Food Additives

Answers to objections from The Retinol Consortium to the “Risk Assessment of vitamin A (retinol and retinyl esters) in cosmetic products”


Report no: 2013: 22

Published: 15.04.2013

Main message:

The Norwegian Scientific Committee for Food Safety (VKM) has considered the objections to the vitamin A risk assessment presented by The Retinol Consortium. VKM concludes that there is no need to revise this risk assessment.

The VKM Panel on Food Additives, Flavourings, Processing Aids, Food Contact Materials and Cosmetics has conducted a risk assessment of vitamin A in cosmetic products in 2012 at a request from the Norwegian Food Safety Authority.

VKM was asked by the Norwegian Food Safety Authority to estimate the total exposure to vitamin A taking into account cosmetic products in addition to the contribution from food and food supplements. VKM was asked to assess both systemic effects and local effects in the skin of vitamin A.

The total exposure to vitamin A for different age groups in the Norwegian population should be estimated, taking into account both oral and dermal exposure routes, and include exposure scenarios that illustrate the effect of increasing the maximum authorized concentration levels of retinol and retinyl esters used in cosmetics (worst-case scenario).

The Retinol Consortium has presented several objections to this risk assessment. The objections mainly target the calculation of the contribution of cosmetics to the total exposure of vitamin A and the data used for the calculation of vitamin A absorption through the skin.

The Retinol Consortium disagrees with VKM’s view that based on the available data it cannot be excluded that applying cosmetic products containing retinol and retinyl esters on the skin may lead to an increased concentration of vitamin A in the body and thus possible negative health effects.

In addition, The Retinol Consortium claims that the calculated exposure in the worst-case scenario is an overestimation.

After reviewing the literature used for the preparation of the risk assessment as well as available literature presented by the Retinol Consortium, the VKM Panel on Food Additives, Flavourings, Processing Aids, Food Contact Materials and Cosmetics concludes that the objections from the Retinol Consortium does not justify altering the original risk assessment.

The Norwegian Scientific Committee for Food and Environment

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P.O. Box 222 Skøyen
0213 Oslo

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