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:
-
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.
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
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