Kosmetiska produkter: SCCS opinion: Vitamin A (Retinol, Retinyl Acetate and Retinyl Palmitate) kan användas säkert om villkor uppfylls

SCCS final opinion om Vitamin A (Retinol, Retinyl Acetate and Retinyl Palmitate), publicerad 6 oktober

 

Bakgrund

EU:s oberoende vetenskapliga kommitté för konsumentsäkerhet, SCCS, publicerade tidigare under 2016 en opinion om Vitamin A (Retinol, Retinyl Acetate and Retinyl Palmitate), som på sedvanligt manér då var öppen för kommentarer. Nu har SCCS publicerat slutgiltig (final) opinion efter remisstiden.

SCCS final opinion om , publicerad 6 oktober

 

 

Förklaring

SCCS, EU:s vetenskapskommitté för konsumentsäkerhets opinion utgår ifrån daglig dos (livsmedel) om 5000 IU (internationell enhet) Vitamin A per dag för normalbefolkningen. Denna är framtagen genom riskvärdering av vetenskapskommittén Scientific Committee of Food (SCF) och riskhantering av myndigheten European Food Safety Authority (EFSA).

 

Sammanfattning

SCCS opinion har inte i sak ändrats efter remisstiden, utan säkerhetsvärdering i relation till gränsvärden för olika produktkategorier och åldersgrupper kvarstår.

 

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, theSCCS 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.

Barnprodukter: …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.

Solskyddsprodukter: …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.