Document pOg8VX07j41o27E3xRvXZvOB

IB ve wacom caomon: EH ECatUinRctOo PExEcuAivNe VCiOMPMrISeSsiIseFOoaNnm Trans HeofCaabidnet ABrreusss(e2l0s2,3)24/897/12209202 Dear[. I would like to thank you, and your cosignatories, for your letter of 4 July 2022 in which you drew the attention of Executive Vice-President Timmermans, Vice President Sefcovi, Commissioner Sinkevitius and Commissioner Breton to the concerns of Europe's battery and metals value chain about the consequences of a proposed hazard classification for three lithium salts Firstly, T would like to reassure you that the opinion of the Risk Assessment Committee from the European Chemicals Agency, which recommended the classification of lithium carbonate, lithium chloride and lithium hydroxide as known toxicants for human reproduction, was developed in full compliance with the EU rules. Two public consultations were held during the process, complemented by ad-hoc stakeholder participation in the Committee's meeting, where representatives from the lithium industry shared their views on the scientific assessment. The arguments of the industry were carefully considered, including the approach taken in their REACH dossiers regarding the applicability of the read-across amongst the three salts. 1 also note that some companies already self-classify lithium compounds as toxic for reproduction Regarding the scientific basis for the classification, the opinion considered a comprehensive data set including both animal studies and evidence from human exposure. However, industry stakeholders have recently identified an additional epidemiological study, which was not part of the original lithium dossiers. I can confirm that the European Commission's services, together with ECHA and the Member States, are carefully assessing this new piece of evidence. If appropriate, the Commission may `mandate ECHA to formally assess this data and provide an updated opinion on the three lithium salts / Eurometaux- European Metals Association E-mail[ll@eurometau be emeissWiiFontRapEi Fut1o.pesocv toCEommiRs 1R019 oli Bs, BELGI"QUEBELOIE+!161, 32 2591111 Furthermore, the adoption of the harmonised classification will trigger downstream risk mitigation measures. Companies processing lithium will face tighter operating rules. However, those rules are in place in the EU to protect workers, users, consumers and the environment against identified hazardous chemicals. Some of those measures may already be implemented, such as in the recycling industry, where lithium-based batteries contain other hazardous chemicals such as cobalt. 1 would also like to recall that several meetings have been held giving concemed stakeholders the opportunity to present to Commission services their concerns in relation to the classification and possible consequences. Stakeholders also have the possibilty to participate in the relevant discussions of the CARACAL! expert group. which is consulted on the Delegated Regulations implementing harmonised classifications Finally, you raise concerns about Europe overall losing its competitive advantages with respect to processing, production and recycling of lithium batteries. The new Battery Regulation, which should be adopted by spring of next year, will ensurae (i) competitive, sustainable and circular battery value chain in Europe, (ii) a level-playing field in the market, and (iii) competition centred around sustainability and circularity. This is important for the European battery industry, and we could not agree more on the role that the batteries sector is playing as a key technology enabler in the climate, energy and digital transitions. All batteries sold in the EU would be manufactured and recycled in a sustainable way, including from a health protection perspective. Yours sincerely, Diederik Samsom `Competent Awborites for Registration. Evaluation. Auborisarion and Restriction of Chemicals (REACH) and Classification, Labelling ind Packaging (CLP) BI cron signed on3/0/2021736 UTC) in cordance wth Avice2 ofComisio(n0) 01/121