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Staff Working Document EN EN EN COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 8 April 2009 SEC(2009) 447 final COMMISSION STAFF WORKING DOCUMENT Accompanying document to the COMMUNICATION FROM THE COMMISSION ON THE REVIEWS OF ANNEXES I, IV AND V TO REGULATION (EC) NO 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL CONCERNING THE REGISTRATION, EVALUATION, AUTHORISATION AND RESTRICTION OF CHEMICALS (REACH) {C(2009) 2482 final} EN EN TABLE OF CONTENTS 1. Introduction................................................................................................................ 5 1.1. Background .................................................................................................................. 5 1.2. Relationship between Annex IV and Annex V............................................................ 6 2. Review of Annex IV ................................................................................................... 7 2.1. Procedure...................................................................................................................... 7 2.2. Agreed criteria.............................................................................................................. 8 2.3. Nanotechnology ........................................................................................................... 8 2.4. Analysis of proposals ................................................................................................... 9 2.4.1. Overview...................................................................................................................... 9 2.4.2. Methodology .............................................................................................................. 10 2.5. Evaluations of substances already in Annex IV......................................................... 11 2.6. Results........................................................................................................................ 12 2.6.1. Existing entries........................................................................................................... 12 2.6.2. Proposed new entries.................................................................................................. 12 2.7. Conclusion.................................................................................................................. 13 3. Review of Annex V................................................................................................... 16 3.1. Introduction................................................................................................................ 16 3.2. Criteria for inclusion in Annex V and interpretation ................................................. 17 3.2.1. Registration is deemed inappropriate or unnecessary................................................ 17 3.2.2. Exemption does not prejudice the objectives of REACH.......................................... 18 3.2.2.1. High level of protection of human health and the environment................................. 18 3.2.2.2. Promotion of alternative methods for assessment of hazards .................................... 19 3.2.2.3. Free movement of substances on the internal market ................................................ 19 3.2.2.4. Enhancing competitiveness........................................................................................ 19 3.2.2.5. Enhancing innovation.................................................................................................19 3.3. Process: Advisory Group, stakeholders and CAs ...................................................... 20 3.4. Analysis of individual exemption categories in Annex V, taking into account the above-mentioned criteria............................................................................................ 20 3.4.1. Annex V, point 1........................................................................................................ 20 EN 2 EN 3.4.1.1. Background ................................................................................................................ 20 3.4.1.2. Analysis...................................................................................................................... 20 3.4.1.3. Commission proposal................................................................................................. 21 3.4.2. Annex V, point 2 ....................................................................................................... 21 3.4.2.1. Background ................................................................................................................ 21 3.4.2.2. Analysis...................................................................................................................... 22 3.4.2.3. Commission proposal................................................................................................. 22 3.4.3. Annex V, point 3 ....................................................................................................... 22 3.4.3.1. Background ................................................................................................................ 22 3.4.3.2. Analysis...................................................................................................................... 22 3.4.3.3. Commission proposal................................................................................................. 23 3.4.4. Annex V, point 4 ....................................................................................................... 23 3.4.4.1. Background ................................................................................................................ 23 3.4.4.2. Analysis...................................................................................................................... 23 3.4.4.3. Commission proposal................................................................................................. 24 3.4.5. Annex V, point 5 ....................................................................................................... 24 3.4.5.1. Background ................................................................................................................ 24 3.4.5.2. Analysis...................................................................................................................... 24 3.4.5.3. Commission proposal................................................................................................. 25 3.4.6. Annex V, point 6 ....................................................................................................... 26 3.4.6.1. Background ................................................................................................................ 26 3.4.6.2. Analysis...................................................................................................................... 26 3.4.6.3. Commission proposal................................................................................................. 27 3.4.7. Annex V, point 7 ....................................................................................................... 27 3.4.7.1. Background ................................................................................................................ 27 3.4.7.2. Analysis...................................................................................................................... 28 3.4.7.3. Existing entries........................................................................................................... 28 3.4.7.4. Proposed new entries.................................................................................................. 30 3.4.7.5. Commission proposal................................................................................................. 34 3.4.8. Annex V, point 8 ....................................................................................................... 35 3.4.8.1. Background ................................................................................................................ 35 EN 3 EN 3.4.8.2. Analysis...................................................................................................................... 35 3.4.8.3. Commission proposal................................................................................................. 36 3.4.9. Annex V, point 9 ....................................................................................................... 37 3.4.9.1. Background ................................................................................................................ 37 3.4.9.2. Analysis...................................................................................................................... 37 3.4.9.3. Commission proposal................................................................................................. 38 Appendix I: Agreed criteria for inclusion of substances in Annex IV to Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)................................................................................................................ 39 Appendix II: Submissions for addition to Annex IV ............................................................... 47 Appendix III: Commission proposals to amend Annexes IV and V........................................ 59 EN 4 EN 1. INTRODUCTION 1.1. Background Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December
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