Report on REACH review regarding extension of the scope of Article 60(3) to Endocrine disruptors

The European Commission published its final <link http: eur-lex.europa.eu legal-content en txt pdf _blank>report on the review of the extension of the scope of Article 60(3) REACH to substances which have been identified under Article 57(f) as substances of very high concern (SVHC) having on endocrine disrupting properties.

As a reminder: Article 60(3) excludes SVHC which have a non-threshold mode of action which have been identified based on Article 57(a-c) criteria (carcinogen, mutagens and reproductive toxicants) and the persistent and bioaccumulative substances identified based on Article 57(d-e) or (f) criteria from the adequate control route in application for authorisation.

It is concluded that it is not appropriate to extend a-priori the scope of Article 60(3) to all substances identified under Article 57(f) as substances with endocrine disrupting (ED) properties which have an equivalent level of concern. It remains the responsibility of applicants for authorisation to demonstrate that a threshold exists and to determine that the threshold is in accordance with Annex I of REACH. It is up to ECHA´s Risk Assessment Committee (RAC) to assess the validity of such an assessment and to ultimately decide on the possible existence of a threshold or not.