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In many respects,REACH is analogous toTSCA regulations in theUS; however, the scope

and requirements aredifferent

On December 18, 2006, the European Parliament passed the final REACHDirective. Work on this legislation began in 2003. REACH will begin to bephased in on June 1, 2007.

REACH is an acronymthat stands for “Registration, Evaluation andAuthorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, andif necessary, restricting the manufacture, import and uses of chemicalswithin EU Member States.

Because REACH also addresses the uses of chemicals, this directive canhave a direct impact on a wide range of organizations.

This regulatory briefing provides a summary of some of the key elementsand concepts of the REACH Directive.

Overview

The basic format for the REACH directive is:

□ All chemicals manufactured and/or imported to the EU involumes more than 1 ton per year are required to beregistered

□ All registered chemicals must identify uses□ Manufacturers and importers must assess the risks associated

with the manufacture and uses of chemicals, and then reportfindings to a central agency, the European Chemicals Agency.

□ The European Chemicals Agency will be responsible forreviewing and evaluating chemical information anddetermining if any further actions to control risks areappropriate.

If chemicals or mixtures contain chemicals of very high concern(carcinogens, mutagens, etc.), then specific authorizations and/orrestrictions on the manufacture, import, and/or uses of the materialsmay 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 ImporterRequirements

4 Chemical UserRequirements

5 What About ExistingChemicals?

5 Useful Links

REACH Basics

Regulatory Briefing

European Union’sREACH Directive

January 2007

©Caltha LLP 2007

Page 2 Regulatory Briefing

Although the burden of risk evaluation and control is placed on themanufacturers and importers, REACH does include requirements thatapply to USERS of regulated materials. The risk assessment process usedto 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 riskassessment, 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 optionsavailable:

1. They can inform their manufacturer or supplier of the new usesand request that the new uses be added to the list ofrecognized uses (which may require further risk assessment)

2. They can perform and submit their own risk assessment on thenew use

REACH shifts theburden of proof

regarding chemicalrisks to the regulated

industry

Much of the REACH Directive details requirements placed onmanufacturers and importers of chemicals. In summary, unlike pastregulations, REACH places the burden of proof regarding potential risks ofchemicals on the manufacturers and importers.

For all regulated materials, manufacturers/importers will be required toprepare an assessment of risks to human health and the environmentassociated with the identified uses of the subject material. Therefore, toaccomplish this, manufacturers/importers will first need to identify theuses of the material. Then, based on the recognized uses, exposurescenarios and risk assessment can be completed. At this point,manufacturers can recommend procedures for use, pollution preventionpractices, personal protective measures, or other measures to mitigatethe risks associated with the recognized uses.

The European Chemicals Agency will review the risk informationsubmitted. The agency will determine if further mitigations are required,or if more broad restrictions need to be developed.

Manufacturer & Importer Requirements

Chemical User Requirements

©Caltha LLP 2007

Regulatory Briefing Page 3

Unlike the previous regulations, REACH applies toALL chemicals currently used or sold in the EU.Existing chemicals, as of 1981, were exempted fromthe previous regulations; since then only newchemicals were required to have risk evaluationsconducted.

All existing chemicals, previously exempted, will nowhave to go through the same risk evaluation. Duringthe next several years, risk evaluations will berequired from manufacturers and/or importers on aphased-in basis.

The REACH Directive does offer partial or fullexemptions for certain materials:

R&D Uses. To prevent the Directive fromunnecessarily hampering R&D developments,substances used in product- or process-developmentdo not need to be registered for up to 5-years

Special Uses. Some special use chemicals, especiallyrelated to Food and Medical Products Sectors, havedifferent requirements

Regulatory Briefings are published periodically byCaltha to highlight new or proposed environmental,health & safety regulations

Caltha LLP2125 Urbandale Lane NorthMinneapolis, MN 55447-2029

Phone:(763) 208-6430

Website:http:/www.calthacompany.com

E-mail:info@calthacompany.com

Currently, about 30,000 chemicals are thoughtto be used in the EU at volumes greater than 1ton/year. About 16% of these have come intothe market since 1981 and have beenregulated as “new” chemicals and wereevaluated using the previous regulatoryframework. Therefore, about 84% of thematerials currently being used in the EU willrequire assessment for chemical risks.

ExistingChemicalsNeedingRisk AssessmentUnder REACH

“New” ChemicalsIntroducedSince 1981

Useful Links

What About Existing Chemicals?

http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

- REACH Overview Websitehttp://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML

- Full text of Regulation (English)