CHEMICAL PRODUCT DEVELOPMENT AND DEFENSE

Only Representative

The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) requires any European Union (EU) manufacturer or importer of a non-exempt substance -- either on its own or in a preparation (i.e., a mixture) -- in quantities of 1 metric ton or more per year, and any EU producer or importer of an article that meets certain criteria, to submit a registration to the European Chemicals Agency (ECHA). Failure to register a substance that is required to be registered means that the substance cannot legally be manufactured, imported, or otherwise placed on the EU market -- a REACH principle often referred to as the “no data, no market" principle.

Non-EU entities (e.g., manufacturers of substances, formulators of preparations, producers of articles) do not have any registration or other obligations under REACH. Yet, because their products are imported into the EU, they are deeply affected by the regulation, particularly when the proprietary aspects of the products (e.g., compositional details) are taken into account. Such companies can rely on the actual EU importers or even establish a new, “friendly" EU legal entity through which all product imports would flow, but each of these approaches has shortcomings. Relying on EU importers to undertake the requisite registrations (assuming, of course, the importers are willing and able to do that, which is a big assumption) means that potentially sensitive information must be disclosed to them, while establishing a friendly EU legal entity presents a host of administrative, financial, and commercial difficulties. Fortunately, a third option is available to non-EU entities whose substances are imported into the EU.

REACH Article 8 enables a non-EU substance manufacturer, preparation formulator, or article producer to appoint an Only Representative (OR) to carry out the registration of a substance imported into the EU. The appointment of an OR relieves the actual EU importers of their registration and other importer obligations under REACH and transforms them instead into downstream users. Not anyone, though, can serve as an OR and bring about this result. The regulation expressly stipulates that an OR must be “a natural or legal person established in the Community" and “have a sufficient background in the practical handling of substances and the information related to them."

The Acta Group EU, Ltd (Acta EU) satisfies both prerequisites and is well-suited to serve as your company’s OR. Acta EU staff are expert with EU chemical regulations, with more than 15 years experience fulfilling the requirements of the EU Notification Of New Chemical Substances (NONS), including duties of Sole Representative Notifier on behalf of non-EU manufacturers, registration of existing chemicals and the International Council of Chemical Associations High Production Volume scheme. Acta EU offers an expert understanding of the REACH regulation, technical knowledge in meeting the requirements of REACH for successful completion of the registration process, and expert service to complete post-registration activities, including the ongoing duties of OR, regulatory support for substances subject to authorization, negotiation with regulatory authorities, socio-economic assessment, and related activities.

By appointing Acta EU, you will be protecting your company’s confidential business information, maintaining anonymity (if desired) within the EU, and enabling yourself to devote your full attention and energies to finding additional EU customers for your company’s products.

As your OR and the registrant, Acta EU will:

• Pre-register your phase-in substance(s) (or register your non-phase-in substance(s));
  
• Engage in pre-Substance Information Exchange Forum (SIEF) discussions (e.g., on substance sameness) with other pre-registrants;
• Participate in the SIEF once it is formed;
• Communicate with and gather use-related information from the actual EU importer(s) and any other downstream user(s);
• Prepare and submit the company-specific portion of the registration dossier;
• Communicate information, as necessary, in the supply chain;
• Maintain an up-to-date list of the EU importers covered by the registration and their volumes, as well as up-to-date information on the supply of the latest version of the Safety Data Sheet; and
• Interact with ECHA and Member State authorities as necessary.