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Regional GHS Workshop for Arab Countries

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1 Regional GHS Workshop for Arab Countries
Alexandria/Egypt, 30 Oct. – 2 Nov. 2006 The GHS: Overview Presentation by Burkhard Wagner UNITAR Special Fellow

2 Acknowledgement Burkhard Wagner thanks
Peter Dawson, New Zealand, Environmental Risk Management Authority (ERMA), and CEFIC, Brussels for using their Power-Point Presentations

3 OUTLINE Background Provisions of the GHS 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

4 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 (original target date) It is now Rio +14

5 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

6 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)

7 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

8 UN SCE GHS Governments Industry Public Interest 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

9 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)

10 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

11 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.

12 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)

13 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

14 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

15 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

16 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

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

18 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

19 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

20 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

21 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 Allocation of Labelling elements Annex 2 Classification & Labelling Summary Tables Annex 3 Precautionary Statements and Pictogrammes Annex 4 Guidance on the preparation of SDSs Annex 5 Consumer Product Risk Based Labelling Annex 6 Comprehensibility Testing Methodology Annex 7 Labelling Examples Annex 8 Classification Example Annex 9 Guidance Document on the aquatic environment Annex 10 Guidance Document on metals

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

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


25 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

26 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

27 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

28 Hazard Classification
GHS Hazard Classification

29 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

30 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 !

31 Physical hazards in the GHS
Explosives (Chap.2.1) Flammable gases (Chap.2.2) Flammable aerosols (Chap.2.3) Oxidizing gases (Chap.2.4) Gases under pressure (Chap.2.5) Flammable liquids (Chap.2.6) Flammable solids (Chap.2.7) Self-reactive substances and mixtures (Chap.2.8) Pyrophoric liquids (Chap.2.9)

32 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

33 Physical Hazard Classification: Explosives
Hazard Communication: Unstable Explosives Division 1.1 Division 1.2 Division 1.3 Division 1.4 Division 1.5 Division 1.6 Nature of Hazard Thermally unstable or very sensitive Mass explosion hazard Projection hazard Fire or minor projection hazard No significant hazard Insensitive substances/ mass explosion hazard Insensitive articles/no mass explosion hazard Pictogram UN TDG Signal word Danger Warning - 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

34 Hazard Class Hazard Category
Explosives Unstable Explosives Div1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6 Flammable Gases 1 2 Flammable Aerosols 1 2 Oxidising Gases 1 Pressurised Gases Compressed Gases 1 Liquefied Gases 1 Refrigerated Liquefied Gases 1 Dissolved Gases 1 Flammable Liquids 1 2 3 4 Flammable Solids 1 2 Self-reactive Substances Type A Type B Type C Type D Type E Type F Type G Pyrophoric Liquids 1 Pyrophoric Solids 1 Self-heating Substances 1 2 Water ReactiveFlammable Gases 1 2 3 Oxidising Liquids 1 2 3 Oxidising Solids 1 2 3 Organic Peroxides Type A Type B Type C Type D Type E Type F Type G Corrosive to Metals 1

35 Health Hazards 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 1(Corrosion) 1A 1B 1C
GHS Human Health Effects Health Hazards Hazard Class Hazard Category Acute Toxicity, Oral 1 2 3 4 5 Acute Toxicity, Dermal 1 2 3 4 5 Acute Toxicity, Inhalation 1 2 3 4 5 Aspiration hazard 1 2 Skin Corrosion/Irritation (Dermal Corrosion = Eye Corrosion) 1(Corrosion) Irritation 1A 1B 1C 2 3 Respiratory Sensitisation Skin Sensitisation Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity - Fertility Reproductive Toxicity - Development Target Organ ST – Single Dose Eye Irritation Target Organ ST – Repeat Dose 1 2A 2B 1 1 1A 1B 2 1A 1B 2 1A 1B 2 Lactation 1A 1B 2 1 2 3 1 2

36 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

37 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

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

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

40 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)

41 Acute toxicity: decision logic (1)
Cont’d Substance: Are there data and/or information to evaluate acute toxicity? No Classification not possible Yes According to the criteria, does the substance have an: Oral LD50  5 mg/kg bodyweight, or Dermal LD50  50 mg/kg bodyweight, or Inhalation (gas) LC50  100 ppm, or Inhalation (vapour) LC50  0.5 mg/l, or Inhalation (dust/mist) LC50  0.05 mg/l? Category 1 Danger · Oral LD50 >5 but < 50 mg/kg bodyweight, or · Dermal LD50 >50 but < 200 mg/kg bodyweight, or · Inhalation (gas) LC50 >100 but < 500 ppm, or · Inhalation (vapour) LC50 > 0.5 but < 2.0 mg/l, or · Inhalation (dust/mist) LC50 >0.05 but  0.5 mg/l? Category 2 Yes

42 Acute toxicity: decision logic (2)
No According to the criteria, does substance have an: · Oral LD50 >50 but < 300 mg/kg bodyweight, or · Dermal LD50 > 200 but < 1000 mg/kg bodyweight, or · Inhalation (gas) LC50 >500 but < 2500 ppm, or · Inhalation (vapour) LC50 >2 but < 10.0 mg/l, or · Inhalation (dust/mist) LC50 >0.5 but < 1.0 mg/l? Yes Category 3 Danger According to the criteria, does the substance have an: · Oral LD50 >300 but < 2000 mg/kg bodyweight, or · Dermal LD50 >1000 but < 2000 mg/kg bodyweight, or · Inhalation (gas) LC50 >2500 but < 5000 ppm, or · Inhalation (vapour) LC50 >10 but < 20 mg/l, or · Inhalation (dust/mist) LC50 >1 but < 5 mg/l? Category 4 Warning Cont’d No

43 Acute toxicity: decision logic (3)
According to the criteria, does the substance have an: · Oral LD50 >2000 but < 5000 mg/kg bodyweight, or · Dermal LD50 >2000 but < 5000 mg/kg bodyweight, or · Inhalation (gas, vapour and/or dust/mist) LC50 in the equivalent range of the oral and dermal LD50 (i.e., mg/kg bodyweight) No Yes Category 5 Warning · 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? Classify in Category 5 (Warning) if assignment to a more hazardous class is not warranted Not classified

44 Carcinogenicity: decision logic
Does the substance have carcinogenicity data? No Classification not possible Yes 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. Category 1 Danger 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. Category 2 Warning Not classified

45 Classification criteria for mixtures
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

46 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

47 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

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

49 Hazard Communication Labels
GHS Hazard Communication Labels

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

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

52 GHS Pictograms !

53 Transport Pictograms

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

55 Pictogram Frame Colour Symbol

56 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

57 Hazard Communication Label Elements
Pictograms GHS UNRTDG

58 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.

59 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)

60 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

61 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.

62 Precautionary Statements
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)

63 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;

64 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.

65 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

66 Labelling according to GHS: Example of arrangement of label elements
Additional examples of arrangements of the GHS labels may be found in Annex 7 of the GHS

67 Hazard Communication Safety Data Sheets (SDS)
GHS Hazard Communication Safety Data Sheets (SDS)

68 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

69 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.

70 Safety Data Sheet: Format
Information should be presented as follows: 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. 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

71 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;

72 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

73 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

74 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

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

76 Important GHS Websites (2)
OECD Classification and Labelling ILO Classification and Labelling WSSD Global Partnership for Capacity Building to Implement GHS

77 Thank you for your attention

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