Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate)

WG on Cosmetic Ingredients
SCCS members: U. Bernauer, Q. Chaudhry, P. Coenraads, G. H. Degen, M. Dusinska, W. Lilienblum, E. Nielsen, T. Platzek, C. Rousselle, J. van Benthem
External experts: A. Bernard, J. Duus-Johansen, J. Ezendam, A. Giménez-Arnau, E. Mirkova, E. Panteri, T. Vanhaecke
Contact: SANCO-C2-SCCSec [dot] europa [dot] eu (SANCO-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1576/16
Adopted on: 6 October 2016

Conclusion of the opinion:

(1) On the basis of data provided does the Scientific Committee on Consumer Safety (SCCS) consider Vitamin A (retinol, retinyl palmitate, and retinyl acetate,) 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 per se 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 per se 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 per se is safe.

The SCCS has also estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate) from all cosmetic products (including lip products) may lead to a daily systemic dose of 4855 IU for an adult. This exposure could constitute up to 97% of the UL of 5000 IU/day of Vitamin A. Excluding lip products, the daily systemic dose is estimated at 4256 IU for an adult, which constitutes up to 85% of the UL of 5000 IU/day of Vitamin A.

It is of note that these estimates are based on a worst-case scenario assuming that all the cosmetic products used (hand and face cream, body lotion, rinse-off products, products for the lips) contain Vitamin A at the maximum concentrations.

If no, what concentration limits in the above mentioned categories of cosmetic products does the SCCS consider Vitamin A to be safe?

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(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 has considered that the teratogenic potential of Vitamin A, and effects on liver and local effects in the skin are the most critical toxicological endpoints. For assessing the systemic toxicity of Vitamin A after cosmetic exposure, the SCCS has relied on the Tolerable Upper Intake Level (UL) for preformed Vitamin A (section 3.4.4).

- To take into account more susceptible population groups such as women suffering osteoporosis or children above 6 years old who may also be exposed to Vitamin A via cosmetic products, the SCCS has used the value of 1500 μg RE/day (5000 IU) for the safety assessment of Vitamin A in cosmetic products. This value 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. Based on information provided by the cosmetic industry, Vitamin A and esters are not used for children in the EU. However, based on a theoretical scenario, exposure to Vitamin A via these products has been assessed in this opinion for children above 1 year.

- The SCCS has used the value of 800 μg RE/day (2700 IU) for the safety assessment of Vitamin A in cosmetic products for children aged 1-3 years. Application of Vitamin Acontaining baby skin care products such as body lotions and creams were also considered by SCCS relevant for 1- and 3-years old children. The SCCS has estimated that exposure to Vitamin A (retinol, retinyl palmitate, and retinyl acetate) via all cosmetic products may lead to a daily systemic dose of 1064 IU for a child of 15 kg. This exposure could constitute up to 39% of the UL of 2700 IU/day of Vitamin A.

It is of note that these estimates are based on a worst-case scenario assuming that all the cosmetic products used (hand and face cream, body lotion, rinse-off products) contain Vitamin A at the maximum concentrations. Based on these estimates, the SCCS considers 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 A (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. Therefore exposure to Vitamin A via these products has not been assessed in this Opinion.

Based on information provided by the cosmetic industry, Vitamin A and esters are not used for children in the EU. However, application of Vitamin A-containing baby skin care products, such as body lotions and creams, were considered by the SCCS safe for 1- and 3-year old children. Exposure to Vitamin A via these products for children below 1 year has not been assessed in this Opinion.

- Retinyl linoleate and retinal may also be used in cosmetic products. However, since no specific data were provided by the applicant, these two Vitamin A derivatives have not been assessed in this Opinion.

- Exposure to Vitamin A may also occur from sources other than cosmetic products. The most important source of Vitamin A in the population is diet, followed by food supplements and cosmetics. This assessment has not taken into account people taking dietary supplement containing Vitamin A.

- On the basis of data from 12 dietary surveys in nine EU countries, Vitamin A intake was assessed and average intake ranged between 409 and 651 μg RE/day in children aged 1 to < 3 years; between 607 and 889 μg RE/day in children aged 3 to < 10 years; between 597 and 1 078 μg RE/day in children aged 10 to < 18 years; and between 816 and 1498 μg RE/day in adults. Therefore 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. It is however not up to the SCCS to advise which portion of the UL should be dedicated to the different sources of exposure. For example, when assessing exposure to chemicals via toys or drinking water, usually 10% or 20% of the reference value is considered. In the case of Vitamin A, these portions would be equivalent to 150 or 300 μg RE/day, which means that at the maximum-notified concentrations, the use of hand and face cream products, rinse-off products, body lotion and cosmetic products for lips may lead to exceeding this value.

- 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 2, entry 375), the applicant should provide information on this particular impurity.

- No data are 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.

Keywords:

SCCS, scientific opinion, Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), Regulation 1223/2009, CAS n. 11103-57-4 / 68-26-8 / 127-47-9 / 79-81-2, EC 234-328-2 / 200-683-7 / 204-844-2 / 201-228-5

Opinion to be cited as:

Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), SCCS/1576/16, 20 April 2016, final version of 6 October 2016.