Background: Vitamin A (CAS no. 68-26-8 /11103-57-4/116-31-4) constitutes a group of lipid-soluble compounds including retinol, retinyl palmitate, retinyl acetate, retinyl linoleate and retinal. Vitamin A is a lipophilic-soluble vitamin and as such a micronutrient essential for most mammalian species. In January 2012, the Commission received some documents from German authorities requesting a safety assessment of Vitamin A in cosmetics products. In February 2012, a safety dossier was submitted by Cosmetics Europe to support the continuous use of Vitamin A in cosmetic products. It relates to the use of retinol, retinyl palmitate and retinyl acetate as cosmetic ingredients at maximum use concentrations of 0.05% retinol equivalent in body lotions and 0.3% retinol equivalent in hand and face creams as well as other leave-on or rinse-off products.

The Commission asked the opinion of the European Medicine Agency (EMA) to exclude the possibility that, at maximum use concentrations of 0.05% retinol equivalent in body lotions, 0.3% retinol equivalent in hand and face creams as well as in other leave-on or rinse-off products, Vitamin A could be considered a medicinal product instead of a cosmetic product. EMA replied that all the products containing Vitamin A at the maximum use concentrations of 0.05% retinol equivalent in body lotions and 0.3% retinol equivalent in hand and face creams are not considered to be medicinal products by virtue of their function.

Conclusion:

1) On the basis of data provided does the Scientific Committee on Consumer Safety (SCCS) consider Vitamin A (retinol, retinyl palmitate, retinyl acetate, retinyl linoleate and retinal) safe when used as cosmetic ingredient:

a) In body lotions up to the maximum concentration of 0.05 % of retinol equivalent? The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate) via body lotion at the maximum concentration of 0.05% may lead to a daily systemic dose of 1003 IU for an adult. This exposure would constitute up to 20% of the Upper Limit (UL) of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in body lotions per se is safe.

b) In hand/face cream, leave-on (other than body lotions) and rinse-off products up to the concentration of 0.3 % of retinol equivalent? The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate): – via hand cream at the maximum concentration of 0.3% may lead to daily systemic dose of 1661 IU for an adult. This exposure could constitute up to 33% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in hand cream products is safe. – via face cream at the maximum concentration of 0.3% may lead to daily systemic dose of 1185 IU for an adult. This exposure could constitute up to 24% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in face cream products is safe. – via rinse-off products at the maximum concentration of 0.3% may lead to a daily systemic dose of 408 IU for an adult. This exposure could constitute up to 8.8% of the UL of 5000 IU/day of Vitamin A. Therefore, the SCCS considers that the use of Vitamin A in rinse-off products is safe. The SCCS estimates that exposure to Vitamin A from all cosmetic products would constitute up to 97% of the UL per day of vitamin A (85% excluding lip products). This is based on the worst case exposure scenario.

2) The SCCS is asked, when making the assessment, to take into account the specific age and sex groups who might be particularly susceptible to the effects of Vitamin A, such as the use of lip products for fertile age and postmenopausal women. The SCCS clarifies that the value of 5000 IU per day for the safety assessment of Vitamin A in cosmetic products is appropriate for women of childbearing age and also for middle age and elderly women who may suffer decreasing bone density as well as men and children above 6 years. Also, based on a reduced value of 2700 IU per day for the safety assessment of Vitamin A in cosmetic products for children aged 1-3 years, the SCCS concludes that the use of Vitamin A in the respective cosmetic products at the maximum notified concentration per se is safe for children above 1 year old.

3) Does the SCCS have any further scientific concerns with regard to the use of Vitamin (retinol, retinyl palmitate, and retinyl acetate,) in cosmetic products? Based on information provided by the applicants, Vitamin A and esters are not used in sunscreen products in the EU and so exposure to Vitamin A via these products was not assessed. No data was submitted for Retinyl linoleate and retinal, therefore these two ingredients have not been assessed. Exposure to Vitamin A may also occur from sources other than cosmetic products. Most importantly diet, followed by food supplements. The assessment has not taken into account people taking dietary supplement containing Vitamin A. Exposure to Vitamin A via food may already be very close to the UL and any additional source of exposure, including cosmetic products, may exceed this UL. No information for the determination of impurities was provided for retinol, retinyl acetate and retinol palmitate. Since the use of retinoic acid in cosmetic products is banned in the EU (Annex II, entry 375), the applicant should provide information on this particular impurity.

No data was available on the stability of Vitamin A in different product formulations. The use of retinol in cosmetic products will need to be stabilised through final formulations. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_199.pdf