GUIDELINES FOR THE PREPARATION OF SAFETY DATA SHEETS EIGA 919/14 Revision of EIGA 919/13 EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL AVENUE DES ARTS 3-5 • B – 1210 BRUSSELS Tel: +32 2 217 70 98 • Fax: +32 2 219 85 14 E-mail: [email protected] • Internet: www.eiga.eu EIGA 919/14 GUIDELINES FOR THE PREPARATION OF SAFETY DATA SHEETS PREPARED BY : Joachim Barbe Messer Group Ewoud Beheydt Praxair Gianluigi Colombo Sapio Produzione Idrogeno Ossigeno Joachim Eiselt Air Liquide Natalie Kingswood The Linde Group Zbigniew Sokolowski Air Products Ben Valk The Linde Group Pierre Wolfs EIGA Disclaimer All technical publications of EIGA or under EIGA's name, including Codes of practice, Safety procedures and any other technical information contained in such publications were obtained from sources believed to be reliable and are based on technical information and experience currently available from members of EIGA and others at the date of their issuance. 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EIGA 2014 - EIGA grants permission to reproduce this publication provided the Association is acknowledged as the source EUROPEAN INDUSTRIAL GASES ASSOCIATION AISBL Avenue des Arts 3-5 B 1210 Brussels Tel +32 2 217 70 98 Fax +32 2 219 85 14 E-mail: [email protected] Internet: www.eiga.eu SAC EIGA 919/14 Table of Contents 1 Introduction ......................................................................................................................... 1 1.1 Scope and purpose ............................................................................................................. 1 1.1.1 Scope....................................................................................................................... 1 1.1.2 Purpose ................................................................................................................... 1 1.2 Legal background of the document ..................................................................................... 1 1.3 Responsibilities and traceability .......................................................................................... 2 1.3.1 Responsibilities (art.31) ........................................................................................... 2 1.3.2 Traceability (art.36) .................................................................................................. 3 1.4 Transitional periods ............................................................................................................. 3 2 Preparation of an extSDS ................................................................................................... 4 2.1 General requirements ......................................................................................................... 4 2.1.1 When is an extSDS needed? .................................................................................. 4 2.1.2 Distribution of extSDS ............................................................................................. 5 2.1.3 Generation of a SDS ............................................................................................... 5 2.2 Exposure Scenarios ............................................................................................................ 6 2.2.1 General .................................................................................................................... 6 2.2.2 Exposure scenarios for gas mixtures ...................................................................... 6 3 LISAM.................................................................................................................................. 7 3.1 Introduction ......................................................................................................................... 7 3.2 Maintenance of the LISAM tool ........................................................................................... 7 3.3 Use of the LISAM tool ......................................................................................................... 8 3.4 Example of a Safety Data Sheet ......................................................................................... 8 4 Glossary .............................................................................................................................. 9 5 References ........................................................................................................................ 10 6 List of Annexes .................................................................................................................. 10 6.1 Annex 1: List of “gases” .................................................................................................... 11 6.2 Annex 2: Detailed content of a SDS for gases ................................................................. 16 6.3 Annex 3: Example of a SDS generated with the LISAM tool ............................................ 40 SAC EIGA 919/14 1 Introduction This document outlines the recommendations of EIGA to supply Safety Data Sheets (SDS) for gases and gas mixtures in accordance with the requirements of the EC Regulation 1907/2006 (REACH Regulation), in particular its Art 31 and its Annex II. The recommendations of EIGA on the supply of SDS were summarised previously in EIGA document 906 (the old Labelling/SDS Guide according to DSD/DPD) and in EIGA document 918 (the New Labelling/SDS Guide according to CLP) . With the new extensive requirements of REACH on “extended Safety Data Sheet (extSDS)”, it became necessary to develop a more comprehensive set of guidelines on SDS, separate from the requirements on Classification and Labelling linked to the CLP, presently in EIGA Doc.169. Both documents are nevertheless still closely connected because the content of an SDS is partially driven by the CLP classification of the substance or the mixture. This revision of the 2013 version covers the new phrases added to the EIGA library (see Annex 2). 1.1 Scope and purpose 1.1.1 Scope The document gives guidance for the issue of SDS for gases and gas mixtures that meet all of the following criteria: a) the products are defined as “gases” according to the CLP Regulation b) they are all allowed to be put on the market in the EU i.e. they have an EINECS number or they have been pre-registered in accordance with the REACH Regulation, c) they are marketed by most EIGA members. The list of “gases” considered by EIGA with their identification numbers and status according to the REACH Regulation can be found in Annex 1. 1.1.2 Purpose The new concept of extended Safety Data Sheet (extSDS) introduces new and extensive requirements on the content of a SDS. The content of the extSDS and in particular of the Exposure Scenario(s) (ESs) to be annexed are linked to the Chemical Safety Reports that may be required in the registration dossiers of the gases under REACH, starting from the end of 2010. This document aims at: 1. Defining how to complete the new structure of the extSDS 2. Defining the new library of “safety phrases” that is necessary for the completion of the new extSDS. 3. Developing a systematic approach for the selection or the generation of the appropriate ESs to be appended to the SDSs for pure gases and for gas mixtures. 4. Explaining how the recommendations of EIGA have been implemented in the LISAM SDS authoring tool supported by EIGA. 1.2 Legal background of the document The requirements on SDS are outlined in Art. 31 and in Annex II of REACH. Annex II has been revised with Regulation (EC) N° 453/2010 (OJ 133 of 31/05/2010) in order to align the structure of the SDS with the structure recommended in Annex IV of the UN-GHS (the Purple Book). Part of the content of the SDS is driven by the classification of the substance or mixture according to the provisions of the CLP Regulation 1272/2008 that are outlined in EIGA Doc. 169. The links between this document and the regulations are illustrated below. 1 SAC EIGA 919/14 UN Committee of Experts on TDG and GHS UN Sub-Committee UN Sub-Committee of Experts on GHS of Experts on TDG GHS RTDG “Purple Book” “Orange Book” WP15 of UN-ECE ADR REACH Regulation CLP Regulation Directive on the TDG (EC) No 1907/2006 (EC) No 1272/2008 2008/68/EC SDS Cl. & Lab. Cl. &Lab. for Tpt. for supply and use Doc. 919 The SDS Guide Doc. 169 (this document) The Cl. & Lab. Guide 1.3 Responsibilities and traceability 1.3.1 Responsibilities (art.31) As actors in the supply chain, EIGA Members may have different roles (manufacturer, importer, retailer, formulator, etc.) as defined in REACH and illustrated in the figure below Possible roles of EIGA members in the supply chain EU Manufacturer EIGA EU Manufacturer Non-EU Manufacturer SDS+ES (Only Rep.) SDS+ES EIGA EU Importer SDS+ES SDS+ES EIGA Downstream User: -Transfilling gases=