15 Dec 2017
European Commission Restricts the Use of Peanut Oil and Hydrolysed Wheat Protein in Cosmetics
Hong Kong’s exporters to the EU of cosmetic products should be alerted to a legislative development that may affect them. On 5 December 2017, Regulation 2017/2228 was published which restricts the use of cosmetic products containing peanut oil, its extracts and its derivatives, and the use of cosmetic products containing hydrolysed wheat proteins (HWP), as they present a potential risk to human health.
It is stated that peanut oil and its derivatives are widely used in cosmetic products. Arachis hypogaea oil, as peanut oil is called under the International Nomenclature of Cosmetic Ingredients (INCI), is most commonly used in body lotions, hydrating creams, and moisturisers, as well as in soaps and cleansers. On the other hand, HWP is present in skin care and particularly hair care products including creams, lotions, shampoos and conditioners (especially for dry skin and hair), sun care, after sun and makeup products, and eye makeup in particular.
In order to ensure the safety of such cosmetic products, the European Commission has felt it appropriate to set a maximum allowable concentration and restrict the peanut protein level of peanut oil, its extracts and its derivatives to maximum 0.5 parts per million (ppm). The molecular weight average of the peptides in HWP has been set at a maximum of 3.5 kDa in cosmetic products.
Hong Kong traders may be familiar with the framework Regulation 1223/2009 on cosmetic products (the Cosmetic Products Regulation), which was adopted in 2009 in order to harmonise the EU rules on cosmetic products. This framework Regulation applies to all cosmetic products (but not to medical or biomedical products) which are placed on the EU market. New Regulation 2017/2228 amends this framework Regulation, which means that the new restrictions will apply EU-wide.
The framework Regulation defines cosmetic products as “any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours”. The Cosmetic Products Regulation regulates the use of substances permitted in cosmetic products, as well as the conditions under which they are allowed to be used.
The Annexes to the Regulation contain a list of prohibited substances (Annex II) and a general list of restricted substances (Annex III). In addition, the Regulation contains specific lists for colorants (Annex IV), preservatives (Annex V), and UV-filters (Annex VI). Newly published Regulation 2017/2228 modifies the list of restricted substances under Annex III to the Cosmetics Products Regulation by adding the new restrictions concerning peanut oil and HWP.
The amendments originate from several Member States’ indications of safety problems in relation to the use of these substances as an ingredient in cosmetic products.
With regard to HWP, a number of cases of contact urticaria (hives or itchy skin rash) provoked by cosmetics containing HWP were reported. When the persons concerned subsequently consumed food containing wheat proteins, their symptoms were followed by anaphylactic shock. With regard to peanut oil, concerns were raised over the fact that an unexpected risk of food allergy to peanuts was reported especially in young children (0-3 years), where it was suspected that the sensitisation might have been induced through the use of cosmetic products containing peanut oil in the first six months of life.
Sensitisation is the beginning of the process in which someone becomes allergic to a certain substance. It occurs when the person’s immune system mistakenly registers that substance as a “threat”. Subsequent exposure may result in the occurrence of an allergic reaction.
An opinion of the EU Scientific Committee on Consumer Safety (SCCS) of 2014 reported that “peanut proteins are known to cause severe potentially life-threatening type-I allergic reactions.” Refined peanut oils however contain only very low levels of the peanut proteins which have the allergenic potential.
The SCCS concluded that although there is insufficient scientific data to define a safe level of skin exposure in the non-sensitised population, the value of 0.5 ppm could be accepted as the maximum allowable concentration based on the documented safe levels of oral intake of peanut proteins in sensitised individuals and with regard to the industry’s capability to refine peanut oil.
Hong Kong traders of cosmetic products will however benefit from a grace period in order to adapt to the new requirements, by making the necessary adjustments to product formulae. Non-compliant products may still be placed on the market up to 25 September 2018 and products placed on the market before that date may still be sold until 25 December 2018.