The European Union REACH initiative is a complex regulation impacting all chemicals and products containing chemicals that are either manufactured in or imported into the EU.

Elements of the regime are Registration, Evaluation, Authorization and potential Restriction of Chemical substances. A firm's failure to comply may result in the inability to market its chemicals or products in Europe.

The regulation places onerous burdens on manufacturers and importers to collect, analyze and submit chemical risk information while also impacting chemical distributors and downstream users including firms in industries not traditionally considered to be producing chemical articles.

THE REDSTONE GROUP has a technical team lead by chemists and toxicologists with significant R&D, formulary implementation as well as international chemical regulatory compliance experience.

This team can assist in multiple aspects of REACH implementation including:

Planning for compliance and review of requirements Analysis of company specific exposure to the new rules Identification of options for secure software to maintain data and track deadlines & activities Product (formulary) review Establishment of an "only representative" in the EU Establishment of a "third party" to represent manufacturers in data development or other activities Preparation of pre-registration submissions Participation in the Substance Information Exchange Fora (SIEF's) Preparation of registration dossiers (including Consortia participation)

Training in REACH implementation as well as IUCLID 5 software Preparation of the new MSDS Preparation of Chemical Safety Reports Preparation of testing plans and testing coordination Preparation of risk assessments Interaction with the new Chemicals Agency or European Commission to resolve questions about application of the rules Preparation of applications for Authorization Ongoing review of responsibilities to update Registrations Coordination with TSCA and other product compliance requirements

REDSTONE has partnered with the law firm of HUNTON & WILLIAMS in this area. This firm with nineteen offices throughout the US, Europe and Asia has been involved with the REACH Regulation since its inception and is prepared to assist clients in multiple legal elements including Strategies, Compliance, EU Representation, Intellectual Property Rights, Regulator Interface and Enforcement and Remedies. Our other global partners combine to provide a full spectrum of REACH implementation services.

Together THE REDSTONE GROUP, LLC, HUNTON & WILLIAMS and our global network are prepared to assist our clients throughout the development, implementation and maintenance of their European Union REACH strategies.

We have also partnered with H2 Compliance, Dublin, Ireland. H2 can provide Only Representative services required by non-EU firms wishing to (pre) register chemicals in the EU under REACH. Baytouch LTD, Lancashire, England provides REACHSuite a comprehensive IT solution for businesses manufacturing or importing substances which have to be registered and for monitoring EU-supplied raw materials/substances to ensure their registration for your uses.





Importers may "pre-register" chemicals between June 1st and December 1st 2008 if the chemicals are currently included in the existing EU registry (EINECS listing). Pre-registration allows for sharing costs of analyses with other producers and later deadlines for registration.



Only firms that are legal entities in the EU may pre-register or register substances. As an exporter to the EU you have three choices for getting your products registered: (1) if you have facilities in the EU you can have one of those facilities register, (2) you can ask your importer (an EU firm) to pre-register or register the materials they import or (3) you can arrange for an "only representative" to register all of your exports to the EU. The "only representative" will act as importer.



Exporters of substances should inventory the chemical constituents in products they currently export or intend to export to the EU and determine which are available for pre-registration. Some substances are exempt from registration e.g. food stuffs, and some are eligible for reduced requirements e.g. polymers. The inventory should include those determinations. The evaluation should include a determination of the correct name and EINECS number of the substance. The inventories should include the annual amount of the products you have exported for the last three years. The name of other substances for which available information is relevant for performing adaptations to testing requirements are required. Use of results from (Q)SAR models and chemicals with similar physicochemical, toxicological and ecotoxicological properties should be included in the inventory.



Downstream users of substances may not have to register if the supplier plans to register the chemical substances and the supplier includes an analysis of the use in the registration process. Downstream users will be considered as manufacturers/importers if upstream suppliers do not register the uses. Be sure to confirm ALL chemical constituents to be registered. Suppliers should catalogue the use of their products by downstream users in the EU to insure that they cover those uses in their registration documents.



REACH has of large number of requirement for manufactures and importers, and many deadlines to meet. Annual reviews of information are also required. Companies face significant sanctions for failing to meet those requirements. Software to track requirements, deadlines and actions will be a great aid to insure that your exports are not excluded from the EU market.



Pre-registration begins in 2008, you should prepare for costs that year for the inventories, and supplier/downstream user inquiries. Pre-registration will trigger the formation of a "Substance Information Exchange Forum" (SIEF) for each unique substance. You should estimate the costs of participation in 2009. Fees for registration and the costs of testing and risk assessments should be estimated for future years.

For more information about this service:
email: mvagasky@redstonegrp.com

H2 Compliance
Hunton & Williams, LLP
SOCMA
3E Company
Baytouch, Ltd
ILMA