Sittings · Document
European Chemicals Agency and amending Regulations (EC) No 1907/2006, (EU) No 528/2012, (EU) No 649/2012 and (EU) 2019/1021
Committee on the Environment, Climate and Food Safety
Amendment 101
Majdouline Sbai
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 and groups thereof, 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 the development and use of non-animal approaches and emerging methodologies. 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
Very similar to AM 1 by the rapporteur, but with the addition of a reference to groups of chemicals and a correction with regard to non-animal approaches.
Amendment 102
Christophe Clergeau
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 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 amendment aims to correct a drafting error in the draft report.
Amendment 103
Per Clausen
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 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, to safeguard and further enhance occupational health standards and promoting 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
Amendment 104
Martin Hojsík, Michal Wiezik
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 and safe use of chemical substances and mixtures in order to achieve a high level of protection of human health, including of the vulnerable population groups, 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. |
Or. en
Amendment 105
Dennis Radtke, Dimitris Tsiodras
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 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 non-animal approaches. |
Or. en
Amendment 106
Pietro Fiocchi
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 and safe use of 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. |
Or. en
Amendment 107
Pietro Fiocchi
Proposal for a regulation
Recital 9 a (new)
| Text proposed by the Commission | Amendment |
| (9 a) Strategic foresight and robust impact assessments of proposed restrictions under Regulation (EC) No 1907/2006, including the assessment of scientific, economic, social, environmental, and geopolitical implications, are essential to ensure informed, proportionate, and effective regulatory decision-making at Union level and to preserve the competitiveness, resilience, and sustainability of the Union’s chemical sector. Such assessments should be based on the best available scientific evidence and reliable data and should consider cumulative and cross-sectoral effects, including impacts on innovation, supply chains, and strategic autonomy. Where the Agency plans or prepares a restriction under Regulation (EC) No 1907/2006, it should prepare, conduct, submit, and publish such impact assessments as part of the preparatory work. In addition, upon request from the European Parliament, the Agency should prepare, conduct, submit, and publish such impact assessments in due time to enable meaningful assessment of the necessity, proportionality, and overall impacts of the proposed restriction under Regulation (EC) No 1907/2006, including its scientific, economic, social, environmental, and geopolitical implications. |
Or. en
Amendment 108
Pietro Fiocchi
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 take into account the experience gained from the Agency’s functioning and performance since its establishment. The Agency’s structure should enable efficient performance while remaining resilient to changes in scope and workload. 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. To maintain confidence in chemicals legislation, the Agency should ensure that its scientific assessments and decision-making processes are transparent, credible, and trusted by all stakeholders and the public. Such trust depends on the independence of the Agency and its Committees, including RAC, SEAC, MSC, the Scientific Committee on Consumer Safety (SCCS), and the Biocidal Products Committee (BPC). Clear and effective rules are therefore required to prevent and manage conflicts of interest. Individuals should not be appointed to Committees where reasonable concerns about conflicts of interest exist. |
Or. en
Amendment 109
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
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. 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 by presenting its activities and their results in a comprehensible and, where possible, quantifiable manner and communicating them regularly to the public. |
Or. en
Amendment 110
Pietro Fiocchi
Proposal for a regulation
Recital 12
| Text proposed by the Commission | Amendment |
| (12) In the interest of efficiency, the staff of the Agency’s Secretariat should be able to perform technical and administrative tasks in support of RAC, SEAC, MSC,Scientific Committee on Consumer Safety (‘SCCS’)10 ,, Biocidal Products Committee (‘BPC’) (collectively, the ‘Committees’), and the Forum. | (12) In the interest of efficiency, the staff of the Agency’s Secretariat should be able to perform technical and administrative tasks in support of the Committees and the Forum, while fully preserving the Committees’ independence and maintaining a clear separation of responsibilities. |
| _________________ | |
| 10 The Scientific Committee on Consumer Safety was established by Commission Decision (EU) 2024/1514 of 7 August 2015 on establishing Scientific Committees in the field of public health, consumer safety and the environment, OJ L, 2024/1514, 31.5.2024, ELI: http://data.europa.eu/eli/dec/2024/1514/oj. |
Or. en
Amendment 111
Per Clausen
Proposal for a regulation
Recital 13
| Text proposed by the Commission | Amendment |
| (13) The Management Board of the Agency should be entrusted with the necessary powers, in particular to appoint the Executive Director, the members of RAC and SEAC and of the Board of Appeal, and to adopt the consolidated annual activity report, the programming document, the annual budget, and the financial rules applicable to the Agency. The Commission, the European Parliament, and the Member States should be represented within the Management Board in order to effectively exercise oversight over it. In the interests of transparency, interested parties without voting rights should be appointed to the Management Board by the Commission. | (13) The Management Board of the Agency should be entrusted with the necessary powers, in particular to appoint the Executive Director, the members of RAC and SEAC and of the Board of Appeal, and to adopt the consolidated annual activity report, the programming document, the annual budget, and the financial rules applicable to the Agency. The Commission, the European Parliament, and the Member States should be represented within the Management Board in order to effectively exercise oversight over it. In the interests of transparency, interested parties without voting rights who together represent a wide range of relevant interests should be appointed to the Management Board by the Commission. |
Or. en
Amendment 112
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Recital 15 a (new)
| Text proposed by the Commission | Amendment |
| (15 a) The Agency's role as an independent scientific point of reference means that a scientific opinion may 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 this and on the basis of predetermined criteria. |
Or. en
Justification
Agency should be allowed to provide scientific opinions also on the request of the Parliament and the Member States. This provision mirrors the mandate given to the EFSA in the General Food Law (Regulation (EC) No 178/2002).
Amendment 113
Per Clausen
Proposal for a regulation
Recital 16
| Text proposed by the Commission | Amendment |
| (16) RAC has, provided 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 in the context of Article 3 of Council Directive 98/24/EC11 . Articles 16, 16a and 18a of Directive 2004/37/EC of the European Parliament and of the Council12 and Articles 18c and 22a of Directive 2009/148/EC of the European Parliament and of the Council13 on the basis of an ad hoc agreement between the Commission and the Agency in the past. Since this task has become customary and in order to consolidate that practice, this Regulation should establish that RAC should provide such opinions upon request from the Commission. In addition, RAC should, upon a request from the Commission, provide scientific opinions on all other matters 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. | (16) RAC has, provided 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 in the context of Article 3 of Council Directive 98/24/EC11 . Articles 16, 16a and 18a of Directive 2004/37/EC of the European Parliament and of the Council12 and Articles 18c and 22a of Directive 2009/148/EC of the European Parliament and of the Council13 on the basis of an ad hoc agreement between the Commission and the Agency in the past. Since this task has become customary and in order to consolidate that practice, this Regulation should establish that RAC should provide such opinions upon request from the Commission. In addition, RAC should, upon a request from the Commission, the European Parliament or the Member States provide scientific opinions on all other matters 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. |
| _________________ | _________________ |
| 11 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p.11, ELI: http://data.europa.eu/eli/dir/1998/24/oj). | 11 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p.11, ELI: http://data.europa.eu/eli/dir/1998/24/oj). |
| 12 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50, ELI: http://data.europa.eu/eli/dir/2004/37/oj). | 12 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50, ELI: http://data.europa.eu/eli/dir/2004/37/oj). |
| 13 Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p.28, ELI: http://data.europa.eu/eli/dir/2009/148/oj). | 13 Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p.28, ELI: http://data.europa.eu/eli/dir/2009/148/oj). |
Or. en
Amendment 114
Pietro Fiocchi
Proposal for a regulation
Recital 16
| Text proposed by the Commission | Amendment |
| (16) RAC has, provided 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 in the context of Article 3 of Council Directive 98/24/EC11 . Articles 16, 16a and 18a of Directive 2004/37/EC of the European Parliament and of the Council12 and Articles 18c and 22a of Directive 2009/148/EC of the European Parliament and of the Council13 on the basis of an ad hoc agreement between the Commission and the Agency in the past. Since this task has become customary and in order to consolidate that practice, this Regulation should establish that RAC should provide such opinions upon request from the Commission. In addition, RAC should, upon a request from the Commission, provide scientific opinions on all other matters 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. | (16) RAC has provided 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 in the context of Article 3 of Council Directive 98/24/EC11 . Articles 16, 16a and 18a of Directive 2004/37/EC of the European Parliament and of the Council12 and Articles 18c and 22a of Directive 2009/148/EC of the European Parliament and of the Council13 on the basis of an ad hoc agreement between the Commission and the Agency in the past. Since this task has become customary and in order to consolidate that practice, this Regulation should establish that RAC should provide such opinions upon request from the Commission. In addition, RAC should, upon a request from the Commission, provide scientific opinions on all other matters 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. |
| _________________ | _________________ |
| 11 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p.11, ELI: http://data.europa.eu/eli/dir/1998/24/oj). | 11 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p.11, ELI: http://data.europa.eu/eli/dir/1998/24/oj). |
| 12 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50, ELI: http://data.europa.eu/eli/dir/2004/37/oj). | 12 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p.50, ELI: http://data.europa.eu/eli/dir/2004/37/oj). |
| 13 Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p.28, ELI: http://data.europa.eu/eli/dir/2009/148/oj). | 13 Directive 2009/148/EC of the European Parliament and of the Council of 30 November 2009 on the protection of workers from the risks related to exposure to asbestos at work (OJ L 330, 16.12.2009, p.28, ELI: http://data.europa.eu/eli/dir/2009/148/oj). |
Or. en
Justification
Use of the term “substances” is recommended to maintain alignment with the definitions and terminology laid down in Regulation (EC) No 1907/2006 (REACH).
Amendment 115
Dennis Radtke, Dimitris Tsiodras
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 approve the rules of procedure, without compromising the independence of the Committees and their working groups, and ensure their correct implementation. |
Or. en
Amendment 116
Pietro Fiocchi
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 and working groups. In order for the Commission to exercise its oversight, the Commission representatives in the Management Board should be consulted on the rules of procedure, without compromising the independence of the Committees and their working groups. |
Or. en
Amendment 117
Pietro Fiocchi
Proposal for a regulation
Recital 18 a (new)
| Text proposed by the Commission | Amendment |
| (18 a) The rules of procedure of the Committees should lay down measures for the identification, prevention, and management of conflicts of interest. |
Or. en
Amendment 118
Daniel Buda, Dan-Ştefan Motreanu
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 one member for RAC and SEAC respectively and should be entitled to nominate up to three additional members. Member States are encouraged to nominate more than one candidate. Member States should continue to be able to nominate persons from any nationality as members of RAC and SEAC. There is no requirement of nationality, or employment as public servants. The nominees should meet the requirements of membership of RAC and SEAC. Upon request from a Member State, the Agency should facilitate finding suitable candidates for RAC and SEAC. If the Agency considers it appropriate, it can establish a list of qualified candidates that could be nominated by Member States for RAC and SEAC. 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. |
Or. en
Amendment 119
Per Clausen
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. The composition of the Committee should be aligned with the knowledge and skills necessary to effectively carry out the Agency’s responsibilities. |
Or. en
Justification
As the Basic Regulation assigns the Committee for Risk Assessment (RAC) a role in establishing occupational exposure limits, it is crucial to involve Member States and relevant scientific bodies at an early and meaningful stage of the EU decision-making process. Levels of protection against chemical and hazardous substance exposure differ across groups, including workers, vulnerable populations, the general public, and the environment. Risk management should therefore be based on exposure-specific assessments rather than uniform approaches that overlook real-world conditions. Drawing on national expertise and scientific evidence in the limit-setting process is essential to ensure that occupational exposure limits achieve effective protection while remaining practically achievable.
Amendment 120
Martin Hojsík, Michal Wiezik
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, who have the necessary expertise and experience, 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, geographical balance and availability of financial resources. |
Or. en
Amendment 121
Pietro Fiocchi
Proposal for a regulation
Recital 19 a (new)
| Text proposed by the Commission | Amendment |
| (19 a) Where a Member State does not make the required nominations for RAC and SEAC within a period of one year, the European Parliament should appoint, on the basis of proven scientific and technical expertise, the members necessary to fill the vacant positions on behalf of that Member State. Such appointments should be made in a transparent manner, with due regard to geographical balance and the avoidance of conflicts of interest. |
Or. en
Amendment 122
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Recital 21 a (new)
| Text proposed by the Commission | Amendment |
| (21 a) A Review Panel should be set up within the Agency to guarantee processing of objections on scientific and technical opinions for any natural or legal person affected by opinions taken by the Agency. |
Or. en
Justification
Addition of a mandate for a Review Panel as described in the proposal for a new Article 25a.
Amendment 123
Per Clausen
Proposal for a regulation
Recital 23 a (new)
| Text proposed by the Commission | Amendment |
| (23 a) 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 across the Agency’s main task areas, ensuring that Union priorities are effectively supported with the appropriate expertise and capacity. |
Or. en
Justification
This amendment is ensuring that Union priorities are not merely aspirational, but are actively incorporated into the Agency’s core programming and capacity planning.
Amendment 124
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Recital 23 a (new)
| Text proposed by the Commission | Amendment |
| (23 a) To prevent setting of negative priorities and to achieve solid performance of the Agency, 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 expenditure. 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 125
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Recital 24
| Text proposed by the Commission | Amendment |
| (24) The financial and administrative framework in which the Agency operates is more complex than for other Union agencies16 , as the Agency is partially financed by fees for its activities under Regulation (EC) No 1907/2006, Regulation (EC) No 1272/200817 and Regulation (EU) No 528/2012 and as it currently has three separate budgets under Regulation (EC) No 1907/2006, under Regulation (EU) No 528/2012, as well as under Regulations (EU) No 649/201218 and (EU) 2019/102119 . To simplify the Agency’s financing model, the requirement for segregated budgets established under Regulation (EU) No 528/2012, Regulation (EU) No 649/2012, and Regulation (EU) 2019/1021 should be abolished, by deleting the relevant provisions in those Regulations, so that the Agency receives one unitary annual contribution from the Union budget. This will allow for more flexibility for the Agency to address workload fluctuations and will respond to the recommendations of the Court of Auditors and to the objective of the CSS to increase the sustainability of the Agency’s financing model. The removal of the segregation of budgets should not affect existing obligations of financial contributions by third countries to the Agency. | (24) The financial and administrative framework in which the Agency operates is more complex than for other Union agencies16 , as the Agency is partially financed by fees for its activities under Regulation (EC) No 1907/2006, Regulation (EC) No 1272/200817 and Regulation (EU) No 528/2012 and as it currently has three separate budgets under Regulation (EC) No 1907/2006, under Regulation (EU) No 528/2012, as well as under Regulations (EU) No 649/201218 and (EU) 2019/102119 . To simplify the Agency’s financing model, the requirement for segregated budgets established under Regulation (EU) No 528/2012, Regulation (EU) No 649/2012, and Regulation (EU) 2019/1021 should be abolished, by deleting the relevant provisions in those Regulations, so that the Agency receives one unitary annual contribution from the Union budget. This will allow for more flexibility for the Agency to address workload fluctuations and will respond to the recommendations of the Court of Auditors and to the objective of the CSS to increase the sustainability of the Agency’s financing model. The removal of the segregation of budgets should not affect existing obligations of financial contributions by third countries to the Agency and should not lead to additional expenditure being incurred without justification. Rather, the principle of cost efficiency applies, according to which the highest possible output should be achieved with the least possible use of resources, without compromising the quality of the results. |
| _________________ | _________________ |
| 16 European Court of Auditors, Future of EU agencies, potential for more flexibility and cooperation, Special Report (2020), doi:10.2865/36103. | 16 European Court of Auditors, Future of EU agencies, potential for more flexibility and cooperation, Special Report (2020), doi:10.2865/36103. |
| 17 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). | 17 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). |
| 18 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p.60, ELI: http://data.europa.eu/eli/reg/2012/649/oj). | 18 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p.60, ELI: http://data.europa.eu/eli/reg/2012/649/oj). |
| 19 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p.45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj). | 19 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p.45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj). |
Or. en
Amendment 126
Pietro Fiocchi
Proposal for a regulation
Recital 24
| Text proposed by the Commission | Amendment |
| (24) The financial and administrative framework in which the Agency operates is more complex than for other Union agencies16 , as the Agency is partially financed by fees for its activities under Regulation (EC) No 1907/2006, Regulation (EC) No 1272/200817 and Regulation (EU) No 528/2012 and as it currently has three separate budgets under Regulation (EC) No 1907/2006, under Regulation (EU) No 528/2012, as well as under Regulations (EU) No 649/201218 and (EU) 2019/102119 . To simplify the Agency’s financing model, the requirement for segregated budgets established under Regulation (EU) No 528/2012, Regulation (EU) No 649/2012, and Regulation (EU) 2019/1021 should be abolished, by deleting the relevant provisions in those Regulations, so that the Agency receives one unitary annual contribution from the Union budget. This will allow for more flexibility for the Agency to address workload fluctuations and will respond to the recommendations of the Court of Auditors and to the objective of the CSS to increase the sustainability of the Agency’s financing model. The removal of the segregation of budgets should not affect existing obligations of financial contributions by third countries to the Agency. | (24) The financial and administrative framework in which the Agency operates is more complex than for other Union agencies16 , as the Agency is partially financed by fees for its activities under Regulation (EC) No 1907/2006, Regulation (EC) No 1272/200817 and Regulation (EU) No 528/2012 and as it currently has three separate budgets under Regulation (EC) No 1907/2006, under Regulation (EU) No 528/2012, as well as under Regulations (EU) No 649/201218 and (EU) 2019/102119 . To simplify the Agency’s financing model, the requirement for segregated budgets established under Regulation (EU) No 528/2012, Regulation (EU) No 649/2012, and Regulation (EU) 2019/1021 should be abolished, by deleting the relevant provisions in those Regulations, so that the Agency receives one unitary annual contribution from the Union budget. This will allow for more flexibility for the Agency to address workload fluctuations and will respond to the recommendations of the Court of Auditors and to the objective of the CSS to increase the sustainability of the Agency’s financing model. For the purposes of ensuring transparency, the Agency should carry out activity-based monitoring of revenue derived from fees and charges. The removal of the segregation of budgets should not affect existing obligations of financial contributions by third countries to the Agency. |
| _________________ | _________________ |
| 16 European Court of Auditors, Future of EU agencies, potential for more flexibility and cooperation, Special Report (2020), doi:10.2865/36103. | 16 European Court of Auditors, Future of EU agencies, potential for more flexibility and cooperation, Special Report (2020), doi:10.2865/36103. |
| 17 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). | 17 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj). |
| 18 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p.60, ELI: http://data.europa.eu/eli/reg/2012/649/oj). | 18 Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicals (OJ L 201, 27.7.2012, p.60, ELI: http://data.europa.eu/eli/reg/2012/649/oj). |
| 19 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p.45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj). | 19 Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p.45, ELI: http://data.europa.eu/eli/reg/2019/1021/oj). |
Or. en
Amendment 127
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Recital 25
| Text proposed by the Commission | Amendment |
| (25) The Agency has experienced difficulties to accurately predict the income from fees and charges even with the most advanced statistical techniques due to the paucity of information on the drivers of demand from duty holders. This impacts the operations of the Agency and requires recurrent amendments to the budget by the Management Board. Therefore, the Agency should be allowed to create a reserve from the surplus of its revenues from fees and charges, subject to the conditions set out in this Regulation. This will allow the Agency to mitigate the consequences of large fluctuation in income from fees and charges. Specifically, the creation of such reserve will allow the Agency to increase the sustainability of its financing model without prejudice to the annual Union contribution and multiannual financial programming. The detailed rules on the parameters, the calculation and the operation of the reserve should be laid down in the Agency’s financial rules and should include the requirements set out in this Regulation. The calculation of the amount of the annual contribution to the reserve or of the amount made available from the reserve, to be included in the draft budget of the Agency, should follow a methodology mechanically applied by the Agency every year. | (25) The Agency has experienced difficulties to accurately predict the income from fees and charges even with the most advanced statistical techniques due to the paucity of information on the drivers of demand from duty holders. The Agency commits to continuously improve its forecasting methods. This impacts the operations of the Agency and requires recurrent amendments to the budget by the Management Board. Therefore, the Agency should be allowed to create a reserve from the surplus of its revenues from fees and charges, subject to the conditions set out in this Regulation. This will allow the Agency to mitigate the consequences of large fluctuation in income from fees and charges. Specifically, the creation of such reserve will allow the Agency to increase the sustainability of its financing model without prejudice to the annual Union contribution and multiannual financial programming. The detailed rules on the parameters, the calculation and the operation of the reserve should be laid down in the Agency’s financial rules and should include the requirements set out in this Regulation. The calculation of the amount of the annual contribution to the reserve or of the amount made available from the reserve, to be included in the draft budget of the Agency, should follow a methodology mechanically applied by the Agency every year. While setting up reserve budget for the Agency is necessary due to its unique financing structure, it does not set a precedent for other EU agencies. |
Or. en
Amendment 128
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Recital 28
| Text proposed by the Commission | Amendment |
| (28) Union citizens should have access to information about chemicals to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. The Agency should therefore provide the public with adequate information pertaining to the hazards, risks and safe use of chemicals. | (28) Union citizens should have access to information about chemicals and mixtures to which they may be exposed, in order to allow them to make informed decisions about their use of chemicals. The Agency should therefore provide the public with adequate and accessible information pertaining to the hazards, risks and safe use of chemicals and their mixtures. |
Or. en
Amendment 129
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Recital 30
| Text proposed by the Commission | Amendment |
| (30) The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its tasks, notably to avoid duplication of work and to ensure access to all data and tools needed for achieving its objectives. In particular, the Agency should cooperate with the European Centre for Disease Prevention and Control, the European Environmental Agency, the European Food Safety Authority, the European Medicines Agency and the European Agency for Safety and Health at Work, to ensure coherence and efficiency of assessments related to chemicals across Union legislation, in line with the ‘One Substance, One Assessment’ approach. Since past cases of divergent opinions have led to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision-making, procedures for the resolution of divergences between scientific opinions between Union agencies should be reinforced. | (30) The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its tasks, notably to avoid duplication of work and to ensure access to all data and tools needed for achieving its objectives. In particular, the Agency should cooperate with the relevant authorities of the Member States, the European Centre for Disease Prevention and Control, the European Environmental Agency, the European Food Safety Authority, the European Medicines Agency and the European Agency for Safety and Health at Work, to ensure coherence and efficiency of assessments related to chemicals across Union legislation, in line with the ‘One Substance, One Assessment’ approach. Since past cases of divergent opinions have led to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision-making, procedures for the resolution of divergences between scientific opinions between Union agencies should be reinforced. |
Or. en
Amendment 130
Per Clausen
Proposal for a regulation
Recital 30
| Text proposed by the Commission | Amendment |
| (30) The Agency should cooperate closely with relevant international organisations, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its tasks, notably to avoid duplication of work and to ensure access to all data and tools needed for achieving its objectives. In particular, the Agency should cooperate with the European Centre for Disease Prevention and Control, the European Environmental Agency, the European Food Safety Authority, the European Medicines Agency and the European Agency for Safety and Health at Work, to ensure coherence and efficiency of assessments related to chemicals across Union legislation, in line with the ‘One Substance, One Assessment’ approach. Since past cases of divergent opinions have led to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision-making, procedures for the resolution of divergences between scientific opinions between Union agencies should be reinforced. | (30) The Agency should cooperate closely with relevant international organisations, trade unions, other governmental and non-governmental bodies and relevant technical bodies from inside and outside the Union in the implementation of its tasks, notably to avoid duplication of work and to ensure access to all data and tools needed for achieving its objectives. In particular, the Agency should cooperate with the European Centre for Disease Prevention and Control, the European Environmental Agency, the European Food Safety Authority, the European Medicines Agency and the European Agency for Safety and Health at Work, to ensure coherence and efficiency of assessments related to chemicals across Union legislation, in line with the ‘One Substance, One Assessment’ approach. Since past cases of divergent opinions have led to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision-making, procedures for the resolution of divergences between scientific opinions between Union agencies should be reinforced. |
Or. en
Amendment 131
Majdouline Sbai
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 the substitution of harmful chemicals and groups of harmful chemicals, and in the development of scientific methods, notably non-animal approaches and emerging methodologies, to assess hazards of chemicals and groups of chemicals as well as risks and socioeconomic 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 should not only be promoted for all harmful chemicals, but also for groups of harmful chemicals. Referring to groups of chemicals is also an alignment with the wording in the new Regulation on a Common data platform which refers to chemicals and groups of chemicals. Alignment with the wording in the Commission proposal in Article 14(5)(2)(a)(v), which also refers to emerging methodologies.
Amendment 132
Martin Hojsík, Michal Wiezik
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 harmful chemicals and their mixtures, simplifying the process and preventing regrettable substitution by making use of group approach, and in the development of scientific methods, non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. |
Or. en
Amendment 133
Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas
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 those chemicals proven to cause harm in the context of specific uses and applications 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. |
Or. en
Amendment 134
Per Clausen
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 chemicals and other hazardous chemicals, and groups of those, 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. |
Or. en
Justification
It is important to enable the regulation of groups of chemicals, as this ensures that chemicals with similar properties cannot simply be used as alternatives. This makes regulation more effective.
Amendment 135
Jorge Buxadé Villalba
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 development of scientific methods to assess hazards of chemicals as well as risks and socio-economic impacts of their use, including the socio-economic impacts of their potential substitution. |
Or. en
Amendment 136
Dennis Radtke, Dimitris Tsiodras
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 chemicals and in the development and prioritisation of non-animal approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. |
Or. en
Amendment 137
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Recital 32
| Text proposed by the Commission | Amendment |
| (32) To ensure that the Agency achieves its objectives in an efficient and effective manner and that it has the necessary means to fulfil its tasks, the Commission should conduct an evaluation of the Agency’s work on a regular basis and its mandate should be adapted accordingly, if needed. | (32) To ensure that the Agency achieves its objectives in an efficient and effective manner and that it has the necessary means to fulfil its tasks, the Commission should conduct an evaluation of the quality and effectiveness of the Agency’s work on a regular basis including, where possible, measurable, quantifiable criteria regarding the Agency's activities and results, and its mandate should be adapted accordingly, if needed. |
Or. en
Amendment 138
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Recital 37
| Text proposed by the Commission | Amendment |
| (37) The objectives of this Regulation, namely the effective and sustainable governance of the Agency, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level. The Union may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, | (37) If Member States identify incompatibilities with the principle of subsidiarity when applying this Regulation, the Union should adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives, |
Or. en
Amendment 139
Per Clausen
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
Amendment 140
Martin Hojsík, Michal Wiezik
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
Following rapporteur´s point on alignment with the "OSOA" package, Article 13 of the Common Data Platform on Chemicals.
Amendment 141
Pietro Fiocchi
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, within its remit, to the implementation and enforcement of Union legislation and policies related to the hazards, risks and safe use of substances, mixtures and articles. It shall provide scientific opinions and advice, as well as independent information, on matters within that field and communicate on those matters. |
Or. en
Amendment 142
Majdouline Sbai
Proposal for a regulation
Article 4 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. 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. | 2. 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 substitution of harmful chemicals and groups of harmful chemicals |
| and the development and use of non-animal approaches and emerging methodologies. | |
| _________________ | _________________ |
| 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
Alignment with the wording in the Commission proposal in Article 14(5)(2)(a)(v), which also refers to emerging methodologies. The objectives of the Agency should also include the promotion of harmful chemicals and groups thereof.
Amendment 143
Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas
Proposal for a regulation
Article 4 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. 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. | 2. 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 the assessment of hazards and of risks of specific uses and applications of chemicals, and in risk 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 enterprises and promoting alternatives to animal testing. |
| _________________ | |
| 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 key principle of “risk-based decision-making” should be added.
Amendment 144
Per Clausen
Proposal for a regulation
Article 4 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. 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. | 2. In the fulfilment of its objectives, the Agency shall aim to contribute to a high level of protection of human health and the environment, including the protection of vulnerable groups. |
| The Agency shall deliver quality, coherence and consistency in chemicals assessment and management across the Union, which is essential to the free circulation of substances in the internal market, while safeguarding and further enhance occupational health standards, contributing to 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, facilitate the use of non-animal approaches, as well as creating alternatives to the most harmful and other hazardous chemicals. | |
| _________________ | _________________ |
| 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
It is necessary to create alternative to hazardous chemicals. This will further contribute to innovation and the goals in the CSS strategy. This amendment holds ECHA accountable for leading the transition to non-animal testing.
Amendment 145
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 4 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. 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. | 2. In the fulfilment of its objectives, the Agency shall contribute to a high level of protection of human health and the environment, paying attention to vulnerable groups, 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 , promoting and deepening expertise and cooperation in alternatives to animal testing and the substitution of harmful chemicals and their groups. |
| _________________ | _________________ |
| 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
Amendment 146
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 4 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. 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. | 2. 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 the development, regulatory acceptance, 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
Amendment 147
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 4 – paragraph 5 – introductory part
| Text proposed by the Commission | Amendment |
| 5. The Agency shall have the following general tasks: | 5. In line with the principles enshrined in Article 191 TFEU, the Agency shall have the following general tasks: |
Or. en
Amendment 148
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – point b
Regulation on the European Chemicals Agency (ECHA) COM(2025)386
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, occupational health standards, the specific needs of SMEs and the requirement of replacing animal testing with non-animal approaches where scientifically possible; |
Or. en
Justification
Replacing animal testing with non-animal approaches is not just a policy aim, but a compulsory legal requirement under EU law requirement under Union law—most notably REACH and Directive 2010/63/EU.
Amendment 149
Dennis Radtke, Dimitris Tsiodras
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 specific needs of SMEs and the requirement of replacing animal testing with appropriate non-animal approaches. |
Or. en
Amendment 150
Pietro Fiocchi
Proposal for a regulation
Article 4 – paragraph 5 – point c a (new)
| Text proposed by the Commission | Amendment |
| (c a) where the Agency plans or prepares a restriction under Regulation (EC) No 1907/2006 on substances, mixtures or articles, the Committees shall, as part of the preparatory work, prepare, conduct, submit and publish a comprehensive impact assessment. Where the European Parliament so requests, the Committees shall do so as a matter of priority and in due time to enable a meaningful assessment of the necessity, proportionality and impacts of the proposed restriction under Regulation (EC) No 1907/2006. The impact assessment shall be based on the best available scientific evidence and reliable data and shall assess, in a proportionate manner, the scientific, economic, social, environmental and geopolitical implications of that proposed restriction, including cumulative and cross-sectoral effects and impacts on innovation, global and Union supply chains, availability, trade flows, regulatory divergence, strategic dependencies and the Union’s strategic autonomy. In order to support strategic foresight and ensure timely preparation of potential restrictions under Regulation (EC) No 1907/2006, the Committees may, within their mandate, also undertake such impact assessments on their own initiative where emerging developments are likely to become relevant for future regulatory action. |
Or. en
Justification
This amendment strengthens the analytical capacity of the Agency by enabling it to assess the broader impacts of restrictions under Regulation (EC) No 1907/2006 (REACH), including socioeconomic, supply-chain and strategic effects. It supports evidence-based and proportionate Union decision-making, enhances regulatory coherence within the REACH framework, and contributes to the resilience, competitiveness and strategic autonomy of the Union, without affecting the scientific risk assessment procedures established under REACH or under other sectoral Union legislation.
Amendment 151
Pietro Fiocchi
Proposal for a regulation
Article 4 – paragraph 5 – point e
| Text proposed by the Commission | Amendment |
| (e) upon request by the Commission, provide scientific and technical assistance in any field within its competence, in the form of scientific or technical work involving the application of well-established scientific or technical principles not requiring scientific evaluation by the Committees or the working groups of those committees; | (e) upon request by the Commission, provide, within its mandate and scope of expertise, scientific and technical assistance in any field within its competence, in the form of scientific or technical work involving the application of well-established scientific or technical principles not requiring scientific evaluation by the Committees or the working groups of those committees; |
Or. en
Amendment 152
Pietro Fiocchi
Proposal for a regulation
Article 4 – paragraph 5 – point h
| Text proposed by the Commission | Amendment |
| (h) engage with relevant stakeholders as appropriate in matters falling within its competences; | (h) engage, as appropriate, with relevant stakeholders on matters within its competences and in relevant processes, including processes supporting the assessment of substances not mandated by legislation; |
Or. en
Justification
In addition to its legally mandated responsibilities, ECHA undertakes activities that are not explicitly laid down in EU legislation but support the implementation of legally defined tasks. ECHA should ensure that stakeholders are consulted as part of any informal decision-making processes.
Amendment 153
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 4 – paragraph 5 – point h a (new)
| Text proposed by the Commission | Amendment |
| (h a) engage with companies affected by matters falling within its competences in direct contacts upon request of the company concerned. |
Or. en
Justification
Companies have diverse obligations under EU legislation and specific cases might be quite complex. Thus, they need an option for direct (oral) dialogue with ECHA staff to support proper understanding of specific case-related obligations and allow them to take best informed decisions on content of submissions. This is relevant for elaboration of dossiers and other submissions as well as drafting of comments to ECHA’s draft decisions, contributions to consultations etc.
Amendment 154
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Article 4 – paragraph 5 – point i
| Text proposed by the Commission | Amendment |
| (i) collaborate with other Union agencies and national authorities as appropriate for the fulfilment of its tasks, in accordance with Articles 40 and 44; | (i) collaborate with national authorities and other Union agencies as appropriate for the fulfilment of its tasks, in accordance with Articles 40 and 44; |
Or. en
Amendment 155
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – point k a (new)
| Text proposed by the Commission | Amendment |
| (k a) upon request from the European Parliament and the Member States, provide scientific opinions and technical assistance in a field falling within its competence |
Or. en
Justification
The Agency should serve as an independent reference point within the EU institutions and contribute to a science‑based democratic decision‑making process in the field of chemicals.
Amendment 156
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 4 – paragraph 5 – point k a (new)
| Text proposed by the Commission | Amendment |
| (k a) upon request from the European Parliament or a Member State, issue a scientific opinion on a matter falling within its mission. |
Or. en
Justification
Copying the possibility provided for under the General Food Law towards EFSA. Additional amendment allows the Agency to reject the request, if the request is unsubstantiated or outside of the responsibilities of the Agency.
Amendment 157
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – point k b (new)
| Text proposed by the Commission | Amendment |
| (k b) promote expertise in non-animal approaches and emerging methodologies |
Or. en
Justification
Promoting non-animal approaches should be important for the Agency, and the Agency should act as a central point for emerging knowledge in the area of non-animal testing.
Amendment 158
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – point k b (new)
| Text proposed by the Commission | Amendment |
| (k c) accompany any refusal to accept a non-animal testing method by a reasoned justification. |
Or. en
Justification
It is crucial that any study involving animals, which is commissioned, be justified in a transparent manner
Amendment 159
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – point k c (new)
| Text proposed by the Commission | Amendment |
| (k d) ensure that staff and committee members undergo yearly training in non-animal methods. |
Or. en
Amendment 160
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – point k d (new)
| Text proposed by the Commission | Amendment |
| (k e) ensure that registrants have access to a forum to discuss potential approaches to non-animal methods and to obtain early clarification of regulatory requirements |
Or. en
Justification
Will make sure animal testing is last resort.
Amendment 161
Per Clausen
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 7 (new)
| Text proposed by the Commission | Amendment |
| The Agency shall establish and keep up-to-date a register containing information about all requests received under points (c), (d), (e), (k) and (ka) of this paragraph. The register shall be published on the Agency's website. The website shall also indicate the progress achieved regarding each request. |
Or. en
Justification
This will ensure transparency for the civil society like the public, scientists and NGOs. Further this will also ensure simplification by helping avoid similar requests and the additional workload.
Amendment 162
Majdouline Sbai
Proposal for a regulation
Article 4 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 5 a. The Agency shall establish and maintain a register on its website of the requests it receives. The Agency shall enter into the register any request received under points (c), (d), (e), (k), and (ka) of paragraph 5 of this Article and in Article 13(2), point (b) within three weeks of receipt. The register shall indicate the status of the processing of each request. The public shall have free and unrestricted access to the register on the Agency’s website. |
Or. en
(Linked partially to the amendment by the rapporteur introducing a new Article 13(2b).)
Justification
To ensure transparency of the work of the Agency, a register of all requests that it receives pursuant to relevant provisions of this Article as well as of requests from the European Parliament or Member States. This would also help avoiding double requests.
Amendment 163
Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas
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 related to risks and hazards of chemicals to human health or the environment, with a sufficient level of specificity about chemicals’ uses and applications as to enable the grading of restriction measures to those who pose an actual risk; |
Or. en
Justification
The RAC mandate should include assessments of risks beyond hazards.
Amendment 164
Martin Hojsík, Michal Wiezik
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
Amendment 165
Martin Hojsík, Michal Wiezik
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 substances and their mixtures; |
Or. en
Amendment 166
Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas
Proposal for a regulation
Article 5 – paragraph 1 – point h a (new)
| Text proposed by the Commission | Amendment |
| (h a) 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; when initiating its assessments, the Agency shall seek the contribution and opinion of interested parties through public call for data, and in particular to solicit the submission of use/application specific data as to enable risk assessments with a high degree of specificity. |
Or. en
Justification
It would be worth to set expectations about the systematic involvement of all interested stakeholders in the review of hazards and risk assessments of the Agency.
Amendment 167
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 5 – paragraph 1 – point j a (new)
| Text proposed by the Commission | Amendment |
| (j a) an Appraisal Panel, which shall decide on objections (review requests) against opinions or decisions taken by the Agency, including its Committees, where no right of appeal is established in sectoral Union legislation. |
Or. en
Justification
Addition of mandates for a Review Panel and a Data Owner Forum as described in proposals for new Articles 25a
Amendment 168
Pietro Fiocchi
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
Aligns with Article 79 of Regulation (EC) No 1907/2006 (REACH).
Amendment 169
Martin Hojsík, Michal Wiezik
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 persons appointed by the European Parliament. |
Or. en
Justification
Alignment with point (b).
Amendment 170
Pietro Fiocchi
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 the 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
Aligns with Article 79 of Regulation (EC) No 1907/2006 (REACH).
Amendment 171
Martin Hojsík, Michal Wiezik
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 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
Amendment 172
Per Clausen
Proposal for a regulation
Article 6 – paragraph 3 – point e a (new)
| Text proposed by the Commission | Amendment |
| (e a) replacement of animal testing |
Or. en
Justification
It is logical and appropriate to include expertise in non-animal testing on the Management Board, given that one of the Agency’s objectives is to promote non-animal testing.
Amendment 173
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 6 – paragraph 3 – point e a (new)
| Text proposed by the Commission | Amendment |
| (e a) replacement of animal testing |
Or. en
Justification
The Management Board should include internal expertise on non-animal approaches. This addition reflects the growing importance of expert discussion on non-animal methodologies, in line with ECHA’s core mandate and the objectives of the Chemicals Strategy for Sustainability, as well as the Action Plan for Chemicals published in July 2025. It is also consistent with the requirements for such expertise in scientific committees, including the SCCS.
Amendment 174
Per Clausen
Proposal for a regulation
Article 6 – paragraph 3 – point e b (new)
| Text proposed by the Commission | Amendment |
| (e b) occupational health and safety |
Or. en
Justification
Since ECHA will set occupational exposure limits, the Management Board should include relevant scientific expertise. Occupational safety should therefore be added to the stakeholder groups in Article 6(3).
Amendment 175
Jorge Buxadé Villalba
Proposal for a regulation
Article 6 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking into account relevant managerial, administrative and budgetary skills. In accordance with the principle of equal treatment between men and women, all parties nominating and appointing members of the Management Board shall aim to achieve gender balance on the Management Board. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board. | 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking into account relevant managerial, administrative and budgetary skills. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board. |
Or. en
Amendment 176
Per Clausen
Proposal for a regulation
Article 6 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking into account relevant managerial, administrative and budgetary skills. In accordance with the principle of equal treatment between men and women, all parties nominating and appointing members of the Management Board shall aim to achieve gender balance on the Management Board. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board. | 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking into account relevant managerial, administrative and budgetary skills. In accordance with the principle of equal treatment between all genders, all parties nominating and appointing members of the Management Board shall aim to achieve gender balance on the Management Board. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board. |
Or. en
Amendment 177
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 6 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking into account relevant managerial, administrative and budgetary skills. In accordance with the principle of equal treatment between men and women, all parties nominating and appointing members of the Management Board shall aim to achieve gender balance on the Management Board. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board. | 4. Members of the Management Board shall be appointed on the basis of their knowledge and relevant experience in the field of chemical safety or regulation of chemicals, taking due regard to their managerial, administrative and budgetary skills. In accordance with the principle of equal treatment between men and women, all parties nominating and appointing members of the Management Board shall aim to achieve gender balance on the Management Board. Members, alternates and observers of the Committees and the Forum or their working groups shall not be eligible to become members of the Management Board. |
Or. en
Justification
The Management Board is the governing body of the Agency. It has a supervisory role with general responsibility for budgetary and planning matters, therefore managerial skills shall be important aspect in the selection procedure of its members.
Amendment 178
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 6 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. 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 in accordance with the conflict of interest policy adopted by the Management Board pursuant to Article 9(1), point (e) of this Regulation, there are reasonable grounds to believe that a conflict of interest exists or may arise in relation to that person. |
Or. en
Justification
The amendment aims to clarify the implementation of policy preventing conflict of interest.
Amendment 179
Majdouline Sbai
Proposal for a regulation
Article 6 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. 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 assessment there are reasonable grounds to believe that a conflict of interest exists or may arise in relation to that person. These parties shall include the criteria of the Agency with regard to conflicts of interests in their assessment. |
Or. en
Justification
It is important to avoid conflicts of interests for Members of the Management Board. The same rules should apply for all parties. Explicit reference should be made to the criteria developed by the Agency for such an assessment.
Amendment 180
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 9 – paragraph 1 – point j
| Text proposed by the Commission | Amendment |
| (j) develop, in agreement with the Commission, appropriate contacts between the Agency and relevant stakeholder organisations; | deleted |
Or. en
Justification
Streamlining the text, as the task seems to be covered by Art. 9.1 point (g)
Amendment 181
Pietro Fiocchi
Proposal for a regulation
Article 9 – paragraph 1 – point m
| Text proposed by the Commission | Amendment |
| (m) adopt, in agreement with the Commission, appropriate implementing rules for giving effect torticle 110 of the Staff Regulations of Regulation No 31 (EEC), 11 (EAEC); | (m) adopt, in agreement with the Commission, appropriate implementing rules for giving effect to Article 110 of the Staff Regulations of Regulation No 31 (EEC), 11 (EAEC); |
Or. en
Justification
Corrects a drafting error in the Commission proposal.
Amendment 182
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 9 – paragraph 1 – point s
| Text proposed by the Commission | Amendment |
| (s) adopt the rules of procedure of the Committees, and of the Forum on the Forum’s proposal in accordance with Article 17(5); | (s) adopt the rules of procedure of the Committees and of the Forum; |
Or. en
Justification
The amendment does not intend to change the content. It is purely editorial, as Article 17(5) refers only to the rules of the Forum, not to Committees, which are equally addressed by the proposed point (s).
Amendment 183
Martin Hojsík, Michal Wiezik
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. Those practical arrangements shall ensure as wide access as possible to documents in its possession and be in line with Regulation (EC) No 1367/2006 of the European Parliament and of the Council1a; |
| _________________ | _________________ |
| 1a 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 Union institutions and bodies (OJ L 264, 25.9.2006, pp. 13–19, ELI: http://data.europa.eu/eli/reg/2006/1367/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). | 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
Amendment 184
Pietro Fiocchi
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
Amendment 185
Martin Hojsík, Michal Wiezik
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, either with a two-thirds majority of all its members with voting rights or by a fourth-fifths majority of the representatives of the Member States |
| _________________ | _________________ |
| 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 proposal introduces veto by the Commission, empowering it compared to other representatives in the Management Board. Deletion of the specific reference would be a better solution to achieve a balanced outcome. Especially, when it is not specified what could constitute a reason for objecting to the act.
Amendment 186
Jorge Buxadé Villalba
Proposal for a regulation
Article 11 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The Executive Director of the Agency shall be appointed by the Management Board on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. The selection procedure shall be open and transparent and shall respect the principles of equal treatment and of gender balance. | 2. The Executive Director of the Agency shall be appointed by the Management Board on the basis of a list of candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or on Internet sites. The selection procedure shall be open and transparent. |
Or. en
Amendment 187
Per Clausen
Proposal for a regulation
Article 12 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Without prejudice to the powers of the Commission and of the Management Board, the Executive Director shall be independent in the performance of his or her duties and shall neither seek nor take instructions from any Union institution, body, office or agency, nor from any government or from any other public and private body.The Executive Director shall report to the European Parliament or the Council on the performance of tasks under this Regulation when invited to do so by the respective institution. | 3. Without prejudice to the powers of the Commission and of the Management Board, the Executive Director shall be independent in the performance of the Executive Director´s duties and shall neither seek nor take instructions from any Union institution, body, office or agency, nor from any government or from any other public and private body.The Executive Director shall report to the European Parliament or the Council on the performance of tasks under this Regulation when invited to do so by the respective institution. |
Or. en
Amendment 188
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Article 12 – paragraph 5 – point q
| Text proposed by the Commission | Amendment |
| (q) prepare a consolidated annual activity report on the Agency’s activities and present it to the Management Board for assessment; | (q) prepare a consolidated annual activity report on the Agency’s activities including, wherever possible, measurable criteria relating to the Agency's activities and results and present this activity report to the Management Board for assessment; |
Or. en
Amendment 189
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Article 12 – paragraph 5 – point s
| Text proposed by the Commission | Amendment |
| (s) prepare the Agency’s provisional draft estimate of revenue and expenditure referred to in Article 28 and implement the Agency’s budget. | (s) prepare the Agency’s provisional draft estimate of revenue and expenditure referred to in Article 28 and implement the Agency’s budget taking into account the principle of cost-effectiveness, according to which the highest possible output shall be achieved with the least possible use of resources, without compromising the quality of the results. |
Or. en
Amendment 190
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Article 12 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. The Executive Director shall be responsible for all staff matters for which authority has been delegated pursuant to Article 9(2). In the recruitment of the Agency’s staff, the Executive Director shall promote diversity and inclusion and aim to achieve gender balance and broad geographical representation. | 6. The Executive Director shall be responsible for all staff matters for which authority has been delegated pursuant to Article 9(2). In the recruitment of the Agency’s staff, the Executive Director shall give priority to the principle of competence and professional suitability. Only on this basis may other factors, such as broad geographical representation and similar considerations, be taken into account at a later stage. |
Or. en
Amendment 191
Jorge Buxadé Villalba
Proposal for a regulation
Article 12 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. The Executive Director shall be responsible for all staff matters for which authority has been delegated pursuant to Article 9(2). In the recruitment of the Agency’s staff, the Executive Director shall promote diversity and inclusion and aim to achieve gender balance and broad geographical representation. | 6. The Executive Director shall be responsible for all staff matters for which authority has been delegated pursuant to Article 9(2). In the recruitment of the Agency’s staff, the Executive Director shall ensure a broad geographical representation, ensuring that representatives from all Member States will play a role in the undertakings of the Agency. |
Or. en
Amendment 192
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 12 – paragraph 6 a (new)
| Text proposed by the Commission | Amendment |
| 6 a. The Executive Director shall ensure a psychologically healthy workplace by giving due consideration to measures beneficial to mental health at work. |
Or. en
Justification
In compliance with Directive 89/391 EEC, the Executive Director, who is responsible for ECHA´s day to day management should, in cooperation with relevant other Manager(s), consider and assess ways how to enhance employees´ mental wellbeing, prevent and manage eventual risks and reduce stress levels, including by training of managers, giving clear assignments, supporting of healthy interactions, engagement or pet-friendly days.
Amendment 193
Per Clausen
Proposal for a regulation
Article 13 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. Each committee of the Agency shall perform the tasks assigned to it under sectoral Union legislation. | 1. Each committee of the Agency shall perform the tasks assigned to it under sectoral Union legislation and grounded in independent scientific literature. |
Or. en
Amendment 194
Pietro Fiocchi
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
Use of the term “substances” is recommended to maintain alignment with the definitions and terminology laid down in Regulation (EC) No 1907/2006 (REACH).
Amendment 195
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 13 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 2 a. The European Parliament or a Member State may submit a request for the Agency to issue a scientific opinion on matters falling within its mission. The request shall be accompanied by background information explaining the scientific issue to be addressed and the Union interest. | |
| The Agency may refuse or propose amendments to a request for an opinion in consultation with the institution or the Member State(s) that made the request. Justifications for the refusal shall be given to the institution or the Member State(s) that made the request. |
Or. en
Justification
Compared to the General Food Law, which lists possible reasons of refusal by the Agency, this amendment provides more flexibility to the Agency, but keeps the condition to justify it.
Amendment 196
Daniel Buda, Dan-Ştefan Motreanu
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 1
| Text proposed by the Commission | Amendment |
| Each Member State shall nominate two candidates for membership of RAC and may nominate up to two additional candidates. | Each Member State shall nominate one candidate for membership of RAC and may nominate up to three additional candidates. |
Or. en
Amendment 197
Daniel Buda, Dan-Ştefan Motreanu
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 1
| Text proposed by the Commission | Amendment |
| Each Member State shall nominate two candidates for membership of SEAC and may nominate up to two additional candidates. | Each Member State shall nominate one candidate for membership of SEAC and may nominate up to three additional candidates. |
Or. en
Amendment 198
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 2 a. At the request of a Member State, the Agency shall assist that Member State with the identification of possible candidates for nomination by that Member State pursuant to paragraphs 1 and 2. |
Or. en
Justification
Some Member States may need a guidance by the Agency regarding the choice of their candidate, based on the particular expertise needed.
Amendment 199
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Each Member State shall appoint one member to BPC and may appoint one alternate member to BPC. BPC members shall be appointed on the basis of their role and experience in performing the tasks assigned to BPC and may work within a competent authority. | 4. Each Member State shall appoint one member to BPC and may appoint one alternate member to BPC. BPC members shall be appointed on the basis of their role and experience in performing the tasks assigned to BPC. |
Or. en
Justification
It is not only for BPC that the representative may work within a competent authority, therefore there is no need to single out BPC.
Amendment 200
Majdouline Sbai
Proposal for a regulation
Article 14 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. 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. The obligation to nominate a candidate shall however remain with the Member States. |
Or. en
Justification
While it is good to foresee that the Agency should assist Member States upon request to find good candidates for nomination, it should be clarified that the responsibility for the nomination remains with the Member State.
Amendment 201
Pietro Fiocchi
Proposal for a regulation
Article 14 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. At the request of a Member State, the Agency shall, in accordance with Article 16(4), assist in the identification of candidates with relevant expertise for nomination pursuant to paragraphs 1 to 4. |
Or. en
Justification
The amendment is intended to support Member States that have encountered difficulties in identifying suitably qualified candidates, while clearly limiting the Agency’s role to the identification of relevant expertise and preserving the Member State’s exclusive responsibility for assessment and nomination.
Amendment 202
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 1
| Text proposed by the Commission | Amendment |
| The members of SCCS shall be appointed by the Management Board from a list of suitable candidates, established following a call for expression of interest launched by the Agency. | The members of SCCS shall be selected and appointed by the Management Board from a list of suitable candidates drawn up by the Executive Director. The list shall be created on the basis of applications received to a call for expression of interest launched by the Agency and shall include at least twice the number of candidates necessary to fill the posts in the SCCS and their expertise. |
Or. en
Justification
The amendment clarifies the appointment and selection process of the SCCS members and aligns it with the selection and appointment procedure established for the members of the EFSA Scientific panels and Committee within the General Food Law Regulation (EC) No 178/2002.
Amendment 203
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point iv
| Text proposed by the Commission | Amendment |
| (iv) exposure and risk assessment; | (iv) exposure assessment; |
Or. en
Amendment 204
Dennis Radtke, Dimitris Tsiodras
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 testing methods, and emerging methodologies, including new approach methodologies and in vitro/ or in silico techniques; |
Or. en
Amendment 205
Martin Hojsík, Michal Wiezik
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
Amendment 206
Per Clausen
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 methods, and emerging methodologies, including new approach methodologies and in vitro/ or in silico techniques; |
Or. en
Amendment 207
Pietro Fiocchi
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point vi a (new)
| Text proposed by the Commission | Amendment |
| (vi a) safety assessment of nanomaterials; |
Or. en
Justification
Given the growing use of nanomaterials in cosmetic products and the specific scientific challenges they present, explicitly identifying competence in nanomaterial safety evaluation as a criterion for SCCS membership is appropriate and forward-looking.
Amendment 208
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point vi a (new)
| Text proposed by the Commission | Amendment |
| (vi a) safety assessment of nanomaterials |
Or. en
Amendment 209
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point vi a (new)
| Text proposed by the Commission | Amendment |
| (vi a) assessment of nanomaterials |
Or. en
Amendment 210
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point vi b (new)
| Text proposed by the Commission | Amendment |
| (vi b) group/ clustering |
Or. en
Amendment 211
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point a – point vi c (new)
| Text proposed by the Commission | Amendment |
| (vi c) computational toxicology |
Or. en
Amendment 212
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 2 – point b
| Text proposed by the Commission | Amendment |
| (b) independence and absence of conflicts of interest. | (b) independence and absence of conflicts of interest, in compliance with rules adopted pursuant to Article 9 (1), point (e) |
Or. en
Amendment 213
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 3
| Text proposed by the Commission | Amendment |
| The SCCS shall consist of maximum 20 members. | The SCCS shall consist of maximum 20 members. The Executive Director may propose to the Management Board an adjustment to the number of SCCS members, depending on its workload. |
Or. en
Amendment 214
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 14 – paragraph 5 – subparagraph 3
| Text proposed by the Commission | Amendment |
| The SCCS shall consist of maximum 20 members. | The SCCS shall consist of maximum 20 members and at least 2 members per each field of expertise shall be nominated. |
Or. en
Amendment 215
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 5 a. Member States shall not nominate or appoint, and the Management Board shall not appoint, members of the committees and the Forum where, inter alia, based on an analysis and rules adopted pursuant to Article 9(1), point (e), there are reasonable grounds to believe that a conflict of interest exists. |
Or. en
Justification
Follows the General Approach of the Council that adds safeguard on suspected or known conflict of interest.
Amendment 216
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 14 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 5 a. Member States shall not nominate or appoint, and the Management Board shall not appoint, members of the Committees where, inter alia, based on an analysis, there are reasonable grounds to believe that a conflict of interest exists. |
Or. en
Justification
The proposed text provides more clarity by clearly indicating that a conflict of interest should be avoided by whether this appointment is done by Member States or the ECHA Management Board. The latter case would apply to the SCCS for which members shall be appointed by the Management Board from a list of suitable candidates, established following a call for expression of interest launched by the Agency, as indicated in Article 14 paragraph 5.
Amendment 217
Pietro Fiocchi
Proposal for a regulation
Article 14 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 5 a. Appointments to the Committees shall be excluded where an analysis identifies reasonable grounds for a conflict of interest, whether the appointment is done by Member States or the Management Board. |
Or. en
Justification
Procedures for appointment must ensure the absence of conflicts of interest, irrespective of whether members are designated by the Member States or appointed by the ECHA Management Board. In the case of the Scientific Committee on Consumer Safety, the Management Board appoints members from a pool of candidates identified through a call for expressions of interest launched by the Agency, in accordance with Article 14(5).
Amendment 218
Dimitris Tsiodras, Dennis Radtke
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, including knowledge of human toxicity, environmental safety assessment, and non-animal approaches. 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. |
Or. en
Justification
All Committees should include internal expertise in human and environmental safety assessment, and non-animal approaches, reflecting REACH Article 1 priorities. This ensures the Committees can effectively support the Agency’s tasks and objectives.
Amendment 219
Martin Hojsík, Michal Wiezik
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 to those members of the committees that they have nominated or appointed allowing their effective participation and shall facilitate the activities of the committees and their working groups. |
Or. en
Justification
Due to the hybrid meetings, it is crucial that all the experts are properly equipped to perform their tasks.
Amendment 220
Katri Kulmuni
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. They shall refrain from any action incompatible with their duties or the performance of their tasks. The procedural guidelines of RAC are drawn up by the committee itself, and may include the possibility of putting the decisions of the working groups on the agenda of the committee's general session for a vote, if necessary, to ensure transparency and quality assessment. |
Or. en
Amendment 221
Martin Hojsík, Michal Wiezik
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. Those members and 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. |
Or. en
Amendment 222
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 14 – paragraph 11
| Text proposed by the Commission | Amendment |
| 11. The members of RAC, SEAC, MSC and BPC shall be appointed for a term of three years and the members of SCCS for a term of five years. Those terms may be renewed. | 11. The members of RAC, SEAC, MSC, SCCS and BPC shall be appointed for a term of three years. Those terms may be renewed. |
Or. en
Justification
The amendment aims to align the term of the SCCS with the other ECHA committees, as the proposal foresees the inclusion of the body into the ECHA.
Amendment 223
Per Clausen
Proposal for a regulation
Article 14 – paragraph 11
| Text proposed by the Commission | Amendment |
| 11. The members of RAC, SEAC, MSC and BPC shall be appointed for a term of three years and the members of SCCS for a term of five years. Those terms may be renewed. | 11. The members of RAC, SEAC, MSC, SCCS and BPC shall be appointed for a term of three years. Those terms may be renewed. |
Or. en
Justification
The aim is to ensure equal conditions across all committees, in line with the principle of one substance, one assessment. Moreover, there is no justification for SCCS members to have longer terms than members of other committees.
Amendment 224
Pietro Fiocchi
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 correction.
Amendment 225
Pietro Fiocchi
Proposal for a regulation
Article 14 a (new)
| Text proposed by the Commission | Amendment |
| Article14a | |
| Appointment in the absence of Member State nominations | |
| Where a Member State fails to nominate the members or alternate members required under this Regulation within a period of one year from the date on which the nomination should have been made, the European Parliament shall appoint, on behalf of that Member State, the members necessary to fill the vacant positions. Appointments made pursuant to the first paragraph shall be based on proven scientific and technical expertise relevant to the tasks of the committee concerned and shall be carried out in a transparent manner, with due regard to geographical balance and the avoidance of conflicts of interest. Members appointed under this Article shall have the same rights and obligations as members nominated by Member States and shall serve for the remainder of the applicable term. |
Or. en
Amendment 226
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 15 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The Executive Director or a representative of the Executive Director as well as Commission representatives shall be entitled to attend all the meetings of the Committees and their working groups as observers. Stakeholders may also be invited to attend such meetings as observers in accordance with the committee’s rules of procedure. | 1. The Executive Director or a representative of the Executive Director as well as Commission representatives shall be entitled to attend all the meetings of the Committees and their working groups as observers. Stakeholders shall also be invited to attend such meetings as observers in accordance with the committee’s rules of procedure. In addition, companies affected shall be entitled to attend a meeting of the Committee, if their case is addressed, in order to contribute to case-specific discussions. |
Or. en
Justification
Authorities have to deal with complex issues in the ECHA Committees. Thus, it shall be ensured that affected companies are adequately consulted on all facts relevant to the Committee decisions and / or opinions, giving consideration to the dynamics of incorporating information into the committee's work and the results of discussions.
Amendment 227
Pietro Fiocchi
Proposal for a regulation
Article 15 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The Executive Director or a representative of the Executive Director as well as Commission representatives shall be entitled to attend all the meetings of the Committees and their working groups as observers. Stakeholders may also be invited to attend such meetings as observers in accordance with the committee’s rules of procedure. | 1. The Executive Director or a representative of the Executive Director as well as Commission representatives shall be entitled to attend all the meetings of the Committees and their working groups as observers. Stakeholders shall also be invited to attend such meetings as observers, with the right to provide oral and written input, in accordance with the committee’s rules of procedure. |
Or. en
Justification
The ECHA Basic Regulation must specify the areas to be governed by the Rules of Procedure, including binding provisions on stakeholder participation in Committee meetings. Where a Committee examines a case affecting identifiable stakeholders, those stakeholders must be granted observer status with the right to provide oral and written input during the discussion of their case.
Amendment 228
Volker Schnurrbusch, Anja Arndt
Proposal for a regulation
Article 15 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The Executive Director or a representative of the Executive Director as well as Commission representatives shall be entitled to attend all the meetings of the Committees and their working groups as observers. Stakeholders may also be invited to attend such meetings as observers in accordance with the committee’s rules of procedure. | 1. The Executive Director or a representative of the Executive Director as well as Commission representatives shall be entitled to attend all the meetings of the Committees and their working groups as observers. Stakeholders shall also be called to attend such meetings as observers in accordance with the committee’s rules of procedure. |
Or. de
Amendment 229
Volker Schnurrbusch, Anja Arndt
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 detailed opinion shall be published. |
Or. de
Amendment 230
Martin Hojsík, Michal Wiezik
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 231
Pietro Fiocchi
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. For the rules of procedure of RAC, SEAC and SCCS, the Executive Director shall consult the representatives of the Commission in the Management Board, when preparing those rules for adoption by the Management Board. |
Or. en
Justification
The RAC, SEAC and SCCS are designed to provide independent scientific and socio-economic advice. Requiring approval by Commission representatives, as specified in the Commission proposal, risks perceived or actual influence over how those opinions are formed.
Amendment 232
Dimitris Tsiodras, Dennis Radtke
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 consider involvement of companies affected by the matters handled in the respective committee related to their case, including the invitation to committee meetings on request of the company affected and sharing of relevant documents. |
| The rules of procedure shall be published. |
Or. en
Justification
To date, companies have only limited opportunities to present well-founded scientific arguments to the relevant ECHA committees. This is not sufficient to take appropriate account of the complex issues that companies and committees have to deal with and to ensure that affected companies are adequately consulted on all facts relevant to the decision, giving consideration to the dynamics of incorporating information into the committee's work and the results of discussions. The ECHA Regulation should therefore take into account the right of a case owner to be heard as a binding element of the “Rules of Procedure” of the ECHA committees (MSC, RAC, SEAC, etc.). Downstream users should be treated equally to registrants in the following cases: SVHC identification, ECHA recommendations for inclusion of substances in Annex XIV, restrictions, and harmonised classifications.
Amendment 233
Pietro Fiocchi
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 include the participation of observers in the Committee meetings, with the right to provide oral and written input, including stakeholders affected by the matters handled in the respective Committee meeting. The rules of procedure shall be published on the Agency’s website. |
Or. en
Justification
The Committees' Rules of Procedure must provide for stakeholder participation in Committee meetings. Where a Committee considers a matter affecting identifiable stakeholders, those stakeholders must be granted observer status with the right to provide oral and written input for the purposes of the discussion concerned.
Amendment 234
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
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. Any delegation of tasks to working groups shall not affect the responsibility of the Committee for the final opinion. The rules of procedure shall be published. |
Or. en
Justification
While the Commission proposal allows committees to delegate certain tasks to working groups, it does not explicitly clarify how responsibility for the final opinion is preserved. Therefore it is important to ensure legal clarity and accountability by confirming that the committee remains fully responsible for opinions prepared with the involvement of working groups. This strengthens transparency and trust in the scientific decision-making process, without limiting flexibility or efficiency gains.
Amendment 235
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 15 – paragraph 6 a (new)
| Text proposed by the Commission | Amendment |
| 6 a. Paragraph 6 shall not apply to the Scientific Committee on Consumer Safety which shall be chaired by two Co- Chairpersons, in line with the dual governance of the Committees as specified in Article 15(3). The Co-Chairmanship shall be organised as follows: | |
| (a) one Co-Chairperson shall be an employee of the Agency and shall be appointed by the Management Board; that Co-Chairperson shall be responsible for the administrative support of the Committee, | |
| (b) one Co-Chairperson shall be a member of the SCCS and shall be elected by the members of the committee; that Co-Chairperson shall be responsible for the scientific direction of the Committee’s work. | |
| The detailed division of tasks between the Co-Chairpersons shall be laid down in the Rules of Procedure of the SCCS, without prejudice to the scientific independence of the Committee. |
Or. en
Amendment 236
Pietro Fiocchi
Proposal for a regulation
Article 15 – paragraph 6 a (new)
| Text proposed by the Commission | Amendment |
| 6 a. Paragraph 6 shall not apply to the Scientific Committee on Consumer Safety (SCCS), which shall nominate its Chairperson from among its members. |
Or. en
Justification
The amendment maintains the current system whereby the SCCS Chairperson is elected from among its members. This is essential to safeguard scientific independence, prevent conflicts of interest, ensure continuity, and preserve the SCCS credibility, effectiveness, and role as the EU reference body for cosmetics risk assessment.
Amendment 237
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 15 a (new)
| Text proposed by the Commission | Amendment |
| Article15a | |
| For all Committee meetings substantial summaries shall be made available to the public in due time, to allow the public to follow the progress made on dossiers and other items discussed, understand outstanding issues and any reasons for decisions, opinions or delays. In addition, any document of a committee, the Agency or the Commission on overarching, non-substance-specific topics of a Committee, shall be published. |
Or. en
Justification
ECHA regularly only publishes so-called “final minutes” after committee meetings. These documents show which topics were discussed, but in most cases do not allow to track the progress of the meeting and the meeting results in detail. For this reason, the approach is often perceived as non-transparent by those affected and also by the public. Greater transparency has two effects: Stakeholders gain a better understanding of how ECHA works, enabling them to prepare better applications for authorisations or better comments for public consultations, for example. Thus, authorities can process applications, decisions, and opinions more efficiently. In addition, documents on overarching, non-substance-specific topics, e.g., the approach for prioritising SVHCs, the inclusion of substances in REACH Annex XIV, the evaluation of authorisation applications and restriction proposals, etc., should be published together with the “full minutes” of a meeting.In addition, documents on overarching, non-substance-specific topics, e.g., the approach for prioritising SVHCs, the inclusion of substances in REACH Annex XIV, the evaluation of authorisation applications and restriction proposals, etc., should be published together with the “full minutes” of a meeting.
Amendment 238
Pietro Fiocchi
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. This list shall be published on the Agency's website. |
Or. en
Amendment 239
Martin Hojsík, Michal Wiezik
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
Amendment 240
Martin Hojsík, Michal Wiezik
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 meetings of the members of the Management Board, the Executive Director, chairpersons and members of the Committees and the Forum and any participating experts or 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
All participating members at the meetings of Management Board should declare any conflict of interests.
Amendment 241
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 23 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| An appeal lodged pursuant to the first paragraph of this Article shall not have suspensive effect. The Board of Appeal may, however, if it considers that circumstances so require, order that application of the contested decision be suspended. |
Or. en
Justification
This provision aims to prevent mis-using of appeals against the Agency´s decisions and aims to establish minimum playing field across the Union.
Amendment 242
Per Clausen
Proposal for a regulation
Article 24 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| 1 a. An appeal submitted under paragraph 1 shall not automatically suspend the effects of the decision. However, where the Board of Appeal deems it necessary due to the circumstances, it may decide to temporarily suspend the application of the contested decision. |
Or. en
Justification
This reduces the risk of appeals being used strategically to delay the regulation of harmful chemicals. Suspension would still be possible, but it should be based on genuine, well-founded reasons. Moreover, automatic suspension risks creating unnecessary administrative burdens.
Amendment 243
Per Clausen
Proposal for a regulation
Article 24 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 2 a. There shall be no automatic suspensive effect of an appeal referred to in paragraph 1. But the Board of Appeal can, if it find it relevant, demand that the that application of the contested decision be suspended. |
Or. en
Amendment 244
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 25 a (new)
| Text proposed by the Commission | Amendment |
| Article25a | |
| 1. Any natural or legal person that is a registrant, manufacturer, importer or downstream user as defined in Article 3 of Regulation (EC) No 1907/2006 may ask for a review of a scientific or technical opinion or decision of the Agency, including its Committees, that is not subject to the appeal procedure according to Article 23 of this Regulation provided that this person | |
| (a) is directly or indirectly affected by such decision or opinion or could be affected by legislative Union acts or acts based on such acts (delegated, implementing legislation) that would be based on such prework by the Agency, | |
| (b) provides a substantiated rationale for any aspect it requests to be reviewed because it is not appropriately considered in the opinion or decision, and | |
| (c) provides a proposal for remediation. | |
| 2. For handling such objections a Review Panel shall be set up: For its composition, membership and exclusion criteria Articles 20 to 22 shall apply mutatis mutandis. | |
| 3. The outcome of the panel’s review shall include, among other results, the complete or partial revocation of the opinion and/or a referral back to the committee for further assessment with conditions. |
Or. en
Justification
Under REACH and the Biocidal Products Regulation, certain ECHA decisions may be appealed before the Agency’s Board of Appeal (BoA). However, no appeal mechanism exists for scientific opinions issued by ECHA committees, such as those delivered in REACH restriction procedures or harmonised classification under the CLP Regulation. Nor is there any independent review of these opinions, despite their scientific complexity and significant regulatory and economic implications.As a result, affected parties currently have no effective administrative remedy and must rely on judicial proceedings before the European courts, often only at a later stage, once legislation based on the opinion has been adopted.To address this gap, an independent review panel, with a composition similar to the BoA, should be established to examine scientific or technical opinions issued by ECHA committees. Registrants, manufacturers, importers and downstream users directly affected should have the right to submit objections.The panel could confirm, partially or fully revoke an opinion, or refer it back to the relevant committee for further assessment under defined conditions. This would enhance procedural fairness, legal certainty and the robustness of scientific decision-making, without undermining ECHA’s scientific independence.
Amendment 245
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 26 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 2 a. 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 195 and 230 of the Treaty respectively. |
Or. en
Justification
Wording of para (4) of Article 118(1) of REACH that the Commission did not mirror in the ECHA Founding Regulation, when deleting this Article from REACH.
Amendment 246
Pietro Fiocchi
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 proposal by the Executive Director, the Management Board shall endorse a draft single programming document containing the following: |
Or. en
Amendment 247
Pietro Fiocchi
Proposal for a regulation
Article 27 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
| (a) all the documents listed in Article 32(1) of Delegated Regulation (EU) 2019/715; | (a) multiannual and annual programming and all the other documents listed in Article 32(1) of Delegated Regulation (EU) 2019/715; |
Or. en
Amendment 248
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 27 – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
| (b) a justification on any potential transfers of financial and human resources between the different activities of the Agency; | (b) assessment of financial and capacity needs to perform its current and future tasks, together with justification of any potential transfers of financial and human resources between the different activities of the Agency; |
Or. en
Amendment 249
Pietro Fiocchi
Proposal for a regulation
Article 27 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. The annual programming shall comprise detailed objectives and expected results including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual programming shall be coherent with the multi-annual programming referred to in paragraph 1. It shall clearly indicate tasks that have been added, changed or deleted in comparison with the previous financial year. | 5. The annual programming shall comprise detailed objectives and expected results, including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual programming shall be coherent with the multiannual programming referred to in paragraph 1 and shall clearly indicate tasks that have been added, changed or deleted in comparison with the previous financial year. It shall ensure that the allocation of the Agency’s financial and human resources is determined by the Agency in a manner consistent with its mandate, operational needs and scientific priorities. |
Or. en
Amendment 250
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Article 27 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. The annual programming shall comprise detailed objectives and expected results including performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual programming shall be coherent with the multi-annual programming referred to in paragraph 1. It shall clearly indicate tasks that have been added, changed or deleted in comparison with the previous financial year. | 5. The annual programming shall comprise detailed objectives and expected results including, wherever possible, measurable criteria and performance indicators. It shall also contain a description of the actions to be financed and an indication of the financial and human resources allocated to each action, in accordance with the principles of activity-based budgeting and management. The annual programming shall be coherent with the multi-annual programming referred to in paragraph 1. It shall clearly indicate tasks that have been added, changed or deleted in comparison with the previous financial year. |
Or. en
Amendment 251
Pietro Fiocchi
Proposal for a regulation
Article 27 – paragraph 8
| Text proposed by the Commission | Amendment |
| 8. The multi-annual programming and the annual programming shall be prepared in accordance with Article 32 of Delegated Regulation (EU) 2019/715. | 8. The multiannual programming and the annual programming shall be prepared in accordance with Article 32 of Delegated Regulation (EU) 2019/715. |
Or. en
Justification
Editorial correction.
Amendment 252
Pietro Fiocchi
Proposal for a regulation
Article 29 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. Fees and charges levied under Union sectoral legislation shall be set at a level sufficient to cover the costs of the services provided in accordance with that legislation. |
Or. en
Justification
Fees and charges are intended to cover the Agency’s costs for providing specific services, including processing registrations and applications for authorisation under REACH and for active substances and biocidal products, and the Basic Regulation should ensure that they are used solely for their intended purpose.
Amendment 253
Pietro Fiocchi
Proposal for a regulation
Article 29 – paragraph 4 b (new)
| Text proposed by the Commission | Amendment |
| 4 b. Within the limits of the budget adopted in accordance with Union budgetary rules, the Agency shall be responsible for determining the internal allocation of financial resources across its activities and tasks, in accordance with its mandate and programming documents. |
Or. en
Amendment 254
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 29 – paragraph 5 – point c a (new)
| Text proposed by the Commission | Amendment |
| (c a) fees and charges under sectorial legislation, together with other sources of revenue of the Agency referred to in paragraph 3, shall continue to sufficiently cover the costs of the services provided under the respective Union sectorial legislation as determined by that legislation. |
Or. en
Amendment 255
Martin Hojsík, Michal Wiezik
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 and shall consider fluctuations in the Agency´s incomes from fees and charges over successive years when doing so, and is empowered to adopt delegated acts in accordance with Article 46(1) to amend paragraph 5 on the basis of such review. |
Or. en
Amendment 256
Majdouline Sbai
Proposal for a regulation
Article 34 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| The Agency shall provide annual training for staff and committee members in relation to key tasks of the Agency. |
Or. en
Justification
The basic regulation should foresee annual training for staff and committee members with regard to key tasks of the Agency. This is formulated in a generic sense on purpose to avoid picking out certain tasks.
Amendment 257
Per Clausen
Proposal for a regulation
Article 37 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| 1 a. Due to the highly sensitive area of its function, it is essential that the Agency puts the highest transparency measures in place, including by signing the interinstitutional agreement of the Transparency Register, and putting in place extreme prudence when dealing with lobbyists. |
Or. en
Amendment 258
Pietro Fiocchi
Proposal for a regulation
Article 37 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. For all other information and data not covered by paragraph 1, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific and technical information concerning the safety of substances on their own, in mixtures or in articles where such information is not of a confidential nature as defined in sectoral Union legislation. | 2. For all other information and data not covered by paragraph 1, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific and technical information concerning the safety of substances on their own, in mixtures or in articles, where such disclosure and availability to the public are provided for in sectoral Union legislation. Those rules shall be adopted in line with the originator principle as defined in Regulation (EU) 2025/2455, and shall ensure that the disclosure of information is without prejudice to Union law on the protection of confidential business information, intellectual property rights, personal data and other legally protected interests. They shall also ensure that the source, integrity and regulatory context of the information, as submitted by the data holder, are preserved. |
Or. en
Justification
The handling of confidential information and the conditions for public access are defined in the relevant sector-specific legislation. ECHA’s rules on publishing information must align with the provisions of the legislation under which the data were generated, ensuring that information subject to confidentiality requirements is not disclosed.
Amendment 259
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 37 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. For all other information and data not covered by paragraph 1, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific and technical information concerning the safety of substances on their own, in mixtures or in articles where such information is not of a confidential nature as defined in sectoral Union legislation. | 2. For all other information and data not covered by paragraph 1, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure public access only to such regulatory, scientific and technical information concerning the safety of substances on their own, in mixtures or in articles that is intended to be made publicly available under the applicable sectoral Union legislation. |
| Information and data elements which, under the originating sectoral Union legislation, are not intended for publication or for which no procedure exists to request confidential treatment shall remain subject to the ‘originator principle’ and shall not be made publicly available. |
Or. en
Amendment 260
Volker Schnurrbusch, Anja Arndt
Proposal for a regulation
Article 37 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. For all other information and data not covered by paragraph 1, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific and technical information concerning the safety of substances on their own, in mixtures or in articles where such information is not of a confidential nature as defined in sectoral Union legislation. | 2. For all other information and data not covered by paragraph 1, the Management Board shall, on the basis of a proposal by the Executive Director and in agreement with the Commission, adopt rules to ensure the availability to the public of regulatory, scientific and technical information concerning the safety of substances on their own, in mixtures or in articles, in line with the principle of ‘originator control’; |
Or. de
Amendment 261
Majdouline Sbai
Proposal for a regulation
Article 37 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 2 a. The Agency shall assess the feasibility of developing a simplified labelling scoreboard with regard to hazardous substances as well as with regard to their presence in mixtures and articles, complementing existing labelling requirements in Union law to allow a fast understanding by the general public of the relative hazardous nature of such products. The Agency shall present different options for such a labelling scoreboard and adopt report of its assessment no later than [OP: please insert the date of 36 months after the entry into force of this Regulation]. The Agency shall present the report to the Commission, the Member States and the European Parliament and make it publicly available. |
Or. en
Justification
In France, ANSES has proposed to categorise household products according to their toxicity. This is a good idea that should be assessed in general at European level and for all kinds of consumer products. The Agency is the right body to make such an assessment and to propose options for it. A clear deadline should be set for such work.
Amendment 262
Per Clausen
Proposal for a regulation
Article 41 – paragraph 1
| Text proposed by the Commission | Amendment |
| The Agency shall maintain a close dialogue with relevant civil society organisations, and relevant competent bodies operating in the field of its competence at national, Union and international level. | The Agency shall maintain a close dialogue with relevant civil society organisations, and relevant competent bodies operating in the field of its competence at national, Union and international level. This can be accomplished through regular stakeholder fora and transparent consultation mechanisms including key actors, involving NGOs with expertise in non-animal approaches, environment, occupational health and trade unions. |
Or. en
Amendment 263
Dennis Radtke, Dimitris Tsiodras
Proposal for a regulation
Article 41 – paragraph 1
| Text proposed by the Commission | Amendment |
| The Agency shall maintain a close dialogue with relevant civil society organisations, and relevant competent bodies operating in the field of its competence at national, Union and international level. | All committees shall offer relevant social partners the opportunity to participate in regular hearings if there is a possibility that they would be affected by decisions of the committees in order to accelerate, in cooperation with the social partners, the decision-making process. |
Or. en
Amendment 264
Dimitris Tsiodras, Dennis Radtke
Proposal for a regulation
Article 41 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| To promote coordination and transparency in its consultation mechanisms, all committees shall offer relevant social partners the opportunity to participate in regular hearings if there is a possibility that they would be affected by decisions of the committees in order to accelerate, in cooperation with the social partners, the decision-making process. |
Or. en
Amendment 265
Majdouline Sbai
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. | The Agency shall assist Member States and the Commission in promoting the substitution of the most harmful and other hazardous chemicals and groups thereof by safer and more sustainable alternative substances and technologies. The Agency shall also assist Member States and the Commission in the development, regulatory acceptance, uptake and international harmonisation of relevant scientific methodologies, including non-animal approaches and emerging methodologies, 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 Council1a. 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
Strengthening the role of the Agency with regard to non-animal approaches.
Amendment 266
Pietro Fiocchi
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. | 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, taking into account relevant socio-economic, supply-chain, and strategic considerations, including external geopolitical developments affecting availability, resilience and competitiveness within the Union. It shall also support the development of relevant scientific methodologies, with a particular emphasis on animal-free approaches, to assess hazards of chemicals as well as risks and socio-economic impacts of their use. Such assistance shall include the facilitation of information exchange and participation in, and facilitation of, relevant research, development and innovation activities within the scope of the applicable Union sectoral legislation. |
Or. en
Amendment 267
Elżbieta Katarzyna Łukacijewska, Ewa Kopacz, Hanna Gronkiewicz-Waltz, Adam Jarubas
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. | 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 for those uses and applications that are proved to pose risks to human health or the environment 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. |
Or. en
Justification
The Agency should focus on potential risks of chemicals to cause harm, by the mean of application targeted risk assessments.
Amendment 268
Jorge Buxadé Villalba
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. | The Agency shall assist Member States and the Commission in the development of relevant scientific methodologies to assess hazards of chemicals, assess the risks and socio-economic impacts of the use of hazardous chemicals, as well as the socio-economic impacts of their potential substitution. 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. |
Or. en
Amendment 269
Dimitris Tsiodras, Dennis Radtke
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. | 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, primarily focused on 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 as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation. |
Or. en
Justification
The proposed amendment reflects the EU’s long-standing commitment to advancing ethical and scientifically robust alternatives to animal testing.
Amendment 270
Dennis Radtke, Dimitris Tsiodras
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. | 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, primarily focused on 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 as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation. |
Or. en
Amendment 271
Martin Hojsík, Michal Wiezik
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. | The Agency shall assist Member States and the Commission in promoting the substitution of harmful chemicals and their mixtures 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 as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation. |
Or. en
Amendment 272
Per Clausen
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. | 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 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 as well as participation in and facilitation of relevant research, development, and innovation activities within the scope of the relevant Union sectoral legislation. |
Or. en
Amendment 273
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 43 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| The Agency may, alone or in cooperation with other Union bodies, publish annual reports on risks, knowledge and data gaps in the field of its competence, including on emerging risks of chemicals. |
Or. en
Amendment 274
Dimitris Tsiodras, Dennis Radtke
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. | 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 non animal approaches, for the assessment of chemicals. |
| In this context, 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
The proposed wording seeks to expressly include EURL ECVAM in the list of bodies with which the Agency should collaborate, given their specific expertise and mandate in the development, validation, and regulatory acceptance of non-animal approaches. This will support and strengthen the Agency’s capacity to promote and implement replacements of animal testing.
Amendment 275
Majdouline Sbai
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. | 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, the European Agency for Safety and Health at Work and with the European Union Reference Laboratory for alternatives to animal testing, 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. |
Or. en
Justification
ECVAM should be listed explicitly amongst the bodies established under Union law with whom the Agency should cooperate.
Amendment 276
Per Clausen
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. | 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 non-animal approaches, for the assessment of chemicals. |
Or. en
Amendment 277
Majdouline Sbai
Proposal for a regulation
Article 48 – paragraph 1 – point 4 a (new)
Regulation (EC) No 1907/2006
Article 91 – paragraph 2
| Text proposed by the Commission | Amendment |
| (4 a) Article 91, paragraph (2) is replaced by the following: | |
| An appellant may request that an appeal lodged pursuant to paragraph 1 has suspensive effect. Such a request shall be justified. The Board of Appeal shall decide whether it would be justified to suspend the contested decision. |
Or. en
Justification
According to the current Article 91(2) of REACH, an appeal lodged to the Board of Appeal shall have suspensive effect. This automatic suspensive effect unduly incentivizes legal challenges. Appellants should be allowed to request interim measures, which are to be justified. However, it should be up to the Board of Appeal to decide whether such interim measures would be justified. This is in analogy to the approach with regard to interim measures in case of legal challenges at the European Court of Justice. The same should be applied for the Board of Appeal.
Amendment 278
Per Clausen
Proposal for a regulation
Article 48 – paragraph 1 – point 4 a (new)
Regulation (EC) No 1907/2006
Article 91 – paragraph 2
| Text proposed by the Commission | Amendment |
| (4 a) in Article 91, paragraph 2 is deleted; |
Or. en
Justification
In line with our amendments to Article 24(2), which provide that an appeal should not have an automatic suspensive effect.
Amendment 279
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 48 – paragraph 1 – point 4 a (new)
Regulation (EC) No 1907/2006
Article 91 – paragraph 2
| Text proposed by the Commission | Amendment |
| (4 a) in Article 91, paragraph 2 is deleted; |
Or. en
Justification
The Board of Appeal should be given the right to consider and make interim decisions, to prevent mis-use of the provision and to establish a level playing field across the Union.
Amendment 280
Majdouline Sbai
Proposal for a regulation
Article 49 – paragraph 1 – point 2 a (new)
Regulation (EU) No 528/2012
Article 77 – paragraph 2
| Text proposed by the Commission | Amendment |
| (2 a) in Article 77. paragraph 2 is replaced by the following: | |
| An appellant may request that an appeal lodged pursuant to paragraph 1 has suspensive effect. Such a request shall be justified. The Board of Appeal shall decide whether it would be justified to suspend the contested decision. |
Or. en
Justification
According to the current Article 77(1) of the Biocides Regulation, an appeal lodged to the Board of Appeal shall have suspensive effect. This automatic suspensive effect unduly incentivizes legal challenges. Appellants should be allowed to request interim measures, which are to be justified. However, it should be up to the Board of Appeal to decide whether such interim measures would be justified. This is in analogy to the approach with regard to interim measures in case of legal challenges at the European Court of Justice. The same should be applied for the Board of Appeal.
Amendment 281
Per Clausen
Proposal for a regulation
Article 49 – paragraph 1 – point 2 a (new)
Regulation (EU) No 528/2012
Article 77 – paragraph 2
| Text proposed by the Commission | Amendment |
| (2 a) in Article 77, paragraph 2 is deleted. |
Or. en
Justification
In line with our amendments to Article 24(2), which provide that an appeal should not have an automatic suspensive effect.
Amendment 282
Martin Hojsík, Michal Wiezik
Proposal for a regulation
Article 49 – paragraph 1 – point 2 a (new)
Regulation (EU) No 528/2012
Article 77 – paragraph 2
| Text proposed by the Commission | Amendment |
| (2 a) in Article 77, paragraph 2 is deleted. |
Or. en
Justification
The Board of Appeal should receive the right to consider and make interim decisions in order to prevent mis-using of the provision and to create level playing field across the Union.
Amendment 283
Ondřej Knotek, Mathilde Androuët, Marie-Luce Brasier-Clain, Viktória Ferenc, Anne-Sophie Frigout, Jana Nagyová, Antonín Staněk
Proposal for a regulation
Article 54 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. Not later than two years after [OP please insert: the date of application of this Regulation], and every five years thereafter, the Commission shall initiate an evaluation of the Agency’s performance in relation to its objectives, tasks and governance. | 1. Not later than two years after [OP please insert: the date of application of this Regulation], and every five years thereafter, in accordance with the principle of cost-effectiveness the Commission shall initiate an evaluation of the Agency’s performance including - wherever possible - measurable indicators in relation to its objectives, tasks, achieved results and governance. |
Or. en
Amendment 284
Martin Hojsík, Michal Wiezik
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 assessment shall include functioning of the Committees and the Forum and possible need to modify their rules for membership or their functioning. |
Or. en