(Organisation for Economic Coopération and Development) The General Harmonized System of Classification and Labelling of Chemicals (GHS) UNITAR Regional Workshop on Chemical Hazard Communication and GHS implementation for countries of the ECOWAS Region Abuja , Nigeria, 13-15 May 2008 Laurence Musset (Organisation for Economic Coopération and Development) UNITAR GHS expert roster
Importance of GHS Harmonises classification criteria and hazard communication in different countries (with or without existing systems for classification/hazard communication) For different types of chemicals (substances et mixtures: e.g., industrial chemicals, pesticides, cosmetic ingredients) For different sectors (transport, workers, consumers) Système déjà harmonisé pour le transport (effets physiques et toxicité aiguë)
Objectives of the GHS Harmonized hazards classes and harmonized categories harmonized Labelling and Safety Data Sheets Increases human health and environment protection in countries without a classification and labelling system Facilitates harmonization of hazard assessment Reduces testing needs Facilitates international exchanges
GHS Historical background (1) ILO Recommendation 177 1992 UN Conference on the Environment and Development (Chapter 19, Agenda 21) 2001 GHS Transfert to ECOSOC 2003 Endorsement by ECOSOC and publication 2005 First revised edition 2007 Second revised edition 2008 GHS Implementation (WSSD) 10 years preparation World Summit on Sustainalble Development, Par. 23 © of its plan of implementation
GHS Historical background (2) Development by three focal points under the umbrella of a coordinating group of the Inter-Organizations Programme for the Sound Management of Chemicals (IOMC) Physical hazards: UN Experts for the transport of dangerous goods (UNSCETDG) Health and environmental hazards : OECD Hazard Communication (Labelling and SDS): ILO
GHS Historical background (3): harmonization of existing systems United States European Union GHS Japan Documents détaillés comparant les différents systèmes; Recommandations OMS/FAO pour les pesticides Recommandations de l’Organisation des Nations-Unies pour le transport Directives de l’UE sur les substances et préparations Réglementation du Canada et des US pour les travailleurs, les consommateurs et les pesticides Recommendation Transport Dangerous Goods* Canada
GHS Historical background (4): Establishment of a new Sub-Committee in 1999 ECOSOC Committee of Expert on the Transport of Dangerous Goods and on the GHS Sub-commmittee of experts on the Transport of Dangerous Goods Sub-commmittee of experts on the GHS
Classification criteria for substances and mixtures Labelling Scope of GHS (1) Classification criteria for substances and mixtures Symbols Safety data sheets Hazard statements Signal words Y compris additifs et impuretés identifiées (concentrations ≥ valeurs seuil Informations minimales et document d’orientation Examples de conseils de prudences Produits pharmaceutiques, additis alimentaires et résidus de pesticide dans les aliments ne sont pas couverts par le SGH en terme d’étiquetage pour leur administration intentionnelle. Conseils de prudence: general (P1XX), prevention (P2XX), réponse (P3XX), stockage (P4XX), élimination (P5XX). Codes pour les mentions de danger ex: H225 Liquide et vapeur très inflammable, et pour les conseils de prudence PXXX, Pictogrammes de prudence No list of classified substances
Scope of GHS (2): Sectors and chemicals covered by the GHS Consumers Workplace/industrial Pesticides/Biocides Transport Others
Scope of SGH (3): hazards covered by the GHS Physical hazards Health hazards Environmental hazards Détails fournis par les autres présentateurs
Scope of GHS (4): physical hazards Explosives (2.1) Flammable gases (2.2) Flammable aerosols (2.3) Oxidizing gases (2.4) Gases under pressure (2.5) Flammable liquids (2.6) Flammable solids (2.7) Self-reactive substances and mixtures (2.8)
Scope of GHS (5): physical hazards (continued) Pyrophoric liquids (2.9) Pyrophoric solids (2.10) Self-heating substances and mixtures (2.11) Substances and mixtures which, in contact with water, emit flammable gases (2.12) Oxidizing liquids (2.13) Oxidizing solids (2.14) Organic peroxides (2.15) Corrosive to metals (2.16)
Scope of GHS (6): health hazards Acute toxicity (3.1) Skin corrosion/irritation (3.2) Serious eye damage/eye irritation (3.3) Respiratory or skin sensitization (3.4) Germ cell mutagenicity (3.5)
Scope of GHS (7): health hazards (continued) Carcinogenicity (3.6) ReproductiveToxicity (3.7) Specific target organ toxicity – Single exposure (3.8) Specific target organ toxicity – Repeated exposures (3.9) Aspiration hazard (3.10)
Scope of GHS (8): environmental hazards Hazards for the aquatic environment (4.1)
Hazard communication (1): label elements Pictograms (square + symbol (S)) Signal words (SW) (« Danger » or « Warning ») Hazard statements (HS) (e.g.: « Toxic in contact with skin ») – Code: H311 Precautionary statements (and pictograms): general (P1XX), prevention (P2XX), response (P3XX), storage (P4XX), disposal (P5XX). Product identifier Supplier identification Codes pour les mentions de danger ex: H225 Liquide et vapeur très inflammable, et pour les conseils de prudence PXXX, Nom, adresse et tel du fabricant ou fournisseur Règles de précédence: Symboles pour la santé humaine: ex: pas de point d’exclamation si “skull and crossbones” applies Mention d’avertissement: si “Danger” s’applique, “Attention” ne s’applique pas
Hazard communication (2): pictograms and symbols Couleurs: blanc, rouge , noir Mêmes symboles pour differents dangers: ex: “Danger pour la santé” est utilisé pour la sensibilisation respiratoire, pour la mutagénicité pour les cellules germinales (catégorie 1A, 1B et 2), pour la cancerogenicité (categories 1A, 1B et 2), pour la toxicité pour la reproduction (catégories 1A, 1B et 2), pour la toxicité pour certains organes cibles (catégories 1 et 2, exposition unique ou répétée) et pour le danger par aspiration. Le point d’exclamation:Toxicité aigue (Cat. 4), corrosion/irritation cutanée (Cat. 2), Lésions occulaires graves/irritation oculaire (Cat. 2A), sensibilisation cutanée, Toxicité pour certains organes cibles (exposition unique, Cat. 3)
Hazard communication (3): other label elements Hazardous substances: chemical identity Mixtures: chemical identities of all ingredients contributing to the classification or only if they contribute to: Acute Toxicity Skin corrosion /Serious eye damage Germ cell mutagenicity Carcinogenicity Reproductive toxicity Skin/respiratory sensitization Specific target oran toxicity
Hazard communication (4): Safety Data Sheets (SDS) – Scope Classified substances and mixtures Non classified mixtures containing substances classified: - carcinogens - Toxic for reproduction - Toxic for specific target organs in concentration exceeding cut-off values In other cases, if required by the competent authority
Hazard communication (5): SDS- Format 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
Hazard communication (5): SDS – Format (continued) 9. Physical and chemical properties 10. Stability and reactivity 11. Toxicological information 12. Ecotoxicological information 13. Disposal considerations 14. Transport information 15. Regulatory information 16. Other information
Principles of the GHS (1) Based on hazards (intrinsec properties), not on risk No general reduction of protection compared to existing systems Use of available data (no requirement for testing)
Principles of GHS (2) Tests conducted according to internationally recognized scientific principles GHS should meet needs of all different users (consumers, workers, transport workers, emergency responders) GHS is designed to permit self classification (however, expert judgement may be necessary in some cases) Poids de l’évidence
Principles of the GHS (3) Bridging principles for mixtures Dilution Batching Concentration of highly toxic mixtures Interpolation within one toxicity category Substantially similar mixtures Principes pour l’étiquetage: le niveau de danger indiqué doir être consistant d’un danger à un autre. Le format et la couleur sont normalisés
GHS Flexibility: Decisions by the competent authorities Building Block approach (classes and categories) Optional criteria/ labelling Specific cut-off values for the classification of some mixtures Labelling of consumer products (risk based) Supplementary labelling
Example of classification criteria and labelling: physical hazard – Flammable gases Category 1: Gases, which at à 20 °C and a standard pressure of 101,3 kPa: are ignitable when in a mixture of 13% or less by volume in air; or have a flammable range with air of at least 12% regardless of the lower flammability limit. (S: flame ; SW: Danger; HS: Extremely flammable gas) Category 2: Gases, other than those of Catégory 1, which, at à 20 °C and a standard pressure of 101,3 kPa, have a flammable range while mixed in air. (no symbol; SW: Warning; HS: Flammable gas) Symbole; Mention d’avertissement: Danger; Mention de danger: Gaz extrêmement inflammable (Critères avec valeur seuils)
Example of classification and labelling criteria: health hazard – sensitization Respiratory sensitizers: a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and /or b) if there are positive results from an appropriate animal test (S: Health hazard; SW: Danger; HS: May cause allergy or asthma symptoms or breathing difficulties if inhaled
Example of classification and labelling criteria: health hazard – sensitization (continued) Skin sensitizers: a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and/or b) if there are positive results from an appropriate animal test. (S: Exclamation mark; SW: Warning; HS: May cause an allergic skin reaction Cut-off for mixtures: ≥ 0,1 or 1,0 % (option)
Example of labelling: hazards to the aquatic environment - Acute Category 1 Category 2 Category 3 Symbol Environment No symbol Signal word Warning No signal word Hazard Statement Very toxic to aquatic life Toxic to aquatic life Harmful to aquatic life Un grand nombre de catégories Révision des catégories pour les dangers à long terme
Example of labelling: Hazards to aquatic life - Chronic Category 1 Category 2 Category 3 Category 4 Symbol Environment No symbol Signal word Warning No signal word Hazard Statement Very toxic to aquatic life with long lasting effects Toxic to aquatic life with long lasting effects Harmful to aquatic life with long lasting effects May cause long lasting harmful effects to aquatic life
GHS update Long term aquatic hazards (revision adopted by the Sub-Committee) Substances and mixtures depleting the ozone layer (proposal) Sub-Categories to differentiate strong versus weak sensitizers (proposal) Hazards for the terrestrial environment (mandate given to OECD for a preliminary study) ► Regular changes of the regulations expected to adapt GHS to technical progress