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Wednesday, December 6, 2017Regulation

Regulation 2017/2228: restrictions for peanut & wheat proteins

© CosmeticOBS-L'Observatoire des Cosmétiques

Regulation 2017/2228 of 4 December 2017, published in Official Journal of the European Union on 5 December, amends Annex III (restricted substances) of Cosmetics Regulation 1223/2009, to limit the peanut protein level of peanut oil, its extracts and its derivatives, as well as the molecular weight average of the peptides in hydrolysed wheat protein in cosmetic products. This provision will apply from 25 September 2018 and will be fully implemented from 25 December 2018.

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The whereas of Regulation 2017/2228

(1) Several Member States have recently indicated safety problems in relation to the use of peanut oil, its extracts and its derivatives in cosmetic products. Concerns have been raised that sensitisation to peanuts might be induced through skin exposure to peanut oil through the use of cosmetic products.

(2) The Scientific Committee on Consumer Safety (‘SCCS’) acknowledged those concerns in its revised opinion of 23 September 2014. In that opinion, the SCCS concluded that there are insufficient data to define a safe level of skin exposure in the non-sensitised population. It added that, however, in view of the documented safe levels of oral intake of peanut proteins in sensitised individuals and in view of the industry’s capability to refine peanut oil to protein levels of 0.5 ppm or below, that value can be accepted as the maximum allowable concentration in (refined) peanut oil, its extracts and its derivatives used in cosmetic products.

(3) Several Member States have also indicated safety problems in relation to cosmetic products containing hydrolysed wheat proteins. A number of cases of contact urticaria provoked by such cosmetic products, followed by anaphylactic shock after the ingestion of food containing wheat proteins, …

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