Guidance on REACH

Mar 14, 2016 - Preparation: A mixture or solution composed of two or more ..... structures (known as Quantitative / Qualitative Structure-Activity ...... REACH requires that substances are not only Registered, but they are only deployed for.
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REACH GUIDANCE DOCUMENT FOR THE OFFSHORE INDUSTRY Version Seventeen – March 2016

NOTE: TO USE THE ‘HYPERLINKS’ PROVIDED IN THIS DOCUMENT, YOU MIGHT NEED TO PRESS THE ‘CTRL’ KEY AND THEN CLICK ON THE ITEM OF INTEREST. ALL OF THE LINKS IN THIS DOCUMENT WERE FUNCTIONING AT THE TIME OF PUBLICATION. URN 10D / 691 © Crown Copyright

Contents Page(s) Introduction  Basic overview of REACH  Enforcement of REACH in the UK

4&5 6-8

Executive Summary

9 & 10

Definitions

11 - 16

Acronyms

17 & 18

CHAPTER ONE The Scope of REACH (A) Substances exempted from the EU REACH Regulation (B) Substances exempt from Registration (C) Substances regarded as Registered

19 19 & 20 20 & 21 21 - 23

CHAPTER TWO Principle elements of REACH

24

Pre-Registration Phase

24

Registration Phase  What is Registration?  The deadlines for Registration  When Registration is / is not needed  The Registration Process an Overview - Data Sharing (a) The Substance Information Exchange Forum (SIEF) (b) Article 26 Inquiry - The Registration Dossier (a) The Technical Dossier (b) Chemical Safety Report (CSR) - EOSCA Generic Exposure Scenario Tool  Other Duties of Registrants (a) Registrants duty of communication with - and provision of Safety Data Sheets to - Downstream Users (b) Provision of other information to Downstream Users  Downstream Users’ Obligations

24 24 & 25 25 & 26 26 26 26 & 27 27 & 28 28 28 28 - 30 30 & 31 31 31 31 & 32 32 & 33 33

Page 2 of 100

 Submitting a Registration

33

 Applicable fees

33

 Access to information and confidentiality

33 & 34

CHAPTER THREE Post-Registration aspects of REACH

35

Post-Registration – What happens next? (a) Assigning a submission number (b) Completeness check and invoicing procedures - Technical completeness check - Financial completeness check (c) Rejection of a Registration dossier (d) Acceptance of a Registration dossier

35 35 35 35 35 36 36

 Informing the relevant Member State Competent Authority

36

 Procedures in the case of a Registration update  Appeals process

36 & 37 37

Evaluation of Substances

37 & 38

Authorisation of Substances

38 & 39

Restriction of Substances

39

APPENDIXES (Appendix 5 contains embedded documents) Appendix 1 - Specific REACH issues pertaining to the offshore 40 - 47 sector Appendix 2 - REACH-related developments 48 - 59 Appendix 3 - Supplemental Commission Legislation on REACH 60 - 75 and other relevant EU regulatory measures on chemicals [Including proposed revisions and expected new measures] Appendix 4 - UK Regulations for the enforcement of REACH and 76 other EU regulatory measures on chemicals Appendix 5 - Guidance from the ECHA and Other Sources 77 - 98 Appendix 6 - OSPAR Recommendation 2010/3 (as amended by 99 Recommendation 2014/17) on a Harmonised Offshore Chemical Notification Format (HOCNF) and OSPAR Recommendation 2010/4 on a Harmonised Pre-Screening Scheme for Offshore Chemicals to align the OSPAR HMCS with the EU REACH Regulation Plus the revised OSPAR Guidelines (2012/05) [Updated 2015] for Completing the HOCNF

Page 3 of 100

Introduction Basic overview of REACH The REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) Regulation (EC) No. 1907/2006 entered into force on 1 June 2007. The Regulation can be accessed from: http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:32006R1907&from=en. Management of the EU REACH Regulation’s requirements at EU level will be handled by the European Chemicals Agency (ECHA). Day-to-day operation of REACH in each Member State is overseen by their Competent Authorities (see Section below on