report parliamentary committee draft, 17 December 2025
On the proposal for a regulation of the European Parliament and of the Council on the European Chemicals Agency and amending Regulations (EC) No 1907/2006, (EU) No 528/2012, (EU) No 649/2012 and (EU) 2019/1021
Document ENVI-PR-781186 · (COM(2025)0386 – C100141/2025 – 2025/0207(COD))
Committee on the Environment, Climate and Food Safety · Rapporteur: Christophe Clergeau
AI:In short
The draft report amends the proposed regulation on the European Chemicals Agency (ECHA), reinforcing its core mission to protect human health and the environment, integrating new tasks from the One Substance One Assessment package, and strengthening governance and cooperation with other EU agencies. It proposes that ECHA conduct regular assessments of its financial and human resources, be able to second staff to member state authorities, and establishes a permanent cross-agency task force with EFSA, EMA, ECDC and EEA to advance the One Health and exposome approach.
Position. The rapporteur proposes to amend the Commission's proposal to reinforce ECHA's mission of protecting health and the environment, integrate new tasks from the OSOA package, strengthen resource governance, and make cross-agency cooperation permanent.
Key points
- The Agency's objectives are refocused on ensuring a high level of protection of human health and the environment, including vulnerable groups, and on the precautionary principle.
- The Agency's tasks are expanded to include monitoring emerging chemical risks, generating data on chemicals, and fostering expertise in non-animal approaches through annual training.
- The European Parliament or a Member State may request scientific opinions from the Agency on matters within its competence.
- The Agency may second its staff to member state authorities or public bodies to reinforce capacity, and may assist member states in identifying candidates for committee membership.
- A Forum of accredited stakeholders is established to structure relations with stakeholders and allow them to contribute to the Agency's tasks.
- The Agency promotes networking of competent organisations designated by member states, which may assist with preparatory work for scientific opinions, data collection and emerging risk identification.
- A permanent task force with ECHA, EFSA, EMA, ECDC and EEA is established to advance the One Health and exposome approach, with rotating coordination and annual frameworks for action.
- Rules on access to documents are strengthened: Regulation (EC) No 1049/2001 applies to Agency documents, and the Management Board must adopt implementing arrangements.
- Members of the Management Board, committees and the Forum, and experts must report attempts of pressure or undue influence to the Executive Director.
- The Commission's role in adopting rules of procedure for committees is reduced from approval to consultation, and the Management Board's voting majority is clarified as two-thirds.
- The Agency must publish an annual report on knowledge and data gaps in regulatory science, and contribute to research on exposomics.
Who is affected
- The European Chemicals Agency (ECHA) and its committees, with expanded tasks and new governance requirements.
- Member state competent authorities, which may receive seconded Agency staff and assistance in identifying committee candidates.
- Stakeholders and civil society, who gain a formal Forum and public access to Agency documents.
- EU agencies EFSA, EMA, ECDC and EEA, which must cooperate in a permanent task force with ECHA.
Figures and deadlines
- The task force shall meet at least six times a year, with at least one annual physical meeting.
- The Agency shall coordinate the task force for 12 months after establishment, with coordination rotating every 12 months thereafter.
Legal basis. Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union
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Draft european parliament legislative resolution 667 paragraphs
(COM(2025)0386 – C100141/2025 – 2025/0207(COD))
(Ordinary legislative procedure: first reading)
The European Parliament,
–having regard to the Commission proposal to Parliament and the Council (COM(2025)0386),
–having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C100141/2025),
–having regard to Article 294(3) of the Treaty on the Functioning of the European Union,
–having regard to the opinion of the European Economic and Social Committee of 23 October 2025,
–having regard to Rules 60 and 58 of its Rules of Procedure,
–having regard to the budgetary assessment by the Committee on Budgets,
–having regard to the report of the Committee on the Environment, Climate and Food Safety (A100000/2025),
1.Adopts its position at first reading hereinafter set out;
2.Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;
Read the rest (655 paragraphs)
3.Instructs its President to forward its position to the Council, the Commission and the national parliaments.
Amendment 1
Proposal for a regulation
Recital 9
| Text proposed by the Commission | Amendment |
|---|---|
| (9) The Agency should continue to contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks and safe use of chemical substances in order to achieve a high level of protection of human health and the environment, the efficient functioning of the internal market and coherence and consistency in chemicals management across the Union, while enhancing competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises and promoting alternatives to animal testing. | (9) The Agency should continue to contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use, and environmental sustainability of chemical substances, mixtures and articles in order to achieve a high level of protection of human health and the environment, including the protection of vulnerable groups, the efficient functioning of the internal market and coherence and consistency in chemicals management across the Union, while enhancing competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises and promoting alternatives to non-animal approaches. By achieving its objectives and tasks, the Agency will contribute to the full implementation of the objectives of the Treaties and, in particular, pursuant to Article 191(2) TFEU, that environmental policy is to be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. |
Or. en
Justification
This wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)
Amendment 2
Proposal for a regulation
Recital 10 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) To reinforce the capacity and contribute to the work of the competent authorities of Member States, the Agency should be able to second officials and other servants in its employment, in the interest of the service and in accordance with Article 37 of Regulation No 31(EEC), 11 (EAEC)1a, to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate, for example to help Member States meet their obligations to appoint committee members and thus ensure that the Agency has the number of committee members and experts it needs to do its work properly. | |
| 1a Regulation No 31 (EEC), 11 (EAEC), laying down the Staff Regulations of Officials and the Conditions of Employment of Other Servants of the European Economic Community and the European Atomic Energy Community (OJ P 045 14.6.1962, p. 1385, ELI: http://data.europa.eu/eli/reg/1962/31(1)/oj). |
Or. en
Justification
To perform its tasks and mission the Agency relies heavily on financial and human resources in the Member States in particular for scientific experts. Some Member States may have less resources or competences in the field of chemicals. Where appropriate, the Agency should be able to use to possibility offered by Article 37 of the Staff Regulation to contribute to the capacity building of the expertise of those Member States for example to help them meet their obligations to appoint committee members and thus ensure that the agency has the number of committee members and experts it needs to do its work properly.
Amendment 3
Proposal for a regulation
Recital 11
| Text proposed by the Commission | Amendment |
|---|---|
| (11) The structure of the Agency should be suitable for its tasks and should take into account the experience gained from the Agency’s functioning and performance since its establishment. It is essential to ensure that the Agency is equipped to perform its tasks with high scientific and technical capacities to ensure the highest possible quality. As trust in the Agency by the Union institutions, the Member States, the general public and interested parties is vital, it should carry out its tasks transparently and efficiently. | (11) The structure of the Agency should be suitable for its tasks and should take into account the experience gained from the Agency’s functioning and performance since its establishment. It is essential to ensure that the Agency is equipped to perform its tasks with high scientific and technical capacities to ensure the highest possible quality. |
Or. en
Justification
Moved to a new recital.
Amendment 4
Proposal for a regulation
Recital 11 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) The Agency should be central to ensuring that chemicals legislation and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the general public. The Agency should also play a pivotal role in coordinating communication around chemicals legislation and its implementation. Trust in the Agency by the Union institutions, the Member States, the general public and interested parties is therefore essential. For that reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities, as well as transparency and efficiency. |
Or. en
Justification
Considering the crucial nature of transparency and efficiency for the Agency, this deserves a separated recital. This recital is based on recital 95 of REACH with modification to give it a more horizontal meaning.
Amendment 5
Proposal for a regulation
Recital 15 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (15a) The Agency's role as an independent scientific point of reference means that a scientific opinion can be requested not only by the Commission, but also by the European Parliament and the Member States. In order to ensure the manageability and consistency of the process of scientific advice, the Agency should be able to refuse or amend a request providing justification for that refusal or amendment and on the basis of predetermined criteria. |
Or. en
Justification
This is a possibility that is given to the European Parliament or a Member State for EFSA in the General Food Law. This should be mirrored in the ECHA Basic Regulation.
Amendment 6
Proposal for a regulation
Recital 18
| Text proposed by the Commission | Amendment |
|---|---|
| (18) The Management Board should adopt the rules of procedure of RAC, SEAC, MSC, BPC and SCCS, including the procedural arrangements for the Committees working groups. In order for the Commission to exercise its oversight, the Commission representatives in the Management Board should approve the rules of procedure, without compromising the independence of the Committees and their working groups. | (18) The Management Board should adopt the rules of procedure of RAC, SEAC, MSC, BPC and SCCS, including the procedural arrangements for the Committees working groups. In order for the Commission to exercise its oversight, the Commission representatives in the Management Board should be consulted by the Executive Director when preparing the rules of procedure of the RAC, SEAC and SCCS, without compromising the independence of the Committees and their working groups. |
Or. en
Amendment 7
Proposal for a regulation
Recital 19
| Text proposed by the Commission | Amendment |
|---|---|
| (19) The opinions of RAC and SEAC should be based on the broadest possible scientific and technical expertise available within the Union. To this end, each Member State should nominate two members for RAC and SEAC respectively and should be entitled to nominate up to two additional members. RAC, SEAC, BPC and SCCS should have the possibility to co-opt members and to rely on the services of experts, taking into account the workload, type of expertise needed and availability of financial resources. | (19) The opinions of RAC and SEAC should be based on the broadest possible scientific and technical expertise available within the Union. To this end, each Member State should nominate two members for RAC and SEAC respectively and should be entitled to nominate up to two additional members. RAC, SEAC, BPC and SCCS should have the possibility to co-opt members and to rely on the services of experts, taking into account the workload, type of expertise needed and availability of financial resources. Committee members should reflect the expertise required for the proper fulfilment of the tasks allocated to the Agency. The Agency should be able to assist Member States in identifying relevant profiles for membership of the RAC, SEAC and BPC, where Member States so request. |
Or. en
Amendment 8
Proposal for a regulation
Recital 21 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (21a) The Agency should set up a Forum for accreditedstakeholders which should aim to structure and reinforce the relationship with all stakeholders, and allow the members of that forum to contribute to the tasks of the Agency. |
Or. en
Justification
ECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.
Amendment 9
Proposal for a regulation
Recital 21 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (21b) In order to enhance scientific cooperation and support the Agency’s work, it is necessary to promote the networking of organisations operating in areas of competence of the Agency’s mandate. This networking aims to foster the exchange of information, coordination of activities, and the development of joint projects, as well as the sharing of expertise and best practices. To achieve this, a list of competent organisations designated by the Member States should be drawn up, enabling these organisations to assist the Agency with tasks such as preparatory work for scientific opinions, data collection, and the identification of emerging risks. The Commission is empowered to adopt delegated acts to establish the criteria for the inclusion of organisations on this list, the quality requirements, and the financial rules governing any financial support that may be provided. |
Or. en
Amendment 10
Proposal for a regulation
Recital 23 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (23a) Additional workload arising from an increase in tasks and responsibilities allocated to the Agency should be accompanied by the allocation of appropriate funding for staff and other necessary costs. As part of the draft single programming document, the Management Board should conduct an assessment of the adequacy of its financial and human resources to carry out its current and upcoming tasks. |
Or. en
Amendment 11
Proposal for a regulation
Recital 31
| Text proposed by the Commission | Amendment |
|---|---|
| (31) The Agency should continue to play an active role in research and innovation, assisting Member States and the Commission in the promotion of substitution of the most harmful chemicals and in the development of scientific methods, notably animal-free approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. | (31) The Agency should continue to play an active role in research and innovation, assisting Member States and the Commission in the promotion of substitution of the most harmful and other hazardous chemicals and in the development of scientific methods, notably non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. In particular, the Agency should assist and contribute to the research on the links between exposure to hazardous chemicals and negative impacts on health in the field of exposomics, the integrated compilation of all the physical, chemical, biological and psychosocial factors, and their interactions, which have an impact on biology and health. |
Or. en
Justification
Substitution effort should not be limited to the most harmful substances. This amendment also outlines research on exposome as one of the key priorities to which the Agency should contribute.
Amendment 12
Proposal for a regulation
Recital 31 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (31a) Strengthened collaboration between Union agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to Union research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between the Agency, the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency (EEA), established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five Union agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As that initiative is to end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome. The Agencies composing the task force should outline a common vision and objectives for that task force, working toward a more permanent and established form of transdisciplinary cooperation between the Union agencies. They should be able to plan coordinated actions and to broaden the scope of their cooperation through annual action plans. |
Or. en
Amendment 13
Proposal for a regulation
Article 4 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Agency shall contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks and safe use of chemical substances, mixtures and articles, provide scientific opinions and advice and independent information on all matters within that field and communicate on those matters. | 1. The Agency shall contribute to the implementation and enforcement of Union legislation and policies related to the hazards, risks, safe use, and environmental sustainability of chemical substances, mixtures and articles, provide scientific opinions and advice and independent information on all matters within that field, monitor emerging chemical risks and generate data on chemicals, and communicate on those matters. |
Or. en
Justification
The 'One Substance One Assessment' package tasks ECHA to collect data on the environmental sustainability of chemicals (Article 13 of the Common Data Platform on Chemicals), this needs to be reflected in the objectives and tasks of the Agency.
Amendment 14
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| In the fulfilment of its objectives, the Agency shall aim to contribute to a high level of protection of human health and the environment, to the free circulation of substances in the internal market and coherence and consistency in chemicals assessment and management across the Union, while enhancing competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises (‘SMEs’) as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises26 and promoting alternatives to animal testing. | In the fulfilment of its objectives, the Agency shall aim to contribute to ensuring a high level of protection of human health and the environment, including the protection of vulnerable groups. The Agency shall aim to deliver quality, coherence and consistency in chemicals assessment and management across the Union which is key to ensure the free circulation of substances in the internal market, while contributing to enhancing the competitiveness and innovation, taking into account the specific needs of small and medium-sized enterprises (‘SMEs’) as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises26 and promoting the development and use of non-animal approaches. |
| 26 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj) | 26 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36, ELI: http://data.europa.eu/eli/reco/2003/361/oj) |
Or. en
Justification
The first and foremost objective of the agency should remain the ensuring a high level of protection of health and the environment. A particular attention should be given to vulnerable groups in alignment with the text adopted in the OSOA Package (Proposal on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals). It is also key to base the objectives of this Regulation in alignment with the general principles of the Treaties regarding protection of health and the environment.
Amendment 15
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| As a body based on scientific and technical expertise, the Agency shall also contribute to ensuring that Union policy on chemicals is based on the principles enshrined in Article 191(2) TFEU. |
Or. en
Justification
The first and foremost objective of the agency should remain the ensuring a high level of protection of health and the environment. A particular attention should be given to vulnerable groups in alignment with the text adopted in the OSOA Package (Proposal on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals). It is also key to base the objectives of this Regulation in alignment with the general principles of the Treaties regarding protection of health and the environment.
Amendment 16
Proposal for a regulation
Article 4 – paragraph 5 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) provide technical and scientific support, guidance, IT tools and digital infrastructure for the development, implementation and enforcement of this Regulation and sectoral Union legislation taking into account the specific needs of SMEs and the goal of replacing animal testing with alternatives where scientifically possible; | (b) provide technical and scientific support, guidance, IT tools and digital infrastructure for the development, implementation and enforcement of this Regulation and sectoral Union legislation taking into account the objectives of ensuring a high level of protection of health and the environment, the specific needs of SMEs and the goal of replacing animal testing with non-animal approaches where scientifically possible; |
Or. en
Justification
Protection of health and the environment should remain the principal compass of the Agency, together with contributing to the competitiveness of the industry and replacing animal testing.
Amendment 17
Proposal for a regulation
Article 4 – paragraph 5 – point g a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ga) ensure that conflicts of interest are prevented or managed, so as to ensure its independence and credibility with stakeholders and the general public; |
Or. en
Justification
The role of the Agency as a point of reference must also go hand in hand with strong rules regarding the prevention of conflict of interests.
Amendment 18
Proposal for a regulation
Article 4 – paragraph 5 – point k a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ka) foster expertise in non-animal approaches through annual training for staff and committee members, and share knowledge with all stakeholders. |
Or. en
Justification
Tasks and objectives of the Agency should reflect the objectives of the Chemicals Strategy for Sustainability to move away from animal testing.
Amendment 19
Proposal for a regulation
Article 5 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) a Committee for Risk Assessment (‘RAC’), which shall be responsible for preparing opinions of the Agency relating to risks of chemicals to human health or the environment; | (c) a Committee for Risk Assessment (‘RAC’), which shall be responsible for preparing opinions of the Agency relating to risks and hazards of chemicals to human health or the environment; |
Or. en
Justification
This Wording better reflects the tasks of RAC which is to prepare opinions of ECHA related to the risks of substances to human health and the environment but also examine the proposals for harmonised classification and labelling and give an opinion on the proposed harmonised classification of substances.
Amendment 20
Proposal for a regulation
Article 5 – paragraph 1 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) a Committee for Socio-economic Analysis (‘SEAC’), which shall be responsible for preparing opinions of the Agency relating to the socio-economic impact of possible legislative measures on substances; | (d) a Committee for Socio-economic Analysis (‘SEAC’), which shall be responsible for preparing opinions of the Agency relating to the socio-economic impact of possible legislative measures on chemicals; |
Or. en
Justification
As part of its task, SEAC is mandated to give opinion not only relating to the socio-economic impact of possible legislative measures on substances on their own, but also on substances in a mixture or in an article, the broader term 'chemicals' is meant to encompass all of these possibilities.
Amendment 21
Proposal for a regulation
Article 5 – paragraph 1 – point h a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ha) a Forum of accredited stakeholders, as established in Article 41a, which shall aim to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency; |
Or. en
Justification
ECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.
Amendment 22
Proposal for a regulation
Article 5 – paragraph 1 – point i
| Text proposed by the Commission | Amendment |
|---|---|
| (i) a Secretariat, which shall work under the leadership of the Executive Director and undertake the work required of the Agency in accordance with sectoral Union legislation, provide technical, scientific and administrative support to the Committees and the Forum, and ensure appropriate coordination between them; | (i) a Secretariat, which shall work under the leadership of the Executive Director and undertake the work required of the Agency in accordance with sectoral Union legislation, provide technical, scientific and administrative support and capacity building and training to the Committees and the Forum, and ensure appropriate coordination between them; |
Or. en
Justification
This draft report introduces several proposals in order to reinforce the capacity building and training role of ECHA, such as training staff and experts on non-animal approaches. This should therefore be reflected in the tasks of the Secretariat.
Amendment 23
Proposal for a regulation
Article 6 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
|---|---|
| (c) two experts appointed by the European Parliament. | (c) two independent persons appointed by the European Parliament. |
Or. en
Justification
Alignment with current REACH wording.
Amendment 24
Proposal for a regulation
Article 6 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The representatives of the Member States, the representatives of the Commission and experts appointed by the European Parliament shall have voting rights. The persons representing interested parties, appointed by the Commission, shall not have voting rights. | 2. The representatives of the Member States, the representatives of the Commission and independent persons appointed by the European Parliament shall have voting rights. The persons representing interested parties, appointed by the Commission, shall not have voting rights. |
Or. en
Justification
Alignment with current REACH wording.
Amendment 25
Proposal for a regulation
Article 6 – paragraph 3 – point d a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (da) occupational health and safety; |
Or. en
Justification
As this Regulation integrates the task for RAC to provide scientific opinions on evaluations of Occupational Exposure Limits (‘OELs’), and other aspects relevant to occupational exposure to hazardous chemicals such as biological limit values for hazardous chemicals, relevant expertise should be integrated in the management board.
Amendment 26
Proposal for a regulation
Article 6 – paragraph 3 – point d b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (db) non-animal approaches. |
Or. en
Justification
Tasks and objectives of the Management Board should reflect the objectives of the Chemicals Strategy for Sustainability to move away from animal testing.
Amendment 27
Proposal for a regulation
Article 6 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. All parties nominating and appointing members of the Management Board shall refrain from nominating or appointing any person as a member of the Management Board where, on the basis of an analysis, there are reasonable grounds to believe that a conflict of interest exists or may arise in relation to that person. |
Or. en
Justification
This amendment aims at strengthening the provisions to avoid conflict of interests for members of the Management Board.
Amendment 28
Proposal for a regulation
Article 6 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Members of the Management Board shall act exclusively in the interests of the Agency. | 6. Members of the Management Board shall act exclusively in the interests of the Agency and the Union. |
Or. en
Justification
Members of the management should not only act in the interests of the Agency but also in the interest of all citizens of the Union.
Amendment 29
Proposal for a regulation
Article 9 – paragraph 1 – point y
| Text proposed by the Commission | Amendment |
|---|---|
| (y) adopt the practical arrangements for complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council28 , including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request; | (y) adopt the practical arrangements for complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council28 , including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request as referred to in Article 37a; |
| 28 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj). | 28 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj). |
Or. en
Justification
The draft proposal deletes Art 118(1) REACH which is the legal basis for ECHA to apply the ATD Regulation (Regulation 1049/2001) to documents that ECHA holds. However, the proposal does not have an equivalent provision setting out such a clear legal basis, unlike the founding regulations of the other Agencies (see e.g. Article 41 Regulation 178/2002). It only has a provision saying the Management Board will adopt implementing rules for the ATD Regulation. The ATD Regulation as such does not apply to ECHA; it only applies to the Commission, Council and EP documents. To ensure proper transparency considering Article 15 TFEU, we propose to create in the Basic Regulation an equivalent to Article 118(1) of REACH in a new article which should be cross-referenced here.
Amendment 30
Proposal for a regulation
Article 10 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Management Board shall act by a two third majority of all its members with voting rights. | 1. The Management Board shall act by a two-thirds majority of all its members with voting rights. |
Or. en
Justification
Editorial
Amendment 31
Proposal for a regulation
Article 10 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. In the event that the Commission raises serious concerns on a decision proposal presented to the Management Board on matters related to Commission Delegated Regulation (EU) 2019/71529 on the Framework financial regulation for decentralised regulatory agencies or to the Staff Regulations and the Conditions of Employment of Other Servants of Regulation No 31 (EEC), 11 (EAEC), the Management Board shall postpone the adoption of the decision. Within 15 days, the Management Board shall re-examine and adopt it, possibly amended, in second reading, either with a two-thirds majority, including the Commission representatives, or by a four fifths majority of the representatives of the Member States. | 3. In the event that the Commission raises serious concerns on a decision proposal presented to the Management Board on matters related to Commission Delegated Regulation (EU) 2019/71529 on the Framework financial regulation for decentralised regulatory agencies or to the Staff Regulations and the Conditions of Employment of Other Servants of Regulation No 31 (EEC), 11 (EAEC), the Management Board shall postpone the adoption of the decision. Within 15 days, the Management Board shall re-examine and adopt it, possibly amended, in second reading. |
| 29 Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1, ELI: http://data.europa.eu/eli/reg_del/2019/715/oj). | 29 Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1, ELI: http://data.europa.eu/eli/reg_del/2019/715/oj). |
Or. en
Justification
The Commission's proposal would give a de facto veto power to the Commission in case of second reading on those matters. We propose instead that the two-thirds majority set in paragraph 1 of this article should apply in all cases.
Amendment 32
Proposal for a regulation
Article 12 – paragraph 5 – point d
| Text proposed by the Commission | Amendment |
|---|---|
| (d) ensure the fulfilment of the time-limits laid down in sectoral Union legislation for the adoption of opinions by the Agency and by the Committees; | (d) ensure the fulfilment of the time-limits laid down in sectoral Union legislation for the adoption of opinions by the Agency and by the Committees and the independence of those opinions; |
Or. en
Justification
Article 4(4) provides that the Agency should serve as a point of reference by virtue of the independence of its assessments and opinions, this needs to be reflected in the tasks and responsibilities of the Executive Director.
Amendment 33
Proposal for a regulation
Article 12 – paragraph 5 – point e
| Text proposed by the Commission | Amendment |
|---|---|
| (e) ensure appropriate and timely coordination between the different bodies within the Agency, including with regard to potential divergence between their scientific opinions, in accordance with Article 45; | (e) ensure appropriate and timely coordination between the different bodies within the Agency, including with regard to potential divergence between their scientific opinions; |
Or. en
Justification
Article 45 is not about resolving potential divergence of opinions between bodies within the Agency, but with other Union bodies. A new item is added to address this specific case.
Amendment 34
Proposal for a regulation
Article 12 – paragraph 5 – point e a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ea) ensure appropriate and timely coordination with other Union bodies with regard to potential divergence of scientific opinion in accordance with Article 45; |
Or. en
Justification
Item added to address the specific case of resolving potential divergence of scientific opinion between the Agency and other Union bodies.
Amendment 35
Proposal for a regulation
Article 12 – paragraph 5 – point h a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (ha) ensure appropriate and timely response to reports of attempts of pressure or undue influence made pursuant to Article 19(3a); a record of all those reports and responses shall be included in the annual activity report referred to in point (q) of this paragraph; |
Or. en
Justification
This report introduces a new provision in Article 19 for Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers to report without delay any attempts of pressure or undue influence they would be the target of to the Executive Director. Hence, the Executive Director should be tasked to responding to and reporting on these potential cases.
Amendment 36
Proposal for a regulation
Article 12 – paragraph 5 – point p a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (pa) appoint the Agency's representative to the task force referred to in Article 44; |
Or. en
Justification
As this report proposes in Article 44 to perpetuate and institutionalise the current cross-agency One Health task, the role of the Executive Director to appoint its representative to the Task Force should be reflected in this Article.
Amendment 37
Proposal for a regulation
Article 13 – paragraph 2 – point b
| Text proposed by the Commission | Amendment |
|---|---|
| (b) all other matters not already covered by paragraph 1 or paragraph 2(a), related to the hazards, risks and safe use of chemical substances, on their own, in mixtures or in articles as defined in Article 3, paragraphs 1, 2 and 3 of Regulation (EC) No 1907/2006. | (b) all other matters not already covered by paragraph 1 or paragraph 2(a), related to the hazards, risks and safe use of substances, on their own, in mixtures or in articles as defined in Article 3, paragraphs 1, 2 and 3 of Regulation (EC) No 1907/2006. |
Or. en
Justification
Editorial
Amendment 38
Proposal for a regulation
Article 13 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. In addition to the tasks referred to in paragraph 1, the Committees shall, at the Executive Director's request, provide technical and scientific support for steps to improve cooperation between the Union, the Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries. |
Or. en
Justification
Article 77(3)(b) of REACH provides the possibility for RAC at the Executive Director's request, to provide provide 'technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries'. This mandate should not be limited to matters related under REACH but should be available for all tasks performed by ECHA, and for all Committees, regardless of the legislation from which it is emanating. Therefore, this possibility is now included in this article, and Article 77(3)(b) of REACH is deleted (see AM to Article 48)
Amendment 39
Proposal for a regulation
Article 13 – paragraph 2 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. The European Parliament or a Member State may request the Agency to issue a scientific opinion on matters falling within the competence of the Agency. |
Or. en
Justification
This is a possibility that is given to the European Parliament or a Member State for EFSA in the General Food Law. This should be mirrored in the ECHA Basic Regulation.
Amendment 40
Proposal for a regulation
Article 13 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The number of such scientific opinions to be delivered and the timelines for their provision shall be decided between the Commission and the Agency on an annual basis. | 3. The number of scientific opinions to be delivered pursuant to paragraph 2 and the timelines for their provision shall be decided between the Commission and the Agency on an annual basis. |
Or. en
Justification
Clarification that this paragraph does not apply to the possibility of requesting a committee opinion by the Executive Director.
Amendment 41
Proposal for a regulation
Article 14 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. At the request of a Member State, the Agency shall assist that Member State with the identification of possible satisfactory candidates for nomination by that Member State pursuant to paragraphs 1, 2 and 3. |
Or. en
Justification
Some Member States sometimes have had difficulty in the past to find candidates with an adequate profile. The Agency should be able, at their request, to help them identify experts with the proper qualification.
Amendment 42
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point iv a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (iva) safety assessment of nanomaterials; |
Or. en
Justification
Nanomaterials are specifically regulated under Article 16 of the Cosmetics Regulation to ensure a high level of protection of human health shall be ensured as this type of material my present specific hazards and risks. A high level of scientific expertise and experience in the field of nanomaterials should therefore be one of the criteria for the nomination of members of the SCCS.
Amendment 43
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point v
| Text proposed by the Commission | Amendment |
|---|---|
| (v) alternative testing methods, and emerging methodologies, including new approach methodologies and in vitro/ or in silico techniques; | (v) non-animal approaches, and emerging methodologies, including new approach methodologies and in vitro/ or in silico techniques; |
Or. en
Justification
This wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)
Amendment 44
Proposal for a regulation
Article 14 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Member States shall refrain from nominating or appointing any person as a member of any of the Committees where, on the basis of an analysis there are reasonable grounds to believe that a conflict of interest exists or may arise in relation to that person. | |
| The Management Board shall not proceed with the appointment of any person as a member of any of the Committees where such reasonable grounds exist. |
Or. en
Justification
This amendment aims at strengthening the provisions to avoid conflict of interests for Committee members.
Amendment 45
Proposal for a regulation
Article 14 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. All Committees shall have a broad range of relevant expertise among their members. The Committees may co-opt additional members chosen on the basis of their specific competence. The maximum number of co-opted members for RAC, SEAC and SCCS shall be set and adjusted by the Management Board on the basis of a proposal from the Executive Director, taking into account the workload of the committees, the type of expertise needed and the availability of financial resources. The MSC and BPC may co-opt a maximum of five additional members. | 6. All Committees shall have a broad range of relevant expertise among their members. The Committees may co-opt additional members chosen on the basis of their specific competence and taking into account geographical diversity. The maximum number of co-opted members for the Committees shall be set and adjusted by the Management Board on the basis of a proposal from the Executive Director, taking into account the workload of the committees, the type of expertise needed and the availability of financial resources. |
Or. en
Amendment 46
Proposal for a regulation
Article 14 – paragraph 7 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. Co-opted members, experts, advisers and stakeholders shall not have voting rights. |
Or. en
Justification
This is already the case in the Rules of Procedure of the different Committees, this amendment is meant to ensure this is a horizontal provision.
Amendment 47
Proposal for a regulation
Article 14 – paragraph 9
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Member States shall provide adequate scientific and technical resources to those members of the committees that they have nominated or appointed and shall facilitate the activities of the committees and their working groups. | 9. Member States shall provide adequate scientific and technical resources, and administrative support to those members of the Committees that they have nominated or appointed and shall facilitate their effective participation in the activities of the Committees and their working groups. |
Or. en
Amendment 48
Proposal for a regulation
Article 14 – paragraph 10
| Text proposed by the Commission | Amendment |
|---|---|
| 10. The members of RAC, SEAC and SCCS shall be independent and they shall neither seek nor take instructions from any government or other institution, body, office or entity. The members of MSC and BPC shall act in the public interest. They shall refrain from any action incompatible with their duties or the performance of their tasks. | 10. The members of RAC, SEAC and SCCS shall be independent and they shall neither seek nor take instructions from any government or other institution, body, office or entity. The members of MSC and BPC shall act in the public interest and in the interest of the Union. They shall refrain from any action incompatible with their duties or the performance of their tasks. |
Or. en
Amendment 49
Proposal for a regulation
Article 14 – paragraph 12
| Text proposed by the Commission | Amendment |
|---|---|
| 12. The members of the Committees that are nominated or appointed by a Member State shall ensure that there is appropriate coordination between the tasks of the Agency and the work of their Member State competent authorities. | 12. The members of the Committees that are nominated or appointed by a Member State shall ensure that there is appropriate coordination between the work in the Committees and the work in their Member State competent authorities. |
Or. en
Amendment 50
Proposal for a regulation
Article 14 – paragraph 15
| Text proposed by the Commission | Amendment |
|---|---|
| 15. The member concerned, or that person’s employer as referred to in paragraph 13, shall be remunerated by the Agency in accordance with the financial arrangements established by the Management Board following a positive opinion by the Commission. The list of tasks for which remuneration may be paid shall be established by the Management Board following a positive opinion of the Commission. Where the member concerned fails to fulfil any of those tasks, the Executive Director may withhold remuneration. | 15. The member concerned, or that person’s employer as referred to in paragraph 14, shall be remunerated by the Agency in accordance with the financial arrangements established by the Management Board following a positive opinion by the Commission. The list of tasks for which remuneration may be paid shall be established by the Management Board following a positive opinion of the Commission. Where the member concerned fails to fulfil any of those tasks, the Executive Director may withhold remuneration. |
Or. en
Justification
Editorial
Amendment 51
Proposal for a regulation
Article 15 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. When preparing an opinion, the committees shall use their best endeavours to reach a consensus among their members. The opinion shall include the grounds for the position of the committee. If a consensus cannot be reached, the opinion shall consist of the position of the majority of the members the minority positions and the grounds for the respective majority and minority positions. The opinion shall be published. | 2. When preparing an opinion, the Committees shall use their best endeavours to reach a consensus among their members. The opinion shall include the grounds for the position of the committee. If a consensus cannot be reached, the opinion shall consist of the position of the majority of the members the minority positions and the grounds for the respective majority and minority positions. The opinion shall be made publicly available on the Agency's website. |
Or. en
Amendment 52
Proposal for a regulation
Article 15 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Secretariat shall provide scientific and administrative support to the technical and scientific work of the Committees. | 3. The Secretariat shall provide scientific and administrative support to the technical and scientific work of the Committees and the Forum. |
Or. en
Amendment 53
Proposal for a regulation
Article 15 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Each committee shall draft a proposal for their own rules of procedure, which shall be prepared for adoption by the Executive Director and then adopted by the Management Board. The rules of procedure of RAC and SEAC shall require the approval of the representatives of the Commission in the Management Board. | 4. Each Committee shall draft a proposal for their own rules of procedure, which shall be prepared for adoption by the Executive Director and then adopted by the Management Board. When preparing the rules of procedure of RAC, SEAC and SCCS, the Executive Director shall consult the representatives of the Commission in the Management Board. |
Or. en
Justification
The Commission's proposal would give a de facto veto power to the Commission for the adoption of the rules of procedure of the Committees. We propose instead that the representatives of the Commission in the management board should only be consulted on the matter.
Amendment 54
Proposal for a regulation
Article 15 – paragraph 5
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The rules of procedure of each committee shall lay down the procedures for replacing and co-opting members, for the creation and organisation of working groups and for delegating certain tasks to such working groups, if applicable. The rules of procedure shall also establish a procedure for the urgent adoption of opinions and the management of conflicts of interest. The rules of procedure shall be published. | 5. The rules of procedure of each Committee shall lay down the procedures for replacing and co-opting members, for the creation and organisation of working groups and for delegating certain tasks to such working groups, if applicable. The rules of procedure shall also establish a procedure for the urgent adoption of opinions and the management of conflicts of interest. The rules of procedure shall be made publicly available on the Agency's website. |
Or. en
Amendment 55
Proposal for a regulation
Article 16 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Agency shall keep a list of experts up-to-date, which shall include the experts referred to in Article 16(1) and other experts identified directly by the Agency. | 4. The Agency shall keep a list of experts up-to-date, which shall include the experts referred to in Article 16(1) and other experts identified directly by the Agency as well as their qualifications. |
Or. en
Justification
Similarly to the requirements for Committee members, qualifications of experts should also be made public.
Amendment 56
Proposal for a regulation
Article 16 – paragraph 5
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The provisions on independence in Article 14(9), on contractual arrangements in Article 14(13) and on the financial arrangements for remuneration in Article 14(14) shall apply mutatis mutandis to any expert serving in a working group of the Committees or of the Forum or performing any other task for the Agency. | 5. The provisions on independence in Article 14(10), on contractual arrangements in Article 14(14) and on the financial arrangements for remuneration in Article 14(15) shall apply mutatis mutandis to any expert serving in a working group of the Committees or of the Forum or performing any other task for the Agency. |
Or. en
Justification
Editorial
Amendment 57
Proposal for a regulation
Article 17 – paragraph 5
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Forum shall draft a proposal for its own rules of procedure to the Management Board. The rules of procedure shall lay down the procedures for appointing and replacing the Chairperson, for replacing members and for delegating certain tasks to working groups. | 5. The Forum shall draft a proposal for its own rules of procedure to be adopted by the Management Board. The rules of procedure shall lay down the procedures for appointing and replacing the Chairperson, for replacing members and for delegating certain tasks to working groups. |
Or. en
Justification
The adoption phase seems to be missing from the original proposal.
Amendment 58
Proposal for a regulation
Article 19 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The membership of the Committees and of the Forum shall be published by the Executive Director on the Agency’s website. Individual members may request that their names not be made public if they believe that such publication could place them at risk. The Executive Director shall decide whether to agree to such requests. When an appointment of a member is published, the professional qualifications of that member shall also be published. | 1. The membership of the Committees and of the Forum and the list of experts referred to in Article 16(4) shall be published by the Executive Director on the Agency’s website. Individual members and experts may request that their names not be made public if they believe that such publication could place them at risk. The Executive Director shall decide whether to agree to such requests. When an appointment of a member is published, the professional qualifications of that member shall also be published. |
Or. en
Justification
For reason of transparency, the name of experts available to serve in a working group of the Committees should also be made public. This amendment also provide that experts may also request anonymity, if they believe that the publication of their name may place them at risk.
Amendment 59
Proposal for a regulation
Article 19 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. At meetings of the members of the Management Board, the Executive Director, chairpersons and members of the Committees and the Forum and any participating experts shall declare any additional interests which could be considered prejudicial to the members’ obligations pursuant to Article 14(10)with respect to any points on the agenda. A person that has declared such interests shall not participate in voting on the relevant point. | 3. At each meeting, the members of the Management Board, the Executive Director, chairpersons and members of the Committees and the Forum and any participating experts and advisers shall declare any additional interests which could be considered prejudicial to the members’ obligations pursuant to Article 14(10) with respect to any points on the agenda. A person that has declared such interests shall not participate in voting on the relevant point. |
Or. en
Justification
Alignment with Article 37 of the General Food Law. This obligation of transparency should also apply to advisers
Amendment 60
Proposal for a regulation
Article 19 – paragraph 3 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers shall report without delay to the Executive Director any attempts of pressure or undue influence of which they are the target. |
Or. en
Justification
This paragraph aims to introduce a new provision for Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers to report without delay any attempts of pressure or undue influence they would be the target of to the Executive Director. This is key that the Executive Director is aware of such attempts and take measures to address them without delay to ensure the independence of the Agency, and prevent further pressure.
Amendment 61
Proposal for a regulation
Article 20 – paragraph 5
| Text proposed by the Commission | Amendment |
|---|---|
| 5. The Commission is empowered to adopt implementing acts determining the qualifications required for the members of the Board of Appeal in the field of chemical safety, natural sciences and regulatory and judicial procedures as set out in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). | 5. The Commission shall adopt implementing acts determining the qualifications required for the members of the Board of Appeal in the field of chemical safety, natural sciences and regulatory and judicial procedures as set out in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). |
Or. en
Amendment 62
Proposal for a regulation
Article 24 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The appeal, together with the statements of the grounds thereof, shall be filed in writing to the Agency within three months of the notification of the decision to the person concerned, or in the absence of such notification, of the day on which the decision became known to the person concerned, unless otherwise provided for in the sectoral Union legislation. | 2. The appeal, together with the statements of the grounds thereof, shall be filed in writing to the Agency within three months of the notification of the decision to the person concerned, or in the absence of such notification, of the day on which the decision became known to the person concerned, unless otherwise provided for in sectoral Union legislation. |
Or. en
Justification
Editorial
Amendment 63
Proposal for a regulation
Article 24 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. A fee may be payable by persons bringing an appeal against a decision of the Agency, where that is set out in the sectoral Union legislation. | 3. A fee may be payable by persons bringing an appeal against a decision of the Agency, where that is set out in sectoral Union legislation. |
Or. en
Justification
Editorial
Amendment 64
Proposal for a regulation
Article 25 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The Commission is empowered to adopt implementing acts determining the procedures of the Board of Appeal and its Registry. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). | 4. The Commission shall adopt implementing acts determining the procedures of the Board of Appeal and its Registry. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). |
Or. en
Amendment 65
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By the end of each year, based on the draft by the Executive Director, the Management Board shall endorse a draft single programming document containing the following: | 1. By the end of each year, based on a draft proposal by the Executive Director, the Management Board shall endorse a draft single programming document containing the following: |
Or. en
Justification
Editorial
Amendment 66
Proposal for a regulation
Article 27 – paragraph 1 – point d a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (da) an assessment of the adequacy of its financial and human resources to carry out its current and upcoming tasks; |
Or. en
Amendment 67
Proposal for a regulation
Article 27 – paragraph 1 – point d b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| (db) a strategy for the mobilisation of members and experts, and the expected needs and expenses resulting from the financial support referred to in Article 35(2a) and Article 41b. |
Or. en
Amendment 68
Proposal for a regulation
Article 29 – paragraph 4
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure expenses, and operational expenditure. | 4. The expenditure of the Agency shall include staff remuneration, administrative and infrastructure expenses, and operational expenditure, and expenses resulting from contracts entered into with third parties or resulting from the financial support referred to in Article 35(2a) and Article 41b. |
Or. en
Amendment 69
Proposal for a regulation
Article 29 – paragraph 6
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Commission may review the conditions for the reserve set out in paragraph 5, and is empowered to adopt delegated acts in accordance with Article 46(1) to amend paragraph 5 on the basis of such review. | 6. The Commission may review the conditions for the reserve set out in paragraph 5 taking into account fluctuations in the Agency's revenues from fees and charges over successive years, and is empowered to adopt delegated acts in accordance with Article 46(1) to amend paragraph 5 on the basis of such review, where appropriate. |
Or. en
Justification
In case where important fluctuations in the Agency's fee revenues over successive years are observed, the Commission should take that factor into account to adapt the maximum percentage of the total actual amount realised in the year N-1 of the Agency’s revenues from the fees and charges to this fluctuation.
Amendment 70
Proposal for a regulation
Article 35 – title
| Text proposed by the Commission | Amendment |
|---|---|
| Seconded national experts and other staff | Seconded national experts and other staff seconded in the interests of the service |
Or. en
Amendment 71
Proposal for a regulation
Article 35 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Officials and other servants employed by the Agency may, in the interest of the service and in accordance with Article 37 of Regulation No 31(EEC), 11 (EAEC), be seconded to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate. | |
| Such secondment shall not affect the independence of the staff concerned and shall be subject to appropriate safeguards concerning conflicts of interest and confidentiality. |
Or. en
Justification
To reinforce the capacity and contribute to the work of Member States Competent Authorities, the Agency should be able to second officials and other servants in its employment, in particular scientific experts, in the interest of the service and in accordance with Article 37 of the Staff Regulations of Officials of the European Union and the Conditions of Employment of Other Servants, to temporarily assign or second them to the competent authorities of the Member States or to other public bodies entrusted with tasks related to the Agency’s mandate, for example to help Member States meet their obligations to appoint committee members and thus ensure that the agency has the number of committee members and experts it needs to do its work properly.
Amendment 72
Proposal for a regulation
Article 35 – paragraph 2 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. The Management Board may adopt a decision laying down the conditions under which temporary assignments or secondments in the interests of the service as referred to in paragraph 2a shall take place. |
Or. en
Amendment 73
Proposal for a regulation
Article 37 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 37a | |
| Access to documents | |
| 1. Notwithstanding the rules on confidentiality provided for in sectoral Union legislation, Regulation (EC) No 1049/2001 of the European Parliament and of the Council1a shall apply to documents held by the Agency. | |
| Where environmental information is concerned, Regulation (EC) No 1367/2006 of the European Parliament and of the Council1b shall also apply. Directive 2003/4/EC of the European Parliament and of the Council shall apply to environmental information held by Member States, notwithstanding the rules on confidentiality provided for in sectoral Union legislation. | |
| 2. The Management Board shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006 by ...[OP please insert: 6 months from the date of entry into force of this Regulation], ensuring as wide access as possible to documents in its possession. | |
| 3. Decisions taken by the Agency pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 228 and 263 TFEU, respectively. | |
| 1a Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43, ELI: http://data.europa.eu/eli/reg/2001/1049/oj). | |
| 1b Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to Community institutions and bodies (OJ L 264, 25.9.2006, pp. 13–19, ELI: http://data.europa.eu/eli/reg/2006/1367/oj). |
Or. en
Justification
The draft proposal deletes Art 118(1) REACH which is the legal basis for ECHA to apply the ATD Regulation (Regulation 1049/2001) to documents that ECHA holds. However, the proposal does not have an equivalent provision setting out such a clear legal basis, unlike the founding regulations of the other Agencies (see e.g. Article 41 Regulation 178/2002). It only has a provision saying the Management Board will adopt implementing rules for the ATD Regulation. The ATD Regulation as such does not apply to ECHA; it only applies to the Commission, Council and EP documents. To ensure proper transparency considering Article 15 TFEU, we propose to create in the Basic Regulation an equivalent to Article 118(1) of REACH.
Amendment 74
Proposal for a regulation
Article 38 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Members of the Management Board, the Executive Director, members of the Committees, the Board of Appeal and the Forum, external experts participating in working groups, and members of the staff of the Agency shall comply with the confidentiality requirements set out in Article 339 TFEU, even after their duties have ceased. | 3. Members of the Management Board, the Executive Director, members of the Committees, the Board of Appeal and the Forum, experts participating in working groups, and members of the staff of the Agency shall comply with the confidentiality requirements set out in Article 339 TFEU, even after their duties have ceased. |
Or. en
Justification
This is the only instance where the proposal refers to 'external' experts, to avoid confusion this amendment aims to align the wording with the rest of the text by referring only to 'experts'.
Amendment 75
Proposal for a regulation
Article 41 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 41a | |
| Forum of accredited stakeholders | |
| 1. For the purpose of Article 41, the Agency shall establish and coordinate a Forum of accredited stakeholders. | |
| 2. All stakeholders invited to attend meetings of the Agency as referred to in Article 15(1) shall be members of the Forum of accredited stakeholders. The Executive Director or a representative of the Executive Director shall be entitled to attend all the meetings of the Forum of accredited stakeholders. The Forum of accredited stakeholders shall be chaired by a representative of the Agency. A list of Agency accredited stakeholders shall be made public on the Agency's website. | |
| 3. The Forum of accredited stakeholders shall aim to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency in accordance with its rules of procedure. | |
| 4. The Forum of accredited stakeholders shall draft a proposal for its own rules of procedure for adoption by the Management Board. |
Or. en
Justification
ECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.
Amendment 76
Proposal for a regulation
Article 41 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| Article 41b | |
| Networking of organisations operating in the areas of competence of the Agency | |
| 1. The Agency shall promote the European networking of organisations operating in the areas of competence of the Agency. The aim of such networking is, in particular, to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices in the areas of competence of the Agency. | |
| 2. The Management Board, acting on a proposal from the Executive Director, shall draw up a list, to be made public, of competent organisations designated by the Member States which may assist the Agency, either individually or in networks, with its tasks. The Agency may entrust to those organisations certain tasks, in particular preparatory work for scientific opinions, scientific and technical assistance, collection of data and identification of emerging risks. Some of those tasks may be eligible for financial support. | |
| 3. The Commission is empowered to adopt delegated acts in accordance with Article 46 in order to supplement this Regulation by establishing the criteria for the inclusion of an organisation on the list of competent organisations designated by the Member States, the arrangements for setting out harmonised quality requirements and the financial rules governing any financial support. | |
| The Commission shall adopt implementing acts for the application of paragraphs 1 and 2, after consulting the Agency. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 47(2). | |
| 4. Within ... [one year from the date of entry into force of this Regulation], the Commission shall publish an inventory of Union systems existing in the areas of competence of the Agency which make provision for Member States to carry out certain tasks in the field of scientific evaluation. The report, which shall be accompanied, where appropriate, by proposals, shall indicate in particular, for each system, any modifications or improvements which might be required to enable the Agency to carry out its tasks, in cooperation with the Member States. |
Or. en
Amendment 77
Proposal for a regulation
Article 42 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| 1. In so far as is necessary to achieve the objectives set out in this Regulation and the sectoral Union legislation, and without prejudice to the respective competences of Member States and the institutions of the Union, the Agency may cooperate with the competent authorities of third countries and with international organisations that have entered into agreements with the Union to that effect. | 1. In so far as is necessary to achieve the objectives set out in this Regulation and sectoral Union legislation, and without prejudice to the respective competences of Member States and the institutions of the Union, the Agency may cooperate with the competent authorities of third countries and with international organisations that have entered into agreements with the Union to that effect. |
Or. en
Justification
Editorial
Amendment 78
Proposal for a regulation
Article 43 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency shall assist Member States and the Commission in promoting the substitution of the most harmful chemicals by safer and more sustainable alternative substances and technologies and in the development of relevant scientific methodologies, including animal-free approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of the use of chemicals. Such assistance shall include facilitation of information exchange as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation. | 1. The Agency shall assist Member States and the Commission in promoting the substitution of the most harmful and other hazardous chemicals by safer and more sustainable alternative substances and technologies and in the development of relevant scientific methodologies, including non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of the use of chemicals. Such assistance shall include facilitation of information exchange, contribution to define data generation needs, as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation, including Regulation (EU) 2021/695 of the European Parliament and of the Council . In particular, the Agency shall assist and contribute to the research on the links between exposure to hazardous chemicals and negative impacts on health in the field of exposomics. |
| 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L 170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj |
Or. en
Justification
Substitution effort should not be limited to the most harmful substances. This amendment also aligns the proposal with the data generation tasks allocated to the Agency under OSOA and also outline research on exposome as one of the key priorities to which the Agency should contribute.
Amendment 79
Proposal for a regulation
Article 43 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The Agency shall publish an annual report presenting its recommendations on knowledge and data gaps in terms of regulatory science and regulatory needs, as well as exploratory and fundamental science, in any field within its competence, taking into account emerging risks and in close cooperation and permanent interaction with relevant Union and international bodies. |
Or. en
Justification
As the central actor on chemical knowledge and expertise in the Union, the ECHA is in a key position to identify further scientific research and regulatory needs in this field, to help building strong partnership and collaboration between regulators and researchers and connecting the latest scientific discoveries with regulatory practices. The Agency should therefore contribute to this debate by publishing an annual report outlining its recommendations on knowledge and data gaps in terms of regulatory and fundamental science needs in any field within its competence.
Amendment 80
Proposal for a regulation
Article 44 – paragraph 1
| Text proposed by the Commission | Amendment |
|---|---|
| The Agency shall cooperate with other bodies established under Union law, including but not limited to the European Centre for Disease Prevention and Control, the European Environment Agency, the European Food Safety Authority, the European Medicines Agency and the European Agency for Safety and Health at Work, on the provision of relevant scientific opinions, on the exchange of data and information, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies, including animal-free approaches, for the assessment of chemicals. | 1. The Agency shall cooperate with other bodies established under Union law, including but not limited to the European Centre for Disease Prevention and Control (ECDC), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA), on the provision of relevant scientific opinions, on the exchange of data and information, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies, including non-animal approaches, for the assessment of chemicals. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 81
Proposal for a regulation
Article 44 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The Agency shall ensure cooperation with the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM), in particular with regard to the development of scientific methodologies and training activities. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 82
Proposal for a regulation
Article 44 – paragraph 1 b (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1b. A permanent task force (the 'task force') is established with the Agency, EFSA, EMA, ECDC and EEA. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 83
Proposal for a regulation
Article 44 – paragraph 1 c (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1c. The task force aims to add value by building on existing mechanisms of cooperation, maximising synergies and avoiding duplication. The task force primarily focuses on cross-sectoral issues that can benefit from a One Health and exposome approach. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 84
Proposal for a regulation
Article 44 – paragraph 1 d (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1d. The Agency shall coordinate the work of the task force for 12 months after the task force is established. The coordination of the work of the task force shall rotate among the agencies every 12 months thereafter in accordance with its framework for action referred to in paragraph 1l. The agency that acts as the rotating chair shall lead the coordination of the task force meetings and activities. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 85
Proposal for a regulation
Article 44 – paragraph 1 e (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1e. The task force shall consist of senior officers from each agency referred in paragraph 1b. The Executive Director of each agency shall appoint a representative to the task force and the representatives shall report to their respective Executive Directors on progress. A representative from the Commission shall be invited to participate in the meetings of the task force to ensure close cooperation between the task force and the Commission. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 86
Proposal for a regulation
Article 44 – paragraph 1 f (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1f. Each agency referred to in paragraph 1b shall establish a focal point within each agency to coordinate the respective inputs to joint activities and convey the position of the agency on strategic matters. Each focal point shall keep their own management and interagency mechanisms informed of relevant developments under the task force. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 87
Proposal for a regulation
Article 44 – paragraph 1 g (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1g. Task force members may seek to engage other representatives from within each agency for input and advice to support the implementation of the actions, as needed. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 88
Proposal for a regulation
Article 44 – paragraph 1 h (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1h. External ad hoc members and observers may attend meetings of the task force as and when required, in agreement with the members of the task force. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 89
Proposal for a regulation
Article 44 – paragraph 1 i (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1i. The task force shall liaise with on-going inter-agency groups and activities and may establish dedicated working groups to support the activities of the task force. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 90
Proposal for a regulation
Article 44 – paragraph 1 j (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1j. The task force shall not act as a decision-making body. The task force may propose recommendations for action to the senior management of the agencies. Representatives of each agency in the task force shall have an advisory role to the Executive Directors and senior management of its own agency and shall engage with the Commission and other stakeholders for input and advice, as appropriate. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 91
Proposal for a regulation
Article 44 – paragraph 1 k (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1k. The task force shall meet at least six times a year, with at least one annual physical meeting of a more strategic nature. Ad hoc meetings may be organised, as needed. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 92
Proposal for a regulation
Article 44 – paragraph 1 l (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1l. By the end of each year, members of the task force shall draw up and endorse an annual framework for action describing a plan for the joint One Health and exposome work of the agencies referred to in paragraph 1b. | |
| The framework for action shall include objectives to be pursued by the task force, concrete actions and outcomes to achieve them, and an approximate timeline for the implementation of such actions, and shall be built around the following objectives: | |
| (a) facilitate strategic coordination in the implementation of the One Health and exposome approach; | |
| (b) promote research coordination and One Health and exposome-driven agenda setting; | |
| (c) enhance capacity building on One Health and exposome; | |
| (d) strengthen One Health and exposome communication and stakeholders' engagement; | |
| (e) support the development of partnerships through joint One Health and exposome activities. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 93
Proposal for a regulation
Article 44 – paragraph 1 m (new)
| Text proposed by the Commission | Amendment |
|---|---|
| 1m. The framework for action referred to in paragraph 1l shall be consistent with the respective mandates of each agency and shall not hinder their statutory activities. |
Or. en
Justification
Strengthened collaboration between EU agencies can play a critical role by ensuring that scientific evidence is aligned, making knowledge more accessible to all relevant stakeholders, providing strategic direction to EU research funding, and facilitating engagement with ongoing research and innovation projects. The cross-agency One Health task force between ECHA, EFSA, EAM, ECDC and EEA, established in 2023, has proved to be a successful initiative to strengthen transdisciplinary cooperation among five EU agencies in order to help them to better address challenges to human, animal, plant and environmental health and successfully contribute to the implementation of the One Health approach in Europe. As this initiative will end in 2026, this Regulation should establish a more permanent and established form of transdisciplinary cooperation with a permanent task force aiming to build on the work of the One Health task force and to broaden the scope of its work to other approach, such as exposome.
Amendment 94
Proposal for a regulation
Article 45 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where the Agency identifies a potential source of divergence, it shall contact the body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues. | 2. Where the Agency identifies a potential source of divergence as referred to in paragraph 1, it shall contact the other body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues. |
Or. en
Justification
Alignment with 'One Substance One Assessment'
Amendment 95
Proposal for a regulation
Article 45 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Agency and the body concerned shall cooperate to resolve the divergence. If the Agency and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and the underlying reasons for the diverging opinions, including on methodological differences, and be made publicly available. Where the body concerned is a Union agency or a scientific committee, the Agency shall present the joint report to the Commission. | 3. The Agency and the other body concerned shall cooperate to resolve the divergence, taking into consideration the objective of a high level of protection of health and the environment. If the Agency and the other body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues, identify the relevant uncertainties in the data and give the underlying reasons for the divergence of opinions, including reasons related to methodological differences. The report shall be made publicly available. Where the other body concerned is a Union agency or a scientific committee, the Agency shall also present the joint report to the Commission. |
Or. en
Justification
The agreement between co-legislators on the "Proposal on the reattribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals" amended the General Food Law with this wording, the ECHA Basic Regulation should therefore be aligned with the provisions on resolving divergent opinions between agencies.
Amendment 96
Proposal for a regulation
Article 48 – paragraph 1 – point 3
| Text proposed by the Commission | Amendment |
|---|---|
| (3) in Article 77, paragraph 1 is deleted; | (3) in Article 77, paragraph 1, and paragraph 3, point (b), are deleted; |
Or. en
Justification
Article 77(3)(b) of REACH provides the possibility for RAC at the Executive Director's request, to provide 'technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries'. This mandate should not be limited to matters regulated under REACH but should be available for all tasks performed by ECHA, regardless of the legislation from which they are emanating. Therefore, this possibility is now included in Article 13 of this proposal to make it a horizontal provision.
Amendment 97
Proposal for a regulation
Article 48 – paragraph 1 – point 6
| Text proposed by the Commission | Amendment |
|---|---|
| (6) in Article 118, paragraphs 1, 3 and 4 are deleted. | deleted |
Or. en
Amendment 98
Proposal for a regulation
Article 54 – title
| Text proposed by the Commission | Amendment |
|---|---|
| Evaluation | Evaluation and review |
Or. en
Amendment 99
Proposal for a regulation
Article 54 – paragraph 2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The evaluation shall address the possible need to modify the mandate of the Agency, and the financial implications of any such modification. | 2. The evaluation shall address the possible need to modify the mandate of the Agency, and the financial implications of any such modification. The evaluation shall also assess the functioning of the Committees and whether it would be warranted to align or adapt the rules for membership and functioning of the Committees. |
Or. en
Justification
SCCS has been incorporated into ECHA but the proposal keeps its particular rules and structure intact. BPC members are not independent from their government, whereas members of RAC and SEAC are. While there is no express reasons to change this approach in this draft report, experience might show in the future that rules should be aligned or adapted for the Committees.
Amendment 100
Proposal for a regulation
Article 54 – paragraph 3
| Text proposed by the Commission | Amendment |
|---|---|
| 3. The Commission shall report to the European Parliament, to the Council, and to the Management Board on the findings of the evaluation. An action plan and a timetable shall be included, if appropriate. The findings of the evaluation shall be made public by the Commission. | 3. The Commission shall report to the European Parliament, to the Council, and to the Management Board on the findings of the evaluation. An action plan and a timetable shall be included, if appropriate, and the Commission may propose a legislative proposal, where appropriate. The findings of the evaluation shall be made public by the Commission. |
Or. en
Explanatory statement 6 paragraphs
The revision of the Basic Regulation of the European Chemicals Agency (ECHA) comes at a decisive moment for the Union’s ambition to better protect human health and the environment from the harmful impacts of chemicals on the one hand and improve the services provided to industry and SMEs on the over hand. As rapporteur, I strongly believe that this reform must give ECHA the tools, capacities and flexibility it needs to deliver on rapidly expanding responsibilities. The Commission’s own explanatory memorandum already underlines the structural underfunding and rigid budgetary framework that have constrained the Agency’s work since its creation. As we expect ECHA to carry out ever more complex scientific assessments, support innovation, and ensure a truly efficient EU chemicals policy, it must be provided with stable, adequate financial resources and greater room for budgetary manoeuvre. Only then will the Agency be able to plan strategically, respond to new scientific needs, and retain the expertise necessary to protect citizens and ecosystems.
My draft report reflects this conviction. First, it reiterates that the core mission of ECHA remains the protection of human health and of the environment. This must be the compass guiding all aspects of its governance, operations and cooperation. The amendments therefore reinforce these primary objectives and clarify the Agency’s responsibilities in assessing both risks and hazards of chemicals, ensuring that the overarching purpose of prevention stays at the heart of the regulation.
Second, the report updates ECHA’s mandate to integrate horizontal tasks stemming from new legislation, most notably the One Substance One Assessment (OSOA) package, which tasks ECHA with new data-gathering and sustainability-assessment functions. The amendments reflect the need to incorporate these priorities structurally within the Agency’s objectives and operations, including enhanced monitoring of emerging risks. In this context, the Agency must also contribute to developing cutting-edge scientific knowledge. This is why the report explicitly mandates ECHA to play a role in research on the exposome, and in particular the links between exposure to hazardous chemicals and negative health impacts. Building this scientific understanding is essential if EU public policies are to reflect the real-life combined exposures European citizens face.
Third, the Basic Regulation must ensure more robust governance of ECHA’s resources. I have therefore proposed that the Agency carry out regular assessments of the adequacy between its mandate and its financial and human resources, ensuring that each expansion of tasks is matched with appropriate capacity. These assessments should directly inform the preparation of the annual budget so that political ambition and operational reality are aligned. My report also proposes that ECHA should be able to temporarily assign staff to other institutions, or finance staff or projects in other institutions, such as Member states bodies, in order to reinforce the capacity and contribute to the work of Member States Competent Authorities on tasks related to the Agency’s mandate and their capacity to appoint committee members and experts ECHA needs to mobilize to achieve its goals.
Another major priority is to strengthen the cooperation between EU agencies working on health, food safety, environment and chemicals. Stakeholders and agencies themselves have repeatedly called for more coherence, shared data and better anticipatory capacity. Building on the very positive experience of the Cross-Agency One Health Task Force, my amendments propose to make this collaboration permanent through a structured and durable task force bringing together ECHA, EFSA, EMA, ECDC and EEA. This framework will help develop joint actions, share methodologies and support a common scientific agenda for chemicals safety. It is a concrete step towards a more integrated, transdisciplinary and efficient EU chemicals governance.
In conclusion, this report aims to equip ECHA with the means, clarity of mission and collaborative architecture it needs to meet the expectations of citizens, policymakers and industry alike. A strong, well-resourced and forward-looking ECHA is indispensable for a healthier and safer Europe.
Annex: declaration of input 4 paragraphs
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur declares that he included in his report input on matters pertaining to the subject of the file that he received, in the preparation of the draft report, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
| 1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register |
| ECHA |
| European Environmental Bureau (EEB) |
| ClientEarth |
| Eurogroup for Animals |
| CEFIC |
| COSMETICS EUROPE |
| IFRA (The International Fragrance Association) |
| EFEO (European Federation of Essential Oils) |
| EFFCI (European federation for Cosmetic ingredients) |
| Deutsche Sozialversicherung Europavertretung / German Social Insurance European Representation |
| ECDC |
| DG SANT |
| DG GROW |
| 2. Representatives of public authorities of third countries, including their diplomatic missions and embassies |
The list above is drawn up under the exclusive responsibility of the rapporteur.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur declares that he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.