SCCS OPINION on the safety of aluminium in cosmetic products - Submission IV - SCCS/1662/23 - Preliminary version
Résumé
SCCS OPINION on the safety of aluminium in cosmetic products - Submission IV - SCCS/1662/23 - Preliminary version
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, E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz
The SCCS adopted this document by written procedure on 14 December 2023
Mise en ligne : 15 December 2023 (30 Pages)
https://health.ec.europa.eu/publications/safety-aluminium-cosmetic-products-submission-iv_en
https://health.ec.europa.eu/document/download/cad5a8dd-c3b1-4cb2-b21d-0afdc7bd886b_en?filename=sccs_o_284.pdf
Details
Publication date : 15 December 2023
Author : Directorate-General for Health and Food Safety
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: E. Benfentati, N. Cabaton, E. Corsini, A. Koutsodimou, H. Louro, W. Uter, N. von Goetz (Rapporteur)
Contact: SANTE-SCCS@ec.europa.eu
On request from: European Commission
SCCS Number: SCCS/1662/23
Adopted on: 14 December 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? 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 and product type.
The SCCS considers that aluminium compounds are safe when used :
- in non-sprayable product categories at the maximum levels indicated in Table 1
- in sprayable products, at the maximum levels indicated in Table 1, 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.
- in talc due to the fact that aluminium is not bioavailable from talc up to a level of 2%
(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?
As mentioned in Opinion SCCS/1644/22, aluminium does not belong to substances classified as CMR 1A or B, so that only exposure from cosmetic uses was considered in this safety assessment with the exposure assessment based on maximum use levels for cosmetic ingredients. However, as evaluated in SCCS/1644/22, aggregated exposure from cosmetics and food may exceed safe limits for consumers at the highest exposure ranges.
It needs to be noted that this Opinion specifically covers the risk to consumers from exposure to aluminium from cosmetic products. As such, this Opinion does not address the safety of the use of talc in cosmetic products beyond the safety of the aluminium content in talc.
Keywords:
SCCS, revision, scientific opinion, aluminium, submission IV, Regulation 1223/2009
Opinion to be cited as:
SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products - Submission IV, preliminary version of 14 December 2023, SCCS/1662/23