A second workshop on advancing the roadmap to phase out animal testing in chemical safety assessments has been scheduled by the European Commission for Friday, 25 October 2024. This event, taking place in Brussels and available online, follows up on the first workshop held in December 2023. Registration for the event opened on 1 September 2024, and the draft agenda is expected to be available later in the same month.
This workshop is part of the European Commission’s response to the European Citizens’ Initiative (ECI) “Save cruelty-free cosmetics – Commit to a Europe without animal testing,” which reflects widespread public concern over animal testing within the EU.
Highlights from the First Workshop
The event featured key presentations and discussions centred around the development of Non-Animal Methods (NAMs) and the regulatory frameworks necessary for their implementation.
Participants stressed the need for continued efforts to transition to animal-free chemical safety assessments fully. De facto, while NAMs appear promising, their acceptance in regulatory practices remains significantly arduous.
Enhanced intersectoral cooperation and international efforts are imperative for the roadmap’s success.
A Brief History of Banning Animal Testing in Cosmetics
The European Union has been a global leader in the movement to ban animal testing for cosmetics, beginning with the first ban in 2004, which prohibited testing finished cosmetic products on animals. This ban was extended in 2009 to include testing of cosmetic ingredients for regulatory compliance. However, animal testing for substances considered carcinogenic, mutagenic, or toxic for reproduction was still permitted until 2013.
As of April 12, 2022, the EU has entirely banned the sale of cosmetic products tested on animals. This comprehensive ban covers both the final product and its ingredients. Consequently, any cosmetic product containing at least one ingredient tested on animals cannot be sold in the EU, even if the final product was not animal-tested.
Despite these stringent regulations, there are a few exceptions. A Member State may request a derogation if serious safety concerns arise regarding using an ingredient. Article 18, paragraph 2 of the EU Cosmetics Regulation outlines specific conditions under which a derogation may be granted, such as when an ingredient is widely used and cannot be replaced by another with the same function or when human health concerns justify the need for animal testing.
Subsequently, the claim “not tested on animals” is not permitted on cosmetic products in the EU because animal testing is already prohibited by law. Such a claim—along with “animal-friendly” or logos implying cruelty-free—breaches Regulation (EU) No 655/2013, which lays down common criteria for the justification of claims used in relation to cosmetic products.
Recent Legal Developments: The Intersection of EU Cosmetics Regulation and REACH
A significant legal development occurred on 22 November 2023, when the European General Court issued a judgment clarifying the relationship between the EU Cosmetics Regulation and the REACH Regulation (Regulation (EC) No 1907/2006). The REACH Regulation governs the registration, evaluation, authorisation, and restriction of chemicals in the EU, aiming to protect human health and the environment from chemical risks across the supply chain.
The case involved Symrise AG, to which the European Chemicals Agency (ECHA) asked in 2018 to conduct animal testing on the substance 2-ethylhexyl salicylate, an approved UV filter used exclusively in cosmetics. Symrise AG refused, arguing that the safety of this substance had already been assessed under the EU Cosmetics Regulation and that the ECHA’s request violated the animal testing ban for cosmetics.
The European General Court rejected Symrise AG’s arguments, ruling that cosmetic ingredients could be tested on animals for REACH compliance. The Court clarified that while the EU Cosmetics Regulation ensures the safety of end-users and professionals using cosmetics under normal conditions, REACH addresses broader risks to human health throughout a substance’s life cycle, including worker exposure during production.
The judgment emphasised that there is no legal precedence between REACH and the EU Cosmetics Regulation; rather, they must be interpreted and applied consistently and compatible.
The European Commission’s roadmap’s ultimate objective is to eliminate animal testing in all sectors, including those under REACH while developing new methods to guarantee human safety and consumer well-being.
References
European Commission Training and Workshops: Roadmap for phasing out animal testing in chemical safety assessments: second workshop. Retrieved on 18/08/2024
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