EU REACH Regulation

1. EU REACH Regulation Only Representative

2. REACH Impact on Non-EU Manufacturers • Almost all exporters of substances, preparations or articles to the EU are affected in some way • Failure to act will result in their products being banned from the EU market and cause Importers to seek alternative suppliers, either within the EU or those who have registered • Non-EU Manufacturers can expect a high level of enquiry from current Importers to ensure continuity of supply • Non-EU Manufacturers should conduct an impact assessment to identify the scale and then plan accordingly • Appointment of an Only Representative can help non-EU manufacturers ease the burden of REACH

3. What is an Only Representative? • Article 8 • Only representative of a non-Community manufacturer • A natural or legal person established outside of the Community who manufactures a substance on its own, in preparations or articles, formulates a preparation or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his only representative, the obligation of importers under his title. • The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall he shall have a sufficient background in the practical handling of substances and the information relating to them and, without prejudice to Article 36, shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet referred to in Article 31. • 3. If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community manufacturer shall inform the importer(s) within the supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

4. What is an Only Representative? • A natural or legal person (i.e. an individual or legal entity) • Legally established in the EU • Appointed by a non-EU Manufacturer to register their substances exported to the EU • Fulfils the obligations of customers, who will be classed as Importers under REACH, including pre-registration, SIEF participation, negotiation on cost-sharing, preparation of dossiers, registration, etc. • Needs to have sufficient expertise and understanding of the substance(s), as well as the resource and capabilities to handle the longer term obligations

5. Further Duties of an Only Representative An Only Representative will take on the further duties of a registrant, as outlined within Article 22 of the Regulation. These include: • Any change in status or identity • Change in composition of a substance • Change to tonnage band • New identified uses and any uses advised against • Knowledge of risks affecting an SDS and/or CSR • Changes in classification and labelling • Updates and amendments to a CSR • Make any requests for permission for additional testing • Any changes in the access granted to information in the registration

6. Registration Process Without an Only Representative Non-EU EU • Under the standard export scenario all customers, providing they import ≥ 1 tonne per year of a substance into the EU, will be obliged to register with the ECHA • In order for EU-based customers to be able to register, the non-EU Manufacturer is obliged to pass on confidential and sensitive intellectual property to all customers • There is no guarantee that the manufacturer can protect his intellectual property once it has been passed to his customers • There is also no guarantee that an EU-based customer will possess the necessary expertise, or want to expose himself to the cost and time that registration will require. Therefore the manufacturer could potentially see a fall in EU sales revenue

7. Registration Process With an Only Representative Non-EU EU • By appointing an Only Representative the manufacturer has to pass intellectual property to just a single entity, keeping tighter control over this sensitive information • The Only Representative takes on the obligations of the importer, placing all customers within the supply chain into the category of Downstream User • By becoming Downstream Users, the obligations and costs for customers are significantly reduced, resulting in retained and, possibly, increased market share as customers of other manufacturers may be looking for substances already registered

8. Advantages of Appointing an Only Representative • An Only Representative takes registration obligations away from the Importers (customers) and lessens the impact of REACH upon them • Useful if the Importer does not possess the expertise to register properly • Avoids the disclosure of sensitive information to the Importer • Avoids the time consuming problem of answering questions from multiple importers – information flow will be restricted to the Manufacturer and Only Representative • Useful to keep control of data and the submission of registrations • Can be used as a marketing tool to retain existing customers and to attract new

9. Important Issues to Consider • Appointment of an Only Representative requires mutual consent of the Importers within the supply chain. The Manufacturer must obtain the approval of his EU-based customers before an Only Representative can be appointed • The Only Representative must have sufficient background in the practical handling of substances

10. Thank You For Your Attention Please Feel Free To Ask Any Questions Dr. Thomas Leonhardt & Neil Oakshott