Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilShow full title

1. PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING U.K.

1.0. Definitions U.K.

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 U.K.

1.1.0. Cooperation to meet the requirements in this Regulation U.K.

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 U.K.

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. U.K.

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. U.K.

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, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. Information on substances or mixtures related to the substance or mixture being classified shall be considered as appropriate, as well as site of action and mechanism or mode of action study results. Both positive and negative results shall be assembled together in a single weight of evidence determination. U.K.

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. U.K.

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. U.K.

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

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

1.1.2.2. Cut-off values U.K.

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). U.K.

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

(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

a Or < 1 % where relevant, see 3.2.3.3.1.
b Or < 1 % where relevant, see 3.3.3.3.1.
c Or < 0,1 % where relevant, see 4.1.3.1.
Hazard class	Generic cut-off values to be taken into account
Acute Toxicity:
Category 1-3	0,1 %
Category 4	1 %
Skin corrosion/Irritation	1 %a
Serious damage to eyes/eye irritation	1 %b
Hazardous to Aquatic Environment
Acute Category 1	0,1 %c
Chronic Category 1	0,1 %c
Chronic Category 2-4	1 %

[F1 Note: U.K.

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.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

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

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 U.K.

[F1 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).

[F1 1.1.3.2. Batching U.K.

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 U.K.

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 toxicity category U.K.

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 U.K.

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.

[F1 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 U.K.

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 U.K.

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 non-aerosolised form of the mixture, provided that the added propellant does not affect the hazardous properties of the mixture upon spraying and scientific evidence is available demonstrating that the aerosolised form is not more hazardous than the nonaerosolised form.

[F1 1.2. Labelling U.K.

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

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

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. U.K.

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 cm ² . U.K.

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

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]

1.3. Derogations from labelling requirements for special cases U.K.

In accordance with Article 23 the following derogations shall apply:

1.3.1. Transportable gas cylinders U.K.

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) U.K.

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 shall only be labelled with the appropriate pictogram and the hazard and precautionary statements concerning flammability. U.K.

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). U.K.

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

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

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 U.K.

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. U.K.

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

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

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.

[F2 1.3.6. Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes U.K.

Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes which are in the finished state as packaged for consumer use do not require on the label the hazard pictogram GHS05.]

Textual Amendments

F2 Inserted by Commission Regulation (EU) No 487/2013 of 8 May 2013 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (Text with EEA relevance).

1.4. Request for use of an alternative chemical name U.K.

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

(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 U.K.

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 U.K.

1.5.1. Exemptions from Article 31 [(Article 29(1))] U.K.

1.5.1.1. Where Article 29(1) applies, the label elements mentioned in Article 17 may be provided in one of the following ways: U.K.

(a)

in fold-out labels; or

(b)

on tie-on tags; or

(c)

on an outer packaging.

1.5.1.2. The label on any inner packaging shall contain at least hazard pictograms, the product identifier referred to in Article 18 and name and telephone number of the supplier of the substance or mixture. U.K.

1.5.2. Exemptions from Article 17 [(Article 29(2)] U.K.

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

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: U.K.

(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: U.K.

(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. [F1 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:] U.K.

(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 U.K.

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)

[F1 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. U.K.

[F2 1.5.2.4. Labelling of inner packaging where the contents do not exceed 10 ml U.K.

1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where: U.K.

(a)

the contents of the inner packaging do not exceed 10 ml;

(b)

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

(c)

the inner packaging is contained within outer packaging that meets the requirements of 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 ” . U.K.

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.] U.K.