REACH

REACH Regulation and the Only Representative

REACH regulation requires European Union (EU)-based manufacturers and importers of chemicals to register individual substances with the European Chemicals Agency (ECHA) before they can continue to manufacture or import those products in the EU. The registration deadline is extended for those companies that pre-register their substances before 1 December 2008. EU manufacturers or importers that do not pre-register or register will not be allowed to continue to manufacture or import substances.

Only Representative
The Only Representative plays a critical role for non-EU manufacturers of chemicals. Non-EU manufacturers that export chemical substances to the EU cannot pre-register or register their substances directly. Article 8 of REACH regulation (Regulation (EC) No 1907/2006) specifies that manufacturers of chemicals substances outside the EU may appoint an Only Representative to fulfill REACH registration obligations as follows:

• A natural or legal person established outside the European Community (EC) who manufactures a substance on its own, in preparations or in articles, formulates a preparation or produces an article that is imported into the EC may by mutual agreement appoint a natural or legal person established in the EC to fulfil, as his only representative, the obligations on importers under this Title.
• The representative shall also comply with all other obligations of importers under this Regulation. To this end, he shall have a sufficient background in the practical handling of substances and the information related 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.
• If a representative is appointed in accordance with paragraphs 1 and 2, the non-EC manufacturer shall inform the importer(s) within the same supply chain of the appointment. These importers shall be regarded as downstream users for the purposes of this Regulation.

Advantages of Appointing Only Representative
Appointing an Only Representative provides many advantages to the manufacturer:

• The manufacturer does not need to operate in the EU.
• The manufacturer’s customers (i.e., importers) are not obliged to register the individual substances. For the purposes of REACH, your importers become downstream users and will face fewer obligations.
• The manufacturer has direct control over the registration process of its substances.
• The manufacturer may expand its customer base without restriction.
• Confidential data are communicated exclusively to an impartial partner (i.e., the Only Representative) rather than the manufacturer’s supply chain customers.

Choosing ENVIRON as your Only Representative
ENVIRON is an international health and environmental consultancy, with over 1,200 staff in 73 offices across Europe, North America, Asia and Asia Pacific. We have worked at the leading edge of chemical risk assessment and regulatory services for over 26 years. We provide a comprehensive range of REACH services to our clients around the world. ENVIRON’s REACH team draws together experts from various offices across Europe, the US and Asia. We work with our clients to develop the team structure that best supports their needs.Although the REACH team in Europe is legally required to perform the Only Representative role, you may request a local point of contact (eg, in the US, Canada, Japan) for your convenience. ENVIRON can act as Only Representative for non-EU manufacturers, including manufacturers who export to the EU via a non-EU customer. We develop a strong relationship and a high degree of mutual trust with our clients, and identify and provide the technical and strategic support that best fits our clients’ needs. We understand that as your Only Representative our role includes securing an ongoing market in the EU, and we constantly seek to improve and add value through the service. We recognise that as your Only Representative, ENVIRON becomes the importer of each of the substances for purposes of REACH. The agreement between the Only Representative and the Client is essential in terms of protecting the interests of both parties. ENVIRON has developed an agreement for Only Representative services that addresses the unique issues associated with this role, specifically addressing protection of confidential information. We are happy to provide this agreement for your consideration.