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by Eloise Power, Doughty Street Chambers
by Eloise Power, Doughty Street Chambers
EC Cosmetics Regulation (Regulation EC No 1223/2009) and Commission Regulation (Regulation EU No 655/2013) now in force
On 11 July 2013 the new EC Cosmetics Regulation came into force. The Cosmetics Regulation concerns product safety in relation to cosmetic products. Commission Regulation 655/2013 also came into force of 11 July 2013. This Regulation concerns advertising claims made in relation to cosmetic products.
Cosmetic products are defined widely for the purposes of the Regulation as any substance or mixture intended to be placed in contact with the external parts of the human body, teeth and mucous membrane 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. This will include products which would more commonly be thought of as toiletries. Examples are likely to include hair dye, soap, shampoo, conditioner, hair styling products, skin whitening creams, self-tanners, deodorant, toothpaste, perfume, depilatory products, nail care products and UV protection cream, as well as make-up.
Under the Regulation, cosmetic products made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use. The preamble to the Regulation states that the risk-benefit reasoning process should not justify a risk to human health.
The following considerations are taken into account in particular when assessing the safety of cosmetic products: presentation, labelling, instructions for use and disposal and any other indication or information provided by the 'responsible person' (please see below).
The Regulation provides that manufacturers and importers must designate a 'responsible person' in relation to all cosmetic products which are placed on the market. The role of the responsible person is to ensure compliance with the obligations set out in the Regulation. This includes ensuring that cosmetic products undergo an evidence-based safety assessment, keeping a product information file and notifying the competent authority of the Member State of all serious undesirable effects relating to the cosmetic product. Centralised records of cosmetic products will now be held electronically.
The Regulation mandates that a high level of protection of human health shall be ensured in relation to every cosmetic product that contains nanomaterials. Nanomaterials are insoluble or biopersistent manufactured materials of between 1 to 100 nm on one or more dimension or internal structure.
Animal testing of ingredients, combinations of ingredients and finished cosmetic products has been prohibited within the European Community. Member States may, however, seek a derogation from the prohibition upon animal testing in exceptional circumstances where serious concerns arise regarding the safety of an existing cosmetic ingredient.
The Annexes to the Regulation contain detail about substances which are prohibited from use in cosmetic products and substances which are restricted and may only be used in certain circumstances. There are defined lists of substances which may be used as colorants, preservatives and UV-filters.
Commission Regulation No 655/2013 provides that the responsible person must ensure that the wording of any claim made in connection with the advertising, marketing or labelling of cosmetic products complies with the following criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.
The new Regulations strengthen the regulatory framework in relation to cosmetic products and bring it somewhat closer to the regulatory framework governing other products such as food and medication. The Regulations replace and strengthen the previous Cosmetics Directive (Council Directive 76/768/EEC of 27 July 1976) and reflect scientific developments and changes in cosmetics technology, including the use of nanomaterials. Product liability practitioners will be aware that the substances used in the manufacture of cosmetic products can be potent and have dramatic effects. It is to be hoped that the new Regulations will provide a more robust regulatory regime to ensure consumer safety in relation to cosmetic products.