In the considered decisions, ECHA had requested a registrant to carry out several studies involving vertebrate animals in order to meet the registration requirements. The registrant was to carry out one 90-day subchronic toxicity study, two prenatal developmental toxicity studies, and two extended one-generation studies. In one of the two cases, ECHA also required the registrant to perform a fish sexual development test.

The registrant argued to the Board of Appeal that ECHA cannot require studies in vertebrate animals for human health endpoints because the substances are used exclusively as ingredients in cosmetic products.

The Board of Appeal argued that the REACH Regulation requires registrants to conduct studies in vertebrate animals even if the substance is used exclusively as an ingredient in cosmetic products. The REACH regulation does not provide an automatic exemption from the information requirements for registration when a substance is used as an ingredient in cosmetic products. A registrant can only benefit from an exemption if he proves that the conditions for an adaptation (e.g. an exemption for the studies) are met.

According to the ECHA, the conclusion is in line with the Cosmetics Regulation, as it contains restrictions on testing on vertebrate animals for cosmetic ingredients. However, these restrictions do not prevent registrants from conducting tests to meet the information requirements of REACH.

Source:
https://echa.europa.eu/about-us/who-we-are/board-of-appeal