The statement, issued today by the Humane Society International’s Animal-free Safety Assessment Collaboration, said the EU animal testing ban for cosmetics and cosmetic ingredients was “being undermined” by ECHA and its Board of Appeal which were “systematically requesting unnecessary animal data despite a legal obligation to promote non-animal methods”.
Symrise v ECHA - Board of Appeal decisions at the centre of statement
Specifically, the statement referenced a recently upheld decision made in August 2020 by ECHA’s Board of Appeal to require German supplier Symrise to carry out several toxicity tests on vertebrate animals for two chemical ingredients – homosalate and 2-ethylhexyl salicylate – which were used exclusively in sunscreen formulations. The testing was said to be necessary to fulfil the requirements of the REACH Regulation to ensure occupational safety for workers in chemical manufacturing plants.
“In reality, these data demands are to ensure ECHA has an administratively complete set of data for hazard classification and labelling, regardless of whether additional data are in fact needed to ensure worker protection. Further, lessons learned in animal-free safety assessment of cosmetics over many years can be readily applied to occupational safety assessment of ingredients without compromising human safety,” the open statement read.
Since the August ruling, Symrise had initiated two actions for annulment against the ECHA Board of Appeal’s decisions in two separate cases: T-656/20 - Symrise v ECHA and T-655/20 - Symrise v ECHA.
Symrise was one of eight signatories of the statement against ECHA, alongside Firmenich, L’Oréal, Unilever, Proctor & Gamble, Avon, Lush and Humane Society International (HSI).
EU animal testing ban
While animals, largely mice, remain extensively used for medical research and testing, the European Union implemented a ban on all animal testing for cosmetic products and cosmetics ingredients under its Cosmetics Regulation 1223/2009 in 2013. The move followed an initial ban on testing for finished products in 2004 and ingredients in 2009.
However, under the European Chemicals Agency ECHA’s REACH regulation 1907/2006, certain aspects require or enable animal testing – notably testing for environmental endpoints like aquatic toxicity, testing for long-term worker safety, the pre-registration of some new chemical substances and registering of chemicals used in non-cosmetic products.
Beauty industry ‘compelled to join forces’ on animal data concerns
According to the HSI, the decision to issue the open statement had emerged from a discussion among its AFSA Collaboration members who “all felt compelled to join forces to defend the EU’s precedent-setting cosmetics testing and sales ban, the integrity of which is threatened”.
Marina Pereira, regulatory science advisor at Humane Society International, said: “For the first time in the decades-long journey to a cruelty-free European cosmetics market, industry and animal welfare have come together in unity to defend the ethical and safety science cornerstone, upon which modern cosmetics regulation is based.”
“It’s almost beyond belief that while chemical authorities like the US EPA [Environmental Protection Agency] have committed to end mammalian testing requirements by 2035, ECHA and some EU Member States seem intent to demand new animal data on an ever-increasing basis. Unless EU chemical authorities shift their perspective to embrace 21st century science, the animal testing demands we have seen for these two cosmetic ingredients will just be the tip of the iceberg,” Pereira said.
ECHA defends decisions – ‘the interface’ between REACH and the Cosmetics Regulation
Speaking to CosmeticsDesign-Europe, Christel Musset, director of hazard assessment at ECHA, said these two decisions made in August by the agency’s Board of Appeal had been made “on the interface between REACH and the Cosmetics Regulation”.
“These endorse the positions of ECHA and the European Commission from 2014 that the Cosmetics Regulation does not prevent registrants of a substance used, exclusively or amongst other uses, as an ingredient in cosmetic products from carrying out studies on vertebrate animals pursuant to the information requirements in the REACH Regulation. This is the law as it currently stands.”
However, Musset said: “Animal tests may only be needed if there is no alternative way to demonstrate safe use of chemicals. REACH requires companies to use alternative methods whenever possible – so companies should only ever test on animals as a last resort.”
The REACH requirement for animal data in the case referenced, she said, had been upheld as it related to protecting human health among workers. “The Cosmetics Regulation aims at protecting consumers. However, it does not protect workers or the environment. To make sure that workers are not at risk, REACH requires safety data on the properties of chemicals they handle. Workers at industrial sites may handle substances used in cosmetics products in great quantities, with higher concentrations and more frequently, leading to a higher exposure than consumers have. To protect the health of people working in that industry, animal testing may be required – but only if no alternative tests are available.”
Musset said that, currently, alternative testing methods could only be systematically applied for acute and short-term effects when considering worker safety, such as eye irritation or bioaccumulation. They could not, she said, demonstrate long-term effects for human health and the environment which was often why animal testing was then necessary under REACH.
Unilever - 'We don't believe that new animal testing is needed'
Julia Fentem, head of the Safety and Environmental Assurance Centre (SEAC) at Unilever – one of the open statement signatories – said additional animal data was not necessary for the two ingredients in question.
“The ingredients at the centre of ECHA’s testing decisions have a long history of safe use by consumers and have been handled safely in factories for many years by ensuring effective exposure-based assessments and controls are in place. We don’t believe that new animal testing is needed,” Fentem said.
“In line with the EU animal protection legislation we should be maximising the use of non-animal ‘next-generation’ assessment approaches. It is essential that we have the opportunity to apply the new scientific capabilities, developed to comply with animal testing bans under the EU Cosmetics Regulations, under chemicals regulations such as REACH,” she said.
The challenge? Getting non-animal approaches accepted by regulatory authorities
John Chave, director-general of trade association Cosmetics Europe, said the future of next-generation non-animal testing would not only rely on continued scientific advances but acceptance of these alternatives among stregulatory authorities.
“Herein lies an opportunity for the industry, which is actively engaged on research into alternatives, to fully engage with ECHA and other regulatory authorities to help them better understand the potential of alternatives,” Chave said.
Scientific progress on alternatives had been “quite successful over recent decades”, he said, but getting authorities to buy into these alternatives was an area where there was “progress still to be made”.
“…It’s important to get buy-in from regulators for the value and usefulness of alternatives, and that is something we’ll be looking hard at,” Chave said.
Procter & Gamble 'ready to work together' with ECHA and European Commission
Harald Schlatter PhD, director of scientific communications and animal welfare advocacy at Procter & Gamble – another open statement signatory, agreed and said: “We, our AFSA partners and others stand ready to work together with ECHA and the European Commission to further enable use of animal-free alternatives by making full use of the new approaches we and many others have contributed to over the past years.”
Schlatter said whilst there were still “some gaps in the available alternative approaches”, industry did have the ability to “further utilise existing non-animal alternative methods in the broader regulatory context, including REACH”.
Such efforts, he said, would mean the EU could remain seen as a global leader in both animal welfare commitments and cosmetics safety legislations.
‘Valid adaptation’ can fill data gaps instead animal tests
Musset said the REACH Regulation did allow registrants to consider alternatives to animal testing and also avoid animal tests altogether if they could submit a “valid adaptation” for not providing these tests – specific conditions of which were outlined in Annexes VII to X of the regulation.
In the case of Symrise and the two recent ECHA Board of Appeal decisions, she said the rulings did not outright insist animal testing was necessary and still allowed the registrant to “consider alternative means to address the data gaps identified in their registration dossier.”
Asked if ECHA believed REACH and its testing requirements ought to fully align with the EU animal testing ban under the Cosmetics Regulation, Musset said: “It is for the legislator to decide whether it is necessary to introduce amendments to the REACH and Cosmetics Regulations in order to align the testing rules of these two regulations.”