FDA and the European Commission's Directorate General III
Bilateral Meeting on the Harmonization of Cosmetic Legislation
Rockville, Maryland
Participants:
EU
Dr. Lee Bansil
Directorate General III
European Commission
US
Dr. John E. Bailey
Director, Office of Cosmetics and Colors
Center for Food Safety and Applied Nutrition
US Food and Drug Administration
Ms. Linda Horton
International Activities Staff
Office of the Commissioner
A meeting between representatives of the FDA's Office of Cosmetics and Colors and the European Commission's Directorate General III (DG III) took place November 5, 1998, in Bethesda, MD, as part of a bilateral meeting between FDA and delegates of the European Union (EU). Topics for discussion included alternatives to animal testing, ultraviolet (UV) filters, color additives, labeling, and future initiatives.
The mutual acceptance of in vitro/in vivo data was tabled. The EU explained that all in vivo data generated in the US would be accepted for the demonstration of safety for products marketed within the European Community (EC). With regard to US acceptance of in vitro data from EU- validated alternatives, DG III committed to submit all files on validation programs for review by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).
It was determined that the dossiers would be reviewed and the methods evaluated for their acceptability in the safety assessment of cosmetics by FDA, and that this review would in no way prejudice deliberations on the applicability or regulatory acceptance of methods for other products regulated by FDA or upon Organisation for Economic Cooperation and Development OECD) discussions.
It was noted that in the US, UV filters are assessed for efficacy, with the Sun Protection Factor (SPF) measured according to a standard FDA protocol, while the EU does not have mandatory methods for assessing SPF. In the EU, companies may use a number of methods to assess SPF, although many follow a standard method developed by the European Cosmetic, Toiletry and Fragrance Association (COLIPA). However, several companies consider methods for SPF determination to be a source of proprietary/competitive advantage.
DG III will work with the industry to determine which methods are in use and compare the techniques to that required by FDA. It may be necessary for DG III to collaborate with COLIPA to develop a standard methodology guideline for SPF determination to be used in the EU.
Because UV filters are regulated as drugs in the US, all of these points are subject to the agreement of the FDA's Center for Drug Evaluation and Research (CDER).
FDA raised the additional point of purity of color additives. In the US, purity is closely regulated, often through batch analysis for individual colors. In the EU, purity is not closely regulated, although in many cases the DGIII refers to purity criteria specified in the EU Foodstuffs Directives. Therefore, various purity criteria as provided for in the respective regulations will be examined.
In the cases of both UV filters and color additives, the administrations were committed to ensuring that no legislative or confidentiality issues would prohibit the exchange of dossiers as described. The administrations also committed to discuss the topic with the respective industry organizations to ensure that issues regarding intellectual property would not arise.
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