On December 18, 2006, the European Parliament passed the final REACH Directive. Work on this legislation began in 2003. REACH will begin to be phased in on June 1, 2007. REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States. Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations. This regulatory briefing provides a summary of some of the key elements and concepts of the REACH Directive. For more information on EH&S and product responsibility services, go to: http://calthacompany.com/compliance-programs-ems-auditing

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In many respects,
REACH is analogous to
TSCA regulations in the
US; however, the scope
and requirements are
different
On December 18, 2006, the European Parliament passed the final REACH
Directive. Work on this legislation began in 2003. REACH will begin to be
phased in on June 1, 2007.
REACH is an acronym thatstandsfor“Registration, Evaluation and
Authorisation of Chemicals”.REACHreplacesabout40differentEU
regulations and provides a uniform approach to evaluating, approving, and
if necessary, restricting the manufacture, import and uses of chemicals
within EU Member States.
Because REACH also addresses the uses of chemicals, this directive can
have a direct impact on a wide range of organizations.
This regulatory briefing provides a summary of some of the key elements
and concepts of the REACH Directive.
Overview
The basic format for the REACH directive is:
□ All chemicals manufactured and/or imported to the EU in
volumes more than 1 ton per year are required to be
registered
□ All registered chemicals must identify uses
□ Manufacturers and importers must assess the risks associated
with the manufacture and uses of chemicals, and then report
findings to a central agency, the European Chemicals Agency.
□ The European Chemicals Agency will be responsible for
reviewing and evaluating chemical information and
determining if any further actions to control risks are
appropriate.
If chemicals or mixtures contain chemicals of very high concern
(carcinogens, mutagens, etc.), then specific authorizations and/or
restrictions on the manufacture, import, and/or uses of the materials
may be required.
I N S I D E T H I S
B R I E F I N G
1 Overview
2 REACH Basics
3 Manufacturer and Importer
Requirements
4 Chemical User
Requirements
5 What About Existing
Chemicals?
5 Useful Links
REACH Basics
Regulatory Briefing
EuropeanUnion’s
REACH Directive
January 2007

2. ©Caltha LLP 2007
Page 2 Regulatory Briefing
Although the burden of risk evaluation and control is placed on the
manufacturers and importers, REACH does include requirements that
apply to USERS of regulated materials. The risk assessment process used
to register materials is based on specific uses and mitigations. Therefore,
the User requirements assure that mitigation measures are actually used,
and that any new uses of materials, which were not included in the risk
assessment, are evaluated.
To accomplish this, Users are required to
- Use materials only for labeled uses
- Understand and use all risk mitigation measures
incorporated into the manufacturers risk analysis
If Users of materials wish to have new uses, they have two options
available:
1. They can inform their manufacturer or supplier of the new uses
and request that the new uses be added to the list of
recognized uses (which may require further risk assessment)
2. They can perform and submit their own risk assessment on the
new use
REACH shifts the
burden of proof
regarding chemical
risks to the regulated
industry
Much of the REACH Directive details requirements placed on
manufacturers and importers of chemicals. In summary, unlike past
regulations, REACH places the burden of proof regarding potential risks of
chemicals on the manufacturers and importers.
For all regulated materials, manufacturers/importers will be required to
prepare an assessment of risks to human health and the environment
associated with the identified uses of the subject material. Therefore, to
accomplish this, manufacturers/importers will first need to identify the
uses of the material. Then, based on the recognized uses, exposure
scenarios and risk assessment can be completed. At this point,
manufacturers can recommend procedures for use, pollution prevention
practices, personal protective measures, or other measures to mitigate
the risks associated with the recognized uses.
The European Chemicals Agency will review the risk information
submitted. The agency will determine if further mitigations are required,
or if more broad restrictions need to be developed.
Manufacturer & Importer Requirements
Chemical User Requirements

3. ©Caltha LLP 2007
Regulatory Briefing Page 3
Unlike the previous regulations, REACH applies to
ALL chemicals currently used or sold in the EU.
Existing chemicals, as of 1981, were exempted from
the previous regulations; since then only new
chemicals were required to have risk evaluations
conducted.
All existing chemicals, previously exempted, will now
have to go through the same risk evaluation. During
the next several years, risk evaluations will be
required from manufacturers and/or importers on a
phased-in basis.
The REACH Directive does offer partial or full
exemptions for certain materials:
R&D Uses. To prevent the Directive from
unnecessarily hampering R&D developments,
substances used in product- or process-development
do not need to be registered for up to 5-years
Special Uses. Some special use chemicals, especially
related to Food and Medical Products Sectors, have
different requirements
Regulatory Briefings are published periodically by
Caltha to highlight new or proposed environmental,
health & safety regulations
Caltha LLP
2125 Urbandale Lane North
Minneapolis, MN 55447-2029
Phone:
(763) 208-6430
Website:
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Currently, about 30,000 chemicals are thought
to be used in the EU at volumes greater than 1
ton/year. About 16% of these have come into
the market since 1981 and have been
regulatedas“new”chemicalsandwere
evaluated using the previous regulatory
framework. Therefore, about 84% of the
materials currently being used in the EU will
require assessment for chemical risks.
Existing
Chemicals
Needing
Risk Assessment
Under REACH
“New”
Chemicals
Introduced
Since 1981
Useful Links
What About Existing Chemicals?
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm
- REACH Overview Website
http://eur-
lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML
- Full text of Regulation (English)