Introduction to GHS. The Globally Harmonised System of Classification and Labelling of Chemicals. Cecilia Westöö April 2014 Bangkok

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1 Introduction to GHS The Globally Harmonised System of Classification and Labelling of Chemicals Cecilia Westöö April 2014 Bangkok

2 Introduction to GHS - Development of GHS - background and scope - Elements of GHS - Implementation - Worldwide / EU

3 Classification and Labelling A hazard communication tool for risk management and risk reduction.

4 Development of the GHS International mandate was adopted in the 1992 United Nations Conference on Environment and Development: 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.

5 Basis for the elaboration of the GHS UN Recommendations on TDG Canadian requirements for workplace, consumers and pesticides EU directives for dangerous substances and preparations US requirements for workplace, consumers and pesticides

6 Purpose of GHS Enhance the protection of human health and the environment by providing an internationally comprehensible system for hazard communication Provide a recognized framework for countries without an existing system Reduce the need for testing and evaluation of chemicals Facilitate international trade in chemicals whose hazards have been properly assessed and identified on an international basis.

7 Other principles 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

8 Benefits of 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 harmonized 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.

9 Elements of GHS Harmonized criteria for classifying substances and mixtures according to their physical health environmental hazards Harmonized hazard communication elements, including requirements for labelling safety data sheets.

10 Elements of GHS Hazard assessment Criteria for classification Labelling Safety Data Sheets Hazard communication

11 Hazard communication Package labelling Safety Data Sheets

12 Hazard classification Hazard Class Nature of hazard (TEST)METHOD & CRITERIA Severity of hazard Category 1 Category 2 Category 3 Not in this Hazard Class Decrease in severity

13 Nature of hazard Severity of hazard Physical Health Environment Hazard classes Hazard categories

14 Hazard versus Risk Hazard = ability to cause damage or harm (intrinsic hazardous properties) Risk = probability for damage or harm to occur Hazard x Exposure = Risk

15 Physical hazards What is a physical hazard? Flammability, explosivity, oxidizing ability, reactivity with air or water, self-reactivity..

16 The origin of GHS physical hazards Since the 1960 s there have been internationally developed rules for transport of dangerous goods (TDG). These so-called Model Regulations focus on immediate (acute) hazards. The methods and criteria for the hazards of fire, explosion and the like were welldeveloped in the TDG world. So when GHS was written, the system of the TDG domain was taken over for the physical hazards.

17 Physical Hazards 16 classes Hazard Class Explosives Flammable Gases (incl. chem unstable gases) Aerosols Oxidising Gases Gases under pressure Compressed Gases Liquefied Gases Refrigerated Liquefied Gases Dissolved Gases Flammable Liquids Flammable Solids Self Reactive Chemicals Pyrophoric Liquids Pyrophoric Solids Self Heating Chemicals Water Reactive - emits Flammable Gases Oxidising Liquids Oxidising Solids Organic Peroxides Corrosive to Metals Hazard Category Div1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div A B Unstable Type A Type B Type C Type D Type E Type F Type G Type A Type B Type C Type D Type E Type F Type G 1

18 Hazard Class Acute Toxicity Oral Dermal Inhalation Skin Corrosion/Irritation Serious Eye Damage/Irritation Sensitization Respiratory Skin Germ Cell Mutagenicity Carcinogenicity Reproductive Toxicity Health Hazards 10 classes STOT - Single Exposure STOT - Repeated Exposure Hazard Category Corrosive 1A 1B 1C 1A 1A 1A 1B 2 1A 1B 2 1A 1B Irritant A 2B 1B 1B Aspiration hazard Lactation

Effects on ecosystems Environmental hazards It is widely accepted that the aquatic Scope environmental compartment is vulnerable, in that it is The classification scheme covers the receiving both

19 Effects on ecosystems Environmental hazards It is widely accepted that the aquatic Scope environmental compartment is vulnerable, in that it is The classification scheme covers the receiving both environment for many harmful short substances, term and and long term effects the organisms that live there can be very sensitive. to both aquatic Effects on ecosystems rather freshwaters than on and individuals within marine a ecosystems species or population.

20 Environmental Hazards 2 classes Hazard Class Hazard Category Hazardous to the aquatic environment Acute hazard 1 2* 3* Chronic (Long-term) hazard Hazardous to the ozone layer 1 * Not normally used when considering packaged goods, (but for transport of bulk quantities).

21 Elements of a label Pictogram Signal word Danger Warning Hazard statement H### Precautionary statement P###

22 Pictograms Pictograms what do they mean? Health hazard Environmental hazard Physical hazard

23 Example of Classification Pictogram SKIN CORROSION/ IRRITATION Category 1 (A-C) Category 2 Category 3 No pictogram Signal word Danger Warning Warning Hazard statement H314: Causes severe skin burns and eye damage H315: Causes skin irritation H316: Causes mild skin irritation

24 Safe use of chemicals Risk management Exposure Assessment and Risk Assessment Hazard communication Labels and Safety Data Sheets Hazard classification

25 Implementation of 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

26 Considerations when implementing GHS Existing national/regional legislation Sector-specific legislation What edition of the Purple Book to use (biannual revision) Application of the building block approach

27 GHS hazard Flammable gas, Cat.2 Application of the Building Block Approach USA (Workpl) EU CLP Reg. NZ AUS (Workpl) Korea Singapore Flammable liquid, Cat.4 Note 1 Note 4 Acute toxicity, Cat.5 Note 2 Skin corrosion, Cat.3 Note 2 Skin corrosion, Sub-Cat 1A/1B/1C Serious eye damage Cat.2 (no sub-categ) Serious eye damage Sub-cat.2A (only) Respiratory/skin sensitization Cat.1A/1B CMR, Cat.1A/1B Aspiration hazard Cat.2 Note 2 Aquatic hazard, Acute 1 n/a Note 3 Note 3 Aquatic hazard, Acute 2 to 5 n/a Note 3 Note 3 Aquatic hazard, Chronic 1, 2 n/a Note 3 Note 3 Aquatic hazard, Chronic 3, 4 n/a Note 3 Note 3 Green = adopted Red= not adopted 1/ Fuel oil (storage) 2/ Consumer and domestic chemicals only 3/ Not mandatory (for information only) 4/ Diesel only n/a = not applicable * Data for USA, NZ and AUS according to draft proposals available at the time of writing (still subject to discussion and final adoption).

28 GHS implementation in EU

29 Hazard classification - a cornerstone in EU chemicals legislation system Industry dangerous to the environment Reach Storage Hazard Classification Major accidents Consumer Products Waste Workers Health and Safety

1999/45/EC (DPD) Regulation (EC) No 1272/2008 DSD DPD REACH (SDS)

30 Pre-GHS GHS National or regional criteria and labels Substances: Dir. 67/548/EEC (DSD) Preparations: Dir. 1999/45/EC (DPD) Regulation (EC) No 1272/2008 DSD DPD REACH (SDS) National ordinance (KIFS) Förordning (EG) nr 1272/2008 Translation into official language of MS

31 GHS in EU CLP Labelling Classification GHS SDS REACH CLP: Regulation 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures REACH: Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals

32 Classification plays a key role in REACH Included in the registration dossier for a substance; Triggers certain provisions e.g.: - exposure assessment and risk characterisation; - the obligation to provide a safety data sheet. CMR classification may lead to restrictions and the need to apply for authorisation.

33 In EU - CLP is introduced stepwise Substances 20 January December June 2015 KIFS CLP(voluntary) KIFS CLP CLP

34 CLP generally applies to all substances and mixtures placed on the market: industrial chemicals, biocides, plant protection products. Exemptions* are e.g. : Radioactive substances and mixtures Substances and mixtures intended for scientific research and development, which are not placed on the market Waste Medical products Veterinary medicinal products Cosmetic products Medical devices Food or feeding stuff in the finished state, intended for the final user *Mainly because they are covered by other EU legal acts

35 Implementing the GHS Applying the Building Block Approach Physical Health Environment All 16 GHS Classes 48 out of 49 GHS Categories All 10 GHS Classes 38 out of 44 GHS Categories All 2 GHS Classes 6 out of 8 GHS Categories

36 GHS Physical Hazard Classes/Categories Hazard Class 2.1 Explosives 2.2 Flammable Gases 2.3 Flammable Aerosols 2.4 Oxidising Gases 2.5 Gases under pressure 2.6 Flammable Liquids 2.7 Flammable Solids 2.8 Self Reactive Chemicals 2.9 Pyrophoric Liquids 2.10 Pyrophoric Solids 2.11 Self Heating Chemicals 2.12 Water Reactive - emits Flammable Gas 2.13 Oxidising Liquids 2.14 Oxidising Solids 2.15 Organic Peroxides 2.16 Corrosive to Metals Hazard Category Div1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div Unstable Compressed gas Liquefied gases Refrigerated liquefied gases Dissolved gases Type A Type B Type C Type D Type E Type F Type G Type A Type B Type C Type D Type E Type F Type G 1

37 GHS Health Hazard Classes/Categories Hazard Class 3.1 Acute Toxicity Oral Dermal Inhalation 3.2 Skin Corrosion/Irritation 3.3 Serious Eye Damage/Irritation 3.4 Respiratory sensitizer & Skin sensitizer 3.5 Germ Cell Mutagenicity 3.6 Carcinogenicity 3.7 Reproductive Toxicity Hazard Category Corrosive 1A 1B 1C 1 1A 1A 1A 1B 2 1A 1B 2 1A 1B 1B 1B Irritant 2 3 2A 2 2A 2B Lactation 3.8 STOT - Single Exposure 3.9 STOT - Repeated Exposure 3.10 Aspiration hazard

38 GHS Environmental Hazard Classes/Categories Hazard Class Hazard Category 4.1 Hazardous to the aquatic environment Acute hazard Long-term hazard Hazardous to the ozone layer 1

39 EU-harmonised (and legally binding) classification and labelling Shall normally be done for all effects/hazard classes of active substances in: plant protection products biocidal products. Shall for other substances normally be done for substances that may be Carcinogenic, Mutagenic or Toxic for Reproduction (CMR); Respiratory sensitiser. Other effects may be considered on a case-by-case basis

40 CLP annex VI Table 3.1 (GHS-format) Index No Intern. Chemical Identific. EG No Cas No Classification Hazard Class and Category code(s) Haz. Statem. Code(s) Labelling Hazard pictogram, Signal word code(s) Hazard Statement code(s) n-butanol Flam. Liq. 3 Acute Tox. 4 (*) STOT SE 3 Skin Irrit. 2 Eye Dam. 1 STOT SE 3 H226 H302 H335 H315 H318 H336 GHS02 GHS05 GHS07 Dgr H226 H302 H335 H315 H318 H336 Danger Causes serious eye damage

41 Art. 53: Adaptation to technical and scientific progress (ATP) ATP 1 (Annex VI rev.) Regulation (EC) No 790/2009 ATP 2 (GHS 3rd rev. ed.) Regulation (EC) No 286/2011 ATP 3 (Annex VI rev.) Regulation (EC) No 618/2012 ATP 4 (GHS 4th rev. ed.) Regulation (EC) No 944/2013

42 Global Disharmonisation What edition of the Purple Book to implement Application of the Building Block Approach Sectorial legislation Data available for hazard classification purposes

Globally Harmonized System of Classification and Labelling of Chemicals (GHS)

Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Rosa Garcia Couto Secretary of the Sub-Committee of Experts on the GHS United Nations Economic Commission for Europe (UNECE)