The new European Cosmetics Regulation

Although many requirements remain the same as in the Cosmetics Directive 76/768/EEC, there are changes that will have an impact on companies, with compliance required by 11 July 2013. The European Commission is close to publishing guidance to complement the Regulation in four major areas: notification, claims, safety assessment and the reporting of Serious Undesirable Effects (SUEs). The European association, Cosmetics Europe (formerly Colipa) has been part of the Commission’s working groups and is also developing common interpretation on other parts of the Regulation for its members. Staff at the Cosmetic, Toiletry and Perfumery Association (CTPA) have been actively involved with all the groups at Cosmetics Europe working on major areas of change and guidance. The Regulation text was finally published1 in December 2009 after intense discussions between the European Commission, Council and Parliament. Unlike the Cosmetics Directive, a Regulation is directly applicable across all 27 European Member States and does not require transposition into national law. In the UK, as is the case with current cosmetics legislation, a regulation providing for enforcement and penalties will be enacted by BIS (the Department for Business Innovation and Skills) and Trading Standards will be the enforcing authorities. We should all welcome improved and effective enforcement as it does two things: maintains a level playing field and helps reinforce our reputation for safe products within a well-regulated framework. Also, as with the Directive, there is no pre-market registration or certification of products, but the system of in-market control remains. The main premise of the legislation remains the same – that only safe products be placed on the market. The layout of the legislation is structured into three main sections: the preamble, including the Recitals, which provide the rationale; the enacting terms made up of Articles, which are split out into titles and chapters (Table 1); and the Annexes. The major changes in the new Regulation text are listed below:

•  Roles and responsibilities.
•  Notification.
•  CMRs.
•  Safety assessment.
•  Nanomaterials.
•  Claims.
•  Reporting of Serious Undesirable Effects.
•  New symbol available for use to indicate period of minimum durability. This symbol can be used if a product only lasts up to 30 months, instead of labelling, and having to translate, the words ‘best used before the end of’ and a date.

Roles and responsibilities