Safety of aluminium in cosmetic products - Submission IV

SCCS members: U. Bernauer, L. Bodin, Q. Chaudhry, 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, M. Henriqueta D.L.G. Louro, W. Uter, N. von Goetz (Rapporteur)
Contact: SANTE-SCCSec [dot] europa [dot] eu (SANTE-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1662/23
Adopted on: 27 March 2024

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 Tables 1 and 2.

- in sprayable products, at the maximum levels for the total formulation (i.e. including propellant) 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.

- the SCCS considers that aluminium in talc is not bioavailable. Therefore, talc with aluminium-content of up to 2% may be used in cosmetic products.

(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 1B, 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.

This Opinion does not apply to nano forms of aluminium for which a separate specific safety assessment would be needed.

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, final version of 27 March 2024, SCCS/1662/23