Tatjana Humar-Jurič; M.Sc, Subsecretary Ministry of Health - Chemicals Office of the Republic of Slovenia

1. Compilation of Safety Data Sheets, according to the Regulation 453/2010/EC, amending relevant REACH Regulation provisionsTA Project: Chemical Safety in Croatia Workshop 16-17 June 2011 Tatjana Humar-Jurič; M.Sc, Subsecretary Ministry of Health - Chemicals Office of the Republic of Slovenia Semira Hajrlahović Meehić, LL.M.,  B.Sc.Chemicals Inspector Ministry of Health -Chemicals Office of Republic of Slovenia

2. Safety Data Sheet (SDS)? (Chemical Safety Report (CSR)) = Informing of users = Control of risk

3. Informing of users Chemical Safety Report (prof. upor.) Safety Data Sheet (SDS) (prof. users, distributors…) LABELS (all users) - - - - - - - - - - - - - - - - - - - - - - - - - → infor., tonage….

4. Legal base REACH Regulation Safety Data Sheet (SDS): • Art. 31 - Requirements for safety data sheet • Art. 32 - Duty to communicate information down the supply chain for substances on their own or in mixtures for which a SDS is not required • Annex II - Guide to the compilation of SDS

5. Additional sources forcompilation of SDS :- - Guidance (ECHA spletne strani:http://guidance.echa.europa.eu/) Offical version of Guidance on compilation of SDSwill be available till the end of this year! = only on CSR

6. Purposes of SDS SDS: • = A mechanism for transmitting appropriate safety informationon classified chemicals including information from therelevant CSR down the supply chain • Shall enable users to take the necessary measures relating toprotection of human health and safety at the workplace, and protection of theenvironment.

7. Providing of SDS (I) SDS: Shall be providedby the supplier: • For all classified (hazardous) chemicals which are putting on the market • For persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) chemicals • For SVHC substances (in Annex XIV of REACH) Shall ALSO be provided for NONHAZRDOUS mixture if contains: • at least ≥ 1 % (non gaseous mixtures) or ≥ 0,2 % (gaseous mixtures) of one or more substances which are HH or ENVH or PBT, vPVB, or • a substance for which there are EU Community workplace exposure limits.

8. Providing of SDS (II) SDS: • Need not be supplied if hazardous chemicals are offered or sold to the general public (sufficient information shall be provided to users), unless requested by a downstream user or distributor. • Shall be supplied in an official language of the Member State(s) where the chemical is placed on the market, unless the Member State(s) concerned provide otherwise.

9. Amendment of Annex II of REACH COMMISSION REGULATION (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the Europan Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH • From 1 Dec 2010 old Annex II is replaced by Annnex I of new Regulation 453/2010 • From 1 Jun 2015Annex I of Reg. 453/2010 will be replaced by Annnex II of this Regulation new SDS shall be prepared progressively

10. SDS: Regulatory references Art. 31 REACH content Annex II amended by Regulation (EU) 453/2010 Chemical Safety Report Art. 14 end Annex I Annex 1 Annex 2 1 December 2010 1 June 2015 Exposure scenario Annex 1 foreseen to manage the transitional period and the inclusion of information from both system (old and new) in the SDS

11. SDS: Timeline of changing SUB MIX ZMES SNOV SUB ZMES MIX SNOV SUB ZMES MIX … old format of SDS shall be accepted (unless the chemicals shall be relabelled and repackaged) … SDS complying with Annex I to Regulation (EU) 453/2010 shall be used … SDS complying with Annex II to Regulation (EU) 453/2010 shall be used … SDS for substances … SDS for mixtures SUB MIX

12. Content of the SDS in accordance with Reg. 453/2010 (1) SECTION 1: Identification of the substance/mixture and of th company/undertaking 1.1. Product identifier 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.3. Details of the supplier of the safety data sheet 1.4. Emergency telephone number SECTION 2: Hazards identification 2.1. Classification of the substance or mixture 2.2. Label elements 2.3. Other hazards SECTION 3: Composition/information on ingredients 3.1. Substances 3.2. Mixtures SECTION 4: First aid measures 4.1. Description of first aid measures 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures 5.1. Extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Advice for firefighters SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures 6.2. Environmental precautions 6.3. Methods and material for containment and cleaning up 6.4. Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) SECTION 8: Exposure controls/personal protection 8.1. Control parameters 8.2. Exposure controls

13. Content of the SDS in accordance with Reg. 453/2010 (2) SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties 9.2. Other informationEN L 133/22 Official Journal of the European Union 31.5.2010 SECTION 10: Stability and reactivity 10.1. Reactivity 10.2. Chemical stability 10.3. Possibility of hazardous reactions 10.4. Conditions to avoid 10.5. Incompatible materials 10.6. Hazardous decomposition products SECTION 11: Toxicological information 11.1. Information on toxicological effects SECTION 12: Ecological information 12.1. Toxicity 12.2. Persistence and degradability 12.3. Bioaccumulative potential 12.4. Mobility in soil 12.5. Results of PBT and vPvB assessment 12.6. Other adverse effects SECTION 13: Disposal considerations 13.1. Waste treatment methods SECTION 14: Transport information 14.1. UN number 14.2. UN proper shipping name 14.3. Transport hazard class(es) 14.4. Packing group 14.5. Environmental hazards 14.6. Special precautions for user 14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code SECTION 15: Regulatory information 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture 15.2. Chemical safety assessment SECTION 16: Other information

14. SECTION 2: Hazards identification 2.1. Classification of the substance or mixture • By SDS for substances:both ( old – regarding Dir. 67/548/EGSand new - regarding Reg.1272/2008 ) classification • By SDS for mixtures: only old ( regarding Dir.1999/45/ES) classification • If the classificationis not written out in full, reference shall be made to Section 16 2.2. Label elements • SDS for substances: In accordance with Reg.1272/2008 following elements shall be provided:hazard pictogram(s), signal word(s), hazard statement(s), precautionary statement(s), full hazard pictogram (may be in black and white) or a symbol only • SDS for mixtures: In accordance withDir. 1999/45/EC following elements shall be provided: symbol(s), indication(s) of danger, risk phrase(s) and safety advice. The symbol may be provided as a graphical reproduction of the symbol (may be in black and white). Also other elements which are should be on the label shall be provided. 2.3. Other hazards: • Information on whether the substance or mixture meets the criteria for PBT or vPvB • Information on other hazards which do not result in classification but which may contribute to the overall hazards of the substance or mixture (formation of air contaminants, freezing, or photochemical ozone creation potential…) NOTE: mixture is classified and labelled regarding old system (Dir. 99/45)!

15. SECTION 3: Composition/information on ingredients (1) 3.1.Substances • The chemical identity of the main constituent of the substance • The chemical identity of any impurity, stabilising additive, or individual constituent other than the main constituent, which is itself classified and which contributes to the classification of the substance . If the product identifier is not available, one of the other names or identification numbers. • Suppliers of substances may choose to list in addition all constituents including non-classified ones. 3.2.Mixtures • The product identifier when available, concentration or concentration ranges and classifications for all substances referred in points 3.2.1 or 3.2.2. • In addition all substances in the mixture may me listed, including substances not meeting the criteria for classification. • The concentrations of the substances in a mixture: - exact percentages in descending order by mass or volume, or - ranges of percentages in descending order by mass or volume. • Where the use of an alternative chemical name has been allowed then that name can be used

16. NOTE: mixture is classified and labelled regarding old system (Dir. 99/45)! SECTION 3: Composition/information on ingredients (2) 3.2 Mixtures 3.2 .3 For substances in the mixture shall be provieded: • Classification regarding old system (Dir. 67/548/EGS) and • Classification regarding old system new system (Reg.1272/2008 ) No need for providing the whole sentences ( provide them in Sec.16)! 3.2 .4 For substances in the mixture shall be provieded: • Name of the substance snovi • ES No. (if it is available ) • CAS No. (if it is available ) • Reg. No. (if it is available ).

17. SDS: Calendar for updating I SUBSTANCES Placed on the market before 01/12/2010 Placed on the market between 01/12/2010 and 01/06/2015 Placed on the market after 01/06/2015 + classified and labelled according to CLP + classified and labelled according to CLP SDS : no changes until 01/12/2012 SDS: format as in Annex I of Regulation (EU) 453/2010 Section 2.1: Classification according to DSD and CLP Section 2.2: Labelling according to CLP SDS: format as in Annex II of Regulation (EU) 453/2010 Section 2.1: Classification according to CLP Section 2.2: Labelling according to CLP DSD : Directive on Dangerous Substances 67/548/EEC

18. SDS: Calendar for updating II MIXTURES SDS provided to any recipient at least once before 01/12/2010 SDS prepared between 01/12/2010 and 01/06/2015* SDS prepared after 01/06/2015 Classified and labelled DPD Classified and labelled CLP Classified and labelled CLP SDS : no changes until 30/11/2012 SDS: format Annex I of Regulation (EU) 453/2010 Section 2.1: Classification according to DPD Section 2.2: Labelling according to DPD Section 3.2: Classification of substances contained in the mixture according to DSD and CLP (if known) SDS: format Annex I or II of Regulation (EU) 453/2010 + information DSD/DPD Section 2.1: Classification according to DPD + CLP Section 2.2: Labelling according to CLP Section 3.2: Classification of substances contained in the mixture according to DSD and CLP SDS: format Annex II Regulation (EU) 453/2010 Section 2.1: Classification according to CLP Section 2.2: Labelling according to CLP Section 3.2: Classification of substances contained in the mixture according to CLP * transitional period until 01/06/2017, if placed on the market before 01/06/2015 DPD: Directive on Dangerous Preparation 1999/45/CE 18

19. SECTION 15: Regulatory information This section shall describe other regulatory information on the chemicals that is not already provided in SDS (whether the substance or mixture is subject to Reg.2037/2000 or Reg. 850/2004 ..) 15.1.Safety, health and environmental regulations/legislation specific for the substance or mixture • Information regarding relevant EU safety, health and environmental provisions, for example: Seveso category/named substances in Annex I of Council Directive 96/82/EC ( 5 )) or national information on the regulatory status of the substance or mixture ….. • If the chemical is the subject of specific provisions in relation to protection of human health or the environment at EU level (such as authorisations regardind REACH ) .. 15.2.Chemical safety assessment It shall be indicated if a chemical safety assessment has been carried out for the substance or the mixture by the supplier.

20. SECTION 16: Other information This section shall describe the information relevant to the compilation of theSDS. It shall incorporate other information that is not included in Sections 1 to 15, such as: • A clear indication of where changes have been made • A key or legend to abbreviations and acronyms, key literature references and sources for data used in the SDS • In the case of mixtures, an indication of which of the methods was used for the purpose of classification; • List of relevant hazard statements and/or precautionary statements. • Advice on any training appropriate for workers to ensure protection of human health and the environme

21. What is CSR? = Document wihch shall be prepared for all substances (subject to registration) up 10t/year/regsitant • Contains: Chemical Safety Assesment and Expoasure assesment • Information related to the hazards of the substance • The exposure arising from the manufacture or import • The identified uses of the substance • Operational conditions • Risk management measures applied or recommended to downstream usersto be taken into account.

22. CSR vis-à-visSDS • Registrant shall put into SDS (Annex) which he supplies appropriate recommendations and measures to adequately control the risks identified in the CSR. The exposure scenarios for appropriate use and exposurecategories = HOW TO USE SUBSTANCE IN THE MOST SAFETY WAY!

23. Safety Data Sheet (SDS)? (Chemical Safety Report (CSR)) = Informed users = Risk/hazard under control

24. Thank you!