Globally Harmonised System (GHS) of Classification and Labelling

Transcription

1 Globally Harmonised System (GHS) of Classification and Labelling Prepared By: Hugo Waeterschoot (ENIA) & Bill Adams (Rio Tinto) February 13,

2 GHS-Background 1992: Rio de Janeiro EARTH Summit United Nations Conference on the Environment and Development Objectives: Promote sustainable development Facilitate international trade A globally harmonised hazard classification and compatible labelling system, including material safety data sheets and easily understood symbols, should be available, by the year 2000 (done) and implemented world-wide by end of 2008 (in progress) 2 2

3 GHS-Background Why? Existing global disharmony in Classification and Labelling Example: Different risk phrases used for a substance with an Acute Oral Toxicity LD 50 = 257 mg/kg/day EU US CAN Australia India Japan Malaysia Thailand New Zealand China Korea GHS Harmful (St Andrew s Cross) Toxic Toxic Harmful Non-toxic Toxic Harmful Harmful Hazardous Not Dangerous Toxic Danger (Skull & Cross Bones) 3 3

4 Purpose and Generic Principles Purpose: (a) Enhance the protection of human health and the environment by providing an international comparable system for hazard communication (b) (c) (d) Provide a recognised framework for those countries without an existing system Reduce the need for testing and evaluation of chemicals Facilitate international trade in chemicals whose hazards have been properly assessed and identified on an international basis 4 4

5 Purpose and Generic Principles General principles Harmonisation means establishing a common and coherent basis for chemical hazard classification and communication, from which appropriate elements relevant to means of transport, consumer, workers and environmental protection can be selected Initially Harmonise Existing Guidelines Best Scientific Practice Existing data should be acceptable No Reduction of Current Level of Control in any Country 5 5

6 GHS - Implementation UN adopted July 2003 encourages all countries to implement GHS ASAP WHEN: by end of 2008! The purple book sets out the approach but allows for flexibility Current text: nd Rev. expected December

7 GHS Implementation Around the World Global Implementation expected ! 7 7

8 Test 1 Terrorist GHS will introduce hazard and labelling system which may be significantly different attack as what is existing today in some countries possible by 1 person 8 8

9 Test 2 Pirates Some hazard symbols are new and/or are differently understood in other cultures!!!! spotted in the Caribbean 9 9

10 Test 3 Dead fish GHS introduces new hazard criteria for many jurisdictions. Lack of experience may lead to nonharmonized classifications! falling out of trees 10 10

11 Metals Organics It s a different can of worms! 11 11

12 Immediate Challenges. Change in labelling Differences in classification categories from the current systems Difference between GHS categories adopted between countries Metal specific characteristics 12 12

13 Physical Hazards Pictograms/Phrases Explosives Self-Reactive Substances and Mixtures Organic Peroxides Flammable Gases Flammable Aerosols Flammable Liquids Flammable Solids Self-Reactive Substances and Mixtures Pyrophoric Solids Self-Heating Substances and Mixtures Contact with Water, Emit Flammable Gas Oxidizing Gases Oxidizing Liquids Oxidizing Solids Corrosive to Metals Skin Corrosion/Irritation: Danger (Corrosion) Eye Damage/Irritation: Danger (Corrosion) Gases under pressure Refrigerated Liquefied gas 13 13

14 Current EU Labelling 14 14

15 Company/Branding Information CLP (GHS) Label GHS Label Transport Information Commercial Information PRODUCT ABC Manufactured by Company XYZ Product Information/Use Instructions Product Identifier Chemical Identities Signal Word Hazard Statement Hazard Statement Precautionary Statement Precautionary Statement Precautionary Statement Supplier Identifier Supplemental Information X X X X X X X X UNXXXX & Proper Shipping Name Other Information ICMM-EM GHS Supplemental REACH-GHS Information 15 15

16 Examples of Labelling changes Current Future Category EU Canada U.S. GHS Flammable None Toxicity/ Health Hazard Danger None Environmental Toxicity None None Chronic Health Hazard (e.g. Respiratory Sensitiser, Carcinogen Various None None 16 16

17 GHS Categories e.g. ACUTE ORAL TOXICITY GHS Category 1 Category 2 Category 3 Category 4 Category 5 UN LD 50 5 mg/kg LD 50 > 5 50 mg/kg LD 50 > mg/kg LD 50 > mg/kg LD 50 > mg/kg Countries following UN GHS for this endpoint: Japan and South Africa New Zealand GHS EU Current DANGER DANGER DANGER WARNING Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed 6.1A 6.1B 6.1C Very Toxic LD mg/kg Toxic LD50 > mg/kg 6.1D Harmful LD50 > 200 2,000 mg/kg No symbol WARNING May be harmful if swallowed 6.1E Very toxic if swallowed Toxic if swallowed Harmful if swallowed (R22) EU and Australia GHS Category 1 Category 2 Category 3 Category 4 EU, Australia, and US Proposed Canada GHS Canada Proposed in position paper DANGER DANGER DANGER WARNING Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed Category 1 Category 2 Category 3 Category 4 DANGER DANGER DANGER WARNING Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed May not include, still under discussion 17 17

18 Acute Aquatic Hazards - Categories GHS Category Acute 1 Category Acute 2 Category Acute 3 UN Very toxic to aquatic life Toxic to aquatic life Harmful to aquatic life Countries following UN GHS for this endpoint: WARNING Japan and South Africa EU GHS EU Proposed New Zealand GHS 96hr L(E)C 50 (Fish) 1mg/L 48hr EC LC 50(crustacean) 1mg/L 72 or 96hr ErC 50(algae) 1mg/L Category 1 WARNING 9.1A Very toxic to aquatic life WARNING 96hr L(E)C 50 (Fish) 1mg/L < L(E)C 50 10mg/L 48hr EC LC 50(crustacean) 1mg/L < L(E)C 50 10mg/L 96hr L(E)C 50 (Fish) 10mg/L < L(E)C mg/L 48hr EC LC 50(crustacean) 10mg/L < L(E)C mg/L 72 or 96hr ErC 50(algae) 1mg/L < L(E)C 50 10mg/L 72 or 96hr ErC 50(algae) 10mg/L < L(E)C mg/L NB: Terrestrial Effects Classified Australia, US and Canada GHS Australia does not require Environmental Classification United States: Not in scope for OSHA, EPA considering adoption 18 18

19 Potential Changes and Implications (M)SDS changes Reformulation of products to eliminate certain ingredients/impurities Warning labels for currently exempt products Changes in shipment labelling and transport precautions Changes in chemical storage, handling and disposal New guidance regarding Hazard Communication within the workplace Need for training of workforce 19 19

20 Additional Key Issues for Metals GHS introduces NEW toxicity END-POINTS STOT: Systemic Target Organ Toxicity GHS changes some END-POINTS drastically Environmental classification Different Classification between massive and powder forms Different Categories Safety net (classification category when data is lacking) CMR: category under EU becomes 1A-1B and 2 (1A & 1B are subject to Authorization under REACH) Not all jurisdictions adopt GHS as published by the UN resulting in different classification on some endpoints 20 20

21 Copper Powder: Proposed GHS Classifications by Country Jurisdiction/ Regulation Future Proposed GHS Classification Pictograms Notes UN GHS Self- Classification Serious Eye Damage/Eye Irritation: Category 2B Hazardous to the Aquatic Environment (Acute & Chronic): Category 1 Classification based on thorough review of available data EU GHS Self- Classification* New Zealand Eye Irritation: 6.4A, Aquatic Effects: 9.1A Terrestrial still data needs to be evaluated to make classifications Australia GHS Serious Eye Damage/Eye Irritation: Category 2B Hazardous to the Aquatic Environment (Acute & Chronic): Category 1 Serious Eye Damage/Eye Irritation: Category 2B Watch for endpoint categories that have not been adopted Environmental classification not mandatory Japan GHS STOT Single Exposure: Category 3 (Lung); STOT Repeated Exposure: Category 1 (Liver); Chronic Hazards to the Environment (Category 4) Japanese NITE Classification; followed UN approach, but used unreliable data

22 What are we doing to help you? 1. Trace & comment on national GHS implementation proposals globally : EU - US - Japan - South Africa Korea China - Russia 2. Preparing generic info and a briefing leaflet 3. Compile effects data reference sheets by various Commodity Associations for self classification & MSDS 4. Provide (visual) GHS overview tables per end-point, allowing self-classification by companies 22 22

23 Conclusions Problem: GHS implementation around the world could result in differing classifications for identical substances; this is contrary to the intent of the UN Challenges: Acquiring the data necessary to assign appropriate classification Determining the correct classification for various jurisdictions Using the correct system within a jurisdiction to make the classification Maintaining consistent classifications within business units and across industry 23 23

24 Links between REACH and GHS 24 24

25 REACH implementation GHS UN-Global Harmonised Classification System (GHS) - EU GHS Parallel introduction with REACH - Industry submissions listed on public website - Platform for worldwide exchange 25 25

26 Status of GHS in the EU REACH itself does not include criteria for Classification and Labelling DraftEU GHS Regulation published on 27 th June 2007 Includes translation of current Annex I into corresponding GHS classifications (Annex VI) - stakeholders not consulted Adoption by Parliament and Council - entry into force by end 2008/early 2009 N.B.: Reach Implementation Project (RIP) 3.6 (in progress) will develop GHS C&L standards/criteria under REACH; industry participates in this RIP 26 26

27 Scope - Comparison R,E, A, Ch Risk REACH Substances produced/imported Hazardous and non-hazardous 1 tonne/year/producer or importer Harmonised classifications European Union Workplace and Supply & Use EU-GHS Classification, Labelling, MSDS Hazard Substances/Mixtures Hazardous Any volumes Self classification World-wide Workplace, Supply & Use and Transport 27 27

28 Transitional Period REACH GHS 3.5 y. HPV etc. 2.5 y. > 100 t/a 5 y. > 1 t/a y. Substances 4.5 y. Mixtures For substances and mixtures: EU-System: binding GHS: optional; Label: GHS if class. For substances: GHS: obligatory for the label SDS must contain EU and GHS classification For mixtures: EU-System: binding GHS: optional; Label: GHS if class. After the entire transition period: For substances & mixtures: GHS: obligatory EU-System: loses its legal status 28 28

29 (REACH GHS) Summary of Issues GHS will be introduced in parallel with REACH Classification and Labelling will need to changed to GHS system (worldwide) GHS introduces a few key issues for metals While GHS harmonises C&L between regions, (critical) differences will remain The clock is ticking for REACH, but it ticks as quickly for GHS 29 29

30 GHS Are you prepared??? 30 30