Cosmetics Regulation animal test ban declared subordinate to REACH registration testing requirements by ECHA

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In the Spotlight

Cosmetics Regulation animal test ban declared subordinate to REACH registration testing requirements by ECHA

by Sherry Ward, AltTox Contributing Editor and member of IFER Scientific Advisory Board
Published: November 25, 2014
On October 27, 2014, the European Chemicals Agency (ECHA) published a short article titled “Clarity on interface between REACH and the Cosmetics Regulation” (ECHA/NA/14/46). The ECHA clarification, in full, was the following:

“To meet the requirements of the new Cosmetics Regulation (Regulation (EC) No 1223/2009) cosmetic products are prohibited to be placed on the market where the final formulation, ingredients in a final formulation or a finished product, have been subject to animal testing. Those same chemical ingredients may, however, also need to be registered under REACH. This has created some uncertainty about whether testing on animals can take place in order to comply with REACH, or whether it should not, in order to comply with the Cosmetics Regulation.

The European Commission, in cooperation with ECHA, has now clarified the relationship between the marketing ban and the REACH information requirements as follows:

  1. Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance. Workers in this context, refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g. hairdressers).
  2. Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints.
  3. Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints.

Therefore, the testing and marketing bans in the Cosmetics Regulation do not apply to testing required for environmental endpoints, exposure of workers, and non-cosmetic uses of substances under REACH.

Registrants of substances registered exclusively for cosmetic use will still have to provide the required information under REACH wherever possible, by using alternatives to animal testing (such as computer modelling, read-across, weight of evidence etc.).”

Under EU regulations, registrants are still obliged to use alternatives to animals whenever possible. A review of non-animal approaches was produced for ECHA by the European Commission’s Joint Research Centre’s European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). This report, Alternative methods for regulatory toxicology – a state-of-the-art review, was published in September 2014. Although the report is not official EU policy, it does provide information on “alternative” methods for assessing a number of human health and ecotoxicological endpoints that the ECHA can take into consideration as it implements regulatory processes for REACH, Biocidal Products, and Classification, Labelling, and Packaging (CLP) regulations.

The EURL ECVAM report explains newer methodologies such as –omics, high-throughput screening, and integrated assessment and testing approaches (IATAs). Adverse outcome pathways (AOPs) and modes of action (MoA) are covered as emerging concepts for understanding the mechanism(s) of toxicity and the assessment of specific endpoints. The ECHA notes that alternative approaches for four endpoints are especially promising: acute toxicity, eye irritation, skin sensitization, and skin corrosion. “These endpoints are relevant for registrants preparing their dossiers for the next registration deadline [2018].”

The October ECHA newsletter article also explains that ECHA is “updating its guidance on information requirements with in vitro methods.” We look forward to seeing this guidance, which will be crucial in understanding the details on which alternative methods will be accepted by ECHA.

Stakeholders with a high interest in this clarification on the Cosmetics Regulation and REACH testing requirements include the cosmetics industry and animal protection organizations. Although formal published statements on their views are not yet available, several news articles mention critical statements made by People for the Ethical Treatment of Animals (PETA) and the European Coalition to End Animal Experiments (ECEAE), including claims for increased animal testing and citing a possible legal challenge based on a previous EU court ruling.

The cosmetics industry has long opposed the animal test ban, and the industry trade association Cosmetics Europe does not even mention the animal test ban component of the Cosmetics Regulation on their website. A cosmetics industry newsletter reported that the clarification “will be welcomed by many in the industry” due to confusion cause by the incompatible regulations.

We welcome statements from both stakeholder groups to further clarify their positions.