22 / 03 / 2021
FRAME supports call to uphold values of EU animal testing ban
An international campaign calling for the EU Cosmetics Animal Testing Ban to be upheld following a series of regulatory decisions made by the European Chemicals Agency has featured the results of a FRAME survey on public attitudes to animal testing in an open letter to the President of the European Commission.
The disappointing outcome of the appeals highlight the need for continued reflection and updating of animal testing regulations.
In August 2020, the European Chemicals Agency’s (ECHA) Board of Appeal rejected two appeals concerning vertebrate animal testing on cosmetic ingredients. In the contested decisions, ECHA had required a registrant – the German company, Symrise – to carry out several studies on vertebrate animals of two chemicals destined for use in cosmetics — homosalate and 2-ethylhexyl salicylate. These substances are both used exclusively as ingredients in cosmetic products, commonly sunscreens and skincare products.
Whilst these decisions appear to be in contradiction to the EU regulatory framework, which prohibits animal testing for finished cosmetic products, or ingredients purely for cosmetic use, this is not the case. The EU wide ban applies to animal tests for assessing safety risks to the end user or consumer, but not necessarily to those exposed to the chemicals during the manufacturing process.
In the open letter ‘Cosmetics Animal Testing Ban Effectively Shredded’ to the President of the European Commission, the Parliament and the Council, cosmetic brands and international animal welfare organisations have called for the EU Cosmetics Animal Testing Ban to be upheld as intended, with no new animal tests allowed for these chemicals.
Need for continued reflection on animal testing regulations
This case highlights the tension between EU REACH Regulation for the control of hazardous chemicals, and EU Cosmetic Regulation 1223/2009 banning the testing of cosmetic products and ingredients on animals. The letter argues that the required testing in these decisions under REACH are at odds with the aims of the Cosmetic Regulation and is in this case due to existing evidence, unnecessary. The decisions also demonstrate how the interface between the two pieces of legislation has potential consequences for citizens across the world who want to purchase cruelty-free products.
Referencing one of the findings of FRAME’s survey: ‘Fact or fiction? Mapping perceptions of animal testing,’ the letter explains that 84% of respondents said they would not buy a cosmetics product if they knew it (or one of its ingredients) had been tested on animals.
The ECHA decisions
According to the ECHA, further testing of the two chemicals in question was required to fulfil registration requirements for human health endpoints. The mandated tests included a 90-day subchronic toxicity study, which would involve the repeated exposure of rodents to the chemical to assess toxicity by inhalation; two pre-natal diagnostic toxicity (PNDT) tests which assess the potential of a substance to cause harm to a developing foetus on two vertebrate species; and two extended one-generation reproduction toxicity (EOGRT) studies to assess adverse effects on reproductive ability and offspring. In one of the two cases, ECHA also required the registrant to carry out a fish sexual development test.
Whilst the Cosmetics Regulation contains restrictions on vertebrate animal testing of cosmetic ingredients, they 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.
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, but the Board of Appeal claimed that the REACH regulation does not contain an automatic exemption from the registration requirements if a substance is used as an ingredient in cosmetic products. In this case, it falls under the exception in the Cosmetics Regulation to allow animal testing on ingredients to assess the risks from exposure to workers. This is laid out in the ECHA fact sheet on the interface between REACH and the EU cosmetic legislation.
The Board of Appeal decision explains that the registrant could not ‘strictly control’ conditions to protect those working with the chemical to formulate the cosmetic product, and so specific human health safety tests using animals were required.
The ECHA also states that a registrant can benefit from an exemption to this rule only if it shows that the conditions for an adaptation (for example, a waiver for the studies) are fulfilled. In this decision, it was indicated that the registrant included adaptations to negate the need for the specified animal tests based on existing animal and human data. The ECHA argued that this option did not meet the specific criteria set out for exposure assessments under the current wording of REACH. However, no explanation was offered as to why these adaptations were not good enough to evidence the safety of the chemical.
The registrant also argued that ECHA could not require a fish sexual development test because the test is not a standard information requirement for registration purposes. The Board of Appeal held that whilst 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, as an adaptation. In this case, ECHA deemed a test necessary because existing information shows 2-ethylhexyl salicylate may be an endocrine disruptor – chemicals that may interfere with the actions of hormones in the body.
In summary, ECHA is now requiring some widely used cosmetics ingredients (and ingredients used in many other types of consumer products) to be tested on thousands of animals under the requirements of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. As a direct result of these decisions, the use of thousands of rats and rabbits in tests is required.
Retreat on animal testing for cosmetics
The decisions made by ECHA represent a concerning retreat on animal testing and, ultimately, mean that animal tests are being conducted on cosmetic ingredients under REACH despite Cosmetics Regulation. As the results of our survey demonstrate, in the main, the view of the general public is that tests should not be carried out on animals in order to bring cosmetic products to market.
The ‘Cosmetics Animal Testing Ban Effectively Shredded’ campaign calls for the EU cosmetics animal testing ban to be upheld as intended, with no new animal tests allowed as they are not needed. Supporting the campaign are 436 consumer goods and cosmetics companies and a coalition of animal welfare organisations.
The situation shows the important role regulatory bodies play in supporting the uptake of non-animal methods and reduction of animal testing, as FRAME Scientific Liaison Officer Amy Beale explains: “These are disappointing decisions by ECHA and seem to undermine the progress made in replacing animal testing for cosmetic purposes. The relationship between REACH and the Cosmetic Regulations was laid out several years ago by ECHA indicating that these animal tests could still be required, but why should this be the case?
“There is overwhelming agreement from the parties supporting this letter that these particular animal tests are not required because there is existing safety data from their historic use, and there are alternative, non-animal methods that can fill any evidence gaps. The chemicals addressed in these decisions are already being used safely in cosmetic ingredients and therefore in manufacturing processes.
“We applaud the registrant for making the appeal and encourage organisations and companies to continue challenging regulatory animal tests where they feel they can provide required safety data in other ways. Regulatory bodies such as ECHA should prioritise the avoidance of animal tests in scenarios where registrants identify them as being scientifically unnecessary, rather than seeing the original animal tests or regulatory requirements as the ‘gold standard.’”
“New approaches must be fully considered and seen as opportunities to collaborate with registrants to help implement robust alternative methods,” Amy adds, “the standard of evidence required to request permission to NOT carry out an animal test in a regulatory situation is high, yet animal tests themselves have never been held accountable in the same way. We also know they are often flawed in predicting adverse outcomes in people. There is a legal requirement under REACH to implement the 3Rs and actively consider non-animal approaches first. This should be the priority on the ground.”
FRAME’s final thoughts
These decisions are actively taking backwards steps that will lead to more animal testing. The cosmetics industry evolved with the cosmetic animal testing ban by implementing new, non-animal methods. As a result, there is a wealth of knowledge, expertise and new technology out there and regulations need to adapt to reflect this.
At FRAME we understand that the world is not yet able to ban the use of all animals in testing and experimentation without halting some basic medical and safety testing. We can however put more time and funding into developing human based research models. Not only will this improve health outcomes for people in the future, it will ultimately provide the replacements that will help end the need for animal use in not only safety testing, but all biomedical and scientific research.