Safety Data Sheet Compliance (SDS) in the EU

Transcription

1 Safety Data Sheet Compliance (SDS) in the EU Inez M. Kasimba Project Manager Health & Environmental Service Intertek May 12,

2 Part 1 Regulation Overview 3

3 Revised Annex II REACH (SDS) COMMISSION REGULATION (EU) No 453/2010 Published May 31 st, 2010 Annex I requirements Mandatory for substances and mixtures from Dec Annex II requirements for substances and mixtures from June (With some delays possible if product is already on the market) 4

4 Overview of Regulation Annex I requirement from 2010 Substances Mixtures Significant changes in format of SDS Increased requirement for information Provide CLP and DSD classification Provide DPD classification in section 2 Provide DSD & CLP classification of hazardous substances in the mixture in section

5 Part 2 SDS Overview 6

6 Do you need to provide a SDS? If you supply a: a dangerous substance or mixture under DSD/DPD or hazardous under CLP. a substance is persistence bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative. a substance of very high concern (SVHC) 7

7 Do you need to provide a SDS? If you are a suppler and your customer requests a SDS for a mixture that is not classified as dangerous but contains either of the following: a substance posing human health or environmental hazards substance that is PBT or vpvb. SVHC on candidate list Europe-wide workplace exposure limits. 8

8 You do not need to provide a SDS if: Substance /mixtures supplied in the EU and not classified as hazardous. Certain products intended for final user: i.e medicinal products or cosmetics 9

9 Mandatory SDS Headings SDS Format 1 Identification of the substance/mixture and the company/undertaking 2 Hazards identification (assessment) 3 Composition/information on ingredients 4 First aid measures 5 Fire fighting measures 6 Accidental release measures 7 Handling and storage 8 Exposure controls / personal protection 9 Physical and chemical properties 10 Stability and reactivity 11 Toxicological information 12 Ecological information 13 Disposal considerations 14 Transport information 15 Regulatory information 16 Other information This 16-point format, based on GHS recommendations, will be acceptable throughout the world. 10

10 Section 1 Identification of the substance/mixture and of the company/undertaking 1.1 Product Identifier For substance, include registration number and name used for registration. Must be consistent with the label. One SDS can be used to cover a range of similar mixtures, but in this case, all names of these mixtures must be included. 1.2 Relevant identified uses of the substance or mixture and uses advised against 1.3 Details of the supplier of the substance or mixture Address of responsible EU supplier and/or local address in Member State if being placed on the market in other member states. Note, that this may also require translation to the appropriate local language. This includes importers, even if an Only Rep has made the registration. The non-eu supplier may be identified for information, but responsible EU legal entity must be given. For Technical Queries contact: [include e mail that will be checked by competent people, but does not have to give name of person] 1.4 Emergency Telephone Specify when it is available, if not 24 hours. 11

11 Section 2 Hazard Identification 2.1 Classification of the substance or mixture [CLP classification] Give the classification of the substance or mixture according to CLP. Until the end of the transitional arrangements in 2015 it will also be necessary to give the classification of a substance in accordance with the Dangerous Substances Directive 67/548/EEC. 2.2 Label elements [Consistent with the label. Pictograms may be used (in black and white if necessary), but this is not obligatory. It is recommended.] 2.3 Other hazard information: Ingestion Skin Contact Eye Contact Inhalation Environment (vpvb / PBT) Additional Information [anything else likely to cause a problem] 12

12 Section 3 - Composition information on ingredients 3. 1 Substances Give chemical identity of the main component plus Chemical identity of other constituents which contribute to the hazards of the substance 3.2 Mixtures The product identifier, concentration or range, * and classification for all components which contribute to a hazardous classification for the mixture. * Concentrations should be given exact, if technically possible, and in descending order. If a range is used, the hazards in section 2 should describe the effects at the highest concentration of each ingredient. 13

13 Section 4 First Aid Measures Instructions that initial first aid responder can understand which are specific to the product and any hazards. 4.1 Description of first aid measures 4.2 Most important symptoms and effects, both acute and delayed 4.3 Indication of immediate medical attention and special treatment needed 14

14 Section 5 Fire Fighting Measures 5.1 Extinguishing media 5.2 Special hazards arising from the substance or mixture 5.3 Special protective actions for fire-fighters Section 6 Accidental Release of Material 6.1 Personal precautions, protective equipment and emergency procedures 6.2 Environmental Precautions 6.3 Methods and material for containment and cleaning up 15

15 Section 7 Handling and Storage 7.1 Precautions for safe handling 7.2 Conditions for safe storage, including any incompatibilities 7.3 Specific end uses Section 8 Exposure Controls/Personal Protection 8.1 Control parameters 8.2 Exposure controls 8.3 Environmental exposure controls 16

16 Section 9 Physical and Chemical Properties 9.1 Information on basic physical and chemical properties Appearance Odor Odor threshold ph [concentration in water?] Freezing/Melting Point (degree C) Initial boiling point and boiling range Flash Point (degree C) Evaporation rate Flammability (solids and gases) Upper/lower flammability or explosive limits Vapour Pressure, Pa at temperature degree C Relative Density Solubility in water and solvents Partition coefficient Autoignition temperature Decomposition temperature Viscosity Explosive properties Oxidising properties 17

17 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 18

18 Section 11 Toxicological Information This section should give specific information about the product for use by medical professionals. It should be consistent with the data for registration and should agree with harmonized classification and labeling or at least consistent with industry agreed classification There are many suggestions on the content to include. For example, Acute toxicity and LD50 s or acute toxicity estimates, information on different routes of exposures, immediate and delayed effects. Also, for mixtures, provide the information on the hazardous substances in the mixture. 19

19 Section 12 Ecological Information 12.1 Toxicity 12.2 Persistence and degradability 12.3 Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment Other adverse effects 20

20 Section 13 Disposal Considerations 13.1 Waste Considerations 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 21

21 Section 15 Regulatory Information This section is intended to contain additional information not given elsewhere Safety, health and environmental regulations/legislation specific for the substance or mixture 15.2 Chemical Safety Assessment Section 16 Other Information Give information about the revision of the SDS, unless given elsewhere. Give any text of abbreviations used. If CLP classification of a mixture is to be communicated before June 2015, in this Annex1 style SDS it should be given in this section. 22

22 Moving to June 2015 Mixtures to be classified, labeled, and packaged in accordance with CLP. Classification under CLP to be communicated on labels and in SDS s. 23

23 Revised SDS June 2015 Safety Data Sheet revised: Applies to substances and mixtures Moves to (revised) REACH Annex II CLP classification for mixtures No requirement for DSD/DPD ****Can choose to provide Annex II style early, but must still communicate DSD/DPD***** 24

24 Part 3 GHS and CLP Classification and communication 25

25 Globally Harmonized System of Classification and Labeling of Chemicals Globally agreed method of classifying and communicating hazards. To be implemented by different regions into their legislation. 26

26 Harmonized? A building block approach to implementation Different regions can choose different blocks or classes of hazards to implement. There are also variations on hazard communication, i.e. Labels and Safety Data Sheets 27

27 In Europe Classification, Labeling and Packaging of substances and mixtures (CLP) Mandatory for substances - Dec 2010 Mandatory for mixtures June

28 CLP Classification Substances, including complex substances, must be classified, labeled and packaged in accordance with CLP by December 1 st 2010 and mixtures by June 1 st, 2015 Many hazards use different criteria than in previous legislation Different terminology 29

29 Two systems in place until 2015 Being phased out Happening Now 30

30 Current DSD/DPD hazard structure Irritant Class of danger Hazard symbol R43 May cause sensitization by skin contact S24 Avoid contact with skin + S37 Wear suitable gloves Risk Phrases Safety phrases 31

31 New GHS/CLP hazard structure Warning Signal Word Pictogram Sensitization Skin hazard Category 1 H317 May cause an allergic skin reaction P261 + P272 + P302/P352 +P333/P313 + P363 + P501 Class & category of Danger Hazard statement Precautionary statements 32

32 Precautions expanded H-317 May cause an allergic skin reaction P272 Contaminated work clothing should not be allowed out of the workplace P302/352 IF ON SKIN: Wash with plenty of soap and water P333/313 If skin irritation or rash occurs: Get medical advice/ attention P363 Wash contaminated clothing before reuse P501 Dispose of contents/container to. 33

33 Timelines - Safety Data Sheets Substances SDS with CLP + DSD information REACH revised Annex 1 Mixtures SDS in accordance with REACH revised Annex 1 Declared components to have CLP + DSD info. Substances Can delay Annex 1 revised SDS, if delaying re-labeling (if already on the Market) Mixtures Can delay Annex 1 SDS if mixture was Provided to a recipient before Dec, 2010 until Nov 2012 Substances & Mixtures SDS in accordance with REACH revised Annex II June 2015 Mixtures Can delay Annex II revised SDS, if delaying relabeling (If already on the market) Can supply early! June 2017 NOW Dec 2010 Dec

34 How to Approach SDS Compliance? Companies need to re-evaluate how their substances and mixtures are classified for each regulatory entity, country and/or region Companies will likely need to re-issue SDSs and labels 35

35 How can Intertek help? Re-Authoring of Existing SDS Data gap assessment Format Changes Translation into required language based per country REACH Regulation updates CLP updates New product SDS Authoring SDS Maintenance Program 36

36 Thank you! 37

37 Questions? Website: