http://www.legislation.gov.uk/id/eur/2017/2228

Commission Regulation (EU) 2017/2228

of 4 December 2017

amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products1, and in particular Article 31(1) thereof,

Whereas:

(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 20142. 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, have been reported.

(4)

In its revised opinion of 22 October 20143 the SCCS considered the use of hydrolysed wheat proteins in cosmetic products safe for consumers, provided that the maximum molecular weight average of the peptides in hydrolysates is 3,5 kDa.

(5)

In light of the opinions given by the SCCS, the use of cosmetic products containing peanut oil, its extracts and its derivatives and the use of cosmetic products containing hydrolysed wheat proteins present a potential risk to human health. In order to ensure the safety of such cosmetic products for human health, it is appropriate to set a maximum concentration of 0,5 ppm for peanut proteins in peanut oil, its extracts and its derivatives used in cosmetic products and to restrict the molecular weight average of the peptides in hydrolysed wheat proteins used in cosmetic products to a maximum of 3,5 kDa.

(6)

The industry should be allowed a reasonable period of time to adapt to the new requirements by making the necessary adjustments to their product formulations to ensure that only products complying with those requirements are placed on the market. The industry should also be allowed a reasonable period of time to withdraw products which do not comply with the new requirements from the market.

(7)

Annex III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS REGULATION: