EU Update—Changes with Implementation of 1223/2009

By: Chris Flower, PhD; and Emma Meredith, PhD, CTPA

Posted: March 5, 2013, from the March 2013 issue of Cosmetics & Toiletries.

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The directive already states that the manufacturer must keep proof of the effect claimed for the cosmetic product in the Product Information File (PIF). This remains in the regulation; however, there is a new requirement allowing the EC to establish common criteria justifying the use of a claim. The EC’s approach has been to work with industry to develop general guidelines applicable to all claims—a “dos and don’ts” list—rather than a comprehensive manual or claim-by-claim approach.

Reporting of SUEs

The concept of addressing and documenting undesirable effects attributable to cosmetic products is not new. This has been a requirement since the 7th Amendment to the directive. Information on any serious undesirable effect attributable to a cosmetic product will already be kept in the PIF. The new requirement is that any SUE will have to be reported to the competent authority of the member state where the SUE occurred. Note that the incidence of serious undesirable effects attributable to cosmetic products is low. The EC will issue guidance on this process and is developing reporting forms.

Implementation

The majority of the requirements in the new regulation will be implemented on July 11, 2013. Up to that date, companies can choose to comply with the directive, the regulation or a mixture of both. However, a word of warning with regard to Annexes II-VI published as part of the regulation text: these are not up-to-date and also contain many errors. CTPA recommends that the annexes to the Cosmetics Directive and its amendments are used until the EC produces a comprehensive update to the annexes of the regulation.