Best Practice Guide - Only Representative

1 ORO best Practice Guide 14 oro Page 1 Only Representatives Organisation best Practice Guide version May 2014 ORO best Practice Guide 14 oro Page 2 CHANGES TO PREVIOUS version Not applicable ORO best Practice Guide 14 oro Page 3 TABLE OF CONTENTS 1. Introduction .. 7 Only Representatives Organisation ..7 Purpose ..7 Structure of this document ..8 Future plans & later versions ..8 Terms used ..9 Disclaimer .. 10 2. Qualifications & 11 Issues .. 11 Legal text & official guidance .. 11 Tasks and services .. 12 best Practice .. 12 The necessary qualifications and requirements for Only Representatives .. 12 Documentation of the Only Representative s qualifications .. 13 Criteria for the selection of an Only Representative .. 14 3. Identification of the 15 Only where an OR has been appointed.

2 15 Topic .. 15 Legal text & official guidance .. 15 best Practice .. 16 Easily identifiable importers .. 16 The Principals agent .. 16 Imported products owned by non-EU companies .. 17 Customs supervision .. 17 Other complicated supply chain situations .. 18 ORO best Practice Guide 14 oro Page 4 4. Volume tracking .. 19 Topics .. 19 Legal text & official guidance .. 19 Distinction between different situations .. 20 Full or partial coverage of the Principal s 20 Substances on their own, Common mixtures and Proprietary 20 best Practice .. 21 The meaning of Up-to date .. 21 Full coverage; Substances on their own & Common 21 Full coverage: Proprietary mixtures & 22 Partial coverage of imports .. 22 The principal does not supply timely information on quantities .. 23 How long must records be kept.

3 23 5. Double registrations & pre-registrations .. 25 Topic .. 25 Legal text & official guidance .. 25 best Practice .. 26 The importer also purchases the substance from other Non EU producers .. 26 Importer s purchases outside the OR arrangement .. 26 6. Records in case of a late OR appointment .. 27 Topics .. 27 Legal text & official guidance .. 27 best Practice .. 28 Quantities preceding the late appointment of an Only Representative .. 28 7. SME claims .. 29 Topics .. 29 Legal text & official guidance .. 29 Company Size Determination .. 30 ORO best Practice Guide 14 oro Page 5 best Practice .. 32 Initial Client engagement .. 32 Periodic Confirmation of Company Size .. 32 Confirmation prior to Registration of Substance .. 32 Verification Process .. 33 Contractual arrangements .. 34 8. Safety Data Sheets.

4 35 Topics .. 35 Legal text & guidance .. 35 Definitions .. 35 best Practice .. 36 Availability of Safety Data Sheets in the supply chain .. 36 Supply of Safety Data Sheets by an Only Representative .. 37 Sharing information .. 37 Registration numbers on Safety Data Sheets for mixtures .. 38 Dissemination records .. 38 New hazard information or new harmonised classification .. 38 Contractual arrangements between OR and Principal .. 39 9. Communications with Downstream Users .. 40 Topics .. 40 Legal text & official guidance .. 40 best Practice .. 40 Appointment and Downstream User Contact Details .. 40 Identified Uses: Registration on the Basis of a Letter of Access to an existing joint 41 Identified uses: Registration dossier prepared by the Only Representative .. 42 Previously unknown risk to human health or the environment.

5 43 Unsolicited downstream user communications .. 43 ORO best Practice Guide 14 oro Page 6 LIST OF ANNEXES Annex 1 Documents required for SME verification. Annex 2 Overview of the legal text and Guidance mentioning Downstream User communications. Annex 3 ORO Position Paper Only Representatives and Safety Data Sheets . Annex 4 Commission letter to an ORO member regarding the OR obligations with regard to Safety Data Sheets. Annex 5 Commission letter dd 24 April 2010, regarding the registration numbers on Safety Data Sheets. ORO best Practice Guide 14 oro Page 7 1. INTRODUCTION Only Representatives Organisation The Only Representative Organisation (ORO) is the international trade association of REACH Only Representatives . Only Representatives have a role that enables non-EU companies to place their product on the EU market in accordance with Article 8 of REACH (1907/2006).

6 ORO has (January 2014 ) approximately thirty members, all of which take their role seriously. The Only Representative keeps in custody his client s right to access to the European market. Reliability, competence and sense of responsibility are obvious requirements. ORO wishes to ensure that its members meet all of these requirements. For this reason, one of the fundamental qualifications and requirements for Only Representatives who are, or wish to become, members of ORO, as adopted by the ORO General Assembly, is the following: ORO members will actively strive to work in accordance with the ORO best Practice Guide Purpose Only a small portion of the REACH legal text is devoted to the Only Representatives role and activities. This is unlike most other roles under REACH, which are in different ways addressed in ECHA Guidance.

7 This lack of guidance affects not only the Only Representatives, their Principals (non-EU clients) and the importers covered by their services, but also REACH inspectors. During inspections the requirements for Only Representatives are seldom clear and there are considerable national differences in the requirements that are put forward. This best Practice Guide (BPG) is aimed at helping both the Only Representative and the REACH inspectors to know what can and should be expected from Only Representatives. It also clarifies the limits to the Only Representatives obligations and responsibilities. This best Practice Guide informs the non-EU producers and their EU based customers. The Only Representatives Principals are shown what is required from them to enable the Only Representative to deliver the required service. The importers/downstream users are shown what they can, and cannot, expect from an Only Representative .

8 The purpose of this best Practice Guide is to provide a de facto standard for the work of all Only Representatives, including those who are not ORO members. The BPG is available on the public access part of the ORO website. All those with an interest in the work of Only Representatives are encouraged to download, read and use the document. Updates and additions will be announced and published on the ORO web site. For each identified issue this Guide provides best Practice ; a recommended way in which to address the issue. In Practice other methods may exist that obtain the same result. Where this is the case, there is no objection against employing these other methods. ORO best Practice Guide 14 oro Page 8 Structure of this document In this ORO best Practice Guide each chapter addresses a specific topic. The most urgent topics are addressed in this first release of the BPG.

9 Additional chapters on other topics will follow in the near future. All chapters have the same format and contain at a minimum the following sections: Topic A short description of the topic addressed in the chapter and the issues at play. A list of subjects for which best Practice is recommended. Legal text & Official Guidance The most relevant parts of legal text. Where applicable a reference to a relevant legal analysis or ORO position paper. The most relevant parts of ECHA Guidance Documents. Relevant correspondence from the European Commission, ECHA or other authorities. best Practice A short description of the issue or topic best Practice recommendations. References to other chapters in the best Practice Guide . Occasionally, where necessary for a good understanding, more sections have been added. Future plans & later versions ORO plans to complete this best Practice Guide in the near future.

10 The Guide will also be updated regularly. Users are advised to visit the ORO web site regularly to ensure that they have the latest version . Users of this BPG in need of further clarification or wishing to suggest changes or additions are requested to contact ORO at ORO best Practice Guide 14 oro Page 9 Terms used Some terms used in this best Practice Guide have a specific meaning; these are defined below. Unless indicated differently other REACH terms are used as defined in the legal text. Downstream User Unless indicated differently this means an Importer who, because of the appointment of the Only Representative , is regarded as a Downstream User in accordance with REACH Principal The non-EU based manufacturer of substances, mixtures or articles who is a customer of the Only Representative and who has appointed the Only Representative in accordance with REACH European Union, EU, Non-EU & EU based Although REACH applies also in Norway, Iceland and Liechtenstein, these terms are used for the sake of brevity.