The Globally Harmonised System of Classification and Labelling of Chemicals (GHS) Revision 8 was recently published. Caroline Raine discusses the changes.

Introduction

Summary of changes made in GHS Revision 8.

  1. New classification criteria, hazard communication elements, decision logics and guidance for chemicals under pressure.

  2. New provisions for the use of in vitro/ex vivo data and non-test methods to assess skin corrosion and skin irritation.

  3. Miscellaneous amendments to clarify the classification criteria for Specific Target Organ Toxicity.

  4. Revised and further rationalized precautionary statements and an editorial revision of Sections 2 and 3 of Annex 3.

  5. New examples of precautionary pictograms to convey the precautionary statement “Keep out reach of children”.

  6. A new example in Annex 7 addressing labelling of sets or kits.

  7. Guidance on the identification of dust explosion hazards and the need for risk assessment, prevention, mitigation, and hazard communication.

New classification criteria, hazard communication elements, decision logics and guidance for chemicals under pressure

Change of classification criteria for aerosols

Aerosols are to be classified in one of the three categories, according to Table 2.3.1. The category will depend on:

  • their flammable properties

  • their heat of combustion

  • and, if applicable, test results from the ignition distance test, the enclosed space ignition test and the aerosol foam flammability test, performed in accordance with sub-sections 31.4, 31.5 and 31.6 of the United Nations Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria.”

The new GHS classification criteria for aerosols is as follows:

Category

Criteria

1

  1. Any aerosol that contains ≥ 85% flammable components (by mass) and has a heat of combustion of ≥ 30kJ/g;

  2. Any aerosol that dispenses a spray that, in the ignition distance test, has an ignition distance of ≥ 75cm; or

  3. Any aerosol that dispenses a foam that, in the foam flammability test, has;

    1. a flame height of ≥ 20cm and a flame duration of ≥ 2 s; or

    2. a flame height of ≥ 4cm and a flame duration of ≥ 7 s.

2

  1. Any aerosol that dispenses a spray that, based on the results of the ignition distance test, does not meet the criteria for Category 1, and which has:

    1. a heat of combustion of ≥ 20 kJ/g;

    2. a heat of combustion of < 20kJ/g along with an ignition distance of ≥ 15cm; or

    3. a heat of combustion of <20kJ/g and an ignition distance of <15cm along with either, in the enclosed space ignition test:

      1. a time equivalent of ≤ 300 s/m3; or

      2. a deflagration density of ≤ 300g/m3; or

  2. Any Aerosol that dispenses a foam that, based on the results of the aerosol foam flammability test, does not meet the criteria for Category 1, and which has a flame height of ≥ 4cm and a flame duration of ≥2 s.

3

  1. Any aerosol that contains ≤ 1% flammable components (by mass) and that has a heat of combustion of < 20 kJ/g; or

  2. Any aerosol that contains > 1% (by mass) flammable components or which has a heat of combustion of ≥ 20 kJ/g but which, based on the results of the ignition distance test, the enclosed space ignition test or the aerosol foam flammability test, does not meet the criteria for Category 1 or Category 2.

Chemicals under pressure

Chemicals under pressure are liquids or solids (eg, pastes or powders), pressurized with a gas at a pressure of 200 kPa (gauge) or more at 20 °C in pressure receptacles other than aerosol dispensers and which are not classified as gases under pressure.

Chemicals under pressure typically contain 50% or more by mass of liquids or solids whereas mixtures containing more than 50% gases are typically considered as gases under pressure.

Table 2.3.2: Criteria for chemicals under pressure

Category

Criteria

1

Any chemical under pressure that:

  1. contains ≥ 85% flammable components (by mass) and

  2. has a heat of combustion of ≥ 20 kJ/g.

2

Any chemical under pressure that:

  1. contains > 1 % flammable components (by mass) and

  2. has a heat of combustion < 20 kJ/g

or that:

  1. contains < 85 % flammable components (by mass) and

  2. has a heat of combustion ≥ 20 kJ/g.

3

Any chemical under pressure that:

  1. contains ≤ 1% flammable components (by mass)

  2. has a heat of combustion of < 20 kJ/g.

Table 2.3.2.1: Label elements for chemicals under pressure

Category 1

Category 2

Category 3

Symbol

Flame Gas cylinder

Flame Gas cylinder

Gas cylinder

Signal word

Danger

Warning

Warning

Hazard statement

H282, Extremely flammable chemical under pressure: May explode if heated

H283, Flammable chemical under pressure: May explode if heated

H284, Chemical under pressure: May explode if heated

New provisions for the use of in vitro/ex vivo data and non-test methods to assess skin corrosion and skin irritation;

The currently available individual in vitro/ex vivo test methods address either skin irritation or skin corrosion, but do not address both endpoints in one single test. Therefore, classification based solely on in vitro/ex vivo test results may require data from more than one method.

Test method nos 430, 431 and 435 for skin corrosion and test no 439 for skin irritation have been added.

Miscellaneous amendments to clarify the classification criteria for Specific Target Organ Toxicity;

There have been some changes to the text which include:

“3.8.1.6: Specific target organ toxicity following a repeated exposure is addressed in the GHS as described in Chapter 3.9 and is therefore excluded from the present chapter. Substances and mixtures should be classified for single and repeated dose toxicity independently.

“Other specific toxic effects, such as acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation, respiratory or skin sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, and aspiration toxicity are assessed separately in the GHS and consequently are not included here.”

The main change is that fact that “As with substances, mixtures should be classified for specific target organ toxicity for single and repeated exposure (Chapter 3.9) independently.”

Revised and further rationalized precautionary statements and an editorial revision of Sections 2 and 3 of Annex 3

We have already learned that we have new H statements for chemicals under pressure:

H282 - Extremely flammable chemical under pressure: may explode if heated.

H283 - Flammable chemical under pressure: may explode if heated.

H284 - Chemical under pressure: may explode if heated.

P201 and P202 are deleted and are replaced by:

P203 - Obtain, read and follow all safety instructions before use.

New statements for chemicals under pressure:

P210 Keep away from heat, hot surfaces, sparks open flames and other ignition sources. No smoking.

P211 Do not spray on an open flame or other ignition source.

P302 - insert the following new row, after the row for hazard class “Acute toxicity, dermal (chapter 3.1)”.

P302 IF ON SKIN:

P303, delete the row for hazard class “Skin corrosion (chapter 3.2)”.

P308, delete the rows for hazard classes “Germ cell mutagenicity (chapter 3.5)”, “Carcinogenicity (chapter 3.6)”, “Reproductive toxicity (chapter 3.7)” and “Reproductive toxicity, effects on or via lactation (chapter 3.7)”.

P310, P311, P312, P313, P314 and P315 are all deleted and are replaced by:

P316 Get emergency medical help immediately.

P317 Get medical help.

P318 IF exposed or concerned, get medical advice.

P319 Get medical help if you feel unwell.

There are other minor changes to some other precautionary statements.

New examples of precautionary pictograms to convey the precautionary statement “Keep out reach of children”;

There is now a GHS pictogram to be used in addition to P102 “Keep out of reach of children.

The following examples convey the meaning of precautionary statement P102 “Keep out of reach of children” and may be used to convey information in more than one way according. One pictogram is from AISE, International Association for Soaps, Detergents and Maintenance Products while the other one is from JSDA, the Japan Soap & Detergent Association. It will be important for the labelling of chemical products supplied to the public.

Safe Use Icon ‘Keep away from children’ (AISE).

Safe use icon developed by the Japan Soap and Detergent Association (JSDA).

New labelling example for sets or kits

To further improve the examples for sets or kits a new example has been added - “Labelling of sets or kits” in annex 7 of the GHS.

“Example 10: Labelling of - sets or kits

A set or kit is a combination packaging intended for defined applications.

Generally, a set or kit contains two or more small removable inner containers. Each inner container contains different products which can be hazardous or not hazardous substances or mixtures.

This example illustrates ways to label sets or kits where the manufacturer/supplier or competent authority has determined there is insufficient space to place together on each inner container within the kit, the GHS pictogram(s), signal word and hazard statement(s) in accordance with 1.4.10.5.4.1. This may occur when, for example, the inner containers are small, or there are a large number of hazard statements assigned to the chemical, or the information needs to be presented in multiple languages, so all the information cannot be printed on the label in a size that is easily legible. Two different scenarios where this may arise are illustrated, together with ways to provide the necessary GHS information.

Scenario A

The set or kit comprises an outer packaging containing the following inner containers: four cuvettes, each filled with the same substance or mixture (reagent 1) and two larger containers each filled with another substance or mixture (reagent 2).

The approach is to provide minimum information on each of the inner containers containing hazardous substances or mixtures, and to provide the full GHS label information for each hazardous substance or mixture on the outer packaging. For clarity, the full label information for each hazardous substance or mixture is grouped together on the outer packaging.

Inner container label

As the area available for a label on the inner containers is not sufficient to include all the required GHS label elements, the following minimum information is included on the label of each hazardous substance or mixture:

  • Product identifier1, and an identifier for each substance or mixture matching the identifier used on the outer packaging label and SDS for that substance or mixture, e.g., “Reagent 1” and “Reagent 2”.

  • Pictogram(s).

  • Signal word.

  • The statement “Read full label”.

  • Supplier identification (ie name and telephone number).

1 Where hazardous components are required to be identified on the label, they are displayed in the appropriate languages on the outer packaging label.

Outer packaging label

In addition to the set or kit identifier, in this case Reagent Kit for water analysis (see below), all the required GHS label elements appear on the outer packaging for each hazardous substance or mixture.

The label elements for each substance or mixture on the outer packaging are grouped together in order to distinguish clearly which label elements are assigned to which substance or mixture.

However, the supplier identification need appear only once on the outer packaging. Where possible any supplemental information may also be included on the outer packaging.

When a large number of precautionary statements are required, the precautionary statements may be located separately from the rest of the label elements, though general precautionary statements (Table A3.2.1) and precautionary statements for storage need only appear once (see also A3.2.5 in Annex 3 on flexibility in the use of precautionary statements) to avoid inappropriate statements, taking into account the nature of the user (eg consumers, employers and workers) the quantities supplied, and the intended and foreseeable circumstances of use. In these circumstances, the precautionary statements for each substance or mixture should be grouped together on the same side of the outer packaging and on a surface that is visible under normal conditions of use.

Scenario B

This scenario addresses the situation where it is not possible to affix all appropriate GHS labelling elements for each hazardous substance or mixture in the kit directly on the outer packaging label (due to technical reasons such as the size and shape of this packaging).

This scenario presents a sample kit used for marketing purposes which consist of a large number of different substances or mixtures in individual containers (sample bottles) presented in an outer packaging (eg a box). Depending upon the contents of each bottle, some or all of the different substances or mixtures may be classified as hazardous. The individual inner containers (eg bottles) are stored in the outer packaging throughout the lifecycle of the sample kit. Customers may select individual bottles and remove them from the box to check clarity, colour or odour and then replace them into the open slot within the outer packaging.

Individual container label

As the area available for a label on the different individual containers is not sufficient to include all required GHS label elements, the following minimum required information should be required:

  • supplier identification (ie name and telephone number)

  • product identifier2

  • pictogram(s)

  • signal word

  • the statement “Read full label enclosed”.

Example of individual container label

2 Where hazardous components are required to be identified on the label they are displayed in the appropriate languages as part of the full label information attached to the inside of the kit.

Full label information

Attached to the inside of the outer packaging is the full GHS label information for each individual container containing a hazardous substance or mixture. The individual product identifiers on the label align with the product identifier on the individual container label. An example of the content of the full label information is shown below.

Product identifier (see 1.4.10.5.2 (d) (ii))

Pictogram(s) (see 1.4.10.4)

Signal word (see 1.4.10.5.2 (a))

Hazard statement(s) (see 1.4.10.5.2 (b))

Precautionary statement(s) (see 1.4.10.5.2 (c))

Supplemental information (see 1.4.10.5.4.2)

123

Warning

Flammable liquid and vapour. Causes skin irritation. Toxic to aquatic life with long lasting effects.

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Keep container tightly closed. Use explosion-proof equipment. Use non-sparking tools. Take action to prevent static discharge. Avoid release to the environment. Wear protective gloves. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse affected areas with water. In case of fire: Use dry sand, dry chemical or alcohol-resistant foam for extinction. Store in a well-ventilated place. Keep cool.

Although the contents of each inner container may not be classified as hazardous in accordance with the GHS, and thus would not need to be identified, it may be identified with a statement such as “Not meeting classification criteria” or “Not classified as hazardous” so as to eliminate confusion on the part of the user if the contents of an inner container is omitted from the full label information.

The document containing the full GHS label information should be organized and printed in a format that allows the user to readily identify the information for each individual container. The visibility of the label elements should be ensured without the aid of any device other than corrective lenses. The approach of this scenario may become infeasible if, given the number of samples, required languages, and precautionary statements, the document grows so large it becomes difficult to locate quickly the label information for a particular inner container.

As shown to the right, full label information regarding each inner container is contained within the outer packaging.

The sheets of full label information are permanently connected to the inside of the combination packaging using a secure method of attachment (eg fold out label adhered to box tie or tag as shown).

Outer packaging label

The outer box, given the limited area for labelling, will display:

  • kit identifier (name of kit)

  • supplier identification (see 1.4.10.5.2(e))

  • storage and general precautionary statements for the kit as a whole

  • pictograms for each single hazardous substance or mixture, without duplication

  • signal word (the most stringent assigned to any component)

  • the statement “Read full label enclosed”.

Guidance on the identification of dust explosion hazards and the need for risk assessment, prevention, mitigation, and hazard communication.

A new annex, Annex 11 has been added to GHS - Guidance on other hazards not resulting in classification.

The guidance aims to provide information that facilitates the identification of hazards which do not result in classification, but which may need to be assessed and communicated.

And so covers a section on dust explosions – giving guidance on the factors that contribute to a dust explosion hazard and on hazard identification and the need for risk assessment, prevention, mitigation, and communication.

Conclusions

  • Revision 8 of GHS has been published.

  • It brings in changes that help to improve hazard communication.

  • New pictograms for “Keep out of reach of children” have been added.

  • Inconsistencies in the presentation of precautionary statements have been eliminated.

  • Additional clarity on the labelling requirements for sets or kits has been given through the use of examples.

Last reviewed 2 December 2019