What changed

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

– having regard to the Commission proposal to Parliament and the Council (COM(2025)0386),

– having regard to Article 294(2) and Article 114114(1) 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 budgetary assessment by the Committee on Budgets,

– 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 assessmentreport byof the Committee on Budgets,the Environment, Climate and Food Safety (A10-0093/2026),

– 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;

Recital 9

Or. en

Justification

This wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)

Amendment 2

Recital 10 a (new)

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

Recital 11

Or. en

Justification

Moved to a new recital.

Amendment 4

Recital 11 a (new)

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)

Recital 13

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

Recital 15 a (new)

Or. en

Amendment 7

Proposal for a regulation

Recital 1916

Or. en

Amendment 8

Proposal for a regulation

Recital 21 a (new)

Recital 18

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)

Recital 19

Or. en

Amendment 10

Proposal for a regulation

Recital 2321 a (new)

Or. en

Amendment 11

Proposal for a regulation

Recital 31

Recital 21 b (new)

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 3123 a (new)

Or. en

Amendment 13

Proposal for a regulation

Article 4 – paragraph 1

Recital 25

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

Recital 26

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)

Recital 31

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

Recital 31 a (new)

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)

Recital 37 a (new)

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 43 – paragraph 5 – point k a (new)1

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 54 – paragraph 1 – point c

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 54 – paragraph 1 – point d2

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 54 – paragraph 15 – point h a (new)b

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 54 – paragraph 15 – point ig a (new)

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 64 – paragraph 15 – point ck a (new)

Or. en

Justification

Alignment with current REACH wording.

Amendment 24

Proposal for a regulation

Article 64 – paragraph 25 – point k b (new)

Or. en

Justification

Alignment with current REACH wording.

Amendment 25

Proposal for a regulation

Article 64 – paragraph 3 – point d5 a (new)

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 65 – paragraph 31 – point d b (new)c

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 65 – paragraph 41 a– (new)point d

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 65 – paragraph 61 – point h a (new)

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 95 – paragraph 1 – point yi

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 106 – paragraph 1 – point c

Or. en

Justification

Editorial

Amendment 31

Proposal for a regulation

Article 106 – paragraph 32

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 126 – paragraph 53 – point db

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 126 – paragraph 53 – point ed a (new)

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 126 – paragraph 5 – point e a (new)4

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 126 – paragraph 5 – point h4 a (new)

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 126 – paragraph 5 – point p a (new)6

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 139 – paragraph 21 – point bs

Or. en

Justification

Editorial

Amendment 38

Proposal for a regulation

Article 139 – paragraph 21 a– (new)point y

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 1310 – paragraph 2 b (new)3

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 1312 – paragraph 3

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 1412 – paragraph 45 a– (new)point d

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 1412 – paragraph 5 – subparagraph 2 – point a – point iv a (new)e

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 1412 – paragraph 5 – subparagraph 2 – point a –e pointa v(new)

Or. en

Justification

This wording is more consistent with other wording used across chemicals legislation (REACH, OSOA, ...)

Amendment 44

Proposal for a regulation

Article 1412 – paragraph 5 – point h a (new)

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 1412 – paragraph 65 – point p a (new)

Or. en

Amendment 46

Proposal for a regulation

Article 1412 – paragraph 76 a (new)

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 1413 – paragraph 92 – point b

Or. en

Amendment 48

Proposal for a regulation

Article 1413 – paragraph 102 a (new)

Or. en

Amendment 49

Proposal for a regulation

Article 1413 – paragraph 122 b (new)

Or. en

Amendment 50

Proposal for a regulation

Article 1413 – paragraph 153

Or. en

Justification

Editorial

Amendment 51

Proposal for a regulation

Article 1514 – paragraph 24

Or. en

Amendment 52

Proposal for a regulation

Article 1514 – paragraph 34 a (new)

Or. en

Amendment 53

Proposal for a regulation

Article 1514 – paragraph 45 – subparagraph 1

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 1514 – paragraph 5 – subparagraph 2 – point a – point iv a (new)

Or. en

Amendment 55

Proposal for a regulation

Article 1614 – paragraph 45 – subparagraph 2 – point a – point v

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 1614 – paragraph 5 – subparagraph 2 – point b

Or. en

Justification

Editorial

Amendment 57

Proposal for a regulation

Article 1714 – paragraph 5 – subparagraph 3

Or. en

Justification

The adoption phase seems to be missing from the original proposal.

Amendment 58

Proposal for a regulation

Article 1914 – paragraph 15 a (new)

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 1914 – paragraph 36

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 1914 – paragraph 37 a (new)

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 2014 – paragraph 59

Or. en

Amendment 62

Proposal for a regulation

Article 2414 – paragraph 210

Or. en

Justification

Editorial

Amendment 63

Proposal for a regulation

Article 2414 – paragraph 312

Or. en

Justification

Editorial

Amendment 64

Proposal for a regulation

Article 2514 – paragraph 415

Or. en

Amendment 65

Proposal for a regulation

Article 2715 – paragraph 1 – introductory part2

Or. en

Justification

Editorial

Amendment 66

Proposal for a regulation

Article 2715 – paragraph 1 – point d a (new)4

Or. en

Amendment 67

Proposal for a regulation

Article 2715 – paragraph 1 – point d b (new)5

Or. en

Amendment 68

Proposal for a regulation

Article 2915 – paragraph 46 a (new)

Or. en

Amendment 69

Proposal for a regulation

Article 2916 – paragraph 64

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 3516 – titleparagraph 5

Or. en

Amendment 71

Proposal for a regulation

Article 3517 – paragraph 2 a (new)5

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 3519 – paragraph 2 b (new)1

Or. en

Amendment 73

Proposal for a regulation

Article 37 a (new)

Article 19 – paragraph 3

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 3819 – paragraph 3 a (new)

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)

Article 27 – paragraph 1 – introductory part

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)

Article 27 – paragraph 1 – point d a (new)

Or. en

Amendment 77

Proposal for a regulation

Article 4227 – paragraph 1 – point d b (new)

Or. en

Justification

Editorial

Amendment 78

Proposal for a regulation

Article 4327 – paragraph 1 – point d c (new)

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 4329 – paragraph 14 a (new)

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 4429 – paragraph 14 b (new)

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 4429 – paragraph 15 a– (new)point a

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 4429 – paragraph 15 b– (new)point b

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 4429 – paragraph 15 – point c a (new)

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 4429 – paragraph 1 d (new)6

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 4430 – paragraph 12 ea (new)

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)

Article 30 a (new)

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)

Article 35 – title

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 4435 – paragraph 12 ha (new)

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 4435 – paragraph 12 ib (new)

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 4437 – paragraph 1 j (new)2

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)

Article 37 a (new)

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 4438 – paragraph 1 l (new)3

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)

Article 41 a (new)

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

Article 41 b (new)

Or. en

Justification

Alignment with 'One Substance One Assessment'

Amendment 95

Proposal for a regulation

Article 4543 – paragraph 31

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 4843 – paragraph 1 – pointa 3(new)

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 4844 – paragraph 1 – point 6

Or. en

Amendment 98

Proposal for a regulation

Article 54 – title

Article 44 – paragraph 1 a (new)

Or. en

Amendment 99

Proposal for a regulation

Article 5444 – paragraph 21 b (new)

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 44 – paragraph 1 c (new)

Amendment 101

Proposal for a regulation

Article 44 – paragraph 1 d (new)

Amendment 102

Proposal for a regulation

Article 44 – paragraph 1 e (new)

Amendment 103

Proposal for a regulation

Article 44 – paragraph 1 f (new)

Amendment 104

Proposal for a regulation

Article 44 – paragraph 1 g (new)

Amendment 105

Proposal for a regulation

Article 44 – paragraph 1 h (new)

Amendment 106

Proposal for a regulation

Article 44 – paragraph 1 i (new)

Amendment 107

Proposal for a regulation

Article 44 – paragraph 1 j (new)

Amendment 108

Proposal for a regulation

Article 44 – paragraph 1 k (new)

Amendment 109

Proposal for a regulation

Article 44 – paragraph 1 l (new)

Amendment 110

Proposal for a regulation

Article 45 – paragraph 2

Amendment 111

Proposal for a regulation

Article 45 – paragraph 3

Amendment 112

Proposal for a regulation

Article 46

Amendment 113

Proposal for a regulation

Article 48 – paragraph 1 – point 3

Amendment 114

Proposal for a regulation

Article 54 – title

Amendment 115

Proposal for a regulation

Article 54 – paragraph 2

Amendment 116

Proposal for a regulation

Article 54 – paragraph 3

Or. en

EXPLANATORY STATEMENT

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.mandate.

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, ECDCECDC, EEA, and EEA.EU-OSHA. 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

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, prior to the adoption thereof in committee, 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:

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.

19.3.2026

BUDGETARY ASSESSMENT OF THE COMMITTEE ON BUDGETS

for the Committee on the Environment, Climate and Food Safety

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

(COM(2025)0386 – C100141/2025 – 2025/0207(COD))

Rapporteur for budgetary assessment: Hélder Sousa Silva

The Committee on Budgets has carried out a budgetary assessment of the proposal under Rule 58 of the Rules of Procedure and has reached the following conclusions:

The Committee on Budgets,

– having regard to Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (Financial Regulation),

– having regard to Council Regulation (EU, Euratom) 2020/2093 of 17 December 2020 laying down the multiannual financial framework for the years 2021 to 2027,

A. whereas this proposal is aimed at strengthening the governance of the European Chemicals Agency (‘the Agency’), while enabling it to effectively perform the tasks assigned to it under existing legislation and allowing its mandate to evolve in line with new responsibilities arising from adopted or forthcoming initiatives;

B. whereas the Agency is partially self-financed, with sources of income deriving from three different regulations; whereas this has required the establishment of three separate budgets and staffing plans, leading to operational inflexibility and a significant administrative burden; whereas the fees received by the Agency are highly volatile and non-linear in terms of amount and timing, mainly as a result of their one-off nature and their dependence on the strategic decisions of chemicals industry players;

C. whereas the Joint Statement of Parliament, the Council and the Commission of 19 July 2012 on decentralised agencies was signed by the three institutions after the creation of the Agency;

D. whereas in 2025, fees charged to industry accounted for around 30 % of the Agency’s general revenues, with fees charged under the REACH Regulation and the CLP Regulation representing the largest share of those fees;

E. whereas revenues from REACH fees are extremely difficult to forecast, as they are usually one-off and there is a reduction of up to 95 % for small and medium-sized enterprises;

F. whereas the Agency currently operates under a universal budgeting model, whereby revenues derived from fees charged to the chemicals industry and the balancing contribution from the EU are not segregated, possibly creating cross-subsidisation between the two;

1. Insists that the resources allocated to the Agency must be in line with the tasks entrusted to it, and notes that, at this stage, the proposal appears to provide sufficient financial and human resources for the planned changes, since the proposal’s estimated financial impact for the remaining period of the current multiannual financial framework (MFF) is limited to EUR 0.577 million in staff expenditure as operational appropriations under Heading 1, and an estimated EUR 2.956 million in administrative appropriations for the post-2027 MFF;

2. Stresses that, should additional responsibilities be granted to the Agency in the course of the negotiations, the financial implications will need to be assessed and the legislative financial and digital statement accompanying the proposal will have to be revised accordingly, in order to ensure that the financial and human resources allocated by the legislative proposal match the tasks entrusted to the Agency;

3. Reiterates that any new tasks entrusted to decentralised agencies should be financed through fresh appropriations, and that redeployments from other programmes and priorities should be limited and examined with due care;

4. Welcomes the abolition of the requirement for segregated budgets and their grouping into a single budget line for the EU budget contribution to the Agency, which simplifies the Agency’s budgeting model, enhances transparency and allows for year-on-year comparison, taking into consideration the additional tasks attributed to the Agency;

5. Welcomes the abolition of the requirement for segregated staffing plans, which removes operational impediments that affect the management of human resources, thus allowing the Agency to better adjust staff allocations in the light of its workload and improving its productivity;

6. Underlines the importance of regularly assessing the level of fees in the light of changes in costs, in line with Commission Delegated Regulation (EU) 2019/715;

7. Considers that, given the volatility of the revenues received by the Agency from fees and charges, the creation of a reserve for the Agency promotes the long-term sustainability of its financial model, increases its resilience to possible future crises and protects the financial interests of the EU’s budget and taxpayers; affirms that the creation of a reserve for the Agency makes it, at present, an exception among partially self-funded EU decentralised agencies, and requires close monitoring of the Agency’s operations as well as assessment in the near future;

8. Determines that the proposal is compatible with the MFF, the system of own resources, the Interinstitutional Agreement of 16 December 2020 and the budgetary principles laid down in the Financial Regulation.

AMENDMENTS

As part of its budgetary assessment, the Committee on Budgets also submits the following amendments to the proposal:

Amendment 1

Proposal for a regulation

Recital 25

Amendment 2

Proposal for a regulation

Recital 38 a (new)

Amendment 3

Proposal for a regulation

Article 29 – paragraph 4 a (new)

Amendment 4

Proposal for a regulation

Article 29 – paragraph 4 b (new)

Amendment 5

Proposal for a regulation

Article 29 – paragraph 5 – point a

Amendment 6

Proposal for a regulation

Article 29 – paragraph 5 – point b

Amendment 7

Proposal for a regulation

Article 29 – paragraph 5 – point c a (new)

Amendment 8

Proposal for a regulation

Article 29 – paragraph 6

Amendment 9

Proposal for a regulation

Article 30 – paragraph 2 a (new)

Amendment 10

Proposal for a regulation

Article 30 a (new)

ANNEX: DECLARATION OF INPUT

Pursuant to Article 8 of Annex I to the Rules of Procedure, The rapporteur for budgetary assessment declares under his exclusive responsibility that he did not include in his budgetary assessment input from interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from representatives of public authorities of third countries, including their diplomatic missions and embassies, to be listed in this Annex pursuant to Article 8 of Annex I to the Rules of Procedure.

PROCEDURE – COMMITTEE ASKED FOR BUDGETARY ASSESSMENT

FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR BUDGETARY ASSESSMENT

PROCEDURE – COMMITTEE RESPONSIBLE

FINAL VOTE BY ROLL CALL BY THE COMMITTEE RESPONSIBLE