globally harmonised system (ghs) of classification and...

1ICMM-EM REACH-GHSSeminar – Rio 2008

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Globally Harmonised System (GHS) of Classification and Labelling

Prepared By:

Hugo Waeterschoot (ENIA) &

Bill Adams (Rio Tinto)

February 13, 2008


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1992:1992: Rio de Janeiro EARTH SummitRio de Janeiro EARTH SummitUnited Nations Conference on the Environment and DevelopmentUnited Nations Conference on the Environment and Development

Objectives: • Promote sustainable development• Facilitate international trade

GHS-Background

A globally harmonised hazard classification and compatiblelabelling system, including material safety data sheets and easily understood symbols, should be available, by the year 2000 (done)

and implemented world-wide by end of 2008 (in progress)


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EU Harmful (St Andrew’s Cross)US ToxicCAN ToxicAustralia HarmfulIndia Non-toxicJapan ToxicMalaysia HarmfulThailand HarmfulNew Zealand HazardousChina Not DangerousKorea ToxicGHSGHS Danger (Skull & Cross Bones)Danger (Skull & Cross Bones)

Why? Existing global disharmony in Classification and LabellingExample: Different risk phrases used for a substance with an Acute Oral Toxicity LD50 = 257 mg/kg/day

GHS-Background


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Purpose:(a) Enhance the protection of human health and the environment

by providing an international comparable system for hazardcommunication

(b) Provide a recognised framework for those countries without an existing system

(c) Reduce the need for testing and evaluation of chemicals

(d) Facilitate international trade in chemicals whose hazards have been properly assessed and identified on an international basis

Purpose and Generic Principles


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General principles“Harmonisation means establishing a common and coherent basis for chemical hazard classification and communication, from which appropriate elements relevant to means of transport, consumer, workers and environmental protection can be selected”

• Initially Harmonise Existing Guidelines

• Best Scientific Practice

• Existing data should be acceptable

• No Reduction of Current Level of Control in any Country

Purpose and Generic Principles


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GHS - Implementation

• UN adopted July 2003 encourages all countries to implement GHS ASAP

• WHEN: by end of 2008!

• “The purple book” sets out the approach but allows for flexibility Current text: 2005Current text: 2005

22ndnd Rev. expected December 2008Rev. expected December 2008

http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html

http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html


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GHS Implementation Around the WorldGHS Implementation Around the World

Global Implementation expected 2008-2009!

2009

2009


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Test 1

Terrorist attack

possible by 1 person

GHS will introduce hazardwhich may be

existing today in some countries

and labelling system significantly different as what is


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Pirates spotted in

the Caribbean

Some hazard symbols are newunderstood in other cultures !!!!

and/or are differently

Test 2


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Dead fish falling out of trees

GHS introduces new hazard criteria for many jurisdictions. Lack of experience may lead to non-

harmonized classifications !

Test 3


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Metals Organics≠

It’s a different can of worms!


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Immediate Challenges….

• Change in labelling• Differences in classification categories

from the current systems• Difference between GHS categories

adopted between countries• Metal specific characteristics


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Physical Hazards Physical Hazards Pictograms/PhrasesPictograms/Phrases

ExplosivesSelf-Reactive Substances and MixturesOrganic Peroxides

Oxidizing GasesOxidizing LiquidsOxidizing Solids

Gases under pressureRefrigerated Liquefied gas

Corrosive to MetalsSkin Corrosion/Irritation: Danger (Corrosion)Eye Damage/Irritation: Danger (Corrosion)

Flammable Gases Self-Reactive Substances and Mixtures

Flammable Aerosols

Pyrophoric Solids

Flammable Liquids Self-Heating Substances and Mixtures

Flammable Solids Contact with Water, Emit Flammable Gas


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Current EU LabellingCurrent EU Labelling


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UNXXXX & Proper Shipping Name

Product Identifier Chemical Identities

Signal Word Hazard Statement Hazard Statement

Precautionary Statement Precautionary Statement Precautionary Statement

Supplier Identifier

Supplemental Information XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Commercial InformationPRODUCT ABC

Manufactured by

Company XYZ

Product Information/Use InstructionsXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

GHS Supplemental Information

TransportInformation

CLP (GHS) CLP (GHS) LabelLabel

Other Information

Company/Branding Information GHS Label


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Current FutureCategory EU Canada U.S. GHSFlammable

None

Toxicity/ Health Hazard Danger None

Environmental ToxicityNone None

Chronic Health Hazard (e.g. Respiratory

Sensitiser, Carcinogen

Various

None None

Examples of Labelling changes


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GHS Categories GHS Categories –– e.g. ACUTE ORAL TOXICITYe.g. ACUTE ORAL TOXICITYGHS Category 5

UN LD50 > 2000 ≤ 5000 mg/kg

Countries following UN GHS for this

endpoint:

No symbol

Japan and South Africa

WARNING

May be harmful if swallowed

New Zealand GHS

6.1E

EU and Australia GHS

Canada GHS

HarmfulLD50 > 200 ≤ 2,000 mg/kg

Harmful if swallowed (R22)Very toxic if swallowed

EU Current

LD50 > 25 ≤ 200 mg/kg

Toxic if swallowed

Toxic

May not include, still under discussion

6.1A 6.1B 6.1C

Category 1 Category 2 Category 3

Category 1

Harmful if swallowed

Canada Proposed in position paper

WARNING

Fatal if swallowed Fatal if swallowed Toxic if swallowed

Category 4

6.1D

WARNING

Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed

EU, Australia, and US Proposed

DANGER DANGER DANGER

Category 2 Category 3 Category 4

Fatal if swallowed Fatal if swallowed Toxic if swallowed Harmful if swallowed

LD50 ≤ 25 mg/kgVery Toxic

DANGER DANGER DANGER WARNING

LD50 > 50 ≤ 300 mg/kg LD50 > 300 ≤ 2000 mg/kg

Category 1 Category 2 Category 3 Category 4

DANGERDANGERDANGER

LD50 ≤ 5 mg/kg LD50 > 5 ≤ 50 mg/kg


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Acute Aquatic Hazards Acute Aquatic Hazards -- CategoriesCategories

GHS Category Acute 2 Category Acute 3

UN Toxic to aquatic life Harmful to aquatic life Countries following

UN GHS for this endpoint:

Japan and South Africa

96hr L(E)C50 (Fish) 1mg/L < L(E)C50 ≤ 10mg/L 96hr L(E)C50 (Fish) 10mg/L < L(E)C50 ≤ 100mg/L

48hr EC LC50(crustacean) 1mg/L < L(E)C50 ≤ 10mg/L

48hr EC LC50(crustacean) 10mg/L < L(E)C50 ≤ 100mg/L

72 or 96hr ErC50(algae) 1mg/L < L(E)C50 ≤ 10mg/L 72 or 96hr ErC50(algae) 10mg/L < L(E)C50 ≤ 100mg/L

EU GHS

EU Proposed

New Zealand GHSNB: Terrestrial Effects Classified

Australia, US and Canada GHS

9.1A

Very toxic to aquatic life

WARNING

Category 1

WARNING

Australia does not require Environmental ClassificationUnited States: Not in scope for OSHA, EPA considering adoption

48hr EC LC50(crustacean) ≤ 1mg/L

72 or 96hr ErC50(algae) ≤ 1mg/L

Category Acute 1

Very toxic to aquatic life WARNING

96hr L(E)C50 (Fish) ≤ 1mg/L


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• (M)SDS changes• Reformulation of products to eliminate certain

ingredients/impurities• Warning labels for currently exempt products• Changes in shipment labelling and transport

precautions• Changes in chemical storage, handling and disposal• New guidance regarding Hazard Communication

within the workplace• Need for training of workforce

…Potential Changes and Implications


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Additional Key Issues for Metals

• GHS introduces NEW toxicity END-POINTS– STOT: Systemic Target Organ Toxicity

• GHS changes some END-POINTS drastically– Environmental classification

• Different Classification between massive and powder forms• Different Categories• Safety net (classification category when data is lacking)

– CMR: category 1-2-3 under EU becomes 1A-1B and 2– (1A & 1B are subject to Authorization under REACH)

• Not all jurisdictions adopt GHS as published by the UN resulting in different classification on some endpoints


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Jurisdiction/Regulation

Future Proposed GHS Classification Pictograms Notes

UN GHS Self-Classification

Serious Eye Damage/Eye Irritation: Category 2B

Hazardous to the Aquatic Environment(Acute & Chronic): Category 1

New Zealand Eye Irritation: 6.4A, Aquatic Effects: 9.1A Terrestrial still data needs to be evaluated to make classifications

Australia GHS Serious Eye Damage/Eye Irritation: Category 2B

Environmentalclassification notmandatory

Classification based onthorough review ofavailable data

EU GHS Self-Classification*

Serious Eye Damage/Eye Irritation: Category 2B

Hazardous to the Aquatic Environment(Acute & Chronic): Category 1

Watch for endpoint categories that have not been adopted

Japan GHS STOT Single Exposure: Category 3(Lung); STOT Repeated Exposure:Category 1 (Liver); Chronic Hazards tothe Environment (Category 4)

Japanese NITE Classification; followed UN approach, but used unreliable data.

Copper Powder: Proposed GHS Classifications by CountryCopper Powder: Proposed GHS Classifications by Country


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What are we doing to help you ?

1. Trace & comment on national GHS implementation proposals globally :

EU - US - Japan - South Africa……Korea – China - Russia…

2. Preparing generic info and a briefing leaflet

3. Compile “effects data” reference sheets by various Commodity Associations for self classification & MSDS

4. Provide (visual) GHS overview tables per end-point,allowing “self-classification” by companies


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ConclusionsConclusions

Problem: GHS implementation around the world could result in differing classifications for identical substances; this is contrary to the intent of the UN

Challenges:– Acquiring the data necessary to assign appropriate

classification– Determining the correct classification for various

jurisdictions– Using the correct system within a jurisdiction to make

the classification– Maintaining consistent classifications within business

units and across industry


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Links between REACH and GHS


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REACH implementationGHS

UN-Global Harmonised Classification System (GHS)

- EU GHS Parallel introduction with REACH

- Industry submissions listed on public website

- Platform for worldwide exchange


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• Draft EU GHS Regulation published on 27th June 2007– Includes translation of current Annex I into corresponding GHS

classifications (Annex VI) - stakeholders not consulted

• Adoption by Parliament and Council - entry into force by end 2008/early 2009

N.B.: Reach Implementation Project (RIP) 3.6 (in progress) will develop GHS C&L standards/criteria under REACH; industry participates in this RIP

Status of GHS in the EU

REACH itself does not include criteria

for Classification and Labelling


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REACH EU-GHSR,E, A, Ch Classification, Labelling, MSDSRisk HazardSubstances produced/imported Substances/MixturesHazardous and non-Hazardous Hazardous≥1 tonne/year/producer or importer

Any volumes

Harmonised classifications Self classificationEuropean Union World-wideWorkplace and Supply & Use Workplace, Supply & Use and

Transport

Scope - Comparison


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REACH

2.5 y. > 100 t/a3.5 y. HPV etc. 5 y. > 1 t/a

3.5 y. Substances 4.5 y. Mixtures

GHS

For substancesand mixtures:EU-System: bindingGHS: optional;Label: GHS if class.

For substances:GHS: obligatory for the labelSDS must contain EU and GHS classificationFor mixtures: EU-System: bindingGHS: optional; Label: GHS if class.

After the entire transitionperiod:For substances & mixtures:GHS: obligatoryEU-System: loses its legalstatus

2010 2013 2018

Transitional Period


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• GHS will be introduced in parallel with REACH• Classification and Labelling will need to changed

to GHS system (worldwide)• GHS introduces a few key issues for metals• While GHS harmonises C&L between regions,

(critical) differences will remain• The clock is ticking for REACH, but it ticks as

quickly for GHS

(REACH (REACH –– GHS) Summary of IssuesGHS) Summary of Issues


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Are you prepared ???

GHSGHS

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