FDA and the European Commission's Directorate General III, Rockville, MD
November 5, 1998
Dr. Lee Bansil
Directorate General III
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.
Alternatives to animal testing
DG III outlined the provisions of the proposed 7th Amendment, which would ban animal testing in the EU, and described the lead role that the EU would take in the validation of alternative methods.
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.
Ultraviolet (UV) filters
It is important to note that these materials are classified as cosmetic ingredients in the EU but as over-the-counter (OTC) drugs in the US. It is feasible that FDA and DG III work on the technical equivalence (at the scientific level) of permitted UV filters, while accepting the fact that they are regulated under different frameworks. As a first step toward any type of recognition, it was viewed as necessary to ensure that common standards of assessments are made on dossiers submitted by industry prior to the acceptance of a material. Therefore, the preliminary stage in these discussions must incorporate a mutual review of EU and US dossiers. It was agreed that the two administrations would exchange dossiers on at least one filter that is permitted in both the US and EU, and at least one UV filter that is permitted in the EU but has not been reviewed in the US, and one that is permitted in the US but not in the EU, in order for the respective safety assessors to determine whether they reach the same conclusions.
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).
In both the EU and the US, only approved color additives may be used. It was agreed that, as with UV filters, the first step should be to confirm common scientific standards. Therefore, the representatives agreed to the following exchange of dossiers:
- At least one color additive that is permitted for use in both the US and EU, in order to determine whether the same data were reviewed and the same assessment criteria employed.
- At least one color additive that is permitted in the EU but has not been reviewed in the US. Conversely, FDA will submit a dossier on a UV filter that is permitted in the US but not in the EU. The objective was to allow safety assessors in each administration to determine whether or not they reach the same conclusions.
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.
A discussion took place on the harmonization of International Nomenclature Cosmetic Ingredient (INCI) labeling. However, because FDA operates under the mandate of the Fair Packaging and Labeling Act (FPLA), it is not in a position to modify current US requirements.
It was agreed that this had been a productive first meeting and further meetings should be encouraged, possibly through the use of video-conferencing. It was suggested that such video-conferences could be held on a quarterly or half-yearly basis. DG III committed to lead and facilitate trilateral negotiations including Japan during early 1999 and would investigate the possibility of DG III funding for such a meeting.