Brussels, 29/06/2004 (Agence Europe) - At their Summit in Ireland (Dromoland Castle) on Saturday, the European Union and the United States defined the next stages in administrative cooperation. Based on the guidelines adopted in 2002, the aim of the new roadmap is to bring legislation closer and avert the adoption of new rules that could pose obstacles to trade. (See yesterday's Europe, pp .5-7, for other outcomes of the Summit).
Alongside questions concerning dialogue in general and the exchange of a wide range of experience, the new roadmap sets targets for specific issues:
Pharmaceuticals: Expand the exchange of information and data on pharmaceuticals as agreed under the September 2003 arrangement between FDA, DG Enterprise and the European Agency for the Evaluation of Medicinal Products (EMEA). As part of this arrangement, engage in parallel scientific advice; promote scientific personnel exchanges and joint meetings; share respective draft guidance on drug safety issues, including adverse reactions; and examine cases where U.S. and EU authorities have adopted different approval decisions for specific drugs ("benchmarking exercises").
Auto Safety: Cooperation between the US National Highway Traffic Safety Administration (NHTSA) and DG Enterprise/Automobile Unit in areas of auto safety regulations.
Information and Communications Technology Standards: Pursue cooperation on specific projects identified under a new EU-U.S. dialogue initiated in March 2004 and coordinated by the Commerce Department and DG Enterprise. Initial projects under this dialogue include e-accessibility, security, and biometrics.
Cosmetics: Cooperation between the U.S. Food and Drug Administration (FDA) and DG Enterprise/Cosmetics Unit regarding: (a) alternative (i.e., non-animal) testing methods; (b) respective regulatory approaches applied in the area of hair dyes; and (c) other projects of mutual interest.
Consumer Product Safety: Cooperation between the U.S. Consumer Product Safety Commission (CPSC) and DG SANCO regarding safety notices and corrective actions of hazardous consumer products.
Nutritional Labelling: Cooperation between FDA and DG SANCO on issues of mutual interest in the field of nutritional labelling. Compare scope of nutritional labelling requirements in the United States and the EU. Identify specific activities for cooperation on technical issues such as reference values for nutrient labelling, nutrient definitions, and energy conversion factors.
Chemicals. Ongoing informal discussions, in the spirit of the Guidelines, between the U.S. Environmental Protection Agency (EPA), DG Environment and DG Enterprise and relevant agencies on chemicals related issues of mutual interest.