SAMANTHA WRIGHT, RICHARD ELSMORE
JSC International limited, Simpson House, Windsor Court, Clarence Drive Harrogate, HG1 2PE, United Kingdom

Abstract

Authorisation and ‘substances of very high concern (SVHC) are new concepts introduced by REACH, which signify extra responsibilities and obligations if you manufacture, import or supply any of these listed substances, or articles containing these substances. This paper examines the definitions and requirements for compliance with SVHC, restriction and the new authorisation procedures, with some important considerations when planning to submit an authorisation to ECHA.

INTRODUCTION

The period up to the end of 2010 was very busy, with all phase-in substances manufactured or imported into the EU at 1000 tonnes per year or greater and other more hazardous, low tonnage substances requiring registration. Although you may give a huge sigh of relief that the first deadline is completed, it’s not over yet as submitted dossiers need to be kept up-to-date with new information. ECHA is also contacting registrants as they review dossiers, testing proposals and confidentiality claims. In addition, REACH has introduced other areas of responsibility relating to SVHC; restriction and authorisation.

SUBSTANCES OF VERY HIGH CONCERN
All actors in the supply chain are required to understand and implement the obligations encompassing SVHC. A SVHC has hazardous properties in respect of human health and/or the environment as follows (1):

1. Carcinogenic, Mutagenic or Reprotoxic (CMR) category 1A or 1B;
2. Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) meeting the criteria of Annex XIII (of the REACH Regulation);
3. Substances such ...
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