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1 International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute.

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Presentation on theme: "1 International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute."— Presentation transcript:

1 1 International Standard for Chemical Safety Globally Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR PAG (United Nations Institute for Training and Research Programme Advisory Group) Edited by Hiroshi JONAI Expert of UNSCGHS

2 2 GHSGHS

3 3 Contents of the CD 1.Introduction to the GHS What is the GHS? Objective History of GHS Classification Criteria Hazard Communication Factors to Consider in the GHS Implementation Other Issues 2.Q & A 3.Classification Examples 4.Pictograms for downloading

4 4 1. Introduction

5 5 What is the GHS? Objective Historical Background

6 6 What is the GHS? A common and coherent approach –To define and classify hazards –To communicate information on labels and safety data sheets (SDS) A simple and transparent method guided by Classification criteria Label requirements SDS requirements

7 7 What is the objective of the GHS? To enhance the protection of human health and the environment

8 8 Benefits of GHS Adoption Protection of humans and environment around the world will be enhanced. International trade in chemicals will be facilitated. An internationally maintained system will be made available to all nations. Avoidance of duplication of testing and evaluation of chemicals to determine their hazardous effects will be ensured.

9 9 Situation analysis of chemical Use Why is there a need for the GHS to address the issues of chemical safety?

10 10 (Insert pictures of modernized society or utilizing chemicals.)

11 11 (Insert pictures of disasters by chemicals.)

12 12 Magnitude of Chemical Use More than 27 million chemicals in the world CAS million work-related deaths every year ILO –1/4 caused by chemicals

13 13 Issues in Hazard information No one country has the ability to identify and regulate ALL hazardous chemicals and chemical products. Requirements for hazard definition, label or safety data sheet may differ from country to country.

14 14 Example of differences: Acute toxicity (oral LD 50 ) Dose [mg/kg] ,000 5,000 GHS __ EU R-phrase R28 T+ Very toxic R25 T Toxic R22 Xn Harmful USA Very toxicToxicHarm- ful UN RTDG 6.1 Toxic substances Very serious risk PG Serious Risk PG Low Risk PG (Liquid) Low Risk PG (Solid)

15 15 GHS as a basis for Chemical management Safe Use of Chemicals Risk Management system Hazard Communication (GHS Labels and SDS) GHS Classification

16 16 Historical Background The Past That Defined GHS

17 17 A Chronology of Initiatives in Developing the GHS 1950s - United Nations issued Recommendations on the Transport of Dangerous Goods (UNRTDG). The GHS criteria for physical hazards based on UNRTDG.

18 18 A Chronology of Initiatives in Developing the GHS ILO adopted a Resolution concerning a Convention on safety in the use of chemicals at work ILO Convention 170 and Recommendation 177 on safety in the use of chemicals at work These instruments require countries to adopt a system for hazard classification and labelling UNRTDG

19 19 A Chronology of Initiatives in Developing the GHS ILO Resolution ILO Convention 170 and Recommendation United Nations Conference on the Environment and Development (UNCED) in Brazil: Established 6 programme areas in Chapter 19, Agenda 21 Chapter 19, Agenda 21, seeks to strengthen national and international efforts related to the environmentally sound management of chemicals UNRTDG

20 20 A Chronology of Initiatives in Developing the GHS ILO Resolution ILO Convention 170 and Recommendation United Nations Conference on the Environment and Development (UNCED) in Brazil: Established 6 programme areas in Chapter 19, Agenda 21 Chapter 19, Agenda 21 A.Risk assessment B.Harmonization of classification and labelling of chemicals C.Information exchange D.Risk reduction programmes E.Strengthening of national chemical management capabilities and capacities F.Prevention of illegal international traffic in toxic and dangerous products UNRTDG

21 21 Chapter 19, Agenda 21 Programme B: Harmonization of classification and labelling of chemicals Specific Mandate: 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.

22 22 Technical Focal Point IFCSIOMC/CG/HCCS OECD/AG/HCLILO/HCUN CETDG Intergovernmental Forum on Chemical Safety Interorganization Programme for the Sound Management of Chemicals Coordinating Group for Harmonization Of Chemical Classification Systems Committee of Experts on Transport of Dangerous Goods (Since 1952) Advisory Group on Harmonization of Classification and labelling Working Group on Harmonization of Chemical Hazard Communication Physical Hazards Health and Environmental Hazard Criteria Hazard Communication Elements UNRTDG: Unique International Standard for Chemical Safety

23 23 Major Basis for GHS UN Transport Recommendations European Union (EU) Directives on Substances and Preparations Canadian Requirements for Workplace, Consumers and Pesticides US Requirements for Workplace, Consumers and Pesticide

24 24 Scope of GHS

25 25 What chemicals are covered by the GHS? Covers ALL hazardous chemical substances, dilute solutions and mixtures

26 26 What chemicals are NOT covered by the GHS? Articles, as defined in the United States OSHA Standard 29 CFR Pharmaceuticals, food additives, cosmetics and pesticide residues in food will not be covered but will be covered where workers may be exposed and in transport

27 27 Methyl Alcohol CH 3 OH=32.04 CAS No UN No Hazard statements: Highly flammable liquid and vapor May be harmful if swallowed Cause serious eye irritation May damage fertility or the unborn child Causes damage to organs (central nervous system, visual organ, systemic toxicity) May cause respiratory irritation May cause drowsiness and dizziness Cause damage to organs (central nervous system, visual organ) through prolonged or repeated exposure Precautionary statements: Do not handle until all safety precautions have been read and understood. Keep container tightly closed. Keep away from heat/sparks/open flame – No smoking. Wear protective gloves and eye/face protection. Do not eat, drink or smoke when using this product. Use only outdoors or in well ventilated area. Wash thoroughly after handling. United Nations Co., Ltd. 1-1, Peace Ave., Geneva Switzerland Tel Fax What will be changed by GHS? Methanol 14kg Methanol Methyl Alcohol CH 3 OH= % 14kg Flammable Toxic Provide Personal Protective Equipment. Install local ventilation system. Wash well when touched. Fraud Co., Ltd. 1-1, Error Ave., Hidden city Imaginary country X OLD NEW

28 28 Target Audience of GHS Employers Workers Transport workers Consumers Emergency responders

29 29 Roles and Responsibilities of Major Stakeholders

30 30 Stakeholders Roles and Responsibilities Manufacturer or Supplier –To classify chemicals and make labels and SDSs Employer –To provide opportunities to educate and train workers on GHS –To ensure successful implementation of GHS in the workplace Worker –To understand value and implication of information on label and SDS and to improve attitudes and practices towards chemical management

31 31 Stakeholders Roles and Responsibilities Consumer –To understand the meaning of contents of a label Government –To harmonize the domestic regulations in order to implement GHS Academe, Scientific Institutions, Professional Organizations, etc. –To do hazard assessment, information dissemination, education and information campaign, etc.

32 32 Classification Criteria

33 33 Principles of Harmonized Classification System Classification is based on the hazards resulting from intrinsic properties of chemicals. Classification is based on currently acceptable and available data. –no test requirement in GHS

34 34 Classification Criteria for Hazards Physical Hazard Health Hazard Environmental Hazard

35 35 Physical Hazards

36 36 Harmonized Criteria for Physical Hazards Explosives Flammable gases Flammable aerosols Oxidizing gases Gases under pressure Flammable liquids Flammable solids Self-reactive substances and mixtures Pyrophoric liquids Pyrophoric solids Self-heating substances and mixtures Substances and mixtures which, in contact with water, emit flammable gases Oxidizing liquids Oxidizing solids Organic peroxide Compressed gas Corrosive to metal

37 37 Flammable Liquids CategoryCriteria 1Flash point < 23 o C and initial boiling point 35 o C 2Flash point 35 o C 3 Flash point 23 o C and 60 o C 4 Flash point > 60 o C and 93 o C

38 38 Health Hazards

39 39 Harmonized Criteria for Health Hazards Acute toxicity Skin corrosion/ irritation Serious eye damage/ eye irritation Respiratory or skin sensitization Germ cell mutagenicity Reproductive toxicity Carcinogenicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard

40 40 Classification criteria for acute toxicity Acute toxicity estimate: LD 50 /LC 50 Category 1 Category 2 Category 3 Category 4 Category 5 Oral (mg/kg) See detailed criteria Dermal (mg/kg) Gases (ppm/4h) Vapours (mg/l/4h) Dusts and Mists (mg/l/4h) (LD 50 /LC 50 : lethal dose/lethal concentration causing death of 50% of test animals)

41 41 Classification Criteria for Carcinogens Category 1 Known or presumed carcinogen Category 2 Suspected carcinogen Limited evidence of human or animal carcinogenicity Subcategory 1A Known human carcinogen based on human evidence Subcategory 1B Presumed human carcinogen based on demonstrated animal carcinogenicity

42 42 Environmental Hazards

43 43 Harmonized Criteria for Environmental Hazards Hazardous to the aquatic environment

44 44 Classification Criteria for Substances Hazardous to Aquatic Environment Acute Category 1 Acute toxicity 1 mg/l Acute Category 2 Acute toxicity 1 but 10 mg/l Acute Category 3 Acute toxicity 10 but 100 mg/l Chronic Category 1 Acute toxicity <1mg/l and lack of rapid degradability and/or BCF > 500 (or, log Kow > 4) Chronic Category 2 Acute toxicity > 1 but < 10 mg/l and lack of rapid degradability and/or BCF > 500 (or, log Kow > 4) and unless chronic toxicity > 1 mg/l Chronic Category 3 Acute toxicity > 10 but < 100 mg/l and lack of rapid degradability and/or BCF > 500 (or, log Kow > 4) and unless chronic toxicity > 1 mg/l Chronic Category 4 No acute toxicity and lack of rapid degradability and BCF > 500 (or, log Kow > 4) and unless chronic toxicity >1 mg/l BCF: Bioconcentration Factor Kow: octanol/water partition coefficient

45 45 Classification of Mixtures

46 46 Classification of Mixtures Where test data are available for the complete mixture, the classification of the mixture will always be based on that data. Physical hazards: For physical hazards, test results of mixtures should be used for classification. However classification of Flammable Gases, Flammable Aerosols, Flammable Liquids and Oxidizing Gases may be determined by calculations in a specific cases.

47 47 Classification of mixtures (cont.) Health and Environmental Hazards: Where test data are not available for the mixture itself, then bridging principles included and explained in each specific chapter should be considered to see whether they permit classification of the mixture. When classifying an untested mixture based on the hazards of its ingredients, generic cut- off values or concentration limits for the classified ingredients of the mixture are used for several hazard classes in the GHS.

48 48 Hazard Communication

49 49 The sequence of chemical lifecycle

50 50 What is harmonized? Labels Safety Data Sheets (SDS)

51 51 Target Groups & Sectors Workplace including pesticides and pharmaceuticals –labels and safety data sheets Consumers –labels Transport –labels, placards, transport documents Emergency responders

52 52 Labels

53 53 Labels lThe Essential Tools 1.Symbols, Pictograms and colour 2.Signal words 3.Hazard statements 4.Precautionary statements and pictograms 5.Product identifiers/declaration of ingredients 6.Supplier identification

54 54 GHS Symbols Gas cylinderSkull & crossbones Exclamation Mark Health Hazard Environmental Hazard FlameFlame over circle Exploding bomb Corrosion

55 55 GHS Pictogram Explosives Self-reactive subst. Organic peroxide Flammable substance Self-reactive substance Pyrophoric and self- heating substance Organic peroxides Oxidizing substance Compressed gasSkin corr./irrit. Eye damage/irrit. Corrosive to metal Environmental hazard Acute toxicity Skin corr./irrit. Eye corr./irrit. Sensitization (Dermal) Target organ toxicity Sensitization (Respiratory) Mutagenicity Carcinogenicity Reproductive toxicity Target organ toxicity Aspiration hazard

56 56 UNRTDG Pictograms

57 57 Precedence of pictograms Skin/Eye irritation Skin sensitization, Skin/Eye irritation Respiratory sensitization

58 58 Signal Word Danger or Warning Used to emphasis hazard and to discriminate between hazard categories (level of hazard) Example: Acute toxicity Category 1, 2, 3 Danger, Category 4 Warning Danger Warning

59 59 Hazard Statements A single harmonised hazard statement for each hazard category within each hazard class e.g. Flammable liquid –Category 1 Extremely flammable liquid and vapour –Category 2 Highly flammable liquid and vapour –Category 3 Flammable liquid and vapour –Category 4 –Combustible liquid

60 60 Hazard Statements (cont.) e.g. Acute toxicity –Category 1 Fatal if swallowed –Category 2 Fatal if swallowed –Category 3 Toxic if swallowed –Category 4 Harmful if swallowed –Category 5 Maybe harmful if swallowed

61 61 Precautionary Statements A precautionary statement means a phrase that describes recommended measures that should be taken to minimize or prevent adverse effects resulting from exposure to hazardous product, or improper storage or handling of a hazardous product.

62 62 Precautionary Statements (cont.)

63 63 Examples of Precautionary Pictograms From European Union (COUNCIL DIRECTIVE 92/58/EEC of 24 June 1992)

64 64 Product Identifier Substances –chemical identity (name as determined by IUPAC, ISO, CAS or technical name) Mixtures –chemical identities of all ingredients contributing to acute toxicity, skin or eye corrosion, mutagenicity, carcinogenicity, reproductive toxicity, skin or respiratory sensitisation or Target Organ Toxicity UN proper shipping name also to be used on the package when substance or mixture covered by the UN RTDG

65 65 Other Points to Consider

66 66 Declaration of Ingredients Competent authorities should establish appropriate mechanisms for CBI (Confidential Business Information) protection. CBI will not be harmonized under the GHS. CBI claims should be limited to the names of chemicals and their concentrations in mixtures. Mechanisms should be established for disclosure in emergency and non-emergency situations.

67 67 Supplementary Information Information on labels not harmonized under the GHS but are important may be placed on labels. Competent authorities determines if additional information are needed. Suppliers may choose to add supplementary information on their own initiative.

68 68 Category 1 Category 2 Category 3 Category 4 Category 5 Danger Fatal if swallowed Danger Fatal if swallowed Danger Toxic if swallowed Warning Harmful if Swallowed No Symbol Warning May be harmful if swallowed Allocation of Label Elements Example : Acute Toxicity (Oral)

69 69 Methanol Methyl Alcohol CH 3 OH=32.04 CAS No UN No Product identifier Pictogram Signal word Hazard statements: Highly flammable liquid and vapor May be harmful if swallowed Cause serious eye irritation May damage fertility or the unborn child Causes damage to organs (central nervous system, visual organ, systemic toxicity) May cause respiratory irritation May cause drowsiness and dizziness Cause damage to organs (central nervous system, visual organ) through prolonged or repeated exposure Hazard statements Precautionary statements: Do not handle until all safety precautions have been read and understood. Keep container tightly closed. Keep away from heat/sparks/open flame – No smoking. Wear protective gloves and eye/face protection. Do not eat, drink or smoke when using this product. Use only outdoors or in well ventilated area. Wash thoroughly after handling. Precautionary statements United Nations Co., Ltd. 1-1, Peace Ave., Geneva Switzerland Tel Fax Supplier identification Example of label elements 14 kg

70 70 Safety Data Sheet (SDS)

71 71 Safety Data Sheet (SDS) Primarily workplace use Criteria for SDS production For all substances and mixtures which meet the harmonized criteria for physical, health or environmental hazards under the GHS.

72 72 Cut off values/Concentration limits for health and environmental hazard class Hazard class Cut-off value /Concentration limit Acute toxicity 1.0 Skin Corrosion/Irritation 1.0 Serious damage to eyes/eye irritation 1.0 Respiratory/Skin sensitization 1.0 Mutagenicity: Category1 0.1 Mutagenicity: Category2 1.0 Carcinogenicity 0.1 Reproductive toxicity 0.1 Specific target organ toxicity (single Exp.) 1.0 Specific target organ toxicity (repeat Exp.) 1.0 Hazardous to the aquatic environment 1.0

73 73 SDS 16 Headings 1.Identification of the substance or mixture and of the supplier 2. Hazard(s) identification 3.Composition/informatio n 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 including information on preparation and revision of the SDS

74 74 Factors to Consider in the GHS Implementation

75 75 Points to implement GHS Harmonization Building Block Approach Translation into the local language Comprehensibility test Risk-based labelling

76 76 Harmonization Harmonization means establishing a common and coherent basis for chemical hazard classification and communication, from which the appropriate elements relevant to means of transport, consumer, worker and environment protection can be selected.

77 77 Building Block Approach Flammable liquids Explosives Oxidizing gases Pyrophoric solids Self reactive substances Corrosive to metals Aquatic toxicity Acute toxicity Carcinogen Reproductive toxicitySensitization Skin corrosion/irritation Mutagenicity Physical hazardHealth hazardEnvironmental hazard Transport Consumers Workplace Pesticides Self heating substances Label requirementSafety data sheet

78 78 Building Block Approach Category 1Category 2Category 3Category 4Category 5 Danger Fatal if swallowed Danger Fatal if swallowed Danger Toxic if swallowed Warning Harmful if Swallowed No Symbol Warning May be harmful if swallowed Not required under the UNRTDG Example : Acute Toxicity (Oral)

79 79 Translation The GHS will be the basis for chemical management in the country or region. Without the GHS document in the local language, without GHS implementation. Translation should be harmonized in different sectors.

80 80 Comprehensibility Test Some information, like pictograms, on a GHS label may be very new to the public. Comprehensibility test on the GHS label or SDS can be recommended before implementing the GHS.

81 81 Risk-based Labelling All systems should use the GHS classification criteria based on hazard. However, competent authorities may authorize consumer labelling systems to provide information based on the likelihood of harm (risk-based labelling). Risk-based labelling maybe done only on chronic health effects (e.g. Specific Target Organ Toxicity following repeated exposure, reproductive toxicity and carcinogenicity).

82 82 Other Issues

83 83 Plans for International Implementation The GHS: will be a non-mandatory recommendation available to countries to implement, but once implemented in the local regulations, it will be mandatory. will be operational in every country before 2008.

84 84 ECOSOC GHS Structure UN ECOSOC Committee of Expert on TDG/GHS Sub-Committee of Experts on TDG Sub-Committee of Experts on GHS

85 85 Technical work concerning GHS Classification –Physical hazards TDG –Health hazard OECD –Environmental hazards OECD Supports to implement GHS in developing countries or countries with economy in transition UNITAR

86 86 Revision of GHS document The GHS document is regularly revised and updated to reflect national, regional and international experiences in implementing requirements into national, regional and international laws, as well as experiences of those doing the classification and labelling.

87 87 Updating of information Suppliers should respond to new and significant information they receive about a chemical hazard by updating the label and safety data sheet for that chemical.

88 88 Other International Programs synchronized with GHS Basel Convention (Wastes) Montreal Protocol (Ozone depleting substances) REACH (Registration, Evaluation, Authorization of Chemicals) Control Banding (Chemical management)

89 89 Information source Agenda 21, Chapter 19 _welcome_e.html GHS homepage m (EU REACH) ns/index.html (US OSHA) (UNITAR)

90 90 Hidden slides The slides after this one should be hidden, but appear by double clicking the item concerned.

91 91 Article US OSHA 29 CFR A manufactured item other than a fluid or particle: (i)which is formed to a specific shape or design during manufacture; (ii)which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii)which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical, and does not pose a physical hazard or health risk to employees.

92 92 Items under each headings 1. Identification of the substance or mixture and of the supplier GHS product identifier. Other means of identification. Recommended use of the chemical and restrictions on use. Suppliers details (including name, address, phone number etc). Emergency phone number. 2. Hazards identification GHS classification of the substance/mixture and any national or regional information. GHS label elements, including precautionary statements. (Hazard symbols may be provided as a graphical reproduction of the symbols in black and white or the name of the symbol e.g. flame, skull and crossbones.) Other hazards which do not result in classification (e.g. dust explosion hazard) or are not covered by the GHS.

93 93 3. Composition/information on ingredients Substance Chemical identity. Common name, synonyms, etc. CAS number and other unique identifiers. Impurities and stabilizing additives which are themselves classified and which contribute to the classification of the substance. Mixture The chemical identity and concentration or concentration ranges of all ingredients which are hazardous within the meaning of the GHS and are present above their cut-off levels. NOTE: For information on ingredients, the competent authority rules for CBI take priority over the rules for product identification.

94 94 4. First aid measures Description of necessary measures, subdivided according to the different routes of exposure, i.e. inhalation, skin and eye contact and ingestion. Most important symptoms/effects, acute and delayed. Indication of immediate medical attention and special treatment needed, if necessary. 5. Fire-fighting measures Suitable (and unsuitable) extinguishing media. Specific hazards arising from the chemical (e.g. nature of any hazardous combustion products). Special protective equipment and precautions for firefighters. 6. Accidental release measures Personal precautions, protective equipment and emergency procedures. Environmental precautions. Methods and materials for containment and cleaning up.

95 95 7. Handling and storage Precautions for safe handling Conditions for safe storage, including any incompatibilities. 8. Exposure controls/personal protection. Control parameters e.g. occupational exposure limit values or biological limit values. Appropriate engineering controls. Individual protection measures, such as personal protective equipment. 9. Physical and chemical properties Appearance (physical state, colour etc). Odour. Odour threshold. PH. Melting point/freezing point. Initial boiling point and boiling range. Flash point. Evaporation rate. Flammability (solid, gas). Upper/lower flammability or explosive limits. Vapour pressure. Vapour density. Relative density. Solubility(ies). Partition coefficient: n- octanol/water. Auto-ignition temperature. Decomposition temperature.

96 Stability and reactivity Chemical stability. Possibility of hazardous reactions. Conditions to avoid (e.g. static discharge, shock or vibration). Incompatible materials. Hazardous decomposition products. 11. Toxicological information Concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects, including: information on the likely routes of exposure (inhalation, ingestion, skin and eye contact); Symptoms related to the physical, chemical and toxicological characteristics; Delayed and immediate effects and also chronic effects from short- and long-term exposure; Numerical measures of toxicity (such as acute toxicity estimates). 12. Ecological information Ecotoxicity (aquatic and terrestrial, where available). Persistence and degradability. Bioaccumulative potential. Mobility in soil. Other adverse effects.

97 Disposal considerations Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging. 14. Transport information UN number. UN Proper shipping name. Transport hazard class(es). Packing group, if applicable. Marine pollutant (Yes/No). Special precautions which a user needs to be aware of or needs to comply with in connection with transport or conveyance either within or outside their premises. 15. Regulatory information Safety, health and environmental regulations specific for the product in question. 16. Other information including information on preparation and revision of the SDS


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