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Registration, Evaluation, Authorization and potential Restriction of Chemicals
Is YOUR company affected by REACH?

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 SDS
  • 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

We have partnered with EU based firms to provide Only Representative (OR) services as well as a leading IT solutions devloper.

If you manufacture or import chemicals, mixtures of chemicals or articles to the European Union (EU) You should be able to answer these six questions:

Have you developed a strategy for REACH compliance?

The initial pre registration period was June 1 to December 1, 2008. Firms placing chemicals on the market for the first time after December 1, 2008 may be eligible for 'late' pre registration.

Who can pre-register or register your chemicals?

Only firms that are legal entities in the EU may pre-register or register substances. Exporters to the EU have three choices for getting 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.

Have you determined which chemicals you should register?

Companies should inventory the chemical constituents in products they currently place on the EU market 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.

Have you contacted your suppliers and downstream customers about their plans to register?

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.

Do you have a system to track deadlines and review requirements of REACH?

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.

Have you budgeted for the costs of pre-registration and registration?

Pre-registration will trigger the formation of a "Substance Information Exchange Forum" (SIEF) for each unique substance. You should estimate the costs of participation going forward. 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

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