1. The GHS: Overview Presentation George Thomas Thai National GHS Workshop 15-17 May 2006 1

2. Content History, scope and application of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Key elements of the GHS Chemical regulation and GHS implementation in Australia 2

3. International mandate 1992 United Nations Conference on Environment and Development (UNCED) Agreement, endorsed by the UN General Assembly: A globally-harmonised hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year 2000. Programme Area B, Chapter 19, Agenda 21 3

4. Structure for Harmonization United Nations Conference on Environment and Development (UNCED) Interorganization Programme for the Sound Management of Chemicals (IOMC) Coordinating Group for the Harmonization of Chemical Classification Systems (CG/HCCS) Physical hazards:Health andHazard UNTDG + ILOenvironmentalcommunication: hazards: OECDILO 4

5. Implementation and Maintenance United Nations Economic and Social Council's Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) Committee of Experts on the Transport of Dangerous Goods and on the GHS (UNCETDG/GHS) Sub-Committee on TDG (UNSCETDG) Sub-Committee on GHS (UNSCEGHS) 5

6. Scope of the GHS The Globally Harmonized System of Classification and Labelling of Chemicals: Is a comprehensive tool that harmonises chemical classification and hazard communication Covers all hazardous chemicals Classification based on the intrinsic properties of the chemical 6

7. The Principles of Harmonization The level of protection should not be reduced as a result of harmonisation. The scope includes both hazard classification criteria and hazard communication tools (labels, SDS). Changes in all existing systems will be required. 7

8. The Principles of Harmonization The GHS does not specify test methods for health and environmental hazards. Target audiences include consumers, workers, transport workers and emergency responders. In relation to chemical hazard communication, Confidential Business Information (CBI) should be protected. 8

9. The Benefits of Harmonisation Countries, international organisations, chemical producers and users of chemicals all benefit Enhanced protection of humans and environment Facilitate international trade in chemicals Reduce need for testing and evaluation Assist countries and international organisations in the sound management of chemicals 9

10. Key Elements of the GHS The GHS Elements include: Classification Criteria Physicochemical Health (acute and chronic) Environmental Hazard communication Labels Safety Data Sheets 10

11. Timeline for Implementation International target 2008 First Revised Edition published in August 2005. Changes include: SDS guidance (new annex) Precautionary statements (new annex) Editorial amendments 11

12. GHS Classification Criteria – Physical Hazards Explosives Flammability – gases, aerosols, liquids, solids Oxidisers – liquid, solid, gases Self-Reactive Pyrophoric – liquids, solids Self-Heating Organic Peroxides Corrosive to Metals Gases Under Pressure Water activated flammable gases 12

13. GHS Classification Criteria – Health & Environmental Hazards Acute Toxicity Skin Corrosion/Irritation Serious Eye Damage/Eye Irritation Respiratory or Skin Sensitization Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity Target Organ Systemic Toxicity – Single and Repeated Dose Aspiration Hazards Hazardous to the Aquatic Environment 13

14. Hazard Categories Each hazard class has one or more categories of hazard, based on severity, eg. Acute Toxicity: Oral LD 50 (mg/kg body weight): ≤ 55 < LD 50 ≤ 5050 < LD 50 ≤ 300 300 < LD 50 ≤ 2000 2000 < LD 50 ≤ 5000 GHS Hazard Category: Category 1Category 2Category 3Category 4Category 5 14

15. Hazard Communication – Label Elements Hazard pictograms Signal words Hazard statements Precautionary statements Product identifier - include chemical identity Supplier identification Standardised 15

16. Hazard communication – Label elements: GHS pictograms 16

17. Hazard communication – Label elements: Transport pictograms 17

18. Hazard communication – Label elements Signal words- indicates relative level of severity of hazard Danger or Warning 18

19. Hazard communication – Label elements Hazard statements- Provide information about nature of the hazard For example: Extremely flammable liquid and vapour Fatal if inhaled Harmful if swallowed 19

20. Standardised Elements for Acute Toxicity - Oral LD 50 (mg/kg body weight): ≤ 55 < LD 50 ≤ 5050 < LD 50 ≤ 300 300 < LD 50 ≤ 20002000 < LD 50 ≤ 5000 GHS Hazard Category: Category 1Category 2Category 3Category 4Category 5 GHS Label Danger Fatal if swallowed Danger Fatal if swallowed Danger Toxic if swallowed Warning Harmful if swallowed No symbol Warning May be harmful if swallowed 20

21. Hazard communication – Label elements Precautionary statements- recommended measures that should be taken to minimise or prevent adverse effects Statements relate to: Prevention Response Storage Disposal 21

22. Example of standardised label elements Product is classified as: Acute toxicity oral, category 3 Skin corrosion/irritation, category 2 Flammable liquid, category 3 22

23. Example of standardised label elements DangerWarning Fatal if swallowedCauses skin irritation Flammable liquid and vapour 23

24. Example of standardised label elements Selected elements after applying precedence rules 24

25. Hazard communication - Safety data sheets 16 header format Address physical, health and environmental hazards Detailed guidance now in Annex 4 Still flexibility to include national information 25

26. Implementation Issues - International Alignment of national hazard classification systems with the GHS Alignment of TDG and GHS systems internationally (underway) Labelling Consistent approach Need for guidance at international level Building block approach – need for common understanding 26

27. Future Directions Additional environmental hazard classes Codification of hazard and precautionary statements Further guidance on labelling? 27

28. Chemical regulation in Australia Generally, policy is developed at the national level and enforced by State and Territory jurisdictions Currently a complex arrangement, several sectors A single chemical may be covered by a number of sectors and therefore subject to numerous pieces of regulation 28

29. Chemical regulation in Australia Assessment of specific chemical types (national level): Pesticides and veterinary medicines Industrial chemicals Domestic poisons Pharmaceuticals 29

30. Chemical regulation in Australia Regulations covering use (mainly at state/territory level) Workplace (OHS) regulations Transport regulations Environmental regulations Health regulations Agriculture regulations 30

31. Australian GHS Implementation – General Implementation of the GHS important for mutual recognition of chemicals with New Zealand Alignment and timing with key chemical trading partners is critical 31

32. Australian GHS Implementation – Workplace sector Workplace sector - working to be in a position to implement by 2008 Development of a single regulatory framework for the control of workplace hazardous chemicals: Amalgamate current workplace frameworks Implement the GHS - new SDS and labelling codes of practice National consistency through adoption in jurisdictional OHS regs 32

33. Australian GHS Implementation – Workplace sector (NICNAS analysis) Since 2003 NICNAS has classified over 400 assessed chemicals using the GHS NICNAS has compared this with the current classification system used for industrial chemicals Analysis of 50+ industrial chemicals showed: 34% classified as hazardous by existing criteria compared to 36% classified as hazardous by GHS 91% alignment of classifiable endpoints between existing and GHS systems 3 endpoints where alignment in classification did not always occur (relatively minor in nature) 33

34. Australian GHS Implementation – Workplace sector (NICNAS analysis) Three endpoints where alignment of classification did not always occur: Acute toxicity (oral, dermal) Skin irritation Eye irritation - differences in irritation score criteria leads to differences in irritancy classification 34

35. Australian GHS Implementation – Agricultural sector The Primary Industries Ministerial Council's Product Safety and Integrity Committee is currently working with government and industry stakeholders to consider how the GHS might be translated into Australia's risk- based labelling system for agricultural and veterinary chemicals. A GHS Reference Group has been established. 35

36. Australian GHS Implementation - Consumer sector Department of Health supports adoption of GHS in respect to health effects elements. GHS has implications for scheduling and therefore State/Territory legislative responsibilities for poisons scheduling and labelling Working Group established and will report in October 2006 36

37. Australian GHS Implementation – Issues Complex sectoral arrangements Multiple layers of government regulation Risk-based versus hazard-based systems Need for list of agreed classifications (workplace sector) Need for transition periods 37

38. Thank you Questions and discussion 38