These decisions relate to compliance checks of registration dossiers for homosalate and 2-ethylhexyl salicylate (cases A-009-2018 and A-010-2018), which according to the ECHA are used exclusively as cosmetic ingredients. In the contested decisions, ECHA required a registrant to conduct studies on these substances in vertebrate animals to fulfil registration requirements for human health endpoints—specifically, a 90-day subchronic toxicity study, two prenatal development toxicity (PNDT) and two extended one-generation reproduction toxicity (EOGRT) studies. In one of the two cases, ECHA also required the registrant to carry out a fish sexual development test.
Vertebrate Animal Testing
The registrant had argued before the board that ECHA cannot require studies on vertebrate animals for human health endpoints because the substances are used exclusively in cosmetics. However, the board found the REACH regulation requires studies on vertebrate animals even if the substance is used exclusively in cosmetics, and that the REACH regulation does not contain an automatic exemption from information requirements for registration if a substance is used as a cosmetic ingredient. A registrant can benefit from an exemption only if it shows that the conditions for an adaptation are fulfilled; e.g., a waiver for the studies.
The ECHA highlights this conclusion is consistent with the Cosmetics Regulation, which contains restrictions for vertebrate animal testing on cosmetic ingredients but does not prevent registrants from carrying out tests in order to comply with the information requirements of REACH.
The relationship between information requirements in REACH and the marketing and testing ‘bans’ in the Cosmetics Regulation have been an issue for years.
Aquatic Toxicity Requirements
The registrant also argued before the board that ECHA cannot require a fish sexual development test because this is not a standard information requirement for registration purposes. The board held that while it is not a standard information requirement (Column 1 of Section 9.1. of Annex IX) the ECHA has the power to require this test if necessary as an adaptation (Column 2 of Section 9.1. of Annex IX).
In this case, the ECHA found that a fish sexual development test was necessary because existing information shows that 2-ethylhexyl salicylate may be an endocrine disruptor. As a consequence, ECHA was entitled to require the registrant to carry out the test.
The Board of Appeal thus rejected both appeals.
Andrew Fasey, Technically Qualified Member of the Board of Appeal and rapporteur for the cases, said: “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.
"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.”
For more information, see the ECHA website.