SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Preliminary Opinion
Résumé
SCCS OPINION on the safety of aluminium in cosmetic products - Submission III - SCCS / 1644/22 – Preliminary Opinion
U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads, M. Dusinska, J. Ezendam, E. Gaffet, C. L. Galli, B. Granum, 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 6 May 2022 (51 Pages)
Mise en ligne 30 Mai 2022
https://ec.europa.eu/health/publications/sccs-safety-aluminium-cosmetic-products-submission-iii_en
Description
SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, P.J. Coenraads (Chairperson), M. Dusinska, J. Ezendam, E. Gaffet, C.L. Galli, B. Granum, 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-C2-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1644/22
Adopted on: 6 May 2022
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
a. in non-sprayable product categories at the maximum levels indicated in Table 4;
and
b. in sprayable antiperspirant products, provided that the maximum percentage of particles with 10 μm diameter does not exceed 20% of the total aerosolised particles
The SCCS could not assess safety of aluminium compounds in sprayable applications other than antiperspirant. These applications (including eau de toilette, eau de parfum and hair spray) are therefore excluded from this Opinion.
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 and B, only exposure from cosmetic uses was considered in this safety assessment.
However, in a scenario provided by the Applicant, where exposure from non-cosmetic sources of aluminium (food and pharmaceuticals) was aggregated with exposure from cosmetics, food contributed in a similar order of magnitude as cosmetics. The aggregate exposure to aluminum from cosmetic and non-cosmetic sources may therefore exceed safe limits.
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, SCCS/1644/22