Introduction to

G.H.S and EU CLP

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 Agenda

GHS Background & Overview

CLP background and overview

Requirement and impact - SDS and Labelling

What do you need to do?

 Conventions & Abbreviations

REACH
Corrigendum to Regulation (EC) No 1907/2006 of the European
Parliament and of the Council of 18 December 2006 concerning the
Registration, Evalu-ation, Authorisation and Restriction of Chemicals
(REACH),
CLP
Regulation (EC) No 1272/2008 of the European Parliament and of the
Council of 16 December 2008 on Classification, Labelling and Packaging of
substances and mixtures, amending and repealing Directives 67/548/EEC
& 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ
31.12.2008, L353/1)
GHS
Globally Harmonized System of Classification and Labelling of Chemicals
(GHS), fifth revised edition, UN 2013

DSD (Dangerous Substance Directive)

Council Directive 67/548/EEC on the approximation of the laws,
regulations and administrative provisions relating to the classification,
packaging and labelling of dangerous substances
 The Road to CLP Why do we need a GHS?
UN GHS Danger (Toxic )
Transport - Liquid: slightly toxic; Solid: not classified
EU - Harmful
US - Toxic UN 2007 TOXIC

Canada - Toxic 6
Substance
Australia - Harmful
Oral toxicity India - Non-toxic
Danger
Japan - Toxic
LD50 = 260 mg/kg Malaysia - Harmful
Thailand - Harmful
New Zealand - Hazardous
China - Not Dangerous
Korea - Toxic
 Background

Situation mid of the 90`s

Diversified laws & regulations in different countries for C&L
(similarities but also significant differences)
continuous changes and developments
(increasing complexity for classification & labelling globally)

GHS Targets
internationally comprehensive system for hazard communication
enhance protection of human health & environment
recognized framework for countries without systems
reduce the need for testing & evaluation of chemicals
facilitate international trade in chemicals
 Background - Implementation
1992
Rio De Janeiro - United Nations Conference on Environment and Development
Establish programmes for sound management of chemicals in which is included
Harmonization of classification and labelling of chemicals.
Johannesburg United Nations World Summit on Sustainable Development
2002 Encouraged countries to implement GHS by 2008
GHS draft taken for approval at UN Economic & Social Council through its sub
2003 comittee on UN GHS. Adopted.

2011 4th revision of GHS adopted.

2013 5th revision of GHS adopted.

Global Harmonised system of classification and labelling becomes mandatory

2015 all countries/regions
 Background GHS Concept
GHS is very similar to the current EU and US system
the ultimate goal is a fully harmonized system worldwide

Building block approach

smooth transition in various jurisdictions

GHS is
rethinking the existing system
Stepwise adaptation in a significant magnitude
requiring a long transition period
substances first
mixtures thereafter
 GHS Goal (1)

Develop a harmonized system for the classification of

materials and for hazard communication (labels and
SDS) by the end of 2000 and implement in 2008.
Provide the underlying infrastructure for
establishment of comprehensive national safety
programmes
GHS Goal (2)
 GHS - Scope

All hazardous chemicals

Target audience:
Workers
Consumers
Transport workers
Emergency responders
Building block approach
Intrinsic (hazardous) properties of substances and
mixtures
Convey information about the identified hazards
 The Road to GHS

ECOSOC
United Nations Economical & Social Council

Strategic
UN CE TDG GHS
United Nations Committee of Experts on the
Transport of Dangerous Goods and on the
Globally Harmonized System of Classification
and Labelling of Chemicals

UN SCE TDG
United Nations Sub-Committee of Experts
on the Transport of Dangerous Goods
Technical
UN SCE GHS
United Nations Sub-Committee of Experts
on the Globally Harmonized System
of Classification & Labelling of Chemicals

http://www.unece.org/trans/welcome.html http://www.unece.org/trans/danger/publi/ghs/mandate_e.html
 GHS - The Purple Book

The UN Purple Book:

The UN Committee of Experts for the Transport of

Dangerous Goods and the Globally Harmonised
System of Classification and Labeling of Chemicals
formally adopted the GHS in December 2002.

Published in 2003
 The Road to GHS

Globally Harmonized System of Classification

and Labelling of Chemicals (GHS)

Purple Book

1st Edition 2003

1st Revised Edition 2005
2nd Revised Edition 2007
3rd Revised Edition July 2009
4th Revised Edition: 2011
5th Revised Edition: July 2013
http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/03files_e.html

The UN GHS is not a formal treaty, but instead is a non-legally

binding international agreement. Therefore countries (or trading
blocks, like the European Union) must establish legislation for
. their jurisdiction in order to implement the UN GHS.
 The Road to GHS
The 6th revised edition of the UN GHS (2015)
Includes:-
A new test method for oxidizing solids.

Miscellaneous provisions intended to further clarify the criteria

for some hazard classes (skin corrosion/irritation, severe eye
damage/irritation, and aerosols) and

To complement the information to be included in the Safety Data

Sheet:-
Revised and simplified classification and labelling summary
tables.

A new codification system for hazard pictograms, and

Revised and further rationalized precautionary statements..

The system is now ready for world-wide implementation.

 Building Block Approach of the GHS
Competent authorities (CAs) will decide how to apply the elements of the
GHS based on their needs and the target audience.
Countries are free to determine which of the building blocks will be
applied in different parts of their systems. However, where a system
covers something that is in the GHS, and implements the GHS, that
coverage should be consistent.
Countries may choose not to cover all of the effects addressed by the
GHS in each use setting.
The full range (of the harmonised elements of the GHS) is available to
everyone but does not have to be adopted completely.
As long as the hazards covered by a sector or system are covered
consistently with the GHS criteria and requirements, it will be considered
appropriate implementation of the GHS.

.
GHS is a toolbox to pick from !
 EU Building Block approach
Physical Hazards Hazard Categories
Explosives unstable Div. 1.1 1.2 1.3 1.4 1.5 1.6

Flammable gases 1 2

Flammable aerosols 1 2

Oxidizing gases 1

Gases under pressure compr. liquif. refrig. dissolv.

Flammable liquids 1 2 3 4

Flammable solids 1 2

Self-reactive substances & m. Type A B C&D E&F G

Pyrophoric liquids 1

Pyrophoric solids 1

Self-heating substances & m. 1 2

In contact with water fl. gas 1 2 3

Oxidizing liquids 1 2 3

Oxidizing solids 1 2 3

Organic peroxides Type A B C&D E&F G

Corrosive to metals 1
 EU Building Block approach
Health Hazard Classes Hazard Categories
Acute Toxicity, Oral 1 2 3 4 5

Acute Toxicity, Dermal 1 2 3 4 5

Acute Toxicity, Inhalation 1 2 3 4 5

Skin Corrosion/Irritation 1A, 1B, 1C 2 3

Eye Damage/Irritation 1 2 (A B)

Respiratory Sensitisation 1

Skin Sensitisation 1

Germ Cell Mutagenicity 1A, 1B 2

Carcinogenicity 1A, 1B 2

Reproductive Toxicity 1A, 1B 2 Lactation

TOST Single Dose 1 2 3

TOST Repeat Dose 1 2

Aspiration Hazard 1 2
 EU Building Block approach

Environmental Hazards Hazard Categories

Acute aquatic toxicity 1 2 3

Chronic aquatic toxicity 1 2 3 4

Additional Hazard Hazard Class

Ozone depleting 1
 GHS Implementation Status around the world

67 countries have implemented GHS.

European Union (EU): Implemented since 2008. 4 threvision of GHS is
implemented for substances from 1st Dec 2014 and mixtures from 1st June 2015

USA: Revised Hazard communication standard published in line with 3 rd revision of GHS and
effective from May 2012. It is not mandatory till June 2015.

Japan: Publication of the National Standard JIS Z 7253 (Hazard communication of chemicals
based on GHS-Labelling and Safety Data Sheet (SDS)) in 2012.

Australia: After 31 December 2016, all workplace chemicals must be classified according to
the GHS and labels and SDS must be updated.

India: In January 2012, India announced that it would issue rules on GHS within a month.
Following comments, the Ministry of Environment and Forests was working on the final document.
No final rules were issued within a month, despite what was mentioned in the January 2012
announcement, although they could be issued at any time.
 Safety Data Sheets - requirement
SDS should be provided for
all substances/mixtures meeting GHS harmonized criteria for physical,
health and environmental hazards
mixtures containing substances meeting criteria for carcinogenicity,
toxicity for reproduction or specific target organ systemic toxicity, in
concentrations exceeding cut-off values
other substances/mixtures not meeting the criteria for classification as
hazardous but containing hazardous substances in certain concentrations,
if required by
the competent authority
 GHS cut-off values / concentration limits
Hazard Class Cut-off value

Acute toxicity 1.0%

Skin corrosion/Irritation 1.0%
Serious damage to eyes/eye irritation 1.0%
Respiratory/Skin sensitization 1.0%
Mutagenicity: Category 1 0.1%
Mutagenicity: Category 2 1.0%
Carcinogenicity 0.1%
Reproductive toxicity 0.1%
Specific target organ systemic toxicity (single exposure) 1.0%
Specific target organ systemic toxicity (repeated 1.0%
exposure)
Hazardous to the aquatic environment 1.0%
 Safety Data Sheets - content
SDS should contain
A clear description of the data used to identify the hazard
The minimum information where applicable (to the specific product) and
available (to the entity preparing the SDS)
No blanks - if specific information is not applicable or available the SDS
should clearly state this
National or regional related information
EC number, occupational exposure limits, etc.
local amendments such as national classifications
additional information my be required by Competent Authorities
 Safety Data Sheets format (cont)
Information should be presented using the 16 headings in
the
order given below
1. Identification 9. Physical and chemical properties
2. Hazard(s) identification 10. Stability and reactivity
3. Composition / information 11. Toxicological information
on ingredients 12. Ecological information
4. First-aid measures 13. Disposal considerations
5. Fire-fighting measures 14. Transport information
6. Accidental release measures 15. Regulatory information
7. Handling and storage 16. Other information
8. Exposure controls / personal
protection
..
 Safety Data Sheets Section 1
Identification
Identification of the substance or mixture
GHS product identifier (as in the label)
Other unique identifiers (names or numbers)
Recommended or intended use of the chemical
Restrictions on use
Suppliers details
Name
Full address
Phone number
Emergency phone number
..
 Safety Data Sheets Section 2
Hazard identification
Classification of the substance or mixture
Hazard classes
Categories

GHS label elements

Signal words
Hazard statements
Precautionary statements
Pictograms (or symbols)
.
Other hazards which do not result in classification
 Safety Data Sheets Section 3
Composition/information on ingredients
Substances
Chemical identity (CAS, IUPAC name)
Common name, synonym of the substance
Identification number (CAS number, EC number)
Classified impurities and stabilizing additives
Mixtures
for all hazardous ingredients present above their cut-off level
Chemical identity
Identification number
.. Concentration range or exact percentage
 Safety Data Sheets Section 4

First aid measures

Description of measures subdivided by route of exposure
Most important symptoms/effects, acute and delayed
If needed, indication of

Immediate medical attention

Special treatment
 Safety Data Sheets Section 5

Fire fighting measures

Suitable (and unsuitable) extinguishing
media
Specific hazards arising from the chemical
e.g. combustion products
Special protective equipment and
precautions for fire-fighters
 Safety Data Sheets Section 6

Accidental release measures

Personal precautions, protective equipment
and emergency procedures
Environmental precautions
Methods and materials for containment &
cleaning up
 Safety Data Sheets Section 7
Handling and storage
Precautions for safe handling
Conditions for safe storage
including incompatibilities and
specific storage requirements

operational conditions and risk management measures for specific uses

(see exposure scenarios)
 Safety Data Sheets Section 8
Exposure controls/personal protection
Control parameters
occupational exposure limits
biological limit values
Exposure controls
appropriate engineering controls
individual protection measures
including personal protective equipment (PPE)
environmental exposure controls
 Safety Data Sheets Section 9
Physical and chemical properties
1. Appearance 11. Vapour pressure
2. Odour 12. Vapour density
3. Odour threshold 13. Relative density
4. pH 14. Solubility(ies)
5. Melting point/freezing point 15. Partition coefficient: n-octanol/water
6. Initial boiling point / boiling 16. Auto-ignition temperature
range 17. Decomposition temperature
7. Flash point 18. Viscosity
8. Evaporation rate 19. Explosive properties
9. Flammability (solid, gas) 20. Oxidising properties
10. Upper/lower flammability or 21. Any other phy/chem parameter
explosive limits considered relevant
 Safety Data Sheets Section 10
Stability and reactivity
Reactivity
specific data for substance or mixture if available
general data for class of chemical
Chemical stability
under normal ambient conditions, storage and handling
Possibility of hazardous reactions (conditions)
Conditions to avoid
e.g. heat, pressure, shock, vibration
Incompatible materials
Hazardous decomposition products
 Safety Data Sheets Section 11
Toxicological information
Provides data for all the health hazards covered by the GHS
Acute toxicity
Skin corrosion /irritation
Serious eye damage / irritation
Respiratory or skin sensitisation
Germ cell mutagenicity
Carcinogenicity Mandatory due to new
Reproductive toxicity C&L system in GHS
STOT-single exposure
. STOT-repeated exposure
Aspiration hazard
 Safety Data Sheets Section 11 (cont)
Information on the likely routes of exposure
inhalation, ingestion, skin and eye contact
Symptoms related to the physical, chemical and toxicological
characteristics
Delayed and immediate effects and chronic effects
from short or long term exposure

Numerical measures of toxicity

such as dose, concentration, condition of exposure
Interactive effects
Information on substance or mixtures as used
Where specific chemical data are not available, data on chemical class
may be used
More demanding & detailed compared to previous EU SDS
Ingredients information if data on mixture not available
 Safety Data Sheets Section 12
Ecological information
Provides information to evaluate the environmental impact of the substance
or mixture if it were released
Eco-Toxicity (aquatic and terrestrial if available)
Persistence and degradability
Bioaccumulative potential
Mobility in soil
Results of PBT and vPvB assessment
Other adverse effects
e.g. environmental fate, ozone depletion potential, etc.
 Safety Data Sheets Section 13

Disposal considerations
Information for proper disposal of substance or
mixture and its contaminated containers
Preferred waste management options
 Safety Data Sheets Section 14
Transport information
Transport by road, rail, inland waterways, sea and air
UN Number
UN Proper Shipping Name
Transport hazard classes
Packing group, if applicable
Environmental hazards (marine pollutant)
Special precautions for user
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC
code if applicable
 Safety Data Sheets Section 15
Regulatory information
Regulatory information not provided elsewhere in the SDS
Safety, health and environmental regulations
specific for the chemical in question
e.g. prohibitions, restrictions in countries or regions
country specific legal requirements
indicate availability of chemical safety assessment

.
 Safety Data Sheets Section 16
Other information
Date of preparation of the latest version of the SDS
Clear indication of the changes made to the previous version
Key/legend to abbreviations and acronyms used in the SDS
Key literature references and sources for data
used to compile the SDS
List of relevant R- & S-phrases, H- & P-statements
training advice for workers if recommended
 Transport "Pictograms"

Flammable Liquid Flammable Gas Flammable solid Self-Reactive Substances Pyrophorics (Spontaneously Combustible)
Flammable Aerosol Self-Heating Substances

Substances, which in contact with water, Oxidizing Gases Oxidizing Liquids Oxidizing Explosive Divisions 1.1, 1.2, 1.3
emit flammable gases (Dangerous When Solids
Wet)

Explosive Division 1.4 Explosive Division 1.5 Explosive Division 1.6

Compressed Gases Acute Toxicity (Poison): Oral, Dermal, Corrosive

Inhalation

Marine Pollutant Organic Peroxides

 DOT Labels
DOT labels may take precedence over similar GHS
pictograms for shipping containers.
DOT does not have labels that correspond to the
Health Hazard or the Acute Toxicity (less severe =
exclamation mark).
 Labels: Pictograms

There are 9 pictograms.

Health Hazards
Physical Hazards
Environmental Hazards (Regulated by DEQ)

DEQ
 Labels: Pictograms Health Hazards

Acute toxicity (Severe) Acute toxicity (Less Severe):

Irritant
Dermal sensitizer
Acute toxicity (harmful)
Acute = short-term effect Narcotic effects
Respiratory tract irritation
 Labels: Pictograms Health Hazards (continued)

Carcinogen
Respiratory sensitizer
Skin corrosion Reproductive toxicity
Serious eye damage/ Target organ toxicity
Eye irritation Mutagenicity
Aspiration Hazard
 Labels: Pictograms Physical Hazards

Flammables
Self reactives
Pyrophorics
Explosives Self heating
Self reactives Emits flammable gas
Organic peroxides Organic peroxides
Labels: Pictograms Physical Hazards
(continued)

Corrosive to Metals Oxidizer

Gases under Pressure

SDS and Labelling - Example of a
GHS Hazard Label
SDS and labelling
Hazard & Transport Labels
 Few Important properties Chemicals

Physical Properties: B.pt., Melting pt., Vap. Pressure,appearance

Flash point
Ignition temperature
LD 50
TLV
Carcinogen /radio active
Corrosivity
Incompatible with
Spillage control (disposal)
Tox-Safety: Toxicity

LD50 and Carcinogenicity

Avoid LD50 < 100mg/kg (teaspoon)
Avoid carcinogens
LD50 Toxic Human lethal
dose
<1 Dangerously Taste
1-50 Seriously 1 teaspoon(~5ml)
50-500 Highly 1 ounce(~30ml)
500-5000 Moderately 1 pint(~475ml)
5000-15000 Slightly 1 quart(~950ml)
> 15000 Low >1 quart

LD50 < 500 care to be taken

Tox-Safety: TLV Values

Acetone 750 ppm

Ammonia 25 ppm 0.24 2000
CO 25 ppm
1500
Chlorine 0.5 ppm 0.1 800
Gasoline 300 ppm
Hexane 50 ppm
Phosgene 0.1 ppm 0.2 50-100
H2S gas 1.0 ppm 0.13 600
MIC 0.02 ppm 2.0 50-100

Take care when TLV <30 ppm

 Some Solvent Data
Flammability Explosion Ignition
flash point limits Temperature (C)
FP (
C) LEL, UEL %

DMF 58 2.2 - 16 445

MeOH 6 36.5 464

11

Tol
5 1.2 - 7.1 536
Pet.Ether -40 1.0 - 7 240

Flash point <20C between 20-60C > 60-93C >93C

Thank you