Question écrite de
M. Alex AGIUS SALIBA
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Commission européenne
Subject: Timing of the public consultation of the Committee for Socio-Economic Analysis
The Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) adopted its opinion in June 2022 and the 60-day public consultation of the ECHA’s Committee for Socio- Economic Analysis (SEAC) ended on 29 August 2022. Because the European Ombudsman found that the opinion’s development was tainted by maladministration1, the RAC was obliged to organise a new targeted public consultation, which ended on 6 October 20222. Therefore, the RAC’s opinion was not final at the time when the 60-day SEAC consultation ended.
Does the Commission consider that it was appropriate to assess the socio-economic impact of the proposed restriction when its fundamental cause (i.e. ‘an unacceptable risk to human health or the environment [...] which needs to be addressed on a Community-wide basis’), as defined in Article 68(1)of REACH3, had not been definitively established at the time when the 60-day SEAC consultation ended?
Submitted:25.1.2024
1 European Ombudsman Decision of 14 November 2022 on how the European Food Safety Authority (EFSA)
dealt with a request for public access to documents related to a proposal to restrict lead in ammunition (case 2124/2021/MIG).
2 Acting Executive Director’s request to the RAC to prepare a supplementary opinion on the dossier on
restricting lead in outdoor shooting and fishing, 21 June 2022.
3 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1.
Answer given by Mr Breton on behalf of the European Commission
(10 April 2024)
The Honourable Member’s written question relates to the relationship between the opinion of the Committee for Socio- Economic Analysis (SEAC) and the supplementary opinion of the Risk Assessment Committee (RAC) on the proposed restriction on lead in outdoor shooting and fishing.
The RAC supplementary opinion was requested by the Commission to allow stakeholders to comment on raw data from the European Food Safety Authority (EFSA) on game meat intake and lead in game meat (which had not been accessible to them before adoption of the main RAC opinion) and to allow RAC to re-assess the EFSA data in the light of their comments (4).
The determination of an unacceptable risk to human health or the environment which needs to be addressed on an EU-wide basis, as referred to in Article 68(1) of the regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (5), falls within the remit of the Commission (6), not of RAC.
The Courts have clarified that the Commission bases its unacceptable risk determination on, inter alia, the opinions of RAC and SEAC (7).
As regards the relationship between the opinions, it is important to note that before SEAC launched the public consultation on its draft opinion, the RAC opinion had already identified a risk.
That risk was duly taken into consideration in SEAC final opinion, as were the conclusions of the supplementary RAC opinion, which confirmed the already identified risk related to game meat lead exposure. The opinions of RAC and SEAC will be taken into account by the Commission in its unacceptable risk determination.
The European Ombudsman Decision referred to by the Honourable Member does not contain any recommendation affecting RAC or SEAC.
1 ∙ ⸱ European Ombudsman Decision of 14 November 2022 on how the European Food Safety Authority (EFSA) dealt with a request for public access to
documents related to a proposal to restrict lead in ammunition (case 2124/2021/MIG). 2 ∙ ⸱ Acting Executive Director’s request to the RAC to prepare a supplementary opinion on the dossier on restricting lead in outdoor shooting and fishing, 21 June 2022. 3 ∙ ⸱
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1. 4 ∙ ⸱
While the full raw data set had always been available to RAC, stakeholders initially had only access to the data summaries that were included in the restriction proposal. 5 ∙ ⸱
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). OJ L 396 30.12.2006, p. 1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20231201 6 ∙ ⸱ Judgment of 30 June 2021, Global Silicones Council and Others v Commission, T-226/18, EU:T:2021:403, paragraph 199 and its appeal Case, Judgment of 9 November 2023, Global Silicones Council and Others v Commission and Others, C-558/21 P, EU:C:2023:839, paragraph 55. See also, for example, Recital 16 of Commission Regulation (EU) 2021/57 of 25 January 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead in gunshot in or around wetlands, OJ L 24, 26.1.2021, p. 19. 7 ∙ ⸱
Ibidem.