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内容提示: Guidance on the compilation of safety data sheets Version 1.1 – December 2011 Guidance on the compilation of safety data sheets Version 1.1 December 2011 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and tha...

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Guidance on the compilation of safety data sheets Version 1.1 – December 2011 Guidance on the compilation of safety data sheets Version 1.1 December 2011 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 LEGAL NOTICE This document contains guidance on REACH explaining the REACH obligations and how to fulfil them. However, users are reminded that the text of the REACH regulation is the only authentic legal reference and that the information in this document does not constitute legal advice. The European Chemicals Agency does not accept any liability with regard to the contents of this document. Guidance on the compilation of safety data sheets Reference: ECHA-2011-G-08.1-EN Publ.date: December 2011 Language: EN © European Chemicals Agency, 2011. Cover page © European Chemicals Agency Reproduction is authorised provided the source is fully acknowledged in the form “Source: European Chemicals Agency, http://echa.europa.eu/”, and provided written notification is given to the ECHA Communication Unit (publications@echa.europa.eu). If you have questions or comments in relation to this document please send them (indicating the document reference, issue date, chapter and/or page of the document which your comment refers to) using the Guidance feedback form. The feedback form can be accessed via the ECHA Guidance website or directly via the following link: http://comments.echa.europa.eu/Comments/FeedbackGuidance.aspx European Chemicals Agency Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland Guidance on the compilation of safety data sheets Version 1.1 – December 2011 Document History Version Comment Date Version 1.0 First edition September 2011 Version 1.1 Corrigendum covering the following: (1) Footnote 25 on page 24 has been corrected by expanding it to include a full listing of hazard classes or categories under (b), (c), (d) as well as those under (a) already given. (2) In the discussion of M-factors for mixture components under 3.2 on page 51 a reference to preference for listing in 2.1 (which applies for substances) has been corrected to clarify that for mixtures M-factors for components should be indicated together with their classification information under 3.2. December 2011 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 TABLE OF CONTENTS CHAPTER 1: GENERAL INTRODUCTION ...................................................................... 1 1.1. The Safety Data Sheet............................................................................................ 1 1.2. Aim of this guidance................................................................................................ 2 1.3. Target audience of this guidance ............................................................................ 2 1.4. Relation with CLP and GHS.................................................................................... 3 CHAPTER 2: WHAT IS NEW WITH RESPECT TO SDSS IN REACH AND CLP............ 4 CHAPTER 3: ISSUES TO CONSIDER WHEN COMPILING AN SDS ........................... 11 3.1. Definition of a Safety Data Sheet (an SDS) .......................................................... 11 3.2. Responsibility for the content of an SDS............................................................... 12 3.3. Claiming an SDS as confidential........................................................................... 12 3.4. Possibility of charging for supply of an SDS.......................................................... 12 3.5. Who should compile an SDS................................................................................. 12 3.5.1. Definition of a competent person.....................................................................12 3.5.2. Training and continued education of competent persons ................................12 3.6. The sequence, naming and numbering of sections and sub-sections which must be used in an SDS ............................................................................................................ 15 3.7. Necessary degree of completeness when providing information in an SDS......... 16 3.8. Need to update SDSs............................................................................................ 16 3.9. Need to communicate changes in the SDS........................................................... 16 3.10. Potential need to keep records of SDSs and their amendments........................... 17 3.11. Example of sequence for collecting and collating information for compiling the SDS 17 3.12. How to help to ensure consistency and completeness of the SDS....................... 19 3.13. Ways in which, and by when, the SDS must be provided ..................................... 19 3.14. Language(s) in which the SDS must be provided ................................................. 19 3.15. Substances and mixtures for which an SDS must be provided without prior request .............................................................................................................................. 20 3.16. Certain mixtures for which an SDS must be provided on request......................... 20 3.17. Labelling required for a mixture not classified as hazardous and not intended for the general public for which an SDS must be available and supplied on request............. 21 3.18. SDSs for hazardous substances and mixtures made available to the general public .............................................................................................................................. 21 3.19. Access to information in the SDS by workers ....................................................... 22 3.20. Products for which an SDS is not required............................................................ 22 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 3.21. Possible compilation of an SDS for substances and mixtures even when not legally required............................................................................................................................. 23 3.22. When attachment of Exposure Scenarios to the SDS is required......................... 23 3.23. Alternative ways to incorporate the Exposure Scenario information into the SDS for a mixture ........................................................................................................................... 24 3.24. Forms of assistance available in the compilation of SDSs.................................... 26 3.25. Selected sources of substance data useful for the compilation of SDSs .............. 26 3.26. How to compile an SDS for a recovered substance or mixtures containing such a substance.......................................................................................................................... 28 3.27. Testing for the purposes of generation of information for an SDS ........................ 28 CHAPTER 4: DETAILED INFORMATION, SECTION BY SECTION ............................. 29 4.1. SDS SECTION 1: Identification of the substance/mixture and of the company/undertaking........................................................................................................ 29 4.2. SDS SECTION 2: Hazards identification............................................................... 36 4.3. SDS SECTION 3: Composition/information on ingredients................................... 45 4.4. SDS SECTION 4: First aid measures ................................................................... 54 4.5. SDS SECTION 5: Firefighting measures .............................................................. 55 4.6. SDS SECTION 6: Accidental release measures................................................... 56 4.7. SDS SECTION 7: Handling and storage............................................................... 60 4.8. SDS SECTION 8: Exposure controls/personal protection..................................... 63 4.9. SDS SECTION 9: Physical and chemical properties ............................................ 74 4.10. SDS SECTION 10: Stability and Reactivity........................................................... 78 4.11. SDS SECTION 11: Toxicological information ....................................................... 83 4.12. SDS SECTION 12: Ecological information............................................................ 90 4.13. SDS SECTION 13: Disposal considerations......................................................... 94 4.14. SDS SECTION 14 Transport Information.............................................................. 96 4.15. SDS SECTION 15: Regulatory information........................................................... 99 4.16. SDS SECTION 16: Other information ................................................................. 102 TABLES Table 1: Overview of new requirements for SDSs.............................................................5 Table 2: Consistency check between Exposure Scenario and SDS sections...........107 FIGURES Figure 1: Example sequence for compiling an SDS........................................................18 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 APPENDICES APPENDIX 1: Timetable for the application of CLP labelling and corresponding requirements for SDSs in amended versions of Annex II of REACH .........................105 APPENDIX 2: SDS (sub-)sections consistency check with Exposure Scenario sections.................................................................................................................................107 APPENDIX 3: SDS for Special Mixtures .........................................................................109 APPENDIX 4: Specific issues relevant to the compilation of SDSs for recovered substances and mixtures. .................................................................................................112 APPENDIX 5: Glossary / List of acronyms .....................................................................116 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 Guidance on the compilation of safety data sheets Version 1.1 – December 2011 1 CHAPTER 1: GENERAL INTRODUCTION 1.1. The Safety Data Sheet Safety data sheets (SDSs) have been a well-accepted and effective method for the provision of information to recipients of substances and mixtures in the EU. They have been made an integral part of the system of Regulation (EC) No 1907/2006 (REACH)1. The original requirements of REACH for SDSs have been further adapted to take into account the rules for safety data sheets of the Global Harmonised System (GHS)2 and the implementation of other elements of the GHS into EU legislation that were introduced by Regulation (EC) No 1272/2008 (CLP)3 via an update to Annex II of REACH4 (henceforth referred to as ”Revision of Annex II”). The SDS provides a mechanism for transmitting appropriate safety information on substances and mixtures where:  a substance (and from 1 June 2015 a mixture) meets the criteria for classification as hazardous according to CLP;  a mixture meets the criteria for classification as dangerous according to the Dangerous Preparations Directive 1999/45/EC (DPD) (until 1 June 2015) or;  a substance is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), according to the criteria given in Annex XIII of REACH, or;  a substance is included in the candidate list for eventual authorisation according to Article 59 (1) of REACH for any other reasons. (See Article 31(1) of REACH). Under certain conditions some mixtures which do not meet the criteria for classification as dangerous according to the DPD or as hazardous according to CLP also require an SDS (See Article 31(3) of REACH as amended by CLP). SDSs do not have to be provided for articles. Although the SDS format may, for a few specific articles, be used to convey safety information down the supply chain, it is not adapted to most articles5. 1 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, corrected version in OJ L136, 29.5.2007, p.3). 2 Third revised edition accessible at: http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html 3 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p.1). 4 Commission Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (O.J. L133 31.05.2010, p1-43) 5 Although according to Article 4(8) and Section 2.1 of Annex I of CLP certain objects described in CLP using the word “article” (specifically in the combinations “explosive articles”, “pyrotechnic article” or “substances, mixtures and articles … … which are manufactured with a view to producing a practical, explosive or pyrotechnic effect” as defined via point 2.1.1.1 (b) or (c) and 2.1.1.2 of Annex I to CLP) should be classified and labelled according to CLP, the usage of the word “article” in this combined context differs from the stand-alone definition of an Guidance on the compilation of safety data sheets Version 1.1 – December 2011 2 The SDS follows a 16 section format which is internationally agreed. The SDS must be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise (Article 31(5) of REACH). Where a Chemical Safety Report (CSR) is required to be prepared for a substance, the information in the SDS for the substance must be consistent with that provided in the CSR as well as with that provided in the registration dossier. In addition, according to Article 31(7) of REACH, registrants and downstream users that are required to prepare a CSR, must place the relevant exposure scenario(s) (ESs)6 into an annex to the Safety Data Sheet. Downstream users have to consider relevant exposure information received from suppliers when compiling their safety data sheets. For mixtures there are several options for placing relevant ESs into an annex or for including relevant exposure information in the core Sections 1 – 16 of the SDS. If however, a Downstream User is required to prepare his own CSR under Article 37 of REACH and this results in the generation of an ES, this ES must be placed in an annex to the SDS. 1.2. Aim of this guidance The aim of this guidance is to assist industry in determining which tasks and requirements have to be complied with in order to fulfil their obligations under Article 31 of REACH (Requirements for safety data sheets) and Annex II of REACH, particularly as amended by Commission Regulation (EU) No. 453/2010. The amended Annex II requires alignment of the SDS with the applicable requirements arising from implementation of the changes in classification and labelling of substances and mixtures according to the CLP Regulation from 1 December 2010 and 1 June 2015 respectively. This guidance provides information especially on:  what is new in SDSs according to REACH by comparison with the previous legislation;  issues to consider when compiling an SDS;  details of the requirements for information to be included in each Section of an SDS, and in particular details of what changes in requirements arise from the revisions of Annex II of REACH (as amended by Commission Regulation 453/2010) which came into force on 1 December 2010 and will come into force on 1 June 2015 (see Appendix 1 for further details);  the timetables for implementation of Annex II and its amended Annexes;  who should compile the SDS and what competences the author should have. 1.3. Target audience of this guidance The main target audience of this guidance is those compiling SDSs for use by suppliers of substances and mixtures for which SDSs are required by Article 31 of REACH. While the REACH requirements regarding SDSs are directed at suppliers of substances and mixtures, this document also provides useful information for recipients of an SDS. It is noted in this context that the information provided by Safety Data Sheets will also help employers to meet “article” both under REACH (Article 3 (3)) and under CLP (Article 2 (9)). For the purposes of REACH they are more likely to be considered as a combination of an article (the container/packaging) and a substance/mixture (see ECHA guidance on requirements for substances in articles). If appropriate, in such cases the SDS would be supplied for the corresponding substance/mixture. 6 Note that in the specific case of the acronym “ES” (or “ESs”) it has only been used in this document where there are multiple occurrences of “exposure scenario” in the same paragraph or heading which make it clear that this is the subject matter – otherwise searching for the two-letter character string “es” in English makes location of all references to exposure scenarios in the document difficult. Guidance on the compilation of safety data sheets Version 1.1 – December 2011 3 their obligations under Directive 98/24/EC7 on the protection of the health and safety of workers from the risks related to chemical agents at work. The SDS should enable users to take the necessary measures relating to protection of human health and safety at the workplace, and protection of the environment. 1.4. Relation with CLP and GHS Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) harmonises the provisions and criteria for the classification and labelling of substances and mixtures within the Community, taking into account the classification criteria and labelling rules of the UN Globally Harmonised System of Classification and Labelling of Chemicals (GHS). The CLP Regulation contributes to the UN GHS aim of describing and communicating the same hazards in the same way around the world. The CLP Regulation entered into force on the 20th of January 2009. In the EEA, the required SDS format and content are defined by Article 31 and Annex II of REACH. These have been adapted to align them with the GHS requirements, in particular with the “guidance on the preparation of safety data sheets (sds)” given in Annex 4 of the GHS8 as well as to be fully in line with the CLP Regulation. This version of the guidance on the compilation of SDSs reflects text of the revision of Annex II of REACH as published on 31 May 2010. 7 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L131, 5..5.1998, p.11). 8 See: http://live.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html Guidance on the compilation of safety data sheets Version 1.1 – December 2011 4 CHAPTER 2: WHAT IS NEW WITH RESPECT TO SDSS IN REACH AND CLP The REACH Annex II requirements for safety data sheets retain, to a large extent, the traditional structure and format of previous legislation. However, REACH has introduced some important changes to the information required in a safety data sheet. Below there is a summary (by section) of what is new for the ‘REACH SDSs’ by comparison with the pre-REACH (and pre-CLP) legislation on SDSs in the EU. Table 1 below provides an overview of the main changes to the different sections for substances / mixtures including new sub-headings. Please note that sections of the SDS for which there are no changes from the previous legislation according to REACH are not covered in this chapter. Also note that only new (or changed) requirements are given in the table – thus, for example, although the original Annex II in REACH requires a name (“The term used for identification shall be identical to that provided on the label as set out in Annex VI to Directive 67/548/EEC) to be given in section 1.1 this is not mentioned in the table below as it was also a requirement of the previous legislation (i.e. Directive 91/155/EEC (SDS Directive) 9) However, where there is an additional requirement or change arising from the Revision of Annex II, this is indicated with detail of the appropriate version of the revision e.g. “Revised Annex II from 1 December 2010” or “Revised Annex II from 1 June 2015” Thus, the new requirements for product identifiers in accordance with Article 18(2) of CLP to be given in Section 1.1 which arise from the Revised Annex II are indicated as such. Please see Chapter 4 for more detailed consideration of the sections and sub-sections in an SDS according to REACH. Table 1 below should not be considered as covering all relevant changes – it is aimed at giving an introductory overview of issues to be considered, and in particular is not a detailed analysis of all changes from previous legislation10. Please note that where specific data are not used, or where data are not available, this must be clearly stated in the corresponding sub-section of the SDS. The reasons given for a lack of information should of course be valid ones. 9 Directive 91/155/EEC defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC, O.J. L 76, 22.03.1991 p. 35 10 Nevertheless, since there had been no formal requirement for guidance at EU level on the compilation of SDSs according to Annex II of REACH, Chapter 2 of the present document compares the changes in requirements for SDSs for all versions of Annex II under REACH with those of the previous legislation, including changes that were already requirements as of 1 June 2007. This is in contrast to Chapter 4 of the present document, which refers only the two new versions of Annex II requirements that will be in force from 1 December 2010 to 1 June 2015 and from 1 June 2015 onwards respectively. Guidance on the compilation of safety data sheets Version 1.1 – December 2011 5 Table 1: Overview of new requirements for SDSs SDS section or sub-section title New requirements for SDSs for substances New requirements for SDSs for mixtures 1.1. Product identifier From 1 December 2010 the product identifier must be provided in accordance with Article 18(2) of Regulation (EC) 1272/2008 (CLP). Details are given in Chapter 4.1 of this document. The inclusion of the EC number is optional. The registration numbers of substances subject to registration must be mentioned by the suppliers once the substances are registered. The part of the registration number referring to the individual registrant of a joint submission (the last four digits of the original full registration number) can be omitted by distributors and downstream users under specific conditions (See Chapter 4.1 and 4.3 of this document). Until 1 June 2015 in the case of a mixture, the trade name or designation must be provided in accordance with Article 10(2.1) of Directive 1999/45/EC (DPD), (unless CLP classification and labelling of the mixture is implemented early). From 1 June 2015 the product identifier for a mixture must be provided in accordance with Article 18(3)a of Regulation (EC) 1272/2008 (CLP) 1.2. Relevant identified uses of the substance or mixture, and uses advised against Suppliers must indicate the relevant identified use(s)11 of a substance using a brief (understandable) description of what the substance is intended to do. Uses advised against and reasons why must be given if applicable. The intention is not to list all the combinations of use descriptors12, but rather to have a general description of uses. This information must be consistent with the identified uses and exposure scenarios (ESs) set out in the annex to the SDS (where one is required). A reference to the annexed ESs can be included here. Suppliers must indicate the relevant identified use(s) of a mixture using a brief (understandable) description of what the mixture is intended to do. Uses advised against and reasons why must be given if applicable. This information must be consistent with the identified uses and exposure scenarios (ESs) set out in any annex(es) to the SDS (where they are required). A reference to the annexed ES (or alternative documents consolidating exposure scenario information from components) can be included here. 1.3 Details of the supplier of the safety data sheet - For registrants, the information must be consistent with the information on the identity of the manufacturer or importer or Only Representative provided in the registration dossier. - e-mail address of the competent person responsible for the SDS should be provided. It is recommended to use a generic e-mail address - e-mail address of the competent person responsible for the SDS should be provided. It is recommended to use a generic e-mail address SECTION 2: Hazards Classification: Classification: 11 ”Identified use” is defined in REACH, Article 3, point 26. 12 See “Guidance on information requirements and chemical safety assessment Chapter R.12: Use descriptor system accessible via: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm Guidance on the compilation of safety data sheets Version 1.1 – December 2011 6 SDS section or sub-section title New requirements for SDSs for substances New requirements for SDSs for mixtures identification From 1 December 2010 until 1 June 2015, the classification of a substance according to both the CLP Regulation and Dangerous Substances Directive (DSD) must be given. After June 1st, 2015, only classification according to CLP is required. See Appendix 1 on transitional periods for more information. Label elements information must be included here (new sub-heading; previously it was given in Section 15). From 1 December 2010 this must be that according to CLP. The symbol/pictogram(s) must be represented graphically. If the substance is subject to authorisation, the authorisation number must be included here. Information on whether the substance meets the criteria for PBT or vPvB in accordance with Annex XIII must be provided. Until 1 June 2015, the classification of the mixture according to the DPD must be given. Where a mixture has been classified and labelled in accordance with CLP before this date the CLP classification must also be included in this section. After June 1st, 2015, only classification according to CLP is required . Label elements information must be included here (new sub-heading; previously it was given in Section 15), From 1 June 2015 this must be that according to CLP. The symbol/pictogram(s) must be represented graphically. If any component substance(s) in the mixture is/are subject to authorisation, the authorisation number(s) must be included here13. Information on whether the mixture meets the criteria for PBT or vPvB in accordance with Annex XIII must be provided14. SECTION 3: Composition / information on ingredients The chemical identity of the main constituents and any impurity, stabilising additive or individual constituent which is itself classified and contributes to the classification of the substance must be provided The criteria for determining (on the basis of cut-off values / concentration limits) which component substances in a mixture must be indicated together with their concentration (range) in this section are expanded from 1 December 2010 to include health or environmental hazards according to CLP as well as those according to 67/548/EEC. From 1 June 2015 only CLP criteria are applicable. In the case of mixtures, PBT/vPvB substances and substances included in the candidate list, have to be disclosed if present at 0.1% or above with registration number (if applicable) The registration numbers of at least a certain predefined group of component substances in the mixture must be mentioned by the suppliers. The part of the registration number referring to the individual registrant of a joint submission can be omitted from this 13 This is not required for substances subject to authorisation listed in Annex XIV of REACH if present in the mixture at a concentration below that indicated in Art. 56(6) of REACH 14 In practice, for mixtures, information on whether the mixture contains PBT or vPvB substances at a concentration of 0.1% or greater assessed in accordance with the criteria of Annex XIII Guidance on the compilation of safety data sheets Version 1.1 – December 2011 7 SDS section or sub-section title New requirements for SDSs for substances New requirements for SDSs for mixtures section by any supplier of a mixture fulfilling specific conditions (See Chapter 4.3 for details). The classification(s) and the information on PBT and vPvB must also be mentioned. SECTION 7: Handling and storage Where a chemical safety report is required, the information in this section must be consistent with the information given for the identified uses in the chemical safety report and, where applicable, the exposure scenarios annexed to the safety data sheet. If available, a reference to industry or sector specific guidance designed for specific uses may be mentioned. If an ES is attached, reference may be made to it. For substances designed for specific end use(s), detailed and operational recommendations relating to the identified use(s) referred to in subsection 1.2 must be made. The SDS may include cross-references to an Exposure Scenario for the mixture where applicable. If available, a reference to industry or sector specific guidance designed for specific uses may be made where applicable. If an ES is attached, reference may be made to it. For mixtures designed for specific end use(s), detailed and operational recommendations relating to the identified use(s) referred to in subsection 1.2 must be made. SECTION 8: Exposure controls/ personal protection List applicable DNELs, OELs, and PNEC: Substance specific information (the DNELs for human health hazards and the PNECs for hazards to the environment) need to be given under the appropriate sub-section in this section. This information (other than OEL values) will mainly be available for registered substances which have been subjected to a Chemical Safety Assessment. Where a chemical safety report is required, the risk management measures for the identified uses must be consistent with the information in this section. The risk management measures given in the sub-sections of this section and any annexed exposure scenario(s) must be consistent. 8.1. Control parameters Where a control banding approach is used to decide on risk management measures in relation to specific uses, sufficient detail must be given to enable effective management of the risk. The context and limitations of the specific control banding recommendation must be made clear. (See Chapter 4.8 for more information on the control banding approach) Where a control banding approach is used to decide on risk management measures in relation to specific uses, sufficient detail must be given to enable effective management of the risk. The context ...

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