The Cosmetic Directive 76/768/EEC entered into force in 1976 and provided the main rules for composition, labelling and packaging of cosmetic products. From 11 July 2013, Regulation (EC) No 1223/2009 will replace the Cosmetics Directive. However, some of the provisions of Regulation (EC) No 1223/2009 will apply to substances that are carcinogenic, mutagenic or toxic for reproduction (CMR) from 1 December 2010.

The definition of a cosmetic product has not changed from the 76/768/EEC Directive. According to Article II of Regulation (EC) No 1223/2009, ‘a ‘cosmetic product’ shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips) 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 and/or correcting body odours and/or protecting them or keeping them in good condition.’

The principal aim of this Regulation is to protect public health by harmonising the previously laws and regulations concerning cosmetic products in the European Union. The Regulation lays down rules on the composition, labelling and packaging of cosmetic products that are to be adopted thoughout the EU member states.

Several key new requirments include:

(i) Safety Report that provides a safety evaluation of cosmetic products, The safety report must contain: quantitative and qualitative composition of the product, information about impurities and information on packaging materials toxicological profiles of the substances used.

(ii) Product Information File (PIF) that the cosmetic product distributor must create and keep for a period of ten years from the last distribution. The Responsible Person (RP) must also have access to the PIF.

(iii) Provisions on Nanomaterials are included for the first time, as the influence of new technological advances is increasingly felt in the cosmetics industry

(iv)  EU-wide notification method

Though the legal implementation date, July 11, 2013, of the Cosmetics Regulation is several years away, it is advisable for cosmetic producers, whose products may have long expiry dates, to apply the changes at the earliest opportunity.

Please contact us to for our Cosmetic Regulation Service.