SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Final Opinion U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven, N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz The SCCS adopted this document by written procedure on 1st Februray 2023 (60 Pages) Mise en ligne : 2 February 2023 https://health.ec.europa.eu/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_en https://health.ec.europa.eu/system/files/2023-02/sccs_o_266.pdf Details Publication date 2 February 2023 Author Scientific Committee on Consumer Safety (SCCS) Description SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, E. Panteri, V. Rogiers, Ch. Rousselle, M. Stepnik, T. Vanhaecke, S. Wijnhoven SCCS external experts: N. Cabaton, A. Koutsodimou, W. Uter, N. von Goetz (Rapporteur) Contact:SANTE-SCCS@ec.europa.eu On request from: European Commission SCCS Number: SCCS/1644/22 Adopted on: 1 February 2023 Conclusion of the opinion: 1. In light of the new data provided, does the SCCS consider Aluminium compounds safe when used in cosmetic products other than deodorants, antiperspirants, lipsticks and toothpastes? In the event that the estimated exposure to Aluminium from cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for each category. The SCCS considers that aluminium compounds are safe when used -in non-sprayable product categories at the maximum levels indicated in Tables 4 and 6; and - in sprayable products, at the maximum levels indicated in Table 4, provided that the percentage of particles/droplets with a diameter of less than 10 μm does not exceed 20% of the total aerosolised particles/droplets. Since the Applicant’s data submission indicated that aluminium is not used in sunscreen aerosol sprays, this Opinion does not cover sunscreen aerosol sprays. 2. Does the SCCS have any further scientific concerns regarding the use of relevant Aluminium compounds in cosmetic products taking into account the newly submitted information on aggregate exposure to Aluminium from cosmetics, medicines (e.g. antacids) and food intake? As aluminium does not belong to substances classified as CMR 1A or B, only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients. However, the submission also provided a scenario where realistic exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated along with exposure from cosmetics at use levels from the year 2016. From this scenario, it can be deduced that contribution to aluminium exposure from food may be at a similar order of magnitude to that from cosmetics used for the safety assessment. Considering the conservative nature of the estimates, the aggregate exposure to aluminium from cosmetic and non-cosmetic sources may exceed safe limits for consumers at the highest exposure ranges. Keywords: SCCS, revision, scientific opinion, aluminium, submission III, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission III, preliminary version of 6 May 2022, final version of 1 February 2023, SCCS/1644/22