Food Additives | Contaminants
Evaluation of local toxicity / irritation of vitamin A in cosmetics
Report no: 2013: 43
The Norwegian Scientific Committee for Food Safety, Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics has at the request of the Norwegian Food Safety Authority conducted an assessment of local adverse effects, such as skin irritation, induced by vitamin A (retinol and retinyl esters) in cosmetic products.
Vitamin A constitutes a group of lipid-soluble compounds including retinyl esters, retinol and retinal.
Retinol and retinyl esters are widely used ingredients in skin care products, such as anti-wrinkle products, moisturisers and sunscreens, due to their effects on various biological processes in the skin.
The use of retinol and retinyl esters in cosmetic products has been restricted in the Norwegian cosmetics regulations with maximum allowed concentrations of 0.3 % retinol and 0.55 % retinyl palmitate. However, upon entry into force of the EU Cosmetics Regulation July 11th 2013, the national regulation of these compounds ceased.
The Norwegian Food Safety Authority is working on compensatory measures to ensure safe use of these products, and has requested VKM to identify the upper concentrations of vitamin A (retinol and retinyl esters) that may be safely used in cosmetics in relation to the ingredients’ ability to irritate the skin.
In order to perform this task, a literature search was performed and the relevant scientific papers were evaluated.
VKM concludes that there are not enough relevant studies with the necessary data on association between concentrations and adverse effects in the skin to define safe upper concentrations for the use of retinol and retinyl esters (retinyl palmitate and retinyl retinoate) in cosmetics.
However, the present available data indicates that local adverse effects in human skin may appear after application of retinol at concentrations of 0.075 % and above. For retinyl esters, no conclusion can be drawn from the available data.