GHS
New legislation on classification and
labelling
Preface
2
Table of contents
Preface................................................................................................................................. 2
Table of contents ................................................................................................................. 3
Introduction/Background .................................................................................................... 6
Building blocks ............................................................................................................... 6
Difference between UN and EU ................................................................................. 7
Part of UN but not part of EU ..................................................................................... 7
Part of EU but not part of UN ..................................................................................... 8
Downstream legislation .................................................................................................. 8
Classification criteria .......................................................................................................... 9
Physical hazards .............................................................................................................. 9
Explosives ................................................................................................................. 11
Flammable gases ....................................................................................................... 11
Flammable aerosols .................................................................................................. 11
Oxidizing gases ......................................................................................................... 11
Gases under pressure................................................................................................. 11
Flammable liquids..................................................................................................... 11
Flammable solids ...................................................................................................... 12
Self-reactive substances and mixtures ...................................................................... 12
Pyrophoric liquids ..................................................................................................... 12
Pyrophoric solids ...................................................................................................... 12
Self-heating substances and mixtures ....................................................................... 12
Substances and mixtures which in contact with water emit flammable gases .......... 12
Oxidizing liquids....................................................................................................... 12
Oxidizing solids ........................................................................................................ 12
Organic peroxides ..................................................................................................... 13
Corrosive to metals ................................................................................................... 13
Health hazards ............................................................................................................... 14
Acute toxicity ............................................................................................................ 15
Skin corrosion/irritation ............................................................................................ 15
Serious eye damage/eye irritation ............................................................................. 15
Respiratory or skin sensitisation ............................................................................... 15
Germ cell mutagenicity ............................................................................................. 15
Carcinogenicity ......................................................................................................... 15
Reproductive toxicity ................................................................................................ 15
Specific target organ toxicity (STOT) – single exposure ......................................... 15
Specific target organ toxicity (STOT) – repeated exposure ..................................... 15
Aspiration hazard ...................................................................................................... 16
Environmental hazards.................................................................................................. 17
Hazardous for the ozone layer. ................................................................................. 17
Differences between DSD and CLP ................................................................................. 18
Physical hazards ............................................................................................................ 18
Flammable liquids..................................................................................................... 18
Health hazards ............................................................................................................... 20
Acute toxicity – inhalation ........................................................................................ 20
3
Acute toxicity – dermal ............................................................................................. 20
Acute toxicity – oral.................................................................................................. 20
Skin corrosion/irritation ............................................................................................ 20
Eye damage/Eye irritation......................................................................................... 21
Sensitisation .............................................................................................................. 21
Mutagenicity ............................................................................................................. 21
Carcinogenicity ......................................................................................................... 21
Reproductive toxicity ................................................................................................ 22
STOT, single exposure.............................................................................................. 22
STOT, repeated exposure.......................................................................................... 22
Environmental hazards.................................................................................................. 23
Classification of substances .............................................................................................. 24
Classification of mixtures ................................................................................................. 24
Bridging Principles ....................................................................................................... 24
Dilution ..................................................................................................................... 25
Batching .................................................................................................................... 25
Concentration of highly hazardous mixtures ............................................................ 25
Similar mixtures ........................................................................................................ 26
Changes in compositions .......................................................................................... 27
Aerosols .................................................................................................................... 27
Calculation principles ................................................................................................... 28
Cut-off values............................................................................................................ 28
Acute toxicity ............................................................................................................ 28
Classification based on concentration thresholds ..................................................... 31
Labelling ........................................................................................................................... 38
Labelling of unclassified mixtures ................................................................................ 38
Content of the label ....................................................................................................... 39
Hazard Pictograms ........................................................................................................ 39
Principles of precedence for hazard pictograms ....................................................... 41
Signal words.................................................................................................................. 41
Hazard statements ......................................................................................................... 42
Additional EU-statements ......................................................................................... 42
Precautionary statements .............................................................................................. 43
Product identifiers ..................................................................................................... 45
Supplemental information......................................................................................... 45
Special rules for packaging not exceeding 125 ml ................................................... 45
Language ....................................................................................................................... 47
Format of a label ........................................................................................................... 47
Outer and inner packaging ............................................................................................ 47
Transport regulation and CLP ....................................................................................... 48
Example of a label ........................................................................................................ 48
Update of label information .......................................................................................... 49
Who is affected by CLP and how? ................................................................................... 50
Importers and manufacturers of substances .................................................................. 50
Classification and labelling inventory ...................................................................... 50
Formulators ................................................................................................................... 50
4
Distributors ................................................................................................................... 50
End-users of chemicals ................................................................................................. 50
Preparation for CLP in the organisation ........................................................................... 51
CLP / GHS in the future.................................................................................................... 51
Transitional period ............................................................................................................ 52
Transitional period for substances ............................................................................ 52
Transitional period for mixtures ............................................................................... 52
Conversion tables .......................................................................................................... 53
Links ................................................................................................................................. 54
GHS/CLP Vocabulary ...................................................................................................... 55
Exercises ........................................................................................................................... 57
Exercise 1. Classification of substances – translation table .......................................... 57
Exercise 2. Classification of mixtures – calculation ..................................................... 57
Exercise 3. Labelling – label for previous classified mixture....................................... 57
Product identifier(s) .................................................................................................. 57
Signal Words ............................................................................................................. 58
Hazard pictograms .................................................................................................... 58
Hazard Statements .................................................................................................... 58
Supplemental information......................................................................................... 58
Exercise 4. Principles of Precedence – Choosing hazard pictograms ......................... 58
Solutions ........................................................................................................................... 59
Exercise 1 ...................................................................................................................... 59
Exercise 2 ...................................................................................................................... 59
Exercise 3 ...................................................................................................................... 62
Exercise 4 ...................................................................................................................... 64
Final labels .................................................................................................................... 65
5
Introduction/Background
GHS was adopted by UN in 2002. The intention was to introduce a global system for
classification and labelling of chemical substances and mixtures. Without a global system
a chemical substance may have quite different classifications from country to country and
from region to region. Some substances may be considered toxic in one country and
harmless in another country. Harmonised criteria for evaluating the hazardous properties
of chemicals will, by time, ensure uniform classifications all over the world. This will
make it easier for companies to import and export chemicals and hopefully it will lead to
a better protection of man and environment.
GHS should by time be implemented worldwide. However, the timeline for
implementation varies. Some countries have already implemented GHS while others are
still in the process of analyzing how to do it.
In EU GHS entered into force in January 2009. GHS is implemented as “Regulation of
the European Parliament and of the council on classification, labelling and packaging of
substances and mixtures”, in short: CLP system or just: CLP.
CLP is in many ways similar to the current EU system for classification and labelling,
and EU has implemented most of the building blocks from GHS. The global GHS text
also states criteria for preparation of safety data sheets. The GHS safety data sheets are
almost similar to the EU safety data sheets, however in EU safety data sheets will not be
regulated under CLP as they are already regulated under REACH.
In this course the current EU-system for classification and labelling of substances
(directive 67/548/EEC) will be referred to as “Dangerous Substance Directive”, DSD,
while the current EU-criteria for classification and labelling of mixtures (directive
1999/45/EC ) will be referred to as “Dangerous Preparations Directive”, DPD.
Building blocks
GHS introduces the term “Building block approach”. GHS is build up by a large number
of blocks, and each country or region (e.g. EU) is free to pick the building blocks they
want, so even if the intention is a globally harmonized system there may still be
differences in the implementation from country to country or region to region. However,
if a country or region chooses to implement a building block they have to implement the
building block as a whole without any changes. If two countries have chosen to
implement the same building block (for example the classification for acute toxicity
category 4) both countries will use the same criteria when classifying chemicals as toxic.
See criteria for Acute toxicity, page 28
6
Difference between UN and EU
When implementing the UN GHS, EU has left out some hazard classes and –categories
and introduced some not represented in the UN GHS. An overview of the main
differences between CLP and the GHS proposal from UN is found in Table 1.
UN
Flammable liquid, category 4
Acute toxicity, category 5
Skin irritation, category 3
Aspiration Hazard, category 2
Hazardous to the aquatic environment,
Acute category 2 and 3
Not part of the UN GHS
Safety data sheets
EU
Not part of CLP
Not part of CLP
Not part of CLP
Not part of CLP
Nor part of CLP
Hazardous for the ozone layer
Not part of CLP. Safety data sheets are
regulated under REACH. However, the
format and contents of a GHS safety data
sheet and an EU safety data sheet are
almost similar.
Table 1. UN-GHS versus EU-CLP
Furthermore CLP covers some hazards that lead to additional labelling which is not part
of GHS. These additional hazards are described further under Additional EU statements.
Part of UN but not part of EU
In EU a flammable liquid is a liquid with a flashpoint of not more than 60 °C. In UN a
flammable liquid is a liquid having a flashpoint of not more than 93 °C. In EU the
flammable liquids are divided into category 1, 2 and 3 while in UN there is also a
category 4 covering liquids with a flashpoint between 60 °C and 93 °C.
In EU an acute toxic substance is a substance having an LD50-value of not more than
2000 mg/kg. The hazard class “Acute Toxic” is divided into four categories with category
4 presenting the lowest level of hazard. UN introduces an Acute Toxic category 5 for
chemicals having an LD50-value between 2000 and 5000 mg/kg. This category 5 is not a
part of CLP.
In EU there are two categories for skin corrosion/irritation, namely category 1 and 2. In
UN there is a category 3 for mild skin irritation which is not a part of CLP.
In EU there is one category for the hazard class Aspiration Hazard while in UN there is
both category 1 and 2.
Regarding Environmental hazards, EU has chosen to implement one category for acute
toxicity, but the UN system introduces three categories.
7
Part of EU but not part of UN
In EU there is an additional hazard class, which is not part of the UN system, namely the
classification as Hazardous for the ozone layer
Downstream legislation
CLP will affect most chemical legislation including REACH. REACH and other
legislations often refer to specific classifications and specific R-phrases. With CLP these
R-phrases will no longer exist and therefore, in time, downstream legislation has to be
updated.
8
Classification criteria
Classification of chemical substances and mixtures means that the physical hazards, the
health hazards and the environmental hazards of the substance/mixture are determined.
A classification consists of a hazard class and a hazard category. Table 2, Table 3 and
Table 4 lists the CLP hazard classes and hazard categories implemented in EU.
This course will briefly go through the definitions and some of the criteria for each
hazard class. Furthermore you will find a short description of the differences between the
CLP criteria and the criteria from the DSD.
Physical hazards
To decide whether a substance or mixture is classified with one or more physical hazards
specific tests must always be performed. Most of the physical tests required according to
the CLP regulation are identical to the tests described in the UN Recommendations on the
transport of Dangerous Goods, Manual of Tests and Criteria.
An overview of the physical hazard classes and hazard categories is found in Table 2. In
addition to the table you will find a brief description of each hazard class.
9
Hazard Class
Hazard category
Explosives
Unstable explosives
Division 1.1
Division 1.2
Division 1.3
Division 1.4
Division 1.5
Division 1.6
1
2
1
2
1
Compresses gas
Liquefied gas
Refrigerated liquefied gas
Dissolved gas
1
2
3
1
2
Type A
Type B
Type C&D
Type E&F
Type G
1
1
1
2
1
Flammable gasses
Flammable aerosols
Oxidizing gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances and mixtures
Pyrophoric liquids
Phyrophoric solids
Self-heating substances and mixtures
Substances and mixtures which in
contact with water emit flammable gases
Oxidizing liquids
Oxidizing solids
Organic peroxides
2
3
1
2
3
1
2
3
Type A
Type B
10
Corrosive to metals
Type C&D
Type E&F
Type G
1
Table 2. Physical hazards
Explosives
The class of explosives comprises solid and liquid substances and mixtures as well as
articles. To classify a substance, a mixture or an article as explosive, tests needs to be
performed. This hazard class is found under DSD. However, DSD does not contain as
many hazard categories for explosives as CLP.
Flammable gases
A flammable gas is a gas or a gas mixture having a flammable range with air at 20 °C and
a pressure of 101.3 kPa. The gas or the gas mixture must be tested to decide whether it
meets the criteria. In DSD gasses are classified as flammable, but DSD only operate with
one term “Flammable”, which is used for both liquids and gasses.
Flammable aerosols
An aerosol dispenser containing compressed gas under pressure shall be classified as
flammable if it contains components classified as flammable liquids, flammable gases or
flammable solids. This hazard class is not a part of DSD.
Oxidizing gases
An oxidizing gas is a gas or a gas mixture which may provide oxygen and thereby
contribute to the combustion of other material more than air does. In DSD oxidising
gasses are classified but they are classified together with other oxidising substances.
Gases under pressure
The gases under pressure comprise compressed gases, liquefied gases, dissolved gases
and refrigerated liquefied gases. This hazard class is not a part of DSD.
Flammable liquids
A flammable liquid is a liquid having a flash point of 60 °C or less. Flammable liquids
are classified under DSD, but the criteria are different.
11
Flammable solids
A flammable solid is a powdered, granular or pasty substance or mixture which can be
easily ignited by brief contact with an ignition source. This hazard class is not a part of
DSD.
Self-reactive substances and mixtures
A self-reactive substance or mixture is a thermally unstable liquid or solid. The liquid or
solid is liable to undergo a strongly, exothermic decomposition even without the presence
of air. This hazard class is not a part of DSD.
Pyrophoric liquids
A pyrophoric liquid is a liquid which, even in small amounts, within 5 minutes of coming
into contact with air is liable to ignite. This hazard class is not a part of DSD.
Pyrophoric solids
A pyrophoric solid is a solid which, even in small amounts, within 5 minutes of coming
into contact with air is liable to ignite. This hazard class is not a part of DSD.
Self-heating substances and mixtures
A self-heating substance or mixture differs from a pyrophoric liquid or solid in that it will
ignite only in large amounts (kilograms) and after a long period of time (hours or days).
This hazard class is not a part of DSD.
Substances and mixtures which in contact with water emit flammable
gases
Hereby means solid or liquid substances or mixtures which in contact with water become
spontaneously flammable or give off flammable gases in dangerous quantities. The
hazard class is also found in DSD.
Oxidizing liquids
An oxidizing liquid is a liquid substance or a liquid mixture which may provide oxygen
and thereby contribute to the combustion of other material. The oxidizing liquid is not
necessarily combustible itself. Part of DSD.
Oxidizing solids
An oxidizing solid is a solid substance or a solid mixture which may provide oxygen and
thereby contribute to the combustion of other material. The oxidizing solid is not
necessarily combustible itself. Part of DSD.
12
Organic peroxides
Organic peroxides are liquid or solid organic substances containing the –O-O– structure.
Whether an organic peroxide is classified or not, depends on the amount of available
oxygen. Organic peroxides are classified under DSD, but they do not have a separate
hazard category. In DSD organic peroxides are classified together with other oxidising
substances.
Corrosive to metals
A substance or mixture is corrosive to metals if it materially damage or destroy metals.
Whether it is classified or not depend on the corrosion rate on either steel or aluminium.
Not a part of DSD.
13
Health hazards
The criteria for classifying a substance or a mixture for one or more health hazards are
very close to the criteria known from the EU system described in DSD.
An overview of the health hazard classes and hazard categories is found in Table 3. In
addition to the table you will find a brief description of each hazard class.
Hazard Class
Hazard category
Acute toxicity
1
2
3
4
1A
1B
1C
2
1
2
Skin sensitiser
Respiratory sensitiser
1A
1B
2
1A
1B
2
1A
1B
2
Additional category for effects
on or via lactation
1
Skin corrosion/irritation
Serious eye damage/eye irritation
Respiratory or skin sensitisation
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity –
single exposure
Specific target organ toxicity –
repeated exposure
Aspiration hazard
2
3
1
2
1
Table 3. Health hazards
14
Acute toxicity
Acute toxicity differs between oral, dermal and inhalation exposure. Acute toxicity takes
into consideration effects occurring after a single dose of a substance or mixture. The
criteria in CLP are different from the criteria described in DSD.
Skin corrosion/irritation
A corrosive substance or mixture is capable of producing irreversible damage to the skin,
while irritating substances and mixtures produce reversible damage to the skin. The
criteria in CLP differ from the criteria in DSD.
Serious eye damage/eye irritation
Chemicals irritating to eyes or chemicals causing serious eye damage are able to damage
the tissue in the eye or to cause a physical decay of vision. Serious eye damage is not
fully reversible while the eye irritation is fully reversible.
Respiratory or skin sensitisation
A respiratory sensitiser will cause hypersensitivity of the airways if inhaled. A skin
sensitiser will cause an allergic response following skin contact.
Germ cell mutagenicity
To meet the criteria for germ cell mutagenicity, a chemical is able to permanently change
the structure or amount of the genetic material in a cell (DNA). The chemical meeting
these criteria will be called a “mutagen”.
Carcinogenicity
A chemical classified as carcinogen may either cause cancer or increase the incidence of
cancer. The classification does not differ between different types of cancer.
Reproductive toxicity
Reproductive toxicity is the ability to affect the sexual function and the fertility of adult
male and female. Furthermore a chemical toxic to reproduction may be able to affect the
development of the offspring.
Specific target organ toxicity (STOT) – single exposure
Specific target organ toxicity – single exposure is defined as non lethal target organ
toxicity. The effects are significant and specific and they occur after only one exposure to
the chemical. Both reversible and irreversible effects are included in this definition.
Specific target organ toxicity (STOT) – repeated exposure
The definition of specific target organ toxicity – repeated exposure is similar to the
Specific target organ toxicity – single exposure except that for the repeated exposure the
effects will only appear after two or more exposures.
15
Aspiration hazard
Chemicals that pose an aspiration hazard are liquids or solids able to enter the lungs e.g.
following vomiting. The chemicals may cause chemical pneumonia or other severe
injuries.
16
Environmental hazards.
When classifying for environmental hazards only the effects to the aquatic environment
are considered. To classify a chemical you will need to know the acute and chronic
toxicity to aquatic organisms as well as the potential to bioaccumulate and the ability of
biodegradation.
An overview of the environmental hazard classes and hazard categories is found in Table
4.
Hazard Class
Hazard category
Hazardous to the aquatic
environment - Acute
Hazardous to the aquatic
environment - Chronic
1
1
2
3
4
Hazardous for the ozone layer
Table 4. Environmental hazards
Hazardous for the ozone layer.
EU has chosen to use an additional hazard class and enable the classification of a
chemical as hazardous for the ozone layer.
17
Differences between DSD and CLP
Even though the principles for classification are the same in DSD and CLP some criteria
are different. The tables below give an overview of the main differences between the
classification criteria according to DSD and CLP for health hazards and environmental
hazards.
Physical hazards
There are major changes between DSD and CLP when it comes to physical hazards.
Some criteria for existing hazard classes have changed, but the main difference is the
addition of a number of hazard classes, which are not part of DSD. The differences
between DSD and CLP for flammable liquid are shown in Table 5, while Table 6 and
Table 7 give an overview of the additional hazard classes under CLP.
Describing all criteria for classification will be much too comprehensive for this course.
Please see the CLP-legislation for details.
Flammable liquids
Extremely
flammable
Highly
flammable
Flammable
DSD
Flash point < 0 °C and boiling
point ≤ 35 °C
Flash point < 21 ° but not
extremely flammable
21 °C ≤ flash point ≤ 55 °C
Category 1
Category 2
Category 3
CLP
Flash point < 23 ° C and
boiling point ≤ 35 °C
Flash point < 23 °C and
boiling point > 35 °C
23 ≤ flash point ≤ 60 °C
Table 5. Comparison between DSD and CLP for flammable liquids
Hazard classes
Explosives
Oxidizing substances
Flammable substances
R-phrases
E;R2
O;R7
F+;R12
E;R3
O;R8
F;R11
O;R9
F;R15
F;R17
R10
Table 6. Physical hazard classes under DSD
18
Hazard classes
Explosives
Flammable gases
Flammable aerosols
Oxidizing gases
Gases under pressure
Compressed gas
Liquified gas
Refrigerated liquefied
gas
Dissolved gas
Flammable liquids
Flammable solids
Self-reactive substances and
mixtures
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and
mixtures
Substances and mixtures
which in contact with water
emit flammable gases
Oxidizing liquids
Oxidizing solids
Organic peroxides
Corrosive to metals
Hazard categories
Unstable Div 1.1 Div 1.2 Div 1.3 Div 1.4
1
2
1
2
1
Div 1.5 Div 1.6
1
1
1
1
1
1
Type A
2
2
Type B
3
Type C
Type D Type E
Type F
Type G
2
3
2
3
2
3
Type B Type C Type D Type E
Type F
Type G
1
1
1
1
1
1
Type A
2
1
Table 7. Hazard classes under CLP
19
Health hazards
Acute toxicity – inhalation
DSD
R26
R23
LC50 (mg/l/4 hours)
≤ 0,5
0,5 -2
CLP
R20
2 - 10
10 -20
Category 1 Category 2 Category 3 Category 4
Acute toxicity – dermal
DSD
R27
LD50 (mg/kg)
≤ 50
CLP
R24
50-200
R21
200-400
Category 1 Category 2
400-1000
Category 3
1000-2000
Category 4
Acute toxicity – oral
DSD
R28
≤5
LD50 (mg/kg)
CLP
R25
5-25
Category 1
25-50
Category 2
R22
50-200
200-300
Category 3
300-2000
Category 4
Skin corrosion/irritation
DSD
Exposure
R35
≤ 3 min
R34
3 min – 1 hour
R38
1 hour – 4 hours
See DSD for criteria
See CLP for criteria
CLP
Category 1A
Category 1B
Category 1C
Category 2
20
Eye damage/Eye irritation
DSD
R41
R36
See DSD for criteria
See CLP for criteria
CLP
Category 1
Category 2
Sensitisation
DSD
R42
R43
CLP
Respiratory sensitiser,
Category 1
Skin sensitiser,
Category 1
Mutagenicity
DSD
Mut, cat 1;R46
Mut, cat 2;R46
Mut, cat 3;R68
See DSD for criteria
See CLP for criteria
CLP
Category 1A
Category 1B
Category 2
Carcinogenicity
DSD
Carc, cat 1;R45
and R49
Carc, cat 2;R45 and
R49
Carc, cat 3;R40
See DSD for criteria
See CLP for criteria
CLP
Category 1A
Category 1B
Category 2
21
Reproductive toxicity
DSD
Rep, cat 1;R60
and R61
Rep, cat 2;R60 and
R61
Rep, cat 3;R62 and R63
See DSD for criteria
See CLP for criteria
CLP
Category 1A
Category 1B
Category 2
STOT, single exposure
DSD
Tx;R39
T;R39
R68
R37, R67
See DSD for criteria
See CLP for criteria
CLP
Category 1
Category 2
Category 3
STOT, repeated exposure
DSD
T;R48
Xn;R48
See DSD for criteria
See CLP for criteria
CLP
Category 1
Category 2
22
Environmental hazards
DSD
L(E)C50
CLP
R50
R52
≤ 1 mg/l
See DSD for criteria
Acute, Category 1
DSD
R50/53
R51/53
R52/53
R53
L(E)C50
≤ 1 mg/l
<1 L(E)C50 ≤ 10
<10 L(E)C50 ≤
100
Log Pow
log Kow
≥3
≥4
≥3
≥4
≥3
≥4
See DSD and
CLP for
criteria
Chronic,
category 1
Chronic, category
2
Chronic,
category 3
CLP
Chronic,
category 4
23
Classification of substances
Classification of a substance is based on test data (in vitro tests and animal data), QSARresults and human experience. For each hazard class and hazards category criteria are set
up which enable the manufacturer of a substance to classify the substance based on
available data.
Classification of mixtures
To classify a mixture the same tests as for substances can be performed and the mixture
can be classified based on data for the mixture. However, test data are normally not
available for mixtures. As it is desirable to avoid animal testing and since testing may be
very expensive, it is possible to classify a mixture if sufficient data for the ingredient
substances are available. Classification of a mixture based on substance data can only be
done for health and environmental hazards.
The physical hazards of a mixture cannot be calculated based on classification on ingoing
substances. Therefore tests always have to be performed for the mixture itself to
determine the physical hazards.
Bridging Principles
If test data are not available for a mixture but there are available test data for a similar
mixture, it is possible to classify the untested mixture using bridging principles. There are
different types of bridging principles.
24
Dilution
If a mixture is diluted with a substance with an equivalent or lower hazard category
classification than the least hazardous original substance and the diluent is not expected
to affect the hazard classification of any other substances in the mixture, one of the
following shall be applied:
Mixture A
Tested
Diluent
Equivalent or lower
hazard than original
substance
Mixture B
Same classification
as mixture A
Mixture A
Tested
Diluent
Water or other nonhazardous substance
Mixture B
Calculation based
on dilution
Batching
When producing a batch of a hazardous substance or mixture under controlled conditions
the hazards of each new batch can be assumed to be equivalent to the previous batch. If
there is reason to believe the composition may vary significantly, a new evaluation is
required.
Concentration of highly hazardous mixtures
When a mixture is already classified in the highest hazard category increasing the
concentration of ingredients in that category shall lead to classification in the same
hazard category without additional testing.
25
Interpolation
For three mixtures which contain the same hazardous substances, where mixtures A and
B are in the same hazard category and mixture C contains the same active hazardous
substances with concentrations intermediate to the concentrations of those hazardous
substances in mixtures A and B, then mixture C is assumed to be in the same hazard
category as A and B.
80%
30%
20%
Mixture A
STOT Kat. 1
70%
Mixture B
STOT Kat. 1
50%
50%
20% to 70%
30% to 80%
Mixture C
Interpolate STOT Kat. 1
Similar mixtures
Two mixtures both contain two substances, where the concentration of substance B is
essentially the same in both mixtures
Mixture 1: A + B (tested)
Mixture 2: B + C (not tested)
If the hazard category of substance A and C is the same and the concentration of A equals
that of C then mixture 2 can be assigned the same hazard category as mixture 1.
26
Changes in compositions
Applying bridging principles the following variations in composition is allowed:
Initial concentration range
≤ 2.5 %
2.5 % < C ≤ 10 %
10 % < C ≤ 25 %
25 % < C ≤ 100 %
Permitted variation in initial
concentration
± 30 %
± 20 %
± 10 %
±5%
Be aware of substance specific concentration limits and the M-factor for substances
classified for environmental hazards.
Aerosols
An aerosol form of a mixture shall be classified in the same hazard category as the nonaerosolized mixture unless it is assumed that the propellant will affect the hazards upon
spraying.
27
Calculation principles
If the hazardous properties of a mixture is unknown but the hazard properties of some or
every ingoing substances are known it is possible to classify the mixture using
calculation.
Cut-off values
Depending on the classification of a substance there are so-called “cut-off” values to take
into consideration when calculating the classification of a mixture. If a substance is
present in a mixture in a concentration below the cut-off value the hazardous properties
of the substance should not be taken into consideration when calculating. CLP lays down
a table containing generic cut-off values for substances. For substances present on the list
of harmonised substances there may be individual concentration limits lower than the
generic cut-off values. In this case, the lowest value must be used. The same goes for
substances present on the Agency’s “Classification and labelling inventory”.
For substances hazardous to the aquatic environment where an M-factor has been set the
generic cut-off value must be adjusted accordingly.
The generic cut-off values for solid and liquid substances are found in Table 8.
Hazard Class
Acute toxicity, category 1-3
Acute toxicity, category 4
Skin corrosion / irritation
Serious damage to eyes / eye irritation
Hazardous to aquatic environment – Acute
category 1
Hazardous to aquatic environment –
Chronic category 1
Hazardous to aquatic environment –
Chronic category 2-4
Cut-off value (weight percentage)
0.1 %
1%
1%
1%
0.1 %
0.1 %
1%
Table 8. Cut-off values
Acute toxicity
The acute toxicity estimate, ATE, equals the LD50/LC50-values for a substance or
mixture.
To decide whether a mixture should be classified as acute toxic, the ATE for the mixture
must be calculated. Every ingoing substance classified as acute toxic and present in
concentrations above the cut-off limit must be taken into consideration when calculating
the ATE for a mixture. When using the formula substances classified for both dermal,
oral and inhalation toxicity must be included.
The formula for calculating the ATE for a mixture where information for all ingoing
substances is available is:
28
100
Ci
=∑
ATEmix
n ATEi
Where:
Ci = concentration of ingredient i (% w/w or v/v)
i = the individual ingredient from 1 to n
n = the number of ingredients
ATEi = acute toxicity estimate for ingredient i.
The formula may also be used even if data are not available for all substances as long as
the concentration of unknown substances does not exceed 10 %.
In some cases actual LD50/LC50-values for a substance are not available, but as long as
the classification of the substance is known it is possible to find a converted ATE using
Table 9.
Exposure routes
Oral
(mg/kg
bodyweight)
Dermal
(mg/kg
bodyweight)
Gases
(ppmV)
Vapours
(mg/l)
Dust/mist
(mg/l)
Classification Category or
experimentally obtained
acute toxicity range
estimate
0 < Category 1 ≤ 5
5 < Category 2 ≤ 50
50 < Category 3 ≤ 300
300 < Category 4 ≤ 2000
0 < Category 1 ≤ 50
50 < Category 2 ≤ 200
200 < Category 3 ≤ 1000
1000 < Category 4 ≤ 2000
0 < Category 1 ≤ 100
100 < Category 2 ≤ 500
500 < Category 3 ≤ 2500
2500 < Category 4 ≤ 20000
0 < Category 1 ≤ 0.5
0.5 < Category 2 ≤ 2.0
2.0 < Category 3 ≤ 10.0
10.0 < Category 4 ≤ 20.0
0< Category 1 ≤ 0.05
0.05 < Category 2 ≤ 0.5
0.5 < Category 3 ≤ 1.0
1.0 < Category 4 ≤ 5.0
Converted Acute Toxicity
point estimate 1
0.5
5
100
500
5
50
300
1100
10
100
700
4500
0.05
0.5
3
11
0.005
0.05
0.5
1.5
Table 9. Converted ATE for substances
1
These values are designed to be used in the calculation of the ATE for classification of a mixture based on
its components and do not represent test results.
29
Using either actual ATE-values for each substance or converted ATE-values, the ATE for
the mixture is determined. Once the ATE for the mixture is known, the classification is
found using Table 10.
Exposure Route
Oral (mg/kg
bodyweight)
Dermal (mg/kg
bodyweight)
Gases (ppmV)
Category 1
ATE ≤ 5
Category 2
5 < ATE ≤ 50
Category 3
50 < ATE ≤ 300
ATE ≤ 50
50 < ATE ≤ 200
200 < ATE ≤ 1000
ATE ≤ 100
100 < ATE ≤ 500
500 < ATE ≤ 2500
Vapours (mg/l)
ATE ≤ 0.5
0.5 < ATE ≤ 2.0
2.0 < ATE ≤ 10.0
Dusts and Mists
(mg/l)
ATE ≤ 0.05
0.05 < ATE ≤ 0.5
0.5 < ATE ≤ 1.0
Category 4
300 < ATE ≤
2000
1000 < ATE ≤
2000
2500 < ATE ≤
20000
10.0 < ATE ≤
20.0
1.0 < ATE ≤ 5.0
Table 10. Hazard categories and ATE
Example:
If a mixture A contains 10 % of substance 1 classified as acute toxic category 3, oral and
5 % of substance 2 classified as acute toxic, category 2, oral, and the rest of the
substances are known to be not hazardous, then the calculations will be as follow:
The converted ATE-values for each substance are found using Table 9.
ATEoral for substance 1: = 100
ATEoral for substance 2 = 5
The converted ATE-values are inserted in the formula.
100
10 5
=
+
⇒ ATEmix, oral = 91
ATEmix, oral 100 5
Using Table 10 we find that an ATE for oral exposure of 91 gives a classification as
acute toxic, category 3
Therefore the classification of mixture A will be acute toxicity, category 3, oral
It is not yet clear how a mixture containing substances classified for acute toxicity but
with different routes of exposure should be handled. Guidance from ECHA is foreseen in
summer 2009.
More than 10 % unknown.
If data are missing for more than 10 % of the ingoing substances, it is still possible to
classify the mixture using calculation. In this case the formula is:
30
100 − (∑ Cunknown)
ATEmix
=∑
n
Ci
ATEi
Where Cunknown is the concentration of each substance where hazard data are not
available.
Classification based on concentration thresholds
Additive concentration limits
Additive concentration limits are used for some hazard classes. Each substance in these
hazard classes contributes to the overall classification of the mixture. The following
hazard classes use additive concentration limits.
•
•
•
Skin corrosion/irritation
Serious eye damage/eye irritation
Hazardous to the aquatic environment
Skin corrosion/irritation
When using the additivity approach to calculate the classification of a mixture each
ingredient classified as skin corrosive or skin irritant should be taken into account. A
weighing factor of 10 is used for a corrosive substance present at a concentration below
the generic cut-off value, if manufacturers or importers find it relevant to take this
substance into consideration when classifying. Table 11 shows the generic concentration
limits using the additivity approach. Below is given examples of calculations based on
the additivity approach.
Sum of ingredients classified as:
Skin corrosive, categories 1A,
1B, 1C
Skin irritant, category 2
(10 x skin corrosive, category 1A,
1B, 1C) + skin irritant, category 2
Concentration limits for classification as:
Skin corrosive, category 1 Skin irritant, category 2
≥ 5 %2
≥ 1 % but < 5 %
≥ 10 %
≥ 10 %
Table 11. Generic concentration limits of ingredients classified for skin corrosive/irritant hazards
If the sum of the Skin Corrosive Category 1A ingredients is ≥ 5 %, the mixture shall be classified as Skin
Corrosive Category 1A. If the sum of the Skin Corrosive Category 1A ingredients is < 5 % but the sum of
Category 1A+1B ingredients is ≥ 5 %, the mixture shall be classified as Skin Corrosive Category 1B.
Similarly, if the sum of Skin Corrosive Category 1A+1B ingredients is < 5 % but the sum of Category
1A+1B+1C ingredients is ≥ 5 % the mixture shall be classified as Skin Corrosive Category 1C.
2
31
Examples of classification using the additivity approach. It is assumed that substance
classified in category 1A should be taken into consideration when present in amounts
below 1 %:
+
4% Category
1A
1% Category
1B
+
3% Category
1A
1% Category
1C
⇒
+
1% Category
1B
Mixture classified as
skin corrosive,
category 1C
1% Category
1C
⇒
+
0.5% Category
1A
⇒
+
Mixture classified as
skin corrosive,
category 1B
Mixture classified as
skin irritant,
category 2
6% Category 2
32
Care must be taken when classifying mixtures containing ingredients such as strong acids
and bases, inorganic salts, aldehydes, phenols, surfactants etc. as the additivity approach
may not be applicable for many of these ingredients. For mixtures containing strong acids
or strong bases the pH shall be used as classification criteria since pH is a better indicator
than concentration limits. Mixtures that cannot be classified using the additivity approach
shall be classified using the approach shown in Table 12.
Ingredient
Acid with pH ≤ 2
Base with pH ≥ 11.5
Other skin corrosive,
categories 1A, 1B, 1C
Other skin irritant, category 2
Concentration
≥1%
≥1%
Classification
Skin corrosive, category 1
Skin corrosive, category 1
≥1%
Skin corrosive, category 1
≥3%
Skin irritant, category 2
Table 12. Generic concentration limits of ingredients for which the additivity approach does not apply
Serious eye damage/eye irritation
When using the additivity approach to calculate the classification of a mixture each
ingredient classified as corrosive or irritant should be taken into account. A weighing
factor of 10 is used for a corrosive substance present at a concentration below the generic
cut-off value, if manufacturers or importers find it relevant to take this substance into
consideration when classifying. Table 13 shows the generic concentration limits using the
additivity approach. Below is given examples of calculations based on the additivity
approach.
Sum of ingredients classified as:
Eye damage, category 1 or Skin
corrosive, categories 1A, 1B, 1C
Eye irritation, category 2
(10 * eye damage, category 1) +
eye irritation, category 2
Skin corrosive, categories 1A,
1B, 1C + eye damage, category 1
10 * (skin corrosive, category 1A,
1B, 1C + eye damage, category 1)
+ eye irritation, category 2
Concentration limits for classification as:
Eye damage, category 1
Eye irritation, category
2
≥3%
≥ 1 % but < 3 %
≥ 10 %
≥ 10 %
≥3%
≥ 1 % but < 3 %
≥ 10 %
Table 13. Generic concentration limits of ingredients classified for corrosive/irritant hazards
Care must be taken when classifying mixtures containing ingredients such as strong acids
and bases, inorganic salts, aldehydes, phenols, surfactants etc. as the additivity approach
may not be applicable for many of these ingredients. For mixtures containing strong acids
or strong bases the pH shall be used as classification criteria since pH is a better indicator
than concentration limits. Mixtures that cannot be classified using the additivity approach
shall be classified using the approach shown in Table 14.
33
Ingredient
Acid with pH ≤ 2
Base with pH ≥ 11.5
Other corrosive, category 1
Other irritant, category 2
Concentration
≥1%
≥1%
≥1%
≥3%
Classification
Eye damage, category 1
Eye damage, category 1
Eye damage, category 1
Eye irritation, category 2
Table 14. Generic concentration limits of ingredients for which the additivity approach does not apply
Non-additive concentration limits
For some hazard classes the concentration limits are non-additive. If any ingredient in the
mixture exceeds the limit the mixture shall be classified in the respective hazard class.
The following hazard classes use non-additive concentration limits:
•
•
•
•
•
Sensitisers (respiratory and skin)
CMR-substances
STOT
Aspiration hazard
Hazardous to the ozone layer
Sensitisation
The mixture shall be classified as a respiratory or skin sensitiser when at lease one
ingredient has been classified as a respiratory or skin sensitiser and is present at or above
the concentration limits shown in Table 15.
Ingredient classified
as:
Skin sensitiser
Respiratory
sensitiser
Concentration limits for classification as:
Skin sensitiser
Respiratory sensitiser
Solid / liquid
gas
3
≥ 0.1 %
≥1%
3
≥ 0.1 %
≥ 0.1 %3
≥1%
≥ 0.2 %
Table 15. Generic concentration limits of ingredients classified for sensitising hazards
3
This concentration limit is used for application of specific label requirements. Safety Data Sheet is
required for mixtures containing ingredients above this limit.
34
CMR-effects
The mixture shall be classified as a carcinogen when at least one ingredient has been
classified as a category 1A, 1B or 2 carcinogen and is present at or above the
concentration limits shown in Table 16.
Ingredient classified as:
Category 1A carcinogen
Category 1B carcinogen
Category 2 carcinogen
Concentration limits for classification as:
Category 1A
Category 1B
Category 2
carcinogen
carcinogen
carcinogen
≥ 0.1 %
≥ 0.1 %
≥ 1 %4
Table 16. Generic concentration limits of ingredients classified for carcinogenic hazards
The mixture shall be classified as a mutagen when at least one ingredient has been
classified as a category 1A, 1B or 2 mutagen and is present at or above the concentration
limits shown in Table 17
Ingredient classified as:
Category 1A mutagen
Category 1B mutagen
Category 2 mutagen
Concentration limits for classification as:
Category 1A
Category 1B
Category 2
mutagen
mutagen
mutagen
≥ 0.1 %
≥ 0.1 %
≥1%
Table 17. Generic concentration limits of ingredients classified for germ cell mutagenic hazards
The mixture shall be classified as a reproductive toxicant when at least one ingredient has
been classified as a category 1A, 1B or 2 reproductive toxicant and is present at or above
the concentration limits shown in Table 18.
The mixture shall be classified for effects on or via lactation when at lease one ingredient
has been classified for effects on or via lactation and is present at or above the
concentration limits shown in Table 18.
Ingredient classified as:
Category 1A reproductive toxicant
Category 1B reproductive toxicant
Category 2 reproductive toxicant
Effects on or via lactation
Concentration limits for classification as:
Category 1A Category 1B Category 2
Effects on
reproductive reproductive reproductive
or via
toxicant
toxicant
toxicant
lactation
≥ 0.3 % 5
≥ 0.3 %5
≥ 3 %5
≥ 0.3 %5
Table 18. Generic concentration limits of ingredients classified for reproductive toxic hazards
If a category 2 carcinogen is present in the mixture at a concentration ≥ 0,1% a safety data sheet shall be
available on request.
5
If the concentration is ≥ 0,1% a safety data sheet shall be available on request.
4
35
STOT – single exposure
The mixture shall be classified as a specific target organ toxicant (specific organ
specified), following single exposure when at least one ingredient has been classified as a
category 1 or 2 specific target organ toxicant and is present at or above the concentration
limits shown in Table 19.
Ingredient classified as:
Category 1, Specific Target Organ
Toxicant
Category 2, Specific Target Organ
Toxicant
Category 3, Specific Target Organ
Toxicant
Concentration limits for classification as:
Category 1
Category 2
≥ 10 %
1 % ≤ conc. < 10 %
≥ 10 % 6
Concentration limit depends on the
hazard(s) of the category 3 substance(s).
However, a generic concentration limit of
20 % is normally appropriate.
Table 19. Generic concentration limits of ingredients classified for specific target organ toxic hazards
STOT – repeated exposure
The mixture shall be classified as a specific target organ toxicant (specific organ
specified), following single exposure, repeat exposure, or both when at least one
ingredient has been classified as a category 1 or 2 specific target organ toxicant and is
present at or above the concentration limits shown in Table 20
Ingredient classified as:
Category 1, Specific Target Organ
Toxicant
Category 2, Specific Target Organ
Toxicant
Concentration limits for classification as:
Category 1
Category 2
≥ 10 %
1 % ≤ conc. < 10 %
≥ 10 % 7
Table 20. Generic concentration limits of ingredients classified for specific target organ toxic hazards
Aspiration hazard
Ingredient classified as:
Category 1, aspiration hazard
Classification of mixture
Category 1, aspiration hazard
≥ 10 % 8,9
Table 21. Classification for Aspiration hazard
If the concentration is ≥ 1% a safety data sheet shall be available on request
If the concentration is ≥ 1% a safety data sheet shall be available on request
8
Kinematic viscosity of mixture is ≤ 20.5 mm2/s at 40 0C
9
Mixtures with two or more distinct layers one of which classified Caterory 1, aspiration hazard and with a
kinematic viscosity of mixture is ≤ 20.5 mm2/s at 40 0C
6
7
36
Environmental effects
All ingredients classified as Acute category 1 must be considered. The effects are
additive. If the sum of the ingredients is ≥ 25 % the mixture shall be classified as Acute
Category 1. The classification is summarised in Table 22
Sum of ingredients classified as:
Acute Category 1 * M 10 ≥ 25 %
Classification of mixture
Acute Category 1
Table 22. Classification for Acute hazards based on summation
The classification of mixtures for Chronic (long term) hazards based on summation of
classified ingredients is shown in Table 23. These effects are additive.
Sum of ingredients classified as:
Chronic Category 1 x M9 ≥ 25 %
(M x 10 x Chronic Category 1) + Chronic Category 2 ≥
25 %
(M x 100 x Chronic Category 1) + (10 x Chronic
Category 2) + Chronic Category 3 ≥ 25 %
Chronic Category 1 + Chronic Category 2 + Chronic
Category 3 + Chronic Category 4 ≥ 25 %
Classification of mixture
Chronic Category 1
Chronic Category 2
Chronic Category 3
Chronic Category 4
Table 23. Classification for Chronic hazards based on summation
Highly toxic components
Acute category 1 and Chronic category 1 with toxicities below 1 mg/l contributes to the
toxicity of the mixture even at low concentration and should therefore be multiplied by a
factor instead of just adding up the percentages. Table 24 shows the corresponding
L(E)C50 value and multiplying factor M.
L(E)C50 value
0.1 < L(E)C50 ≤ 1
0.01 < L(E)C50 ≤ 0.1
0.001 < L(E)C50 ≤ 0.01
0.0001 < L(E)C50 ≤ 0.001
0.00001 < L(E)C50 ≤ 0.0001
continue in factor 10 intervals
Multiplying factor (M)
1
10
100
1000
10000
Table 24. Multiplying factor (M)
Hazardous for the ozone layer
Mixtures shall be classified as hazardous for the ozone layer on the basis of the individual
concentration of the substance(s). This hazard is not an additive effect.
Ingredient classified as:
Hazardous for the ozone layer
Classification of mixture
≥ 0.1 %
Table 25. Classification as hazardous for the ozone layer
10
See Table 24 for explanation of the M-factor
37
Labelling
The supplier of a substance or mixture shall ensure that any substance or mixture
classified as hazardous according to the criteria described in CLP carries a label.
Unclassified mixtures must, in some cases, be labelled as well.
Labelling of unclassified mixtures
Mixtures not classified as hazardous must be labelled if they fulfil the criteria described
in Table 26. They should be labelled with one or more of the supplemental statements
described in the chapter: Supplemental information. Please note that the criteria in some
cases also apply for classified mixtures.
Unclassified mixture containing:
Lead ≥ 0.15 %
Cyanoacrylate
Cement containing > 0.0002 % Chromium (VI)
Isocyanates
Epoxy constituents, MW ≤ 700
> 1 % active chlorine and sold to the general public
Cadmium and intended to be used for soldering or brazing
Halogenated hydrocarbon and > 5 % flammable or highly
flammable substances
≥ 0.1 % of a substance classified as skin or respiratory sensitiser,
category 1
≥ 0.1 % of a substance classified as carcinogenic, category 2
≥ 0.1 % of a substance classified as toxic to reproduction, category
1A, 1B or 2 or with effects via lactation
≥ 1 % (0.2 % for gaseous mixtures) of a substance classified with
other health or environmental hazards than mentioned above
≥ 1 % (0.2 % for gaseous mixtures) of a substance with an EU
exposure limit value
Table 26. Unclassified mixtures with demand for a label
38
Content of the label
A label must contain the following information:
1. Name, address and telephone number of the supplier of the substance or mixture
2. For chemicals sold to the general public: The nominal quantity
3. Product identifiers (see page 45)
4. Hazard pictogram(s), if required
5. Signal word, if required
6. Hazard statement(s), if required
7. Precautionary statement(s), if required
8. Supplemental information, if required (see page 45)
For placement of the above information on the label please see Example of a label, page
48.
Hazard Pictograms
With CLP new hazard pictograms are introduced. The EU symbols which are black on an
orange background will no longer be used. The new hazard pictograms for
physical/chemical hazards are found in Table 27.
Pictogram
Name
Exploding bomb
Number
GHS01
Flame
GHS02
Flame over circle
GHS03
Gas cylinder
GHS04
Corrosion
GHS05
Table 27. Pictograms for physical/chemical hazards
39
The hazard pictograms for health hazards and environmental hazards are found in Table
28.
Pictogram
Name
Skull and
crossbones
Number
GHS06
Corrosion
GHS05
Exclamation mark
GHS07
Health hazard
GHS08
Environment
GHS09
Table 28. Pictograms for health hazards
40
Principles of precedence for hazard pictograms
Labels for substances and mixtures labelled according to DSD and DPD will contain
three hazard symbols as a maximum. This is due to the fact that only one hazard symbol
for health hazards, one for physical/chemical hazards and one for environmental hazards
must be stated on the label.
With CLP there is no upper limit for the number of hazard pictograms. Therefore more
than three pictograms on the label are possible. However, CLP introduces principles of
precedence for hazard pictograms which will, in some cases, reduce the number of
pictograms on the label. An overview of the principles of precedence is found in Table
29.
If this pictogram is used
Do NOT use
Comments
Flame and Flame over
Circle must be on the
label if both hazard
pictograms are mandatory
for skin or eye
irritation
for respiratory
sensitisation
for skin
sensitisation or for skin and
eye irritation
Table 29. Principles of precedence for hazard pictograms
Signal words
CLP introduces two signal words: “Danger” and “Warning”. For each hazard class and
category a signal word is assigned. “Danger” indicates the more severe hazard category
while “Warning” indicates the less severe hazard categories. The signal words are used
on the hazard labels for substances and mixtures. Only one signal word is used on a label.
If “Danger” is used on the label, “Warning” shall not appear on the label. See also
Example of a label page 48.
41
Hazard statements
The CLP hazard statements correspond to the R-phrases (Risk phrases) known from the
DSD/DPD system. There are no principles of precedence for the CLP hazard statements.
All hazard statements resulting from the classification of a substance or a mixture must
appear on the label. This includes hazards statements where the corresponding hazard
pictogram has been left out due to precedence principles. However, a hazard statement
may be omitted if there is evident duplication.
Examples of hazard statements are shown in Table 30 and also in Example of a label.
H225
H301
Highly flammable liquid and vapour
Toxic if swallowed
Table 30 Example of hazard statements
Additional EU-statements
To maintain the present level of protection for human and environment, EU has chosen to
add some additional hazard statements and labelling elements. These hazard statements
and labelling elements are not a part of the global GHS-system. The criteria for use are
given in the Annex II of the CLP-regulation.
CLP contains 14 additional hazard statements. The additional hazard statements are
found in Table 31.
EUH001
EUH006
EUH014
EUH018
EUH019
EUH030
EUH044
EUH029
EUH031
EUH032
EUH066
EUH070
EUH071
EUH059
Explosive when dry
Explosive with or without contact with air
Reacts violently with water
In use may form flammable/explosive vapour-air mixture
May form explosive peroxides
Can become highly flammable in use
Risk of explosion if heated under confinement
Contact with water liberates toxic gas
Contact with acids liberates toxic gas
Contact with acids liberates very toxic gas
Repeated exposure may cause skin dryness or cracking
Toxic by eye contact
Corrosive to the respiratory tract
Hazardous to the ozone layer
Table 31. Additional EU hazard statements
Furthermore the CLP contains additional statements for labelling of certain substances
and mixtures. The supplemental label elements are found in Table 32.
42
EUH201
EUH201A
EUH202
EUH203
EUH204
EUH205
EUH206
EUH207
EUH208
EUH209
EUH209A
EUH210
EUH401
Contains lead. Should not be used on surfaces liable to be chewed or
sucked by children
Warning! Contains lead
Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of
the reach of children
Contains chromium (VI). May produce an allergic reaction
Contains isocyanates. May produce an allergic reaction
Contains epoxy constituents. May produce an allergic reaction
Warning! Do not use together with other products. May release
dangerous gases (chlorine)
Warning! Contains cadmium. Dangerous fumes are formed during
use. See information supplied by the manufacturer. Comply with
safety instructions
Contains “name”. May produce an allergic reaction
Can become highly flammable in use
Can become flammable in use
Safety data sheet available on request
To avoid risk to human health and the environment, comply with the
instructions for use
Table 32. Additional EU labelling statements
Precautionary statements
The CLP precautionary statements correspond to the S-phrases (Safety phrases) known
from the DSD/DPD-system. The precautionary statements are supposed to guide the user
of a substance or a mixture to a safe use of a chemical. Furthermore the precautionary
statements tell about disposal of the chemical and first aid measures in case of accidents.
The precautionary statements are divided into five groups: General, prevention, response,
storage and disposal. For each hazard class and category a number of precautionary
statements are assigned. The general precautionary statements are not assigned for
specific hazard classes and they are used for consumer products only. In Table 33 is
shown an example of precautionary statements for hazard class flammable liquid and
hazard category 3. See also Example of a label, page 48.
43
Hazard statement
Precautionary statements – Prevention
H226: Flammable liquid and vapour
P210: Keep away from heat/sparks/open
flames/hot surfaces. – No smoking.
P233: Keep container tightly closed.
P240: Ground/bond container and receiving
equipment.
P241: Use explosion-proof
electrical/ventilating/lighting/…/equipment.
P242: Use only non-sparking tools.
P243: Take precautionary measures against
static discharge.
P280: Wear protective gloves/protective
clothing/eye protection/face protection.
Precautionary statements – Response
P303 + P361 +P353: Remove/Take off
immediately all contaminated clothing.
P370 + P378: In case of fire: Use … for
extinction.
Precautionary statements – Storage
P403 + P235: Store in a well-ventilated
place. Keep cool.
Precautionary statements – Disposal
P501: Dispose of contents/container to
Table 33. Example of precautionary statements for flammable liquid, category 3
The number of precautionary statements on a label should not exceed six. However, EU
still needs to set criteria for choosing precautionary statements.
44
Product identifiers
The product identifier for a substance consists normally of a name and an identification
number. If the substance is present on the List of Harmonised Classifications (Annex VI,
part 3) the name and an identification number from this list must be used. If the substance
is present in the Classification and Labelling Inventory (See page 50) the name and
identification number from this list must be used. If the substance is not present on any of
the lists mentioned above, the CAS-number together with the IUPAC-name must be
stated.
The product identifier for a mixture consists of the trade name for the mixture (identical
with the name stated in the SDS) and, in some cases, the identity of certain ingoing
substances. For certain classifications of the mixture the substance(s) contributing to the
classification must be stated. It is important to notice, that the demand for identity of
substances on the label for a mixture is only relevant if the mixture is classified in one or
more of the categories stated in Table 34.
Classification of mixture which leads to a demand for identity of substance(s) on
mixture label
Acute toxicity, category 1, 2, 3 and 4
Skin corrosion, category 1A, 1B and 1C
Serious eye damage, category 1
Germ cell mutagenicity, category 1A, 1B and 2
Carcinogenicity, category 1A, 1B and 2
Reproductive toxicity, category 1A, 1B and 2
Respiratory sensitisation
Skin sensitisation
Specific target organ toxicity (STOT), single exposure, category 1, 2 and 3
Specific target organ toxicity (STOT), repeated exposure, category 1 and 2
Aspiration hazard, category 1
Table 34. Mixture classifications which lead to a demand for identity of substance(s) responsible for mixture
classification
Supplemental information
For the label for a substance or mixture there may be a demand for additional EU
statements as described in Annex II of the CLP regulation. The additional EU statements
are given in Table 32
Special rules for packaging not exceeding 125 ml
If the package of a substance or mixture does not exceed 125 ml, the hazard statements
and the precautionary statements may be omitted from the label if the substance or
mixture is classified as given in Table 35
45
Oxidising gas, category 1
Gas under pressure
Flammable liquid, category 1, 2 or 3
Flammable solid, category 1 or 2
Self-reactive substance or mixture, type C, D, E or F
Self heating substance or mixture, category 2
Substance which in contact with water emit flammable gases, category 1, 2 or 3
Oxidising Liquid, category 2 or 3
Oxidising solid, category 2 or 3
Organic peroxides, type C, D, E or F
Acute Toxicity, category 4, unless supplied to the general public
Skin irritant, category 2
Eye irritant, category 2
Specific Target Organ Toxicity (STOT), single exposure, category 2 or 3, unless supplied
to the general public
Specific Target Organ Toxicity (STOT), repeated exposure, category 2, unless supplied
to the general public
Hazardous to the aquatic environment, Acute category 1
Hazardous to the aquatic environment, Chronic category 1 or 2
Table 35. Classifications which allow omission of hazard- and precautionary statements on label given that
package ≤ 125 ml
If the size of the packaging does not exceed 125 ml then precautionary statements (but
not hazard statements) may be omitted on the label if the substance or mixture is
classified as given in Table 36.
Flammable gas, category 2
Reproductive toxicity, effects on or via lactation
Hazardous to the aquatic environment, chronic category 3 or 4.
Table 36. Classifications which allow omission of precautionary statements on label given that package≤ 125 ml
The hazard pictogram(s) and the signal word related to the classification of a substance or
mixture must be on the label even if the hazard statements and precautionary statements
are omitted. If a packaging does not exceed 125 ml but the substance or mixture does not
meet the requirement for certain classifications allowing omission of hazard- and/or
precautionary statements, then ALL hazard statements and precautionary statements
relevant for the substance or mixture must be stated on the label. It is not allowed to omit
only some of the hazard statements. En example is given in Table 37.
46
Classification
Pictogram
Mixture 1
(packaging
< 125 ml)
Mixture 2
(packaging
< 125 ml)
Flammable
liquid, category
2
Flammable
liquid, category
2
Acute toxicity,
oral, category 3
Signal
word
Danger
Labelling
Hazard
statement(s)
Omitted
H225: Highly
flammable
liquid
and vapour
Danger
H301:
Toxic if
swallowed
Precautionary
statements
Omitted
To be chosen
according to
Annex I
Table 37. Label elements of packaging less than 125 ml
Language
The language of the label must be in the official language(s) of the member state(s)
where the chemical is marketed. The label may contain information in more than one
language. In that case, all information must appear in all languages. Furthermore groups
of hazards statements and groups of precautionary statements must be located together on
the label by language.
Format of a label
The CLP regulation sets up requirements for a label format. Those requirements are
similar to the requirements known from the DSD and DPD.
The dimensions of the label depend of the size of the package. The dimensions shall be as
stated in Table 38.
Size of the package
3 litres or less
More than 3 litres but not more than 50 litres
More than 50 litres but not more than 500 litres
More than 500 litres
Label dimensions (in millimetres)
At least 52 x 74, if possible
At least 74 x 105
At least 105 x 148
At least 148 x 210
Table 38. Dimension of a label
Each hazard pictogram shall cover at least 1/15 of the surface area of the label. However,
the size of each hazard pictogram shall not be less than 1 cm2.
Outer and inner packaging
If a package consists of an outer and an inner packaging it is sufficient to label the outer
packaging according to the rules on the transport of dangerous goods. The inner
packaging must be labelled according to the CLP-regulation. If the chemical does not
47
need labelling according to the rules on the transport of dangerous goods both the inner
and the outer packaging must be labelled according to the CLP-regulation.
Transport regulation and CLP
A chemical may be classified as dangerous according to the CLP-regulation and
according to the rules on the transport of dangerous goods. If the hazard pictogram(s)
required according to the CLP-regulation relate to the same hazard as in rules on the
transport of dangerous goods, the CLP-pictograms for this/these hazard(s) are not
required on the label. Only the pictograms assigned according to the rules on the
transportation of dangerous goods are required.
Example of a label
The example below is for a product classified as flammable liquid, category 2 Flammable
liquid and category 3 acute toxicity, oral and containing 0.5 % of a substance classified as
a skin sensitiser, category 1. The size of the packaging is assumed to be > 125 ml and the
product is assumed to be sold to professional users only. In Table 39 an example of a
label is shown.
48
CLP Test Product Name 11
CLP-Company
CLP-street 111
1111 CLP-city
CLP- country
+45 11 11 11 11
Contains: CLP-substance(s)11
contributing to the
classification as toxic.
12
Danger 13
Highly flammable liquid and
vapour 14
Toxic if swallowed
Contains (name of sensitising
substance). May produce an
allergic reaction16
Wash hands thoroughly after handling 15
Do not eat, drink or smoke when using this product
IF SWALLOWED: Immediately call a POISON
CENTER or doctor/physician
Store in a well-ventilated place
Store locked up
Dispose of contents/container in accordance with
national regulation
Table 39. Example of a label
Update of label information
The supplier of a chemical shall update his label at once if the classification of the
chemical changes and the new hazard is more severe. Furthermore the label shall be
updated at once if new supplemental information is required.
If there are changes to the label for other reasons than mentioned above e.g. changes in
classification to a lower hazard or change of product name, the label must be updated
within 18 months.
11
Product identifiers
Hazard pictograms
13
Signal word
14
Hazard statements
15
Precautionary statements
16
Additional EU statement
12
49
Who is affected by CLP and how?
Importers and manufacturers of substances
Manufacturers of substances will have to change classification, labels and safety data
sheets for all substances. If a substance has already been classified according to DSD, the
manufacturer does not have to re-evaluate the hazardous properties of the substance.
Instead the manufacturer can “translate” the DSD classification into a CLP classification
by using a conversion table given in the legislation. However, for substances placed on
the market after 1 December 2010 the manufacturer will have to evaluate all hazardous
properties according to CLP criteria. For substances already labelled and placed on the
market before 1 December 2010 the deadline for re-labelling is 1 December 2012.
Classification and labelling inventory
THE GHS/CLP system is mainly a system for self-classification of substances and
mixtures. However, to ensure transparency of classifications of substances The European
Chemicals Agency (ECHA) will establish a classification and labelling inventory. Every
manufacturer or importer of substances must report the classification of a substance to
ECHA no later than 1 December 2010 unless the substance has to be registered under
REACH. These classifications will be gathered in the classification and labelling
inventory, which will be accessible via internet. It is the hope that manufacturers and
importers by time will agree upon the same classification for the same substance.
Formulators
Formulators/Manufacturers of mixtures should keep the date 1 June 2015 in mind. From
this date classification of all mixtures must be amended. Both labels and safety data
sheets must be changed. If a mixture has already been classified according to criteria
from DPD, the manufacturers may choose simply to translate the existing classification
into the new CLP classification. For mixtures already labelled and placed on the market
before 1 June 2015 the deadline for re-labelling is 1 June 2017.
Distributors
Distributors of chemicals must keep the dates for re-classification of substances and
mixtures in mind and they should make sure that the labels and safety data sheets from
their suppliers are in compliance with the CLP legislation.
End-users of chemicals
The end-user of a chemical substance or mixture does not have any obligation under
CLP. However, every user of chemicals must get used to the new pictograms, hazard
statements and precautionary statements. The users must be properly educated to
50
understand the pictograms and phrases in order to work safely with the chemicals.
Internal work place instructions may need a revision due to changed classifications.
Preparation for CLP in the organisation
When preparing for CLP it is first of all important to understand your role, hence your
obligations under CLP. Furthermore you should ask yourself whether you have the
resources within the company to do the work or whether you need additional assistance.
Most companies use IT-systems for Chemicals Management. Furthermore a lot of
companies use IT-systems for classification of mixtures and for preparation of safety data
sheets. There are also various IT-systems for labelling of chemicals on the market. It is
important to find out whether the various IT-systems used in the company are ready for
CLP or whether updates are required.
Overall you should consider the resources needed for:
-
Training
Update of software / IT-systems (classification, labels, SDS etc.)
Generating new labels
Generating new Safety Data Sheets
Packaging
Evaluation of currently non-hazardous products – may become classified as hazardous
under CLP
CLP / GHS in the future
Guidance on how to apply the provisions of the new Regulation on classification,
labelling and packaging is currently developed at the European Commission's Joint
Research Centre (JRC) within REACH Implementation Project 3.6 (RIP 3.6). Four
working groups have been established, dealing with general aspects, physical, health and
environmental hazards. They consist largely of Member State experts. The RIP 3.6
guidance document will be finalized in the first half of 2009. In addition to the guidance
given in RIP 3.6, it is planned to provide short and industry-oriented guidance on basic
features and procedures of the proposed GHS-implementing act in form of a
downloadable print document.
All over the world countries are working on implementing GHS. An overview of the
worldwide GHS-implementation status can be found on UNECE’s website.
The plan is to update CLP / GHS biannually.
51
Transitional period
The transitional periods for substances and mixtures are found in Table 40 and Table 41.
Transitional period for substances
20 January 2009
1 December 2012
1 December 2010
1 June 2015
Classification
DSD 17
DSD and CLP
DSD and CLP
CLP
Labelling
DSD or CLP
CLP 18
CLP
CLP
Table 40. Transitional period for substances
Transitional period for mixtures
20 January 2009
1 June 2015
1 December 2010
1 June 2017
Classification
DPD 19
DPD19
CLP
CLP
Labelling
DPD or CLP
DPD or CLP
CLP 20
CLP
Table 41. Transitional period for mixtures
17
In addition substances may, before 1 December 2010, be classified, labelled and packaged in accordance
with CLP. In that case the provisions on labelling and packaging in DSD shall not apply.
18
Substances placed on the market before 1. December 2010 need not to be labelled according to CLP until
1 December 2012.
19
In addition mixtures may, before 1 June 2015, be classified, labelled and packaged in accordance with
CLP. In that case the provisions on labelling and packaging in DPD shall not apply.
20
Mixtures placed on the market before 1 June 2015 need not to be labelled according to CLP until 1 June
2017.
52
Conversion tables
To facilitate the re-classification of existing substances and mixtures a conversion table
has been made. Substances already classified according to DSD before 1 December 2010
do not have to be evaluated according to new CLP criteria. For these substances it is
possible to use the conversion table and simply “translate” every R-phrase into
corresponding CLP hazard statements. For mixtures classified according to DPD before 1
June 2015 the same conversion table can be used. It is important to notice, that in some
cases the classification resulting from the conversion table will be different from a
classification resulting from evaluating a chemical according to new CLP criteria. One
should also notice that for some physical-chemical properties no direct conversion is
possible. When the transitional period is over, the conversion table is no longer relevant,
as all substances and mixtures shall then be evaluated according to CLP criteria.
For substances and mixtures which are not classified according to DSD or DPD, the
conversion table cannot be used. The substance or mixture must be evaluated according
to CLP criteria.
The list of harmonised classifications from the DSD, Annex 1, has already been
converted into CLP classifications. The converted list is now a part of the CLP-system.
53
Links
CLP Regulation:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF
The CLP Regulation is published as one, large document containing all Annexes. The
content of the Annexes are:
Annex I – Classification and labelling requirements for substances and mixtures
Annex II – Special rules for labelling and packaging
Annex III – Hazard Statements
Annex IV – Precautionary statements:
Annex V – Hazard Pictograms
Annex VI - Harmonised classification and labelling for certain hazardous substances, part
1 and 2
Annex VI – List of harmonised classification and labelling of hazardous substances, part
3
Annex VII – Conversion table
GHS pictograms: http://www.unece.org/trans/danger/publi/ghs/pictograms.html
ECHA, European Chemicals Agency: http://echa.europa.eu
UNECE – Overview of GHS-implementation status:
http://www.unece.org/trans/danger/publi/ghs/implementation_e.html
UN GHS text: http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/02files_e.html
European Commission – Enterprise and Industry:
http://ec.europa.eu/enterprise/reach/ghs_more_on_com_proposal_en.htm
54
GHS/CLP Vocabulary
Term
Substance
Mixture
Chemical
Classification
GHS
DSD
DPD
CLP
Formulator
Importer
Manufacturer
QSAR
ECHA
Explanation
Pure chemical substance. May be a liquid,
a gas or a solid substance
Mixture of two or more chemical
substances. The mixture may be a liquid, a
gas or a solid mixture. A water-based
dilution of a pure substance is also
considered a mixture. The term “mixture”
used in CLP is equal to the term
“preparation” used under REACH
A common term used for both substances
and mixtures
Determination of the hazardous properties
of a chemical substance or mixture. It is
important to notice that the classification is
not a risk assessment. The classification
tells about the inherent hazards of a
chemical.
Globally Harmonised System of
classification and labelling of chemicals
Dangerous Substance Directive
(67/548/EEC)
Dangerous Preparations Directive
(1999/45/EC)
Regulation of Classification, Labelling and
Packaging of substances and mixtures
Any natural or legal person established
within the Community who manufactures a
mixture and place it on the market within
the Community
Any natural or legal person established
within the Community who is responsible
for import into the Community.
Any natural or legal person established
within the Community who manufactures a
substance within the Community.
Quantitative Structure Activity
Relationship. The process by which
chemical structure is quantitatively
correlated with a well defined process, such
as biological activity or chemical reactivity.
European Chemicals Agency
55
End User
Any professional user or consumer who
buys and uses chemicals but who do not
market the chemicals.
56
Exercises
Exercise 1. Classification of substances – translation table
Convert the DSD classifications of the following substances into CLP classifications
using the translation table in Annex VII. In addition, list the relevant hazard statement for
each hazard class and category.
Substance A: T;R25 C;R34 Carc3;R40 R43
Substance B: F;R11 Xi;R41 R67 and initial boiling point > 35 °C
Substance C: Xn;R22 Xi;R38 N;R50/5321
Exercise 2. Classification of mixtures – calculation
Classify the following mixtures based on the CLP classifications of the ingoing
substances found in exercise 1. Use the calculation principles described in Annex I or in
this compendium.
Mixture 1
Substance
Substance A
Substance C
Rest: Water
Weight %
4%
2%
94 %
Mixture 2 22
Substance
Substance A 23
Substance B
Substance C
Rest: Water
Weight %
0.5 %
9%
7%
83.5 %
Exercise 3. Labelling – label for previous classified mixture
Product identifier(s)
State which (if any) substance(s) must be stated on the label for mixture 1 and mixture 2.
Use table 31 in this compendium.
21
LC50 = 0,03 mg/l for substance C
Flash point of mixture > 60 °C
23
Substance A should be taken into consideration for skin and eye irritation even when present in amounts
below the generic cut-off value
22
57
Signal Words
State the signal word on the label for mixture 1 and mixture 2. Use the label elements
tables in Annex 1 to assign the correct signal word.
Hazard pictograms
State the hazard pictograms required on the label for mixture 1 and 2. Do not use
principles of precedence yet. Use the label elements tables in Annex 1 to choose the
correct hazard pictograms.
Hazard Statements
State the hazard statements resulting from the classification of mixture 1 and 2. Assume
that packaging > 125 ml. Use the label elements tables in Annex 1 to assign the correct
hazard statements.
Supplemental information
State which (if any) supplemental information is required on the label for mixture 1 and
2. Use table 29 in this compendium.
Exercise 4. Principles of Precedence – Choosing hazard
pictograms
Using principles of precedence, state the hazard pictograms required on the label for
mixture 1 and 2. In addition consider whether evident duplication makes it relevant to
omit one or more hazard statements. Use Table 29 in this compendium.
58
Solutions
Exercise 1
The CLP-classifications are:
Substance
DSD
CLP
Hazard
Category
Hazard Class
A
A
A
A
B
T;25
C;R34
Carc3;R40
R43
F;R11
B
B
Xi;R41
R67
C
C
C
C
Xn;R22
Xi;R38
N;R50/53
N;R50/53
Acute toxicity
Skin Corrosion
Carcinogenicity
Skin Sensitiser
Flammable
liquid
Eye Damage
STOT, single
exposure
Acute toxicity
Skin irritation
Aquatic Acute
Aquatic
Chronic
3
1B
2
1
2
Hazard
statement
H301
H314
H351
H317
H225
1
3
H318
H336
4
2
1
1
H302
H315
H400
H410
Exercise 2
Mixture 1
Substance
Substance A
Acute toxicity, cat 3, oral
Skin corr., cat 1B
Carc, cat 2
Skin sens., cat 1
Substance C
Skin irrit., cat 2
Acute toxicity, cat 4, oral
Aquatic Acute, cat 1
Aquatic Chronic, cat 1
Water
Not classified
Weight %
4%
2%
94 %
59
Acute toxicity
Converted ATE-values for substance A and C for oral exposure are found using Table 9.
100
Oral exposure: 𝐴𝐴𝐴𝐴𝐴𝐴
𝑚𝑚𝑚𝑚𝑚𝑚
4
2
= 100 + 500 → 𝐴𝐴𝐴𝐴𝐴𝐴𝑚𝑚𝑚𝑚𝑚𝑚 = 2.273
Using Table 10 we find that mixture 1 not classified for acute toxicity.
Skin corrosion/irritation
The additivity formula in Table 11 is used:
10 x 4 % + 1 x 2 % = 42 % → Mixture classified as skin irritant, category 2.
Eye irritation/eye damage
Table 13 is used:
A mixture containing 3 % or more of a substance classified as corrosive to skin category
1 will be classified for eye effects → Mixture classified for eye effects, cat. 1
Carcinogenicity
A mixture containing 1 % or more of a substance classified as carcinogenic, cat 2 will be
classified as carcinogenic, category 2
Sensitisation
A mixture containing 1 % or more of a substance classified as skin sensitising, category 1
will be classified as a skin sensitiser, category 1.
Environmental toxicity, acute
The M-factor for substance C is found using Table 24. As the LC50-value for the
substance is 0.03 mg/l the M-factor is 10. Using the formula in Table 22 we find:
10 x 2 % = 20 % → no classification as aquatic acute
Environmental toxicity, chronic
The M-factor for substance C is 10. Table 23 is used:
10 x 2 % = 20 % → no classification as aquatic chronic, cat. 1
10 x 10 x 2 % = 200 % → mixture classified as chronic, cat. 2
Classification for mixture 1
Skin irritant, cat. 2, H315
Eye effects, cat. 1, H318
Carc, cat. 2, H351
Skin sensitiser, cat 1, H317
Aquatic chronic, cat. 2, H411
60
Mixture 2
Substance
Substance A
Acute tocixity,cat 3, oral
Skin corr., cat 1
Carc, cat 2
Skin sens., cat 1
Substance B
Flammable liquid, cat 2
Eye dam., cat 1
STOT, single, cat 3
Substance C
Skin irrit., cat 2
Acute toxicity, cat 4, oral
Aquatic Acute, cat 1
Aquatic Chronic, cat 1
Water
Not classified
Weight %
0.5 %
9%
7%
83.5 %
Acute toxicity
Converted ATE-values for substance A and C for oral exposure are found using Table 9.
100
Oral exposure: 𝐴𝐴𝐴𝐴𝐴𝐴
𝑚𝑚𝑚𝑚𝑚𝑚
0.5
7
= 100 + 500 → 𝐴𝐴𝐴𝐴𝐴𝐴𝑚𝑚𝑚𝑚𝑚𝑚 = 5.263
Using Table 10 we find that mixture 2 is not classified for acute toxicity.
Skin corrosion/irritation
The additivity formula in Table 11 is used:
10 x 0.5 % + 1 x 7 % = 12 % → Mixture 2 classified as skin irritant, category 2.
Eye irritation/eye damage
Table 13 is used:
A mixture containing 3 % or more of a substance classified for eye effects category 1 will
be classified → Mixture 2 classified for eye effects, cat. 1
Carcinogenicity
A mixture containing 1 % or more of a substance classified as carcinogenic, cat 2 will be
classified as carcinogenic, category 2 → mixture 2 is not classified as carcinogenic, cat 2.
Sensitisation
A mixture containing 1 % or more of a substance classified as skin sensitising, category 1
will be classified as a skin sensitiser, category 1 → mixture 2 not classified as sensitising.
61
STOT
Using Table 19 and a generic concentration value of 20 % we find that mixture 20 is not
classified for STOT.
Environmental toxicity, acute
The M-factor for substance C is found using Table 24. As the LC50-value for the
substance is 0.03 mg/l the M-factor is 10. Using the formula in Table 22 we find:
10 x 7 % = 70 % → mixture 2 classified as acute, cat. 1
Environmental toxicity, chronic
The M-factor for substance C is 10. Table 23 is used:
10 x 7 % = 70 % → mixture classified as chronic, cat. 1
Classification for mixture 2
Skin irritant, cat. 2, H315
Eye effects, cat. 1, H318
Aquatic acute, cat 1, H400
Aquatic chronic, cat. 1, H410
Exercise 3
62
Hazard pictogram(s)
Mixture 1
Signal
Hazard
Word
Statement(s)
Danger
H318: Causes
serious eye
damage.
Supplemental
hazard
statements
None
Product
identifier
Substance
A
H315: Causes
skin irritation.
H351:
Suspected of
causing
cancer
H317: May
cause an
allergic skin
reaction
H411: Toxic
to aquatic life
with long
lasting effects
63
Hazard
pictogram(s)
Signal Word
Danger
Mixture 2
Hazard
Statement(s)
H318: Causes
serious eye
damage.
H315: Causes
skin irritation.
Supplemental
hazard
statements
Contains
substance A.
May produce
an allergic
reaction
Product
identifier
Substance B
H400: Very
toxic to aquatic
life.
H410: Very
toxic to aquatic
life with long
lasting effects.
Exercise 4
For mixture 1 no principles of precedence will be relevant. There is no duplication of
hazard statements.
For mixture 2 the hazard pictogram “Exclamation mark” must be omitted, as the
pictogram appears for skin irritation and as the pictogram “Corrosive” is mandatory.
The hazard statement H400 may be omitted as the exact same statement is found in
H410.
Therefore, the label elements for mixture 2 are:
64
Hazard
pictogram(s)
Signal Word
Danger
Mixture 2
Hazard
Statement(s)
Supplemental
hazard
statements
Contains
substance A.
May produce
an allergic
reaction
H318: Causes
serious eye
damage.
H315: Causes
skin irritation.
Product
identifier
Substance B
H410: Very
toxic to aquatic
life with long
lasting effects.
Final labels
The final label for mixture 1 may appear as follows:
Company name
Mixture 1
Company address
City
Telephone
Contains: Substance A
DANGER
Causes serious eye damage.
Causes skin irritation.
Suspected of causing cancer.
May cause an allergic skin reaction.
Toxic to aquatic life with long lasting
effects.
Obtain special instruction before use.
Wear protective gloves and protective
clothing.
IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact
lenses, if present and easy to do. Continue
rinsing.
Dispose of contents in according with local
regulation.
Avoid release to the environment.
65
The final label for mixture 2 may appear as follows:
Company name
Mixture 2
Company address
City
Telephone
Contains: Substance B
DANGER
Causes serious eye damage.
Causes skin irritation.
Very toxic to aquatic life with long
lasting effects.
Contains substance A. May produce an
allergic reaction
Wear protective gloves and protective
clothing.
IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact
lenses, if present and easy to do. Continue
rinsing.
IF ON SKIN: Wash with plenty of soap
and water.
Dispose of contents in according with local
regulation.
Avoid release to the environment.
66