The relationship between the EU’s REACH requirements and the Cosmetics Regulation’s marketing and testing bans continue to cause friction
The European Chemicals Agency’s (ECHA) Board of Appeal has disappointed cruelty-free campaigners by rejecting two appeals concerning vertebrate animal testing on cosmetic ingredients.
In the contested decisions, ECHA had required a registrant to carry out several studies on vertebrate animals on two substances: homosalate and 2-ethylhexyl salicylate, which are both used exclusively as ingredients in cosmetic products.
According to ECHA, the studies are required to fulfil registration requirements for human health endpoints and include 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 European Union’s Cosmetics Regulation contains restrictions for vertebrate animal testing on ingredients for cosmetic products, but these restrictions do not prevent the carrying out of tests in order to comply with the information requirements of the EU’s pan-industry chemicals regulation REACH.
While the registrant argued before the Board of Appeal that ECHA could not require studies on vertebrate animals for human health endpoints because the substances are used exclusively as ingredients in cosmetic products, the Board of Appeal maintained that the REACH regulation requires registrants to perform studies on vertebrate animals even if the substance is used exclusively as an ingredient in cosmetics.
It noted that 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.
According to ECHA, 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.
The registrant further argued that ECHA could not require a fish sexual development test because the test is not a standard information requirement for registration purposes.
In response, the Board of Appeal held that while the test is not a standard information requirement for registration purposes, ECHA has the power to require a fish sexual development test from a registrant if necessary.
In this case, ECHA deemed a test necessary because existing information shows 2-ethylhexyl salicylate may be an endocrine disruptor.
“The two decisions published today are among the most important taken by the Board of Appeal to date,” said Andrew Fasey, Technically Qualified Member of the Board of Appeal and rapporteur for the cases.
“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.”
The decision has been met with disappointment by animal rights campaigners, who say such rulings are an erosion of the meaning of ‘cruelty-free’.
“The Board of Appeal’s decisions effectively allow registrants and ECHA to ignore the Cosmetics Regulation’s testing and marketing bans,” said Dr Julia Baines, adviser to the PETA International Science Consortium Ltd.
“The will of the public and the European Parliament is that tests on animals not be required in order to bring a cosmetics product to market.
"Relying on animal tests – albeit conducted under REACH rather than the Cosmetics Regulation – undermines the purpose of the testing and marketing bans, which are meant to ensure that only non-animal methods are relied upon to bring a cosmetics product to market.
“The meaning of ‘cruelty-free’, and the ability of a manufacturer to refer to its product as such, is eroded.”
In a statement to Cosmetics Business, Baines noted that if animal testing is needed to ensure a cosmetic ingredient meets the requirements of REACH, then it should not be used in cosmetics at all.
“Circumventing the Cosmetics Regulation’s testing and marketing bans by requiring that animal test data be generated and subsequently be available for scrutiny by relevant authorities under the regulation, only for the data to be ignored in the cosmetics product safety assessment, undermines the purpose of the bans: to ensure that a cosmetics product can be safely brought to market without relying on animal tests,” she said.
“If this can’t be achieved while also meeting the requirements of REACH, the substance should not be used in cosmetics products.”