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EU Regulatory Update: Recast of the Cosmetics Directive Published
By: Annelie Struessmann, PhD, CONUSBAT
Posted: January 12, 2010
Regulation (EC) No 1223/2009, the new European regulatory framework for cosmetics of the European Parliament and of the European Council, was published in the Official Journal of the European Union on Dec. 22, 2009. The new legal framework is a recast of Council Directive 76/768/EEC, the Cosmetics Directive. Regulation (EC) No 1223/2009 entered into force 20 days after its publication in the journal on Jan. 11, 2010, while the majority of the Regulation (EC) No 1223/2009 ’s provisions will be enacted on July 11, 2013. On the same date, the Cosmetics Directive 76/768/EEC will be repealed.
Different deadlines will apply for the enforcement of two provisions of Regulation (EC) No 1223/2009. The provisions for the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), i.e., Category 2 according to Regulation (EC) No 1272/2008 (CLP), will apply on Dec. 1, 2010. In addition, the notification provisions for nanomaterials will apply on Jan. 11, 2013. During transitional periods, cosmetic products already in compliance Regulation (EC) No 1223/2009 may be placed on the market. Notifications that are performed according to Article 13 of the regulation will be compliant on Jan. 11, 2012, and Regulation (EC) No 1223/2009 applies in the countries of the European Economic Area (EEA), including the 27 EU Member States, Iceland, Liechtenstein and Norway.
The EU Council considers recasting to be a legal technique, which comprises the conversion of the provisions of a directive into a regulation while making substantive amendments to all the provisions of the earlier act, which it replaces and repeals. The background for the recast of the cosmetic framework was to simplify rules and procedures related to the marketing of cosmetic products--a need resulting from different implementations of the directive in the 27 EU member states. According to the EU treaties, a directive must be translated into national legislation and with that translation, member states can include additional requirements; for example, a member state can set higher standards for substances of interest. As such, the directive had created 27 national legal frameworks and 3,500 pages of legal text.
Contrary to a directive, a regulation is immediately enforceable in all EU member states; therefore, Regulation (EC) No 1223/2009 represents a common European code of law. In line with this principal will be a change in notification provisions to harmonize them in a central digital platform to replace all existing national notification procedures.
Another key goal for the recast is to ensure a higher level of consumer protection. In relation to this requirement, major measures will include the enhanced coordination of market surveillance activities, reinforcement of responsibilities along the supply chain, and clearer provisions for the content and format of product safety assessments and product information files (PIF).