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

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)

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,

(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 European Union.

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

(3) The classification criteria and labelling rules of the GHS are periodically reviewed at UN level. The third revised edition of the GHS was adopted in December 2008 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 (UNCETDG/GHS). It contains amendments concerning, inter alia, the provisions for the allocation of hazard statements and for the labelling of small packaging, new sub-categories for respiratory and skin sensitisation, the revision of the classification criteria for long-term hazards (chronic toxicity) to the aquatic environment and a new hazard class for substances and mixtures hazardous to the ozone layer. It is therefore necessary to adapt the technical provisions and criteria in the Annexes to Regulation (EC) No 1272/2008 to the third revised edition of the GHS.

(4) The GHS allows authorities to adopt supplemental labelling provisions to protect individuals already sensitised to a specific chemical that may elicit a response at very low concentration. Requirements should be introduced to add the name of such chemical on the label even if present at very low concentration in a mixture.

(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 foreseen 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 pursuant to 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)Article 25(5) is deleted;

(2)the following new section (e) is inserted in Article 26(1): ‘(e)if the hazard pictogram “GHS02” or “GHS06” applies, the use of the hazard pictogram “GHS04” shall be optional.’;

(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

Transitional provisions

Article 3

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

It shall apply in respect of substances from 1 December 2012 and in respect of mixtures from 1 June 2015.

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

ANNEX I

A.Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows: (1)in section 1.1.2.2.2, the Note under Table 1.1 is replaced by the following: ‘Note: Generic cut-off values are in weight percentages except for gaseous mixtures for those hazard classes where the generic cut-off values may be best described in volume percentages.’; (2)in section 1.1.3.1, the beginning of the first sentence is replaced by ‘If a tested mixture’; (3)sections 1.1.3.2, 1.1.3.3 and 1.1.3.4 are replaced by the following: ‘1.1.3.2.   Batching The hazard category of a tested production batch of a mixture can be assumed to be substantially equivalent to that of another untested production batch of the same commercial product, when produced by or under the control of the same supplier, unless there is reason to believe there is significant variation such that the hazard classification of the untested batch has changed. If the latter occurs, a new evaluation is necessary. 1.1.3.3.   Concentration of highly hazardous mixtures In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, if a tested mixture is classified in the highest hazard category or sub-category, and the concentration of the components of the tested mixture that are in that category or sub-category is increased, the resulting untested mixture shall be classified in that category or sub-category without additional testing. 1.1.3.4.   Interpolation within one toxicity category In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, for three mixtures (A, B and C) with identical components, where mixtures A and B have been tested and are in the same hazard category, and where untested mixture C has the same hazardous components as mixture A and B but has concentrations of those hazardous components intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B.’; (4)in section 1.1.3.5, the last sentence is replaced by the following: ‘If mixture (i) or (ii) is already classified based on test data, then the other mixture shall be assigned the same hazard category.’; (5)sections 1.2, 1.2.1, 1.2.1.1, 1.2.1.2 and 1.2.1.3 are replaced by the following: ‘1.2.   Labelling 1.2.1.   General rules for the application of labels required by Article 31 1.2.1.1. Hazard pictograms shall be in the shape of a square set at a point. 1.2.1.2. Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible. 1.2.1.3. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by Article 17. The minimum area of each hazard pictogram shall not be less than 1 cm². 1.2.1.4. The dimensions of the label and of each pictogram shall be as follows:

Table 1.3 Minimum dimensions of labels and pictograms Capacity of the package Dimensions of the label (in millimetres) for the information required by Article 17 Dimensions of each pictogram (in millimetres) Not exceeding 3 litres: If possible, at least 52 × 74 Not smaller than 10 × 10 If possible, at least 16 × 16 Greater than 3 litres but not exceeding 50 litres: At least 74 × 105 At least 23 × 23 Greater than 50 litres but not exceeding 500 litres: At least 105 × 148 At least 32 × 32 Greater than 500 litres: At least 148 × 210 At least 46 × 46’ (6)the introductory sentence in section 1.5.2.1.3 is replaced by the following: ‘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:’; (7)in section 1.5.2.2, point (b) is replaced by the following: ‘(b)The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and’.

B.Part 2 of Annex I to Regulation (EC) No 1272/2008 is amended as follows: (1)section 2.1.4.1 is amended as follows: (a)the footnote under Figure 2.1.1 is replaced by the following: ‘(*)See UN Recommendations on the Transport of Dangerous Goods, Model Regulations, 16th rev. ed, sub-section 2.1.2.’; (b)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) ’ (c)Figure 2.1.4, is replaced by the following: ‘Figure 2.1.4 Procedure for the classification of ammonium nitrate emulsion, suspension or gel (ANE) ’ (2)in section 2.1.4.2, the Note is replaced by the following: ‘Note: Neither a series 1 type (a) propagation of detonation test nor a series 2 type (a) test of sensitivity to detonative shock is required if the exothermic decomposition energy of organic materials is less than 800 J/g. For organic substances and mixtures of organic substances with a decomposition energy of 800 J/g or more, tests 1 (a) and 2 (a) need not be performed if the outcome of the ballistic mortar Mk.IIId test (F.1), or the ballistic mortar test (F.2) or the BAM Trauzl test (F.3) with initiation by a standard No 8 detonator (see Appendix 1 to the UN RTDG, Manual of Tests and Criteria) is “no”. In this case, the results of test 1 (a) and 2 (a) are deemed to be “-”.’; (3)in section 2.2.2.1, the Note under Table 2.2.1 is replaced by the following: ‘Note: Aerosols shall not be classified as flammable gases; see section 2.3.’; (4)in section 2.3.2.1, the Note is replaced by the following notes: ‘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: Flammable aerosols do not fall additionally within the scope of sections 2.2 (flammable gases), 2.6 (flammable liquids) or 2.7 (flammable solids).’; (5)in section 2.3.2.2, the following Note is inserted at the end of the paragraph: ‘Note: Aerosols not submitted to the flammability classification procedures in this section shall be classified as flammable aerosols, Category 1.’; (6)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” mean pure gases or gas mixtures with an oxidising power greater than 23,5 % as determined by a method specified in ISO 10156 as amended or 10156-2 as amended.’; (7)in section 2.5.3, the following Note is inserted under Table 2.5.2: ‘Note: Pictogram GHS04 is not required for gases under pressure where pictogram GHS02 or pictogram GHS06 appears.’; (8)in section 2.6.2.1 the following Note is inserted under Table 2.6.1: ‘Note: Aerosols shall not be classified as flammable liquids; see section 2.3.’; (9)section 2.6.4.2 is amended as follows: (a)the first paragraph is replaced by the following: ‘In the case of mixtures (⁴) 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, is at least 5 °C (⁵) greater than the relevant classification criterion (23 °C and 60 °C, respectively) and provided that: (b)in point (b), the words ‘of the mixture’ shall be added; (10)in section 2.6.4.4, Table 2.6.3, the complete row ‘British Standard Institute, BS 2000 Part 170 as amended (identical to EN ISO 13736)’ is deleted; (11)section 2.6.4.5 is replaced by the following: ‘2.6.4.5 Liquids with a flash point of more than 35 °C and not more than 60 °C need not be classified in Category 3 if negative results have been obtained in the sustained combustibility test L.2, Part III, section 32 of the UN RTDG, Manual of Tests and Criteria.’; (12)the following new section 2.6.4.6 is inserted: ‘2.6.4.6. Possible test methods for determining the initial boiling point of flammable liquids are listed in Table 2.6.4.

Table 2.6.4 Methods for determining the initial boiling point of flammable liquids European standards: EN ISO 3405 as amended Petroleum products — Determination of distillation characteristics at atmospheric pressure EN ISO 3924 as amended Petroleum products — Determination of boiling range distribution — Gas chromatography method EN ISO 4626 as amended Volatile organic liquids — Determination of boiling range of organic solvents used as raw materials Regulation (EC) No 440/2008 (¹) Method A.2 as described in Part A of the Annex to Regulation (EC) No 440/2008 (¹)OJ L 142, 31.5.2008, p. 1.’ (13)in section 2.7.2.3, the Note under Table 2.7.1 is replaced by the following: ‘Note 1: 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 shall also be tested in the new form. Note 2: Aerosols shall not be classified as flammable solids; see section 2.3.’; (14)in section 2.8.4.2, Figure 2.8.1, points 7.4, 8.4 and 9.4, the word ‘No’ is replaced by ‘None’; (15)section 2.11.1.2 is replaced by the following: ‘2.11.1.2. Self-heating of a substance or a mixture is a process where the gradual reaction of that substance or mixture with oxygen (in the air) generates heat. If the rate of heat production exceeds the rate of heat loss, then the temperature of the substance or mixture will rise which, after an induction time, may lead to self-ignition and combustion.’; (16)in section 2.15.4.2, Figure 2.15.1, points 7.4, 8.4 and 9.4, the word ‘No’ is replaced by ‘None’.

C.Part 3 of Annex I to Regulation (EC) No 1272/2008 is amended as follows: (1)section 3.1.2.1 is replaced by the following: ‘3.1.2.1. Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are shown following Table 3.1.1.