This is a question that all non-EU manufacturers and formulators will ask themselves before appointing an Only Representative. While the benefits of appointing an Only Representative will be discussed here at a later date, this article will focus on the factors and scenarios that would result in the need for an Only Representative to be appointed.
Only Representative Role:
Non-EU manufacturers and formulators can appoint an EU based legal entity as their Only Representative. The Only Representative (OR) will assume the REACH obligations of the EU Importer who is placing the substances on the EU market.
A Lubricant Formulator based in New Jersey supplying finished products to the EU market. All raw materials used are sourced locally in North America. Currently, the Formulator has predicted EU customer base of five but expects this to increase year on year.
What are the key factors resulting in the need for this Formulator to appoint an Only Representative?
1. No presence in the EU
Given the current size of their EU market, it is not financially viable for the Formulator to set up a legal entity in the EU. This is something that they may consider in the future as their market expands.
2. Unable to obtain REACH Coverage from the upstream supplier
If the raw material supplier registers under REACH, this registration can be used to cover all the subsequent users down the supply chain. The Formulator can request the Supplier to provide registration cover. However, if the Supplier has not registered under REACH, or is not willing to provide registration coverage, then the Formulator would need to complete a registration through an Only Representative.
Another scenario is that the Formulator is unable to obtain registration coverage from both Suppliers of the same substance.
3. The Supplier will provide REACH coverage, but unwilling to disclose EU customers
If the Supplier has registered, this will have been completed through the use of an Only Representative. If the Supplier it to provide REACH coverage for the Formulator, then the Formulator will need to provide the details of their EU Importers to be covered by the Supplier. If this is confidential data, then Supplier Coverage is not an option that can be pursued.
4. Widespread EU customer base
As per the REACH regulation, the Formulator does not have any obligations under the REACH regulation. It is the obligation of the EU Importer to ensure that the substances they import are in compliance with REACH. The Formulator can push back on the Importer to ensure that they complete the required registrations for the substances they import. However this approach is less likely to be successful if there is a large number EU Importers. Each EU Importer will need to be registered under REACH to allow the Formulator to supply their products. If one EU Importer fails to register, then the Formulator will need to appoint an Only Representative to provide REACH coverage for all their EU importers
Still confused as to your OR needs?
If you are still unsure as to your need for an Only Representative, contact the experts at H2 Compliance for a 30 minute Free Consultation on your OR needs. H2 Compliance has extensive experience in the delivery of OR services since the implementation of REACH.