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1GHS Implementation Training 1:- Introduction
William G. Machin
Manager; Classification and Hazard Communication
Cefic
European Chemical Industry Council
Brussels
2GHS Implementation Training 1:- Introduction
GHS
Globally Harmonised System
Overview and Issues
3GHS Implementation Training 1:- Introduction
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
4GHS Implementation Training 1:- Introduction
1.1 GHS Background and History
5GHS Implementation Training 1:- Introduction
Rio de Janeiro 3-14 June 1992
United Nations Conference on the Environment and Development
Agenda 21
Agenda 21 - 40 Chapters
6GHS Implementation Training 1:- Introduction
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
7GHS Implementation Training 1:- Introduction
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.
8GHS Implementation Training 1:- Introduction
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
9GHS Implementation Training 1:- Introduction
Program Area B
Classification Criteria for Substances Classification Methods for Mixtures Hazard/Risk Communication
Labelling Safety Data Sheets Training
Implementation
10GHS Implementation Training 1:- Introduction
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
11GHS Implementation Training 1:- Introduction
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"
12GHS Implementation Training 1:- Introduction
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.
13GHS Implementation Training 1:- Introduction
1.2 GHS Instrument
14GHS Implementation Training 1:- Introduction
IAEA UNEPUNITARWTO
WHOFAOILOUN CE GHS & TDG
United NationsInternational
Court ofJustice
SecurityCouncil
Economic& SocialCouncil
GeneralAssembly
UN SCEGHS
TrusteeshipCouncil
UNSecretariat
UN SCETDG
15GHS Implementation Training 1:- Introduction
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
16GHS Implementation Training 1:- Introduction
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
17GHS Implementation Training 1:- Introduction
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)
18GHS Implementation Training 1:- Introduction
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
19GHS Implementation Training 1:- Introduction
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.
20GHS Implementation Training 1:- Introduction
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
21GHS Implementation Training 1:- Introduction
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
22GHS Implementation Training 1:- Introduction
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
23GHS Implementation Training 1:- Introduction
1 2 3Aquatic Toxicity, AcuteAquatic Toxicity, Chronic 1 2 3 4
Environmental Hazard Classes Hazard Category
24GHS Implementation Training 1:- Introduction
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
25GHS Implementation Training 1:- Introduction
1.3 GHS/EU Interface
26GHS Implementation Training 1:- Introduction
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)
27GHS Implementation Training 1:- Introduction
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
28GHS Implementation Training 1:- Introduction
1.4 GHS Optionality Building Block Approach
Competent Authority Options
Cut-offs for Mixture Hazard Communication
29GHS Implementation Training 1:- Introduction
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
30GHS Implementation Training 1:- Introduction
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)
31GHS Implementation Training 1:- Introduction
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
32GHS Implementation Training 1:- Introduction
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
33GHS Implementation Training 1:- Introduction
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
34GHS Implementation Training 1:- Introduction
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
35GHS Implementation Training 1:- Introduction
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.
36GHS Implementation Training 1:- Introduction
1.5 GHS Impact
37GHS Implementation Training 1:- Introduction
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
38GHS Implementation Training 1:- Introduction
Current EU Labelling
39GHS Implementation Training 1:- Introduction
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
40GHS Implementation Training 1:- Introduction
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)
41GHS Implementation Training 1:- Introduction
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
42GHS Implementation Training 1:- Introduction
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
43GHS Implementation Training 1:- Introduction
1.6 European Commission
GHS Draft Proposal
44GHS Implementation Training 1:- Introduction
• 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
45GHS Implementation Training 1:- Introduction
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
46GHS Implementation Training 1:- Introduction
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
47GHS Implementation Training 1:- Introduction
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
European Commission GHS Draft Proposal
48GHS Implementation Training 1:- Introduction
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
European Commission GHS Draft Proposal