Safety Data Sheets (SDSs), according to Annex II of REACH and its revisions

Transcription

1 Safety Data Sheets (SDSs), according to Annex II of REACH and its revisions Peter Megaw Guidance Team, ECHA UEIL Conference, Vienna, October 22, of 14

2 What this presentation covers 1. History - SDSs in the European Community 2. Effect of revision of Annex II of REACH on SDS requirements 3. Understanding the changes from the point of view of the drivers for change 4. Consequences - correspondence with CLP (i) for substances, (ii) for mixtures. 5. Transition periods in practice - when you actually need to make changes due to the revision 6. (Other reasons for revision and retrospective re-issue - Article 31(9)) 7. Particular issues for the re-cycling industry (i) registration number and (ii) exposure scenarios 8. ECHA work on-going on guidance on compilation of SDSs 2 of 14

3 1. History - SDSs in the European Community Safety data sheets (SDSs) for substances and preparations were already required under previous legislation (Dangerous substances directive, dangerous preparations directive, SDS directive). Notably Directive 91/155 and its amendment by 93/112/EEC gave the 16 headings under which information was to be provided and a Guide to the compilation of the SDS. The SDS directive has already been repealed and replaced by the requirements of Article 31 and Annex II of REACH since 1 June The most fundamental change in REACH requirements for SDS is the provision of Exposure Scenarios as an Annex where required the concept of an extended Safety Data Sheet. The CLP Regulation has also come into force in the meantime Article 57 of CLP refers to and amends Article 31 of REACH concerning SDSs. An amendment to REACH, (Commission Regulation (EU) 453/2010 of 20 May 2010) specifically addressing changes in the requirements for SDSs, came into force on 20 June 2010 and makes changes to the requirements for SDSs as of 1 December In particular, the regulation changes the text of Annex II from a guide to the compilation of safety data sheets to requirements for the compilation of safety data sheets i.e. it is much more prescriptive. 3 of 14

4 2. Effect of revision of Annex II of REACH on SDS requirements The structure of 453/2010 looks complex. In effect it means that there are three versions of Annex II (called X, Y, Z below) to be considered during the respective transition periods: up to 30 November 2010, between 1 December 2010 and 31 May 2015, and from 1 June 2015: X: Original text of Annex II as published with the REACH regulation in 2006 ANNEX II GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS. This text was in force between 1 June 2007 and 19 June 2010 (but changes to it arising from coming into force of Regulation 453/2010 on 20 June 2010 only concern voluntary options to implement CLP elements early no new obligatory requirements apply before 1 December 2010). Y: Annex I to Commission Regulation 453/20, version starting on page L133/4 ANNEX II REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS PART A New obligations from this text will be in force between 1 December 2010 and 31 May (Some voluntary options will already have been available from 20 June 2010) Z: Annex II to Commission Regulation 453/20, version starting on page L133/24 ANNEX II REQUIREMENTS FOR THE COMPILATION OF SAFETY DATA SHEETS PART A This text will be in force from 1 June (Some voluntary options will already have been available from 20 June 2010). 4 of 14

5 3. Understanding the changes from the point of view of the drivers for change: The EU has undertaken to implement the Globally Harmonised System (GHS). The elements of the GHS to be implemented in the EU are being implemented via the CLP Regulation. However, under EU legislation there were already existing provisions for SDSs under the REACH Regulation. Annex 4 of the GHS Guidance on the preparation of Safety Data Sheets (in combination with certain EU-specific needs), has therefore been used as the basis of the new Annex II of REACH rather than becoming part of CLP. Changes to the SDS, especially those involving reference to the classification and labelling of the substances and mixtures must be correlated with the timing of the changes in the actual classification and labelling of substances and mixtures under CLP. 5 of 14

6 4. Consequences (i) - correspondence with CLP for substances For substances: From 1 December CLP requires that substances be classified according to both CLP and the Dangerous Substances Directive (DSD) and labelled according (only) to CLP until 1 June (After June 2015 only CLP classification and labelling are required). From 1 December 2010 REACH (as amended by Regulation 453/2010) requires CLP classification of a substance to be given in the SDS of substances, (And until 31 May 2015 also the DSD classification to be quoted in Section 2.1 for those classifying mixtures ). Derogations until 1 December are allowed by both sets of regulations for substances already placed on the market ( on the shelf ) before 1 December 2010 and classified, labelled and packaged according to the DSD during transition periods: these substances need not be relabelled or repackaged according to CLP until 01 December 2012, and the Safety Data Sheets for these substance need not be replaced before the same date. 6 of 14

7 4. Consequences (ii) - correspondence with CLP for mixtures For mixtures: Until 1 June according to CLP - mixtures continue to be classified, labelled and packaged in accordance with the Dangerous Preparations Directive (DPD). From 1 June according to CLP, - they are required to be classified and labelled according to CLP. Until 1 June according to REACH - the requirement for information in the SDSs for mixtures are based on classification and labelling according to DPD (and the Dangerous Substances Directive [DSD]) only. From 1 June 2015 REACH requires information to be given in the SDSs on the CLP classification and labelling. Derogations until 1 June are allowed by both regulations for mixtures during transition periods: mixtures already placed on the market ( on the shelf ) before 1 June 2015, and classified, labelled and packaged according to the DPD need not be relabelled or repackaged according to CLP until 01 June (For mixtures only there is a further derogation allowing continued use of an SDS provided to any recipient before 1 December 2010 without having to comply with the new Annexes before 1 December of 14

8 5. Transition periods - summary Summary: For substances CLP information in SDS (as well as on labels) from 1 December 2010, with possible transition to 1 December For mixtures - CLP information in SDS (as well as on labels) from 1 June 2015, with possible transition to 1 June No transition for either substances or mixtures with respect to SDS if any of the conditions in Article 31 (9) of REACH apply requiring an update. Early implementation allowed under certain conditions for both substances and mixtures. The above transition periods apply to material already classified packaged and labelled before start of transition period and in the supply chain ( on the shelf ). More general transition applies to all mixtures which were already supplied to any recipient before 1 December 2010 until 1 December 2012 only. 8 of 14

9 6. Other reasons for revision: Article 31(9) of REACH: 9. Suppliers shall update the safety data sheet without delay on the following occasions: (a) as soon as new information which may affect the risk management measures, or new information on hazards becomes available; (b) once an authorisation has been granted or refused; (c) once a restriction has been imposed. The new, dated version of the information, identified as Revision: (date), shall be provided free of charge on paper or electronically to all former recipients to whom they have supplied the substance or mixture within the preceding 12 months. Any updates following registration shall include the registration number. 9 of 14

10 7. Particular issues for the re-cycling industry: (i) Registration number Registration numbers are assigned as a result of a Registration under REACH Title II Registration of Substances Article 2(7)d of REACH gives an exemption from registration requirements: 7. The following shall be exempted from Titles II, V and VI:. (d) substances, on their own, in mixtures or in articles, which have been registered in accordance with Title II and which are recovered in the Community if: (i) the substance that results from the recovery process is the same as the substance that has been registered in accordance with Title II; and (ii) the information required by Articles 31 or 32 relating to the substance that has been registered in accordance with Title II is available to the establishment undertaking the recovery. As a consequence, a recovery operator may produce an SDS which quotes no registration number. (He may wish to explain why this is so within the SDS) of 14

11 7. Particular issues for the re-cycling industry: (ii) Exposure Scenario Similarly, the requirement to carry out a Chemical Safety Assessment, complete a Chemical Safety Report and potentially to generate an Exposure Scenario for certain substances which arises in particular from Article 14(4) of REACH (which is also part of Title II), can be the subject of an exemption via Article 2(7)d. There is more information on these exemptions in the ECHA guidance on waste and recovered substances available at: of 14

12 8. ECHA work on-going on guidance on compilation of SDSs (i) ECHA guidance on SDSs was not foreseen by the original REACH text Annex II was itself originally a guide ECHA held a workshop in 2009 on possible need for guidance on specific aspects of SDSs ECHA became aware during the workshop of both plan by the Commission to revise Annex II and of plan by Cefic to generate its own guidance on SDSs It was agreed to use output of Cefic work as basis for an ECHA guidance on SDSs and to clarify some issues highlighted during the drafting of the revised Annex II. First draft guidance produced March 2010, but did not fully take into account new text of Annex II which had not been published until after development of the guidance of 14

13 8. ECHA work on-going on guidance on compilation of SDSs (ii) New draft should be on ECHA web site during Autumn 2010, final version Spring This will include almost the whole text of Annex II within it in a consolidated form, with the main aim of clarification of the requirements where needed/desirable. In view of the date of coming into force of the major requirements of the amended Annex II (1 December 2010 for substances) priority will be given to making an improved draft guidance available even before the publication of the final version. The latest drafts will be available at: of 14

14 Thanks for your attention 14 of 14