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Product Safety –safe products, safe business

REACH and GHS

GHS: Core Elements of the New System:

- Physical Hazards- Health Hazards- Environmental Hazards

Dr. Helmut FleigProduct SafetyRegulations, Toxicology and Ecology

Vienna, Hofburg, March 29, 2006

fg-kb7419; March 2006

Product Safety –

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safe business

Human Health & Welfare

Environ-mental

Hazards

Physical

Hazards

Health

Hazards

GHS: Core elements of the new system


Product Safety –

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safe business

Contents

� Introduction� General Principles

� Physical Hazards

� Health Hazards � Environmental Hazards

� Mixtures (Preparations)� Hazard Communication (Labelling)

� Comparison GHS vs. EU� Outlook / Conclusion


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GHS: General Principles

• No reduction in protection level

• Classification criteria based on intrinsic hazards,

i.e. properties

• No requirement for testing (exception some PH)


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� 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


- Definitions


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LabellingClassification

Highly

flammable

liquid and

vapour

DangerCat. 2 (4)Flammable liquidsPH

HazardStatement

Signal Word

SymbolsHazard Category(Total no. of

Categories)

Hazard ClassHazard


- Example C&L


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Physical Hazards (PH)


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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


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GHS: PH

- Overview / Comparison

EU: not existing1Corrosive to Metals

EU: only 2 hazard levels3Oxidizng Solids

EU: classification as Oxidisier3Organic Peroxides

EU:Same3Water Reactive → Flammable Gases

EU: only 2 hazard levels3Oxidizing Liquids

EU :Same1Pyrophoric Lquids

EU :Same1Pyrophoric Solids

EU :No correspondence: Explos., Flam., No CTypes: A - GSelf-Reactive Substances / Mixtures

EU :Similar; only 1 hazard level2Flammable Solids

EU: no classification criterion2Self-Heating Substances / Mixtures

EU: not existing; 4 groups: compressed; liquified; refrigerated liquified dissolved;;no intrinsic property

1Gases under Pressure

EU :Same1Oxidizing Gases

2Flammable Aerosols

.EU: only 1 hazard level;most gases classified

2Flammable Gases

4Flammable Liquids EU :Similar; differing cut-offs ,1 hazard level less

GHS includes articles;very complex allocation procedure

Div. 1 - 6Explosives

Comparison to EU; RemarksHazard CatsGHS - Hazard Class


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GHS: PH

- Corrosive to Metals

Definition:A substance or a mixture which by chemical action will materially damage, or even destroy, metals.

Classification Criteria:

Corrosion rate on steel or aluminium surfaces exceeding 6.25 mm

per year at a test temperature of 55 °C

1

CriteriaCategory

Label elements:

Category 1Label element

CorrosiveSymbol

May be corrosive to metalsHazard statement

WarningSignal word


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Health Hazards (HH)


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GHS: Health Hazards (HH)

- Overview

3• Germ cell mutagenicity

3• Carcinogenicity

Subdivision: Fertility and DevelopmentAdditional category : Lactation

3• Reproductive toxicity

2 categories: serious non-lethal effects3rd category: transient effects(Respiratory Tract Irritation; Narcotic Effects)

3• Spec. Target Organ Systemic Toxicity –Single Exposure ( STOST )

1• SensitiziationRespiratory or skin

2• Aspiration Hazard

2• Spec. Target Organ Systemic Toxicity –Repeated Exposure

2• Serious eye damage / irritation

3 subcategories for Corrosivity: 1A, 1B, 1C ;1optional Irritation Category ( 3;mild )

3• Skin corrosion / irritation

3 subgroups: oral, dermal, inhalation5• Acute Toxicity

RemarksHazard Categories

Hazard Classes


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GHS: HH

- Classification Criteria for Acute Toxicity

510.50.05Dust and mists (mg/l)

201020.5Vapours (mg/l)

5,0002,500500100Gases (ppm)

2,0001,00020050Dermal (mg/kg)

5,000

Equivalent doses for dermal and inhalation

Remark: for “Vulnerable Populations”

ATE = Acute Toxicity Estimate

(e.g. LD50 / LC50 = Median

Lethal Dose/Concentration)

2,000300505Oral (mg/kg)

Cat. 5Cat. 4Cat. 3Cat. 2Cat. 1Acute toxicity(ATE )


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GHS: HH

- Examples: Acute Toxicity

1) CoffeinLD50 rat, oral: 279 mg/kg bw

2) NaCl = Sodium chlorideLD50 rat, oral: 3,000 mg/kg bw

Classification

Cat. 5--2)

Cat. 3-Xn; harmfulR 22 = Harmful by ingestion

1)

GHSTransport (UNO)EU


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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 inducesensitization 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


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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

GHS: HH

- Sensitization


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GHS: HH

- Criteria for Reproductive Toxicity

Additional category

Effects on or via lactation

Category 2

Suspected

Category 1BPresumed(animal studies )

Category 1AKnown

Optional cut-offs for mixtures: – 0.1% – 0.3%

Optional cut-offs formixtures:s. Cat. 1

Optional cut-offs formixtures:– 0.1%– 3%

Category 1

Adverse effects on sexual functionand fertility (F), or development (D)


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GHS: HH


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GHS: HH

Criteria for STOST (Specific Target Organ Systemic Toxicity) - Single Exposure

Remarks: No cut-off values for Cat. 3

Remarks: - Significant toxicity: severe non-lethal effects-Cut-off (guidance) values identical with those of

Cat. 3 and 4 Acute Toxicity

Category 3

Transient Target Organ Effects

Respiratory Tract Irritation and Narcotic Effects

Category 2

Presumed

- Animal studies at moderate exposure

- Human evidence in exceptional cases

Category 1

Significant toxicity :

-Known

-Presumed: animal studies at low exposure


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GHS: HH

- Examples for STOST – Single Exposure

Drowsiness/dizziness in humansDiethylether3Narcotic Effects

Distinct irritation in humansSulfur dioxide3Respiratory TractIrritation

Significant neurotoxicity in rats(E D >300,<2,000mg/kg )

Neurotoxicant2

Visual damage in humansMethanol1

EffectSubstanceCategory


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Changes compared to EUHazard Class

↑� Aspiration

↑� Reproduction

~� Mutagenicity

~� Carcinogenicity

~� Narcotic Effects (STOST* Cat . 3)

↑� Chronic Toxicity (STOST* Cat. 1 & 2)

~

~

� Sensitization• Skin• Respiratory tract

~� Corrosion

↑↑~

� Irritation• Skin• Eyes• Respiratory tract (STOST* Cat. 3)

↑↑

� Acute Toxicity• Mortality / Evident Toxicity• Irreversible non lethal effects (STOST Cat. 1 & 2*)

* = Specific Target Organ Systemic Toxicity; ↑ = aggravation; ~ = comparable

GHS: HH

- Comparison vs. EU


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Environmental Hazards

(EnvH)


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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


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GHS: EnvH

- Aquatic Toxicity

� Fish, LC50, 96 h

� Crustacea, EC50, 48 h

� Algae, EC50, 72 or 96 h (or other aquatic plant test)

-Surrogates for all aquatic organisms

-LC/EC50 :Lethal / Effect Concentration


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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


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GHS: EnvH

- Aquatic Toxicity- Acute Categories

� Acute 1: L(E)C50 < 1 mg/l

� Acute 2: 1 mg/l > L(E)C50 < 10 mg/l

� Acute 3: 10 mg/l > L(E)C50 < 100 mg/l


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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


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Mixtures (Preparations)


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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)


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� Hierarchy: – Generally use test data for the mixtures – Use “bridging principles”, if applicable

↓– Estimate hazards using ingredient information

* Remark: Ambiguity (options ) with CMRs

GHS: Mixtures

- Main Principles

� Tiered approach; Method dependent on:

– type of effect

– amount of information for the mixture itself and/or for its ingredients


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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


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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 )


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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 andconcentrations of ingredients into account

Prerequisite: Effects regarded as additive

*ATE = Acute Toxicity Estimate (e.g. LD50 / LC50 = Median Lethal Dose/Concentration)

GHS: Mixtures

- Additivity Methods


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α) Data / Information available for all ingredients:Use additivity formula:

ATE = Acute Toxicity Estimate (LC50/LC%)

Ci = Concentration of i

n ingredients, i running from 1 to n

100ATEmix

Ci

ATEi

=Σn(cf. UNO Transport)

Remark: Problem with the formula for toxic gas mixtures

GHS: Mixtures



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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“

GHS: Mixtures


γ) > 10% ingredients of unkown toxicity

• modified additivity formula: malus system

• statement (s. β)


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Example:Carcinogenicity: General cut-off for Cat. 1: 0.1%

NC*0.090.06

Σ 0.15

Benzene and Asbestos

Cat. 10.15Benzene

NC*0.09Benzene

Classification of the mixture

%Chemical

*NC = No Classification

GHS: Mixtures

- Non-additivity


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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 !)

GHS: Mixtures

- Specific Concentration Limits:


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Hazard Communication

(Labelling)


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� 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)

GHS: Hazard Communication

- Standardized Labelling Elements


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!

Explosive Flammable Oxidizing Compressed gases

ToxicCMRs

Sensitizing ( respir.)STOST Cats 1&2

Corrosion Hazardousto the aquaticenvironment

Acute Tox Cat 4Irritation

Sensitizing (skin )STOST Cat 3

GHS: Hazard Communication; Labelling

- Symbols


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- Example


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- Proposals for the New Health HazardSymbol (2002)


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Comparison GHS vs. EU


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GHS:

- Comparison GHS vs. EU (Overview)

I) General Issues

no consequencesSubstances: no consequencesMixtures, acute toxicity:additional statement and more rigorous C&L

Data Gaps

generally not appliedfor consumersRisk based Labelling

Symbol; R- & S-Phrasesadditonal information

Symbol; Signal Word; Hazard Statement; additional information

Labelling (L)

EU:Conflicting interpretation

a general criterion„likelihood of adverse effects may be considered“

Normal Handling & Use

for substances not in Annex I„as far as possible“Self Classification

for PH, HHnot possibleAdditional HazardStatements

allocation of an indication of danger & R-phrase

Hazard Class &Hazard Category

Definition of Classification(C)

RemarksEUGHSIssues


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GHS:


I) General Issues

not applicable (n.a.)Options:

n.a.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

- Mixture C & L

n.a.optional classes; e.g. mild irritant (Cat. 3)

- Substance C & L

separate presentation

n.a.General principle - Building Block Approach (BBA)

RemarksEUGHSIssues


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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

GHS:



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Outlook / Conclusion


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GHS: Outlook

Outlook:

Program of work (UNO / OECD, 2005 – 2006)

Health Hazards:

� Water reactive substances releasing toxic/corrosive gases

� Toxic gas mixtures

� Sensitization (induction / elicitation; strong vs. weak)

� Carcinogenicity / Reproductive toxicity: potency


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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


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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

reach and ghs - umweltbundesamt · reach and ghs ghs: core elements of ... definition: a substance...

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