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Expert opinion

Revision of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)

Final Opinion

Details

Publication date
26 October 2022
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/1639/21
Adopted on:  24-25 October 2022

Conclusion of the opinion:

(1) In light of the data provided, does the SCCS consider that the contribution of the cosmetic products among the overall/total exposure to Vitamin A is of concern?

The SCCS is of the opinion that vitamin A in cosmetics at the concentrations of 0.05% Retinol Equivalent (RE) in body lotion, and 0.3% RE for other leave-on and rinse-off products is safe.

Regarding the contribution from cosmetics to overall/total exposure, no conclusion can be drawn due to inconsistencies in the presented model calculations. However, the probabilistic assessment regarding the contribution from food and food supplements shows that the exposure to vitamin A of the most exposed consumers (5% of the total population) may already exceed the upper limit. Compared to food, the contribution of vitamin A from cosmetics is lower. However, it will add to the overall consumer exposure and this may be of concern for consumers with the highest exposure (5% of the total population) to vitamin A from food and food supplements.

(2) SCCS is invited to update accordingly opinion SCCS/1576/16 on Vitamin A notably as regards, as needed, the maximum concentration limits for the different categories of cosmetic products indicated in that Opinion.

Since cosmetics alone do not exceed the upper limit, the allocation of contributions of different exposure sources is a risk management issue and cannot be addressed at the level of risk assessment.
Therefore, it is beyond the scope of the SCCS to suggest maximum concentration limits that take into account contributions from other sources e.g. food, food supplements.

Keywords:

SCCS, revision, scientific opinion, vitamin A, Retinol, Retinyl Acetate, Retinyl Palmitate, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), revision of the scientific Opinion (SCCS/1576/16) on vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), preliminary version of 10 December 2021, final version of 24-25 October 2022, SCCS/1639/21.

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