Chemical Regulation in the European Union:
Registration, Evaluation, and Authorization
of Chemicals
Linda-Jo Schierow
Specialist in Environmental Policy
March 1, 2012
Congressional Research Service
7-5700
www.crs.gov
RS22673
CRS Report for Congress
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epared for Members and Committees of Congress
Chemical Regulation in the European Union
Summary
On June 1, 2007, the European Union (EU) began to implement a new law governing chemicals
in EU commerce: Registration, Evaluation, Authorization, and Restriction of Chemicals
(REACH). 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 that existed under the former law. 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. Some U.S. chemical
industry representatives believe that REACH is “impractical,” in part due to the large number of
chemicals and difficulties of identifying end uses of chemicals in many products. In contrast,
some public-interest groups are urging U.S. legislators to adopt a similar legislative approach.
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Contents
Background...................................................................................................................................... 1
Registration................................................................................................................................ 1
Evaluation.................................................................................................................................. 2
Authorization............................................................................................................................. 2
Views ............................................................................................................................................... 3
Contacts
Author Contact Information............................................................................................................. 4
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Chemical Regulation in the European Union
epending 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
D 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 an EU law for
Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) in EU
commerce, which went into force June 1, 2007.1 This report summarizes REACH and progress in
its implementation. For information about U.S. chemical law, see CRS Report RL34118, The
Toxic Substances Control Act (TSCA): Implementation and New Challenges, by Linda-Jo
Schierow.
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 of European industry.
Although certain chemicals are exempt entirely, and requirements for the other chemicals are
being 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.
Registration
REACH requires all chemical producers and importers of more than one metric ton (t) per year of
any chemical2 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 (ECHA).3 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. Since June 1,
2008, when the ECHA began to function, registration has been required for new chemicals before
they enter commerce. Companies had between one year and 18 months to pre-register existing
1 REACH is a “Regulation” (Regulation No. 1907/2006) which is “binding in its entirety on” and “directly applicable
in all Member States” of the European Union (i.e., the nations that are members of the European Union) (Isabelle
Laborde, “Sources of European Environmental Law,” Natural Resources & Environment, v. 25, n. 4 (Spring) 2011).
2 All polymers and some intermediate chemicals are exempted from at least some provisions. Chemicals sold for
specific regulated purposes (e.g., to control agricultural pests or to treat medical conditions) also are not affected by the
new law.
3 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. Pre-registration ended November 30, 2008. The first registration deadline for existing
chemicals was in November 2010, and applied only to “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. About 4,725 substances reportedly were registered in this
category.4 The second registration deadline for existing chemicals is May 31, 2012, and applies to
substances produced in the 100 to 1,000 t range annually. The final deadline is June 1, 2018, by
which point all substances produced or imported in small quantities, between one and 100 t
annually, must be registered.
Evaluation
Member states (i.e., the nations of the EU) evaluate the dossiers based on guidelines provided by
the ECHA, 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.
On October 21, 2011, ECHA announced that it had used the information submitted in the first
round of data collection for substances produced in high volumes to identify 91 high-priority
substances for risk evaluation by Member States. These will be the first chemicals subject to the
evaluation stage of REACH, because ECHA suspects that use of these substances might pose a
risk to human health or the environment. The evaluations will aim to clarify such risks to
determine whether additional data should be collected and whether authorizations or restrictions
may be necessary.5
Authorization
Producers of “substances of very high concern” may be required to apply for authorization of
each particular use, demonstrate that the risks can be adequately controlled (e.g., 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.
As of February 27, 2012, 14 substances6 have been identified as substances of very high concern
(SVHC) that are effectively banned from use in the EU unless such use is authorized under the
law. In all, ECHA has identified 73 chemicals or chemical groups as SVHC candidates for
4 Stephen Gardner, “EU Chemicals Agency Says 4,725 Substances Now Registered Under REACH Legislation,” Daily
Environment Report, March 14, 2011, Bureau of National Affairs, Inc.
5 ECHA, “Draft Community Rolling Action Plan (CoRAP),” October 25, 2011, December 15, 2011,
http://www.element14.com/community/docs/DOC-38813/l/draft-community-rolling-action-plan-corap.
6 European Chemicals Agency, “Authorisation List,” February 27, 2012, http://echa.europa.eu/web/guest/addressing-
chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/authorisation-list. The
chemicals are hexabromocyclododecane, tris(2-chloroethyl)phosphate, 2,4-dinitrotoluene, lead chromate, diarsenic
pentaoxide, diarsenic trioxide, lead sulfochromate yellow, lead chromate molybdate sulphate red, bis(2-ethylhexyl)
phthalate, benzyl butyl phthalate, diisobutyl phthalate, dibutyl phthalate, 5-tert-butyl-2,4,6-trinitro-m-xylene, and 4,4’-
diaminodiphenylmethane.
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authorization,7 with many more chemicals being evaluated for this designation, including
approximately 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). According to the law, no use of PBTs or
vPvBs is to 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. 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.8
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).
Some 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 (i.e., no longer producing or selling products in 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 addressed some of what they saw as flaws in older EU laws covering
7 European Chemicals Agency, “Candidate List table,” February 27, 2012, http://echa.europa.eu/chem_data/
candidate_list_table_en.asp.
8 Prescott, Jennifer Yoder, “U.S. Government Responds to the E.U. Chemicals Policy,” Chemistry Business, June 2002.
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chemicals.9 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 encouraging 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.10 For more discussion of the perceived flaws of U.S. law, see
CRS Report RL34118, The Toxic Substances Control Act (TSCA): Implementation and New
Challenges, by Linda-Jo Schierow.
Author Contact Information
Linda-Jo Schierow
Specialist in Environmental Policy
lschierow@crs.loc.gov, 7-7279
9 See, for example, the presentation by Daryl Ditz of the Center for International Environmental Law at
http://www.chemicalstrategies.org/pdf/workshop_events/DDitz_Emerging%20Int%27l%20Issues.pdf.
10 Ibid.
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