Order Code RS22673
June 7, 2007
Chemical Regulation in the European Union:
Registration, Evaluation, and Authorization of
Chemicals
Linda-Jo Schierow
Specialist in Environmental Policy
Resources, Science, and Industry
Summary
On June 1, 2007, the European Union (EU) began to implement a new law,
Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH), in EU
commerce. It is intended to protect human health and the environment from hazardous
chemicals while at the same time protecting the competitiveness of European industry.
REACH evolved over eight years and reflects compromises reached among EU
stakeholders. The final regulation reduces and coordinates EU regulatory requirements
for chemicals new to the EU market and increases collection of such information for
chemicals already in the EU market, thus potentially removing disincentives to
innovation. It also shifts responsibility for safety assessments from government to
industry and encourages substitution of less toxic for more toxic chemicals in various
chemical applications. The Bush Administration expressed concerns about its trade
implications for U.S.-produced chemicals. U.S. chemical industry representatives
believe that REACH is “impractical.” In contrast, some public-interest groups are urging
U.S. legislators to adopt a similar legislative approach.
Depending on one’s point of view, new chemicals legislation in the European Union
(EU) is likely to vastly improve environmental and public health protections and serve as
a model for future U.S. law, or it might unnecessarily burden commercial enterprises with
regulations and interfere with international trade. The subject of such conjecture is a new
EU law for Registration, Evaluation, Authorization, and Restriction of Chemicals
(REACH) in EU commerce, which went into force June 1, 2007.
Background
On June 1, 2007, the EU began to implement a new approach to the management of
chemicals in EU commerce. The REACH directive simplifies and consolidates more than
40 former regulations in an effort to balance two EU goals: to protect public health and
the environment from hazardous chemicals and to ensure the continuing competitiveness

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of European industry. Although certain chemicals are exempt entirely, and requirements
for the other chemicals will be phased in over 11 years, the law generally will apply to
nearly all chemicals in EU commerce, including imported chemicals, chemical mixtures,
and certain articles that release chemicals to the environment.
The REACH legislation is based on a proposal developed by the EU General
Directorates for Enterprise and Environment, which was adopted by the European
Commission in February 2001. The draft law was revised several times in response to
public comments and amendments adopted by the European Parliament and Council of
Ministers (which is comprised of the executive officers of EU member states). The final
regulation is binding on all member states.
REACH requires all chemical producers and importers of more than one metric ton
(t) per year of any chemical1 to register the product by submitting a technical dossier of
information about the properties of that chemical and its uses to a new agency created by
the law, the European Chemicals Agency (ECA).2 The dossier also must contain
information about how any risks associated with use of that chemical should be managed.
Downstream users of chemicals are required to manage their risks in the manner indicated
by producers. Information requirements for the dossier increase as production volume
increases beyond 10 t, 100 t, and 1,000 t. Companies have between one year and 18
months to pre-register. The first registration deadline for existing chemicals is in
November 2010, and applies only to selected substances of “very high concern,” or
substances produced in volumes greater than 1,000 t annually or greater than 100 t
annually if they are very toxic to aquatic life. New chemicals must be registered before
they enter commerce, beginning June 1, 2008, when the ECA begins to function.
Member states (that is, the nations of the EU) will evaluate the dossiers based on
guidelines provided by the ECA, and may require additional data, if such data are needed
to assess health and environmental effects of potential chemical exposure. Member states
also may determine that action should be taken to authorize or restrict particular chemical
uses.
Producers of chemicals of “very high concern” may be required to apply for
authorization of each particular use, demonstrate that the risks can be adequately
controlled (for example, through labeling or worker training), and justify such uses by
submitting additional information to authorities. Companies will not be allowed to
manufacture, import, or use a chemical after a specified date unless they have obtained
an authorization for a use. In addition, producers will be required to submit an analysis
of possible substitutes, a “substitution plan” if substitutes are available, or a research and
development plan if no suitable substitute exists.
1 All polymers and some intermediate chemicals are exempted. Chemicals sold for specific
regulated purposes (for example, to control agricultural pests or to treat medical conditions) also
are not affected by the new law.
2 A metric ton is 1,000 kilograms, or about 2,200 pounds. The current EU requirement for
registration applies to chemicals produced or imported in amounts equal to or greater than 10
kilograms, but only if they have not been produced or imported into the EU previously — so-
called “new” chemicals.

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Chemicals of “very high concern” include about 1,350 chemicals known or likely to
be carcinogens, mutagens, or chemicals toxic to reproductive systems; persistent,
bioaccumulative, and toxic chemicals (PBTs); or very persistent and very
bioaccumulative chemicals (vPvBs). No use of PBTs or vPvBs will be authorized unless
there is no suitable alternative and the socio-economic benefits of the use outweigh the
risks. If a chemical use presents unacceptable risks, that chemical use may be restricted.
The EU Commission will decide within six years whether endocrine disruptors also are
of very high concern and should be subject to similar requirements.3 High-production-
volume chemicals routinely will be subject to the authorization process. The
authorization and restriction processes also may be applied to chemicals produced or
imported in volumes less than 1 t.
Views
The U.S. Government was actively engaged throughout the development of REACH.
The Bush Administration expressed concerns about its trade implications for U.S.-
produced chemicals.4 Specific concerns included increased costs of and time lines for
testing chemicals exported to the EU; placement of responsibility on businesses (as
opposed to governments or consumers) to generate data, assess risks, and demonstrate the
safety of chemicals; possible inconsistency with international rules for trade adopted by
the World Trade Organization (WTO); and the effect of the legislation on efforts to
improve the coherence of chemical regulatory approaches among countries in the
Organization for Economic Cooperation and Development (OECD).
U.S. chemical industry representatives believe that REACH is “impractical.”
Industry has expressed objections to the proposed list of “high concern” chemicals, some
of which are essential building blocks for the manufacture of other chemicals. The EU
chemical industry is concerned about the cost of compliance, and what it might mean to
innovation and international competitiveness. Some national governments of the EU also
are concerned about the impact of REACH on their economies and employment,
especially if REACH leads to companies relocating outside the EU. The EU has
estimated that about 12% of chemicals in commerce will be withdrawn by chemical
producers, because continued production under REACH will be costly and distribution
not sufficiently profitable to recoup costs. In cases where no substitute is available, loss
of a production source might leave some end users without the chemicals they need.
Many environmental, health, and U.S. and EU labor organizations strongly supported
the original proposal for REACH, but some are less enthusiastic about the final
regulation, which retains its basic purpose and shape but exempts some chemicals from
requirements. Nevertheless, these groups agree that REACH addresses what they see as
3 Endocrine disruptors are chemicals that interfere with the normal functioning of glands or the
hormones they produce. For more on endocrine disruptors in the environment, see CRS Report
RL31267, Environmental Exposure to Endocrine Disruptors: What Are the Human Health Risks?
by Linda-Jo Schierow and Eugene H. Buck
4 Prescott, Jennifer Yoder, “U.S. Government Responds to the E.U. Chemicals Policy,”
Chemistry Business, June 2002.

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flaws in U.S. and EU laws covering chemicals.5 (For more information about U.S.
chemical law, see CRS Report RL31905, The Toxic Substances Control Act: A Summary
of the Act and Its Major Requirements, by Linda-Jo Schierow.) For example, REACH
reduces and coordinates EU regulatory requirements for providing health and safety
information about chemicals new to the EU market (as well as the number of new
chemicals subject to such requirements), while at the same time increasing collection of
such information for chemicals already in the EU market, thus potentially removing
disincentives to innovation and substitution of less toxic for more toxic chemicals in
various chemical applications. In addition, to address concerns about the slow pace of
chemical risk assessment and management by the EU government, REACH shifts
responsibility for assessing and managing the safety of chemicals away from the
government and onto chemical manufacturers, importers, and users. Some public interest
groups are urging U.S. legislators to adopt a similar legislative approach.6
5 See for example the statement on the website of the Trans Atlantic Consumer Dialog, a group
which claims “to promote the consumer interest in EU and US policy making,” at
[http://www.tacd.org/docs/?id=253].
6 Ibid.

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