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.
- 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,
- 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
- 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
- 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)
- Telecommunications and Radio-communications Equipment, Electromagnetic
Compatibility: consider cooperative approaches for achieving consistent
regulatory treatment of telecommunications and radio-communications products
- Medical Devices: Promotion of cooperative activities, including the
preparation of guidance documents and compatible regulatory approaches for