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.

Evaluation of the Safety of Cosmetic Ingredients and Their Skin Compatibility through In Silico and In Vivo Assessments of a Newly Developed Eye Serum

“…Even if NAMs are currently widely used for the risk assessment of cosmetic ingredients and formulations, there is still a high demand for a combined risk evaluation methodology, as alternative tests are not always fully applicable for multicomponent ingredients and cosmetic formulations, this representing a main disadvantage compared, e.g., to in vivo evaluation [9].…”

“…Quality control of the formulation, evaluating the physicochemical characteristics and microbiology, and including a challenge (preservative efficacy evaluation), was performed in this study. Another objective of this study was to carry out an in silico safety assessment, in order to Even if NAMs are currently widely used for the risk assessment of cosmetic ingredients and formulations, there is still a high demand for a combined risk evaluation methodology, as alternative tests are not always fully applicable for multicomponent ingredients and cosmetic formulations, this representing a main disadvantage compared, e.g., to in vivo evaluation [9].…”

Endocrine Disruptors in Cosmetic Products and the Regulatory Framework: Public Health Implications

“…Before substances are included in these annexes, a scientific risk assessment is carried out by an independent scientific committee, the Scientific Committee on Consumer Safety (SCCS). During the risk assessment process for substances used as ingredients in cosmetics, the SCCS examines exposure assessments for specific vulnerable groups, such as children and pregnant women [74]. This is crucial because cosmetic products are consumer goods used on a wide scale by citizens every day [54].…”

Integration of the Natural Language Processing of Structural Information Simplified Molecular-Input Line-Entry System Can Improve the In Vitro Prediction of Human Skin Sensitizers

“…Skin sensitizers are chemicals capable of inducing skin hypersensitivity [ 1 ], a condition that can progress to allergic contact dermatitis [ 2 ]. Consequently, the identification and regulation of skin sensitizers are imperative in compliance with chemicals and cosmetics regulations [ 3 ]. Traditional methods, such as the murine local lymph node assay (LLNA), have been employed for the identification of skin sensitizers [ 4 ].…”