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).
Image 8

Category 2

No pictogram

Warning

Does it have a lower flammability limit &gt; 6 % by volume in air, and/or does it have a fundamental burning velocity &lt; 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

(l)

In section 2.2.3, Figure 2.2.2 is deleted.

(m)

Section 2.2.4 is amended as follows:

Section 2.2.4.1 is replaced by the following:

‘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.’

The following sections 2.2.4.2 and 2.2.4.3 are inserted:

‘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.’

(n)

Section 2.2.4.2 is renumbered as follows:

‘2.2.4.4.’

(o)

The text before paragraphs (a) to (d) in section 2.6.4.2 is replaced by the following:

‘2.6.4.2.

In the case of mixtures (5) containing known flammable liquids in defined concentrations, although they may contain non-volatile components e.g. polymers, additives, the flash point need not be determined experimentally if the calculated flash point of the mixture, using the method given in 2.6.4.3 below, is at least 5 °C (6) greater than the relevant classification criterion and provided that:

(5)   Up to now, the calculation method is validated for mixtures containing up to six volatile components. These components may be flammable liquids like hydrocarbons, ethers, alcohols, esters (except acrylates), and water. It is however not yet validated for mixtures containing halogenated, sulphurous, and/or phosphoric compounds as well as reactive acrylates. "

(6)   If the calculated flash point is less than 5 °C greater than the relevant classification criterion, the calculation method may not be used and the flash point shall be determined experimentally. ’ "

(p)

Section 2.7.2.2 is replaced by the following:

‘2.7.2.2.

Powders of metals or metal alloys shall be classified as flammable solids when they can be ignited and the reaction spreads over the whole length of the sample (100 mm) in 10 min or less.’

(q)

In section 2.12.2.1, Table 2.12.1 is replaced by the following:

Table 2.12.1

Criteria for substances and mixtures, which in contact with water, emit flammable gases

Category

Criteria

1

Any substance or mixture which reacts vigorously with water at ambient temperatures and demonstrates generally a tendency for the gas produced to ignite spontaneously, or which reacts readily with water at ambient temperatures such that the rate of evolution of flammable gas is equal to or greater than 10 litres per kilogram of substance over any one minute.

2

Any substance or mixture which reacts readily with water at ambient temperatures such that the maximum rate of evolution of flammable gas is equal to or greater than 20 litres per kilogram of substance per hour, and which does not meet the criteria for Category 1.

3

Any substance or mixture which reacts slowly with water at ambient temperatures such that the maximum rate of evolution of flammable gas is greater than 1 litre per kilogram of substance per hour, and which does not meet the criteria for Categories 1 and 2.

Note:

The test shall be performed on the substance or mixture in its physical form as presented. If, for example, for the purposes of supply or transport, the same chemical is to be presented in a physical form different from that which was tested and which is considered likely to materially alter its performance in a classification test, the substance must also be tested in the new form.’

(r)

The following section 2.17 is added:

‘2.17.   Desensitised explosives

2.17.1.   Definitions and general considerations

2.17.1.1.   Desensitised explosives are solid or liquid explosive substances or mixtures which are phlegmatised to suppress their explosive properties in such a manner that they do not mass explode and do not burn too rapidly and therefore may be exempted from the hazard class “Explosives” (see also paragraph 3 in section 2.1.4.1) (7)

2.17.1.2.   The hazard class of desensitised explosives comprises:

(a)

Solid desensitised explosives: explosive substances or mixtures, which are wetted with water or alcohols or are diluted with other substances, to form a homogeneous solid mixture to suppress their explosive properties.

NOTE: This includes desensitisation achieved by formation of hydrates of the substances.

(b)

Liquid desensitised explosives: explosive substances or mixtures, which are dissolved or suspended in water or other liquid substances, to form a homogeneous liquid mixture to suppress their explosive properties.

2.17.2.   Classification criteria

2.17.2.1.   Any explosive while in a desensitised state shall be considered in this class unless, in that state:

(a)

It is intended to produce a practical explosive or pyrotechnic effect;

(b)

It has a mass explosion hazard according to test series 6 (a) or 6 (b) or the corrected burning rate according to the burning rate test described in part V, subsection 51.4 of the UN RTDG, Manual of Tests and Criteria is greater than 1 200 kg/min; or

(c)

The exothermic decomposition energy is less than 300 J/g.

NOTE 1: Substances or mixtures, which meet the criterion (a) or (b) in their desensitised state shall be classified as explosives (see Section 2.1). Substances or mixtures which meet the criterion (c) may fall within the scope of other physical hazard classes.

NOTE 2: The exothermic decomposition energy may be estimated using a suitable calorimetric technique (see section 20, sub-section 20.3.3.3 in Part II of the UN RTDG, Manual of Tests and Criteria).

2.17.2.2.   Desensitised explosives shall be classified and packaged for supply and use in one of the four categories of this class depending on the corrected burning rate (Ac) using the test “burning rate test (external fire)” described in Part V, sub-section 51.4 of the UN RTDG, Manual of Tests and Criteria, according to Table 2.17.1:

Table 2.17.1.

Criteria for desensitised explosives

Category

Criteria

1

Desensitised explosives with a corrected burning rate (AC) equal to or greater than 300 kg/min but not more than 1 200 kg/min

2

Desensitised explosives with a corrected burning rate (AC) equal to or greater than 140 kg/min but less than 300 kg/min

3

Desensitised explosives with a corrected burning rate (AC) equal to or greater than 60 kg/min but less than 140 kg/min

4

Desensitised explosives with a corrected burning rate (AC) less than 60 kg/min

Note 1: Desensitised explosives shall be prepared so that they remain homogeneous and do not separate during normal storage and handling, particularly if desensitised by wetting. The manufacturer/supplier shall give information in the safety data sheet about the shelf-life and instructions on verifying desensitisation. Under certain conditions the content of desensitising agent (e.g. phlegmatiser, wetting agent or treatment) may decrease during supply and use, and thus, the hazard potential of the desensitised explosive may increase. In addition, the safety data sheet shall include advice on avoiding increased fire, blast or projection hazards when the substance or mixture is not sufficiently desensitised.

Note 2: Explosive properties of desensitised explosives shall be determined by test series 2 of the UN RTDG, Manual of Tests and Criteria, and shall be communicated in the safety data sheet.

Note 3: For the purposes of storage, supply and use, desensitised explosives do not fall additionally within the scope of Sections 2.1 (explosives), 2.6 (flammable liquids) and 2.7 (flammable solids).

2.17.3.   Hazard communication

Label elements shall be used for liquid or solid substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.17.2.

Table 2.17.2.

Label elements for desensitised explosives

 

Category 1

Category 2

Category 3

Category 4

GHS Pictogram

Image 9

Image 10

Image 11

Image 12

Signal word

Danger

Danger

Warning

Warning

Hazard statement

H206 Fire, blast or projection hazard; increased risk of explosion if desensitising agent is reduced

H207 Fire or projection hazard; increased risk of explosion if desensitising agent is reduced

H207 Fire or projection hazard; increased risk of explosion if desensitising agent is reduced

H208: Fire hazard; increased risk of explosion if desensitising agent is reduced

Precautionary statement Prevention

P210

P212

P230

P233

P280

P210

P212

P230

P233

P280

P210

P212

P230

P233

P280

P210

P212

P230

P233

P280

Precautionary Statement Response

P370 +

P380+

P375

P370 +

P380+

P375

P370 +

P380+

P375

P371 +

P380 +

P375

Precautionary Statement Storage

P401

P401

P401

P401

Precautionary Statement Disposal

P501

P501

P501

P501

2.17.4.   Additional classification considerations

Figure 2.17.1.

Desensitised explosives