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Document 32019R0521

Commission Regulation (EU) 2019/521 of 27 March 2019 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.)

C/2019/2263

OJ L 86, 28.3.2019, p. 1–36 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg/2019/521/oj

28.3.2019   

EN

Official Journal of the European Union

L 86/1


COMMISSION REGULATION (EU) 2019/521

of 27 March 2019

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(1) thereof,

Whereas:

(1)

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

(2)

Regulation (EC) No 1272/2008 takes into account the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) of the United Nations (UN).

(3)

The classification criteria and labelling rules of the GHS are periodically reviewed at the UN level. The sixth and seventh revised editions of the GHS result from changes adopted in 2014 and 2016 respectively 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.

(4)

The sixth and seventh revised editions of the GHS trigger the need to amend some technical provisions and criteria on classification, labelling and packaging in Regulation (EC) No 1272/2008. In particular, these further developments of the GHS introduce a new hazard class for desensitised explosives and a new hazard category, pyrophoric gases, within the hazard class flammable gases. Other changes include adaptations to: the criteria for substances and mixtures which in contact with water emit flammable gases, the generic cut-off values; the general provisions to classify aerosol forms of mixtures; and the detail of the definitions and classification criteria as appropriate for the hazard classes explosives, flammable gases, flammable liquids, flammable solids, acute toxicity, skin corrosion/irritation, serious eye damage/eye irritation, respiratory and skin sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity and aspiration hazard. In addition, amendments are introduced to some hazard and precautionary statements. It is therefore necessary to adapt some technical provisions and criteria in Annexes I, II, III, IV, V and VI to Regulation (EC) No 1272/2008 to take account of the sixth and seventh revised editions of the GHS.

(5)

Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(6)

To ensure that suppliers of substances and mixtures have time to adapt to the new classification, labelling and packaging provisions, the application of this Regulation should be deferred.

(7)

In line with the transitional provisions of Regulation (EC) No 1272/2008 which allow the application of the new provisions at an earlier stage on a voluntary basis, suppliers should have the possibility of applying the new classification, labelling and packaging provisions on a voluntary basis before the date of application of this Regulation.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by 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)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

Article 2

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 from 17 October 2020.

By way of derogation from the second paragraph, substances and mixtures may, before 17 October 2020, be classified, labelled and packaged in accordance with this Regulation.

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

Done at Brussels, 27 March 2019.

For the Commission

The President

Jean-Claude JUNCKER


(1)   OJ L 353, 31.12.2008, p. 1.

(2)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).


ANNEX I

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

1.

Part 1 is amended as follows:

(a)

In section 1.1.2.2.2, Table 1.1 is replaced by the following:

Table 1.1

Generic cut-off values

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 % (1)

Serious damage to eyes/eye irritation

1 % (2)

Specific target organ toxicity, single exposure, Category 3

1 % (3)

Aspiration toxicity

1 %

Hazardous to Aquatic Environment

Acute Category 1

0,1 % (4)

Chronic Category 1

0,1 % (4)

Chronic Category 2-4

1 %’

(b)

Section 1.1.3.7 is replaced by the following:

‘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.’

(c)

Section 1.3.2.1 is replaced by the following:

‘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.’

2.

Part 2 is amended as follows:

(a)

In section 2.1.1.1, point (c) is replaced by the following:

‘(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.’

(b)

In section 2.1.2.2, point (f) is replaced by the following:

‘(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.’

(c)

In section 2.1.4.1, the third paragraph is replaced by the following:

‘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).’

(d)

In section 2.1.4.1, figure 2.1.3 is replaced by the following:

Figure 2.1.3

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

Image 1

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.’

(e)

Section 2.1.4.3 is amended as follows:

(i)

the introductory wording is replaced by the following:

‘2.1.4.3.

The acceptance procedure for the hazard class “explosives” need not be applied if:’

(ii)

point (c) is replaced by the following:

‘(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.’

(iii)

Table 2.1.3 is added to 2.1.4.3 (c):

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).’

(f)

In section 2.2 the title is replaced by the following:

‘2.2.   Flammable gases’

(g)

Section 2.2.1 is replaced by the following:

‘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.’

(h)

Sections 2.2.2.1 and 2.2.2.2 are replaced by the following:

‘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

Criteria

1A

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

Pyrophoric gas

Flammable gases that ignite spontaneously in air at a temperature of 54 °C or below

Chemically unstable gas

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

1B

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

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).’

(i)

In section 2.2.3, Table 2.2.3 is replaced by the following:

Table 2.2.2

Label elements for flammable gases

 

Category 1A

Gases categorised as 1A meeting pyrophoric or unstable gas A/B criteria

Category 1B

Category 2

 

Pyrophoric gas

Chemically unstable gas

 

 

Category A

Category B

GHS Pictogram

Image 2

Image 3

Image 4

Image 5

Image 6

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

 

 

 

 

 

 

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

(j)

In section 2.2.3, the following paragraph is added after Table 2.2.2:

‘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.’

(k)

In section 2.2.3, Figure 2.2.1 is replaced with the following:

Figure 2.2.1

Flammable gases

Image 7

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).