Tonnage Aggregation or Not? Separate (pre-)registration or Not?

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1 Session I Tonnage Aggregation or Not? Separate (pre-)registration or Not? - REACH ( , ) REACH,.

2 OR , Q&A Question: Does it mean that the representative "substitutes" the manufacturer? Answer: In effect the only representative substitutes for the importer of the substance as the 3rd country manufacturer cannot register , Guidance on Registration If a non-eu manufacturer decides to change his OR, the newly appointed OR can, in agreement with the former OR, update the registration dossier, by changing the registrant identity , Commission Regulation Article 11 If the OR represents more than one enterprise, the level of the fee or charge shall be determined by reference to the total size of all the enterprises that are represented by that OR , FAQs Ver.2 An OR representing more than one non-eu company must submit one registration dossier for the same substance. He must register the volume of the substance he is responsible for, that is exported by all of the non-eu companies that appointed him and fulfil all registration requirements , Guidance on Registration Ver.1 23 page: If a non-eu manufacturer decides to change his OR, the successor will have to submit a new registration dossier, as there is no link between the two ORs who are separate legal entities. 23 page: As OR is fulfilling the registration obligations of importers, the tonnage of the substance to be registered is the total of the tonnages of the same substance covered by the contractual agreements with him and all non-eu manufacturers represented by him. The information requirement for the registration dossier shall be determined according to this total tonnage.

3 OR , Guidance on Registration Ver.1 24 Page: Non-EU Manufacturer 2 and 3 export 8 tonnes each and appoint same OR. OR registers the tonnage exported by the non-eu manufacturers 2 and 3, i.e. 16 tonnes of substance. The registration dossier should be made for tonnes, including a CSR , FAQs Ver.2.1 FAQs Ver , ECHA Workshop, Otto Linher OR must submit a separate (pre-)registration for every non-eu manufacturer he represents. Note that this is a change from earlier interpretation , Commission Regulation (EC) No., 340/2008 Article 12 Draft OR , CEFIC( ), Preparation for Pre-registration 9 page A substance can only be pre-registered once for each legal entity that manufactures or imports that substance , Guidance on Registration Ver.1.1 OR /. Notice: It is currently being reviewed whether it is legally possible for an OR to aggregate the tonnages if he represents several non-eu manufacturers. ECHA will make every effort to publish an updated version of the guidance before 1 June 2008.

4 LEGAL NOTICE Legal Notice of Guidance This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The ECHA does not accept any liability with regard to the contents of this document. Legal Notice of FAQs and Q&A Users are reminded that the text of the REACH Regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The ECHA does not accept any liability with regard to the contents of this document. Disclaimer of Workshop 14 April 2008, Brussels The views expressed in the workshop slides and videos are purely those of the presenters and may not in any circumstances be regarded as stating an official position of the European Commission. The European Commission cannot give a binding interpretation of Community legislation, as this is the prerogative of the European Court of Justice. Decision Basis is not Guidance, FAQs, Q&A or Workshop, but Legislation.

5 OR , Regulation of The European Parliament and The Council for REACH Article 8 (1) Non-EU Manufacturers may by mutual agreement appoint a natural or legal person established in the Community to fulfil, as his OR. (2) The OR shall also comply with all other obligations of importers under this Regulation. (3) These importers shall be regarded as downstream users for the purposes of this Regulation , Commission Regulation Article 12 The assessment of whether the reduction for SMEs applies shall be determined by reference to the headcount, turnover and balance sheet information of the non-eu manufacturer that is represented by that OR in connection with the transaction concerned, including relevant information from linked and partner companies of the non-eu manufacturer, in accordance with Recommendation 2003/361/EC. OR

6 Aggregation? Separate Registration? I don t know. The Probability is that half-and-half. Why? Tonnage Aggregation Separate Registration OR equal Importer OR has Obligation & Right Non-EU EU European Parliament & Council welcome OR OR equal Agent OR has Obligation, no Right REACH-IT/IUCLID ECHA, EU manufacturers & ORs welcome ECHA OR

7 OR , EC ECHA Workshop, / EC Commission , OR ECHA /??

8 An Immutable Law Only Representative? No,! OR, OR ( ) Legal Entity Non-EU Manufacturer Legal Entity