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GHS

New legislation on classification and labelling

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Preface

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Table of contents Preface ................................................................................................................................. 2Table of contents ................................................................................................................. 3Introduction/Background .................................................................................................... 6

Building blocks ............................................................................................................... 6Difference between UN and EU ................................................................................. 7Part of UN but not part of EU ..................................................................................... 7Part of EU but not part of UN ..................................................................................... 8

Downstream legislation .................................................................................................. 8Classification criteria .......................................................................................................... 9

Physical hazards .............................................................................................................. 9Explosives ................................................................................................................. 11Flammable gases ....................................................................................................... 11Flammable aerosols .................................................................................................. 11Oxidizing gases ......................................................................................................... 11Gases under pressure ................................................................................................. 11Flammable liquids ..................................................................................................... 11Flammable solids ...................................................................................................... 12Self-reactive substances and mixtures ...................................................................... 12Pyrophoric liquids ..................................................................................................... 12Pyrophoric solids ...................................................................................................... 12Self-heating substances and mixtures ....................................................................... 12Substances and mixtures which in contact with water emit flammable gases .......... 12Oxidizing liquids ....................................................................................................... 12Oxidizing solids ........................................................................................................ 12Organic peroxides ..................................................................................................... 13Corrosive to metals ................................................................................................... 13

Health hazards ............................................................................................................... 14Acute toxicity ............................................................................................................ 15Skin corrosion/irritation ............................................................................................ 15Serious eye damage/eye irritation ............................................................................. 15Respiratory or skin sensitisation ............................................................................... 15Germ cell mutagenicity ............................................................................................. 15Carcinogenicity ......................................................................................................... 15Reproductive toxicity ................................................................................................ 15Specific target organ toxicity (STOT) – single exposure ......................................... 15Specific target organ toxicity (STOT) – repeated exposure ..................................... 15Aspiration hazard ...................................................................................................... 16

Environmental hazards. ................................................................................................. 17Hazardous for the ozone layer. ................................................................................. 17

Differences between DSD and CLP ................................................................................. 18Physical hazards ............................................................................................................ 18

Flammable liquids ..................................................................................................... 18Health hazards ............................................................................................................... 20

Acute toxicity – inhalation ........................................................................................ 20

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Acute toxicity – dermal ............................................................................................. 20Acute toxicity – oral .................................................................................................. 20Skin corrosion/irritation ............................................................................................ 20Eye damage/Eye irritation ......................................................................................... 21Sensitisation .............................................................................................................. 21Mutagenicity ............................................................................................................. 21Carcinogenicity ......................................................................................................... 21Reproductive toxicity ................................................................................................ 22STOT, single exposure .............................................................................................. 22STOT, repeated exposure .......................................................................................... 22

Environmental hazards .................................................................................................. 23Classification of substances .............................................................................................. 24Classification of mixtures ................................................................................................. 24

Bridging Principles ....................................................................................................... 24Dilution ..................................................................................................................... 25Batching .................................................................................................................... 25Concentration of highly hazardous mixtures ............................................................ 25Similar mixtures ........................................................................................................ 26Changes in compositions .......................................................................................... 27Aerosols .................................................................................................................... 27

Calculation principles ................................................................................................... 28Cut-off values ............................................................................................................ 28Acute toxicity ............................................................................................................ 28Classification based on concentration thresholds ..................................................... 31

Labelling ........................................................................................................................... 38Labelling of unclassified mixtures ................................................................................ 38Content of the label ....................................................................................................... 39Hazard Pictograms ........................................................................................................ 39

Principles of precedence for hazard pictograms ....................................................... 41Signal words .................................................................................................................. 41Hazard statements ......................................................................................................... 42

Additional EU-statements ......................................................................................... 42Precautionary statements .............................................................................................. 43

Product identifiers ..................................................................................................... 45Supplemental information ......................................................................................... 45Special rules for packaging not exceeding 125 ml ................................................... 45

Language ....................................................................................................................... 47Format of a label ........................................................................................................... 47Outer and inner packaging ............................................................................................ 47Transport regulation and CLP ....................................................................................... 48Example of a label ........................................................................................................ 48Update of label information .......................................................................................... 49

Who is affected by CLP and how? ................................................................................... 50Importers and manufacturers of substances .................................................................. 50

Classification and labelling inventory ...................................................................... 50Formulators ................................................................................................................... 50

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Distributors ................................................................................................................... 50End-users of chemicals ................................................................................................. 50

Preparation for CLP in the organisation ........................................................................... 51CLP / GHS in the future .................................................................................................... 51Transitional period ............................................................................................................ 52

Transitional period for substances ............................................................................ 52Transitional period for mixtures ............................................................................... 52

Conversion tables .......................................................................................................... 53Links ................................................................................................................................. 54GHS/CLP Vocabulary ...................................................................................................... 55Exercises ........................................................................................................................... 57

Exercise 1. Classification of substances – translation table .......................................... 57Exercise 2. Classification of mixtures – calculation ..................................................... 57Exercise 3. Labelling – label for previous classified mixture ....................................... 57

Product identifier(s) .................................................................................................. 57Signal Words ............................................................................................................. 58Hazard pictograms .................................................................................................... 58Hazard Statements .................................................................................................... 58Supplemental information ......................................................................................... 58

Exercise 4. Principles of Precedence – Choosing hazard pictograms ......................... 58Solutions ........................................................................................................................... 59

Exercise 1 ...................................................................................................................... 59Exercise 2 ...................................................................................................................... 59Exercise 3 ...................................................................................................................... 62Exercise 4 ...................................................................................................................... 64Final labels .................................................................................................................... 65

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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

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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 EU Flammable liquid, category 4 Not part of CLP Acute toxicity, category 5 Not part of CLP Skin irritation, category 3 Not part of CLP Aspiration Hazard, category 2 Not part of CLP Hazardous to the aquatic environment, Acute category 2 and 3

Nor part of CLP

Not part of the UN GHS Hazardous for the ozone layer Safety data sheets 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.

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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.

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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.

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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 Flammable gasses 1 2 Flammable aerosols 1 2 Oxidizing gases 1 Gases under pressure Compresses gas Liquefied gas Refrigerated liquefied gas Dissolved gas Flammable liquids 1 2 3 Flammable solids 1 2 Self-reactive substances and mixtures Type A Type B Type C&D Type E&F Type G Pyrophoric liquids 1 Phyrophoric solids 1 Self-heating substances and mixtures 1 2 Substances and mixtures which in contact with water emit flammable gases

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2 3 Oxidizing liquids 1 2 3 Oxidizing solids 1 2 3 Organic peroxides Type A Type B

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Type C&D Type E&F Type G Corrosive to metals 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.

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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.

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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.

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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 Skin corrosion/irritation 1A 1B 1C 2 Serious eye damage/eye irritation 1 2 Respiratory or skin sensitisation Skin sensitiser Respiratory sensitiser Germ cell mutagenicity 1A 1B 2 Carcinogenicity 1A 1B 2 Reproductive toxicity 1A 1B 2 Additional category for effects

on or via lactation Specific target organ toxicity – single exposure

1

2 3 Specific target organ toxicity – repeated exposure

1

2 Aspiration hazard 1 Table 3. Health hazards

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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.

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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.

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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

1

Hazardous to the aquatic environment - Chronic

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.

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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

DSD CLP Extremely flammable

Flash point < 0 °C and boiling point ≤ 35 °C

Category 1 Flash point < 23 ° C and boiling point ≤ 35 °C

Highly flammable

Flash point < 21 ° but not extremely flammable

Category 2 Flash point < 23 °C and boiling point > 35 °C

Flammable 21 °C ≤ flash point ≤ 55 °C Category 3 23 ≤ flash point ≤ 60 °C Table 5. Comparison between DSD and CLP for flammable liquids

Hazard classes R-phrases Explosives E;R2 E;R3 Oxidizing substances O;R7 O;R8 O;R9 Flammable substances F+;R12 F;R11 F;R15 F;R17 R10

Table 6. Physical hazard classes under DSD

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Hazard classes Hazard categories Explosives Unstable Div 1.1 Div 1.2 Div 1.3 Div 1.4 Div 1.5 Div 1.6 Flammable gases 1 2 Flammable aerosols 1 2 Oxidizing gases 1 Gases under pressure Compressed gas 1 Liquified gas 1

Refrigerated liquefied gas 1

Dissolved gas 1 Flammable liquids 1 2 3 Flammable solids 1 2 Self-reactive substances and mixtures Type A Type B Type C Type D Type E Type F Type G Pyrophoric liquids 1 Pyrophoric solids 1 Self-heating substances and mixtures 1 2 Substances and mixtures which in contact with water emit flammable gases 1 2 3 Oxidizing liquids 1 2 3 Oxidizing solids 1 2 3 Organic peroxides Type A Type B Type C Type D Type E Type F Type G Corrosive to metals 1

Table 7. Hazard classes under CLP

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Health hazards

Acute toxicity – inhalation DSD R26 R23 R20

LC50 (mg/l/4 hours) ≤ 0,5 0,5 -2 2 - 10 10 -20

CLP Category 1 Category 2 Category 3 Category 4

Acute toxicity – dermal DSD R27 R24 R21

LD50 (mg/kg) ≤ 50 50-200 200-400 400-1000 1000-2000


Acute toxicity – oral DSD R28 R25 R22

LD50 (mg/kg) ≤ 5 5-25 25-50 50-200 200-300 300-2000


Skin corrosion/irritation DSD R35 R34 R38

Exposure ≤ 3 min 3 min – 1 hour 1 hour – 4 hours See DSD for criteria

See CLP for criteria

CLP Category 1A Category 1B Category 1C Category 2

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Eye damage/Eye irritation DSD R41 R36

See DSD 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



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




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Reproductive toxicity DSD Rep, cat 1;R60

and R61 Rep, cat 2;R60 and

R61 Rep, cat 3;R62 and R63




STOT, single exposure DSD Tx;R39 T;R39 R68 R37, R67



CLP Category 1 Category 2 Category 3

STOT, repeated exposure DSD T;R48 Xn;R48



CLP Category 1 Category 2

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Environmental hazards DSD R50 R52

L(E)C50 ≤ 1 mg/l See DSD for criteria

CLP 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

See DSD and CLP for criteria Log Pow

log Kow

≥ 3 ≥ 4

≥ 3 ≥ 4

≥ 3 ≥ 4

CLP Chronic, category 1

Chronic, category 2

Chronic, category 3

Chronic, category 4

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Classification of substances Classification of a substance is based on test data (in vitro tests and animal data), QSAR-results 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.

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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:

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.

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 non-hazardous substance

Mixture B Calculation based

on dilution

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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.

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.

80% 70% 30%

50% 50%

Mixture A STOT Kat. 1

Mixture B STOT Kat. 1

Mixture C Interpolate STOT Kat. 1

30% to 80% 20% to 70%

20%

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Changes in compositions Applying bridging principles the following variations in composition is allowed:

Initial concentration range Permitted variation in initial concentration

≤ 2.5 % ± 30 % 2.5 % < C ≤ 10 % ± 20 % 10 % < C ≤ 25 % ± 10 % 25 % < C ≤ 100 % ± 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 non-aerosolized mixture unless it is assumed that the propellant will affect the hazards upon spraying.

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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 Cut-off value (weight percentage) Acute toxicity, category 1-3 0.1 % Acute toxicity, category 4 1 % Skin corrosion / irritation 1 % Serious damage to eyes / eye irritation 1 % Hazardous to aquatic environment – Acute category 1

0.1 %

Hazardous to aquatic environment – Chronic category 1

0.1 %

Hazardous to aquatic environment – Chronic category 2-4

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:

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∑=n i

i

mix ATEC

ATE100

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 Classification Category or

experimentally obtained acute toxicity range estimate

Converted Acute Toxicity point estimate 1

Oral (mg/kg bodyweight)

0 < Category 1 ≤ 5 5 < Category 2 ≤ 50 50 < Category 3 ≤ 300 300 < Category 4 ≤ 2000

0.5 5 100 500

Dermal (mg/kg bodyweight)


5 50 300 1100

Gases (ppmV)


10 100 700 4500

Vapours (mg/l)

0 < Category 1 ≤ 0.5 0.5 < Category 2 ≤ 2.0 2.0 < Category 3 ≤ 10.0 10.0 < Category 4 ≤ 20.0

0.05 0.5 3 11

Dust/mist (mg/l)

0< Category 1 ≤ 0.05 0.05 < Category 2 ≤ 0.5 0.5 < Category 3 ≤ 1.0 1.0 < Category 4 ≤ 5.0

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.

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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 Category 1 Category 2 Category 3 Category 4 Oral (mg/kg bodyweight)

ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000

Dermal (mg/kg bodyweight)

ATE ≤ 50 50 < ATE ≤ 200 200 < ATE ≤ 1000 1000 < ATE ≤ 2000

Gases (ppmV)

ATE ≤ 100 100 < ATE ≤ 500 500 < ATE ≤ 2500

2500 < ATE ≤ 20000

Vapours (mg/l)

ATE ≤ 0.5 0.5 < ATE ≤ 2.0 2.0 < ATE ≤ 10.0 10.0 < ATE ≤ 20.0

Dusts and Mists (mg/l)

ATE ≤ 0.05 0.05 < ATE ≤ 0.5 0.5 < ATE ≤ 1.0 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.

ATE100

oral mix,=

10010 +

55 ⇒ ATEmix, oral = 91

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:

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∑∑ =−

n i

i

mix

unknown

ATEC

ATEC )(100

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: Concentration limits for classification as: Skin corrosive, category 1 Skin irritant, category 2 Skin corrosive, categories 1A, 1B, 1C ≥ 5 %2 ≥ 1 % but < 5 %

Skin irritant, category 2 ≥ 10 % (10 x skin corrosive, category 1A, 1B, 1C) + skin irritant, category 2 ≥ 10 % Table 11. Generic concentration limits of ingredients classified for skin corrosive/irritant hazards

2If 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.

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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 %:

Mixture classified as skin corrosive,

category 1B

Mixture classified as skin corrosive,

category 1C

⇒

⇒

+ +

+ +

4% Category 1A

1% Category 1B

1% Category 1C

3% Category 1A

1% Category 1B

1% Category 1C

0.5% Category 1A

6% Category 2

+ ⇒ Mixture classified as

skin irritant, category 2

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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 Concentration Classification Acid with pH ≤ 2 ≥ 1 % Skin corrosive, category 1 Base with pH ≥ 11.5 ≥ 1 % Skin corrosive, category 1 Other skin corrosive, categories 1A, 1B, 1C ≥ 1 % Skin corrosive, category 1

Other skin irritant, category 2 ≥ 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: Concentration limits for classification as: Eye damage, category 1 Eye irritation, category

2 Eye damage, category 1 or Skin corrosive, categories 1A, 1B, 1C ≥ 3 % ≥ 1 % but < 3 %

Eye irritation, category 2 ≥ 10 % (10 * eye damage, category 1) + eye irritation, category 2 ≥ 10 %

Skin corrosive, categories 1A, 1B, 1C + eye damage, category 1 ≥ 3 % ≥ 1 % but < 3 %

10 * (skin corrosive, category 1A, 1B, 1C + eye damage, category 1) + eye irritation, category 2

≥ 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.

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Ingredient Concentration Classification

Acid with pH ≤ 2 ≥ 1 % Eye damage, category 1 Base with pH ≥ 11.5 ≥ 1 % Eye damage, category 1 Other corrosive, category 1 ≥ 1 % Eye damage, category 1 Other irritant, category 2 ≥ 3 % 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:

Concentration limits for classification as: Skin sensitiser Respiratory sensitiser

Solid / liquid gas Skin sensitiser ≥ 0.1 %3 - -

≥ 1 % - - Respiratory sensitiser

- ≥ 0.1 %3 ≥ 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.

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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: Concentration limits for classification as:

Category 1A carcinogen

Category 1B carcinogen

Category 2 carcinogen

Category 1A carcinogen ≥ 0.1 % Category 1B carcinogen ≥ 0.1 % Category 2 carcinogen ≥ 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: Concentration limits for classification as:

Category 1A mutagen

Category 1B mutagen

Category 2 mutagen

Category 1A mutagen ≥ 0.1 % Category 1B mutagen ≥ 0.1 % Category 2 mutagen ≥ 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:

Concentration limits for classification as: Category 1A reproductive

toxicant

Category 1B reproductive

toxicant

Category 2 reproductive

toxicant

Effects on or via

lactation Category 1A reproductive toxicant ≥ 0.3 %5 Category 1B reproductive toxicant ≥ 0.3 %5 Category 2 reproductive toxicant ≥ 3 %5 Effects on or via lactation ≥ 0.3 %5 Table 18. Generic concentration limits of ingredients classified for reproductive toxic hazards

4 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.

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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: Concentration limits for classification as: Category 1 Category 2

Category 1, Specific Target Organ Toxicant

≥ 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: 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: Classification of mixture Category 1, aspiration hazard Category 1, aspiration hazard ≥ 10 %8,9 Table 21. Classification for Aspiration hazard

6 If the concentration is ≥ 1% a safety data sheet shall be available on request 7 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

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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: Classification of mixture Acute Category 1 * M10 Acute Category 1 ≥ 25 % 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: Classification of mixture Chronic Category 1 x M9 ≥ 25 % Chronic Category 1 (M x 10 x Chronic Category 1) + Chronic Category 2 ≥ 25 %

Chronic Category 2

(M x 100 x Chronic Category 1) + (10 x Chronic Category 2) + Chronic Category 3 ≥ 25 %

Chronic Category 3

Chronic Category 1 + Chronic Category 2 + Chronic Category 3 + Chronic Category 4 ≥ 25 %

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 Multiplying factor (M) 0.1 < L(E)C50 ≤ 1 1

0.01 < L(E)C50 ≤ 0.1 10 0.001 < L(E)C50 ≤ 0.01 100

0.0001 < L(E)C50 ≤ 0.001 1000 0.00001 < L(E)C50 ≤ 0.0001 10000

continue in factor 10 intervals 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: Classification of mixture Hazardous for the ozone layer ≥ 0.1 % Table 25. Classification as hazardous for the ozone layer

10 See Table 24 for explanation of the M-factor

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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

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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 Number

Exploding bomb GHS01

Flame GHS02

Flame over circle GHS03

Gas cylinder GHS04

Corrosion GHS05

Table 27. Pictograms for physical/chemical hazards

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The hazard pictograms for health hazards and environmental hazards are found in Table 28. Pictogram Name Number

Skull and crossbones

GHS06

Corrosion GHS05

Exclamation mark GHS07

Health hazard GHS08

Environment GHS09

Table 28. Pictograms for health hazards

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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.

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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 Highly flammable liquid and vapour H301 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 Explosive when dry EUH006 Explosive with or without contact with air EUH014 Reacts violently with water EUH018 In use may form flammable/explosive vapour-air mixture EUH019 May form explosive peroxides EUH030 Can become highly flammable in use EUH044 Risk of explosion if heated under confinement EUH029 Contact with water liberates toxic gas EUH031 Contact with acids liberates toxic gas EUH032 Contact with acids liberates very toxic gas EUH066 Repeated exposure may cause skin dryness or cracking EUH070 Toxic by eye contact EUH071 Corrosive to the respiratory tract EUH059 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.

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EUH201 Contains lead. Should not be used on surfaces liable to be chewed or sucked by children

EUH201A Warning! Contains lead EUH202 Cyanoacrylate. Danger. Bonds skin and eyes in seconds. Keep out of

the reach of children EUH203 Contains chromium (VI). May produce an allergic reaction EUH204 Contains isocyanates. May produce an allergic reaction EUH205 Contains epoxy constituents. May produce an allergic reaction EUH206 Warning! Do not use together with other products. May release

dangerous gases (chlorine) EUH207 Warning! Contains cadmium. Dangerous fumes are formed during

use. See information supplied by the manufacturer. Comply with safety instructions

EUH208 Contains “name”. May produce an allergic reaction EUH209 Can become highly flammable in use EUH209A Can become flammable in use EUH210 Safety data sheet available on request EUH401 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.

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Hazard statement H226: Flammable liquid and vapour Precautionary statements – Prevention 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.

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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

46

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.

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Classification Labelling Pictogram Signal

word Hazard

statement(s) Precautionary

statements

Mixture 1 (packaging < 125 ml)

Flammable liquid, category 2

Danger Omitted Omitted

Mixture 2 (packaging < 125 ml)

Flammable liquid, category 2 Acute toxicity, oral, category 3

Danger

H225: Highly flammable liquid and vapour H301: Toxic if swallowed

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 Label dimensions (in millimetres) 3 litres or less At least 52 x 74, if possible More than 3 litres but not more than 50 litres At least 74 x 105 More than 50 litres but not more than 500 litres At least 105 x 148 More than 500 litres 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

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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.

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CLP-Company CLP Test Product Name11 CLP-street 111 1111 CLP-city CLP- country

+45 11 11 11 11

12

Contains:

CLP-substance(s)11 contributing to the classification as toxic.

Danger13 Highly flammable liquid and vapour14

Toxic if swallowed

Wash hands thoroughly after handling15 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

Contains (name of sensitising substance). May produce an allergic reaction16

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 12 Hazard pictograms 13 Signal word 14 Hazard statements 15 Precautionary statements 16 Additional EU statement

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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

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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.

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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 DSD17 DSD and CLP DSD and CLP CLP

Labelling DSD or CLP CLP18 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 DPD19 DPD 19 CLP CLP

Labelling DPD or CLP DPD or CLP CLP20 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.

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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.

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Links CLP Regulation: http://eur-lex.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

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF�

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF�

http://www.unece.org/trans/danger/publi/ghs/pictograms.html�

http://echa.europa.eu/�

http://www.unece.org/trans/danger/publi/ghs/implementation_e.html�

http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/02files_e.html�

http://ec.europa.eu/enterprise/reach/ghs_more_on_com_proposal_en.htm�

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GHS/CLP Vocabulary

Term Explanation Substance Pure chemical substance. May be a liquid,

a gas or a solid substance Mixture 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

Chemical A common term used for both substances and mixtures

Classification 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.

GHS Globally Harmonised System of classification and labelling of chemicals

DSD Dangerous Substance Directive (67/548/EEC)

DPD Dangerous Preparations Directive (1999/45/EC)

CLP Regulation of Classification, Labelling and Packaging of substances and mixtures

Formulator Any natural or legal person established within the Community who manufactures a mixture and place it on the market within the Community

Importer Any natural or legal person established within the Community who is responsible for import into the Community.

Manufacturer Any natural or legal person established within the Community who manufactures a substance within the Community.

QSAR 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.

ECHA European Chemicals Agency

http://en.wikipedia.org/wiki/Chemical_structure�

http://en.wikipedia.org/wiki/Correlation�

http://en.wikipedia.org/wiki/Biological_activity�

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End User Any professional user or consumer who buys and uses chemicals but who do not market the chemicals.

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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 Weight %

Substance A 4 % Substance C 2 % Rest: Water 94 %


Substance A23 0.5 % Substance B 9 % Substance C 7 % Rest: Water 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 22 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

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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.

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Solutions

Exercise 1 The CLP-classifications are:

Substance DSD CLP Hazard Class Hazard

Category Hazard

statement A T;25 Acute toxicity 3 H301 A C;R34 Skin Corrosion 1B H314 A Carc3;R40 Carcinogenicity 2 H351 A R43 Skin Sensitiser 1 H317 B F;R11 Flammable

liquid 2 H225

B Xi;R41 Eye Damage 1 H318 B R67 STOT, single

exposure 3 H336

C Xn;R22 Acute toxicity 4 H302 C Xi;R38 Skin irritation 2 H315 C N;R50/53 Aquatic Acute 1 H400 C N;R50/53 Aquatic

Chronic 1 H410

Exercise 2


Substance A 4 % Acute toxicity, cat 3, oral Skin corr., cat 1B Carc, cat 2 Skin sens., cat 1 Substance C 2 % Skin irrit., cat 2 Acute toxicity, cat 4, oral Aquatic Acute, cat 1 Aquatic Chronic, cat 1 Water 94 % Not classified

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Acute toxicity Converted ATE-values for substance A and C for oral exposure are found using Table 9. Oral exposure: 100

𝐴𝐴𝐴𝐴𝐴𝐴𝑚𝑚𝑚𝑚𝑚𝑚 = 4

100+ 2

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

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Substance A 0.5 % Acute tocixity,cat 3, oral Skin corr., cat 1 Carc, cat 2 Skin sens., cat 1 Substance B 9 % Flammable liquid, cat 2 Eye dam., cat 1 STOT, single, cat 3 Substance C 7 % Skin irrit., cat 2 Acute toxicity, cat 4, oral Aquatic Acute, cat 1 Aquatic Chronic, cat 1 Water 83.5 % Not classified Acute toxicity Converted ATE-values for substance A and C for oral exposure are found using Table 9. Oral exposure: 100

𝐴𝐴𝐴𝐴𝐴𝐴𝑚𝑚𝑚𝑚𝑚𝑚 = 0.5

100+ 7

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.

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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

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Mixture 1 Hazard pictogram(s) Signal

Word Hazard Statement(s)

Supplemental hazard statements

Product identifier

Danger H318: Causes serious eye damage. 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

None Substance A

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Mixture 2 Hazard pictogram(s)

Signal Word Hazard Statement(s)


Product identifier

Danger H318: Causes serious eye damage. H315: Causes skin irritation. H400: Very toxic to aquatic life. H410: Very toxic to aquatic life with long lasting effects.

Contains substance A. May produce an allergic reaction

Substance B

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:

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Mixture 2 Hazard pictogram(s)

Signal Word Hazard Statement(s)


Product identifier

Danger H318: Causes serious eye damage. H315: Causes skin irritation. H410: Very toxic to aquatic life with long lasting effects.


Substance B

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.

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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.

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.


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