Understanding the EU Cosmetics Regulation and attaining compliance

Understanding the updated EU Cosmetics RegulationIt has been almost three years since the EU Cosmetics Regulation was put in force across Europe, replacing the preceding EU Cosmetics Directive. It is evident that it has become a real challenge for the cosmetics industry – even global brand leaders – to meet the robust regulatory requirements of the regulations. Even now, we are witnessing many providers of cosmetics products supplying products that do not fulfil all of the robust regulatory requirements of the cosmetic regulation.

This whitepaper examines the bulk of changes and main points surrounding the EU Cosmetics Regulation including Safety Assessments, GMP, Marking and Labelling Requirements, Product Information File requirements and the role of the Responsible Person.

Regulatory Drivers

The aim of the regulation was to simplify and harmonise the regulatory requirements across each member state and it is clear this has essentially worked. With simplification and improved clarification of the regulatory details, this offered the potential to improve product safety and reduce costs for businesses as well as to minimise legal uncertainties and inconsistencies in order to avoid the divergence in national transposition. However, there is still differing interpretation across some member states. This continues to create difficulties for the cosmetics industry to easily supply and market their products across the whole of the EU.

Regulation Recast – The Highlights

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 – such as the 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.

The recast was intended to bring clarification in regard to the definition of ‘Responsible Person’, Good Manufacturing Practice (GMP) and improve safety reporting. There is no doubt this new regulation certainly has assisted in implementing consistency across the EEA with regard to notification, allowing for a central commission to be developed and tightening the requirements for the product information file.

As an example, definition, notification, labelling and safety assessment became necessary for nanomaterials but only for those which are not already restricted in the cosmetic product regulation. Substances classified as carcinogenic, mutagenic or toxic for reproduction continue to be prohibited and currently need to be reviewed by the Scientific Committee on Consumer Safety (SCCS) before use is granted. Some chemicals classified as ‘CMR’ (defined as being ‘carcinogenic, mutagenic or toxic for reproduction’) are now banned including boric acid derivatives, some of which have already prompted a RAPEX recall of cosmetic products.

New criteria have now been published for product claims in the form of Commission Regulation (EU) No 655/201, which lays down common criteria for the justification of claims used in relation to cosmetic products. Alongside these are guidelines to the justification of claims used in relation to cosmetic products.

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