Ref. Ares(2018)5807288 - 13/11/2018
Ref. Ares(2019)2527775 - 10/04/2019
CEFIC-ACC JOINT PROPOSAL
ENHANCING EU-US CHEMICAL REGULATORY COOPERATION
The business of chemistry in the United States and the European Union are strong supporters
of transatlantic cooperation and therefore welcome the joint statement between Commission
President Juncker and President Trump on 25 July. This statement includes chemicals as one
of the sectors for which both sides will work to reduce barriers and increase trade.
Enhanced regulatory cooperation has the potential to significantly address non-tariff barriers and
increase reciprocal trade in chemicals, while maintaining high levels of protection for human
health and the environment. An effective regulatory cooperation will improve standards, open
markets and increase investment and jobs.
Industries on both sides of the Atlantic recognise the fundamental differences in both regulatory
approaches to chemicals, and uphold REACH and TSCA as well as their respective
implementation. These differences will not allow for mutual recognition. Within these
parameters, and while maintaining the highest standards of chemicals safety and the right to
regulate of each side, there are areas of common interest worth pursuing through EU-US
regulatory cooperation. Cooperation efforts on these areas are already ongoing either bilaterally
or at international level. Their inclusion in the regulatory talks will accelerate this process.
Moreover, harmonized approaches to regulatory cooperation between the US and the EU could
serve as a global blueprint.
This document therefore suggests three priority areas for Cefic and ACC for which work is
already underway and that would be enhanced through EU-US regulatory cooperation. Finally,
ACC and Cefic support a cooperation on a voluntary, transparent and accountable basis.
Promoting alignment in classification and labelling of chemicals
This is an area with great potential for co-operation given that an international standard already
exists, which is the UN GHS, Globally Harmonised System of Classification and Labelling of
Chemicals. GHS follows a “building block” approach to facilitate implementation. The different
take up of building blocks and the variation in interpretation has led to differences between EU
and US classifications. EU and US authorities could commit to work towards convergence when
implementing the GHS, by seeking alignment on the use of the same building blocks. This
would be in line with a UN GHS initiative to develop a global list of agreed GHS classifications.
While respecting each other procedures, an enhanced EU-US co-operation on classification of
chemicals could serve as a model for other countries adopting GHS requirements and become
a good basis for a global list. This would help facilitate trade and provide a level playing field for
business on both sides of the Atlantic. Companies would also benefit from harmonised safety
data sheets and labelling of chemical products. This is particularly relevant for SMEs.
Co-operation in prioritising chemicals for assessment and assessment methodologies
EPA and ECHA already cooperate in the area of methods for assessment and evaluation of
chemicals. This cooperation can be intensified, in particular in the development and integration
of new scientific developments. The already existing Statement of Intent signed between ECHA
and EPA could be a good basis for developing further co-operation activities.
The OECD programme for assessment of chemicals could be used as a model. This
programme evaluates the hazardous properties and hazard characterization of high volume
production of chemicals and generates OECD-agreed assessments. Similarly, evaluations by
EPA or EU Member States could be shared and considered as a common basis. This would
avoid redundant work and limit the time for authority examination and approval. The risk
evaluation should remain separate as the models of exposure in the two regulatory systems
differ. While benefits will mainly accrue to the authorities (reduction of the administrative
burden), industry - including downstream customers - would also benefit by having quicker
access to market for innovative products. Information sharing and protection of IP rights & confidential business information (CBI)
US and EU authorities exchange data and information on chemical substances, such as
summaries of test or study results, on a regular basis. This information is sometimes made
public. A proper mechanism for data and information sharing that includes adequate safeguards
to ensure the protection of commercial and proprietary interests is crucial for industry.
ECHA and EPA have already started a dialogue on data sharing. Agreeing on a common format
like IUCLID (The International Uniform Chemical Information Database) as the basis for
exchange on safety studies would significantly facilitate data sharing. IUCLID is a database co-
develop by ECHA and the OECD to record, store, maintain and exchange data on chemical
substances. It provides harmonised templates for results of studies and allows full
exchangeability of datasets. Finally, this initiative would be in line with calls from several animal
welfare organisations to increase data exchange between regulators to avoid duplication of
tests involving animals.