MEMO/05/213

Washington / Brussels, 20 June 2005

2005 Roadmap for EU-US Regulatory Cooperation - Sectoral Activities

Today, EU-US Leaders endorsed a concrete roadmap to improve regulatory cooperation. The “2005 Roadmap for Regulatory Cooperation” sets the agenda for a number of concrete regulatory cooperation activities between the European Commission and the US Government for the coming year. The Summit encouraged cooperation on matters such as automobile safety and hydrogen fuel cells or non-animal testing methods in cosmetics. The 2005 Roadmap outlines a range of proposed cooperative initiatives that the United States and the European Commission intend to advance in the coming year.

Industry Sectors:

Pharmaceuticals

• Human medicinal products: Cooperation on matters related to ensuring the safety, quality, and efficacy of pharmaceutical products.
• Veterinary medicinal products: cooperation on harmonized guidelines for regulatory requirements where significant differences exist.
• Car Safety: cooperation on safety of hydrogen fuel cell vehicles and vehicle compatibility. Additional topics that may be suitable for cooperation are future collision mitigation technologies, electronic stability systems and dummies used in side-impact crash tests.
• Information and Communications Technology Standards: Initial projects under this dialogue include information exchange on e-accessibility, security, and biometrics.
• Cosmetics: Cooperation regarding: alternative (i.e., non-animal) testing methods; hair dyes and sunscreen ingredients (UV filters); and other projects of mutual interest.
• Consumer Product Safety: Developing an implementation plan for specific cooperative projects to be pursued.
• Consumer Protection Enforcement Cooperation: Develop mutual assistance mechanisms.
• Unfair Commercial Practices: Dialogue aimed at increasing convergence in this area starting with comparing EU with U.S. federal law.
• Nutritional Labelling: Possible collaboration on the EU’s Estimated Average Requirement (EAR) and the U.S. Recommended Daily Allowances (RDA) for nutrients. Further specific activities for cooperation on technical issues should be identified, such as reference values for nutrient labelling, nutrient definitions, and energy conversion factors.
• Food Safety: Exploring new ways to accomplish food safety goals and regulatory cooperation projects of mutual interests, such as in the fields of seafood and dairy products:
• Meat: Continue the discussion in order to explore how to concretely pursue equivalence between the respective Hazard Analysis and Critical Control Point systems, although based on the same principles, are still different for important points.
• Food safety: Pursuing a confidentiality agreement to facilitate the sharing of non-public information and development of a strategy for the conduct of microbial risk assessments.
• Risk assessments for animal, plant, and consumer safety: identifying possible areas for further discussion and sharing of information.
• Marine Equipment: Developing an agreed work plan aimed at achieving equivalent U.S. and EU technical regulations for specific marine equipment and expanding the product scope of the U.S.-EC Marine Equipment MRA.
• Eco-Design: Exploring possibilities to share experience on respective approaches relative to the eco-design of energy-using products (EuP), Integrated Product Policy (IPP), restrictions on hazardous substances (RoHS) and waste from electrical and electronic equipment (WEEE).
• Chemicals: Collaborating in the OECD framework on the development of the Global High Production Volume (HPV) chemicals information Portal.
• Energy Efficiency: The United States and EC will build on the Energy-Efficiency Labelling Programs for Office Equipment (“Energy Star”) to encourage energy efficiency while retaining the philosophical basis and market-focused approach of the existing program. This program currently covers computers, monitors, printers, fax machines, copiers, scanners, and multi-function devices. This year, and into next, the U.S. and the EC will cooperate on revising the specifications for imaging equipment (printers, copiers, scanners, fax machines, mailing machines, and multifunction devices) and computers.
• Telecommunications and Radio-communications Equipment, Electromagnetic Compatibility: consider cooperative approaches for achieving consistent regulatory treatment of telecommunications and radio-communications products whenever possible.
• Medical Devices: Promotion of cooperative activities, including the preparation of guidance documents and compatible regulatory approaches for medical