EUR-Lex Access to European Union law

Back to EUR-Lex homepage

This document is an excerpt from the EUR-Lex website

Document 32013R0487

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

OJ L 149, 1.6.2013, p. 1–59 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

This document has been published in a special edition(s) (HR)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg/2013/487/oj

1.6.2013   

EN

Official Journal of the European Union

L 149/1


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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to 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 (1), and in particular Article 53 thereof,

Whereas:

(1)

Regulation (EC) No 1272/2008 harmonises the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the Union.

(2)

That Regulation takes into account the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter ‘GHS’) of the United Nations (UN).

(3)

The classification criteria and labelling rules of the GHS are periodically reviewed at UN level. The fourth revised edition of the GHS results from changes adopted in December 2010 by the United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonised System of Classification and Labelling of Chemicals. It contains amendments concerning, inter alia, new hazard categories for chemically unstable gases and non-flammable aerosols and further rationalisation of precautionary statements. It is therefore necessary to adapt the technical provisions and criteria in the Annexes to Regulation (EC) No 1272/2008 to the fourth revised edition of the GHS.

(4)

The GHS allows authorities to adopt labelling derogations for substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes. It also allows the possibility to omit certain label elements from the packaging where the volume of the substance or mixture is below a certain amount. Provisions should be included to implement those measures at the Union level.

(5)

The terminology of different provisions in the Annexes and certain technical criteria should also be amended to facilitate implementation by operators and enforcement authorities, to improve consistency of the legal text and to enhance clarity.

(6)

To ensure that suppliers of substances can adapt to the new classification, labelling and packaging provisions introduced by this Regulation, a transitional period should be provided and the application of this Regulation should be deferred. This should allow for the possibility to apply the provisions laid down in this Regulation on a voluntary basis before the transitional period is over.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2),

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1272/2008 is amended as follows:

(1)

in Article 14(2), point (c) is deleted;

(2)

in Article 23, the following point (f) is added:

‘(f)

substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes.’;

(3)

Annex I is amended in accordance with Annex I to this Regulation;

(4)

Annex II is amended in accordance with Annex II to this Regulation;

(5)

Annex III is amended in accordance with Annex III to this Regulation;

(6)

Annex IV is amended in accordance with Annex IV to this Regulation;

(7)

Annex V is amended in accordance with Annex V to this Regulation;

(8)

Annex VI is amended in accordance with Annex VI to this Regulation;

(9)

Annex VII is amended in accordance with Annex VII to this Regulation.

Article 2

1.   By way of derogation from the second paragraph of Article 3, substances and mixtures may, before 1 December 2014 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by this Regulation.

2.   By way of derogation from the second paragraph of Article 3, substances classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 and placed on the market before 1 December 2014, shall not be required to be relabelled and repackaged in accordance with this Regulation until 1 December 2016.

3.   By way of derogation from the second paragraph of Article 3, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC of the European Parliament and of the Council (3) or Regulation (EC) No 1272/2008 and placed on the market before 1 June 2015, shall not be required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.

Article 3

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

It shall apply in respect of substances from 1 December 2014 and in respect of mixtures from 1 June 2015.

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

Done at Brussels, 8 May 2013.

For the Commission

The President

José Manuel BARROSO


(1)   OJ L 353, 31.12.2008, p. 1.

(2)   OJ L 396, 30.12.2006, p. 1.

(3)   OJ L 200, 30.7.1999, p. 1.


ANNEX I

Annex I to Regulation (EC) No 1272/2008 is amended as follows:

A.

Part 1 is amended as follows:

(1)

The following section 1.3.6 is inserted:

‘1.3.6.    Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes

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.’

(2)

The following sections 1.5.2.4 and 1.5.2.5 are inserted:

‘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:

(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”.

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.’

B.

Part 2 is amended as follows:

(1)

The second sentence in section 2.1.2.1 is replaced by the following:

‘The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria.’;

(2)

In point (f) of section 2.1.2.2, the word ‘detonating’ is deleted;

(3)

In section 2.1.2.3 and in the column entitled ‘Criteria’ of Table 2.1.1 the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(4)

In section 2.1.3, the column entitled ‘Unstable Explosive’ of Table 2.1.2, the precautionary statement ‘P281’ is replaced by ‘P280’;

(5)

In the first paragraph and in the footnote to Figure 2.1.1 of section 2.1.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(6)

In the first paragraph of section 2.1.4.2, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(7)

In point (a) of section 2.1.4.3, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(8)

Sections 2.2 to 2.3.4.1 are replaced by the following:

‘2.2.   Flammable gases (including chemically unstable 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 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 shall be classified in this class in accordance with Table 2.2.1:

Table 2.2.1

Criteria for flammable gases

Category

Criteria

1

Gases, which at 20 °C and a standard pressure of 101,3 kPa:

(a)

are 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 flammable limit.

2

Gases, other than those of Category 1, which, at 20 °C and a standard pressure of 101,3 kPa, have a flammable range while mixed in air.

Note:

Aerosols shall not be classified as flammable gases; see section 2.3.

2.2.2.2.

A flammable gas that is also chemically unstable shall additionally be classified in one of the two categories for chemically unstable gases using the methods described in Part III of the UN RTDG, Manual of Tests and Criteria according to the following table:

Table 2.2.2

Criteria for chemically unstable gases

Category

Criteria

A

Flammable gases which are chemically unstable at 20 °C and a standard pressure of 101,3 kPa

B

Flammable gases which are chemically unstable at a temperature greater than 20 °C and/or a pressure greater than 101,3 kPa

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 2.2.3

Label elements for flammable gases (including chemically unstable gases)

Classification

Flammable gas

Chemically unstable gas

Category 1

Category 2

Category A

Category B

GHS Pictogram

Image 1

No pictogram

No additional pictogram

No additional pictogram

Signal Word

Danger

Warning

No additional signal word

No additional signal word

Hazard Statement

H220: Extremely flammable gas

H221: Flammable gas

H230: May react explosively even in the absence of air

H231: May react explosively even in the absence of air at elevated pressure and/or temperature

Precautionary Statement Prevention

P210

P210

P202

P202

Precautionary Statement Response

P377

P381

P377

P381

 

 

Precautionary Statement Storage

P403

P403

 

 

Precautionary Statement Disposal

 

 

 

 

The classification procedure is set out in the following decision logic (see Figures 2.2.1 to 2.2.2).

Figure 2.2.1

Flammable gases

Image 2

Gaseous substance or mixture of gases

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

NO

Not classified

YES

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

(a) ignite 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 flammable limit?

YES

Category 1

Danger

NO

Category 2

No pictogram

Warning

Figure 2.2.2

Chemically unstable gases

Image 3

Flammable gas or gas mixture

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

YES

Category A

(chemically unstable gas)

No additional pictogram

No additional signal word

NO

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

YES

Category B

(chemically unstable gas)

No additional pictogram

No additional signal word

NO

Not classified as chemically unstable

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 outlet). Where insufficient data are available to use these methods, test method EN 1839 as amended (Determination of explosion limits of gases and vapours) may be used.

2.2.4.2.

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 considered for classification as flammable in accordance with section 2.3.2.2 if they contain any component which is classified as flammable according to the following criteria set out in this Part:

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

Flammable gases (see section 2.2);

Flammable solids (see section 2.7).

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)

Aerosols

Image 4

AEROSOL

Does it contain ≤ 1 % flammable components and does it have a heat of combustion < 20 kJ/g?

YES

Category 3

No pictogram

Warning

NO

Does it contain ≥ 85 % flammable components and does it have a heat of combustion ≥ 30 kJ/g?

YES

Category 1

Danger

NO

For spray aerosols, go to decision logic 2.3.1(b)

For foam aerosols, go to decision logic 2.3.1(c)

Figure 2.3.1 (b)

Spray aerosols

Image 5

SPRAY AEROSOL

In the ignition distance test, does ignition occur at a distance ≥ 75 cm?

YES

Category 1

Danger

NO

Does it have a heat of combustion < 20 kJ/g?

NO

Category 2

Warning

YES

In the ignition distance test, does ignition occur at a distance ≥ 15 cm?

YES

Category 2

Warning

NO

In the enclosed space ignition test; is:

(a) the time equivalent ≤ 300 s/m3; or

(b) the deflagration density ≤ 300 g/m3?

YES

Category 2

Warning

NO

Category 3

No pictogram

Warning

Figure 2.3.1 (c)

Foam aerosols

Image 6

FOAM AEROSOL

In the foam test, is:

(a) the flame height ≥ 20 cm and the flame duration ≥ 2 s; or

(b) the flame height ≥ 4 cm and the flame duration ≥ 7s?

YES

Category 1

Danger

NO

In the foam test, is the flame height ≥ 4 cm and the flame duration ≥ 2 s?

YES

Category 2

Warning

NO

Category 3

No pictogram

Warning

2.3.3.    Hazard Communication

Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.3.1.

Table 2.3.1

Label elements for flammable and non-flammable aerosols

Classification

Category 1

Category 2

Category 3

GHS Pictograms

Image 7

Image 8

No pictogram

Signal Word

Danger

Warning

Warning

Hazard Statement

H222: Extremely flammable aerosol

H229: Pressurised container: May burst if heated

H223: Flammable aerosol

H229: Pressurised container: May burst if heated

H229: Pressurised container: May burst if heated

Precautionary Statement Prevention

P210

P211

P251

P210

P211

P251

P210

P251

Precautionary Statement Response

 

 

 

Precautionary Statement Storage

P410 + P412

P410 + P412

P410 + P412

Precautionary Statement Disposal

 

 

 

2.3.4.    Additional Classification Considerations

2.3.4.1.

The chemical heat of combustion (ΔΗc), in kilojoules per gram (kJ/g), is the product of the theoretical heat of combustion (ΔΗcomb), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95 %).

For a composite aerosol formulation, the chemical heat of combustion is the summation of the weighted heats of combustion for the individual components, as follows:

Formula

where:

ΔΗc

=

chemical heat of combustion (kJ/g);

wi %

=

mass fraction of component i in the product;

ΔΗc(i)

=

specific heat of combustion (kJ/g)of component i in the product.

The chemical heats of combustion can be found in the literature, calculated or determined by tests (see ASTM D 240 as amended — Standard Test Methods for Heat of Combustion of Liquid Hydrocarbon Fuels by Bomb Calorimeter, EN/ISO 13943 as amended, 86.l to 86.3 — Fire safety — Vocabulary, and NFPA 30B as amended — Code for the Manufacture and Storage of Aerosol Products).’;

(9)

In section 2.4.2.1, the Note under Table 2.4.1 is replaced by the following:

Note:

“Gases which cause or contribute to the combustion of other material more than air does” means pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended.’;

(10)

Section 2.4.4 is replaced by the following:

‘2.4.4.    Additional Classification Considerations

To classify an oxidising gas, tests or calculation methods as described in ISO 10156 as amended, “Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet” shall be performed.’;

(11)

In section 2.5.1.1, the first paragraph is replaced by the following:

‘Gases under pressure are gases which are contained in a receptacle at a pressure of 200 kPa (gauge) or more at 20 °C, or which are liquefied or liquefied and refrigerated.’;

(12)

Section 2.5.2 is replaced by the following:

‘2.5.2.    Classification criteria

2.5.2.1.

Gases under pressure shall be classified, according to their physical state when packaged, in one of four groups in accordance with Table 2.5.1:

Table 2.5.1

Criteria for gases under pressure

Group

Criteria

Compressed gas

A gas which when packaged under pressure is entirely gaseous at – 50 °C; including all gases with a critical temperature ≤ – 50 °C.

Liquefied gas

A gas which, when packaged under pressure, is partially liquid at temperatures above – 50 °C. A distinction is made between:

(i)

high pressure liquefied gas: a gas with a critical temperature between – 50 °C and + 65 °C; and

(ii)

low pressure liquefied gas: a gas with a critical temperature above + 65 °C.

Refrigerated liquefied gas

A gas which when packaged is made partially liquid because of its low temperature.

Dissolved gas

A gas which when packaged under pressure is dissolved in a liquid phase solvent.

Note:

Aerosols shall not be classified as gases under pressure. See section 2.3.’;

(13)

In section 2.5.4, the second paragraph is replaced by the following:

‘Data can be found in the literature, calculated or determined by testing. Most pure gases are already classified in the UN RTDG, Model Regulations.’;

(14)

In sections 2.7.2.1 and 2.7.2.3, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(15)

The footnote relating to point (e) of section 2.8.2.1 is replaced by the following:

‘(1)

See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’;

(16)

In section 2.8.2.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(17)

In section 2.8.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(18)

In points (a) and (b) of 2.8.4.2, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(19)

In the introductory sentence of sections 2.9.2.1, 2.10.2.1, 2.11.2.1, 2.11.2.2, 2.12.2.1 and 2.13.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(20)

In section 2.13.4.4, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(21)

In the introductory sentence of section 2.14.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(22)

The footnote relating to point (g) of section 2.15.2.2 is replaced by the following:

‘(1)

See UN RTDG, Manual of Tests and Criteria, subsections 28.1, 28.2, 28.3 and Table 28.3.’;

(23)

Section 2.15.2.3 is amended as follows:

(i)

the footnote relating to point (b) is replaced by the following: ‘(1) As determined by test series E as prescribed in UN RTDG, Manual of Tests and Criteria, Part II.’;

(ii)

in the second paragraph, the words ‘UN Recommendation on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(24)

In section 2.15.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(25)

In the introductory sentence of section 2.16.2.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’;

(26)

In section 2.16.3, the following Note is inserted under Table 2.16.2:

Note:

Where a substance or mixture is classified as corrosive to metals but not corrosive to skin and/or eyes, the labelling provisions set out in section 1.3.6 shall be used.’;

(27)

In the introductory sentence of section 2.16.4.1, the words ‘UN Recommendations on the Transport of Dangerous Goods’ are replaced by ‘UN RTDG’.

C.

Part 3 is amended as follows:

(1)

In section 3.1.2.1, Note (c) under Table 3.1.1 is replaced by the following:

‘(c)

The ranges of the acute toxicity estimates (ATE) for inhalation toxicity used in the Table are based on 4-hour testing exposures. Conversion of existing inhalation toxicity data which have been generated using a 1-hour exposure can be carried out by dividing by a factor of 2 for gases and vapours and 4 for dusts and mists.’;

(2)

Sections 3.1.3.6.2.2 and 3.1.3.6.2.3 are replaced by the following:

‘3.1.3.6.2.2.

In the event that a component without any useable information for classification is used in a mixture at a concentration ≥ 1 %, it is concluded that the mixture cannot be attributed a definitive acute toxicity estimate. In this situation the mixture shall be classified based on the known components only, with the additional statement on the label and in the SDS that “x per cent of the mixture consists of component(s) of unknown acute toxicity”, taking into account the provisions set out in section 3.1.4.2.

3.1.3.6.2.3.

If the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤ 10 % then the formula presented in section 3.1.3.6.1 shall be used. If the total concentration of the relevant ingredient(s) with unknown toxicity is > 10 %, the formula presented in section 3.1.3.6.1 shall be corrected to adjust for the percentage of the unknown ingredient(s) as follows: