- motor vehicles
- pharmaceutical products
- textiles and clothing
Current EU and US regulations on chemicals differ significantly. So neither harmonisation nor mutual recognition are feasible. The EU sees scope for working together in four areas, within the limits of our respective rules, to:
- prioritise chemicals for assessment and agree on how best to test them
- classify and label chemicals
- identify and address new or emerging issues
- share data and protect confidential business information more effectively.
Doing so could make our systems more efficient and thereby cut firms' costs.
The paper builds on work which EU and US regulators already undertake jointly. It proposes working together to:
- recognise each other's lists of permitted or banned substances
- recognise each other's Good Manufacturing Practices (GMPs)
- develop and use alternatives to animal testing
- harmonise our methods and requirements for testing products
- align each other's requirements for labelling
- work more closely together in the International Council on Cosmetics Regulation (ICCR), which brings together regulators from the EU, the US, Canada and Japan.
3. Motor vehicles
For cars and trucks, EU and US technical requirements differ. But on both sides they aim to ensure high standards of health, safety and environmental protection. This paper sets out our aim: to achieve compatibility without lowering standards on either side. As such it identifies two main objectives:
- recognising each other's existing standards and regulations
- working together more closely to draw up regulations in future, especially on new technologies.
Closer EU-US cooperation within the United Nations Economic Commission for Europe (UNECE) could also help to set new global regulations. Agreement in these areas could lower costs to manufacturers and ultimately to consumers.
In this area regulators on either side of the Atlantic already work closely together. The paper proposes several areas for further joint work. These are:
- recognising each other's Good Manufacturing Practice (GMP) inspections of manufacturing plants, to avoid duplicating work
- exchanging information
- harmonising our requirements for approving 'biosimilars' - products similar to already-licensed biological medicines, such as vaccines
- streamlining systems for authorising generic drugs
- harmonising the terms we use, and carrying out more joint assessments
- working together to revise the paediatrics guidelines issued by the International Conference on Harmonisation (ICH).
5. Textiles and clothing
The paper proposes strengthening existing EU-US cooperation in three main areas:
- labelling - including mutual recognition of care instruction symbols and aligning our names of new textile fibres
- product safety and consumer protection – including working jointly to:
- clarify requirements on fire safety of fabrics,
- align the list of substances whose use in textiles is restricted, and
- set technical standards for protective clothing and other specialist products.
- standards - seeking convergence in certain areas.