ghs implementation training 1:- introduction 1 william g. machin manager; classification and hazard...

1GHS Implementation Training 1:- Introduction

William G. Machin

Manager; Classification and Hazard Communication

Cefic

European Chemical Industry Council

Brussels


GHS

Globally Harmonised System

Overview and Issues


Module 1 – Contents

1.1 GHS Background & History

1.2 GHS Instrument

1.3 GHS/EU Interface

1.4 GHS Optionality

1.5 GHS Impact

1.6 EC GHS Draft Proposal


1.1 GHS Background and History


Rio de Janeiro 3-14 June 1992

United Nations Conference on the Environment and Development

Agenda 21

Agenda 21 - 40 Chapters


Agenda 21 Chapter 19

Agenda 21 An Agenda for the 21st Century

Chapter 19 An International Strategy for the Environmentally sound management of Toxic

Chemicals

Objective

To Promote SUSTAINABLE DEVELOPMENT


Chapter 19: 6 Program Areas

A Expanding and accelerating international assessment of chemical risks;

B Harmonisation of classification and labelling of chemicals;

C Information exchange on toxic chemicals and chemical risks;

D Establishment of risk reduction programs;

E Strengthening of national capabilities and capacities for management of chemicals;

F Prevention of illegal international traffic in toxic and dangerous products.


Agenda 21 and Chemicals Management Tools

Program A OECD/ICCA HPV Chemicals Program

Program B GHS – Classification and Labelling

Program C PIC Convention

Program D POPS Convention

Program E Capacity Building


Program Area B

Classification Criteria for Substances Classification Methods for Mixtures Hazard/Risk Communication

Labelling Safety Data Sheets Training

Implementation


Purpose (1.1.1.4)(a) enhance the protection of human health and the environment by

providing an internationally comprehensible system for hazard communication;

(b) provide a recognized framework for those countries without an existing system;

(c) reduce the need for testing and evaluation of chemicals; and(d) to facilitate international trade in chemicals whose hazards have

been properly assessed and identified on an international basis.

Scope (1.1.2.5)(a) The GHS covers all hazardous chemicals.

The application of the hazard communication components of the GHS may vary by product category or stage in the life cycle.Target audiences for the GHS include consumers, workers, transport workers, and emergency responders

NOTE: The term supply is used to cover Consumers, Workers & Emergency Responders


Principles1.1.1.6 (a) the hazard classification process refers principally to the hazards arising from the intrinsic properties of chemicals1.1.1.6 (h) validated data already generated under the existing systems should be accepted when reclassifying chemicals1.1.2.4 Pharmaceuticals, food additives, cosmetics, and pesticide residues in food will not be covered by the GHS in terms of labelling at the point of intentional intake.1.1.2.5 Parameter 2GHS does not include establishment of uniform test methods or promotion of further testing to address adverse health outcomes.1.1.2.5 Parameter 3In addition to animal data and valid in vitro testing, human experience, epidemiological data, and clinical testing provide important information that should be considered in application of the GHS.1.3.2.1.2 Objective of the GHS is … to allow for "self classification"


MilestonesJanuary 2001 UN SCE GHS comes into being

September 2002 WSSD seeks adoption of GHS by 2008

December 2002 Work on First Edition of GHS completed

July 2003 UN ECO SOC Resolution adopts the GHS

December 2004 First Revised Edition of GHS completed

December 2006 Second Revised Edn. of GHS completed

WSSD Plan of implementation,paragraph 23(c);

Encourage countries to implement the new globally

Harmonized system for the classification and labelling of

chemicals as soon as possible with a view to having the

system fully operational by 2008.


1.2 GHS Instrument


IAEA UNEPUNITARWTO

WHOFAOILOUN CE GHS & TDG

United NationsInternational

Court ofJustice

SecurityCouncil

Economic& SocialCouncil

GeneralAssembly

UN SCEGHS

TrusteeshipCouncil

UNSecretariat

UN SCETDG


UN SCE GHS

Works on biennia (2 Year Cycle of Work)

Odd Years Sub-Committee meetings July, December

Even Years Sub-Committee meetings July, December

Committee meeting December

Draft Resolution to UN ECO-SOC

Publication of GHS Revised Edition

Approval of Work Program


UN SCE GHS

Industry

EC & Member States

ClassificationCriteria

Phys-Chem.UN SCE TDG

ClassificationCriteria

EnvironmentOECD

ClassificationCriteriaHealthOECD

HazardCommunication

Labels/SDSs

GHS Structure & Hierarchy for Implementation

ClassificationInventory


UN SCE GHS Hierarchy of Membership

There are 5 Levels of Membership

• Expert Countries (The only members allowed to vote)

• Other Countries

• United Nations Organisations (e.g. UNEP, UNITAR)

• Inter-Government Organisations (e.g. EC, OECD)

• NGOs (should be on the UN roster, e.g. Cefic)


GHS Responsibilities• UN SCE GHS is the body responsible for all aspects of GHS

• UN SCE GHS delegates technical work and some other work

• Technical work on Health & Environmental Criteria to OECD

• Capacity Building and related work delegated to UNITAR

• UN SCE GHS responsible for monitoring implementation. See www.unece.org/trans/danger/publi/ghs/implementation_e.html

• UN SCE GHS will not classify Substances (see ToR next slide)

• UN SCE GHS will not establish global substance inventory.

• WSSD Global Partnership led by UNITAR/ILO/OECD


UN SCE GHS Terms of Reference(a) To act as custodian of the GHS, managing and giving direction

to the harmonization process;(b) To keep the GHS system up-to-date as necessary, considering

the need to introduce changes, ensure its continued relevance and practical utility, and determining the need for and timing of the updating of technical criteria, working with existing bodies as appropriate;

(c) To promote understanding and use of the GHS and to encourage feedback;

(d) To make the GHS available for worldwide use and application;(e) To make guidance available on the application of the GHS, and

on the interpretation and use of technical criteria to support consistency of application;*

(f) To prepare work programmes and submit recommendations to the committee.


GHS Document (First Revised Edition)UN GHS Web Sitewww.unece.org/trans/danger/publi/ghs/ghs_rev01/01files_e.html

Part 1 Introduction and Hazard communication 5 ChaptersPart 2 Physical-Chemical Hazards Criteria 16 ChaptersPart 3 Health Hazards Criteria 10 ChaptersPart 4 Environmental Hazards Criteria 1 Chapter

Annex 1 Allocation of Labelling elementsAnnex 2 Classification & Labelling Summary TablesAnnex 3 Precautionary Statements and PictogramsAnnex 4 Guidance on the preparation of SDSsAnnex 5 Consumer Product Risk Based LabellingAnnex 6 Comprehensibility Testing MethodologyAnnex 7 Labelling ExamplesAnnex 8 Classification ExampleAnnex 9 Guidance DocumentAnnex 10 Guidance Document


Div1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5Explosives

Physical-Chemical Hazard Classes Hazard Category

Div 1.6Flammable GasesFlammable Aerosols Oxidising Gases

1 21 21

Pressurised Gases Compressed Gases Liquefied Gases

Dissolved Gases Refrigerated Liquefied Gases

1111

Flammable Liquids Flammable Solids

11

2 3 42

Self Reactive Substances Type AType BType CType DType E Type FType GPyrophoric Liquids Pyrophoric Solids Self Heating Substances Water ReactiveFlammable Gases Oxidising Liquids Oxidising Solids Organic PeroxidesCorrosive to Metals

Type AType BType CType DType E Type FType G

1

1 21

1 2 31 2 31 2 3

1

UnstableExplosives


1 2 3 4 5 1 Acute Toxicity, Oral 1 Acute Toxicity, Dermal 1 Acute Toxicity, Inhalation 2 Skin Corrosion/Irritation 1 2 3

1 2 3 4 51 432 5

Health Hazard Classes Hazard Category

4 Respiratory Sensitisation 4 Skin Sensitisation 5 Germ Cell Mutagenicity 6 Carcinogenicity 7 Reproductive Toxicity 8 Target Organ ST – Single Dose

3 Eye Damage/Irritation

1 1A/B 21 1A/B 21 1A/B 21 2 3

11

1 2 2A/B

Lactation

9 Target Organ ST – Repeat Dose 1 21 2

1A/B/C

10 Aspiration Hazard


1 2 3Aquatic Toxicity, AcuteAquatic Toxicity, Chronic 1 2 3 4

Environmental Hazard Classes Hazard Category


GHS Status

A non-binding International Recommendation

WTO (view 1999) An International Standard for Trade

No changes to GHS at country level

GHS non compliance could constitute a TBT

Countries cannot change criteria or other provisions

Countries must implement the GHS as written

Only flexibility is the optionality already in the GHS


1.3 GHS/EU Interface


GHS applies in all systems using classification

OBJECTIVE - One substance, one global classification

GHS is a global system that will replace EU Directives

GHS EU (supply)Classification Criteria – Substances 67/548/EEC Substances Dir.

(EU GHS Regulation in future)

Classification Methods – Mixtures 1999/45/EC Preparations Dir.(EU GHS Regulation in future)

Hazard Communication Labelling

(EU GHS Regulation in future)

Safety Data Sheets 91/155/EEC SDS Directive(REACH Regulation from 01/06)


REACH and the GHS – Scope comparison

REACH GHS

R,E,A,Ch Classification, Labelling, SDS

Risk Hazard

Substances Produced Substances/Mixtures

Hazardous and Non-Hazardous Hazardous

> 1 Tonne per Manufacturer Any volumes

Harmonised Classifications Self Classification

CMRs at EU Level

Other Endpoints - Industry

European Union Global

Supply Supply and Transport


1.4 GHS Optionality Building Block Approach

Competent Authority Options

Cut-offs for Mixture Hazard Communication


Building Block Approach(NOTE: Interpretation still under discussion at UN SCE GHS)

The GHS contains “Harmonised” and “Standardised” components;

These components are the “Building Blocks”

• Harmonised refers to the use and application of the component

• Standardised refers to the content of the component

Component Harmonised Standardised

Hazard Classes Yes Yes

Hazard Categories Yes Yes

Label Elements

Pictograms Yes Yes

Signal words Yes Yes

Hazard Statements Yes Yes

Precautionary Statements (Guidance) No

Safety Data Sheet Yes Yes


Building Block ApproachBuilding Block Optionality (See paras. 1.1.3.1.5.1 to 1.1.3.5.3)

Component Optional

Hazard Classes Yes

Hazard Categories Yes (subject to certain rules)

Label Elements No (but see exceptions below)

Pictograms

Signal words Exception – Transport (see 1.4.1.5)

Hazard Statements Exception – Transport (see 1.4.1.5)

Precautionary Statements Exception – Transport

Safety Data Sheet Yes (Not used by Consumers or Transport Sectors)


Building Block ApproachConditions applying to Building Block optionalityComponent Conditions

Hazard Classes If a Hazard Class is adopted, the GHS classification criteria shall be applied

Hazard Categories Hazard Categories shall be adopted in sequence from most severe to least severe. For example, for acute toxicity Hazard Categories 1, 2 and 3 or 1, 2, 3 and 4 could be adopted, but not 1 and 3 or 1, 3 and 4. For the Hazard Classes and Categories adopted the appropriate GHS Label Elements shall be applied. (See exceptions for Transport)

Safety Data Sheet The GHS SDS format and content shall be applied


Building Block ApproachBuilding Block Approach Application ExampleHazard Classes Supply Transport

Aquatic Environment Yes YesPhysico-Chemical Hazards Yes Yes Acute Toxicity Yes YesCorrosion - Skin and Eyes Yes Yes (skin)Irritation - Skin and Eyes Yes NoSensitisation Yes NoCMRs Yes NoTarget Organ Toxicity Yes No

Hazard Categories Acute Oral Toxicity

Cat. 1 Cat. 2 Cat. 3 Cat. 4 Cat. 5

Transport Yes Yes Yes No NoSupply (EU) Yes Yes Yes Yes No


Comparison of Building Block Approach and Competent Authority Options

Building Block Approach enables;

inclusion or exclusion of certain GHS harmonised components If included;

– the harmonised GHS components shall be applied

Competent Authority Options enable;

inclusion of non-harmonised GHS components nationally If included;

– the non-harmonised components may be applied


Optional Cut-off/Concentration Limits for Hazard Communication of Mixtures

Sensitisation Table 3.4.1

Carcinogenicity Table 3.6.1

Reproductive Toxicity Table 3.7.1

STOST Single Exposure Table 3.8.2

STOST Repeated Exposure Table 3.9.3

For the Hazard Categories involved there will be a requirement for;

• an SDS in all cases above the lower cut-off concentration limit

• a Label in all cases above the higher cut-off concentration limit

• but a Competent Authority can choose whether to require a Label between the lower and higher cut-off concentration limits

Unless lower Specific Concentration Limits (SCLs) are specified


Ingredient Classified as:

Cut-off/concentration limits triggering classification of a mixture as:

Category 1 Category 2

Category 1 Target Organ Systemic Toxicant

1.0 % (note 1) 1.0 ingredient 10% (note 3)

10 % (note 2) 1.0 ingredient 10% (note 3)

Category 2 Target Organ Systemic Toxicant

1.0 % (note 4)

10 % (note 5)

Mixtures Optional Cut-Offs - Applicability of Notes

NOTE 1: If a Category 1 specific target organ/systemic toxicant is present in the mixture as an ingredient at a concentration between 1.0% and 10%, every regulatory authority would require information on the SDS for a product. However, a label warning would be optional. Some authorities will choose to label when the ingredient is present in the mixture between 1.0% and 10%, whereas others would normally not require a label in this case.NOTE 2: If a Category 1 specific target organ/systemic toxicant is present in the mixture as an ingredient at a concentration of > 10%, both an SDS and a label would generally be expected.NOTE 3: If a Category 1 target organ/systemic toxicant is present in the mixture as an ingredient at a concentration between 1.0% and 10%, some authorities classify this mixture as a Category 2 target organ/systemic toxicant, whereas others would not. NOTE 4: If a Category 2 specific target organ/systemic toxicant is present in the mixture as an ingredient at a concentration between 1.0% and 10%, every regulatory authority would require information on the SDS for a product. However, a label warning would be optional. Some authorities will choose to label when the ingredient is present in the mixture between 1.0% and 10%, whereas others would normally not require a label in this case.NOTE 5: If a Category 2 specific target organ/systemic toxicant is present in the mixture as an ingredient at a concentration of > 10%, both an SDS and a label would generally be expected.


1.5 GHS Impact


GHS will not be fully “Harmonised” at first

GHS will have optionality to facilitate countries with existing systems to make the transition to GHS

GHS provides an integrated approach to Classification andHazard Communication

GHS provides common basis for classification for allsystems

GHS provides a single Hazard Communication message for supply and transport

A package labelled in accordance with the GHS shouldensure regulatory compliance for all the stages during itshandling and use

Differences will be seen in the hazard communication


Current EU Labelling


UNXXXX & Proper Shipping Name

GHS Product Identifier (§1.4.10.5.2(d)(i))[GHS Chemical Identities (§1.4.10.5.2(d)(ii))]

GHS Signal Word (§1.4.10.5.2(a))GHS Hazard Statement (§1.4.10.5.2(b))GHS Hazard Statement (§1.4.10.5.2(b))

GHS Precautionary Statement (§1.4.10.5.2(c))GHS Precautionary Statement (§1.4.10.5.2(c))GHS Precautionary Statement (§1.4.10.5.2(c))

GHS Supplier Identifier (§1.4.10.5.2(e))

GHS Supplemental Information (§1.4.6.3)XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Commercial Information

PRODUCT ABCManufactured by

Company XYZ

Product Information/Use InstructionsXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

GHS Supplemental Information §1.4.10.5.4.2

TransportInformation

§1.4.10.5.2(d)(i)

GHS Label

Other Information

Company/Branding Information GHS Label §1.4.10.5.4.1


GHS Impact

Actors in the chain

RegulatorsRegulators will only have to deal with the elements of theGHS that they adopt

Manufacturers (of both substances and mixtures) Manufacturers will not need to learn the classification

systems of those countries with which they trade, but; Manufacturers will have to deal with all the differing

elements of the GHS adopted by those countries with which they trade and the optionality adopted by those countries (e.g. hazard communication)


GHS ImpactBenefitsRegulatorsA single system should improve accurate information flow

Manufacturers Facilitation of International Trade A single internal group can classify for global supply Less manpower required to track national legislation Greater likelihood of providing correct information globally

UsersUsers should receive information on chemicals communicated on a consistent global basis which should lead to improvements and benefits in consumer and worker protection Less confusion when using global suppliers Improvement in worker risk assessment before use


GHS Impact in EUSubstance Classification Estimated 30,000 Marketed substances subject to REACH + Other substances to enter into the Inventory Reclassification according to GHS criteria The EU is proposing to adopt the elements of the GHS that are

consistent with the current EU system, therefore the impact on substances should be relatively neutral

Mixtures Classification Estimated approximately 2,000,000 mixtures marketed Reclassification according to GHS criteria where relevant Existing classified Mixtures will be more severely classified Significant increase in the number of classified Mixtures

Hazard Communication Labelling Significant changes Safety Data Sheets GHS & EU SDS requirements similar


1.6 European Commission

GHS Draft Proposal


• Commission are keeping as close as possible to the current EU System

Remember:

• The Commission have to implement the GHS as written

• The only optionality the Commission has is the optionality in the GHS

• Issues related to the technical content of the GHS have to be addressed at the UN SCE GHS, not to the Commission

European Commission GHS Draft Proposal


GHS Regulation StructureArticles

Annexes

Annex I C&L 6 Parts

Annex II Other Labelling and Packaging rules

Annex III Hazard Statements (20 Languages)

Annex IV Precautionary Statements (20 Languages)

Annex V Pictograms

Annex VI Legally Binding DSD Annex I Translation

Annex VII Milieu Tables of Equivalence


GHS Regulation StructureAnnex I

Part 1 Introduction & Principles for Classification

Part 2 Physical Hazards C&L

Part 3 Health Hazards C&L

Part 4 Environmental Hazards C&L

Part 5 EU Hazard Class – Ozone Depletants

Part 6 Criteria for Precautionary Statements


Articles, (exclude Explanatory Memorandum & Whereas Clauses) 29 PagesAnnex I, Part 1 – General Principles for Classification & Labelling 18 PagesAnnex I, Part 2 – Physical Hazards 50 PagesAnnex I, Part 3 – Health Hazards 75 PagesAnnex I, Part 4 – Environmental Hazards 18 PagesAnnex I, Part 5 – Additional EU Hazard Class (Ozone Depletants) 1½ PagesAnnex I, Part 6 – Application of Precautionary Statements 3 PagesAnnex II – (5 Parts) Special Labelling Rules 11 PagesAnnex III – (3 Parts) Hazard Statement Translations 106 PagesAnnex IV – (1 Part) Precautionary Statement Translations 5 PagesAnnex V – Allocation of Pictograms 11 PagesAnnex VI – Substances with Harmonised Classifications, Notes 1 PagesAnnex VII – Classification Conversion Tables 1 Pages



Interface with REACH• SDS to remain in REACH

• Transitional period for substances 3 years, but this expires 30/11/2010 (REACH Tier 1 Registration deadline)

• Transitional period for mixtures 4½ years starting 01/12/2010

• Repeal of 67/548/EEC and 1999/45/EEC from the end of the transitional period

• Title XI of REACH will move to the GHS Regulation

• Harmonised Substance Classifications will go into Annex VI of GHS


ghs implementation training 1:- introduction 1 william g. machin manager; classification and hazard...

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