SCCS REVISION of the scientific Opinion (SCCS/1576/16) on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) SCCS/1639/21- Final version
Résumé
The SCCS concludes the following:
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.
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