WIREDGOV

This follows publication in July 2013 of our initial positions and is part of our efforts to be fully transparent about the negotiations (more on our transparency efforts).

The papers released include proposals for enhancing the compatibility of each other's existing rules and regulations, or working more closely together in setting them in future, in five sectors:

• Chemicals

• Cosmetics

• Pharmaceutical products

• Motor vehicles

• Textiles and clothing

In each sector, the papers focus on ways we can:

• end the unnecessary duplication of product testing or plant inspections

• recognise each other's existing regulations, or bring them more closely together

• align our respective procedures for approving or registering new products.

Details

1. Chemicals

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.

2. Cosmetics

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

• aligning each other's requirements for labelling

• working 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. 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.

4. Pharmaceuticals

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

• 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.

• seek convergence on certain standards.

Further information

You can find the full versions of all the documents here:

Chemicals: http://trade.ec.europa.eu/doclib/html/152468.htm

Cosmetics: http://trade.ec.europa.eu/doclib/html/152470.htm

Motor vehicles: http://trade.ec.europa.eu/doclib/html/152467.htm

Pharmaceuticals: http://trade.ec.europa.eu/doclib/html/152471.htm

Textiles and clothing: http://trade.ec.europa.eu/doclib/html/152469.htm