Only Representative Service
REACH, the Registration, Evaluation and Authorisation of Chemicals, requires that by December 2008 all chemicals to be placed on the market in the European Union, should be pre-registered with the European Chemicals Agency (ECHA). These substances will then need to continue through the full registration process if you wish to continue to sell them into Europe.
A non-European company cannot register substances under the REACH regulation, so how can they continue to do business in the EU?
Set up a European based company
Establishing a European company may be costly and need careful management.
Work through importers
May need to disclose confidential business and formulation information to each of your importers for them to submit a REACH registration. May restrict development of future distribution channels into Europe
Appoint an Only Representative
This has many advantages:
- An independent third party takes on all obligations of the importers under REACH. The Importers then become downstream users.
- If an importer registers a product the importing company will own the registration. It may then be more difficult for the manufacturer to expand or change the route to the European market.
- If an importer changes supplier the non-EU manufacturer may lose access to the European market.
The Only Representative will prepare and submit the pre-registration information to the European Chemicals Agency (ECHA) between June and December 2008. Because there may be other manufacturers of this chemical in the EU and other sources of importation, there will potentially be a number of pre-registrations notified to the ECHA. The Only Representative can participate in the Substance Information Exchange Forum (SIEF) for this chemical, following the end of the pre-registration period. Once the SIEF determines the information package required to support registration, the Only Representative can arrange, prepare and submit the registration dossier.
*What will this cost?
ReFaC will work with the non-European company to set up and manage the pre-registration process and bases its fees on the number of substances put forward for pre-registration:
In accordance with the requirement of the REACH regulation article 8 section 2: ReFaC's technical support team is able to demonstrate many years of industry expertise in regulatory affairs and the safe handling of chemicals.
ReFaC offers the Only Representative service to assist non-EU chemical manufacturers to continue to supply chemical substances into the EU market or to their EU based distributors.
If you wish to discuss the Only Representative Service please contact ReFaC for an initial, confidential discussion:
email: manager@refac.eu
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