Product Safety: REACH considerations and Cosmetics Regulation

Since 11 July 2013 Article 18 of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products ("Cosmetics Regulation") bans animal testing for the safety assessment of cosmetic products or of its ingredients if alternative validated testing methods are available. A violation of this prohibition not only results in the product not being marketable in the European Union, but the manufacturer could also commit an offense or a misdemeanour. (Depending on Member States’ national provisions; in Germany it is for example a regulatory offence to put such products into circulation, punishable by a fine up to EUR 20,000).

This being said, manufacturers of cosmetic products may need to perform animal testing to comply with the requirements of the REACH Regulation (Regulation (EC) No 1907/2006), entered into force on 1 June 2007, (1) if the cosmetic ingredient is used not solely for cosmetics, but for other industries as well and therefore fall under the REACH Regulation as well or (2) if the ingredient is used solely for cosmetics, but to assess the risks to workers exposed to the ingredient during manufacturing, formulation, packaging etc. under the REACH Regulation.

This divergence often leads to a dilemma for manufacturers if they want to put their products onto the market without animal testing and who may even want to advertise their products being completely animal test free.

A recently published analysis shows, that registrants of REACH dossiers for chemicals with cosmetics as only reported use, used largely alternative testing methods, but some conducted even new in vivo tests to comply with REACH requirements (see Knight et al., Continuing Animal Tests on Cosmetic Ingredients for REACH in the EU, published 18 August 2021).

Manufacturers' juggling with REACH and Cosmetics Regulation has been evident at least since the Decision of the Board of Appeal of the European Chemicals Agency of 18 August 2020 (case number: A-010-2018). The appellant has unsuccessfully challenged a decision of ECHA demanding to submit information on certain toxicity studies in vivo for a substance (2-ethylhexyl salicylate), exclusively used as an ingredient in cosmetic products, in a registration dossier.

In its decision, the Board of Appeal of ECHA upheld the ECHA's understanding of the interface between REACH and Cosmetics regulations (see "Factsheet" of the ECHA of October 2014 on this topic). The European Commission in cooperation with the ECHA already clarified in 2014 the relationship between the Cosmetics Regulation and the REACH Regulation regarding substances exclusively used in cosmetics (All news - ECHA (europa.eu)). According to which, in summary "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.)."

In its decision, the Board of Appeal of the ECHA stated that "the REACH Regulation and the Cosmetics Regulation must (…) be interpreted and applied so that each is compatible and coherent with the other".

Comparing the intended purpose of the Cosmetics Regulation and the REACH Regulation becomes clear, that the REACH Regulation wants to cover all environmental risks that may arise from the product during its entire life cycle which includes especially workers during manufacturing, formulation and packaging of the product. Whereas the Cosmetics Regulation is aiming at the protection of the end user of the product.

In this context, it should be noted that the prohibitions in Article 18 of the Cosmetics Regulation apply if the animal tests are intended to demonstrate the safety of the cosmetic product or its ingredient for cosmetic use to meet the requirements of the Cosmetics Regulation (and the animal test is for example listed in the safety report). However, the prohibitions  in Article 18 do not already apply if the animal tests are only stated in the product information file and not in the safety report, as Article 11 of the Cosmetics Regulation stipulates that data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries should be included in the product information file (see judgment of the European Court of Justice of 21 September 2016, C-592/14).

Outlook

The position of the European Commission and the ECHA on the interface between REACH Regulation and Cosmetics Regulation seems clear. Manufacturers of cosmetics products will have to carefully consider how to respond to the challenge. New in vivo tests to comply with REACH requirements may be last resort if no alternative methods are validated/recognized by the Commission, ECHA or international bodies. But legal implications must be flagged.

To achieve the targeted goal that cosmetic products marketed in the European Union should be completely free of animal testing, the competent authorities and international bodies need to validate/develop alternative methods to animal testing where they are still lacking in the REACH Regulation. It is a start to validate alternative testing methods for the Cosmetics Regulation. However, one needs to validate alternative testing methods for the REACH Regulation and may need different testing methods as the two Regulations have different protection purposes and therefore may need different alternative methods to avoid animal testing. Of course those alternative methods need to be able to provide the same level of protection for the environment, the users and the workers.

Authored by Katrin Weixlgartner.