REACH and GHS. GHS: Core Elements of the New System: - Physical Hazards - Health Hazards - Environmental Hazards

Transcription

1 REACH and GHS GHS: Core Elements of the New System: - Physical Hazards - Health Hazards - Environmental Hazards Dr. Helmut Fleig Product Safety Regulations, Toxicology and Ecology Vienna, Hofburg, March 29, 2006 fg-kb; 7419

2 GHS: Core elements of the new system Physical Hazards Health Hazards Human Health & Welfare Environmental Hazards Slide 2 fg-kb7419; March 2006

3 Contents Introduction General Principles Physical Hazards Health Hazards Environmental Hazards Mixtures (Preparations) Hazard Communication (Labelling) Comparison GHS vs. EU Outlook / Conclusion Slide 3 fg-kb7419; March 2006

4 GHS: General Principles No reduction in protection level Classification criteria based on intrinsic hazards, i.e. properties No requirement for testing (exception some PH) Slide 4 fg-kb7419; March 2006

5 GHS: General Principles - Definitions Classification (C): Assignment of a chemical to a Hazard Class (nature of hazard) and to a Hazard Category (degree of hazard) Labelling (L): Hazard Communication via Label (package) Safety Data Sheet Slide 5 fg-kb7419; March 2006

6 GHS: General Principles - Example C&L Classification Labelling Hazard Hazard Class Hazard Category (Total no. of Categories) Symbols Signal Word Hazard Statement PH Flammable liquids Cat. 2 (4) Danger Highly flammable liquid and vapour Slide 6 fg-kb7419; March 2006

7 GHS: Core elements of the new system Physical Hazards (PH) Slide 7 fg-kb7419; March 2006

8 GHS: Physical [Chemical] Hazards (PH) - Origin Basis for a GHS: UN Transport System (TDG*; Orange Book) TDG start 1957; detailed; continuously amended Worldwide acceptance and use Related with standard test methods (UN Manual ) Conclusion:TDG most appropriate basis for GHS-PH (ILO - Working Group; UNO) *TDG = Transport of Dangerous Goods Slide 8 fg-kb7419; March 2006

9 GHS: PH - Overview / Comparison GHS - Hazard Class Explosives Flammable Gases Flammable Aerosols Oxidizing Gases Gases under Pressure Flammable Liquids Flammable Solids Self-Reactive Substances / Mixtures Pyrophoric Lquids Pyrophoric Solids Self-Heating Substances / Mixtures Water Reactive Flammable Gases Oxidizing Liquids Oxidizng Solids Organic Peroxides Corrosive to Metals Hazard Cats Div Types: A - G Comparison to EU; Remarks GHS includes articles; very complex allocation procedure.eu: only 1 hazard level; most gases classified EU :Same EU: not existing; 4 groups: compressed; liquified; refrigerated liquified dissolved;;no intrinsic property EU :Similar; differing cut-offs,1 hazard level less EU :Similar; only 1 hazard level EU :No correspondence: Explos., Flam., No C EU :Same EU :Same EU: no classification criterion EU:Same EU: only 2 hazard levels EU: only 2 hazard levels EU: classification as Oxidisier EU: not existing Slide 9 fg-kb7419; March 2006

10 GHS: PH - Corrosive to Metals Definition: A substance or a mixture which by chemical action will materially damage, or even destroy, metals. Classification Criteria: Category 1 Criteria Corrosion rate on steel or aluminium surfaces exceeding 6.25 mm per year at a test temperature of 55 C Label elements: Label element Symbol Signal word Hazard statement Category 1 Corrosive Warning May be corrosive to metals Slide 10 fg-kb7419; March 2006

11 GHS: Core elements of the new system Health Hazards (HH) Slide 11 fg-kb7419; March 2006

12 GHS: Health Hazards (HH) - Overview Hazard Classes Hazard Categories Remarks Acute Toxicity Skin corrosion / irritation Serious eye damage / irritation Sensitiziation Respiratory or skin Germ cell mutagenicity Carcinogenicity Reproductive toxicity Spec. Target Organ Systemic Toxicity Single Exposure ( STOST ) Spec. Target Organ Systemic Toxicity Repeated Exposure Aspiration Hazard subgroups: oral, dermal, inhalation 3 subcategories for Corrosivity: 1A, 1B, 1C ; 1optional Irritation Category ( 3;mild ) Subdivision: Fertility and Development Additional category : Lactation 2 categories: serious non-lethal effects 3rd category: transient effects (Respiratory Tract Irritation; Narcotic Effects) Slide 12 fg-kb7419; March 2006

13 GHS: HH - Classification Criteria for Acute Toxicity Acute toxicity (ATE ) Cat. 1 Cat. 2 Cat. 3 Cat. 4 Cat. 5 Oral (mg/kg) ,000 5,000 Dermal (mg/kg) ,000 2,000 Equivalent doses for dermal and inhalation Gases (ppm) Vapours (mg/l) , , Remark: for Vulnerable Populations Dust and mists (mg/l) ATE = Acute Toxicity Estimate (e.g. LD 50 / LC 50 = Median Lethal Dose/Concentration) Slide 13 fg-kb7419; March 2006

14 GHS: HH - Examples: Acute Toxicity 1) Coffein LD 50 rat, oral: 279 mg/kg bw 2) NaCl = Sodium chloride LD 50 rat, oral: 3,000 mg/kg bw Classification EU Transport (UNO) GHS 1) Xn; harmful R 22 = Harmful by ingestion - Cat. 3 2) - - Cat. 5 Slide 14 fg-kb7419; March 2006

15 GHS: HH - Decision Logic for Skin Sensitization Does the substance (mixture) have skin sensitization data or information? No Classification not possible Yes Is there evidence in humans that the substance (mixture) can induce sensitization by skin contact in a substantial number of persons or Are there positive results from an appropriate animal test? Yes Category 1 Warning No Not classified Slide 15 fg-kb7419; March 2006

16 GHS: HH - Sensitization Allergic contact eczema Cause: single exposure to an allergen after preceding sensitization Substance: Tenside in skin cleansing agent Localisation: whole body Measures: stationary treatment wear protective cloth Slide 16 fg-kb7419; March 2006

17 GHS: HH - Criteria for Reproductive Toxicity Category 1 Adverse effects on sexual function and fertility (F), or development (D) Category 2 Suspected Additional category Effects on or via lactation Category 1A Known Category 1B Presumed (animal studies ) Optional cut-offs for mixtures: 0.1% 0.3% Optional cut-offs for mixtures: 0.1% 3% Optional cut-offs for mixtures: s. Cat. 1 Slide 17 fg-kb7419; March 2006

18 GHS: HH Slide 18 fg-kb7419; March 2006

19 GHS: HH Criteria for STOST (Specific Target Organ Systemic Toxicity) - Single Exposure Category 1 Category 2 Category 3 Significant toxicity : -Known -Presumed: animal studies at low exposure Presumed - Animal studies at moderate exposure - Human evidence in exceptional cases Remarks: - Significant toxicity: severe non-lethal effects -Cut-off (guidance) values identical with those of Cat. 3 and 4 Acute Toxicity Transient Target Organ Effects Respiratory Tract Irritation and Narcotic Effects Remarks: No cut-off values for Cat. 3 Slide 19 fg-kb7419; March 2006

20 GHS: HH - Examples for STOST Single Exposure Category Substance Effect 1 Methanol Visual damage in humans 2 3 Respiratory Tract Irritation 3 Narcotic Effects Neurotoxicant Sulfur dioxide Diethylether Significant neurotoxicity in rats (E D >300,<2,000mg/kg ) Distinct irritation in humans Drowsiness/dizziness in humans Slide 20 fg-kb7419; March 2006

21 GHS: HH - Comparison vs. EU Hazard Class Acute Toxicity Mortality / Evident Toxicity Irreversible non lethal effects (STOST Cat. 1 & 2*) Irritation Skin Eyes Respiratory tract (STOST* Cat. 3) Corrosion Sensitization Skin Respiratory tract Chronic Toxicity (STOST* Cat. 1 & 2) Narcotic Effects (STOST* Cat. 3) Carcinogenicity Mutagenicity Reproduction Aspiration Changes compared to EU ~ ~ ~ ~ ~ ~ ~ * = Specific Target Organ Systemic Toxicity; = aggravation; ~ = comparable Slide 21 fg-kb7419; March 2006

22 GHS: Core elements of the new system Environmental Hazards (EnvH) Slide 22 fg-kb7419; March 2006

23 GHS: EnvH - Aquatic Toxicity - Basis Classification is based on: acute aquatic toxicity potential for bioaccumulation degradation (biotic/ abiotic ) for organic chemicals chronic aquatic toxicity Remark: Detailed guidance is given in annexes 9 and 10 of the Purple Book Slide 23 fg-kb7419; March 2006

24 GHS: EnvH - Aquatic Toxicity Fish, LC 50, 96 h Crustacea, EC 50, 48 h Algae, EC 50, 72 or 96 h (or other aquatic plant test) -Surrogates for all aquatic organisms -LC/EC 50 :Lethal / Effect Concentration Slide 24 fg-kb7419; March 2006

25 GHS: EnvH - Aquatic Toxicity - Categories Three separate acute categories: Four chronic categories: acute toxicity and environmental fate data Remark: EU only with one acute category Slide 25 fg-kb7419; March 2006

26 GHS: EnvH - Aquatic Toxicity - Acute Categories Acute 1: L(E)C 50 < 1 mg/l Acute 2: 1 mg/l > L(E)C 50 < 10 mg/l Acute 3: 10 mg/l > L(E)C 50 < 100 mg/l Slide 26 fg-kb7419; March 2006

27 GHS: EnvH - Aquatic Toxicity - Chronic Categories Chronic 1 Classified as Acute Toxicity Cat. 1 AND not rapidly degradable and /or has the potential for bioaccumulation Remark: declassification possible by use of chronic data Slide 27 fg-kb7419; March 2006

28 GHS: Core elements of the new system Mixtures (Preparations) Slide 28 fg-kb7419; March 2006

29 GHS: Mixtures (Preparations) - Overview Physical Hazards: testing (e.g. flammable solids) calculation (e.g. flammable aerosols) testing or calculation (e.g. flammable gases) Health and Environmental Hazards: testing tiered approach (decision tree) Slide 29 fg-kb7419; March 2006

30 GHS: Mixtures - Main Principles Tiered approach; Method dependent on: type of effect amount of information for the mixture itself and/or for its ingredients Hierarchy: Generally use test data for the mixtures Use bridging principles, if applicable Estimate hazards using ingredient information * Remark: Ambiguity (options ) with CMRs Slide 30 fg-kb7419; March 2006

31 GHS: Mixtures - Bridging Principles Dilution with an equivalent or less toxic substance (e.g. acute toxicity) Classification: equivalent to original mixture use additivity method (formula) Remark: Discrepancy US-DE in evaluating an example (UN) Batching: Conclusion from a tested mixture to an equivalent batch: Classification equivalent to original mixture Slide 31 fg-kb7419; March 2006

32 GHS: Mixtures - Ingredient Based Methods Additivity methods, applied for e.g.: acute toxicity HH and EnvH skin corrosion/irritation (certain substances ) Non-additivity methods, applied for e.g.: - CMRs - skin corrosion/irritation (e.g.acids ) Slide 32 fg-kb7419; March 2006

33 GHS: Mixtures - Additivity Methods Test data / information available for all or some ingredients: A combination of the toxicities of the components by a weighted summation procedure taking ATE* values and concentrations of ingredients into account Prerequisite: Effects regarded as additive *ATE = Acute Toxicity Estimate (e.g. LD 50 / LC 50 = Median Lethal Dose/Concentration) Slide 33 fg-kb7419; March 2006

34 GHS: Mixtures - Additivity Methods α) Data / Information available for all ingredients: Use additivity formula: 100 ATE mix =Σn C i ATE i ATE = Acute Toxicity Estimate (LC50/LC%) C i = Concentration of i n ingredients, i running from 1 to n (cf. UNO Transport) Remark: Problem with the formula for toxic gas mixtures Slide 34 fg-kb7419; March 2006

35 GHS: Mixtures - Additivity Methods Data / Information not available for all ingredients: β) < 10% ingredients of unkown toxicity additivity formula and statement: x% of the mixture consists of ingredients of unkown toxicity γ) > 10% ingredients of unkown toxicity modified additivity formula: malus system statement (s. β) Slide 35 fg-kb7419; March 2006

36 GHS: Mixtures - Non-additivity Example: Carcinogenicity: General cut-off for Cat. 1: 0.1% Chemical Benzene Benzene Benzene and Asbestos % Σ 0.15 Classification of the mixture NC* Cat. 1 NC* *NC = No Classification Slide 36 fg-kb7419; March 2006

37 GHS: Mixtures - Specific Concentration Limits: Possibility for substance Specific Concentration Limits ( case by case) Lower : if identifiable hazard assumed to exist Higher : if conclusive data that no hazard is posed Remark: A convincing rationale with adequate documentation required (expert judgement!) Slide 37 fg-kb7419; March 2006

38 GHS: Core elements of the new system Hazard Communication (Labelling) Slide 38 fg-kb7419; March 2006

39 GHS: Hazard Communication - Standardized Labelling Elements Symbol: Easily understandable graphical element (pictogram) Signal word: Indication of the relative level of severity of hazard Hazard statement: Describing the nature and the degree of hazard Remark: In addition further labelling elements (e.g. product-/supplier identification, precautionary statements, supplemental information) Slide 39 fg-kb7419; March 2006

40 GHS: Hazard Communication; Labelling - Symbols Explosive Flammable Oxidizing Compressed gases! Toxic Corrosion CMRs Sensitizing ( respir.) STOST Cats 1&2 Acute Tox Cat 4 Irritation Sensitizing (skin ) STOST Cat 3 Hazardous to the aquatic environment Slide 40 fg-kb7419; March 2006

41 GHS: Hazard Communication; Labelling - Example Slide 41 fg-kb7419; March 2006

42 GHS: Hazard Communication; Labelling - Proposals for the New Health Hazard Symbol (2002) Slide 42 fg-kb7419; March 2006

43 GHS: Core elements of the new system Comparison GHS vs. EU Slide 43 fg-kb7419; March 2006

44 GHS: - Comparison GHS vs. EU (Overview) I) General Issues Issues GHS EU Remarks Definition of Classification (C) Hazard Class & Hazard Category allocation of an indication of danger & R-phrase Additional Hazard Statements not possible for PH, HH Self Classification as far as possible for substances not in Annex I Normal Handling & Use likelihood of adverse effects may be considered a general criterion EU:Conflicting interpretation Labelling (L) Symbol; Signal Word; Hazard Statement; additional information Symbol; R- & S-Phrases additonal information Risk based Labelling for consumers generally not applied Data Gaps Substances: no consequences Mixtures, acute toxicity: additional statement and more rigorous C&L no consequences Slide 44 fg-kb7419; March 2006

45 GHS: - Comparison GHS vs. EU (Overview) I) General Issues Issues GHS EU Remarks Options: not applicable (n.a.) - Building Block Approach (BBA) General principle n.a. separate presentation - Substance C & L optional classes; e.g. mild irritant (Cat. 3) n.a. - Mixture C & L e.g. -acute toxicity: different methods: dilution or additivity formula -reprotox :cat. 2 cut-offs: 0.1 or 3% -CMRs ::use of test or ingredient data n.a. Slide 45 fg-kb7419; March 2006

46 GHS: - Comparison GHS vs. EU (Overview) II) Criteria 1) PH: GHS covers a great spectrum of hazards: more hazard classes and categories than in EU 2) HH: Increase in number and serverity of classified substances and mixtures: acute toxicity, chronic toxicity (STOST), skin and eye irritation, reproductive toxicity, aspiration 3) EnvH: GHS based on EU system, thus in principle comparable GHS has more separate acute Hazard Classes More classified substances and mixtures Slide 46 fg-kb7419; March 2006

47 GHS: Core elements of the new system Outlook / Conclusion Slide 47 fg-kb7419; March 2006

48 GHS: Outlook Outlook: Program of work (UNO / OECD, ) Health Hazards: Water reactive substances releasing toxic/corrosive gases Toxic gas mixtures Sensitization (induction / elicitation; strong vs. weak) Carcinogenicity / Reproductive toxicity: potency Slide 48 fg-kb7419; March 2006

49 GHS: Outlook Environmental Hazards: Criteria development for terrestrial hazard Examination of possibilities to develop criteria for Ozone Depleting Substances Chronic aquatic toxicity Hazard Communication: Guidance for Building Block Approach Hierarchy of labelling elements Slide 49 fg-kb7419; March 2006

50 GHS: Conclusion The GHS is a worldwide applicable comprehensive system for Classification and Hazard Communication is intended for all target audiences is generally broader and more stringent than existing systems, e.g. EU will not lead in near future to a totally globally harmonized C&L system due to optional regulations is a big step foreward giving the chance for a worldwide better protection against hazardous chemicals Slide 50 fg-kb7419; March 2006