The Skin Sensitisation of Cosmetic Ingredients: Review of Actual Regulatory Status.

Abstract

All cosmetics products must be safe under foreseeable conditions of use. Allergenic responses are one of the most frequent adverse reactions noted for cosmetics. Thus, the EU cosmetics legislation requires skin sensitisation assessment for all cosmetics ingredients, including the regulated ones (for which the full toxicological dossier needs to be analysed by the Scientific Committee on Consumer Safety (SCCS)) and those (perceived as less toxic) which are assessed by industrial safety assessors. Regardless of who performs the risk assessment, it should be carried out using scientifically and regulatory body-accepted methods. In the EU, reference methods for chemical toxicity testing are defined in the relevant Annexes (VII-X) of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation. Recommendations for Skin Sensitization (Skin Sens) testing are provided in Annex VII, and this particular endpoint information is required for all EU-registered chemicals. Historically, in vivo animal and human methods have been used. Both raise ethical doubts, and some of them cause practical problems in the objective analysis of skin sensitising potency. Previous decades of huge effort have resulted in the regulatory acceptance of the alternative Skin Sens IATA (Integrated Approaches to Testing and Assessment) and NGRA (Next Generation Risk Assessment). Regardless of the testing issues, a serious sociological problem are observed within the market: the consumer assumes the presence of strong sensitisers in cosmetics formulations and insufficient risk management tools used by the industry. The present review aims to provide an overview of methods for assessing skin sensitisation. Additionally, it aims to answer the following question: what are the most potent skin sensitisers used in cosmetics? The answer considers the mechanistic background along with the actual regulatory status of ingredients and practical examples of responsible industry solutions in the area of risk management.