According to the authors, the background is the contradictory legislation of the European Cosmetics Regulation and the Chemicals Regulation. The researchers are calling for a revision of these conflicting laws.

Chemical substances manufactured and marketed exclusively for cosmetic products are subject to the European Cosmetics Regulation 1223/2009 (1). According to this regulation, in principle, the marketing of finished cosmetic products whose ingredients or combinations of ingredients have been determined to comply with the provisions of this regulation by animal testing is prohibited, where an alternative method is to be used after such an alternative method has been validated and adopted at the Community level with due regard to the development of validation within the OECD. However, there are exceptions if, for example, the chemical is also used in products other than cosmetics.

Chemicals in general are subject to REACH Regulation 1907/2006 (2). The Chemicals Directive prescribes animal testing as a last resort in cases where new methods to replace animal testing have not been recognized. Which animal tests, if any, have to be performed depends on the annual production volume (Annex VII to X of the REACH Regulation). According to this, a chemical safety assessment must be submitted for all substances subject to registration. This contains, among other things, information on the identification of adverse effects on human health and the environment as well as an exposure description.

According to Article 14(5)(b), the chemical safety report is not required to take into account risks to human health arising from end-uses in cosmetic products within the scope of the Cosmetics Regulation (Directive 76/768/EEC up to the year 2013, then 1223/2009).

Rear exit: occupational health and safety
Nevertheless, the European Chemicals Agency (ECHA) has also repeatedly demanded animal testing, against which registrants have resisted, sometimes successfully, sometimes less effectively.

As recently in 2020, the Board of Appeal adopted two decisions of the European Chemicals Agency (ECHA) on required animal testing for the substances homomenthyl salicylate (an organic compound used in some sunscreens) and 2-Ethylhexyl salicylate (a substance used as a UV filter in sunscreens), although the substances are used exclusively as ingredients in cosmetic products. The ECHA had required Symrise, a manufacturer of sunscreen products, to carry out animal tests on the two substances used as UV filters in their sunscreen products. The reason given was worker protection.

In the appealed decisions, ECHA had asked a registrant to conduct a 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 conduct a fish sexual development test (3). The Board of Appeal found that the REACH Regulation could require registrants to conduct studies on vertebrate animals, even if the substance was used exclusively as an ingredient in cosmetic products. The REACH Regulation does not contain an automatic exemption from the information requirements for registration when a substance is used as an ingredient in cosmetic products.

In a statement released later by numerous companies and animal rights organizations, stakeholders accused ECHA of undermining the EU's ban on animal testing. In reality, it was assumed, these data requirements were intended to ensure that ECHA could have an administratively complete set of data for hazard classification and labeling, regardless of whether additional data were actually needed to ensure worker protection (4).

In the meantime, a broad alliance of animal protection and animal rights organizations as well as more than 450 cosmetics companies producing without animal testing have addressed several EU institutions and demanded compliance with the groundbreaking ban on cosmetics animal testing (5).  The last 15 to 20 years, especially the cosmetic, but also the chemical industry has invested tens of millions of euros in new methods to replace animal testing.

Further information:
https://www.altex.org/index.php/altex/article/view/2291/version/2353
https://www.theguardian.com/environment/2021/aug/19/hundreds-of-uk-and-eu-cosmetics-products-contain-ingredients-tested-on-animals
(1) https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:de:PDF
(2) https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:136:0003:0280:de:PDF
(3) https://www.invitrojobs.com/index.php/de/neuigkeiten/news-archiv/item/4846-widerspruchskammer-registrant-muss-tierversuche-fuer-kosmetischen-inhaltsstoff-durchfuehren
(4) https://www.invitrojobs.com/index.php/de/neuigkeiten/news-archiv/item/4960-tierversuche-fuer-kosmetik-hersteller-erklaeren-tierversuche-abzulehnen
(5) https://www.invitrojobs.com/index.php/de/neuigkeiten/news-archiv/item/4994-offener-brief-an-die-eu-kosmetik-muss-tierversuchsfrei-bleiben