Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)

• 1. in the table in Annex XVII, the column ‘Designation of the substance, of the groups of substances or of the mixture’ shall be amended as follows:
• (a) entry 3 shall be replaced by the following: ‘3.Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
• (a) hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
• (b) hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
• (c) hazard class 4.1;
• (d) hazard class 5.1.’;
• (b) entry 40 shall be replaced by the following: ‘40.Substances classified as flammable gases category 1 or 2, flammable liquids categories 1, 2 or 3, flammable solids category 1 or 2, substances and mixtures which, in contact with water, emit flammable gases, category 1, 2 or 3, pyrophoric liquids category 1 or pyrophoric solids category 1, regardless of whether they appear in Part 3 of Annex VI to that Regulation or not’.

Article 59

Amendments to Regulation (EC) No 1907/2006 from 1 June 2015

Regulation (EC) No 1907/2006 shall be amended from 1 June 2015 as follows:

• 1. Article 14(2) shall be replaced by the following: ‘2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than (a) the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008; (b) 0,1  % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.’;

• 1. Article 31 shall be amended as follows:
• (a) in paragraph 1, point (a) shall be replaced by the following:
• ‘(a) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or’;
• (b) paragraph 3 shall be replaced by the following: ‘3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains: (a) in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2  % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or (b) in an individual concentration of ≥ 0,1  % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or (c) a substance for which there are Community workplace exposure limits’;
• (c) paragraph 4 shall be replaced by the following: ‘4. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.’;

• 1. Article 56(6)(b) shall be replaced by the following:
• ‘(b) for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.’;

• 1. in Article 65 the words ‘and Directive 1999/45/EC’ shall be deleted;

• 1. Annex II shall be amended as follows:
• (a) point 1.1 shall be replaced by: ‘1.1.Identification of the substance or mixture The term used for identification of a substance shall be identical to that provided on the label in accordance with Article 18(2) of Regulation (EC) No 1272/2008. The term used for identification of a mixture shall be identical to that provided on the label in accordance with Article 18(3)(a) of Regulation (EC) No 1272/2008.’;
• (b) footnote 1 to point 3.3(a), first indent, shall be deleted;
• (c) point 3.6 shall be replaced by: ‘3.6.Where, in accordance with Article 24 of Regulation (EC) No 1272/2008, the Agency has agreed that the chemical identity of a substance may be kept confidential on the label and in the safety data sheet, their chemical nature shall be described under heading 3 in order to ensure safe handling. The name used on the safety data sheet (including for the purposes of paragraphs 1.1, 3.2, 3.3 and 3.5) shall be the same as that used on the label, agreed in accordance with the procedure set out in Article 24 of Regulation (EC) No 1272/2008.’;

• 1. in Annex VI section 4.3 shall be replaced by the following: ‘4.3Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.’;

• 1. Annex XVII shall be amended as follows:
• (a) in the column ‘Designation of the substance, of the groups of substances or of the mixture’ of the table in entry 3, the words ‘which are regarded as dangerous in accordance with Directive 1999/45/EC or are’ shall be deleted;
• (b) in the column ‘Conditions of restriction’ of the table, entry 28 shall be amended as follows:
• (i) the second indent of point 1 shall be replaced by the following:
• — - ‘— the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.’;
• (ii) point 2 (d) shall be replaced by the following:
• ‘(d) artists’ paints covered by Regulation (EC) No 1272/2008’.

Article 60

Repeal

Directive 67/548/EEC and Directive 1999/45/EC shall be repealed with effect from 1 June 2015.

Article 61

Transitional provisions

Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC.

By way of derogation from the second subparagraph of Article 62 of this Regulation, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC and already placed on the market before 1 June 2015 are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.

It is a precondition that a decision on the proposed classification and labelling by the Commission in accordance with the safeguard clause of Directive 67/548/EEC has not yet been taken before 20 January 2009.

If the proposed harmonised classification and labelling submitted under the first subparagraph is not included or is included in an amended form in Part 3 of Annex VI in accordance with Article 37(5), the exemption in the first subparagraph of this paragraph is no longer valid.

Article 62

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Titles II, III and IV shall apply in respect of substances from 1 December 2010 and in respect of mixtures from 1 June 2015.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES

This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met.

1. PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING

1.0.   Definitions

Gas means a substance which:

• (i) at 50 ^oC has a vapour pressure greater than 300 kPa (absolute); or

• (ii) is completely gaseous at 20 ^oC at a standard pressure of 101,3 kPa;

Liquid means a substance or mixture which:

• (i) at 50 ^oC has a vapour pressure of not more than 300 kPa (3 bar);

• (ii) is not completely gaseous at 20 ^oC and at a standard pressure of 101,3 kPa; and

• (iii) which has a melting point or initial melting point of 20 ^oC or less at a standard pressure of 101,3 kPa;

Solid means a substance or mixture which does not meet the definitions of liquid or gas.

1.1.   Classification of substances and mixtures

1.1.0.   Cooperation to meet the requirements in this Regulation

Suppliers in a supply chain shall cooperate to meet the requirements for classification, labelling and packaging set out in this Regulation.

Suppliers in an industry sector may cooperate to manage the transitional arrangements in Article 61 for substances and mixtures placed on the market.

Suppliers in an industry sector may cooperate through formation of a network or by other means to share data and expertise when classifying substances and mixtures in accordance with Title II of this Regulation. In these circumstances suppliers in an industry sector shall document fully the basis on which classification decisions are made and shall make available to the competent authorities and, on request, to the relevant enforcement authorities the documentation, together with the data and information on which classifications are based. However, where suppliers in an industry sector cooperate in this way, each supplier shall remain fully responsible for the classification, labelling and packaging of substances and mixtures he places on the market, and for meeting any other requirements of this Regulation.

The network may also be used to exchange information and best practices with a view to simplifying fulfilment of the notification obligations.

1.1.1.   The role and application of expert judgement and weight of evidence determination

• 1.1.1.1.Where the criteria cannot be applied directly to available identified information, or where only the information referred to in Article 6(5) is available, the weight of evidence determination using expert judgment shall be applied in accordance with Article 9(3) or 9(4) respectively.

• 1.1.1.2.The approach to classifying mixtures may include the application of expert judgement in a number of areas in order to ensure existing information can be used for as many mixtures as possible in order to provide protection for human health and the environment. Expert judgement may also be required in interpreting data for hazard classification of substances, especially where weight of evidence determinations are needed.

• 1.1.1.3.A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and (Q)SAR results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, where appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action found in study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.

• 1.1.1.4.For the purpose of classification for health hazards (Part 3) established hazardous effects seen in appropriate animal studies or from human experience that are consistent with the criteria for classification shall normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated in order to resolve the question of classification. Generally, adequate, reliable and representative data on humans (including epidemiological studies, scientifically valid case studies as specified in this Annex or statistically backed experience) shall have precedence over other data. However, even well-designed and conducted epidemiological studies may lack a sufficient number of subjects to detect relatively rare but still significant effects, to assess potentially confounding factors. Therefore, positive results from well-conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the robustness, quality and statistical power of both the human and animal data.

• 1.1.1.5.For the purpose of classification for health hazards (Part 3) route of exposure, mechanistic information and metabolism studies are pertinent to determining the relevance of an effect in humans. When such information, as far as there is reassurance about the robustness and quality of the data, raises doubt about relevance in humans, a lower classification may be warranted. When there is scientific evidence that the mechanism or mode of action is not relevant to humans, the substance or mixture should not be classified.

1.1.2.   Specific concentration limits, M-factors and generic cut-off values

• 1.1.2.1.Specific concentration limits or M-factors shall be applied in accordance with Article 10.

1.1.2.2.   Cut-off values

• 1.1.2.2.1.Cut-off values indicate when the presence of a substance needs to be taken into account for the purposes of classification of a substance or a mixture containing that hazardous substance, whether as an identified impurity, additive, or individual constituent (see Article 11).

• 1.1.2.2.2.The cut-off values referred to in Article 11 shall be the following:

• (a) For health and environmental hazards in Parts 3, 4 and 5 of this Annex:
• (i) for substances where a specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is mentioned in Table 1.1, the lower of the specific concentration limit and the relevant generic cut-off value in Table 1.1; or
• (ii) for substances where a specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is not mentioned in Table 1.1, the specific concentration limit set either in Part 3 of Annex VI or in the classification and labelling inventory; or
• (iii) for substances where no specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is mentioned in Table 1.1, the relevant generic cut-off value set out in that table; or
• (iv) for substances where no specific concentration limit is set for the relevant hazard class or differentiation either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, and where the hazard class or differentiation is not mentioned in Table 1.1, the generic concentration limit for classification in the relevant sections of Parts 3, 4 and 5 of this Annex.

• (b) For aquatic environmental hazards in section 4.1 of this Annex:
• (i) for substances where an M-factor has been set for the relevant hazard category either in Part 3 of Annex VI, or in the classification and labelling inventory referred to in Article 42, the generic cut-off value in Table 1.1 adjusted using the calculation set out in section 4.1 of this Annex; or
• (ii) for substances where no M-factor is set for the relevant hazard category either in Part 3 of Annex VI or in the classification and labelling inventory referred to in Article 42, the relevant generic cut-off value set out in Table 1.1.

Table 1.1

Generic cut-off values

Hazard class	Generic cut-off values to be taken into account
Acute Toxicity:	Acute Toxicity:
— Category 1-3	0,1 %
— Category 4	1 %
Skin corrosion/Irritation	1 % [^E0013]
Serious damage to eyes/eye irritation	1 % [^E0014]
Specific target organ toxicity, single exposure, Category 3	1 % [^E0015]
Aspiration toxicity	1 %
Hazardous to Aquatic Environment	Hazardous to Aquatic Environment
— Acute Category 1	0,1 % [^E0016]
— Chronic Category 1	0,1 % [^E0016]
— Chronic Category 2-4	1 %

Or < 1 % where relevant, see 3.2.3.3.1.

Or < 1 % where relevant, see 3.3.3.3.1.

Or < 1 % where relevant, see 3.8.3.4.6.

Or < 0,1 % where relevant, see 4.1.3.1.

Note:

Generic cut-off values are in weight percentages except for gaseous mixtures for those hazard classes where the generic cut-off values may be best described in volume percentages.

1.1.3.   Bridging principles for the classification of mixtures where test data are not available for the complete mixture

Where the mixture itself has not been tested to determine its hazardous properties, but there are sufficient data on similar tested mixtures and individual hazardous ingredient substances to adequately characterise the hazards of the mixture, these data shall be used in accordance with the following bridging rules referred to in Article 9(4) for each individual hazard class in Part 3 and Part 4 of this Annex, subject to any specific provisions for mixtures in each hazard class.

1.1.3.1.   Dilution

If a tested mixture is diluted with a substance (diluent) which has an equivalent or lower hazard category classification than the least hazardous original ingredient substance and which is not expected to affect the hazard classification of other ingredient substances, then one of the following shall be applied:

• — the new mixture shall be classified as equivalent to the original mixture;

• — the method explained in each section of Part 3 and in Part 4 for classification of mixtures when data are available for all components or only some components of the mixture;

• — in the case of acute toxicity, the method for classification of mixtures based on ingredients of the mixture (additivity formula).

1.1.3.2.   Batching

The hazard category of a tested production batch of a mixture can be assumed to be substantially equivalent to that of another untested production batch of the same commercial product, when produced by or under the control of the same supplier, unless there is reason to believe there is significant variation such that the hazard classification of the untested batch has changed. If the latter occurs, a new evaluation is necessary.

1.1.3.3.   Concentration of highly hazardous mixtures

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, if a tested mixture is classified in the highest hazard category or sub-category, and the concentration of the components of the tested mixture that are in that category or sub-category is increased, the resulting untested mixture shall be classified in that category or sub-category without additional testing.

1.1.3.4.   Interpolation within one hazard category

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, for three mixtures (A, B and C) with identical components, where mixtures A and B have been tested and are in the same hazard category, and where untested mixture C has the same hazardous components as mixture A and B but has concentrations of those hazardous components intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B.

1.1.3.5.   Substantially similar mixtures

Given the following:

• (a) two mixtures each containing two ingredients:
• (i) A + B
• (ii) C + B;

• (b) the concentration of ingredient B is essentially the same in both mixtures;

• (c) the concentration of ingredient A in mixture (i) equals that of ingredient C in mixture (ii);

• (d) hazard data for A and C are available and substantially equivalent, i.e. they are in the same hazard category and are not expected to affect the hazard classification of B.

If mixture (i) or (ii) is already classified based on test data, then the other mixture shall be assigned the same hazard category.

1.1.3.6.   Review of classification where the composition of a mixture has changed

The following variations in initial concentration are defined for the application of Article 15(2)(a):

Table 1.2

Bridging Principle for changes in the composition of a mixture

Initial concentration range of the constituent	Permitted variation in initial concentration of the constituent
≤ 2,5  %	± 30 %
2,5 < C ≤ 10 %	± 20 %
10 < C ≤ 25 %	± 10 %
25 < C ≤ 100 %	± 5 %

1.1.3.7.   Aerosols

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.4, 3.8 and 3.9, an aerosol form of a mixture shall be classified in the same hazard category as the tested non-aerosolised form of the mixture, provided that the added propellant does not affect the hazardous properties of the mixture upon spraying.

1.2.   Labelling

1.2.1.   General rules for the application of labels required by Article 31

• 1.2.1.1. Hazard pictograms shall be in the shape of a square set at a point.

• 1.2.1.2. Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible.

• 1.2.1.3. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by Article 17. The minimum area of each hazard pictogram shall not be less than 1 cm².

• 1.2.1.4. The dimensions of the label and of each pictogram shall be as follows:

Table 1.3

Minimum dimensions of labels and pictograms

Capacity of the package	Dimensions of the label (in millimetres) for the information required by Article 17	Dimensions of each pictogram (in millimetres)
Not exceeding 3 litres:	If possible, at least 52 × 74	Not smaller than 10 × 10 If possible, at least 16 × 16
Greater than 3 litres but not exceeding 50 litres:	At least 74 × 105	At least 23 × 23
Greater than 50 litres but not exceeding 500 litres:	At least 105 × 148	At least 32 × 32
Greater than 500 litres:	At least 148 × 210	At least 46 × 46

• 1.2.1.6. Fold-out labels

• 1.2.1.6.1.The front page of the fold-out label shall include at least the following elements:

• (i) the name, address and phone number of suppliers;

• (ii) nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;

• (iii) the product identifiers in accordance with Article 18(2) for substances and Article 18(3)(a) for mixtures in all languages of the label that are used in the inside pages;

• (iv) where applicable, the hazard pictograms;

• (v) where applicable, the signal words in all languages of the label that are used in the inside pages;

• (vi) where applicable, the unique formula identifier, unless printed or affixed on the inner packaging in accordance with Part A, point 5.3, of Annex VIII to this Regulation;

• (vii) a reference to the full safety information inside the fold-out label in all languages of the label or a symbol to inform a user that the label can be opened and to illustrate that additional information is available on inside pages;

• (viii) an abbreviation of the language (country code or language code) for all the languages that are used in the inside pages.

• 1.2.1.6.2.The inner pages of the fold-out label shall contain all the label elements provided for in Article 17(1), except for the hazard pictogram and the supplier identification, in each of the languages mentioned on the front page and grouped by language, using the language abbreviation (country code or language code).

• 1.2.1.6.3.The back page of the fold-out label shall contain all the label elements provided on the front page, except for the abbreviations of the languages that are used in the inside pages.

1.3.   Derogations from labelling requirements for special cases

In accordance with Article 23 the following derogations shall apply:

1.3.1.   Transportable gas cylinders

For transportable gas cylinders, one of the following shall be permitted to be used for gas cylinders with a water capacity of less than or equal to 150 litres:

• (a) A format and dimensions following the prescriptions of the current edition of Standard ISO 7225 relating to ‘Gas cylinders — Precautionary labels’. In this case, the label can bear the generic name or industrial or commercial name of the substance or mixture provided that the hazardous substances in a mixture are shown on the body of the gas cylinder in a clear and indelible way.

• (b) The information specified in Article 17 provided on a durable information disc or label held captive on the cylinder.

1.3.2.   Gas containers intended for propane, butane or liquefied petroleum gas (LPG)

• 1.3.2.1.If propane, butane and liquefied petroleum gas or a mixture containing these substances classified in accordance with the criteria of this Annex, is placed on the market in closed refillable cylinders or in non-refillable cartridges within the scope of EN 417 as fuel gases which are only released for combustion (current edition of EN 417, relating to ‘Non-refillable metallic gas cartridges for liquefied petroleum gases, with or without a valve, for use with portable appliances; construction, inspection, testing and marking’), these cylinders or cartridges need be labelled only with the appropriate pictogram and the hazard and precautionary statements concerning flammability.

• 1.3.2.2.No information concerning the effects on human health and the environment is required on the label. Instead the supplier shall provide the information concerning effects on human health and the environment to downstream users or distributors by means of the safety data sheet (SDS).

• 1.3.2.3.For consumers, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety.

1.3.3.   Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard

With regard to the application of section 3.10.4, substances or mixtures classified in accordance with the criteria of sections 3.10.2 and 3.10.3 need not be labelled for this hazard when placed on the market in aerosol containers or in containers fitted with a sealed spray attachment.

1.3.4.   Metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers

• 1.3.4.1.Metals in massive form, alloys, mixtures containing polymers and mixtures containing elastomers do not require a label according to this Annex, if they do not present a hazard to human health by inhalation, ingestion or contact with skin or to the aquatic environment in the form in which they are placed on the market, although classified as hazardous in accordance with the criteria of this Annex.

• 1.3.4.2.Instead, the supplier shall provide the information to downstream users or distributors by means of the SDS.

1.3.5.   Explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect

Explosives, as referred to in section 2.1, placed on the market with a view to obtaining an explosive or pyrotechnic effect shall be labelled and packaged in accordance with the requirements for explosives only.

1.3.6.   Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1)

Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) which are in the finished state and packaged for consumer use do not require on the label the hazard pictogram GHS05.

1.3.7.   Ammunition

In the case of ammunition that is a substance or mixture and that is shot through a firearm, the label elements may be provided on the intermediate packaging instead of on the inner packaging, or, if there is no intermediate packaging, on the outer packaging.

1.4.   Request for use of an alternative chemical name

1.4.1.   Requests for use of an alternative chemical name under Article 24 may be granted only where

• (I) the substance has not been assigned a Community workplace exposure limit; and

• (II) the manufacturer, importer or downstream user can demonstrate that the use of the alternative chemical name meets the need to provide enough information for necessary health and safety precautions to be taken in the workplace and the need to ensure that risks from handling the mixture can be controlled; and

• (III) the substance is classified exclusively as one or more of the following hazard categories:
• (a) any of the hazard categories referred to in Part 2 of this Annex;
• (b) Acute toxicity, Category 4;
• (c) Skin corrosion/irritation, Category 2;
• (d) Serious eye damage/eye irritation, Category 2;
• (e) Specific target organ toxicity — Single exposure, Category 2 or 3;
• (f) Specific target organ toxicity — Repeated exposure, Category 2;
• (g) Hazardous to the aquatic environment — Chronic, Category 3 or 4.

1.4.2.   The choice of the chemical name(s) for mixtures intended for the fragrance or perfume industry

In the case of substances occurring in nature, a chemical name or chemical names of the type ‘essential oil of …’ or ‘extract of …’ may be used instead of the chemical names of the components of that essential oil or extract as referred to in Article 18(3)(b).

1.5.   Exemptions from labelling and packaging requirements

1.5.1.   Exemptions from Article 31 in accordance with Article 29(1)

• 1.5.1.1.Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging.

• 1.5.1.2.Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and telephone number of the suppliers of the substance or mixture.

1.5.2.   Exemptions from Article 17 in accordance with Article 29(2)

1.5.2.1.   Labelling of packages where the contents do not exceed 125 ml

• 1.5.2.1.1.The hazard statements and the precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:

• (a) the contents of the package do not exceed 125 ml; and

• (b) the substance or mixture is classified in one or more of the following hazard categories:
• 1) Oxidising gases of category 1;
• 2) Gases under pressure;
• 3) Flammable liquids of category 2 or 3;
• 4) Flammable solids of category 1 or 2;
• 5) Self-reactive substances or mixtures Types C to F;
• 6) Self-heating substances or mixtures of category 2;
• 7) Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3;
• 8) Oxidising liquids of category 2 or 3;
• 9) Oxidising solids of category 2 or 3;
• 10) Organic peroxides Types C to F;
• 11) Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public;
• 12) Skin irritation of category 2;
• 13) Eye irritation of category 2;
• 14) Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public;
• 15) Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public;
• 16) Hazardous to the aquatic environment — Acute of category 1;
• 17) Hazardous to the aquatic environment — Chronic of category 1 or 2. The exemptions for labelling of small packages of aerosols as flammable laid down in Directive 75/324/EEC shall apply to aerosol dispensers.

• 1.5.2.1.2.The precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:

• (a) the contents of the package do not exceed 125 ml; and

• (b) the substance or mixture is classified in one or more of the following hazard categories:
• 1) Flammable gases of category 2;
• 2) Reproductive toxicity: effects on or via lactation;
• 3) Hazardous to the aquatic environment — Chronic of category 3 or 4.

• 1.5.2.1.3. The pictogram, the signal word, the hazard statement, and the precautionary statement linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:

• (a) the contents of the package do not exceed 125 ml; and

• (b) the substance or mixture is classified in one or more of the following hazard categories:
• 1) Corrosive to metals.

1.5.2.2.   Labelling of soluble packaging for single use

The label elements required by Article 17 may be omitted from soluble packaging intended for single use where:

• (a) The content of each soluble packaging does not exceed a volume of 25 ml;

• (b) The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and

• (c) The soluble packaging is contained within outer packaging that fully meets the requirements of Article 17.

• 1.5.2.3.Section 1.5.2.2 shall not apply to substances or mixtures within the scope of Directives 91/414/EEC or 98/8/EC.

1.5.2.4.   Labelling of inner packaging where the contents do not exceed 10 ml

• 1.5.2.4.1.The label elements required by Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml and any of the following applies:

• (a) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis and the inner packaging is contained within outer packaging that meets the requirements set out in Article 17;

• (b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:
• (i) acute toxicity, any category;
• (ii) specific target organ toxicity – single exposure, categories 1 and 2;
• (iii) specific target organ toxicity – repeated exposure, any category;
• (iv) skin corrosion, category 1, any sub-category;
• (v) serious eye damage, category 1;
• (vi) respiratory sensitisation, any category;
• (vii) aspiration hazard;
• (viii) germ cell mutagenicity, any category;
• (ix) carcinogenity, any category;
• (x) reproductive toxicity, any category;
• (xi) endocrine disruption for human health, any category;

• (c) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II but is not classified in any of the hazard classes and categories referred to in point (b) of this section and has an inner packaging that is contained within outer packaging that meets the requirements set out in Article 17.

• 1.5.2.4.2.Notwithstanding sections 1.5.1.2 and 1.5.2.4.1, the label on the inner packaging shall contain the product identifier and, where appropriate, the hazard pictograms “GHS01”, “GHS05”, “GHS06” and/or “GHS08”. Where more than two pictograms are assigned, “GHS06” and “GHS08” may take precedence over “GHS01” and “GHS05”.

• 1.5.2.5. Section 1.5.2.4 shall not apply to substances or mixtures within the scope of Regulation (EC) No 1107/2009 or (EU) No 528/2012.

1.6.   Label elements that may be provided on a digital label only

Supplemental information referred to in Article 25(3).

2. PART 2: PHYSICAL HAZARDS

2.1.   Explosives

2.1.1.   Definitions

• 2.1.1.1.The class of explosives comprises

• (a) explosive substances and mixtures;

• (b) explosive articles, except devices containing explosive substances or mixtures in such quantity or of such a character that their inadvertent or accidental ignition or initiation shall not cause any effect external to the device either by projection, fire, smoke, heat or loud noise; and

• (c) substances, mixtures and articles not mentioned in points (a) and (b) above, which are manufactured with the view to producing a practical explosive or pyrotechnic effect.

• 2.1.1.2.For the purposes of this Regulation the following definitions shall apply:

• An explosive substance or mixture is a solid or liquid substance or mixture of substances which is in itself capable by chemical reaction of producing gas at such a temperature and pressure and at such a speed as to cause damage to the surroundings. Pyrotechnic substances are included even when they do not evolve gases.

• A pyrotechnic substance or mixture is a substance or mixture of substances designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the result of non-detonative self-sustaining exothermic chemical reactions.

• An unstable explosive is an explosive substance or mixture which is thermally unstable and/or too sensitive for normal handling, transport and use.

• An explosive article is an article containing one or more explosive substances or mixtures.

• A pyrotechnic article is an article containing one or more pyrotechnic substances or mixtures.

• An intentional explosive is a substance, mixture or article which is manufactured with a view to producing a practical, explosive or pyrotechnic effect.

2.1.2.   Classification criteria

• 2.1.2.1.Substances, mixtures and articles of this class are classified as an unstable explosive on the basis of the flowchart in Figure 2.1.2.  The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria.

• 2.1.2.2.Substances, mixtures and articles of this class, which are not classified as an unstable explosive, shall be assigned to one of the following six divisions depending on the type of hazard they present:

• (a) Division 1.1 Substances, mixtures and articles which have a mass explosion hazard (a mass explosion is one which affects almost the entire quantity present virtually instantaneously);

• (b) Division 1.2 Substances, mixtures and articles which have a projection hazard but not a mass explosion hazard;

• (c) Division 1.3 Substances, mixtures and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard:
• (i) combustion of which gives rise to considerable radiant heat; or
• (ii) which burn one after another, producing minor blast or projection effects or both;

• (d) Division 1.4 Substances, mixtures and articles which present no significant hazard:
• — substances, mixtures and articles which present only a small hazard in the event of ignition or initiation. The effects are largely confined to the package and no projection of fragments of appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package;

• (e) Division 1.5 Very insensitive substances or mixtures which have a mass explosion hazard:
• — substances and mixtures which have a mass explosion hazard but are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions;

• (f) Division 1.6 Extremely insensitive articles which do not have a mass explosion hazard:
• — articles which predominantly contain extremely insensitive substances or mixtures;
• — and which demonstrate a negligible probability of accidental initiation or propagation.

• 2.1.2.3.Explosives, which are not classified as an unstable explosive, shall be classified in one of the six divisions referred to in paragraph 2.1.2.2 of this Annex based on Test Series 2 to 8 in Part I of the  UN RTDG, Manual of Tests and Criteria according to the results of the tests laid down in Table 2.1.1:

Table 2.1.1

Criteria for explosives

Category	Criteria
Unstable explosives or explosives of Divisions 1.1 to 1.6	For explosives of Divisions 1.1 to 1.6, the following are the core set of tests that need to be performed:
Unstable explosives or explosives of Divisions 1.1 to 1.6	Explosibility: according to UN Test Series 2 (section 12 of the  UN RTDG, Manual of Tests and Criteria). Intentional explosives [^E0017] shall not be subject to UN Test Series 2.
Unstable explosives or explosives of Divisions 1.1 to 1.6	Sensitiveness: according to UN Test Series 3 (section 13 of the  UN RTDG, Manual of Tests and Criteria).
Unstable explosives or explosives of Divisions 1.1 to 1.6	Thermal stability: according to UN Test 3(c) (sub-section 13.6.1 of the  UN RTDG, Manual of Tests and Criteria). Further tests are necessary to allocate the correct Division.

This comprises substances, mixtures and articles which are manufactured with a view to producing a practical, explosive or pyrotechnic effect.

• 2.1.2.4.If explosives are unpackaged or repacked in packaging other than the original or similar packaging, they shall be retested.

2.1.3.   Hazard Communication

Label elements shall be used for substances, mixtures or articles meeting the criteria for classification in this hazard class in accordance with Table 2.1.2.

Table 2.1.2

Label elements for explosives

Classification	Unstable Explosive	Division 1.1	Division 1.2	Division 1.3	Division 1.4	Division 1.5	Division 1.6
GHS Pictograms	Image omitted; see official source	Image omitted; see official source	Image omitted; see official source	Image omitted; see official source	Image omitted; see official source
Signal Word	Danger	Danger	Danger	Danger	Warning	Danger	No signal word
Hazard Statement	H200: Unstable Explosive	H201: Explosive; mass explosion hazard	H202: Explosive; severe projection hazard	H203: Explosive; fire, blast or projection hazard	H204: Fire or projection hazard	H205: May mass explode in fire	No hazard statement
Precautionary Statement Prevention	P201 P250 P280	P210 P230 P234 P240 P250 P280	P210 P230 P234 P240 P250 P280	P210 P230 P234 P240 P250 P280	P210 P234 P240 P250 P280	P210 P230 P234 P240 P250 P280	No precautionary statement
Precautionary Statement Response	P370 + P372 + P380 + P373	P370 + P372 + P380 + P373	P370 + P372 + P380 + P373	P370 + P372 + P380 + P373	P370 + P372 + P380 + P373 P370 + P380 + P375	P370 + P372 + P380 + P373	No precautionary statement
Precautionary Statement Storage	P401	P401	P401	P401	P401	P401	No precautionary statement
Precautionary Statement Disposal	P501	P501	P501	P501	P501	P501	No precautionary statement

NOTE 1: Unpackaged explosives or explosives repackaged in packaging other than the original or similar packaging shall include all of the following label elements:

• (a) the pictogram: exploding bomb;

• (b) the signal word ‘Danger’; and

• (c) the hazard statement: ‘Explosive; mass explosion hazard’

unless the hazard is shown to correspond to one of the hazard categories in Table 2.1.2, in which case the corresponding symbol, the signal word and/or the hazard statement shall be assigned.

NOTE 2: Substances and mixtures, as supplied, with a positive result in Test Series 2 in Part I, Section 12, of the UN RTDG, Manual of Tests and Criteria, which are exempted from classification as explosives (based on a negative result in Test Series 6 in Part I, Section 16 of the UN RTDG, Manual of Tests and Criteria) still have explosive properties. The user shall be informed of these intrinsic explosive properties because they have to be considered for handling — especially if the substance or mixture is removed from its packaging or is repackaged — and for storage. For this reason, the explosive properties of the substance or mixture shall be communicated in Section 2 (Hazards identification) and Section 9 (Physical and chemical properties) of the Safety Data Sheet and other sections of the Safety Data Sheet, as appropriate.

2.1.4.   Additional Classification Considerations

• 2.1.4.1.The classification of substances, mixtures and articles in the explosives hazard class and further allocation to a division is a very complex, three step procedure. Reference to Part I of the  UN RTDG, Manual of Tests and Criteria is necessary.

• The first step is to ascertain whether the substance or mixture has explosive effects (Test Series 1). The second step is the acceptance procedure (Test Series 2 to 4) and the third step is the assignment to a hazard division (Test Series 5 to 7). The assessment whether a candidate for ‘ammonium nitrate emulsion or suspension or gel, intermediate for blasting explosives (ANE)’ is insensitive enough for inclusion as an oxidising liquid (section 2.13) or an oxidising solid (section 2.14) is answered by Test Series 8 tests.

• Some explosive substances and mixtures are wetted with water or alcohols, diluted with other substances or dissolved or suspended in water or other liquid substances to suppress or reduce their explosives properties. They may be a candidate for classification as desensitised explosives (see Section 2.17).

• Certain physical hazards (due to explosive properties) are altered by dilution, as is the case for desensitised explosives, by inclusion in a mixture or article, packaging or other factors.

• The classification procedure is set out in the following decision logic (see Figures 2.1.1 to 2.1.4).

Figure 2.1.1

Overall scheme of the procedure for classifying a substance, mixture or article in the class of explosives (Class 1 for transport)

Image omitted; see official source

Text of image

SUBSTANCE, MIXTURE OR ARTICLE FOR CLASSIFICATION

ACCEPTANCE PROCEDURE

CLASSIFY as an UNSTABLE EXPLOSIVE

REJECT Not an EXPLOSIVE

CLASSIFY AS AN EXPLOSIVE

HAZARDOUS DIVISION ASSIGNMENT

COMPATIBILITY GROUP ASSIGNMENT

DIVISION 1.1, 1.2, 1.3, 1.4, 1.5, OR 1.6 COMPATIBILITY GROUP A, B, C, D, E, F, G, H, J, K, L, N or S (*)

CLASSIFICATION CODE (*)

(*) see UN Recommendations on the Transport of Dangerous Goods, Model Regulations, 15th rev. ed, sub-section 2.1.2.

Figure 2.1.2

Procedure for provisional acceptance of a substance, mixture or article in the class of explosives (Class 1 for transport)

Image omitted; see official source

Text of image

SUBSTANCE/MIXTURE FOR CLASSIFICATION

ARTICLE FOR CLASSIFICATION

Is the substance/ mixture manufactured with a view to producing a practical explosive or pyrotechnic effect

Yes

Substance/mixture to be considered for this Class

No

TEST SERIES 3

Is the substance/ mixture a candidate for ammonium nitrate emulsion suspension or gel, intermediate for blasting explosive ANE?

Is the substance/mixture thermally stable?

Yes

No

No

Yes

TEST SERIES 8 Go to figure 2.1.4

TEST SERIES 1 (*)

Is the substance/mixture too dangerous in the form in which it was tested?

No

Yes

No

Is it an explosive substance/mixture?

Encapsulate and/or package the substance/mixture

Yes

TEST SERIES 2

TEST SERIES 4

Yes

Is the substance/mixture too insensitive for acceptance into this Class?

No

Is the article, packed article or packaged substance/mixture too dangerous?

No

Yes

NOT AN EXPLOSIVE

CLASSIFY as an Unstable Explosive

PROVISIONALLY ACCEPT INTO THIS CLASS (go to figure 2.1.3)

(*) For classification purposes, start with Test Series 2.

Figure 2.1.3

Procedure for assignment to a division in the class of explosives (Class 1 for transport)

Image omitted; see official source

Text of image

DIVISION 1.1

DIVISION 1.2

DIVISION 1.3

DIVISION 1.5

DIVISION 1.6

NOT AN EXPLOSIVE

Is the major hazard that from dangerous projections?

Is the result a mass explosion?

Is the substance/mixture a candidate for Divison 1.5?

Would the hazard hinder firefighting in the immediate vicinity?

Is the major hazard radiant heat and/or violent burning but with no dangerous blast or projection hazard?

Is it an extremely insensitive article?

Is the article a candidate for Division 1.6?

Is it a very insensitive explosive substance/mixture with a mass explosion hazard?

Is the substance/mixture or article manufactured with the view of producing a practical explosive or pyrotechnic effect?

Are there hazardous effects outside the package?

Is the product article excluded by definition? (se 2.1.1.1 (b))

Package the substance/mixture

Does special provision 347 apply? (1)

DIVISION 1.4

Compatibility groups other than S

DIVISION 1.4

Compatibility group S

TEST SERIES 5

TEST SERIES 6

ARTICLE OR SUBSTANCE/MIXTURES PROVISIONALLY ACCEPTED IN THIS CLASS (from figure 2.1.2)

TEST SERIES 7

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No

No

No

No

No

No

No

• (¹) See Chapter 3.3 of the UN RTDG, Model Regulations for details.

Figure 2.1.4

Procedure for the classification of ammonium nitrate emulsion, suspension or gel (ANE)

Image omitted; see official source

Text of image

TEST SERIES 8

TEST 8 (a) Thermal stability test. Is the substance/mixture thermally stable?

No

Classify as unstable explosive

Yes

TEST 8 (b) ANE Large scale gap test Is the substance/mixture too sensitive to shock to be accepted as an oxidising liquid or an oxidising solid?

Yes

Substance/mixture to be considered for classification as an explosive other than as an unstable explosive; If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘no’, the substance/mixture shall be classified in Division 1.1

No

TEST 8 (c) Koenen test Is the substance/mixture too sensitive to the effect of intensive heat under confinement?

Yes

Substance/mixture to be considered for classification as an explosive of Division 1.5, proceed with Test Series 5. If the answer to the question ‘is it a very insensitive explosive substance/mixture with a mass explosion hazard?’ in figure 2.1.3 is ‘yes’, the substance/mixture shall be classified in Division 1.5; if the answer is ‘no’ the substance/mixture shall be classified in Division 1.1

No

ANE substance/mixture shall be classified as a Category 2 oxidising liquid or a Category 2 oxidising solid (sections 2.13 and 2.14)

2.1.4.2.   Screening procedure

Explosive properties are associated with the presence of certain chemical groups in a molecule which can react to produce very rapid increases in temperature or pressure. The screening procedure is aimed at identifying the presence of such reactive groups and the potential for rapid energy release. If the screening procedure identifies the substance or mixture to be a potential explosive, the acceptance procedure (see section 10.3 of the  UN RTDG, Manual of Tests and Criteria) has to be performed.

Note:

Neither a series 1 type (a) propagation of detonation test nor a series 2 type (a) test of sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. For organic substances and mixtures of organic substances with a decomposition energy of 800 J/g or more, tests 1 (a) and 2 (a) need not be performed if the outcome of the ballistic mortar Mk.IIId test (F.1), or the ballistic mortar test (F.2) or the BAM Trauzl test (F.3) with initiation by a standard No 8 detonator (see Appendix 1 to the UN RTDG, Manual of Tests and Criteria) is ‘no’. In this case, the results of test 1 (a) and 2 (a) are deemed to be ‘-’.

• 2.1.4.3.The acceptance procedure for the hazard class ‘explosives’ need not be applied if:

• (a) There are no chemical groups associated with explosive properties present in the molecule. Examples of groups which may indicate explosive properties are given in Table A6.1 in Appendix 6 of the  UN RTDG, Manual of Tests and Criteria; or

• (b) The substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than - 200; The oxygen balance is calculated for the chemical reaction: CxHyOz+ [x+ (y/4)-(z/2)] O2 → x CO2 + (y/2) H2O Using the formula: Oxygen balance = -1 600 [2x + (y/2)-z]/molecular weight;

• (c) For an organic substance, or a homogenous mixture of organic substances, containing a chemical group (or groups) associated with explosive properties:
• — the exothermic decomposition energy is less than 500 J/g, or
• — the onset of exothermic decomposition is 500 °C or above as indicated in Table 2.1.3. Table 2.1.3 Decision to apply the acceptance procedure for the hazard class ‘Explosives’ for an organic substance or a homogenous mixture of organic substances Decomposition energy (J/g) Decomposition onset temperature (°C) Apply acceptance procedure? (Yes/No) < 500 < 500 No < 500 ≥ 500 No ≥ 500 < 500 Yes ≥ 500 ≥ 500 No The exothermic decomposition energy may be determined using a suitable calorimetric technique (see section 20.3.3.3 of the UN RTDG, Manual of Tests and Criteria).

• (d) For mixtures of inorganic oxidising substances with organic material(s), the concentration of the inorganic oxidising substance is:
• — less than 15 % by mass, if the oxidising substance is assigned to Categories 1 or 2;
• — less than 30 % by mass, if the oxidising substance is assigned to Category 3.

• 2.1.4.4.In the case of mixtures containing any known explosives, the acceptance procedure has to be performed.

2.2.   Flammable gases

2.2.1.   Definitions

• 2.2.1.1. Flammable gas means a gas or gas mixture having a flammable range with air at 20 °C and a standard pressure of 101,3 kPa.

• 2.2.1.2. A pyrophoric gas means a flammable gas that is liable to ignite spontaneously in air at a temperature of 54 °C or below.

• 2.2.1.3. A chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen.

2.2.2.   Classification criteria

• 2.2.2.1.A flammable gas is classified in Category 1A, 1B or 2 in accordance with Table 2.2.1. Flammable gases that are pyrophoric and/or chemically unstable are always classified in Category 1A.

Table 2.2.1

Criteria for categorisation of flammable gases

Category	Category	Category	Criteria
1A	Flammable gas	Flammable gas	Gases, which at 20 °C and a standard pressure of 101,3 kPa are: (a) ignitable when in a mixture of 13 % or less by volume in air; or (b) have a flammable range with air of at least 12 percentage points regardless of the lower flammability limit unless data show they meet the criteria for Category 1B
1A	Pyrophoric gas	Pyrophoric gas	Flammable gases that ignite spontaneously in air at a temperature of 54 °C or below
1A	Chemically unstable gas	A	Flammable gases which are chemically unstable at 20 °C and a standard pressure of 101,3 kPa
1A	Chemically unstable gas	B	Flammable gases which are chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa
1B	Flammable gas	Flammable gas	Gases which meet the flammability criteria for Category 1A, but which are not pyrophoric, nor chemically unstable, and which have at least either: (a) a lower flammability limit of more than 6 % by volume in air; or (b) a fundamental burning velocity of less than 10 cm/s;
2	Flammable gas	Flammable gas	Gases, other than those of Category 1A or 1B, which, at 20 °C and a standard pressure of 101,3 kPa, have a flammable range while mixed in air.

• NOTE 1:

Aerosols shall not be classified as flammable gases. See Section 2.3.

• NOTE 2:

In the absence of data allowing classification into Category 1B, a flammable gas that meets the criteria for Category 1A is classified by default in Category 1A.

• NOTE 3:

Spontaneous ignition for pyrophoric gases is not always immediate, and there may be a delay.

• NOTE 4:

In the absence of data on its pyrophoricity, a flammable gas mixture shall be classified as a pyrophoric gas if it contains more than 1 % (by volume) of pyrophoric component(s).

2.2.3.   Hazard Communication

Label elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.2.3.

Table 2.2.2

Label elements for flammable gases

	Category 1A	Gases categorised as 1A meeting pyrophoric or unstable gas A/B criteria	Gases categorised as 1A meeting pyrophoric or unstable gas A/B criteria	Gases categorised as 1A meeting pyrophoric or unstable gas A/B criteria	Category 1B	Category 2
		Pyrophoric gas	Chemically unstable gas	Chemically unstable gas
		Pyrophoric gas	Category A	Category B
GHS Pictogram	Image omitted; see official source	Image omitted; see official source	Image omitted; see official source	Image omitted; see official source	Image omitted; see official source	No pictogram
Signal Word	Danger	Danger	Danger	Danger	Danger	Warning
Hazard Statement	H220: Extremely flammable gas	H220: Extremely flammable gas. H232: May ignite spontaneously if exposed to air	H220: Extremely flammable gas. H230: May react explosively even in the absence of air	H220: Extremely flammable gas. H231: May react explosively even in the absence of air at elevated pressure and/or temperature	H221: Flammable gas	H221: Flammable gas
Precautionary Statement Prevention	P210	P210 P222 P280	P202 P210	P202 P210	P210	P210
Precautionary Statement Response	P377 P381	P377 P381	P377 P381	P377 P381	P377 P381	P377 P381
Precautionary Statement Storage	P403	P403	P403	P403	P403	P403
Precautionary Statement Disposal

If a flammable gas or gas mixture is classified as pyrophoric and/or chemically unstable, then all relevant classification(s) shall be communicated on the safety data sheet as specified in Annex II of Regulation (EC) No 1907/2006, and the relevant hazard communication elements included on the label.

The classification procedure is set out in the following decision logic (see Figure 2.2.1).

Figure 2.2.1

Flammable gases

Image omitted; see official source

Text of image

Category 1A

Chemically unstable gas A

Category 1A

Pyrophoric gas

Category 1A

Pyrophoric gas and chemically unstable gas B

Danger

Danger

Danger

Danger

Category 1A

Pyrophoric gas and chemically unstable gas A

Is it chemically unstable at 20 °C and a standard pressure of 101,3 kPa?

Is it chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa?

Is it chemically unstable at 20 °C and a standard pressure of 101,3 kPa?

Does it ignite spontaneously in air at 54 °C or below? (1)

Not classified as a flammable gas

Does it have a flammable range with air at 20 °C and a standard pressure of 101,3 kPa?

Yes

No

No

No

Yes

Yes

No

No

Yes

Yes

The substance/mixure is a gas

• (¹) In the absence of data on its pyrophoricity, a flammable gas mixture shall be classified as a pyrophoric gas if it contains more than 1 % (by volume) of pyrophoric component(s).

Image omitted; see official source

Text of image

Category 2

No pictogram

Warning

Does it have a lower flammability limit > 6 % by volume in air, and/or does it have a fundamental burning velocity < 10 cm/s?

At 20 °C and a standard pressure of 101,3 kPa, does it:

(a) ignite when a mixture of 13 % or less by volume in air?; or

(b) have a flammable range with air of at least 12 percentage poins regardless of the lower flammability limit?

Is it chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa?

No or unknown

Yes

Yes

Yes

No

No

Category 1B

Category 1A

Danger

Danger

Danger

Category 1A

Chemically unstable gas B

2.2.4.   Additional Classification Considerations

• 2.2.4.1.Flammability shall be determined by tests or, for mixtures where there are sufficient data available, by calculation in accordance with the methods adopted by ISO (see ISO 10156 as amended, ‘Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlets’ and, if using fundamental burning velocity for Category 1B, see ISO 817 as amended ‘Refrigerants-Designation and safety classification, Annex C:- Method of test for burning velocity measurement of flammable gases’). Instead of the test apparatus according to ISO 10156 as amended, the test apparatus for the tube method according to clause 4.2 of EN 1839 as amended (Determination of explosion limits of gases and vapours) may be used.

• 2.2.4.2.Pyrophoricity shall be determined at 54 °C in accordance with either IEC 60079-20-1 ed1.0 (2010-01) ‘Explosive atmospheres – Part 20-1: Material characteristics for gas and vapour classification – Test methods and data’ or DIN 51794 ‘Determining the ignition temperature of petroleum products’.

• 2.2.4.3.The classification procedure for pyrophoric gases need not be applied when experience in production or handling shows that the substance does not ignite spontaneously on coming into contact with air at a temperature of 54 °C or below. Flammable gas mixtures, which have not been tested for pyrophoricity and contain more than one percent pyrophoric components, shall be classified as a pyrophoric gas. Expert judgement on the properties and physical hazards of pyrophoric gases and their mixtures shall be used in assessing the need for classification of flammable gas mixtures containing one percent or less pyrophoric components. In this case, testing need only be considered if expert judgement indicates a need for additional data to support the classification process.

• 2.2.4.4. Chemical instability shall be determined in accordance with the method described in Part III of the UN RTDG, Manual of Tests and Criteria. If the calculations in accordance with ISO 10156 as amended show that a gas mixture is not flammable it is not necessary to carry out the tests for determining chemical instability for classification purposes.

2.3.   Aerosols

2.3.1.   Definitions

Aerosols, this means aerosol dispensers, are any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state.

2.3.2.   Classification criteria

• 2.3.2.1.Aerosols shall be classified in one of the three categories of this hazard class, depending on their flammable properties and their heat of combustion. They shall be considered for classification in Category 1 or 2 if they contain more than 1 % components (by mass) which are classified as flammable according to the following criteria set out in this Part:

• — Flammable gases (see Section 2.2);

• — Liquids with a flash point ≤ 93 °C, which includes Flammable Liquids according to Section 2.6;

• — Flammable solids (see Section 2.7);

• or if their heat of combustion is at least 20 kJ/g.

NOTE 1: Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.

NOTE 2: Aerosols do not fall additionally within the scope of Sections 2.2 (flammable gases), 2.5 (gases under pressure), 2.6 (flammable liquids) and 2.7 (flammable solids). Depending on their contents, aerosols may however fall within the scope of other hazard classes, including their labelling elements.

• 2.3.2.2.An aerosol shall be classified in one of the three categories for this Class on the basis of its components, of its chemical heat of combustion and, if applicable, of the results of the foam test (for foam aerosols) and of the ignition distance test and enclosed space test (for spray aerosols) in accordance with Figures 2.3.1(a) to 2.3.1(c) of this Annex and subsections 31.4, 31.5 and 31.6 of Part III of the UN RTDG, Manual of Tests and Criteria. Aerosols which do not meet the criteria for inclusion in Category 1 or Category 2 shall be classified in Category 3.

Note:

Aerosols containing more than 1 % flammable components or with a heat of combustion of at least 20 kJ/g, which are not submitted to the flammability classification procedures in this section shall be classified as aerosols, Category 1.

Figure 2.3.1 (a)

For aerosols

Image omitted; see official source

Text of image

AEROSOL