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Under the REACH authorisation regime, companies may continue using substances classified as “of very high concern” if they justify that the risk is adequately controlled, or if there are no alternatives available and the benefits outweigh the risk.
Whether or not alternatives can be deemed “available in general” and “feasible” for an applicant company is a challenging assessment the Socio-Economic Analysis Committee of ECHA must undertake and provide an opinion on, based on the company’s data. While it is for the Commission to take the final decision to grant the authorisation, the opinion of SEAC, including on alternatives, is a very important basis for the decision-making. Yet, on many occasions it led the Commission to grant authorisation despite the existence of suitable alternatives on the market, hence in breach of REACH.
Important clarifications on what is an alternative available in general, and how to verify the applicants’ commitment to substitute to that alternative, were provided by the General Court in the first instance of the Lead Chromate case (T-837/16). The decision by the Court of Justice in appeal (C-389/19P) further clarifies the need for the Commission to systematically and strictly account for uncertainties before granting an authorisation. The presence of non-negligible uncertainties in the analysis of alternatives should lead to a refusal to grant the authorisation, the Court said.
This judgment has important consequences for the Commission but also for the day-to-day work of SEAC, and those are the ones we detail in our paper. Changes are required to bring SEAC work in compliance with the Court’s interpretation of REACH. They notably include the need to amend the decision-making documents that frame applications for authorisation and SEAC opinions.