Changes from report parliamentary committee draft to plenary report

Article 4 – paragraph 5 – point g a (new): (ga) ensure that conflicts of interest are prevented or managed, so as to ensure its independence and credibility with stakeholders and the general public;

Change 7

RemovedThe role of the Agency as a point of reference must also go hand in hand with strong rules regarding the prevention of conflict of interests.

AddedArticle 4 – paragraph 5 – point k a (new): (ka) upon request from the European Parliament or a Member State, provide scientific opinions and technical assistance in a field falling within its competences;

Change 8

ChangedArticle 4 – paragraph 5 – point k ab (new): (ka) foster expertise in non-animal approaches(kb) throughprovide annual training for staff and committee members, and share knowledge with all stakeholders.

Change 9

RemovedTasks and objectives of the Agency should reflect the objectives of the Chemicals Strategy for Sustainability to move away from animal testing.

AddedArticle 4 – paragraph 5 a (new): 5a. Requests received under paragraph 5, points (c), (d), (e), (k) and (ka), of this Article and under Article 13(2), point (b), as well as a regular update on their status shall be made publicly available on the Agency’s website.

Change 10

ChangedArticle 5 – paragraph 1 – point c: (c) a Committee for Risk Assessment (‘RAC’), which shall be responsible for preparing opinions of the Agency relating to riskshazards and hazardsrisks of chemicals to human health or the environment;

Change 11

RemovedThis Wording better reflects the tasks of RAC which is to prepare opinions of ECHA related to the risks of substances to human health and the environment but also examine the proposals for harmonised classification and labelling and give an opinion on the proposed harmonised classification of substances.

Article 5 – paragraph 1 – point d: (d) a Committee for Socio-economic Analysis (‘SEAC’), which shall be responsible for preparing opinions of the Agency relating to the socio-economic impact of possible legislative measures on chemicals;

Change 12

RemovedAs part of its task, SEAC is mandated to give opinion not only relating to the socio-economic impact of possible legislative measures on substances on their own, but also on substances in a mixture or in an article, the broader term 'chemicals' is meant to encompass all of these possibilities.

AddedArticle 5 – paragraph 1 – point h a (new): (ha) an Assembly of accredited stakeholders, as established in Article 41a, which shall aim to reinforce the relationship between accredited stakeholders and the Agency, and facilitate their contribution to the tasks of the Agency;

Change 13

ChangedArticle 5 – paragraph 1 – point hi: (i) a (new):Secretariat, (ha)which ashall Forumwork ofunder accreditedthe stakeholders,leadership asof establishedthe inExecutive ArticleDirector 41a,and whichundertake shallthe aimwork torequired structureof andthe reinforceAgency thein relationshipaccordance with allsectoral stakeholders,Union legislation, provide technical, scientific and allowadministrative itssupport, memberscapacity tobuilding contributeand training, to the tasksCommittees ofand the Agency;Forum, and ensure appropriate coordination between them;

Change 14

RemovedECHA has had a long standing practice of interaction and exchange with stakeholders and civil society in general, in particular via its accredited stakeholders. The proposal for a Basic Regulation is the opportunity to institutionalise this practice to structure and reinforce the relationship with all stakeholders, and allow its members to contribute to the tasks of the Agency.

AddedArticle 6 – paragraph 1 – point c: (c) two independent persons appointed by the European Parliament, those persons shall be independent in the performance of their duties and shall neither seek nor take instructions from any Union institution, body, office or agency, any government or from any other public or private body.

RemovedArticle 5 – paragraph 1 – point i: (i) a Secretariat, which shall work under the leadership of the Executive Director and undertake the work required of the Agency in accordance with sectoral Union legislation, provide technical, scientific and administrative support and capacity building and training to the Committees and the Forum, and ensure appropriate coordination between them;

AddedArticle 6 – paragraph 2: 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.

RemovedThis draft report introduces several proposals in order to reinforce the capacity building and training role of ECHA, such as training staff and experts on non-animal approaches. This should therefore be reflected in the tasks of the Secretariat.

AddedArticle 6 – paragraph 3 – point b: (b) trade unions, including occupational health and safety;

Change 15

ChangedArticle 6 – paragraph 13 – point c: (c) two independent personsd appointeda by(new): the(da) Europeannon-animal Parliament.approaches;

Change 16

RemovedAlignment with current REACH wording.

AddedArticle 6 – paragraph 4: 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 of their relevant managerial, administrative and budgetary skills. In accordance with the principle of equal treatment of 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.

Change 17

ChangedArticle 6 – paragraph 2:4 2.a The(new): representatives4a. Members of the Member States, theManagement representativesBoard ofshall thebe Commissionnominated and independent persons appointed by the European Parliament shallin haveaccordance votingwith rights.the Therules personson representingconflicts interestedof parties,interest appointedadopted by the Commission,Management shallBoard notpursuant haveto votingArticle rights.9(1), point (e).

Change 18

RemovedAlignment with current REACH wording.

AddedArticle 6 – paragraph 6: 6. Members of the Management Board shall act exclusively in the interests of the Agency and of the Union.

RemovedArticle 6 – paragraph 3 – point d a (new): (da) occupational health and safety;

AddedArticle 9 – paragraph 1 – point s: (s) adopt the rules of procedure of the Committees, the Forum, and the Assembly of stakeholders;

RemovedAs this Regulation integrates the task for RAC to provide scientific opinions on evaluations of Occupational Exposure Limits (‘OELs’), and other aspects relevant to occupational exposure to hazardous chemicals such as biological limit values for hazardous chemicals, relevant expertise should be integrated in the management board.

AddedArticle 9 – paragraph 1 – point y: (y) adopt the practical arrangements for complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council28, including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request as referred to in Article 37a;

RemovedArticle 6 – paragraph 3 – point d b (new): (db) non-animal approaches.

RemovedTasks and objectives of the Management Board should reflect the objectives of the Chemicals Strategy for Sustainability to move away from animal testing.

RemovedArticle 6 – paragraph 4 a (new): 4a. All parties nominating and appointing members of the Management Board shall refrain from nominating or appointing any person as a member of the Management Board where, on the basis of an analysis, there are reasonable grounds to believe that a conflict of interest exists or may arise in relation to that person.

RemovedThis amendment aims at strengthening the provisions to avoid conflict of interests for members of the Management Board.

RemovedArticle 6 – paragraph 6: 6. Members of the Management Board shall act exclusively in the interests of the Agency and the Union.

RemovedMembers of the management should not only act in the interests of the Agency but also in the interest of all citizens of the Union.

RemovedArticle 9 – paragraph 1 – point y: (y) adopt the practical arrangements for complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council28 , including appeals or remedies necessary for reviewing a partial or full rejection of a confidentiality request as referred to in Article 37a;

RemovedThe draft proposal deletes Art 118(1) REACH which is the legal basis for ECHA to apply the ATD Regulation (Regulation 1049/2001) to documents that ECHA holds. However, the proposal does not have an equivalent provision setting out such a clear legal basis, unlike the founding regulations of the other Agencies (see e.g. Article 41 Regulation 178/2002). It only has a provision saying the Management Board will adopt implementing rules for the ATD Regulation. The ATD Regulation as such does not apply to ECHA; it only applies to the Commission, Council and EP documents. To ensure proper transparency considering Article 15 TFEU, we propose to create in the Basic Regulation an equivalent to Article 118(1) of REACH in a new article which should be cross-referenced here.

RemovedArticle 10 – paragraph 1: 1. The Management Board shall act by a two-thirds majority of all its members with voting rights.

RemovedEditorial

Article 10 – paragraph 3: 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.

Change 19

RemovedThe Commission's proposal would give a de facto veto power to the Commission in case of second reading on those matters. We propose instead that the two-thirds majority set in paragraph 1 of this article should apply in all cases.

AddedArticle 12 – paragraph 3: 3. Without prejudice to the powers of the Commission and of the Management Board, the Executive Director shall be independent in the performance of their 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.

Change 20

ChangedArticle 12 – paragraph 5 – point d: (d) ensure the fulfilment of the time-limits laid down in sectoral Union legislation for the adoption of opinions by the Agency and by the Committees and of the independence of those opinions;

Change 21

RemovedArticle 4(4) provides that the Agency should serve as a point of reference by virtue of the independence of its assessments and opinions, this needs to be reflected in the tasks and responsibilities of the Executive Director.

Article 12 – paragraph 5 – point e: (e) ensure appropriate and timely coordination between the different bodies within the Agency, including with regard to potential divergence between their scientific opinions;

Change 22

RemovedArticle 45 is not about resolving potential divergence of opinions between bodies within the Agency, but with other Union bodies. A new item is added to address this specific case.

AddedArticle 12 – paragraph 5 – point e a (new): (ea) ensure an appropriate and timely coordination with other Union bodies, including in relation to potential divergence of scientific opinion as referred to in Article 45;

Change 23

ChangedArticle 12 – paragraph 5 – point eh a (new): (ea)(ha) ensure appropriate and timely coordinationresponse withto otherreports Unionof bodiesattempts withto regardexert pressure or attempts of undue influence made pursuant to potentialArticle divergence19(3a); a record of scientificall opinionthose reports and responses shall be included in accordancethe annual activity report referred to in point (q) of this paragraph; with Articleanonymisation 45;of those who have reported;

Change 24

RemovedItem added to address the specific case of resolving potential divergence of scientific opinion between the Agency and other Union bodies.

AddedArticle 12 – paragraph 5 – point p a (new): (pa) appoint the Agency's representative to the task force as referred to in Article 44;

RemovedArticle 12 – paragraph 5 – point h a (new): (ha) ensure appropriate and timely response to reports of attempts of pressure or undue influence made pursuant to Article 19(3a); a record of all those reports and responses shall be included in the annual activity report referred to in point (q) of this paragraph;

AddedArticle 12 – paragraph 6 a (new): 6a. The Executive Director shall ensure a psychologically healthy workplace by giving due consideration to measures beneficial to mental health at work.

RemovedThis report introduces a new provision in Article 19 for Members of the Management Board, chairpersons and members of the Committees and the Forum and any participating experts and advisers to report without delay any attempts of pressure or undue influence they would be the target of to the Executive Director. Hence, the Executive Director should be tasked to responding to and reporting on these potential cases.

RemovedArticle 12 – paragraph 5 – point p a (new): (pa) appoint the Agency's representative to the task force referred to in Article 44;

RemovedAs this report proposes in Article 44 to perpetuate and institutionalise the current cross-agency One Health task, the role of the Executive Director to appoint its representative to the Task Force should be reflected in this Article.

Article 13 – paragraph 2 – point b: (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.

Change 25

RemovedEditorial

AddedArticle 13 – paragraph 2 a (new): 2a. In addition to the tasks referred to in paragraph 1, the Committees shall, at the Executive Director's request: / (a) provide technical and scientific support for steps to improve cooperation among the Union, Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on the sound management of chemicals in developing countries; / (b) draw up an opinion on any other aspects concerning the safety of substances on their own, in mixtures or in articles.

RemovedArticle 13 – paragraph 2 a (new): 2a. In addition to the tasks referred to in paragraph 1, the Committees shall, at the Executive Director's request, provide technical and scientific support for steps to improve cooperation between the Union, the Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries.

AddedArticle 13 – paragraph 2 b (new): 2b. The European Parliament or a Member State may submit a request to the Agency to issue a scientific opinion on matters falling within its competences. 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 European Parliament or the Member State(s) that made the request. Justifications for the refusal shall be given to the European Parliament or the Member State(s) that made the request.

RemovedArticle 77(3)(b) of REACH provides the possibility for RAC at the Executive Director's request, to provide provide 'technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity building activities on sound management of chemicals in developing countries'. This mandate should not be limited to matters related under REACH but should be available for all tasks performed by ECHA, and for all Committees, regardless of the legislation from which it is emanating. Therefore, this possibility is now included in this article, and Article 77(3)(b) of REACH is deleted (see AM to Article 48)