The new EU regulation – changes and compliance

In 1972, a manufacturing incident in France led to the inclusion of hexachlorophene in a talc which caused a poisoning epidemic resulting in the injury of 208 children and the tragic death of 36. Subsequently, on 27 July 1976, there was a seminal event for the EU cosmetic products industry with the introduction of Council Directive 76/768/EEC for the safety of cosmetic products. Its aim was to define the safety criteria to which cosmetic products must conform and to prescribe rules for their labelling and packaging. Over thirty years later on 22 December 2009, the directive was recast as the Cosmetic Products Regulation (EC) No. 1223/2009, which entered into force on 11 January 2010 and takes full effect from 11 July 2013. The main driver for change has been simplification, to strengthen product safety and reduce costs for businesses, removing legal uncertainties and inconsistencies to avoid the divergence in national transposition. A Commission Directive has to be transposed into the national law of each Member State. After 30 years, the Cosmetics Directive consisted of the core text with seven amendments and more than 40 technical adaptations. It also included 27 national legal frameworks and 3,500 pages of legal text. Hence the move towards a single piece of legislation which is instantly and directly enforced across the whole 27 EU Member States, along with Norway, Iceland and Liechtenstein under the European Economic Area (EEA) Agreement.

Cosmetic Products Regulation recast – highlights

The recast has given improvement and clarification especially in regards to the ‘responsible person’ definition, Good Manufacturing Practice (GMP), and safety reporting. It will implement consistency across the EEA with regards to notification, allowing for a central commission to be developed. Notification, labelling, definition and safety assessment will be necessary for nanomaterials. Substances classified as carcinogenic, mutagenic or toxic for reproduction are prohibited and will be reviewed by the Scientific Committee on Consumer Safety (SCCS) before use is granted. New criteria will be developed for product claims. The responsible person will be clearer in their objectives and responsibilities to list corrective actions in the event of non-compliance or following reports of serious undesirable effects from the cosmetic product. The definition of a cosmetic product has not really changed under the Regulation, except for some minor editorial changes. As defined, a ‘cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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 or keeping them in good condition or correcting body odours.