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Introduction to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) August 2011.

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Presentation on theme: "Introduction to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) August 2011."— Presentation transcript:

1 Introduction to the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) August 2011

2 Course Objectives Understand how and why the GHS was developed Understand the purpose, objectives and benefits of the GHS Understand the scope and application of the GHS Become familiar with the basic elements of the GHS Understand the GHS in relation to other international agreements and standards 2

3 Chapter 1 Background, Context, and Scope and Application of the GHS Lesson 1: Background on the GHS Lesson 2: Scope and Application of the GHS

4 Chapter 1: Objectives Learn what the GHS is, and who is responsible for it Understand why the GHS was developed, and how it relates to other international agreements and standards Learn how the GHS was developed 4

5 Lesson 1: Background on the GHS This lesson will show: What is the GHS What is the “Purple Book” Why and how the GHS was developed What the role of the GHS is in chemical safety management Who is responsible for the GHS How GHS relates to other international agreements and standards on chemicals 5

6 The GHS The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) is: An international system that harmonises the classification and labelling of hazardous chemicals A logical and comprehensive approach for: Defining health, physical, and environmental hazards of chemicals Applying agreed hazard criteria to classify chemicals based on their hazardous effects Communicating hazard information on labels and safety data sheets 6

7 The Purple Book United Nations (UN) publication of the GHS Outlines the provisions in four parts: Introduction (scope, definitions, hazard communication) Classification criteria for physical hazards Classification criteria for health hazards Classification of environmental hazards 7

8 Annexes 8 Annex 1Allocation of label elements Annex 2Classification and labeling summary table Annex 3Codification of hazard statements, codification and use of precautionary statements and examples of precautionary pictograms Annex 4Guidance on the preparation of Safety Data Sheets (SDS) Annex 5Consumer product labeling based on the likelihood of injury Annex 6Comprehensibility testing methodology Annex 7Examples of arrangements of the GHS label elements Annex 8An example of Classification in the Globally Harmonized System Annex 9Guidance on hazards to the aquatic environment Annex 10Guidance on transformation/dissolution of metals and metal compounds in aqueous media

9 9 Need for the GHS

10 Why was the GHS developed Chemicals contribute to improving the standard of living around the world: Purifying water Promoting growth of food Improving hygiene Producing essential goods Use of these chemicals involves risks to safety and health 10

11 How extensive is chemical use? The world’s largest substance data base is the Chemical Abstracts Service Registry: Currently has over 60 million organic and inorganic substances recorded Not all are produced on a regular basis Potential for harm to people is great: Chemicals cause a broad range of health effects and adverse effects on the environment The International Labor Organization (ILO) estimates that 25% of workplace deaths worldwide are due to chemical exposures 11

12 Availability of chemical information Many countries have tried to address protection from chemicals through laws that require dissemination of information about their hazards: These laws are similar, but vary in definitions of hazards covered, information required on labels, and provisions for safety data sheets The result is a disparity in the extent of information provided, the form it is provided in, and the coverage of chemicals and people Other countries have no coverage 12

13 Results of conflicting requirements Extensive international trade in chemicals results in exposed people seeing a wide variety of labels and safety data sheets Differences in communication practices lead to differences in effectiveness The broad range of provisions also leads to technical barriers to trade Small companies in particular are effectively left out of international trade by the difficulties of complying with all these requirements 13

14 14

15 The GHS addresses these issues Provides a chemical classification and labelling system that is updated and maintained internationally Includes provisions for a common and coherent approach to classifying hazards and preparing labels and safety data sheets Results in more effective communication worldwide Facilitates trade in chemicals 15

16 Benefits of the GHS Provides global benefits, as well as benefits to governments, industry, and chemical users (workers and consumers): Enhances the protection of human health and the environment through the provision of harmonised chemical safety and health information Reduces the need for duplicative testing of chemicals Provides the informational infrastructure for chemical safety and health management programs Increases efficiencies; reduces costs of compliance; lowers health care costs, etc. 16

17 How was the GHS developed? International mandate was adopted in the 1992 United Nations Conference on Environment and Development: 17 “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.”

18 Development of the GHS Agenda 21 of the UNCED agreements included the mandate, and instructed the developers to build on existing systems The process ultimately included numerous countries, multiple international organizations, and many stakeholder representatives The GHS was developed based on consensus among the participants 18

19 What is the GHS based on? A meeting of experts convened by the ILO identified the following existing systems as the primary basis for the GHS: Requirements of systems in the United States for the workplace, consumers and pesticides Requirements of Canada for the workplace, consumers and pesticides European Union directives for classification and labelling of substances and preparations The United Nations Recommendations on the Transport of Dangerous Goods 19

20 Basis Principles of Harmonisation In order to guide the discussions, the participants agreed to a set of basic principles Key among these was an agreement that the level of protection offered by existing systems would not be reduced as a result of harmonising the provisions This allowed countries to participate in negotiations on the basis that the protection of their current systems would be maintained or enhanced as a result of harmonisation 20

21 Other principles The GHS would be based on the classification of hazards (i.e., intrinsic properties) Sectors would be able to choose those parts of the GHS relevant to them Hazard communication would be addressed in addition to classification Comprehensibility (communicating information in an understandable manner) is key Validated data can continue to be used Confidential business information needs to be addressed 21

22 Who developed the GHS? The Interorganization Programme for the Sound Management of Chemicals’ Coordinating Group for the Harmonisation of Chemical Classification Systems managed the process of harmonisation The Coordinating Group included representatives of interested countries, international organizations, and stakeholders The technical work was completed by technical focal points with expertise in the area involved 22

23 International organization responsibilities International Labor Organization (ILO): Secretariat for the Coordinating Group and the hazard communication work group Organization for Economic Cooperation and Development (OECD): Secretariat for health and environmental hazard criteria, including mixtures United Nations’ Subcommittee of Experts on the Transport of Dangerous Goods: Secretariat for physical hazard criteria 23

24 Who is responsible for implementing the GHS? The type of international legal instrument the GHS is considered to be is a “non-mandatory recommendation” The GHS provisions become mandatory in countries or regions that adopt the GHS Overseeing national or regional implementation is the responsibility of the competent authorities that adopt the GHS provisions. There is no international body that monitors implementation for compliance 24

25 Who is responsible Internationally, the UN Subcommittee of Experts on the GHS is responsible for the maintenance, updating and promotion of the GHS: Over 30 countries have jointed the S/C Observer countries and stakeholders also participate 25

26 26 GHS as the Basis for National Chemicals Management Programmes

27 GHS/Other international instruments Strategic Approach to International Chemicals Management (SAICM) Rotterdam Convention/Prior Informed Consent (PIC) Stockholm Convention/Persistent Organic Pollutants (POPs) Basel Convention/Hazardous Waste ILO Instruments re: chemicals International Chemical Control Toolkit (Control Banding) 27

28 Lesson 2: Scope and application of the GHS This lesson will show: What chemicals are covered in the GHS Sectors affected by the GHS How the hazard communication components are applied The Building Block approach Principles of hazard vs. risk Principles of consumer product labelling based on likelihood of injury 28

29 What chemicals are covered? All hazardous chemicals are covered: Includes substances, products, mixtures, preparations, formulations, and solutions. 29

30 Chemical product life cycle 30

31 Application of the hazard communication components The need for labels and safety data sheets varies by the product and the stage of the life cycle: Pharmaceuticals, food additives, cosmetics, and pesticide residues in food will not be covered at the point of consumption (e.g., where a patient is taking a pharmaceutical), but will be covered in the workplace and in transport These types of products are generally regulated based on risk where the consumer is exposed so are not subject to hazard communication 31

32 Sectors affected by the GHS The GHS is intended to cover any place where people are exposed to hazardous chemicals Considering coverage of chemicals by sector is a convenient way to indicate different ways they may be covered due to differing exposures However, countries may identify the sectors in any way that is appropriate to their regulatory system, as long as they consider all types of exposures 32

33 Sectors that may be considered Industrial workplace: Workers are a key sector to be considered. Chemicals are often present in all types of workplaces, from manufacturing facilities to construction, retail services to health care. Agriculture (pesticides): Involves both workplace and consumer exposures, and is often regulated separately by countries. 33

34 Sectors, cont. Transport (emergency response): Another subset of occupational exposures that is often regulated separately. Involves many provisions beyond classification and labelling (e.g., packaging). These are addressed in the UN Recommendations on the Transport of Dangerous Goods. Also impacts public exposures. Consumer Products (public): Involves products sold to the general public, and exposures of vulnerable populations (e.g., children). 34

35 Building block approach The GHS includes all of the regulatory tools needed to cover any of the sectors, hazards, or chemicals present: Competent authorities can choose their own scope of coverage from the comprehensive choices presented in the GHS Coverage may vary among sectors in the same country The GHS provides the building blocks to construct an appropriate regulatory system 35

36 Expected sector application Transport: similar to current transport system covering physical hazards, acute toxicity, corrosivity, and aquatic toxicity; pictograms used to convey hazards Workplace: all types of health and physical hazards; labels and safety data sheets, supplemented by training Consumers: labels primary focus 36

37 Differentiating hazard vs. risk GHS is based primarily on the identification of the intrinsic properties of chemicals (hazards) that may cause harm Risk is the likelihood of the harm, and is characterized by relating the expected exposure to the hazard identified 37 Hazard x Exposure = Risk

38 GHS Hazard Classification  The purpose of the GHS is to provide information about the hazards of a chemical in order to help people determine the appropriate protections. This involves identifying the hazard; assessing the severity of the effect; and communicating the information to users.  When chemical users have information about the hazards, they can relate it to the exposure where it is used, and thus determine the risk. This is referred to as risk assessment. Determining the way to protect people is risk mitigation. Risk assessment and risk mitigation are uses of the GHS hazard classifications. 38

39 Hazard Assessment Process 39

40 Risk Assessment 40

41 Optional consumer product labels Some systems provide information on consumer labels regarding chronic health hazards only after considering risk (not based on hazards alone) Since labels are the only means to provide information to consumers, these systems consider it important to consider the likelihood of injury before providing information on chronic effects Annex 5 of the GHS outlines general principles for this process while not addressing harmonisation of risk-based labelling for consumer products 41

42 Lesson 1Classification Lesson 2Hazard Communication Chapter 2 Technical Overview of the GHS

43 Chapter 2 Objectives Be familiar with the main elements of the GHS Understand who is responsible for development of the elements Learn what hazards are covered by the GHS Learn what the GHS hazard communication tools include and how the information is obtained by users 43

44 Lesson 1: Classification This lesson will show: How classification is done under the GHS, and who is responsible for it What physical, health, and environmental hazards are covered under the GHS 44

45 What is hazard classification? The GHS describes the process as follows: Identification of relevant data regarding the specific hazard of the substance or mixture. Subsequent review and quality check of those data to ascertain the hazards associated with the substance or mixture. A decision on whether the substance or mixture will be classified as a hazardous substance or mixture and the degree of hazard, where appropriate, by comparison of the data with agreed hazard classification criteria. 45

46 Key definitions “Hazard class” means the nature of the physical, health or environmental hazard, e.g., flammable solid, carcinogen, oral acute toxicity “Hazard category” means the division of criteria within each hazard class, e.g. oral acute toxicity includes five hazard categories and flammable liquids include four hazard categories 46

47 Acute Toxicity 47

48 Who classifies hazards? The GHS is designed to be a “self” classification system, i.e., chemical manufacturers classify their products based on evaluation of data and expert judgment Some competent authorities may choose to classify chemicals, and provide lists of classifications Chemical users do not have to undertake the classification process, but can rely on the information provided by their suppliers with the products when they purchase them 48

49 How were the criteria developed? Physical hazard criteria were based on the existing definitions in the UN transport system, revised to address other sectors Health and environmental hazard criteria in existing systems were compared and analyzed The most current scientific information was reviewed (and will be updated as necessary by the Subcommittee) Negotiators agreed to harmonised approaches based on the information assembled 49

50 50

51 51 Health Hazards Hazard Class Hazard Category Acute Toxicity 12345 Acute Toxicity: Oral Acute Toxicity: Dermal Acute Toxicity: Inhalation Skin Corrosion/Irritation 1A1B1C23 Serious Eye Damage/Eye Irritation 12A2B Respiratory or Skin Sensitisation 11A1B Germ Cell Mutagenicity 1A1B2 Carcinogenicity 1A1B2 Reproductive Toxicity - Fertility 1A1B2Lactation Specific Target Organ Toxicity - Single Exposure 123 Specific Target Organ Toxicity - Repeated Exposure 12 Aspiration hazard 12

52 52 Environmental Hazards Hazard ClassHazard Category Aquatic toxicity, acute 123 Aquatic toxicity, chronic 1234 Hazardous to the ozone layer 1

53 Mixture Classification  Where test data are available for the complete mixture, the classification will generally be based on that data.  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. Bridging principles allow extrapolation of data from similar mixtures to perform classifications of untested mixtures. 53

54 Mixture Classification, cont. In addition, for health and environmental hazards: If (i) test data are not available for the mixture itself, and (ii) the available information is not sufficient to allow application of the above mentioned bridging principles, then the agreed method(s) described in each chapter for estimating the hazards based on the information known will be applied to classify the mixture. 54

55 Lesson 2: Hazard communication This lesson will show: The purpose of hazard communication in the GHS The core label elements on a GHS label How to read a label and find the GHS information How to identify the elements of a safety data sheet (SDS) in the GHS How to find information in a GHS SDS How confidential business information is addressed in the GHS 55

56 Hazard communication tools Once the hazards are identified in the classification process, the information must be provided to: Downstream users and handlers Professionals providing services or designing protective measures for those exposed Information provided must be accurate, comprehensive, and provided in an understandable manner Information tools and needs may vary by sector 56

57 Comprehensibility principles Information should be conveyed in more than one way. Comprehensibility should consider the findings of existing studies and data. Phrases indicating degree of hazard should be consistent across different hazard types. Words and phrases should retain comprehensibility when translated into other languages. Format and color of the label elements and SDS format should be standardized. 57

58 Tools available Labelling/Placards Safety Data Sheets (SDSs)/Transport Documents Training 58

59 Tools available by sector Workplace/industrial sector: labels, SDSs, specific training Agriculture/pesticides: labels, specific training, SDSs in some situations Consumers: labels Emergency responders: labels, placards, specific training, transport documents Transport: labels, placards, transport documents, specific training 59

60 Hazard vs. risk communication GHS is a hazard communication system—the information is provided on the basis of the intrinsic properties of the chemical It is difficult for suppliers to fully understand the exposures that may be generated by their users The information provided should lead to risk mitigation—having hazard information allows users to choose appropriate protective measures 60

61 Confidential business information The GHS recognizes that there is legitimate confidential business information regarding chemicals, and that there is a legitimate safety and health need for disclosure of that information in some situations The GHS provides principles regarding CBI that countries should follow when addressing this issue 61

62 CBI Principles Limit to chemical names/concentrations Indicate information has been withheld Disclose CBI to competent authority on request Disclose to medical professionals in emergencies Non-emergency disclosure should be done where there is a need and a means to protect confidentiality Process for challenges to disclosure 62

63 Understand and read GHS labels Harmonised label elements: Symbol/pictogram Signal word Hazard statement(s) Other core information to be provided Product identifier Supplier identification Precautionary statement(s) 63

64 Allocation of label elements 64

65 65

66 66

67 Signal words Signal words serve two purposes in the GHS: Get the attention of the label reader Indicate the severity of the hazard There are two signal words in the GHS Danger Warning 67

68 Hazard statements Describe the hazards covered by the GHS Indicate the degree of severity of the hazard Text of the statements has been harmonised Harmonised statements are assigned to each hazard class and category, and have been codified (a numbering system has been applied to them for ease of reference) Example: H318 Causes serious eye damage. 68

69 Allocation of harmonised label elements The GHS includes an appendix which specifies the harmonised label elements for each hazard class and category: Pictogram Signal word Hazard statement 69

70 70

71 Other required information Precautionary statements are required. The GHS includes possible statements, but they have not yet been harmonised There are 5 types of statements: General, Prevention, Response, Storage, and Disposal These have been assigned to hazard classes and categories, and codified (numbered). Example: P280 Wear eye protection/face protection. 71

72 Precautionary pictograms Some systems may choose to illustrate precautionary information using pictograms. These are not harmonised in the GHS. 72

73 Product and supplier identification Chemical identity required for substances For mixtures either: All the ingredients contributing to the hazard of the mixture/alloy, or All the ingredients contributing to any health hazards presented by the product other than irritation and aspiration Supplier identification required on all labels, including name, address, and phone number 73

74 Other label provisions Supplementary information may also be required or permitted by competent authorities to provide other items such as directions for use Competent authorities should also specify how often labels are to be updated 74

75 GHS Label 75 ToxiFlam (Contains XYZ Hazardous Ingredients) Toxic if Swallowed Highly Flammable Liquid and Vapour IF SWALLOWED: Immediately call a Poison Control Center or physician. Rinse mouth. Do not eat, drink, or use tobacco when using this product. Wash hands thoroughly after handling. Wear protective gloves and eye/face protection. Keep container tightly closed. Keep away from heat/sparks/open flame. No smoking. Ground containers and receiving equipment. Use explosion- proof electrical equipment. Take precautionary measures against static discharge. Use only non-sparking tools. Store in cool/well-ventilated place. In case of fire, use water fog, dry chemical, carbon dioxide or “alcohol” foam. ToxiFlam Manufacturing CompanyRoute 66, MyTown, TX 000001 555 666 8888

76 Combination GHS/transport label 76

77 Workplace labeling 77

78 GHS safety data sheet Comprehensive sources of information about substances and mixtures Provides information about the hazards, but also information to establish risk management programs Audiences for the 16 sections vary, but include workers, safety engineers, physicians, and other professionals providing protection to exposed people 78

79 SDS 16 sections specified in a given order of information Information in the beginning sections have a broad audience More detailed, technical information included in following sections Required for substances/mixtures meeting criteria; mixtures containing chronic hazards above cut- offs; and unclassified substances or mixtures as required by competent authorities 79

80 Minimum SDS Information by Section 80

81 Minimum SDS Information by Section cont. 81

82 Minimum SDS Information by Section cont. 82

83 Minimum SDS Information by Section cont. 83

84 Chapter 3 Other Issues Related to Implementation 84

85 UNITAR Steps to Implementation UNITAR has identified the following outcomes as leading to a successful implementation process:  Multi-stakeholder engagement and collaboration  Situation and gap analysis  Awareness raising and training  National GHS-implementing legislation  Sectoral implementation plans  High-level endorsement of a National GHS Implementation Strategy (“road map” for future activities) 85

86 UNITAR/ILO Approach for GHS Implementation 86

87 Participatory Process Questions to consider re: stakeholder involvement: What types of groups are relevant? What is the nature of participation by business and industry, and civil society” What types of resources are available to support involvement? How will lead organizations/points of contact be identified? 87

88 Types of Activities to Involve Stakeholders  Information and awareness raising meetings  Industry or civil society-specific workshops  Training and information-sharing  Committees  Review/comment on draft policies/legislation  Develop networking and alliances  Involvement in the UN Subcommittee of Experts on GHS 88

89 Legislative options Depends on a number of factors: Existing industrial infrastructure Legal frameworks Implementation capacity UNITAR Guidance Document: Developing a National GHS Implementation Strategy (2010) 89

90 Common Implementation Issues  GHS Building Block approach and its application vs. international harmonisation for each sector  Need to improve “harmonisation” of implementation as an on-going process (e.g. consultation with trading partners, transition times, regional coordination, sharing experience, etc.)  Countries need to recognize that to be harmonised, they must give up some of their existing requirements while maintaining overall protections 90

91 Contacts Training and Capacity Building Programmes in Chemicals and Waste Management UNITAR Palais des Nations CH-1211 Geneva 10 Switzerland Fax:+ 41 22 917 8047 91

92 Contacts Orange House Partnership npo/VZW Postal address: Kampendaal 83, 1653 Dworp (Brussels), Belgium Visiting address: Rond Point Schuman 9, 6 th floor, 1040 Brussels, Belgium Tel: +32 23045903 Email: Website: 92

93 Photo Credits UNITAR (Zambian chemical worker) US Chemical Safety and Hazard Investigation Board (chemical incidents) US Environmental Protection Agency (heavy equipment operation) 93


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