Guidance on registration - ECHA - Europa

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114 <strong>Guidance</strong> on registration Version 2.0 May 2012 Appendix 1. Acronyms C&L CBI Chesar CMR CSA CSR CWG DNELs DU ECHA EEA EFTA EINECS ELINCS ES EU GHS GLP IP IPCS ITS IUCLID IUPAC NGO NLP OC OECD HPV OECD SIDS OECD SIDS SIAR PA PBT PNECs PPORD QSARs REACH RIPs RMM SDS SIEF SME SVHC UVCB substance vPvB Classification and Labelling Confidential Business Information Chemical Safety Assessment and Reporting tool Carcinogenic, Mutagenic and Reprotoxic substance Chemical Safety Assessment Chemical Safety Report Commission Working Group Derived No Effect Levels Downstream User European Chemicals Agency European Economic Area European Free Trade Agreement European Inventory of Existing Commercial Chemical Substances European List of Notified Chemical Substances Exposure Scenario European Union Globally Harmonised System for classification and labelling Good Laboratory Practice Intellectual Property International Programme on Chemical Safety Integrated Testing Strategies International Uniform Chemical Information Database International Union of Pure and Applied Chemistry Non-Governmental Organisation No-Longer Polymer Operational Conditions Organisation for Economic Co-operation and Development High Production Volume OECD Screening Information Data Set OECD SIDS Initial Assessment Report Publicly Available Persistent, Bioaccumulative, Toxic substances Predicted No Effect Concentrations Product and Process Orientated Research and Development Quantitative structure-activity relationships Registration, Evaluation, Authorisation and Restriction of Chemicals REACH Implementation Projects Risk Management Measures Safety Data Sheet Substance Information Exchange Forum Small and Medium Sized Enterprise Substances of Very High Concern substances of Unknown or Variable Composition, Complex reaction products or Biological materials vPvB - very Persistent and very Bioaccumulative substances Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
<strong>Guidance</strong> on registration Version 2.0 May 2012 115 Appendix 2. Roles and duties of the main actors of REACH This appendix provides an overview of the main responsibilities defined by REACH or derived from REACH in the context of the registration, evaluation, authorisation and restriction processes. It should be noted that it is not an exhaustive list and should only be used for reference purposes. The reader is advised to consult the related guidance document if in need of detailed information on a specific process. I. Industry (1) Manufacturers and importers of substances in quantities of less than 1 tonne per year need to: Prepare and supply safety data sheets (SDS) for substances and mixtures as required by Article 31 and Annex II to downstream users and distributors. Prepare and supply information on substances that do not require an SDS as defined by Article 32 to direct customers. Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII. Apply for authorisation for use(s) of substances listed in Annex XIV. In the case of having relevant data, decide whether to act as data holder in Substance Information Exchange Fora (SIEF). (2) Manufacturers of substances in quantities of 1 tonne or more per year need to: Pre-register their substances with ECHA if they wish to secure their substances’ phasein status In case their substance is a non phase-in substance, send an inquiry to ECHA as to whether a registration has already been submitted for the same substance. Collect and share existing, and generate and propose to generate new, information on properties and use conditions of substances. Prepare a technical dossier (note that special provisions apply for intermediates). Prepare CSA and CSR (for each substance ≥ 10 tonnes per year per manufacturer). Prepare CSA and CSR including exposure scenarios and risk characterisation (for each substance ≥ 10 tonnes per year per manufacturer, which fulfils the criteria for any of the hazard classes or categories set out in Article 14(4) or is assessed to be a PBT or vPvB). Implement appropriate Risk Management Measures (RMM) for own manufacture and use. Submit registration for substances (≥ 1 tonne per year per manufacturer) unless an exemption applies. Keep the information submitted in the registration up to date and submit updates to ECHA. Prepare and supply safety data sheets (SDSs) for substances and mixtures as required by Article 31 and Annex II to downstream users and distributors. Recommend appropriate RMMs in the SDS. Communicate ESs developed in CSA as annex(es) to the SDS (≥ 10 tonnes per year per manufacturer). Annankatu 18, P.O. Box 400, FI-00121 Helsinki, Finland | Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu
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