Continuing animal tests on cosmetic ingredients for REACH in the EU

Jean Knight

doi:10.14573/altex.2104221

Abstract

EU cosmetic ingredients are governed by two regulations that conflict. Regulation EC 1223/2009, the Cosmetic Regulation, bans in vivo (animal) testing for cosmetic product safety assessments, including both final products and ingredients. At the same time, the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation can impose in vivo testing of those same ingredients under its chemical testing requirements. Here, we examined REACH dossiers for chemicals for which the only reported use is cosmetics to determine the extent of new in vivo testing caused by REACH. We found the REACH database has 3,206 chemical dossiers with cosmetics as a reported use. Of these, 419 report cosmetics as the only use, and 63 of these have in vivo tests completed after the Cosmetic Regulation ban on in vivo testing. Registrants largely used alternative, non-animal methods to evaluate ingredients for REACH, but some still conducted new in vivo tests to comply with REACH requirements for toxicity data and worker safety assessments. In some cases, ECHA, the agency that evaluates REACH dossiers, rejected registrants’ alternative methods as insufficient and required new in vivo tests. As ECHA continues to evaluate dossiers, more requests for in vivo tests are likely. REACH tests on cosmetic ingredients appear only as “industrial chemicals legislation” tests in EU reports. Given the importance to consumers and the cosmetic industry of having cosmetics free of animal testing, the public should be made aware of REACH testing until the conflict between the regulations is resolved.

Highlights

The use of in vivo tests for cosmetic products has raised ethical concerns for many years
The product category options were based on the EU Cosmetic Regulation definition of a cosmetic product: “...any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours” (Article 2) (EC, 2009)
“Dual use” cosmetic substances This paper focuses on the 419 dossiers for 413 cosmetic-only substances, but the European Chemicals Agency (ECHA) database search returned more than 2700 other dossiers with cosmetics reported as one of multiple uses

Summary

Introduction

The use of in vivo tests for cosmetic products has raised ethical concerns for many years. Risk assessment of cosmetic ingredients in the EU must be performed based on historical in vivo studies, new in vitro (non-animal) studies, or other approaches not requiring new tests on vertebrate animals. Such approaches include the read-across approach, which predicts health effects of a chemical by using data from similar chemicals; the quantitative structure-activity relationship (QSAR) approach, which uses mathematical models to relate chemical structure to bioactivity; and the weight of evidence (WoE) approach, which uses data from multiple studies to develop conclusions (Patlewicz et al, 2014; Linkov et al, 2015; Chesnut et al, 2018; Rovida et al, 2020)

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