European Commission propose a Regulation to replace the Cosmetics Directive

After public consultation and an impact assessment, the European Commission has published proposed Regulations to replace the existing Cosmetics Directive (Council Directive 76/768/EC).

The Cosmetics Directive, which dates back over thirty years, has been amended some 55 times since its entry into force and this, together with the numerous transposing pieces of national legislation, have led to a “patchwork” of legislation across Europe. One of the key complaints made against the Cosmetics Directive is that it has become a complicated, often inconsistent and sometimes incoherent regulatory framework.

By changing the basis of the legislation from that of a Directive to that of Regulations, the Commission is aiming to create one harmonised and transparent legislative system, applicable throughout each Member State.

The proposed Regulations will incorporate all 55 amendments, together with new proposals, in one document, with the aims of:

• removing legal uncertainties and inconsistencies; many of which are due to the absence of a set of definitions and to the high number of amendments made to the Cosmetics Directive;
• avoiding any discrepancies and divergences in national legislation; which in the past have led to an increased regulatory burden which can result in increased compliance costs; and
• ensuring the safety of all cosmetic products placed on the EU market.

The proposed changes include:

• the introduction of a set of definitions, including definitions for ‘manufacturer’, ‘responsible person’ and ‘making available on the market’;
• clarification of what information must be contained within a cosmetic product safety assessment. (The Cosmetics Directive requires an assessment be completed prior to a product being placed on the market, however the content of the assessment is not specified);
• introduction of a centralised, electronic notification system for information that must be provided prior to a product being placed on the market;
• introduction of market surveillance requirements, which include requiring that the responsible person notifies the competent authority of any and all serious undesirable effects known to him or which should have been known to him; and
• tougher rules on non-compliant products, including corrective actions to bring the products into compliance and the withdrawal or recall of products.