REACH regulation requires registrants to perform studies on vertebrate animals.
The European Chemical Board of Appeals (ECHA) has rejected two appeals to its decision to require animal testing for REACH authorization. The Board of Appeal adopted two decisions concerning compliance checks of registration dossiers for homosalate and 2-ethylhexyl salicylate, which are used exclusively as ingredients in cosmetic products (cases A-009-2018 and A-010-2018).
“The two decisions published today are among the most important taken by the Board of Appeal to date. The relationship between the information requirements in REACH and the marketing and testing ‘bans’ in the Cosmetics Regulation have been an issue for many years with several different interpretations,” said Andrew Fasey, technically qualified member of the board of appeal and rapporteur for the cases. “The two decisions adopted today are based on a rigorous analysis of the wording and objectives of the two pieces of legislation. I don’t expect that everyone will agree entirely with these decisions. We have however tried to set out as clearly as possible how and why we have arrived at our conclusions.”
In the contested decisions, ECHA had required a registrant to carry out several studies on vertebrate animals on the substances to fulfil registration requirements for human health endpoints, namely a 90-day subchronic toxicity study, two PNDT and two EOGRT studies. In one of the two cases, ECHA also required the registrant to carry out a fish sexual development test.
The registrant argued before the Board of Appeal that ECHA cannot require studies on vertebrate animals for human health endpoints because the substances are used exclusively as ingredients in cosmetic products.
The Board of Appeal found that the REACH Regulation requires registrants to perform studies on vertebrate animals even if the substance is used exclusively as an ingredient in cosmetic products. The REACH Regulation does not contain an automatic exemption from the information requirements for registration if a substance is used as an ingredient in cosmetic products. A registrant can benefit from an exemption only if it shows that the conditions for an adaptation (for example, a waiver for the studies) are fulfilled.
HAPPI, 18 August 2020