GHS. Egypt, 25th of January, 2007 The GHS: Overview Presentation by Dr. Tarek eid

Transcription

1 GHS Egypt, 25th of January, 2007 The GHS: Overview Presentation by Dr. Tarek eid

2 OUTLINE Background Objective and Mandate Purpose and Scope Principles of Harmonization Benefits Actors of the supply chain Provisions of the GHS Hazard classification Hazard communication: Labels and Safety Data Sheets

3 GHS - Background 1992 United Nations Conference on Environment and Development (UNCED) Rio Earth Summit, agreed in Agenda 21, Chapter 19, to develop Globally Harmonised Chemical Classification and Hazard Communication Systems (GHS) - by 2000 (original target date) It is now Rio +14

4 GHS Objective of Agenda 21 Chapter 19 A globally harmonized hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, should be available, if feasible, by the year Paragraph 19.27

5 World Summit on Sustainable Development (2003) The plan of Implementation includes: Encourage countries to implement the new globally harmonized system for the classification and labelling of chemicals as soon as possible with a view to having the system fully operational by Paragraph 23(c)

6 UN Responsibilities United Nations International Court of Justice Security Council General Assembly Economic & Social Council Trusteeship Council UN Secretariat IAEA UNEP UNITAR WTO WHO FAO ILO UN ECE GHS & TDG UN SCE GHS UN SCE TDG

7 UN SCE GHS Classification Criteria Phys-Chem. UN SCE TDG Classification Criteria Health OECD Classification Criteria Environment OECD Hazard Communication SDS s/labels ILO Governments Industry Public Interest

8 GHS Development A series of working parties developed the GHS criteria UN Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) (Physical hazard classification) OECD Chemical Group (Biological hazard classification) ILO (Hazard communication) Agreed proposals for: classification of chemicals and mixtures hazard communication systems label elements, safety data sheets (SDS)

9 GHS Development United Nations Economic and Social Council Committee of Experts for the Transport of Dangerous Goods and the GHS Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG) Sub-Committee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (UNSCEGHS) Proposals adopted by the UN Committee of Experts on the TDG and GHS in December 2002 First edition of Purple Book published July 2003 Revised edition (Rev.1) published July 2005

10 Purpose of the GHS To enhance the protection of human health and the environment by providing an internationally comprehensible system for hazard communication; To provide a recognized framework for countries without an existing system; To reduce the need for testing and evaluation of chemicals; and To facilitate international trade in chemicals whose hazards have been properly assessed and identified on an international basis.

11 Scope of the GHS The Globally Harmonized System of Classification and Labelling of Chemicals: Is a comprehensive tool that harmonizes chemical hazard classification criteria and hazard communication tools (label elements, SDS) Covers all hazardous chemical substances, solutions and mixtures some exceptions e.g. Pharmaceuticals, food additives at point of intake Classification is based on the hazardous properties of the substance (not risk based)

12 Hazard versus Risk Hazard means the intrinsic property of a chemical substance Risk means the probability of a hazard to occur and is expressed by Risk = Exposure times Hazard Exposure means human or environmental exposure

13 The Principles of Harmonization Changes in all existing systems will be required The level of protection should not be reduced as a result of harmonization The GHS does not include requirements or criteria for testing Existing data can be used GHS not intended to harmonise risk assessment procedures

14 The Principles of Harmonization Application of elements of GHS may vary by product category or stage in life-cycle ( building block approach) Target audiences include consumers, workers, transport workers and emergency responders In relation to hazard communication, confidential business information (CBI) should be protected

15 GHS Implementation GHS will not be Harmonised at first GHS will have optionality to facilitate countries with existing systems to make the transition to GHS GHS provides common basis for classification for all systems GHS provides a single Hazard Communication message for supply and transport Differences will be seen in the hazard communication

16 GHS Optionality Building Block Approach Classification cut-off for mixtures Competent Authority Options

17 The Building Block Approach Competent authorities will decide how to apply the various elements of the GHS based on the needs of the competent authority and the target audience Countries are free to determine which of the building blocks will be applied in different parts of their systems. However, where a system covers something that is in the GHS, and implements the GHS, that coverage should be consistent Countries choosing not to cover all of the effects addressed by the GHS in each use setting The full range (of the harmonised elements of the GHS) does not have to be adopted As long as the hazards covered by a sector or system are covered consistently with the GHS criteria and requirements, it will be considered appropriate implementation of the GHS

18 Benefits of Harmonization Countries, international organizations, chemical producers and users of chemicals all benefit, from: Enhanced protection of humans and environment Facilitation of international trade in chemicals Reduced need for testing and evaluation Assisting countries and international organizations in the sound management of chemicals International training acitivities

19 Key Elements of the GHS The GHS elements include: Classification criteria Physicochemical Health (acute and chronic) Environmental Mixtures covered also Hazard communication Labels Safety Data Sheets Education and training

20 GHS Document (First Revised Edition, 2005) UN GHS Web Site Part 1 Introduction and Hazard communication 5 Chapters Part 2 Physical-Chemical Hazards Criteria 16 Chapters Part 3 Health Hazards Criteria 10 Chapters Part 4 Environmental Hazards Criteria 1 Chapter Annex 1 Annex 2 Annex 3 Annex 4 Annex 5 Annex 6 Annex 7 Annex 8 Annex 9 Annex 10 Allocation of Labelling elements Classification & Labelling Summary Tables Precautionary Statements and Pictogrammes Guidance on the preparation of SDSs Consumer Product Risk Based Labelling Comprehensibility Testing Methodology Labelling Examples Classification Example Guidance Document on the aquatic environment Guidance Document on metals

21 Import Store Transport Producer Recycler Formulator Retailer Export Waste User Actors in the Supply Chain

22 Life Cycle of Chemical Production Formulation Use Industrial use Professional use Consumer use Service life Recovery Waste disposal (landfill, incineration)

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24 GHS Terminology (1) Hazard Class: nature of physical, health, environmental hazard Category: division of criteria within each hazard class Hazard Statement: is a wording associated to hazard class and category

25 GSH Terminology (2) Symbol means graphical element to convey hazard information Pictogram means graphical composition of symbol plus other graphic elements Signal word means level of severity: either Danger or Warning Precautionary statement: means phrase or pictogram that describes recommended measures

26 GHS Terminology (3) Label means appropriate group of written, printed or graphic information element concerning a hazardous product Safety Data Sheet (SDS): Data and Information sheet on chemical or mixture

27 GHS Hazard Classification

28 What is a substance? Broad definition - A pure chemical element or compound A mixture of compounds (a formulated product) A mixture of compounds with the components specified in defined ranges (e.g., a product range) Certain manufactured articles with explosive properties

29 What is a hazardous substance? A substance that exceeds the regulatory threshold for one or more of the following properties: Explosiveness Flammability Ability to oxidise Corrosiveness (metallic and biological) Toxicity (including chronic toxicity) Ecotoxicity (aquatic toxicity) Non hazardous substances do not fall under GHS!

30 Physical hazards in the GHS 1. Explosives (Chap.2.1) 2. Flammable gases (Chap.2.2) 3. Flammable aerosols (Chap.2.3) 4. Oxidizing gases (Chap.2.4) 5. Gases under pressure (Chap.2.5) 6. Flammable liquids (Chap.2.6) 7. Flammable solids (Chap.2.7) 8. Self-reactive substances and mixtures (Chap.2.8) 9. Pyrophoric liquids (Chap.2.9)

31 Physical hazards in the GHS 10 Pyrophoric solids (Chap.2.10) 11 Self-heating substances and mixtures (Chap. 2.11) 12 Substances and mixtures which, in contact with water, emit flammable gases (Chap.2.12) 13 Oxidizing liquids (Chap.2.13) 14 Oxidizing solids (Chap.2.14) 15 Organic peroxides (Chap.2.15) 16 Corrosive to metals (Chap.2.16

32 Nature of Hazard Physical Hazard Classification: Explosives Hazard Communication: Unstable Explosives Thermally unstable or very sensitive Division 1.1 Mass explosion hazard Division 1.2 Projection hazard Division 1.3 Fire or minor projection hazard Division 1.4 No significant hazard Division 1.5 Insensitive substances/ mass explosion hazard Division 1.6 Insensitive articles/no mass explosion hazard Pictogram UN TDG Signal word Danger Danger Danger Danger Warning Danger - Hazard Statement Unstable explosive Explosive; mass explosion hazard Explosive; severe projection hazard Explosive; fire, blast or projection hazard Fire or projection hazard May mass explode in fire -

33 Hazard Class Explosives Flammable Gases Flammable Aerosols Oxidising Gases Pressurised Gases Compressed Gases Liquefied Gases Refrigerated Liquefied Gases Dissolved Gases Flammable Liquids Flammable Solids Self-reactive Substances Pyrophoric Liquids Pyrophoric Solids Self-heating Substances Water Reactive Flammable Gases Oxidising Liquids Oxidising Solids Organic Peroxides Corrosive to Metals Unstable Explosives Hazard Category Div1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div Type AType BType CType DType EType FType G Type AType BType CType DType EType FType G 1

34 Hazard Class Acute Toxicity, Oral Acute Toxicity, Dermal Acute Toxicity, Inhalation Health Hazards Aspiration hazard 1 2 Skin Corrosion/Irritation (Dermal Corrosion = Eye Corrosion) Eye Irritation Respiratory Sensitisation Skin Sensitisation Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity - Fertility Reproductive Toxicity - Development Target Organ ST Single Dose Target Organ ST Repeat Dose Hazard Category (Corrosion) 1A 1 1B 2A 1C 2B 1 1 1A 1B 2 1A 1A 1B 1B 2 2 1A 1B GHS Human Health Effects Irritation 2 3 Lactation

35 Flammable liquids Flammable liquids are liquids having a flash point of not more than 93 C. They are classified under one of the 4 categories of this class according to their: Flash point; and Initial boiling point

36 Flammable liquids Category 1: Extremely flammable liquid and vapour Flash point < 23 C and initial boiling point 35 C Category 2: Highly flammable liquid and vapour Flash point < 23 C and initial boiling point > 35 C Category 3: Flammable liquid and vapour Flash point 23 C and 60 C Category 4: Combustible liquid Flash point > 60 C and 93 C

37 Flammable liquids The substance/mixture is a liquid Does it have a flash point 93 C? Yes Does it have a flash point >60 C? No Does it have a flash point 23 C? No No Yes Yes Not classified Category 4 No symbol Warning Category 3 Warning Cont d

38 Flammable liquids No Does it have an initial boiling point > 35 C? Yes Category 2 Danger No Category 1 Danger

39 Health and environmental hazards 1 Acute toxicity (Chapter 3.1); 2 Skin corrosion/irritation (Chapter 3.2); 3 Serious eye damage/eye irritation (Chapter 3.3); 4 Respiratory or skin sensitization (Chapter 3.4); 5 Germ cell mutagenicity (Chapter 3.5); 6 Carcinogenicity (Chapter 3.6); 7 Reproductive toxicity (Chapter 3.7); 8 Specific target organ systemic toxicity- single exposure (Chapter 3.8); 9 Specific target organ systemic toxicity- repeated exposure (Chapter 3.9) 10 Aspiration hazard (Chapter 3.10); 11 Hazardous to the aquatic environment (Chapter 4.1)

40 Acute toxicity: decision logic (1) Substance: Are there data and/or information to evaluate acute toxicity? Yes According to the criteria, does the substance have an: Oral LD 50 5 mg/kg bodyweight, or Dermal LD mg/kg bodyweight, or Inhalation (gas) LC ppm, or Inhalation (vapour) LC mg/l, or Inhalation (dust/mist) LC mg/l? No According to the criteria, does the substance have an: Oral LD 50 >5 but < 50 mg/kg bodyweight, or Dermal LD 50 >50 but < 200 mg/kg bodyweight, or Inhalation (gas) LC 50 >100 but < 500 ppm, or Inhalation (vapour) LC 50 > 0.5 but < 2.0 mg/l, or Inhalation (dust/mist) LC 50 >0.05 but 0.5 mg/l? No No Yes Yes Classification not possible Category 1 Danger Category 2 Danger Cont d

41 Acute toxicity: decision logic (2) No According to the criteria, does substance have an: Oral LD 50 >50 but < 300 mg/kg bodyweight, or Dermal LD 50 > 200 but < 1000 mg/kg bodyweight, or Inhalation (gas) LC 50 >500 but < 2500 ppm, or Inhalation (vapour) LC 50 >2 but < 10.0 mg/l, or Inhalation (dust/mist) LC 50 >0.5 but < 1.0 mg/l? No According to the criteria, does the substance have an: Oral LD 50 >300 but < 2000 mg/kg bodyweight, or Dermal LD 50 >1000 but < 2000 mg/kg bodyweight, or Inhalation (gas) LC 50 >2500 but < 5000 ppm, or Inhalation (vapour) LC 50 >10 but < 20 mg/l, or Inhalation (dust/mist) LC 50 >1 but < 5 mg/l? No Yes Yes Category 3 Danger Category 4 Warning Cont d

42 Acute toxicity: decision logic (3) No According to the criteria, does the substance have an: Oral LD 50 >2000 but < 5000 mg/kg bodyweight, or Dermal LD 50 >2000 but < 5000 mg/kg bodyweight, or Inhalation (gas, vapour and/or dust/mist) LC 50 in the equivalent range of the oral and dermal LD 50 (i.e., mg/kg bodyweight) No Is there reliable information available indicating significant toxicity effects in humans?; or Was any mortality observed when tested up to Category 4 values by the oral, inhalation or dermal routes?; or Is there expert judgement that confirms significant clinical signs of toxicity, when tested up to Category 4 values, except for diarrhea, piloerection or an ungroomed appearance?; or Is there expert judgement that confirms reliable information indicating the potential for significant acute effects from other animals? Yes Yes Category 5 Warning Classify in Category 5 (Warning) if assignment to a more hazardous class is not warranted No Not classified

43 Carcinogenicity: decision logic Does the substance have carcinogenicity data? Yes No Classification not possible According to the criteria, is the substance : known to have carcinogenic potential for humans, or presumed to have carcinogenic potential for humans? Application of the criteria needs expert judgment in a strength and weight of evidence approach. Yes Category 1 Danger No According to the criteria, is the substance a suspected human carcinogen? Application of the criteria needs expert judgment in a strength and weight of evidence approach. No Yes Category 2 Warning Not classified

44 Classification criteria for mixtures Mixture: Mixtures or solutions composed of two or more substances in which they do not react Classification based on the criteria for substances Consider the classification of any impurities, additives or individual constituents of a substance which have been identified, if they exceed the cut-off value/concentration limit for a given hazard class

45 Tier approach to classification Generally use test data for mixture when available If not, use bridging principles, if applicable If not, estimate hazards based on the known ingredient information It is assumed that mixtures will be tested for physical hazards - same criteria as for substances For health and environmental hazards, use additivity formula or cut-off concentrations

46 Bridging Provides for the situation in which the mixture has not been tested, but a similar mixture has been tested. Similar can be defined in terms of: Dilution Batching Concentration of Chronic I or Acute I components Interpolation Substantially similar mixtures

47 Carcinogenicity: decision logic Classification based on individual ingredients of the mixture Category 1 Does the mixture contain one or more ingredients classified as a Category 1 carcinogen at: 0.1%? No Yes Danger Does the mixture contain one or more ingredients classified as a Category 2 carcinogen at 0.1%? 1.0%? Yes Category 2 Warning No Not classified Cont d

48 GHS Hazard Communication Labels

49 Target Audiences Consumers Labels Workers Labels, Safety Data Sheets (includes pharmaceuticals, cosmetics, food additives, pesticides) Transport Labels, placards, documentation Emergency Responders Labels, placards

50 Hazard Communication Label Elements Hazard pictograms Signal words Hazard statements Precautionary statements Product identifier Supplier identifier Chemical identity

51 GHS Pictograms!

52 Transport Pictograms

53 Harmonised Labelling Elements Hazard Class Acute Toxicity Oral Hazard Category 1 Pictograms or Signal Word Hazard Statement Danger Fatal if swallowed

54 Pictogram Frame Colour Symbol

55 Relationship to Dangerous Goods (International) Dangerous goods refers to goods regulated by the UN Recommendations on the Transport of Dangerous Goods Model Regulations UN Orange Book Does not cover some toxic, ecotoxic and flammable categories covered by GHS Covers radioactive and infectious substances that are excluded from GHS Covers some manufactured articles excluded from GHS Focus on transport versus GHS whole lifecycle

56 Hazard Communication Label Elements Pictograms GHS UNRTDG

57 Hazard Communication Label Elements Two signal words Danger (for more severe hazard categories) Warning (for less severe hazard categories) Definition: word used to indicate the relative level of severity of hazard and alert the reader to a potential hazard on the label.

58 Hazard Communication Label Elements Hazard statements Phrase assigned to hazard class and category Provides information about the hazard Fatal if inhaled (for Acute toxicity: Inhalation Category 1) Extremely flammable liquid and vapour (for Flammable Liquids - Category 1)

59 Hazard Communication Label Elements Precautionary statements Statements that relate to: Prevention Emergency Response Storage Disposal Measures to take to minimize or prevent adverse effects (e.g. Wear protective gloves) Generally up to 3 statements for each of these per hazard category

60 Product Identifier and Chemical Identities (i) A product identifier has to be used on a label which should match the product identifier used on the SDS. Where a substance or mixture is covered by the UN Model Regulations on the Transport of Dangerous Goods, the UN proper shipping name should also be used; (ii) For a substance, the label should include the chemical identity of the substance. For mixtures or alloys, the label should include the chemical identities of all ingredients or alloying elements that contribute to acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitisation, or Target Organ Systemic Toxicity (TOST), when these hazards appear on the label.

61 ACUTE TOXICITY - ORAL Symbol Skull and crossbones Hazard Category Signal Word Hazard Statement 3 Danger Toxic if swallowed (H301) Precautionary Statements Prevention Response Storage Disposal Do not eat, drink or smoke when using this product. (P270) Wash hands thoroughly after handling. (P264) Keep out of reach of children IF SWALLOWED: Immediately call the POISON CENTRE (0800 POISON) (P301+P310) Rinse mouth (P330) Specific treatment is urgent (see. <reference to supplemental first aid instruction>. on this label) (P320) Store locked up. (P405) Dispose of contents/container to... (P501)

62 GHS rules of precedence If the skull and crossbones applies, the exclamation mark should not appear; If the corrosive symbol applies, the exclamation mark should not appear where it is used for skin or eye irritation; If the health hazard symbol appears for respiratory sensitization, the exclamation mark should not appear where it is used for skin sensitisation or for skin or eye irritation;

63 GHS rules of precedence If the signal word Danger applies, the signal word Warning should not appear; If several precautionary statements are required that convey the same information, a selection of the most stringent of these statements may be used on labels. It must be ensured, however, that precautionary information is not lost by the use of fewer statements.

64 GHS rules of precedence Where a Transport pictogram appears a GHS pictogram for the same hazard should not appear A transport pictogram can be used in the workplace instead of a GHS pictogram but the reverse cannot apply Transport pictograms must be used for transport

65 Labelling according to GHS: Example of arrangement of label elements CODE PRODUCT NAME COMPANY NAME Street Address City, State, Postal Code, Country Phone Number Emergency Phone Number DIRECTIONS FOR USE: XXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXX Fill weight: XXXX Lot Number: XXXX Gross weight: XXXX Fill Date: XXXX Expiration Date: XXXX Danger Keep out of the reach of children. Read label before use. Highly flammable liquid and vapour. Harmful if inhaled. May cause liver and kidney damage through prolonged or repeated exposure. Keep container tightly closed. Keep away from heat/sparks/open flame-no smoking. Use only outdoors or in a well-ventilated area. Do not breath fume/gas/mist/vapours/spray. Wear protective gloves and eye/face protection [as specified.] Ground/bond container and receiving equipment. IN CASE OF FIRE use [as specified] for extinction FIRST AID IF INHALED: Remove to fresh air and keep at rest in a position comfortable for breathing. Call a Poison Center or doctor/physician if you feel unwell. Store in a cool, well-ventilated place. UN Number Proper shipping name [Universal Product Code (UPC)] Additional examples of arrangements of the GHS labels may be found in Annex 7 of the GHS

66 GHS Hazard Communication Safety Data Sheets (SDS)

67 Safety Data Sheets (1): Provide comprehensive information of a substance/mixture, particularly for use in workplace Are product related The information provided enables the employer: - To develop worker protection measures specific to the workplace; - To consider measures to protect the environment

68 Safety Data Sheets (2): SDS should be provided for: - all substances/mixtures meeting GHS harmonized criteria for physical, health and environmental hazards - mixtures containing substances meeting criteria for carcinogenicity, toxicity for reproduction or specific target organ systemic toxicity, in concentration exceeding cut-off values - other substances/mixtures not meeting the criteria for classification as hazardous but containing hazardous substances in certain concentrations, if required by the competent authority.

69 Safety Data Sheet: Format Information should be presented as follows: 1. Identification 2. Hazard(s) identification 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.

70 Confidential Business Information (CBI) GHS states Protection of CBI should be consistent with the following general principles: (a) For information otherwise required on labels or safety data sheets, CBI claims should be limited to the names of chemicals, and their concentrations in mixtures. All other information should be disclosed on the label and/or safety data sheet, as required; (b) Where CBI has been withheld, the label or chemical safety data sheet should so indicate; (c) CBI should be disclosed to the competent authority upon request. The competent authority should protect the confidentiality of the information in accordance with applicable law and practice;

71 International Implementation Implementation internationally aimed for 2008 World Summit on Sustainable Development First reversion of the GHS released in August 2005 SDS guidance (16 header format) new appendix New precautionary statements Some new and some revised classification criteria Editorial amendments Codification of hazard and precautionary statements presented to July 2006 GHS meeting

72 Implementation Issues Alignment of hazard classification systems with the GHS Alignment of TDG and GHS systems (underway) Labelling Consistent approach Need for guidance at international level Consumer products

73 GHS Issues with implementation Differences in the results of classification labelling No list of agreed classifications of chemicals, however classifications exist, e.g. in the EU, in New Zealand GHS Building Block approach and its application vs. international harmonization for each sector

74 Important GHS Websites (1) UN ECE GHS 1st Revision ev01/01files_e.html UN ECE Transport of Dangerous Goods UNITAR/ILO Capacity Training Programme New Zealand ERMA European Chemicals Bureau: Classification and Labelling

75 Important GHS Websites (2) OECD Classification and Labelling _1_1_1_1_1,00.html ILO Classification and Labelling rk/chemsfty/ghs.htm WSSD Global Partnership for Capacity Building to Implement GHS tm

76 Thank you for your attention