use of its supervisory powers to ensure that credit rating agencies’ models properly account for all ESG risks;
2022/02/17
Committee: ECON
Amendment 258 #

2021/2184(INI)

Motion for a resolution
Paragraph 14
14. Draws attention to the dangers of a very loose monetary policy stimulating inflation; points out the need for the gradual tightening of monetary policy;deleted
2022/02/17
Committee: ECON
Amendment 284 #

2021/2184(INI)

Motion for a resolution
Paragraph 16
16. Notes the problems and challenges related to home/host issues; points out that greater market integration requires credible safeguards in EU law for host Member Statesconsiders that the home/host tension will not be allayed until the European risk sharing architecture has been completed and sees the establishment of a fully-fledged EDIS as an integral part of the solution; further calls for a better inclusion of 'local risk' into the group’s requirements that would reduce the need to 'ring-fence', a review of the SRM governance to accommodate voting modalities with a more direct involvement of both host and home authorities, and harmonisation of insolvency law to facilitate resolution- planning for cross-border banking groups within the Banking Union;
2022/02/17
Committee: ECON
Amendment 299 #

2021/2184(INI)

Motion for a resolution
Paragraph 17
17. Stresses the need for effective anti- money laundering supervision; notwelcomes the Commission’s adoption of the anti- money laundering (AML) package of proposals, in particular the establishment of an EU Anti-Money Laundering authority and the transfer of parts of the AML Directive into a Regulation;
2022/02/17
Committee: ECON
Amendment 301 #

2021/2184(INI)

Motion for a resolution
Paragraph 17 a (new)
17 a. Regrets that not all Member States have yet fully transposed the Anti-Money Laundering Directive V and even more Member States have serious shortcomings in their effective implementation; calls for the Commission to ensure that all existing anti-money laundering rules are applied and to open infringement cases in those Member States where those rules are not effectively implemented; stresses the need for better coordination of law enforcement across Europe and calls for the establishment of a European Criminal Office as the next step in the fight against organised crime and money laundering;
2022/02/17
Committee: ECON
Amendment 305 #

2021/2184(INI)

Motion for a resolution
Paragraph 17 b (new)
17 b. Stresses that any accession of new Member States to the euro area should be conditional to the presence of a robust and effective anti-money laundering framework in the country concerned;
2022/02/17
Committee: ECON
Amendment 306 #

2021/2184(INI)

Motion for a resolution
Paragraph 17 c (new)
17 c. Deplores the fact that the requirements for the fit and proper assessments of members of the management body of credits institutions are implemented non-uniformly across Member States; therefore calls for further harmonisation in this area; insists that fit and proper assessments by the competent authorities must always be conducted ex- ante and not ex-post;
2022/02/17
Committee: ECON
Amendment 326 #

2021/2184(INI)

Motion for a resolution
Paragraph 20