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Document 02008R1272-20200101
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 (Text with EEA relevance)Text with EEA relevance
Consolidated text: 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 (Text with EEA relevance)Text with EEA relevance
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 (Text with EEA relevance)Text with EEA relevance
02008R1272 — EN — 01.01.2020 — 014.002
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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 (OJ L 353 31.12.2008, p. 1) |
Amended by:
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L 235 |
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5.9.2009 |
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L 83 |
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30.3.2011 |
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L 179 |
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11.7.2012 |
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L 149 |
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1.6.2013 |
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L 158 |
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10.6.2013 |
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L 216 |
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10.8.2013 |
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L 261 |
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3.10.2013 |
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L 167 |
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6.6.2014 |
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Amended by: COMMISSION REGULATION (EU) 2015/491 of 23 March 2015 |
L 78 |
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24.3.2015 |
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L 350 |
1 |
6.12.2014 |
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L 197 |
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25.7.2015 |
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L 156 |
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14.6.2016 |
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L 195 |
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20.7.2016 |
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L 78 |
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23.3.2017 |
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L 116 |
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5.5.2017 |
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L 115 |
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4.5.2018 |
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C 239 |
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9.7.2018 |
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L 251 |
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5.10.2018 |
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REGULATION (EU) 2019/1243 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 |
L 198 |
241 |
25.7.2019 |
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COMMISSION DELEGATED REGULATION (EU) 2020/11 of 29 October 2019 |
L 6 |
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10.1.2020 |
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COMMISSION DELEGATED REGULATION (EU) 2020/217 of 4 October 2019 |
L 44 |
1 |
18.2.2020 |
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Corrected by:
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
(Text with EEA relevance)
TITLE I
GENERAL ISSUES
Article 1
Purpose and scope
1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by:
harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;
providing an obligation for:
manufacturers, importers and downstream users to classify substances and mixtures placed on the market;
suppliers to label and package substances and mixtures placed on the market;
manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006;
providing an obligation for manufacturers and importers of substances to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006;
establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;
establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d).
2. This Regulation shall not apply to the following:
radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation ( 1 );
substances and mixtures which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;
non-isolated intermediates;
substances and mixtures for scientific research and development, which are not placed on the market, provided they are used under controlled conditions in accordance with Community workplace and environmental legislation.
3. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste ( 2 ) is not a substance, mixture or article within the meaning of Article 2 of this Regulation.
4. Member States may allow for exemptions from this Regulation in specific cases for certain substances or mixtures, where necessary in the interests of defence.
5. This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user:
medicinal products as defined in Directive 2001/83/EC;
veterinary medicinal products as defined in Directive 2001/82/EC;
cosmetic products as defined in Directive 76/768/EEC;
medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;
food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used:
as a food additive in foodstuffs within the scope of Directive 89/107/EEC;
as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;
as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003;
in animal nutrition within the scope of Directive 82/471/EEC.
6. Save where Article 33 applies this Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways.
Article 2
Definitions
For the purpose of this Regulation, the following definitions shall apply:
‘hazard class’ means the nature of the physical, health or environmental hazard;
‘hazard category’ means the division of criteria within each hazard class, specifying hazard severity;
‘hazard pictogram’ means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned;
‘signal word’ means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:
‘Danger’ means a signal word indicating the more severe hazard categories;
‘Warning’ means a signal word indicating the less severe hazard categories;
‘hazard statement’ means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard;
‘precautionary statement’ means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal;
‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;
‘mixture’ means a mixture or solution composed of two or more substances;
‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;
‘producer of an article’ means any natural or legal person who makes or assembles an article within the Community;
‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:
a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
less than a simple weight majority of molecules of the same molecular weight.
In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;
‘monomer’ means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;
‘registrant’ means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006;
‘manufacturing’ means production or extraction of substances in the natural state;
‘manufacturer’ means any natural or legal person established within the Community who manufactures a substance within the Community;
‘import’ means the physical introduction into the customs territory of the Community;
‘importer’ means any natural or legal person established within the Community who is responsible for import;
‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;
‘downstream user’ means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user;
‘distributor’ means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;
‘intermediate’ means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as ‘synthesis’);
‘non-isolated intermediate’ means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;
‘the Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;
‘competent authority’ means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;
‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;
‘supplier’ means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;
‘alloy’ means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation;
‘UN RTDG’ means the United Nations Recommendations on the Transport of Dangerous Goods;
‘notifier’ means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency;
‘scientific research and development’ means any scientific experimentation, analysis or chemical research carried out under controlled conditions;
‘cut-off value’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified;
‘concentration limit’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively;
‘differentiation’ means distinction within hazard classes depending on the route of exposure or the nature of the effects;
‘M-factor’ means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present;
‘package’ means the complete product of the packing operation, consisting of the packaging and its contents;
‘packaging’ means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions;
‘intermediate packaging’ means packaging placed between inner packaging, or articles, and outer packaging.
Article 3
Hazardous substances and mixtures and specification of hazard classes
A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.
Where, in Annex I, hazard classes are differentiated on the basis of the route of exposure or the nature of the effects, the substance or mixture shall be classified in accordance with such differentiation.
Article 4
General obligations to classify, label and package
1. Manufacturers, importers and downstream users shall classify substances or mixtures in accordance with Title II before placing them on the market.
2. Without prejudice to the requirements of paragraph 1, manufacturers, producers of articles and importers shall classify those substances not placed on the market in accordance with Title II where:
Articles 6, 7(1) or (5), 17 or 18 of Regulation (EC) No 1907/2006 provide for registration of a substance;
Articles 7(2) or 9 of Regulation (EC) No 1907/2006 provide for notification.
3. If a substance is subject to harmonised classification and labelling in accordance with Title V through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be performed for the hazard classes or differentiations covered by that entry.
However, where the substance also falls within one or more hazard classes or differentiations not covered by an entry in Part 3 of Annex VI, classification under Title II shall be carried out for those hazard classes or differentiations.
4. Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is labelled and packaged in accordance with Titles III and IV, before placing it on the market.
5. In fulfilling their responsibilities under paragraph 4, distributors may use the classification for a substance or mixture derived in accordance with Title II by an actor in the supply chain.
6. In fulfilling their responsibilities under paragraphs 1 and 4, downstream users may use the classification of a substance or mixture derived in accordance with Title II by an actor in the supply chain, provided that they do not change the composition of the substance or mixture.
7. A mixture referred to in Part 2 of Annex II that contains any substance classified as hazardous shall not be placed on the market, unless it is labelled in accordance with Title III.
8. For the purposes of this Regulation, the articles referred to in section 2.1 of Annex I shall be classified, labelled and packaged in accordance with the rules for substances and mixtures before being placed on the market.
9. Suppliers in a supply chain shall cooperate to meet the requirements for classification, labelling and packaging in this Regulation.
10. Substances and mixtures shall not be placed on the market unless they comply with this Regulation.
TITLE II
HAZARD CLASSIFICATION
CHAPTER 1
Identification and examination of information
Article 5
Identification and examination of available information on substances
1. Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:
data generated in accordance with any of the methods referred to in Article 8(3);
epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases;
any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006;
any new scientific information;
any other information generated under internationally recognised chemical programmes.
The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used.
2. Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title.
Article 6
Identification and examination of available information on mixtures
1. Manufacturers, importers and downstream users of a mixture shall identify the relevant available information on the mixture itself or the substances contained in it for the purposes of determining whether the mixture entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:
data generated in accordance with any of the methods referred to in Article 8(3) on the mixture itself or the substances contained in it;
epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it, such as occupational data or data from accident databases;
any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it;
any other information generated under internationally recognised chemical programmes for the mixture itself or the substances contained in it.
The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used.
2. Subject to paragraphs 3 and 4, where the information referred to in paragraph 1 is available for the mixture itself, and the manufacturer, importer or downstream user has ascertained that information to be adequate and reliable and where applicable, scientifically valid, that manufacturer, importer or downstream user shall use that information for the purposes of the evaluation pursuant to Chapter 2 of this Title.
3. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’ and ‘reproductive toxicity’ hazard classes referred to in sections 3.5.3.1, 3.6.3.1 and 3.7.3.1 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.
Further, in cases where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction effects which have not been identified from the information on the individual substances, those data shall also be taken into account.
4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ‘biodegradation and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ hazard class referred to in sections 4.1.2.8 and 4.1.2.9 of Annex I, the manufacturer, importer or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.
5. Where no or inadequate test data on the mixture itself of the kind referred to in paragraph 1 are available, the manufacturer, importer or downstream user shall use other available information on individual substances and similar tested mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that that manufacturer, importer or downstream user has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).
Article 7
Animal and human testing
1. Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible.
2. Tests on non-human primates shall be prohibited for the purposes of this Regulation.
3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation.
Article 8
Generating new information for substances and mixtures
1. For the purposes of determining whether a substance or a mixture entails a health or environmental hazard as set out in Annex I to this Regulation, the manufacturer, importer or downstream user may, provided that he has exhausted all other means of generating information including by applying the rules provided for in section 1 of Annex XI to Regulation (EC) No 1907/2006, perform new tests.
2. For the purposes of determining whether a substance or a mixture entails any of the physical hazards referred to in Part 2 of Annex I, the manufacturer, importer or downstream user shall perform the tests required in that Part, unless there is adequate and reliable information already available.
3. The tests referred to in paragraph 1 shall be conducted in accordance with one of the following methods:
the test methods referred to in Article 13(3) of Regulation (EC) No 1907/2006;
or
sound scientific principles that are internationally recognised or methods validated according to international procedures.
4. Where the manufacturer, importer or downstream user carries out new ecotoxicological or toxicological tests and analyses, these shall be carried out in compliance with Article 13(4) of Regulation (EC) No 1907/2006.
5. Where new tests for physical hazards are carried out for the purposes of this Regulation, they shall be carried out, at the latest from 1 January 2014, in compliance with a relevant recognised quality system or by laboratories complying with a relevant recognised standard.
6. Tests that are carried out for the purposes of this Regulation shall be carried out on the substance or on the mixture in the form(s) or physical state(s) in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
CHAPTER 2
Evaluation of hazard information and decision on classification
Article 9
Evaluation of hazard information for substances and mixtures
1. Manufacturers, importers and downstream users of a substance or a mixture shall evaluate the information identified in accordance with Chapter 1 of this Title by applying to it the criteria for classification for each hazard class or differentiation in Parts 2 to 5 of Annex I, so as to ascertain the hazards associated with the substance or mixture.
2. In evaluating available test data for a substance or a mixture which have been obtained from test methods other than those referred to in Article 8(3), manufacturers, importers and downstream users shall compare the test methods employed with those indicated in that Article in order to determine whether the use of those test methods affects the evaluation referred to in paragraph 1 of this Article.
3. Where the criteria cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.
4. Where only the information referred to in Article 6(5) is available, manufacturers, importers and downstream users shall apply the bridging principles referred to in section 1.1.3 and in each section of Parts 3 and 4 of Annex I for the purposes of the evaluation.
However, where that information permits the application neither of the bridging principles nor the principles for using expert judgement and weight of evidence determination as described in Part 1 of Annex I, manufacturers, importers and downstream users shall evaluate the information by applying the other method or methods described in each section of Parts 3 and 4 of Annex I.
5. When evaluating the available information for the purposes of classification, the manufacturers, importers and downstream users shall consider the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
Article 10
Concentration limits and M-factors for classification of substances and mixtures
1. Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.
Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when the substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.
In exceptional circumstances specific concentration limits may be set by the manufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information that a hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.
2. M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, shall be established by manufacturers, importers and downstream users.
3. Notwithstanding paragraph 1, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.
4. Notwithstanding paragraph 2, M-factors shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.
However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this M-factor shall be used.
5. In setting the specific concentration limit or M-factor manufacturers, importers and downstream users shall take into account any specific concentration limits or M-factors for that substance which have been included in the classification and labelling inventory.
6. Specific concentration limits set in accordance with paragraph 1 shall take precedence over the concentrations in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification in the relevant sections of Parts 3, 4 and 5 of Annex I.
7. The Agency shall provide further guidance for the application of paragraphs 1 and 2.
Article 11
Cut-off values
1. Where a substance contains another substance, itself classified as hazardous, whether in the form of an identified impurity, additive or individual constituent, this shall be taken into account for the purposes of classification, if the concentration of the identified impurity, additive or individual constituent is equal to, or greater than, the applicable cut-off value in accordance with paragraph 3.
2. Where a mixture contains a substance classified as hazardous, whether as a component or in the form of an identified impurity or additive, this information shall be taken into account for the purposes of classification, if the concentration of that substance is equal to or greater than its cut-off value in accordance with paragraph 3.
3. The cut-off value referred to in paragraphs 1 and 2 shall be determined as set out in section 1.1.2.2 of Annex I.
Article 12
Specific cases requiring further evaluation
Where, as a result of the evaluation carried out pursuant to Article 9, the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:
adequate and reliable information demonstrates that in practice the physical hazards of a substance or a mixture differ from those shown by tests;
conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;
adequate and reliable scientific information demonstrates the potential occurrence of synergistic or antagonistic effects among the substances in a mixture for which the evaluation was decided on the basis of the information for the substances in the mixture.
Article 13
Decision to classify substances and mixtures
If the evaluation undertaken pursuant to Article 9 and Article 12 shows that the hazards associated with the substance or mixture meet the criteria for classification in one or more hazard classes or differentiations in Parts 2 to 5 of Annex I, manufacturers, importers and downstream users shall classify the substance or mixture in relation to the relevant hazard class or classes or differentiations by assigning the following:
one or more hazard categories for each relevant hazard class or differentiation;
subject to Article 21, one or more hazard statements corresponding to each hazard category assigned in accordance with (a).
Article 14
Specific rules for the classification of mixtures
1. The classification of a mixture shall not be affected where the evaluation of the information indicates any of the following:
that the substances in the mixture react slowly with atmospheric gases, in particular oxygen, carbon dioxide, water vapour, to form different substances at low concentration;
that the substances in the mixture react very slowly with other substances in the mixture to form different substances at low concentration;
that the substances in the mixture may self-polymerise to form oligomers or polymers, at low concentration.
2. A mixture need not be classified for explosive, oxidising, or flammable properties as referred to in Part 2 of Annex I provided that any of the following requirements are met:
none of the substances in the mixture possesses any of those properties and, on the basis of the information available to the supplier, the mixture is unlikely to present hazards of this kind;
in the event of a change in the composition of a mixture, scientific evidence indicates that an evaluation of the information on the mixture will not lead to a change in classification.
▼M4 —————
Article 15
Review of classification for substances and mixtures
1. Manufacturers, importers and downstream users shall take all reasonable steps available to them to make themselves aware of new scientific or technical information that may affect the classification of the substances or mixtures they place on the market. When a manufacturer, importer or downstream user becomes aware of such information which he considers to be adequate and reliable, that manufacturer, importer or downstream user shall without undue delay carry out a new evaluation in accordance with this Chapter.
2. Where the manufacturer, importer or downstream user introduces a change to a mixture that has been classified as hazardous, that manufacturer, importer or downstream user shall carry out a new evaluation in accordance with this Chapter where the change is either of the following:
a change in the composition of the initial concentration of one or more of the hazardous constituents in concentrations at or above the limits in Table 1.2 of Part 1 of Annex I;
a change in the composition involving the substitution or addition of one or more constituents in concentrations at or above the cut-off value referred to in Article 11(3).
3. A new evaluation in accordance with paragraphs 1 and 2 shall not be required if there is valid scientific justification that this will not result in a change of classification.
4. Manufacturers, importers and downstream users shall adapt the classification of the substance or the mixture in accordance with the results of the new evaluation except where there are harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.
5. For paragraphs 1 to 4 of this Article, when the substance or mixture concerned is within the scope of Directive 91/414/EEC or Directive 98/8/EC, the requirements of those Directives shall also apply.
Article 16
Classification of substances included in the classification and labelling inventory
1. Manufacturers and importers may classify a substance differently from the classification already included in the classification and labelling inventory, provided they submit the reasons for the classification to the Agency together with the notification in accordance with Article 40.
2. Paragraph 1 shall not apply if the classification included in the classification and labelling inventory is a harmonised classification included in Part 3 of Annex VI.
TITLE III
HAZARD COMMUNICATION IN THE FORM OF LABELLING
CHAPTER 1
Content of the label
Article 17
General rules
1. A substance or mixture classified as hazardous and contained in packaging shall bear a label including the following elements:
the name, address and telephone number of the supplier(s);
the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;
product identifiers as specified in Article 18;
where applicable, hazard pictograms in accordance with Article 19;
where applicable, signal words in accordance with Article 20;
where applicable, hazard statements in accordance with Article 21;
where applicable, the appropriate precautionary statements in accordance with Article 22;
where applicable, a section for supplemental information in accordance with Article 25.
2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used.
Article 18
Product identifiers
1. The label shall include details permitting the identification of the substance or mixture (hereinafter referred to as ‘product identifiers’).
The term used for identification of the substance or mixture shall be the same as that used in the safety data sheet drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006 (hereinafter referred to as ‘safety data sheet’), without prejudice to Article 17(2) of this Regulation.
2. The product identifier for a substance shall consist of at least the following:
if the substance is included in Part 3 of Annex VI, a name and an identification number as given therein;
if the substance is not included in Part 3 of Annex VI, but appears in the classification and labelling inventory, a name and an identification number as given therein;
if the substance is not included in Part 3 of Annex VI nor in the classification and labelling inventory, the number provided by the CAS (hereinafter referred to as ‘the CAS number’), together with the name set out in the nomenclature provided by the IUPAC (hereinafter referred to as ‘the IUPAC Nomenclature’), or the CAS number together with another international chemical name(s); or
if the CAS number is not available, the name set out in the IUPAC Nomenclature or another international chemical name(s).
Where the name in the IUPAC nomenclature exceeds 100 characters, one of the other names (usual name, trade name, abbreviation) referred to in section 2.1.2 of Annex VI to Regulation (EC) No 1907/2006 may be used provided that the notification in accordance with Article 40 includes both the name set out in the IUPAC Nomenclature and the other name used.
3. The product identifier for a mixture shall consist of both of the following:
the trade name or the designation of the mixture;
the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard.
Where, in the case referred to in (b), that requirement leads to the provision of multiple chemical names, a maximum of four chemical names shall suffice, unless more than four names are needed to reflect the nature and the severity of the hazards.
The chemical names selected shall identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements.
Article 19
Hazard pictograms
1. The label shall include the relevant hazard pictogram(s), intended to convey specific information on the hazard concerned.
2. Subject to Article 33, hazard pictograms shall fulfil the requirements laid down in section 1.2.1 of Annex I and in Annex V.
3. The hazard pictogram relevant for each specific classification is set out in the tables indicating the label elements required for each hazard class in Annex I.
Article 20
Signal words
1. The label shall include the relevant signal word in accordance with the classification of the hazardous substance or mixture.
2. The signal word relevant for each specific classification is set out in the tables indicating the label elements required for each hazard class in Parts 2 to 5 of Annex I.
3. Where the signal word ‘Danger’ is used on the label, the signal word ‘Warning’ shall not appear on the label.
Article 21
Hazard statements
1. The label shall include the relevant hazard statements in accordance with the classification of the hazardous substance or mixture.
2. The hazard statements relevant for each classification are set out in the tables indicating the label elements required for each hazard class in Parts 2 to 5 of Annex I.
3. Where a substance is included in Part 3 of Annex VI, the hazard statement relevant for each specific classification covered by the entry in that Part shall be used on the label, together with the hazard statements referred to in paragraph 2 for any other classification not covered by that entry.
4. The hazard statements shall be worded in accordance with Annex III.
Article 22
Precautionary statements
1. The label shall include the relevant precautionary statements.
2. The precautionary statements shall be selected from those set out in the tables in Parts 2 to 5 of Annex I indicating the label elements for each hazard class.
3. The precautionary statements shall be selected in accordance with the criteria laid down in Part 1 of Annex IV taking into account the hazard statements and the intended or identified use or uses of the substance or the mixture.
4. The precautionary statements shall be worded in accordance with Part 2 of Annex IV.
Article 23
Derogations from labelling requirements for special cases
The specific provisions on labelling laid down in section 1.3 of Annex I shall apply in respect of the following:
transportable gas cylinders;
gas containers intended for propane, butane or liquefied petroleum gas;
aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard;
metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers;
explosives, as referred to in section 2.1 of Annex I, placed on the market with a view to obtaining an explosive or pyrotechnic effect;
substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1).
Article 24
Request for use of an alternative chemical name
1. The manufacturer, importer or downstream user of a substance in a mixture may submit a request to the Agency to use an alternative chemical name which refers to that substance in a mixture either by means of a name that identifies the most important functional chemical groups or by means of an alternative designation, where the substance meets the criteria set out in Part 1 of Annex I and where he can demonstrate that disclosure on the label or in the safety data sheet of the chemical identity of that substance puts the confidential nature of his business, in particular his intellectual property rights, at risk.
2. Any request referred to in paragraph 1 of this Article shall be made in the format referred to in Article 111 of Regulation (EC) No 1907/2006 and shall be accompanied by a fee.
The level of the fees shall be determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2) of this Regulation.
A reduced fee shall be set for SMEs.
3. The Agency may require further information from the manufacturer, importer or downstream user making the request if such information is necessary to take a decision. If the Agency raises no objection within six weeks of the request or the receipt of further required information, the use of the requested name shall be deemed to be allowed.
4. If the Agency does not accept the request, the practical arrangements referred to in Article 118(3) of Regulation (EC) No 1907/2006 shall apply.
5. The Agency shall inform competent authorities of the outcome of the request in accordance with paragraph 3 or 4 and provide them with the information submitted by the manufacturer, importer or downstream user.
6. Where new information shows that an alternative chemical name used does not provide sufficient information for necessary health and safety precautions to be taken at the workplace and to ensure that risks from handling the mixture can be controlled, the Agency shall review its decision on the use of that alternative chemical name. The Agency may withdraw its decision or amend it by a decision specifying which alternative chemical name is allowed to be used. If the Agency withdraws or amends its decision, the practical arrangements referred to in Article 118(3) of Regulation (EC) No 1907/2006 shall apply.
7. Where the use of an alternative chemical name has been allowed, but the classification of the substance in a mixture for which the alternative name is used no longer meets the criteria set out in section 1.4.1 of Annex I, the supplier of that substance in a mixture shall use the product identifier for the substance in accordance with Article 18 on the label and in the safety data sheet, and not the alternative chemical name.
8. For substances, whether on their own or in a mixture, where a justification in accordance with Article 10(a)(xi) of Regulation (EC) No 1907/2006 regarding information referred to in Article 119(2)(f) or (g) of that Regulation has been accepted as valid by the Agency, the manufacturer, importer or downstream user may use on the label and in the safety data sheet a name that will be made publicly available over the Internet. For those substances in a mixture for which Article 119(2)(f) or (g) of that Regulation no longer applies, the manufacturer, importer or downstream user may submit a request to the Agency to use an alternative chemical name as provided for in paragraph 1 of this Article.
9. Where the supplier of a mixture, before 1 June 2015, has demonstrated under Article 15 of Directive 1999/45/EC that the disclosure of the chemical identity of a substance in a mixture puts the confidential nature of his business at risk, he can continue to use the agreed alternative name for the purposes of this Regulation.
Article 25
Supplemental information on the label
1. Statements shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous has the physical properties or health properties referred to in sections 1.1 and 1.2 of Annex II.
The statements shall be worded in accordance with sections 1.1 and 1.2 of Annex II and Part 2 of Annex III.
Where a substance is included in Part 3 of Annex VI, any supplemental hazard statements given therein for the substance shall be included in the supplemental information on the label.
2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Directive 91/414/EEC.
The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation.
3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1 and 2, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (a) to (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements.
4. Statements such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or any other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not appear on the label or packaging of any substance or mixture.
▼M2 —————
6. Where a mixture contains any substance classified as hazardous, it shall be labelled in accordance with Part 2 of Annex II.
The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label.
The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture.
7. Where under Annex VIII the submitter creates a unique formula identifier, it shall be included in the supplemental information on the label in accordance with the provisions of Section 5 of Part A of that Annex.
Article 26
Principles of precedence for hazard pictograms
1. Where the classification of a substance or mixture would result in more than one hazard pictogram on the label, the following rules of precedence shall apply to reduce the number of hazard pictograms required:
if the hazard pictogram ‘GHS01’ applies, the use of the hazard pictograms ‘GHS02’ and ‘GHS03’ shall be optional, except in cases where more than one of these hazard pictograms are compulsory;
if the hazard pictogram ‘GHS06’ applies, the hazard pictogram ‘GHS07’ shall not appear;
if the hazard pictogram ‘GHS05’ applies, the hazard pictogram ‘GHS07’ shall not appear for skin or eye irritation;
if the hazard pictogram ‘GHS08’ applies for respiratory sensitisation, the hazard pictogram ‘GHS07’ shall not appear for skin sensitisation or for skin and eye irritation;
if the hazard pictogram ‘GHS02’ or ‘GHS06’ applies, the use of the hazard pictogram ‘GHS04’ shall be optional.
2. Where the classification of a substance or mixture would result in more than one hazard pictogram for the same hazard class the label shall include the hazard pictogram corresponding to the most severe hazard category for each hazard class concerned.
For substances that are included in Part 3 of Annex VI and also subject to classification pursuant to Title II, the label shall include the hazard pictogram corresponding to the most severe hazard category for each relevant hazard class.
Article 27
Principles of precedence for hazard statements
If a substance or mixture is classified within several hazard classes or differentiations of a hazard class, all hazard statements resulting from the classification shall appear on the label, unless there is evident duplication or redundancy.
Article 28
Principles of precedence for precautionary statements
1. Where the selection of the precautionary statements results in certain precautionary statements being clearly redundant or unnecessary given the specific substance, mixture or packaging, such statements shall be omitted from the label.
2. Where the substance or mixture is supplied to the general public, one precautionary statement addressing the disposal of that substance or mixture as well as the disposal of packaging shall appear on the label, unless not required under Article 22.
In all other cases, a precautionary statement addressing disposal shall not be required, where it is clear that the disposal of the substance or mixture or the packaging does not present a hazard to human health or the environment.
3. Not more than six precautionary statements shall appear on the label, unless necessary to reflect the nature and the severity of the hazards.
Article 29
Exemptions from labelling and packaging requirements
1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements of Article 31 for a label in the languages of the Member State in which the substance or mixture is placed on the market, the label elements in accordance with the first subparagraph of Article 17(2) shall be provided in accordance with section 1.5.1 of Annex I.
2. If the full label information cannot be provided in the way specified in paragraph 1 the label information may be reduced in accordance with section 1.5.2 of Annex I.
3. When a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging it shall be accompanied by a copy of the label elements in accordance with Article 17.
4. For certain mixtures classified as hazardous to the environment, exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling may be determined in accordance with the procedure referred to in Article 53, where it can be demonstrated that there would be a reduction in the environmental impact. Such exemptions or specific provisions are defined in Part 2 of Annex II.
4a. Where under Annex VIII the submitter creates a unique formula identifier, the submitter may, instead of including it in the supplemental information on the label, opt to show it in another way permitted by Section 5 of Part A of that Annex.
5. The Commission may request the Agency to prepare and submit to it further draft exemptions from labelling and packaging requirements.
Article 30
Updating information on labels
1. The supplier shall ensure that the label is updated, without undue delay, following any change to the classification and labelling of that substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required under Article 25, taking into account the nature of the change as regards the protection of human health and the environment. Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay.
2. Where labelling changes are required other than those referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months.
3. The supplier of a substance or a mixture within the scope of Directives 91/414/EEC or 98/8/EC shall update the label in accordance with those Directives.
CHAPTER 2
Application of labels
Article 31
General rules for the application of labels
1. Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally.
2. The colour and presentation of any label shall be such that the hazard pictogram stands out clearly.
3. The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and be of such size and spacing as to be easily read.
4. The shape, colour and the size of a hazard pictogram as well as the dimensions of the label shall be as set out in section 1.2.1 of Annex I.
5. A label shall not be required when the label elements referred to in Article 17(1) are shown clearly on the packaging itself. In such cases, the requirements of this Chapter applicable to a label shall be applied to the information shown on the packaging.
Article 32
Location of information on the label
1. The hazard pictograms, signal word, hazard statements and precautionary statements shall be located together on the label.
2. The supplier may decide the order of the hazard statements on the label. However, subject to paragraph 4, all hazard statements shall be grouped on the label by language.
The supplier may decide the order of the precautionary statements on the label. However, subject to paragraph 4, all precautionary statements shall be grouped on the label by language.
3. Groups of hazard statements and groups of precautionary statements referred to in paragraph 2 shall be located together on the label by language.
4. The supplemental information shall be placed in the supplemental information section referred to in Article 25, and shall be located with the other label elements specified in Article 17(1)(a) to (g).
5. In addition to its use in hazard pictograms, colour may be used on other areas of the label to implement special labelling requirements.
6. Label elements resulting from the requirements provided for in other Community acts shall be placed in the section for supplemental information on the label referred to in Article 25.
Article 33
Specific rules for labelling of outer packaging, inner packaging and single packaging
1. Where a package consists of an outer and an inner packaging, together with any intermediate packaging, and the outer packaging meets labelling provisions in accordance with the rules on the transport of dangerous goods, the inner and any intermediate packaging shall be labelled in accordance with this Regulation. The outer packaging may also be labelled in accordance with this Regulation. Where the hazard pictogram(s) required by this Regulation relate to the same hazard as in the rules for the transport of dangerous goods, the hazard pictogram(s) required by this Regulation need not appear on the outer packaging.
2. Where the outer packaging of a package is not required to meet labelling provisions in accordance with rules on the transport of dangerous goods, both the outer and any inner packaging, including any intermediate packaging, shall be labelled in accordance with this Regulation. However, if the outer packaging permits the inner or intermediate packaging labelling to be clearly seen, the outer packaging need not be labelled.
3. Single packages that meet the labelling provisions in accordance with the rules on the transport of dangerous goods shall be labelled both in accordance with this Regulation and the rules on the transport of dangerous goods. Where the hazard pictogram(s) required by this Regulation relate to the same hazard as in rules on the transport of dangerous goods, the hazard pictogram(s) required by this Regulation need not appear.
Article 34
Report on communication on safe use of chemicals
1. By 20 January 2012, the Agency shall carry out a study on the communication of information to the general public on the safe use of substances and mixtures and the potential need for additional information on labels. This study shall be carried out in consultation with competent authorities and stakeholders and drawing as appropriate on relevant best practice.
2. Without prejudice to the labelling rules provided for in this Title, the Commission shall, on the basis of the study referred to in paragraph 1, submit a report to the European Parliament and the Council and, if justified, present a legislative proposal to amend this Regulation.
TITLE IV
PACKAGING
Article 35
Packaging
1. Packaging containing hazardous substances or mixtures shall satisfy the following requirements:
the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;
the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;
the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;
packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.
2. Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.
Where the packaging contains a substance or mixture which meets the requirements in section 3.1.1 of Annex II it shall have a child-resistant fastening in accordance with sections 3.1.2, 3.1.3 and 3.1.4.2 of Annex II.
Where the packaging contains a substance or mixture which meets the requirements in section 3.2.1 of Annex II it shall bear a tactile warning of danger in accordance with section 3.2.2 of Annex II.
Where a liquid consumer laundry detergent, as defined in Article 2(1a) of Regulation (EC) No 648/2004 of the European Parliament and of the Council ( 3 ), is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply.
3. The packaging of substances and mixtures shall be deemed to satisfy the requirements of paragraph 1(a), (b) and (c) if it complies with the requirements of the rules on the transport of dangerous goods by air, sea, road, rail or inland waterways.
TITLE V
HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND THE CLASSIFICATION AND LABELLING INVENTORY
CHAPTER 1
Establishing harmonised classification and labelling of substances
Article 36
Harmonisation of classification and labelling of substances
1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:
respiratory sensitisation, category 1 (Annex I, section 3.4);
germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);
carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);
reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).
2. A substance that is an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 and 6 shall apply.
3. Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised classification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.
Article 37
Procedure for harmonisation of classification and labelling of substances
1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.
The proposal shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.
2. A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.
The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.
3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).
4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.
5. The Commission shall without undue delay adopt delegated acts in accordance with Article 53a, where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, to amend Annex VI by inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.
A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.
Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.
Article 38
Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information
1. Any opinion referred to in Article 37(4) and any decision according to Article 37(5) shall at least specify for each substance:
the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;
the classification of the substance referred to in Article 36, including a statement of reasons;
the specific concentration limits or M-factors, where applicable;
the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);
any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.
2. When making publicly available an opinion or a decision as referred to in Article 37(4) and (5) of this Regulation, Article 118(2) and Article 119 of Regulation (EC) No 1907/2006 shall apply.
CHAPTER 2
Classification and labelling inventory
Article 39
Scope
This Chapter shall apply to:
substances subject to registration in accordance with Regulation (EC) No 1907/2006;
substances within the scope of Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this Regulation or Directive 1999/45/EC, where relevant, which results in the classification of the mixture as hazardous.
Article 40
Obligation to notify the Agency
1. Any manufacturer or importer, or group of manufacturers or importers (hereinafter referred to as ‘the notifier(s)’), who places on the market a substance referred to in Article 39, shall notify to the Agency the following information in order for it to be included in the inventory referred to in Article 42:
the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;
the identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No 1907/2006;
the classification of the substance or substances in accordance with Article 13;
where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;
specific concentration limits or M-factors, where applicable, in accordance with Article 10 of this Regulation together with a justification using the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;
the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1).
The information referred to in (a) to (f) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.
The notifier shall submit this information in the format specified pursuant to Article 111 of Regulation (EC) No 1907/2006.
2. The information listed in paragraph 1 shall be updated and notified to the Agency by the notifier(s) concerned when, pursuant to the review in Article 15(1), a decision to change the classification and labelling of the substance has been taken.
3. Substances placed on the market on or after 1 December 2010 shall be notified in accordance with paragraph 1 within one month after their placing on the market.
However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.
Article 41
Agreed entries
Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly.
Article 42
The classification and labelling inventory
1. The Agency shall establish and maintain a classification and labelling inventory in the form of a database.
The information notified pursuant to Article 40(1) shall be included in the inventory, as well as information submitted as part of registrations under Regulation (EC) No 1907/2006.
Information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006 shall be publicly accessible. The Agency shall grant access to the other information on each substance in the inventory to the notifiers and registrants who have submitted information on that substance in accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall grant access to such information to other parties subject to Article 118 of that Regulation.
2. The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.
3. In addition to the information referred to in paragraph 1, the Agency shall, where applicable, include the following information in each entry:
whether, in respect of the entry, there is harmonised classification and labelling at Community level by inclusion in Part 3 of Annex VI;
whether, in respect of the entry, it is a joint entry between registrants of the same substance as referred to in Article 11(1) of Regulation (EC) No 1907/2006;
whether it is an agreed entry of two or more notifiers or registrants in accordance with Article 41;
whether the entry differs from another entry on the inventory for the same substance.
The information referred to in (a) shall be updated where a decision is taken in accordance with Article 37(5).
TITLE VI
COMPETENT AUTHORITIES AND ENFORCEMENT
Article 43
Appointment of competent authorities and enforcement authorities and cooperation between authorities
Member States shall appoint the competent authority or competent authorities responsible for proposals for harmonised classification and labelling and the authorities responsible for the enforcement of the obligations set out in this Regulation.
The competent authorities and the authorities responsible for enforcement shall cooperate with each other in the performance of their tasks under this Regulation and shall give the corresponding authorities of other Member States all necessary and useful support to this end.
Article 44
Helpdesk
Member States shall establish national helpdesks to provide advice to manufacturers, importers, distributors, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation.
Article 45
Appointment of bodies responsible for receiving information relating to emergency health response
1. Member States shall appoint a body or bodies responsible for receiving information relevant, in particular, for formulating preventative and curative measures, in particular in the event of emergency health response, from importers and downstream users placing mixtures on the market. This information shall include the chemical composition of mixtures placed on the market and classified as hazardous on the basis of their health or physical effects, including the chemical identity of substances in mixtures for which a request for use of an alternative chemical name has been accepted by the Agency, in accordance with Article 24.
2. The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used:
to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency;
and
where requested by the Member State, to undertake statistical analysis to identify where improved risk management measures may be needed.
The information shall not be used for other purposes.
3. The appointed bodies shall have at their disposal all the information required from the importers and downstream users responsible for marketing to carry out the tasks for which they are responsible.
4. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).
Article 46
Enforcement and reporting
1. Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with this Regulation.
2. Member States shall submit a report to the Agency every five years by 1 July on the results of the official controls, and other enforcement measures taken. The first report shall be submitted by 20 January 2012. The Agency shall make those reports available to the Commission, which shall take them into account for its report under Article 117 of Regulation (EC) No 1907/2006.
3. The Forum referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006 shall undertake the tasks specified in Article 77(4)(a) to (g) of Regulation (EC) No 1907/2006 concerning enforcement of this Regulation.
Article 47
Penalties for non-compliance
Member States shall introduce penalties for non-compliance with this Regulation and shall take all measures necessary to ensure that this Regulation is applied. The penalties must be effective, proportionate and dissuasive. Member States shall notify the Commission of the provisions for penalties by 20 June 2010 and shall notify it without delay of any subsequent amendment affecting them.
TITLE VII
COMMON AND FINAL PROVISIONS
Article 48
Advertisement
1. Any advertisement for a substance classified as hazardous shall mention the hazard classes or hazard categories concerned.
2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label.
The first subparagraph shall be without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts ( 4 ).
Article 49
Obligation to maintain information and requests for information
1. The supplier shall assemble and keep available all the information used by that supplier for the purposes of classification and labelling under this Regulation for a period of at least 10 years after the substance or the mixture was last supplied by that supplier.
The supplier shall keep this information together with the information required in Article 36 of Regulation (EC) No 1907/2006.
2. In the event of a supplier ceasing activity, or transferring part or all of his operations to a third party, the party responsible for liquidating the supplier's undertaking or assuming responsibility for the placing on the market of the substance or mixture concerned shall be bound by the obligation in paragraph 1 in place of the supplier.
3. The competent authority or the enforcement authorities of a Member State in which a supplier is established or the Agency may require the supplier to submit to it any information referred to in the first subparagraph of paragraph 1.
However, where that information is available to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006 or a notification pursuant to Article 40 of this Regulation, the Agency shall use that information and the authority shall address itself to the Agency.
Article 50
Tasks of the Agency
1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with this Regulation.
2. The Secretariat of the Agency shall:
provide industry with technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;
provide competent authorities with technical and scientific guidance on the operation of this Regulation and provide support to the helpdesks established by Member States under Article 44.
Article 51
Free movement clause
On grounds relating to the classification, labelling or packaging of substances and mixtures within the meaning of this Regulation, Member States shall not prohibit, restrict or impede the placing on the market of substances or mixtures which comply with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.
Article 52
Safeguard clause
1. Where a Member State has justifiable grounds for believing that a substance or a mixture, although satisfying the requirements of this Regulation, constitutes a serious risk to human health or the environment due to reasons of classification, labelling or packaging, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving the reasons for its decision.
2. Within 60 days of receipt of the information from the Member State, the Commission shall in accordance with the regulatory procedure referred to in Article 54(2) either authorise the provisional measure for a time period defined in the decision or require the Member State to revoke the provisional measure.
3. In the case of an authorisation of a provisional measure related to classification or labelling of a substance as referred to in paragraph 2, the competent authority of the Member State concerned shall in accordance with the procedure laid down in Article 37 submit a proposal to the Agency for harmonised classification and labelling, within three months of the date of the Commission decision.
Article 53
Adaptations to technical and scientific progress
1. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases.
Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
2. Member States and the Commission shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances at the level of the UN.
Article 53a
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 37(5), Article 45(4) and Article 53(1) shall be conferred on the Commission for a period of five years from 26 July 2019. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Articles 37(5), Article 45(4) and Article 53(1) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ( 5 ).
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 37(5), Article 45(4) and Article 53(1) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 53b
Urgency procedure
1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.
2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 53a(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.
Article 53c
Separate delegated acts for different delegated powers
The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation.
Article 54
Committee procedure
1. The Commission shall be assisted by the Committee instituted by Article 133 of Regulation (EC) No 1907/2006.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5 (6) of Decision 1999/468/EC shall be set at three months.
▼M19 —————
Article 55
Amendments to Directive 67/548/EEC
Directive 67/548/EEC shall be amended as follows:
in Article 1(2), the second subparagraph shall be deleted;
Article 4 shall be amended as follows:
paragraph 3 shall be replaced by the following:
‘3. Where an entry containing the harmonised classification and labelling for a particular substance has been included in Part 3 of Annex VI 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 ( *1 ), the substance shall be classified in accordance with that entry and paragraphs 1 and 2 shall not apply to the danger categories covered by that entry.
paragraph 4 shall be deleted;
Article 5 shall be amended as follows:
paragraph 1, second subparagraph shall be deleted;
paragraph 2 shall be replaced by the following:
‘2. The measures in the first subparagraph of paragraph 1 shall apply until the substance is listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the danger categories covered by that entry or until a decision not to list it has been taken in accordance with the procedure laid down in Article 37 of Regulation (EC) No 1272/2008.’;
Article 6 shall be replaced by the following:
‘Article 6
Obligation to carry out investigations
Manufacturers, distributors and importers of substances which appear in the EINECS but for which no entry has been included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label dangerous substances according to the rules laid down in Articles 22 to 25 of this Directive and the criteria in Annex VI to this Directive.’;
Article 22(3) and (4) shall be deleted;
Article 23(2) shall be amended as follows:
in point (a), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in point (c), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in point (d), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in point (e), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in point (f), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI of Regulation (EC) No 1272/2008’;
Article 24(4) second subparagraph shall be deleted;
Article 28 shall be deleted;
Article 31(2) and (3) shall be deleted;
the following Article shall be inserted after Article 32:
‘Article 32a
Transitional provision regarding labelling and packaging of substances
Articles 22 to 25 shall not apply to substances from 1 December 2010.’;
Annex I shall be deleted.
Article 56
Amendments to Directive 1999/45/EC
Directive 1999/45/EC shall be amended as follows:
in Article 3(2), first indent, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI 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 ( *2 ).
the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’ in:
Article 3(3);
Article 10(2), points 2.3.1, 2.3.2, 2.3.3 and 2.4 first indent;
Annex II, points (a) and (b) and the last paragraph of the Introduction;
Annex II, Part A,
Annex II, the introductory paragraph of Part B;
Annex III, point (a) and (b) of the Introduction;
Annex III, Part A, section (a) Aquatic environment
Annex III, Part A, section (b) Non-aquatic environment point 1.1 (a) and (b);
Annex V, section A points 3 and 4;
Annex V, section B point 9;
Annex VI, Part A, the third column of the table under point 2;
Annex VI Part B point 1, first paragraph, and the first column of the table under point 3;
Annex VIII, Appendix 1, second column of the table;
Annex VIII, Appendix 2, second column of the table;
in Annex VI, Part B, point 1, paragraph 3 first indent and paragraph 5, the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in Annex VI, Part B, point 4.2, final paragraph, the words ‘Annex I to Directive 67/548/EEC (19th adaptation)’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’.
Article 57
Amendments to Regulation (EC) No 1907/2006 from the entry into force of this Regulation
Regulation (EC) No 1907/2006 shall be amended as from the entry into force of this Regulation as follows:
Article 14(2) shall be amended as follows:
point (b) shall be replaced by the following:
the specific concentration limits that have been set in Part 3 of Annex VI 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 ( *3 );
for substances classified as hazardous to the aquatic environment, if a multiplying factor (hereinafter referred to as “M-factor”) has been set in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;
point (e) shall be replaced by the following:
the specific concentration limits given in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008;
for substances classified as hazardous to the aquatic environment, if an M-factor has been set in an agreed entry in the classification and labelling inventory referred to in Article 42 of Regulation (EC) No 1272/2008, the cut-off value in Table 1.1 of Annex I to that Regulation adjusted using the calculation set out in section 4.1 of Annex I to that Regulation;’;
Article 31 shall be amended as follows:
paragraph 8 shall be replaced by the following:
‘8. A safety data sheet shall be provided free of charge on paper or electronically no later than the date on which the substance or mixture is first supplied.’;
the following paragraph shall be added:
‘10. Where substances are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 December 2010, that classification may be added in the safety data sheet together with the classification in accordance with Directive 67/548/EEC.
From 1 December 2010 until 1 June 2015, the safety data sheets for substances shall contain the classification according to both Directive 67/548/EEC and Regulation (EC) No 1272/2008.
Where mixtures are classified in accordance with Regulation (EC) No 1272/2008 during the period from its entry into force until 1 June 2015, that classification may be added in the safety data sheet, together with the classification in accordance with Directive 1999/45/EC. However, until 1 June 2015, where substances or mixtures are both classified and labelled in accordance with Regulation (EC) No 1272/2008 that classification shall be provided in the safety data sheet, together with the classification in accordance with Directives 67/548/EEC and 1999/45/EC respectively, for the substance, the mixture and its constituents.’;
Article 56(6)(b) shall be replaced by the following:
for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Part 3 of Annex VI to Regulation (EC) No 1272/2008 which result in the classification of the mixture as dangerous.’;
Article 59(2) and 3 shall be amended as follows:
in paragraph 2, the second sentence shall be replaced by the following:
‘The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
in paragraph 3, the second sentence shall be replaced by the following:
‘The dossier may be limited, if appropriate, to a reference to an entry in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
in Article 76(1)(c), the words ‘Title XI’ shall be replaced by ‘Title V of Regulation (EC) No 1272/2008’;
Article 77 shall be amended as follows:
in paragraph 2, the first sentence of point (e) shall be replaced by the following:
establishing and maintaining database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list established in accordance with Regulation (EC) No 1272/2008;’;
in paragraph 3, point (a), the words ‘Titles VI to XI’ shall be replaced by ‘Titles VI to X’;
Title XI shall be deleted;
Annex XV, sections I and II shall be amended as follows:
section I shall be amended as follows:
the first indent shall be deleted;
the second indent shall be replaced by the following:
the identification of CMRs, PBTs, vPvBs, or a substance of equivalent concern in accordance with Article 59,’;
in section II, point 1 shall be deleted;
the table in Annex XVII shall be amended as follows:
the column ‘Designation of the substance, of the groups of substances or of the preparation’, shall be amended as follows:
entries 28, 29 and 30 shall be replaced by the following:
‘28. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B (Table 3.1) or carcinogen category 1 or 2 (Table 3.2) and listed as follows:
29. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as germ cell mutagen category 1A or 1B (Table 3.1) or mutagen category 1 or 2 (Table 3.2) and listed as follows:
30. Substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as toxic to reproduction category 1A or 1B (Table 3.1) or toxic to reproduction category 1 or 2 (Table 3.2) and listed as follows:
in the column ‘Conditions of restriction’, in entry 28, the first indent of point 1 shall be replaced by the following:
either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or’;
Appendices 1 to 6 to Annex XVII shall be amended as follows:
the Foreword shall be amended as follows:
in the section entitled ‘Substances’, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in the section entitled ‘Index number’, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;
in the section entitled ‘Notes’, the words ‘the foreword of Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 1 of Annex VI to Regulation (EC) No 1272/2008’;
Note A shall be replaced by the following:
‘Note A:
Without prejudice to Article 17(2) of Regulation (EC) No 1272/2008, the name of the substance must appear on the label in the form of one of the designations given in Part 3 of Annex VI to that Regulation.
In that Part, use is sometimes made of a general description such as “... compounds” or “... salts”. In this case, the supplier who places such a substance on the market is required to state on the label the correct name, due account being taken of Section 1.1.1.4 of Annex VI to Regulation (EC) No 1272/2008.
In accordance with Regulation (EC) No 1272/2008, where a substance is included in Part 3 of Annex VI to that Regulation, the labelling elements relevant for each specific classification covered by the entry in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation.
For substances belonging to one particular group of substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the labelling elements relevant for each specific classification covered by the entry in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation.
For substances belonging to more than one group of substances included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, the labelling elements relevant for each specific classification covered by both entries in that Part shall be included in the label, together with the applicable label elements for any other classification not covered by that entry, and any other applicable label elements in accordance with Article 17 of that Regulation. In cases where two different classifications are given in the two entries for the same hazard class or differentiation, the classification reflecting the more severe classification shall be used.’;
Note D shall be replaced by the following:
‘Note D:
Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier who places such a substance on the market must state on the label the name of the substance followed by the words “non-stabilised”.’;
Note E shall be deleted;
Note H shall be replaced by the following:
‘Note H:
The classification and label shown for this substance applies to the hazard or hazards indicated by the hazard statement or hazard statements in combination with the hazard classification shown. The requirements of Article 4 of Regulation (EC) No 1272/2008 on suppliers of this substance apply to all other hazard classes, differentiations and categories.
The final label shall follow the requirements of section 1.2 of Annex I to Regulation (EC) No 1272/2008.’;
Note K shall be replaced by the following:
‘Note K:
The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3 of Annex VI to Regulation (EC) No 1272/2008.’;
Note S shall be replaced by the following:
‘Note S:
This substance may not require a label according to Article 17 of Regulation (EC) No 1272/2008 (see section 1.3 of Annex I to that Regulation).’;
in Appendix 1, the title shall be replaced by the following:
‘Point 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
Appendix 2 shall be amended as follows:
the title shall be replaced by ‘Point 28 — Carcinogens: category 1B (Table 3.1)/ category 2 (Table 3.2)’;
in the entries index Nos 024-017-00-8, 611-024-001, 611-029-00-9, 611-030-00-4 and 650-017-00-8, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Annex VI to Regulation (EC) No 1272/2008.’;
in Appendix 3, the title shall be replaced by the following:
‘Point 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2)’;
in Appendix 4, the title shall be replaced by the following:
‘Point 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2)’;
in Appendix 5, the title shall be replaced by the following:
‘Point 30 — Reproductive toxicants: category 1A (Table 3.1)/category 1 (Table 3.2)’;
in Appendix 6, the title shall be replaced by the following:
‘Point 30 — Reproductive toxicants: category 1B (Table 3.1)/category 2 (Table 3.2)’;
the word ‘preparation’ or ‘preparations’ within the meaning of Article 3 (2) of Regulation (EC) 1907/2006 shall be replaced by ‘mixture’ or ‘mixtures’ respectively throughout the text.
Article 58
Amendments to Regulation (EC) No 1907/2006 from 1 December 2010
Regulation (EC) No 1907/2006 shall be amended from 1 December 2010 as follows:
in Article 14(4), the introductory sentence shall be replaced by the following:
‘4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1,
or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:’;
Article 31 shall be amended as follows
paragraph 1(a) shall be replaced by the following:
where a substance meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008 or a mixture meets the criteria for classification as dangerous in accordance with Directive 1999/45/EC; or’;
paragraph 4 shall be replaced by the following:
‘4. The safety data sheet need not be supplied where substances that are hazardous in accordance with Regulation (EC) No 1272/2008 or mixtures that are dangerous in accordance with Directive 1999/45/EC, offered or sold to the general public, are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.’;
Article 40(1) shall be replaced by the following:
‘1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1.’;
Article 57(a), (b) and (c) shall be replaced by the following:
substances meeting the criteria for classification in the hazard class carcinogenicity category 1A or 1B in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008;
substances meeting the criteria for classification in the hazard class germ cell mutagenicity category 1A or 1B in accordance with section 3.5 of Annex I to Regulation (EC) No 1272/2008;
substances meeting the criteria for classification in the hazard class reproductive toxicity category 1A or 1B, adverse effects on sexual function and fertility or on development in accordance with section 3.7 of Annex I to Regulation(EC) No 1272/2008;’;
in Article 65 the words ‘Directive 67/548/EEC’ shall be replaced by ‘Directive 67/548/EEC and Regulation (EC) No 1272/2008’;
Article 68(2) shall be replaced by the following:
‘2. For a substance on its own, in a mixture or in an article which meets the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, and could be used by consumers and for which restrictions to consumer use are proposed by the Commission, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4). Articles 69 to 73 shall not apply.’;
Article 119 shall be amended as follows:
in paragraph 1, point (a) shall be replaced by the following:
without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
paragraph 2 shall be amended as follows:
point (f) shall be replaced by the following:
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for non-phase-in substances referred to in paragraph 1(a) of this Article for a period of six years;’
in point (g), the introductory phrase shall be replaced by the following:
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for substances referred to in paragraph 1(a) of this Article that are only used as one or more of the following:’;
in Article 138(1), the second sentence of the introductory phrase shall be replaced by the following:
‘However, for substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008, the review shall be carried out by 1 June 2014.’;
Annex III shall be amended as follows:
point (a) shall be replaced by the following:
substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;’;
in point (b), point (ii) shall be replaced by the following:
for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008.’;
in Annex V, point 8, the words ‘Directive 67/548/EEC’ shall be replaced by ‘Regulation (EC) No 1272/2008’;
in Annex VI, sections 4.1, 4.2 and 4.3 shall be replaced by the following:
‘4.1 The hazard classification of the substance(s), resulting from the application of Title I and II of Regulation (EC) No 1272/2008 for all hazard classes and categories in that Regulation,
In addition, for each entry, the reasons why no classification is given for a hazard class or differentiation of a hazard class should be provided (i.e. if data are lacking, inconclusive, or conclusive but not sufficient for classification),
4.2 The resulting hazard label for the substance(s), resulting from the application of Title III of Regulation (EC) No 1272/2008,
4.3 Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008 and Articles 4 to 7 of Directive 1999/45/EC.’;
Annex VIII shall be amended as follows:
in column 2, the second indent of point 8.4.2 shall be replaced by the following:
the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2.’;
in column 2, the second and third paragraphs of point 8.7.1 shall be replaced by the following:
‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered.
If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’;
in Annex IX, column 2, point 8.7, the second and third paragraphs shall be replaced by the following:
‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered.
If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’;
Annex X shall be amended as follows:
in column 2, point 8.7, the second and third paragraphs shall be replaced by the following:
‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered.
If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’
in column 2, point 8.9.1, the second indent of the first paragraph shall be replaced by the following:
the substance is classified as germ cell mutagen category 2 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.’
in column 2, the second paragraph of point 8.9.1 shall be replaced by the following:
‘If the substance is classified as germ cell mutagen category 1A or 1B, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required.’;
in Annex XIII, the second and third indents of point 1.3 shall be replaced by the following:
the substance is classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2), or
there is other evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) according to Regulation (EC) No 1272/2008’;
in the table in Annex XVII, the column ‘Designation of the substance, of the groups of substances or of the mixture’ shall be amended as follows:
entry 3 shall be replaced by the following:
‘3. Liquid substances or mixtures which are regarded as dangerous in accordance with Directive 1999/45/EC or are fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
hazard class 4.1;
hazard class 5.1.’;
entry 40 shall be replaced by the following:
‘40. Substances classified as flammable gases category 1 or 2, flammable liquids categories 1, 2 or 3, flammable solids category 1 or 2, substances and mixtures which, in contact with water, emit flammable gases, category 1, 2 or 3, pyrophoric liquids category 1 or pyrophoric solids category 1, regardless of whether they appear in Part 3 of Annex VI to that Regulation or not’.
Article 59
Amendments to Regulation (EC) No 1907/2006 from 1 June 2015
Regulation (EC) No 1907/2006 shall be amended from 1 June 2015 as follows:
Article 14(2) shall be replaced by the following:
‘2. A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than
the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;
0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.’;
Article 31 shall be amended as follows:
in paragraph 1, point (a) shall be replaced by the following:
where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or’;
paragraph 3 shall be replaced by the following:
‘3. The supplier shall provide the recipient at his request with a safety data sheet compiled in accordance with Annex II, where a mixture does not meet the criteria for classification as hazardous in accordance with Titles I and II of Regulation (EC) No 1272/2008, but contains:
in an individual concentration of ≥ 1 % by weight for non-gaseous mixtures and ≥ 0,2 % by volume for gaseous mixtures at least one substance posing human health or environmental hazards; or
in an individual concentration of ≥ 0,1 % by weight for non-gaseous mixtures at least one substance that is carcinogenic category 2 or toxic to reproduction category 1A, 1B and 2, skin sensitiser category 1, respiratory sensitiser category 1, or has effects on or via lactation or is persistent, bioaccumulative and toxic (PBT) in accordance with the criteria set out in Annex XIII or very persistent and very bioaccumulative (vPvB) in accordance with the criteria set out in Annex XIII or has been included for reasons other than those referred to in point (a) in the list established in accordance with Article 59(1); or
a substance for which there are Community workplace exposure limits’;
paragraph 4 shall be replaced by the following:
‘4. The safety data sheet need not be supplied where hazardous substances or mixtures offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of human health, safety and the environment, unless requested by a downstream user or distributor.’;
Article 56(6)(b) shall be replaced by the following:
for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.’;
in Article 65 the words ‘and Directive 1999/45/EC’ shall be deleted;
Annex II shall be amended as follows:
point 1.1 shall be replaced by:
‘1.1. Identification of the substance or mixture
The term used for identification of a substance shall be identical to that provided on the label in accordance with Article 18(2) of Regulation (EC) No 1272/2008.
The term used for identification of a mixture shall be identical to that provided on the label in accordance with Article 18(3)(a) of Regulation (EC) No 1272/2008.’;
footnote 1 to point 3.3(a), first indent, shall be deleted;
point 3.6 shall be replaced by:
‘3.6. Where, in accordance with Article 24 of Regulation (EC) No 1272/2008, the Agency has agreed that the chemical identity of a substance may be kept confidential on the label and in the safety data sheet, their chemical nature shall be described under heading 3 in order to ensure safe handling.
The name used on the safety data sheet (including for the purposes of paragraphs 1.1, 3.2, 3.3 and 3.5) shall be the same as that used on the label, agreed in accordance with the procedure set out in Article 24 of Regulation (EC) No 1272/2008.’;
in Annex VI section 4.3 shall be replaced by the following:
‘4.3 Specific concentration limits, where applicable, resulting from the application of Article 10 of Regulation (EC) No 1272/2008.’;
Annex XVII shall be amended as follows:
in the column ‘Designation of the substance, of the groups of substances or of the mixture’ of the table in entry 3, the words ‘which are regarded as dangerous in accordance with Directive 1999/45/EC or are’ shall be deleted;
in the column ‘Conditions of restriction’ of the table, entry 28 shall be amended as follows:
the second indent of point 1 shall be replaced by the following:
the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.’;
point 2 (d) shall be replaced by the following:
artists’ paints covered by Regulation (EC) No 1272/2008’.
Article 60
Repeal
Directive 67/548/EEC and Directive 1999/45/EC shall be repealed with effect from 1 June 2015.
Article 61
Transitional provisions
1. Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC.
Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC.
2. By way of derogation from the second subparagraph of Article 62 of this Regulation and in addition to the requirements of paragraph 1 of this Article, substances and mixtures may, before 1 December 2010 and 1 June 2015 respectively, be classified, labelled and packaged in accordance with this Regulation. In that case, the provisions on labelling and packaging in Directives 67/548/EEC and 1999/45/EC shall not apply.
3. From 1 December 2010 until 1 June 2015, substances shall be classified in accordance with both Directive 67/548/EEC and this Regulation. They shall be labelled and packaged in accordance with this Regulation.
4. By way of derogation from the second subparagraph of Article 62 of this Regulation, substances classified, labelled and packaged in accordance with Directive 67/548/EEC and already placed on the market before 1 December 2010, are not required to be relabelled and repackaged in accordance with this Regulation until 1 December 2012.
By way of derogation from the second subparagraph of Article 62 of this Regulation, mixtures classified, labelled and packaged in accordance with Directive 1999/45/EC and already placed on the market before 1 June 2015 are not required to be relabelled and repackaged in accordance with this Regulation until 1 June 2017.
5. Where a substance or mixture has been classified in accordance with Directive 67/548/EEC or 1999/45/EC before 1 December 2010 or 1 June 2015 respectively, manufacturers, importers and downstream users may amend the classification of the substance or mixture using the conversion table in Annex VII to this Regulation.
6. Until 1 December 2011 a Member State may maintain any existing and more stringent classification and labelling of substances entered into Part 3 of Annex VI to this Regulation, provided that these classifications and labelling elements have been notified to the Commission in accordance with the safeguard clause in Directive 67/548/EEC before 20 January 2009 and that the Member State submits a proposal for harmonised classification and labelling containing these classifications and labelling elements to the Agency in accordance with Article 37(1) of this Regulation by 1 June 2009.
It is a precondition that a decision on the proposed classification and labelling by the Commission in accordance with the safeguard clause of Directive 67/548/EEC has not yet been taken before 20 January 2009.
If the proposed harmonised classification and labelling submitted under the first subparagraph is not included or is included in an amended form in Part 3 of Annex VI in accordance with Article 37(5), the exemption in the first subparagraph of this paragraph is no longer valid.
Article 62
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Titles II, III and IV shall apply in respect of substances from 1 December 2010 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
CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES
This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met.
1. PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING
1.0. Definitions
Gas means a substance which:
at 50 oC has a vapour pressure greater than 300 kPa (absolute); or
is completely gaseous at 20 oC at a standard pressure of 101,3 kPa;
Liquid means a substance or mixture which:
at 50 oC has a vapour pressure of not more than 300 kPa (3 bar);
is not completely gaseous at 20 oC and at a standard pressure of 101,3 kPa; and
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
1.1.0. Cooperation to meet the requirements in this Regulation
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
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.
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.
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.
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.
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.
1.1.2. Specific concentration limits, M-factors and generic cut-off values
1.1.2.1. Specific concentration limits or M-factors shall be applied in accordance with Article 10.
1.1.2.2. Cut-off values
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).
1.1.2.2.2. The cut-off values referred to in Article 11 shall be the following:
For health and environmental hazards in Parts 3, 4 and 5 of this Annex:
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
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
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
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.
For aquatic environmental hazards in section 4.1 of this Annex:
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
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
|
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 % () |
|
Serious damage to eyes/eye irritation |
1 % () |
|
Hazardous to Aquatic Environment |
|
|
— Acute Category 1 |
0,1 % () |
|
— Chronic Category 1 |
0,1 % () |
|
— Chronic Category 2-4 |
1 % |
|
(1) Or < 1 % where relevant, see 3.2.3.3.1. (2) Or < 1 % where relevant, see 3.3.3.3.1. (3) Or < 0,1 % where relevant, see 4.1.3.1. |
|
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.
1.1.3. Bridging principles for the classification of mixtures where test data are not available for the complete mixture
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
►M2 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:
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 hazard 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.
1.1.3.5. Substantially similar mixtures
Given the following:
two mixtures each containing two ingredients:
A + B
C + B;
the concentration of ingredient B is essentially the same in both mixtures;
the concentration of ingredient A in mixture (i) equals that of ingredient C in mixture (ii);
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.
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
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
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.
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
|
1.3. Derogations from labelling requirements for special cases
In accordance with Article 23 the following derogations shall apply:
1.3.1. Transportable gas cylinders
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 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.
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)
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.
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).
1.3.2.3. For consumers, sufficient information shall be transmitted to enable them to take all necessary measures for health and safety.
1.3.3. Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard
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
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.
1.3.4.2. Instead, the supplier shall provide the information to downstream users or distributors by means of the SDS.
1.3.5. Explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect
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.
1.3.6. Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1)
Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) which are in the finished state and packaged for consumer use do not require on the label the hazard pictogram GHS05.
1.4. Request for use of an alternative chemical name
1.4.1. Requests for use of an alternative chemical name under Article 24 may be granted only where
the substance has not been assigned a Community workplace exposure limit; and
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
the substance is classified exclusively as one or more of the following hazard categories:
any of the hazard categories referred to in Part 2 of this Annex;
Acute toxicity, Category 4;
Skin corrosion/irritation, Category 2;
Serious eye damage/eye irritation, Category 2;
Specific target organ toxicity — Single exposure, Category 2 or 3;
Specific target organ toxicity — Repeated exposure, Category 2;
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
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
1.5.1. Exemptions from Article 31 [(Article 29(1))]
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:
in fold-out labels; or
on tie-on tags; or
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.
1.5.2. Exemptions from Article 17 [(Article 29(2)]
1.5.2.1. Labelling of packages where the contents do not exceed 125 ml
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:
the contents of the package do not exceed 125 ml; and
the substance or mixture is classified in one or more of the following hazard categories:
Oxidising gases of category 1;
Gases under pressure;
Flammable liquids of category 2 or 3;
Flammable solids of category 1 or 2;
Self-reactive substances or mixtures Types C to F;
Self-heating substances or mixtures of category 2;
Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3;
Oxidising liquids of category 2 or 3;
Oxidising solids of category 2 or 3;
Organic peroxides Types C to F;
Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public;
Skin irritation of category 2;
Eye irritation of category 2;
Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public;
Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public;
Hazardous to the aquatic environment — Acute of category 1;
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:
the contents of the package do not exceed 125 ml; and
the substance or mixture is classified in one or more of the following hazard categories:
Flammable gases of category 2;
Reproductive toxicity: effects on or via lactation;
Hazardous to the aquatic environment — Chronic of category 3 or 4.
1.5.2.1.3. ►M2 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: ◄
the contents of the package do not exceed 125 ml; and
the substance or mixture is classified in one or more of the following hazard categories:
Corrosive to metals.
1.5.2.2. Labelling of soluble packaging for single use
The label elements required by Article 17 may be omitted from soluble packaging intended for single use where:
The content of each soluble packaging does not exceed a volume of 25 ml;
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
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.
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:
the contents of the inner packaging do not exceed 10 ml;
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
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. |
2. PART 2: PHYSICAL HAZARDS
2.1. Explosives
2.1.1. Definitions
2.1.1.1. The class of explosives comprises
explosive substances and mixtures;
explosive articles, except devices containing explosive substances or mixtures in such quantity or of such a character that their inadvertent or accidental ignition or initiation shall not cause any effect external to the device either by projection, fire, smoke, heat or loud noise; and
substances, mixtures and articles not mentioned in points (a) and (b) which are manufactured with a view to producing a practical, explosive or pyrotechnic effect.
2.1.1.2. For the purposes of this Regulation the following definitions shall apply:
An explosive substance or mixture is a solid or liquid substance or mixture of substances which is in itself capable by chemical reaction of producing gas at such a temperature and pressure and at such a speed as to cause damage to the surroundings. Pyrotechnic substances are included even when they do not evolve gases.
A pyrotechnic substance or mixture is a substance or mixture of substances designed to produce an effect by heat, light, sound, gas or smoke or a combination of these as the result of non-detonative self-sustaining exothermic chemical reactions.
An unstable explosive is an explosive substance or mixture which is thermally unstable and/or too sensitive for normal handling, transport and use.
An explosive article is an article containing one or more explosive substances or mixtures.
A pyrotechnic article is an article containing one or more pyrotechnic substances or mixtures.
An intentional explosive is a substance, mixture or article which is manufactured with a view to producing a practical, explosive or pyrotechnic effect.
2.1.2. Classification criteria
2.1.2.1. Substances, mixtures and articles of this class are classified as an unstable explosive on the basis of the flowchart in Figure 2.1.2. ►M4 The test methods are described in Part I of the UN RTDG, Manual of Tests and Criteria. ◄
2.1.2.2. Substances, mixtures and articles of this class, which are not classified as an unstable explosive, shall be assigned to one of the following six divisions depending on the type of hazard they present:
Division 1.1 Substances, mixtures and articles which have a mass explosion hazard (a mass explosion is one which affects almost the entire quantity present virtually instantaneously);
Division 1.2 Substances, mixtures and articles which have a projection hazard but not a mass explosion hazard;
Division 1.3 Substances, mixtures and articles which have a fire hazard and either a minor blast hazard or a minor projection hazard or both, but not a mass explosion hazard:
combustion of which gives rise to considerable radiant heat; or
which burn one after another, producing minor blast or projection effects or both;
Division 1.4 Substances, mixtures and articles which present no significant hazard:
Division 1.5 Very insensitive substances or mixtures which have a mass explosion hazard:
Division 1.6 Extremely insensitive articles which do not have a mass explosion hazard:
2.1.2.3. Explosives, which are not classified as an unstable explosive, shall be classified in one of the six divisions referred to in paragraph 2.1.2.2 of this Annex based on Test Series 2 to 8 in Part I of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria according to the results of the tests laid down in Table 2.1.1:
Table 2.1.1
Criteria for explosives
|
Category |
Criteria |
|
Unstable explosives or explosives of Divisions 1.1 to 1.6 |
For explosives of Divisions 1.1 to 1.6, the following are the core set of tests that need to be performed: |
|
Explosibility: according to UN Test Series 2 (section 12 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria). Intentional explosives () shall not be subject to UN Test Series 2. |
|
|
Sensitiveness: according to UN Test Series 3 (section 13 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria). |
|
|
Thermal stability: according to UN Test 3(c) (sub-section 13.6.1 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria). Further tests are necessary to allocate the correct Division. |
|
|
(1) This comprises substances, mixtures and articles which are manufactured with a view to producing a practical, explosive or pyrotechnic effect. |
|
2.1.2.4. If explosives are unpackaged or repacked in packaging other than the original or similar packaging, they shall be retested.
2.1.3. Hazard Communication
Label elements shall be used for substances, mixtures or articles meeting the criteria for classification in this hazard class in accordance with Table 2.1.2.
Table 2.1.2
Label elements for explosives
|
Classification |
Unstable Explosive |
Division 1.1 |
Division 1.2 |
Division 1.3 |
Division 1.4 |
Division 1.5 |
Division 1.6 |
|
GHS Pictograms |
|
|
|
|
|
|
|
|
Signal Word |
Danger |
Danger |
Danger |
Danger |
Warning |
Danger |
No signal word |
|
Hazard Statement |
H200: Unstable Explosive |
H201: Explosive; mass explosion hazard |
H202: Explosive; severe projection hazard |
H203: Explosive; fire, blast or projection hazard |
H204: Fire or projection hazard |
H205: May mass explode in fire |
No hazard statement |
|
Precautionary Statement Prevention |
P201 P250 P280 |
P210 P230 P234 P240 P250 P280 |
P210 P230 P234 P240 P250 P280 |
P210 P230 P234 P240 P250 P280 |
P210 P234 P240 P250 P280 |
P210 P230 P234 P240 P250 P280 |
No precautionary statement |
|
Precautionary Statement Response |
P370 + P372 + P380 + P373 |
P370 + P372 + P380 + P373 |
P370 + P372 + P380 + P373 |
P370 + P372 + P380 + P373 |
P370 + P372 + P380 + P373 P370 + P380 + P375 |
P370 + P372 + P380 + P373 |
No precautionary statement |
|
Precautionary Statement Storage |
P401 |
P401 |
P401 |
P401 |
P401 |
P401 |
No precautionary statement |
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
P501 |
P501 |
P501 |
No precautionary statement |
NOTE 1: Unpackaged explosives or explosives repackaged in packaging other than the original or similar packaging shall include all of the following label elements:
the pictogram: exploding bomb;
the signal word ‘Danger’; and
the hazard statement: ‘Explosive; mass explosion hazard’
unless the hazard is shown to correspond to one of the hazard categories in Table 2.1.2, in which case the corresponding symbol, the signal word and/or the hazard statement shall be assigned.
NOTE 2: Substances and mixtures, as supplied, with a positive result in Test Series 2 in Part I, Section 12, of the UN RTDG, Manual of Tests and Criteria, which are exempted from classification as explosives (based on a negative result in Test Series 6 in Part I, Section 16 of the UN RTDG, Manual of Tests and Criteria) still have explosive properties. The user shall be informed of these intrinsic explosive properties because they have to be considered for handling — especially if the substance or mixture is removed from its packaging or is repackaged — and for storage. For this reason, the explosive properties of the substance or mixture shall be communicated in Section 2 (Hazards identification) and Section 9 (Physical and chemical properties) of the Safety Data Sheet and other sections of the Safety Data Sheet, as appropriate.
2.1.4. Additional Classification Considerations
2.1.4.1. The classification of substances, mixtures and articles in the explosives hazard class and further allocation to a division is a very complex, three step procedure. Reference to Part I of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria is necessary.
The first step is to ascertain whether the substance or mixture has explosive effects (Test Series 1). The second step is the acceptance procedure (Test Series 2 to 4) and the third step is the assignment to a hazard division (Test Series 5 to 7). The assessment whether a candidate for ‘ammonium nitrate emulsion or suspension or gel, intermediate for blasting explosives (ANE)’ is insensitive enough for inclusion as an oxidising liquid (section 2.13) or an oxidising solid (section 2.14) is answered by Test Series 8 tests.
Explosive substances and mixtures wetted with water or alcohols, or diluted with other substances to suppress their explosive properties, may be treated differently in terms of classification and other hazard classes may apply, according to their physical properties (see also Annex II section 1.1.).
Certain physical hazards (due to explosive properties) are altered by dilution, as is the case for desensitised explosives, by inclusion in a mixture or article, packaging or other factors.
The classification procedure is set out in the following decision logic (see Figures 2.1.1 to 2.1.4).
Figure 2.1.1
Overall scheme of the procedure for classifying a substance, mixture or article in the class of explosives (Class 1 for transport) 
►(1) M2
►(2) M4
Figure 2.1.2
Procedure for provisional acceptance of a substance, mixture or article in the class of explosives (Class 1 for transport) 
Figure 2.1.3
Procedure for assignment to a division in the class of explosives (Class 1 for transport)
Figure 2.1.4
Procedure for the classification of ammonium nitrate emulsion, suspension or gel (ANE)
2.1.4.2. Screening procedure
Explosive properties are associated with the presence of certain chemical groups in a molecule which can react to produce very rapid increases in temperature or pressure. The screening procedure is aimed at identifying the presence of such reactive groups and the potential for rapid energy release. If the screening procedure identifies the substance or mixture to be a potential explosive, the acceptance procedure (see section 10.3 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria) has to be performed.
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 ‘-’.
2.1.4.3. A substance or mixture shall not be classified as explosive if:
There are no chemical groups associated with explosive properties present in the molecule. Examples of groups which may indicate explosive properties are given in Table A6.1 in Appendix 6 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria; or
The substance contains chemical groups associated with explosive properties which include oxygen and the calculated oxygen balance is less than - 200;
The oxygen balance is calculated for the chemical reaction:
CxHyOz+ [x+ (y/4)-(z/2)] O2 → x CO2 + (y/2) H2O
Using the formula:
Oxygen balance = -1 600 [2x + (y/2)-z]/molecular weight;
When the organic substance or a homogenous mixture of organic substances contains chemical groups associated with explosive properties but the exothermic decomposition energy is less than 500 J/g and the onset of exothermic decomposition is below 500 oC. The exothermic decomposition energy can be determined using a suitable calorimetric technique; or
For mixtures of inorganic oxidising substances with organic material(s), the concentration of the inorganic oxidising substance is:
2.1.4.4. In the case of mixtures containing any known explosives, the acceptance procedure has to be performed.
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 |
|
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 |
Additional hazard statement H230: May react explosively even in the absence of air |
Additional hazard statement 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
Figure 2.2.2
Chemically unstable gases
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 classified in one of the three categories of this hazard class, depending on their flammable properties and their heat of combustion. They shall be considered for classification in Category 1 or 2 if they contain more than 1 % components (by mass) which are classified as flammable according to the following criteria set out in this Part:
or if their heat of combustion is at least 20 kJ/g.
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)
For aerosols
Figure 2.3.1 (b)
Spray aerosols
Figure 2.3.1 (c)
Foam aerosols
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 aerosols
|
Classification |
Category 1 |
Category 2 |
Category 3 |
|
GHS Pictograms |
|
|
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:
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).
2.4. Oxidising gases
2.4.1. Definitions
Oxidising gas means any gas or gas mixture which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does.
2.4.2. Classification criteria
2.4.2.1. An oxidising gas shall be classified in a single category for this class in accordance with Table 2.4.1.:
Table 2.4.1
Criteria for oxidising gases
|
Category |
Criteria |
|
1 |
Any gas which may, generally by providing oxygen, cause or contribute to the combustion of other material more than air does. |
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.
2.4.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.4.2.
Table 2.4.2
Label elements for oxidising gases
|
Classification |
Category 1 |
|
GHS Pictogram |
|
|
Signal Word |
Danger |
|
Hazard Statement |
H270: May cause or intensify fire; oxidiser |
|
Precautionary Statement Prevention |
P220 P244 |
|
Precautionary Statement Response |
P370 + P376 |
|
Precautionary Statement Storage |
P403 |
|
Precautionary Statement Disposal |
|
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.
2.5. Gases under pressure
2.5.1. Definition
2.5.1.1. ►M4 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. ◄
They comprise compressed gases, liquefied gases, dissolved gases and refrigerated liquefied gases.
2.5.1.2. The critical temperature is the temperature above which a pure gas cannot be liquefied, regardless of the degree of compression.
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. |
|
2.5.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.5.2.
Table 2.5.2
Label elements for gases under pressure
|
Classification |
Compressed gas |
Liquefied gas |
Refrigerated liquefied gas |
Dissolved gas |
|
GHS Pictograms |
|
|
|
|
|
Signal Word |
Warning |
Warning |
Warning |
Warning |
|
Hazard Statement |
H280: Contains gas under pressure; may explode if heated |
H280: Contains gas under pressure; may explode if heated |
H281: Contains refrigerated gas; may cause cryogenic burns or injury |
H280: Contains gas under pressure; may explode if heated |
|
Precautionary Statement Prevention |
|
|
P282 |
|
|
Precautionary Statement Response |
|
|
P336 + P315 |
|
|
Precautionary Statement Storage |
P410 + P403 |
P410 + P403 |
P403 |
P410 + P403 |
|
Precautionary Statement Disposal |
|
|
|
|
Note:
Pictogram GHS04 is not required for gases under pressure where pictogram GHS02 or pictogram GHS06 appears.
2.5.4. Additional Classification Considerations
For this group of gases, the following information is required to be known:
Data can be found in the literature, calculated or determined by testing. Most pure gases are already classified in the UN RTDG, Model Regulations.
2.6. Flammable liquids
2.6.1. Definition
Flammable liquid means a liquid having a flash point of not more than 60 oC.
2.6.2. Classification criteria
2.6.2.1. A flammable liquid shall be classified in one of the three categories for this class in accordance with Table 2.6.1:
Table 2.6.1
Criteria for flammable liquids
|
Category |
Criteria |
|
1 |
Flash point < 23 oC and initial boiling point ≤ 35 oC |
|
2 |
Flash point < 23 oC and initial boiling point > 35 oC |
|
3 |
Flash point ≥ 23 oC and ≤ 60 oC () |
|
(1) For the purpose of this Regulation gas oils, diesel and light heating oils having a flash point between ≥ 55 oC and ≤ 75 oC may be regarded as Category 3. |
|
Note:
Aerosols shall not be classified as flammable liquids; see section 2.3.
2.6.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.6.2.
Table 2.6.2
Label elements for flammable liquids
|
Classification |
Category 1 |
Category 2 |
Category 3 |
|
GHS Pictograms |
|
|
|
|
Signal Word |
Danger |
Danger |
Warning |
|
Hazard Statement |
H224: Extremely flammable liquid and vapour |
H225: Highly flammable liquid and vapour |
H226: Flammable liquid and vapour |
|
Precautionary Statement Prevention |
P210 P233 P240 P241 P242 P243 P280 |
P210 P233 P240 P241 P242 P243 P280 |
P210 P233 P240 P241 P242 P243 P280 |
|
Precautionary Statement Response |
P303 + P361 + P353 P370 + P378 |
P303 + P361 + P353 P370 + P378 |
P303 + P361 + P353 P370 + P378 |
|
Precautionary Statement Storage |
P403 + P235 |
P403 + P235 |
P403 + P235 |
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
2.6.4. Additional Classification Considerations
2.6.4.1. For the classification of flammable liquids data on flash point and initial boiling point are needed. Data can be determined by testing, found in literature or calculated. If data are not available, the flash point and the initial boiling point shall be determined through testing. For flash point determination a closed-cup method shall be used.
2.6.4.2. ►M2 In the case of mixtures ( 6 ) 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 ( 7 ) greater than the relevant classification criterion (23 °C and 60 °C, respectively) and provided that: ◄
the composition of the mixture is accurately known (if the material has a specified range of composition, the composition with the lowest calculated flash point shall be selected for assessment);
the lower explosion limit of each component is known (an appropriate correlation has to be applied when these data are extrapolated to other temperatures than test conditions) as well as a method for calculating the lower explosion limit ►M2 of the mixture ◄ ;
the temperature dependence of the saturated vapour pressure and of the activity coefficient is known for each component as present in the mixture;
the liquid phase is homogeneous.
2.6.4.3. One suitable method is described in Gmehling and Rasmussen (Ind. Eng. Fundament, 21, 186, (1982)). For a mixture containing non-volatile components the flash point is calculated from the volatile components. It is considered that a non-volatile component only slightly decreases the partial pressure of the solvents and the calculated flash point is only slightly below the measured value.
2.6.4.4. Possible test methods for determining the flash point of flammable liquids are listed in Table 2.6.3.
Table 2.6.3
Methods for determining the flash point of flammable liquids
|
European standards: |
EN ISO 1516 as amended Determination of flash/no flash — Closed cup equilibrium method |
|
EN ISO 1523 as amended Determination of flash point — Closed cup equilibrium method |
|
|
EN ISO 2719 as amended Determination of flash point — Pensky-Martens closed cup method |
|
|
EN ISO 3679 as amended Determination of flash point — Rapid equilibrium closed cup method |
|
|
EN ISO 3680 as amended Determination of flash/no flash — Rapid equilibrium closed cup method |
|
|
EN ISO 13736 as amended Petroleum products and other liquids — Determination of flash point — Abel closed cup method |
|
|
National standards: |
|
|
Association française de normalisation, AFNOR: |
NF M07-036 as amended Détermination du point d'éclair — Vase clos Abel-Pensky (identical to DIN 51755) |
|
▼M2 ————— |
|
|
Deutsches Institut für Normung |
DIN 51755 (flash points below 65 C) as amended Prüfung von Mineralölen und anderen brennbaren Flüssigkeiten; Bestimmung des Flammpunktes im geschlossenen Tiegel, nach Abel-Pensky (identical to NF M07-036) |
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.
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. |
|
2.7. Flammable solids
2.7.1. Definition
2.7.1.1. A flammable solid means a solid which is readily combustible, or may cause or contribute to fire through friction.
Readily combustible solids are powdered, granular, or pasty substances or mixtures which are dangerous if they can be easily ignited by brief contact with an ignition source, such as a burning match, and if the flame spreads rapidly.
2.7.2. Classification criteria
2.7.2.1. Powdered, granular or pasty substances or mixtures (except powders of metals or metal alloys — see 2.7.2.2) shall be classified as readily combustible solids when the time of burning of one or more of the test runs, performed in accordance with the test method described in Part III, sub-section 33.2.1, of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria, is less than 45 seconds or the rate of burning is more than 2,2 mm/s.
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 in 10 minutes or less.
2.7.2.3. A flammable solid shall be classified in one of the two categories for this class using Method N.1 as described in 33.2.1 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria in accordance with Table 2.7.1:
Table 2.7.1
Criteria for flammable solids
|
Category |
Criteria |
|
1 |
Burning rate test Substances and mixtures other than metal powders: (a) wetted zone does not stop fire and (b) burning time < 45 seconds or burning rate > 2,2 mm/s Metal powders burning time ≤ 5 minutes |
|
2 |
Burning rate test Substances and mixtures other than metal powders: (a) wetted zone stops the fire for at least 4 minutes and (b) burning time < 45 seconds or burning rate > 2,2 mm/s Metal powders burning time > 5 minutes and ≤ 10 minutes |
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.
2.7.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.7.2.
Table 2.7.2
Label elements for flammable solids
|
Classification |
Category 1 |
Category 2 |
|
GHS Pictograms |
|
|
|
Signal Word |
Danger |
Warning |
|
Hazard Statement |
H228: Flammable Solid |
H228: Flammable Solid |
|
Precautionary Statement Prevention |
P210 P240 P241 P280 |
P210 P240 P241 P280 |
|
Precautionary Statement Response |
P370 + P378 |
P370 + P378 |
|
Precautionary Statement Storage |
|
|
|
Precautionary Statement Disposal |
|
|
2.8. Self-reactive substances and mixtures
2.8.1. Definition
2.8.1.1. Self-reactive substances or mixtures are thermally unstable liquid or solid substances or mixtures liable to undergo a strongly exothermic decomposition even without participation of oxygen (air). This definition excludes substances and mixtures classified according to this Part as explosives, organic peroxides or as oxidising.
2.8.1.2. A self-reactive substance or mixture is regarded as possessing explosive properties when in laboratory testing the formulation is liable to detonate, to deflagrate rapidly or to show a violent effect when heated under confinement.
2.8.2. Classification criteria
2.8.2.1. Any self-reactive substance or mixture shall be considered for classification in this class as a self-reactive substance or mixture unless:
they are explosives, according to the criteria given in 2.1;
they are oxidising liquids or solids, according to the criteria given in 2.13 or 2.14, except that mixtures of oxidising substances, which contain 5 % or more of combustible organic substances shall be classified as self-reactive substances according to the procedure defined in 2.8.2.2;
they are organic peroxides, according to the criteria given in 2.15;
their heat of decomposition is less than 300 J/g; or
their self-accelerating decomposition temperature (SADT) is greater than 75 oC for a 50 kg package ( 8 ).
2.8.2.2. Mixtures of oxidising substances, meeting the criteria for classification as oxidising substances, which contain 5 % or more of combustible organic substances and which do not meet the criteria mentioned in (a), (c), (d) or (e) in 2.8.2.1, shall be subjected to the self-reactive substances classification procedure;
Such a mixture showing the properties of a self-reactive substance type B to F (see 2.8.2.3) shall be classified as a self-reactive substance.
Where the test is conducted in the package form and the packaging is changed, a further test shall be conducted where it is considered that the change in packaging will affect the outcome of the test.
2.8.2.3. Self-reactive substances and mixtures shall be classified in one of the seven categories of ‘types A to G’ for this class, according to the following principles:
any self-reactive substance or mixture which can detonate or deflagrate rapidly, as packaged, shall be defined as self-reactive substance TYPE A;
any self-reactive substance or mixture possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package shall be defined as self-reactive substance TYPE B;
any self-reactive substance or mixture possessing explosive properties when the substance or mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion shall be defined as self-reactive substance TYPE C;
any self-reactive substance or mixture which in laboratory testing:
detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or
does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or
does not detonate or deflagrate at all and shows a medium effect when heated under confinement;
shall be defined as self-reactive substance TYPE D;
any self-reactive substance or mixture which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement shall be defined as self-reactive substance TYPE E;
any self-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power shall be defined as self-reactive substance TYPE F;
any self-reactive substance or mixture which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable (SADT is 60 oC to 75 oC for a 50 kg package), and, for liquid mixtures, a diluent having a boiling point not less than 150 oC is used for desensitisation shall be defined as self-reactive substance TYPE G. If the mixture is not thermally stable or a diluent having a boiling point less than 150 oC is used for desensitisation, the mixture shall be defined as self-reactive substance TYPE F.
Where the test is conducted in the package form and the packaging is changed, a further test shall be conducted where it is considered that the change in packaging will affect the outcome of the test.
2.8.2.4. Criteria for temperature control
Self-reactive substances need to be subjected to temperature control if their SADT is less than or equal to 55 oC. Test methods for determining the SADT as well as the derivation of control and emergency temperatures are given in, Part II, section 28 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria. The test selected shall be conducted in a manner which is representative, both in size and material, of the package.
2.8.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.8.1.
Table 2.8.1
Label elements for self-reactive substances and mixtures
|
Classification |
Type A |
Type B |
Type C & D |
Type E & F |
Type G (1) |
|
GHS Pictograms |
|
|
|
|
There are no label elements allocated to this hazard category |
|
Signal Word |
Danger |
Danger |
Danger |
Warning |
|
|
Hazard Statement |
H240: Heating may cause an explosion |
H241: Heating may cause a fire or explosion |
H242: Heating may cause a fire |
H242: Heating may cause a fire |
|
|
Precautionary Statement Prevention |
P210 P234 P235 P240 P280 |
P210 P234 P235 P240 P280 |
P210 P234 P235 P240 P280 |
P210 P234 P235 P240 P280 |
|
|
Precautionary Statement Response |
P370 + P372 + P380 + P373 |
P370 + P380 + P375 [+ P378] (2) |
P370 + P378 |
P370 + P378 |
|
|
Precautionary Statement Storage |
P403 P411 P420 |
P403 P411 P420 |
P403 P411 P420 |
P403 P411 P420 |
|
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
P501 |
|
|
(1) Type G has no hazard communication elements assigned but should be considered for properties belonging to other hazard classes. (2) See the introduction to Annex IV for details on the use of square brackets. |
|||||
Type G has no hazard communication elements assigned but shall be considered for properties belonging to other hazard classes.
2.8.4. Additional Classification Considerations
2.8.4.1. The properties of self-reactive substances or mixtures which are decisive for their classification shall be determined experimentally. The classification of a self reactive substance or mixture shall be performed in accordance with test series A to H as described in Part II of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria. The procedure for classification is described in Figure 2.8.1.
2.8.4.2. The classification procedures for self-reactive substances and mixtures need not be applied if:
There are no chemical groups present in the molecule associated with explosive or self reactive properties. Examples of such groups are given in Tables A6.1 and A6.2 in Appendix 6 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria; or
For a single organic substance or a homogeneous mixture of organic substances, the estimated SADT for a 50 kg package is greater than 75 oC or the exothermic decomposition energy is less than 300J/g. The onset temperature and decomposition energy can be estimated using a suitable calorimetric technique (see Part II, sub-section 20.3.3.3 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria).
Figure 2.8.1
Self-reactive substances and mixtures
2.9. Pyrophoric liquids
2.9.1. Definition
Pyrophoric liquid means a liquid substance or mixture which, even in small quantities, is liable to ignite within five minutes after coming into contact with air.
2.9.2. Classification criteria
2.9.2.1. A pyrophoric liquid shall be classified in a single category for this class using test N.3 in Part III, sub-section 33.3.1.5 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria according to Table 2.9.1:
Table 2.9.1
Criteria for pyrophoric liquids
|
Category |
Criteria |
|
1 |
The liquid ignites within 5 min when added to an inert carrier and exposed to air, or it ignites or chars a filter paper on contact with air within 5 min. |
2.9.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.9.2.
Table 2.9.2
Label elements for pyrophoric liquids
|
Classification |
Category 1 |
|
GHS Pictogram |
|
|
Signal Word |
Danger |
|
Hazard Statement |
H250: Catches fire spontaneously if exposed to air |
|
Precautionary Statement Prevention |
P210 P222 P231 + P232 P233 P280 |
|
Precautionary Statement Response |
P302 + P334 P370 + P378 |
|
Precautionary Statement Storage |
|
|
Precautionary Statement Disposal |
|
2.9.4. Additional Classification Considerations
2.9.4.1. The classification procedure for pyrophoric liquids need not be applied when experience in manufacture or handling shows that the substance or mixture does not ignite spontaneously on coming into contact with air at normal temperatures (i.e. the substance is known to be stable at room temperature for prolonged periods of time (days)).
2.10. Pyrophoric solids
2.10.1. Definition
Pyrophoric solid means a solid substance or mixture which, even in small quantities, is liable to ignite within five minutes after coming into contact with air.
2.10.2. Classification criteria
2.10.2.1. A pyrophoric solid shall be classified in a single category for this class using test N.2 in Part III, sub-section 33.3.1.4 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria in accordance with Table 2.10.1:
Table 2.10.1
Criteria for pyrophoric solids
|
Category |
Criteria |
|
1 |
The solid ignites within 5 minutes of coming into contact with air. |
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 shall also be tested in the new form.
2.10.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.10.2.
Table 2.10.2
Label elements for pyrophoric solids
|
Classification |
Category 1 |
|
GHS Pictogram |
|
|
Signal Word |
Danger |
|
Hazard Statement |
H250: Catches fire spontaneously if exposed to air |
|
Precautionary Statement Prevention |
P210 P222 P231 + P232 P233 P280 |
|
Precautionary Statement Response |
P302 + P335 + P334 P370 +P378 |
|
Precautionary Statement Storage |
|
|
Precautionary Statement Disposal |
|
2.10.4. Additional Classification Considerations
2.10.4.1. The classification procedure for pyrophoric solids need not be applied when experience in manufacture or handling shows that the substance or mixture does not ignite spontaneously on coming into contact with air at normal temperatures (i.e. the substance is known to be stable at room temperature for prolonged periods of time (days)).
2.11. Self-heating substances and mixtures
2.11.1. Definition
2.11.1.1. A self-heating substance or mixture is a liquid or solid substance or mixture, other than a pyrophoric liquid or solid, which, by reaction with air and without energy supply, is liable to self-heat; this substance or mixture differs from a pyrophoric liquid or solid in that it will ignite only when in large amounts (kilograms) and after long periods of time (hours or days).
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.
2.11.2. Classification criteria
2.11.2.1. A substance or mixture shall be classified as a self-heating substance or mixture of this class, if in the tests performed in accordance with the test method given in the ►M4 UN RTDG ◄ , Manual of Tests and Criteria, Part III, sub-section 33.3.1.6:
a positive result is obtained using a 25 mm cube sample at 140 oC;
a positive result is obtained in a test using a 100 mm sample cube at 140 oC and a negative result is obtained in a test using a 100 mm cube sample at 120 oC and the substance or mixture is to be packed in packages with a volume of more than 3 m3;
a positive result is obtained in a test using a 100 mm sample cube at 140 oC and a negative result is obtained in a test using a 100 mm cube sample at 100 oC and the substance or mixture is to be packed in packages with a volume of more than 450 litres;
a positive result is obtained in a test using a 100 mm sample cube at 140 oC and a positive result is obtained in a test using a 100 mm cube sample at 100 oC.
2.11.2.2. A self-heating substance or mixture shall be classified in one of the two categories for this class if, in a test performed in accordance with test method N.4 in Part III, sub-section 33.3.1.6 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria, the result meets the criteria according to Table 2.11.1:
Table 2.11.1
Criteria for self-heating substances and mixtures
|
Category |
Criteria |
|
1 |
A positive result is obtained in a test using a 25 mm sample cube at 140 oC |
|
2 |
(a) a positive result is obtained in a test using a 100 mm sample cube at 140 oC and a negative result is obtained in a test using a 25 mm cube sample at 140 oC and the substance or mixture is to be packed in packages with a volume of more than 3 m3; or (b) a positive result is obtained in a test using a 100 mm sample cube at 140 oC and a negative result is obtained in a test using a 25 mm cube sample at 140 oC, a positive result is obtained in a test using a 100 mm cube sample at 120 oC and the substance or mixture is to be packed in packages with a volume of more than 450 litres; or (c) a positive result is obtained in a test using a 100 mm sample cube at 140 oC and a negative result is obtained in a test using a 25 mm cube sample at 140 oC and a positive result is obtained in a test using a 100 mm cube sample at 100 oC. |
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 shall also be tested in the new form.
2.11.2.3. Substances and mixtures with a temperature of spontaneous combustion higher than 50 oC for a volume of 27 m3 shall not be classified as a self-heating substance or mixture.
2.11.2.4. Substances and mixtures with a spontaneous ignition temperature higher than 50 oC for a volume of 450 litres shall not be assigned to Category 1 of this class.
2.11.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.11.2.
Table 2.11.2
Label elements for self-heating substances and mixtures
|
Classification |
Category 1 |
Category 2 |
|
GHS Pictograms |
|
|
|
Signal Word |
Danger |
Warning |
|
Hazard Statement |
H251: Self-heating; may catch fire |
H252: Self-heating in large quantities; may catch fire |
|
Precautionary Statement Prevention |
P235 P280 |
P235 P280 |
|
Precautionary Statement Response |
|
|
|
Precautionary Statement Storage |
P407 P413 P420 |
P407 P413 P420 |
|
Precautionary Statement Disposal |
|
|
2.11.4. Additional Classification Considerations
2.11.4.1. For detailed schemes for the decision logic for classification and the tests to be carried out for ascertaining the different categories, see Figure 2.11.1.
2.11.4.2. The classification procedure for self-heating substances or mixtures need not be applied if the results of a screening test can be adequately correlated with the classification test and an appropriate safety margin is applied. Examples of screening tests are:
The Grewer Oven test (VDI guideline 2263, Part 1, 1990, Test methods for the Determination of the Safety Characteristics of Dusts) with an onset temperature 80 K above the reference temperature for a volume of 1 l;
The Bulk Powder Screening Test (Gibson, N. Harper, D.J. Rogers, R.Evaluation of the fire and explosion risks in drying powders, Plant Operations Progress, 4 (3), 181-189, 1985) with an onset temperature 60 K above the reference temperature for a volume of 1 l.
Figure 2.11.1.
Self-heating substances and mixtures
2.12. Substances and mixtures which in contact with water emit flammable gases
2.12.1. Definition
Substances or mixtures which, in contact with water, emit flammable gases means solid or liquid substances or mixtures which, by interaction with water, are liable to become spontaneously flammable or to give off flammable gases in dangerous quantities.
2.12.2. Classification criteria
2.12.2.1. A substance or mixture which, in contact with water, emits flammable gases shall be classified in one of the three categories for this class, using test N.5 in Part III, sub-section 33.4.1.4 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria, in accordance with Table 2.12.1:
Table 2.12.1
Criteria for substances or 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 equal to or 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.
2.12.2.2. A substance or mixture shall be classified as a substance or mixture which in contact with water emits flammable gases if spontaneous ignition takes place in any step of the test procedure.
2.12.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.12.2.
Table 2.12.2
Label elements for substances and mixtures which in contact with water emit flammable gases
|
Classification |
Category 1 |
Category 2 |
Category 3 |
|
GHS Pictograms |
|
|
|
|
Signal Word |
Danger |
Danger |
Warning |
|
Hazard Statement |
H260: In contact with water releases flammable gases which may ignite spontaneously |
H261: In contact with water releases flammable gases |
H261: In contact with water releases flammable gases |
|
Precautionary Statement Prevention |
P223 P231 + P232 P280 |
P223 P231 + P232 P280 |
P231 + P232 P280 |
|
Precautionary Statement Response |
P302 + P335 + P334 P370 + P378 |
P302 + P335 + P334 P370 + P378 |
P370 + P378 |
|
Precautionary Statement Storage |
P402 + P404 |
P402 + P404 |
P402 + P404 |
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
2.12.4. Additional Classification Considerations
2.12.4.1. The classification procedure for this class need not be applied if:
the chemical structure of the substance or mixture does not contain metals or metalloids; or
experience in production or handling shows that the substance or mixture does not react with water, e.g. the substance is manufactured with water or washed with water; or
the substance or mixture is known to be soluble in water to form a stable mixture.
2.13. Oxidising liquids
2.13.1. Definition
Oxidising liquid means a liquid substance or mixture which, while in itself not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material.
2.13.2. Classification criteria
2.13.2.1. An oxidising liquid shall be classified in one of the three categories for this class using test O.2 in Part III, sub-section 34.4.2 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria in accordance with Table 2.13.1:
Table 2.13.1
Criteria for oxidising liquids
|
Category |
Criteria |
|
1 |
Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, spontaneously ignites; or the mean pressure rise time of a 1:1 mixture, by mass, of substance (or mixture) and cellulose is less than that of a 1:1 mixture, by mass, of 50 % perchloric acid and cellulose. |
|
2 |
Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 40 % aqueous sodium chlorate solution and cellulose; and the criteria for Category 1 are not met. |
|
3 |
Any substance or mixture which, in the 1:1 mixture, by mass, of substance (or mixture) and cellulose tested, exhibits a mean pressure rise time less than or equal to the mean pressure rise time of a 1:1 mixture, by mass, of 65 % aqueous nitric acid and cellulose; and the criteria for Category 1 and 2 are not met. |
2.13.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.13.2.
Table 2.13.2
Label elements for oxidising liquids
|
Classification |
Category 1 |
Category 2 |
Category 3 |
|
GHS Pictograms |
|
|
|
|
Signal Word |
Danger |
Danger |
Warning |
|
Hazard Statement |
H271: May cause fire or explosion; strong oxidiser |
H272: May intensify fire; oxidiser |
H272: May intensify fire; oxidiser |
|
Precautionary Statement Prevention |
P210 P220 P280 P283 |
P210 P220 P280 |
P210 P220 P280 |
|
Precautionary Statement Response |
P306 + P360 P371 + P380 + P375 P370 + P378 |
P370 + P378 |
P370 + P378 |
|
Precautionary Statement Storage |
P420 |
|
|
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
2.13.4. Additional Classification Considerations
2.13.4.1. For organic substances or mixtures the classification procedure for this class shall not apply if:
the substance or mixture does not contain oxygen, fluorine or chlorine; or
the substance or mixture contains oxygen, fluorine or chlorine and these elements are chemically bonded only to carbon or hydrogen.
2.13.4.2. For inorganic substances or mixtures the classification procedure for this class shall not apply if they do not contain oxygen or halogen atoms.
2.13.4.3. In the event of divergence between test results and known experience in the handling and use of substances or mixtures which shows them to be oxidising, judgments based on known experience shall take precedence over test results.
2.13.4.4. In cases where substances or mixtures generate a pressure rise (too high or too low), caused by chemical reactions not characterising the oxidising properties of the substance or mixture, the test described in Part III, sub-section 34.4.2 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria shall be repeated with an inert substance, e.g. diatomite (kieselguhr), in place of the cellulose in order to clarify the nature of the reaction and to check for a false positive result.
2.14. Oxidising solids
2.14.1. Definition
Oxidising solid means a solid substance or mixture which, while in itself is not necessarily combustible, may, generally by yielding oxygen, cause, or contribute to, the combustion of other material.
2.14.2. Classification criteria
2.14.2.1. ►M12 An oxidising solid shall be classified in one of the three categories for this class using test O.1 in Part III, sub-section 34.4.1 or test O.3 in Part III, sub-section 34.4 3 of the UN RTDG, Manual of Tests and Criteria in accordance with Table 2.14.1: ◄
Table 2.14.1
Criteria for oxidising solids
|
Category |
Criteria using test O.1 |
Criteria using test O.3 |
|
1 |
Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time less than the mean burning time of a 3:2 mixture, (by mass), of potassium bromate and cellulose. |
Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate greater than the mean burning rate of a 3:1 mixture (by mass) of calcium peroxide and cellulose. |
|
2 |
Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 2:3 mixture (by mass) of potassium bromate and cellulose and the criteria for Category 1 are not met. |
Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate equal to or greater than the mean burning rate of a 1:1 mixture (by mass) of calcium peroxide and cellulose and the criteria for Category 1 are not met. |
|
3 |
Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning time equal to or less than the mean burning time of a 3:7 mixture (by mass) of potassium bromate and cellulose and the criteria for Categories 1 and 2 are not met. |
Any substance or mixture which, in the 4:1 or 1:1 sample-to-cellulose ratio (by mass) tested, exhibits a mean burning rate equal to or greater than the mean burning rate of a 1:2 mixture (by mass) of calcium peroxide and cellulose and the criteria for Categories 1 and 2 are not met. |
Note 1
Some oxidising solids also present explosion hazards under certain conditions (when stored in large quantities). Some types of ammonium nitrate may give rise to an explosion hazard under extreme conditions and the ‘Resistance to detonation test’ ►M12 (IMSBC Code (International Maritime Solid Bulk Cargoes Code, IMO), Appendix 2, Section 5) ◄ can be used to assess this hazard. Appropriate information shall be made in the SDS.
Note 2
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.
2.14.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.14.2.
Table 2.14.2
Label elements for oxidising solids
|
|
Category 1 |
Category 2 |
Category 3 |
|
GHS Pictograms |
|
|
|
|
Signal Word |
Danger |
Danger |
Warning |
|
Hazard Statement |
H271: May cause fire or explosion; strong oxidiser |
H272: May intensify fire; oxidiser |
H272: May intensify fire; oxidiser |
|
Precautionary Statement Prevention |
P210 P220 P280 P283 |
P210 P220 P280 |
P210 P220 P280 |
|
Precautionary Statement Response |
P306 + P360 P371 + P380 + P375 P370 + P378 |
P370 + P378 |
P370 + P378 |
|
Precautionary Statement Storage |
P420 |
|
|
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
2.14.4. Additional Classification Considerations
2.14.4.1. For organic substances or mixtures the classification procedure for this class shall not apply if:
the substance or mixture does not contain oxygen, fluorine or chlorine; or
the substance or mixture contains oxygen, fluorine or chlorine and these elements are chemically bonded only to carbon or hydrogen.
2.14.4.2. For inorganic substances or mixtures the classification procedure for this class shall not apply if they do not contain oxygen or halogen atoms.
2.14.4.3. In the event of divergence between test results and known experience in the handling and use of substances or mixtures which shows them to be oxidising, judgments based on known experience shall take precedence over test results.
2.15. Organic peroxides
2.15.1. Definition
2.15.1.1. Organic peroxides means liquid or solid organic substances which contain the bivalent -O-O- structure and may be considered derivatives of hydrogen peroxide, where one or both of the hydrogen atoms have been replaced by organic radicals. The term organic peroxide includes organic peroxide mixtures (formulations) containing at least one organic peroxide. Organic peroxides are thermally unstable substances or mixtures, which can undergo exothermic self-accelerating decomposition. In addition, they can have one or more of the following properties:
be liable to explosive decomposition;
burn rapidly;
be sensitive to impact or friction;
react dangerously with other substances.
2.15.1.2. An organic peroxide is regarded as possessing explosive properties when in laboratory testing the mixture (formulation) is liable to detonate, to deflagrate rapidly or to show a violent effect when heated under confinement.
2.15.2. Classification criteria
2.15.2.1. Any organic peroxide shall be considered for classification in this class, unless it contains:
not more than 1,0 % available oxygen from the organic peroxides when containing not more than 1,0 % hydrogen peroxide; or
not more than 0,5 % available oxygen from the organic peroxides when containing more than 1,0 % but not more than 7,0 % hydrogen peroxide.
Note
The available oxygen content ( %) of an organic peroxide mixture is given by the formula:
where:
|
ni |
= |
number of peroxygen groups per molecule of organic peroxide i; |
|
ci |
= |
concentration (mass %) of organic peroxide i; |
|
mi |
= |
molecular mass of organic peroxide i. |
2.15.2.2. Organic peroxides shall be classified in one of the seven categories of ‘Types A to G’ for this class, according to the following principles:
any organic peroxide which, as packaged, can detonate or deflagrate rapidly shall be defined as organic peroxide TYPE A;
any organic peroxide possessing explosive properties and which, as packaged, neither detonates nor deflagrates rapidly, but is liable to undergo a thermal explosion in that package shall be defined as organic peroxide TYPE B;
any organic peroxide possessing explosive properties when the substance or mixture as packaged cannot detonate or deflagrate rapidly or undergo a thermal explosion shall be defined as organic peroxide TYPE C;
any organic peroxide which in laboratory testing:
detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or
does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or
does not detonate or deflagrate at all and shows a medium effect when heated under confinement;
shall be defined as organic peroxide TYPE D;
any organic peroxide which, in laboratory testing, neither detonates nor deflagrates at all and shows low or no effect when heated under confinement shall be defined as organic peroxide TYPE E;
any organic peroxide which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows only a low or no effect when heated under confinement as well as low or no explosive power shall be defined as organic peroxide TYPE F;
any organic peroxide which, in laboratory testing, neither detonates in the cavitated state nor deflagrates at all and shows no effect when heated under confinement nor any explosive power, provided that it is thermally stable, i.e. the SADT is 60 oC or higher for a 50 kg package ( 9 ), and, for liquid mixtures, a diluent having a boiling point of not less than 150 oC is used for desensitisation, shall be defined as organic peroxide TYPE G. If the organic peroxide is not thermally stable or a diluent having a boiling point less than 150 oC is used for desensitisation, the organic peroxide shall be defined as organic peroxide TYPE F.
Where the test is conducted in the package form and the packaging is changed, a further test shall be conducted where it is considered that the change in packaging will affect the outcome of the test.
2.15.2.3. Criteria for temperature control
The following organic peroxides need to be subjected to temperature control:
Organic peroxide types B and C with an SADT ≤ 50 C;
Organic peroxide type D showing a medium effect when heated under confinement ( 10 ) with an SADT ≤ 50 oC or showing a low or no effect when heated under confinement with an SADT ≤ 45 oC; and
Organic peroxide types E and F with an SADT ≤ 45 oC.
Test methods for determining the SADT as well as the derivation of control and emergency temperatures are given in the ►M4 UN RTDG ◄ , Manual of Tests and Criteria, Part II, section 28. The test selected shall be conducted in a manner which is representative, both in size and material, of the package.
2.15.3. Hazard Communication
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.15.1.
Table 2.15.1
Label elements for organic peroxides
|
Classification |
Type A |
Type B |
Type C & D |
Type E & F |
Type G |
|
GHS Pictograms |
|
|
|
|
There are no label elements allocated to this hazard category |
|
Signal Word |
Danger |
Danger |
Danger |
Warning |
|
|
Hazard Statement |
H240: Heating may cause an explosion |
H241: Heating may cause a fire or explosion |
H242: Heating may cause a fire |
H242: Heating may cause a fire |
|
|
Precautionary Statement Prevention |
P210 P234 P235 P240 P280 |
P210 P234 P235 P240 P280 |
P210 P234 P235 P240 P280 |
P210 P234 P235 P240 P280 |
|
|
Precautionary Statement Response |
P370 + P372 + P380 + P373 |
P370 + P380 + P375[+ P378] (1) |
P370 + P378 |
P370 + P378 |
|
|
Precautionary Statement Storage |
P403 P410 P411 P420 |
P403 P410 P411 P420 |
P403 P410 P411 P420 |
P403 P410 P411 P420 |
|
|
Precautionary Statement Disposal |
P501 |
P501 |
P501 |
P501 |
|
|
(1) See the introduction to Annex IV for details on the use of square brackets. |
|||||
Type G has no hazard communication elements assigned but shall be considered for properties belonging to other hazard classes.
2.15.4. Additional Classification Considerations
2.15.4.1. Organic peroxides are classified by definition based on their chemical structure and on the available oxygen and hydrogen peroxide contents of the mixture (see 2.15.2.1). The properties of organic peroxides which are necessary for their classification shall be determined experimentally. The classification of organic peroxides shall be performed in accordance with test series A to H as described in Part II of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria. The procedure for classification is described in Figure 2.15.1.
2.15.4.2. Mixtures of already classified organic peroxides may be classified as the same type of organic peroxide as that of the most dangerous component. However, as two stable components can form a thermally less stable mixture, the SADT of the mixture shall be determined.
Note: The sum of the individual parts can be more hazardous than the individual components.
Figure 2.15.1
Organic Peroxides
2.16. Corrosive to metals
2.16.1. Definition
A substance or a mixture that is corrosive to metals means a substance or a mixture which by chemical action will materially damage, or even destroy, metals.
2.16.2. Classification criteria
2.16.2.1. A substance or a mixture which is corrosive to metals is classified in a single category for this class, using the test in Part III, sub-section 37.4 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria, in accordance with Table 2.16.1:
Table 2.16.1
Criteria for substances and mixtures corrosive to metals
|
Category |
Criteria |
|
1 |
Corrosion rate on either steel or aluminium surfaces exceeding 6,25 mm per year at a test temperature of 55 oC when tested on both materials. |
Note
Where an initial test on either steel or aluminium indicates the substance or mixture being tested is corrosive the follow up test on the other metal is not required.
2.16.3. Hazard Communication
Label elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.16.2.
Table 2.16.2
Label elements for substances and mixtures corrosive to metals
|
Classification |
Category 1 |
|
GHS Pictogram |
|
|
Signal Word |
Warning |
|
Hazard Statement |
H290: May be corrosive to metals |
|
Precautionary Statement Prevention |
P234 |
|
Precautionary Statement Response |
P390 |
|
Precautionary Statement Storage |
P406 |
|
Precautionary Statement Disposal |
|
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.
2.16.4. Additional Classification Considerations
2.16.4.1. The corrosion rate can be measured according to the test method of Part III sub-section 37.4 of the ►M4 UN RTDG ◄ , Manual of Tests and Criteria. The specimen to be used for the test shall be made of the following materials:
for the purposes of testing steel, steel types
for the purposes of testing aluminium: non-clad types 7075-T6 or AZ5GU-T6.
3. PART 3: HEALTH HAZARDS
3.1. Acute toxicity
3.1.1. Definitions
3.1.1.1. Acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.
3.1.1.2. The hazard class Acute Toxicity is differentiated into:
3.1.2. Criteria for classification of substances as acutely toxic
3.1.2.1. ►M12 Substances can be allocated to one of four hazard 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.
Table 3.1.1
Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories
|
Exposure route |
Category 1 |
Category 2 |
Category 3 |
Category 4 |
|
|
Oral (mg/kg bodyweight) |
ATE ≤ 5 |
5 < ATE ≤ 50 |
50 < ATE ≤ 300 |
300 < ATE ≤ 2 000 |
|
|
See: |
Note (a) Note (b) |
||||
|
Dermal (mg/kg bodyweight) |
ATE ≤ 50 |
50 < ATE ≤ 200 |
200 < ATE ≤ 1 000 |
1 000 < ATE ≤ 2 000 |
|
|
See: |
Note (a) Note (b) |
||||
|
Gases (ppmV (1)) |
ATE ≤ 100 |
100 < ATE ≤ 500 |
500 < ATE ≤ 2 500 |
2 500 < ATE ≤ 20 000 |
|
|
see: |
Note (a) Note (b) Note (c) |
||||
|
Vapours (mg/l) |
ATE ≤ 0,5 |
0,5 < ATE ≤ 2,0 |
2,0 < ATE ≤ 10,0 |
10,0 < ATE ≤ 20,0 |
|
|
see: |
Note (a) Note (b) Note (c) Note (d) |
||||
|
Dusts and mists (mg/l) |
ATE ≤ 0,05 |
0,05 < ATE ≤ 0,5 |
0,5 < ATE ≤ 1,0 |
1,0 < ATE ≤ 5,0 |
|
|
see: |
Note (a) Note (b) Note (c) |
||||
|
(1) Gas concentrations are expressed in parts per million per volume (ppmV). |
|||||
Notes to Table 3.1.1:
The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where available.
The acute toxicity estimate (ATE) for the classification of a substance in a mixture is derived using:
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.
For some substances the test atmosphere will not just be a vapour but will consist of a mixture of liquid and vapour phases. For other substances the test atmosphere may consist of a vapour which is near the gaseous phase. In these latter cases, classification shall be based on ppmV as follows: Category 1 (100 ppmV), Category 2 (500 ppmV), Category 3 (2 500 ppmV), Category 4 (20 000 ppmV).
The terms ‘dust’, ‘mist’ and ‘vapour’ are defined as follows:
Dust is generally formed by mechanical processes. Mist is generally formed by condensation of supersaturated vapours or by physical shearing of liquids. Dusts and mists generally have sizes ranging from less than 1 to about 100 μm.
3.1.2.2. Specific considerations for classification of substances as acutely toxic
3.1.2.2.1. The preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat, while the rat or rabbit are preferred for evaluation of acute dermal toxicity. When experimental data for acute toxicity are available in several animal species, scientific judgement shall be used in selecting the most appropriate LD50 value from among valid, well-performed tests.
3.1.2.3. Specific considerations for classification of substances as acutely toxic by the inhalation route
3.1.2.3.1. Units for inhalation toxicity are a function of the form of the inhaled material. Values for dusts and mists are expressed in mg/l. Values for gases are expressed in ppmV. Acknowledging the difficulties in testing vapours, some of which consist of mixtures of liquid and vapour phases, the table provides values in units of mg/l. However, for those vapours which are near the gaseous phase, classification shall be based on ppmV.
3.1.2.3.2. ►M12 Of particular importance in classifying for inhalation toxicity is the use of well articulated values in the highest hazard categories for dusts and mists. ◄ Inhaled particles between 1 and 4 microns mean mass aerodynamic diameter (MMAD) will deposit in all regions of the rat respiratory tract. This particle size range corresponds to a maximum dose of about 2 mg/l. In order to achieve applicability of animal experiments to human exposure, dusts and mists would ideally be tested in this range in rats.
3.1.2.3.3. In addition to classification for inhalation toxicity, if data are available that indicates that the mechanism of toxicity was corrosivity, the substance or mixture shall also be labelled as ‘corrosive to the respiratory tract’ (see note 1 in 3.1.4.1). Corrosion of the respiratory tract is defined by destruction of the respiratory tract tissue after a single, limited period of exposure analogous to skin corrosion; this includes destruction of the mucosa. The corrosivity evaluation can be based on expert judgment using such evidence as: human and animal experience, existing (in vitro) data, pH values, information from similar substances or any other pertinent data.
3.1.3. Criteria for classification of mixtures as acutely toxic
3.1.3.1. The criteria for classification of substances for acute toxicity as outlined in section 3.1.2 are based on lethal dose data (tested or derived). For mixtures, it is necessary to obtain or derive information that allows the criteria to be applied to the mixture for the purpose of classification. The approach to classification for acute toxicity is tiered, and is dependent upon the amount of information available for the mixture itself and for its ingredients. The flow chart of Figure 3.1.1 outlines the process to be followed.
3.1.3.2. For acute toxicity each route of exposure shall be considered for the classification of mixtures, but only one route of exposure is needed as long as this route is followed (estimated or tested) for all components and there is no relevant evidence to suggest acute toxicity by multiple routes. When there is relevant evidence of toxicity by multiple routes of exposure, classification is to be conducted for all appropriate routes of exposure. All available information shall be considered. The pictogram and signal word used shall reflect the most severe hazard category and all relevant hazard statements shall be used.
3.1.3.3. In order to make use of all available data for purposes of classifying the hazards of the mixtures, certain assumptions have been made and are applied where appropriate in the tiered approach:
the ‘relevant ingredients’ of a mixture are those which are present in concentrations of 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases) or greater, unless there is a reason to suspect that an ingredient present at a concentration of less than 1 % is still relevant for classifying the mixture for acute toxicity (see Table 1.1).
where a classified mixture is used as an ingredient of another mixture, the actual or derived acute toxicity estimate (ATE) for that mixture may be used, when calculating the classification of the new mixture using the formulas in section 3.1.3.6.1 and paragraph 3.1.3.6.2.3.
If the converted acute toxicity point estimates for all components of a mixture are within the same category, then the mixture should be classified in that category.
When only range data (or acute toxicity hazard category information) are available for components in a mixture, they may be converted to point estimates in accordance with Table 3.1.2 when calculating the classification of the new mixture using the formulas in sections 3.1.3.6.1 and 3.1.3.6.2.3.
Figure 3.1.1
Tiered approach to classification of mixtures for acute toxicity
3.1.3.4. Classification of mixtures where acute toxicity data are available for the complete mixture
3.1.3.4.1. Where the mixture itself has been tested to determine its acute toxicity, it shall be classified according to the same criteria as those used for substances, presented in Table 3.1.1. If test data for the mixture are not available, the procedures presented under sections 3.1.3.5 and 3.1.3.6 shall be followed.
3.1.3.5. Classification of mixtures where acute toxicity data are available for the complete mixture: bridging principles
3.1.3.5.1. Where the mixture itself has not been tested to determine its acute toxicity, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in section 1.1.3.
3.1.3.5.2. If a tested mixture is diluted with a diluent that has an equivalent or lower toxicity classification than the least toxic original components, and which is not expected to affect the toxicity of other components, then the new diluted mixture may be classified as equivalent to the original tested mixture. Alternatively, the formula explained in section 3.1.3.6.1 can be applied.
3.1.3.6. Classification of mixtures based on ingredients of the mixture (Additivity formula)
3.1.3.6.1.
In order to ensure that classification of the mixture is accurate, and that the calculation need only be performed once for all systems, sectors, and categories, the acute toxicity estimate (ATE) of ingredients shall be considered as follows:
►M12 include ingredients with a known acute toxicity, which fall into any of the acute hazard categories shown in Table 3.1.1; ◄
ignore ingredients that are presumed not acutely toxic (e.g., water, sugar);
ignore components if the data available are from a limit dose test (at the upper threshold for Category 4 for the appropriate route of exposure as provided in Table 3.1.1) and do not show acute toxicity.
Components that fall within the scope of this section are considered to be components with a known acute toxicity estimate (ATE). See note (b) to Table 3.1.1 and section 3.1.3.3 for appropriate application of available data to the equation below, and section 3.1.3.6.2.3.
The ATE of the mixture is determined by calculation from the ATE values for all relevant ingredients according to the following formula for Oral, Dermal or Inhalation Toxicity:
where:
|
Ci |
= |
concentration of ingredient i ( % w/w or % v/v) |
|
i |
= |
the individual ingredient from 1 to n |
|
n |
= |
the number of ingredients |
|
ATEi |
= |
Acute Toxicity Estimate of ingredient i. |
3.1.3.6.2.
3.1.3.6.2.1. Where an ATE is not available for an individual ingredient of the mixture, but available information, such as that listed below, can provide a derived conversion value such as those laid out in Table 3.1.2, the formula in section 3.1.3.6.1 shall be applied.
This includes evaluation of:
extrapolation between oral, dermal and inhalation acute toxicity estimates ( 11 ). Such an evaluation could require appropriate pharmacodynamic and pharmacokinetic data;
evidence from human exposure that indicates toxic effects but does not provide lethal dose data;
evidence from any other toxicity tests/assays available on the substance that indicates toxic acute effects but does not necessarily provide lethal dose data; or
data from closely analogous substances using structure/activity relationships.
This approach generally requires substantial supplemental technical information, and a highly trained and experienced expert (expert judgement, see section 1.1.1), to reliably estimate acute toxicity. If such information is not available, proceed to paragraph 3.1.3.6.2.3.
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:
Table 3.1.2
Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for use in the formulas for the classification of mixtures
|
Exposure routes |
Classification Category or experimentally obtained acute toxicity range estimate |
Converted acute toxicity point estimate (see Note 1) |
|
Oral (mg/kg bodyweight) |
0 < Category 1 ≤ 5 5 < Category 2 ≤ 50 50 < Category 3 ≤ 300 300 < Category 4 ≤ 2 000 |
0,5 5 100 500 |
|
Dermal (mg/kg bodyweight) |
0 < Category 1 ≤ 50 50 < Category 2 ≤ 200 200 < Category 3 ≤ 1 000 1 000 < Category 4 ≤ 2 000 |
5 50 300 1 100 |
|
Gases (ppmV) |
0 < Category 1 ≤ 100 100 < Category 2 ≤ 500 500 < Category 3 ≤ 2 500 2 500 < Category 4 ≤ 20 000 |
10 100 700 4 500 |
|
Vapours (mg/l) |
0 < Category 1 ≤ 0,5 0,5 < Category 2 ≤ 2,0 2,0 < Category 3 ≤ 10,0 10,0 < Category 4 ≤ 20,0 |
0,05 0,5 3 11 |
|
Dust/mist (mg/l) |
0< Category 1 ≤ 0,05 0,05 < Category 2 ≤ 0,5 0,5 < Category 3 ≤ 1,0 1,0 < Category 4 ≤ 5,0 |
0,005 0,05 0,5 1,5 |
Note 1
These values are designed to be used in the calculation of the ATE for classification of a mixture based on its components and do not represent test results.
3.1.4. Hazard Communication
3.1.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.1.3. ►M2 Without prejudice to Article 27, combined hazard statements may be used in accordance with Annex III. ◄
Table 3.1.3
Acute toxicity label elements
|
Classification |
Category 1 |
Category 2 |
Category 3 |
Category 4 |
|
GHS Pictograms |
|
|
|
|
|
Signal Word |
Danger |
Danger |
Danger |
Warning |
|
Hazard Statement: — Oral |
H300: Fatal if swallowed |
H300: Fatal if swallowed |
H301: Toxic if swallowed |
H302: Harmful if swallowed |
|
— Dermal |
H310:Fatal in contact with skin |
H310:Fatal in contact with skin |
H311: Toxic in contact with skin |
H312: Harmful in contact with skin |
|
— Inhalation (see Note 1) |
H330:Fatal if inhaled |
H330: Fatal if inhaled |
H331: Toxic if inhaled |
H332: Harmful if inhaled |
|
Precautionary Statement Prevention (oral) |
P264 P270 |
P264 P270 |
P264 P270 |
P264 P270 |
|
Precautionary Statement Response (oral) |
P301 + P310 P321 P330 |
P301 + P310 P321 P330 |
P301 + P310 P321 P330 |
P301 + P312 P330 |
|
Precautionary Statement Storage (oral) |
P405 |
P405 |
P405 |
|
|
Precautionary Statement Disposal (oral) |
P501 |
P501 |
P501 |
P501 |
|
Precautionary Statement Prevention (dermal) |
P262 P264 P270 P280 |
P262 P264 P270 P280 |
P280 |
P280 |
|
Precautionary Statement Response (dermal) |
P302 + P352 P310 P321 P361 + P364 |
P302 + P352 P310 P321 P361 + P364 |
P302 + P352 P312 P321 P361 + P364 |
P302 + P352 P312 P321 P362 + P364 |
|
Precautionary Statement Storage (dermal) |
P405 |
P405 |
P405 |
|
|
Precautionary Statement Disposal (dermal) |
P501 |
P501 |
P501 |
P501 |
|
Precautionary Statement Prevention (inhalation) |
P260 P271 P284 |
P260 P271 P284 |
P261 P271 |
P261 P271 |
|
Precautionary Statement Response (inhalation) |
P304 + P340 P310 P320 |
P304 + P340 P310 P320 |
P304 + P340 P311 P321 |
P304 + P340 P312 |
|
Precautionary Statement Storage (inhalation) |
P403 + P233 P405 |
P403 + P233 P405 |
P403 + P233 P405 |
|
|
Precautionary Statement Disposal (inhalation) |
P501 |
P501 |
P501 |
|
Note 1
In addition to classification for inhalation toxicity, if data are available that indicates that the mechanism of toxicity is corrosivity, the substance or mixture shall also be labelled as EUH071: ‘corrosive to the respiratory tract’ — see advice at 3.1.2.3.3. In addition to an appropriate acute toxicity pictogram, a corrosivity pictogram (used for skin and eye corrosivity) may be added together with the statement ‘corrosive to the respiratory tract’.
Note 2
In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1 % or greater, the mixture shall be labelled with the additional statement that ‘x percent of the mixture consists of ingredient(s) of unknown toxicity’ — see advice at 3.1.3.6.2.2.
3.1.4.2. The acute toxicity hazard statements differentiate the hazard based on the route of exposure. Communication of acute toxicity classification should also reflect this differentiation. If a substance or mixture is classified for more than one route of exposure then all relevant classifications should be communicated on the safety data sheet as specified in Annex II to Regulation (EC) No 1907/2006 and the relevant hazard communication elements included on the label as prescribed in section 3.1.3.2. If the statement ‘x % of the mixture consists of ingredient(s) of unknown acute toxicity’ is communicated, as prescribed in section 3.1.3.6.2.2, then, in the information provided in the safety data sheet, it can also be differentiated based on the route of exposure. For example, ‘x % of the mixture consists of ingredient(s) of unknown acute oral toxicity’ and ‘x % of the mixture consists of ingredient(s) of unknown acute dermal toxicity’.
3.2. Skin corrosion/irritation
3.2.1. Definitions and general considerations
|
3.2.1.1. |
Skin corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions.
Skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
|
|
3.2.1.2. |
In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data and then other sources of information. Classification results directly when the data satisfy the criteria. In some cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of skin corrosion/irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5). |
3.2.2. Classification criteria for substances
Substances shall be allocated to one of the following two categories within this hazard class:
Category 1 (skin corrosion)
This category is further subdivided in three sub-categories (1A, 1B, 1C). Corrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation. When data are sufficient, substances shall be classified in one of the three sub-categories 1A, 1B, or 1C (see Table 3.2.1.)
Category 2 (skin irritation) (see Table 3.2.2).
3.2.2.1. Classification based on standard animal test data
3.2.2.1.1.
3.2.2.1.1.1. A substance is corrosive to skin when it produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis in at least one tested animal after exposure for up to 4 hours.
3.2.2.1.1.2. Corrosive substances shall be classified in Category 1 where data is not sufficient for sub-categorisation.
3.2.2.1.1.3. When data are sufficient substances shall be classified in one of the three sub-categories 1A, 1B, or 1C in accordance with the criteria in Table 3.2.1.
3.2.2.1.1.4. Three sub-categories are provided within the corrosion category: sub-category 1A — where corrosive responses are noted following up to 3 minutes exposure and up to 1 hour observation; sub-category 1B — where corrosive responses are described following exposure greater than 3 minutes and up to 1 hour and observations up to 14 days; and sub-category 1C — where corrosive responses occur after exposures greater than 1 hour and up to 4 hours and observations up to 14 days.
Table 3.2.1
Skin corrosion category and sub-categories
|
Category |
Criteria |
|
Category 1 (1) |
Destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least one tested animal after exposure ≤ 4 h |
|
Sub-Category 1A |
Corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h |
|
Sub-Category 1B |
Corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days |
|
Sub-Category 1C |
Corrosive responses in at least one animal after exposures > 1 h and ≤ 4 h and observations ≤ 14 days |
|
(1) See the conditions for the use of Category 1 in paragraph (a) of Section 3.2.2. |
|
3.2.2.1.1.5. The use of human data is discussed in Sections 3.2.1.2 and 3.2.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.
3.2.2.1.2.
3.2.2.1.2.1. A substance is irritant to skin when it produces reversible damage to the skin following its application for up to 4 hours. The major criterion for the irritation category is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 and ≤ 4,0.
3.2.2.1.2.2. A single irritation category (Category 2) is presented in Table 3.2.2, using the results of animal testing.
3.2.2.1.2.3. Reversibility of skin lesions is also considered in evaluating irritant responses. When inflammation persists to the end of the observation period in 2 or more test animals, taking into consideration alopecia (limited area), hyperkeratosis, hyperplasia and scaling, then a material shall be considered to be an irritant.
3.2.2.1.2.4. Animal irritant responses within a test can be variable, as they are with corrosion. A separate irritant criterion accommodates cases where there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfil this criterion. However, it should be ascertained that the responses are the result of chemical exposure.
Table 3.2.2
Skin irritation category ()
|
Category |
Criteria |
|
Irritation (Category 2) |
(1) Mean score of ≥ 2,3 and ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or (2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling reactions; or (3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above . |
|
(1) Grading criteria are understood as described in Regulation (EC) No 440/2008. |
|
3.2.2.1.2.5. The use of human data is discussed in Sections 3.2.1.2 and 3.2.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.
3.2.2.2. Classification in a tiered approach
|
3.2.2.2.1. |
A tiered approach to the evaluation of initial information shall be considered, where applicable, recognising that not all elements may be relevant. |
|
3.2.2.2.2. |
Existing human and animal data including information from single or repeated exposure shall be the first line of evaluation, as they give information directly relevant to effects on the skin. |
|
3.2.2.2.3. |
Acute dermal toxicity data may be used for classification. If a substance is highly toxic by the dermal route, a skin corrosion/irritation study is not practicable since the amount of test substance to be applied considerably exceeds the toxic dose and, consequently, results in the death of the animals. When observations are made of skin corrosion/irritation in acute toxicity studies and are observed up through the limit dose, these data may be used for classification, provided that the dilutions used and species tested are equivalent. Solid substances (powders) may become corrosive or irritant when moistened or in contact with moist skin or mucous membranes. |
|
3.2.2.2.4. |
In vitro alternatives that have been validated and accepted shall be used to make classification decisions. |
|
3.2.2.2.5. |
Likewise, pH extremes like ≤ 2 and ≥ 11,5 may indicate the potential to cause skin effects, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally, such substances are expected to produce significant effects on the skin. In the absence of any other information, a substance is considered as corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test. |
|
3.2.2.2.6. |
In some cases, sufficient information may be available from structurally related substances to make classification decisions. |
|
3.2.2.2.7. |
The tiered approach provides guidance on how to organize existing information on a substance and to make a weight of evidence decision about hazard assessment and hazard classification. Although information might be gained from the evaluation of single parameters within a tier (see Section 3.2.2.2.1.), consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters. |
3.2.3. Classification criteria for mixtures
3.2.3.1. Classification of mixtures when data are available for the complete mixture
|
3.2.3.1.1. |
The mixture shall be classified using the criteria for substances, taking into account the tiered approach to evaluate data for this hazard class. |
|
3.2.3.1.2. |
When considering testing of the mixture, classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and irritation (Sections 3.2.1.2 and 3.2.2.2), to help ensure an accurate classification as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the mixture may not be corrosive despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test. |
3.2.3.2. Classification of mixtures when data are not available for the complete mixture: bridging principles
|
3.2.3.2.1. |
Where the mixture itself has not been tested to determine its skin corrosion/irritation potential, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3. |
3.2.3.3. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
|
3.2.3.3.1. |
In order to make use of all available data for purposes of classifying the skin corrosion/irritation hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach: The ‘relevant ingredients’ of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g., in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for skin corrosion/irritation. |
|
3.2.3.3.2. |
In general, the approach to classification of mixtures as corrosive or irritant to skin when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or skin irritant ingredient contributes to the overall skin corrosive or skin irritant properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as skin irritant. The mixture is classified as corrosive or irritant to skin when the sum of the concentrations of such ingredients exceeds a concentration limit. |
|
3.2.3.3.3. |
Table 3.2.3 provides the generic concentration limits to be used to determine if the mixture is considered to be corrosive or irritant to the skin. |
|
3.2.3.3.4.1. |
Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.2.3.3.1 and 3.2.3.3.2 may not be applicable given that many such substances are corrosive or irritant to the skin at concentrations < 1 %. |
|
3.2.3.3.4.2. |
For mixtures containing strong acids or bases the pH shall be used as a classification criterion (see Section 3.2.3.1.2) since pH is a better indicator of skin corrosion than the concentration limits in Table 3.2.3. |
|
3.2.3.3.4.3. |
A mixture containing ingredients that are corrosive or irritant to the skin and that cannot be classified on the basis of the additivity approach (Table 3.2.3), due to chemical characteristics that make this approach unworkable, shall be classified as Skin Corrosion Category 1 if it contains ≥ 1 % of an ingredient classified as Skin Corrosion or as Skin Irritation (Category 2) when it contains ≥ 3 % of an skin irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.2.3 does not apply is summarised in Table 3.2.4. |
|
3.2.3.3.5. |
On occasion, reliable data may show that the skin corrosion/irritation hazard of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4 in Section 3.2.3.3.6. In these cases the mixture shall be classified according to that data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazard of an ingredient is not evident when present at a level at or above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4, testing of the mixture shall be considered. In those cases the tiered weight of evidence approach shall be applied, as described in Section 3.2.2.2. |
|
3.2.3.3.6. |
If there are data showing that (an) ingredient(s) is/are corrosive or irritant to skin at a concentration of < 1 % (skin corrosive) or < 3 % (skin irritant), the mixture shall be classified accordingly.
Table 3.2.3 Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C)/skin irritation (Category 2) that trigger classification of the mixture as skin corrosion/skin irritation where the additivity approach applies
Note: The sum of all ingredients of a mixture classified as Skin Corrosion Sub-Category 1A, 1B, or 1C respectively, shall each be ≥ 5 % in order to classify the mixture as either Skin Corrosion Sub-Category 1A, 1B or 1C. If the sum of the ingredients classified as Skin Corrosion Sub-Category 1A is < 5 % but the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B is ≥ 5 %, the mixture shall be classified as Skin Corrosion Sub-Category 1B. Similarly, if the sum of ingredients classified as Skin Corrosion Sub-Category 1A + 1B ingredients is < 5 % but the sum of ingredients classified as Sub-Category 1A + 1B + 1C is ≥ 5 % the mixture shall be classified as Skin Corrosion Sub-Category 1C. Where at least one relevant ingredient in a mixture is classified as Category 1 without sub-categorisation, the mixture shall be classified as Category 1 without sub-categorisation if the sum of all ingredients corrosive to skin is ≥ 5 %.
Table 3.2.4 Generic concentration limits of ingredients that trigger classification of the mixture as skin corrosion/skin irritation, where the additivity approach does not apply
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3.2.4. Hazard Communication
|
3.2.4.1. |
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.2.5.
Table 3.2.5 Label elements for skin corrosion/irritation
|
3.3. Serious eye damage/eye irritation
3.3.1. Definitions and general considerations
|
3.3.1.1. |
Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
|
|
3.3.1.2. |
In a tiered approach, emphasis shall be placed upon existing human data, followed by existing animal data, followed by in vitro data, and then other sources of information. Classification results directly when the data satisfy the criteria. In other cases, classification of a substance or a mixture is made on the basis of the weight of evidence within a tier. In a total weight of evidence approach all available information bearing on the determination of serious eye damage/eye irritation is considered together, including the results of appropriate validated in vitro tests, relevant animal data, and human data such as epidemiological and clinical studies and well-documented case reports and observations (see Annex I, Part 1, Section 1.1.1.3). |
3.3.2. Classification criteria for substances
Substances are allocated to one of the categories within this hazard class, Category 1 (serious eye damage) or Category 2 (eye irritation), as follows:
Category 1 (serious eye damage):
substances that have the potential to seriously damage the eyes (see Table 3.3.1).
Category 2 (eye irritation):
substances that have the potential to induce reversible eye irritation (see Table 3.3.2).
3.3.2.1. Classification based on standard animal test data
3.3.2.1.1.
3.3.2.1.1.1. A single hazard category (Category 1) is adopted for substances that have the potential to seriously damage the eyes. This hazard category includes as criteria the observations listed in Table 3.3.1. These observations include animals with grade 4 cornea lesions and other severe reactions (e.g. destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Hazard classification as Category 1 also contains substances fulfilling the criteria of corneal opacity ≥ 3 or iritis > 1,5 observed in at least 2 of 3 tested animals, because severe lesions like these usually do not reverse within a 21-day observation period.
3.3.2.1.1.2. The use of human data is discussed in Section 3.3.2.2 and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.
Table 3.3.1
Serious eye damage ()
|
Category |
Criteria |
|
Category 1 |
A substance that produces: (a) in at least one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or (b) in at least 2 of 3 tested animals, a positive response of: (i) corneal opacity ≥ 3; and/or (ii) iritis > 1,5; calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material. |
|
(1) Grading criteria are understood as described in Regulation (EC) No 440/2008. |
|
3.3.2.1.2.
3.3.2.1.2.1. Substances that have the potential to induce reversible eye irritation shall be classified in Category 2 (eye irritation).
3.3.2.1.2.2. For those substances where there is pronounced variability among animal responses, this information shall be taken into account in determining the classification.
3.3.2.1.2.3. The use of human data is addressed in Sections 3.3.2.2, and also in Sections 1.1.1.3, 1.1.1.4 and 1.1.1.5.
Table 3.3.2
Eye irritation ()
|
Category |
Criteria |
|
Category 2 |
Substances that produce in at least 2 of 3 tested animals a positive response of: (a) corneal opacity ≥ 1; and/or (b) iritis ≥ 1; and/or (c) conjunctival redness ≥ 2; and/or (d) conjunctival oedema (chemosis) ≥ 2 calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material, and which fully reverses within an observation period of normally 21 days. |
|
(1) Grading criteria are understood as described in Regulation (EC) No 440/2008. |
|
3.3.2.2. Classification in a tiered approach
|
3.3.2.2.1. |
A tiered approach to the evaluation of initial information shall be considered where applicable, recognizing that not all elements may be relevant. |
|
3.3.2.2.2. |
Existing human and animal data shall be the first line of evaluation as they give information directly relevant to effects on the eye. Possible skin corrosion has to be evaluated prior to consideration of any testing for serious eye damage/eye irritation in order to avoid testing for local effects on eyes with skin corrosive substances. Skin corrosive substances shall be considered as leading to serious eye damage (Category 1) as well, while skin irritant substances may be considered as leading to eye irritation (Category 2). |
|
3.3.2.2.3. |
In vitro alternatives that have been validated and accepted shall be used to make classification decisions. |
|
3.3.2.2.4. |
Likewise, pH extremes like ≤ 2 and ≥ 11,5, may indicate serious eye damage, especially when associated with significant acid/alkaline reserve (buffering capacity). Generally such substances are expected to produce significant effects on the eyes. In the absence of any other information, a substance is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkaline reserve suggests the substance may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably by data from an appropriate validated in vitro test. |
|
3.3.2.2.5. |
In some cases sufficient information may be available from structurally related substances to make classification decisions. |
|
3.3.2.2.6. |
The tiered approach provides guidance on how to organize existing information and to make a weight-of-evidence decision about hazard assessment and hazard classification. Animal testing with corrosive substances shall be avoided whenever possible. Although information might be gained from the evaluation of single parameters within a tier (see 3.3.2.1.1) consideration shall be given to the totality of existing information and making an overall weight of evidence determination. This is especially true when there is conflict in information available on some parameters. |
3.3.3. Classification criteria for mixtures
3.3.3.1. Classification of mixtures when data are available for the complete mixture
|
3.3.3.1.1. |
The mixture shall be classified using the criteria for substances, and taking into account the tiered approach to evaluate data for this hazard class. |
|
3.3.3.1.2. |
When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence approach as included in the criteria for classification of substances for skin corrosion and serious eye damage/eye irritation to help ensure an accurate classification, as well as to avoid unnecessary animal testing. In the absence of any other information, a mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2 or ≥ 11,5. However, if consideration of acid/alkali reserve suggests the mixture may not cause serious eye damage despite the low or high pH value, this needs to be confirmed by other data, preferably data from an appropriate validated in vitro test. |
3.3.3.2. Classification of mixtures when data are not available for the complete mixture: bridging principles
|
3.3.3.2.1. |
Where the mixture itself has not been tested to determine its skin corrosivity or potential to cause serious eye damage/eye irritation, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in Section 1.1.3. |
3.3.3.3. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
|
3.3.3.3.1. |
In order to make use of all available data for purposes of classifying the serious eye damage/eye irritation properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach: The ‘relevant ingredients’ of a mixture are those which are present in concentrations ≥ 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases), unless there is a presumption (e.g. in the case of skin corrosive ingredients) that an ingredient present at a concentration < 1 % can still be relevant for classifying the mixture for serious eye damage/eye irritation. |
|
3.3.3.3.2. |
In general, the approach to classification of mixtures as seriously damaging to the eye/eye irritant when data are available on the ingredients, but not on the mixture as a whole, is based on the theory of additivity, such that each skin corrosive or serious eye damaging/eye irritant ingredient contributes to the overall serious eye damage/eye irritation properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for skin corrosive and serious eye damaging ingredients when they are present at a concentration below the generic concentration limit for classification with Category 1, but are at a concentration that will contribute to the classification of the mixture as eye irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such ingredients exceeds a concentration limit. |
|
3.3.3.3.3. |
Table 3.3.3 provides the generic concentration limits to be used to determine if the mixture shall be classified as seriously damaging to the eye or as eye irritant. |
|
3.3.3.3.4.1. |
Particular care must be taken when classifying certain types of mixtures containing substances such as acids and bases, inorganic salts, aldehydes, phenols, and surfactants. The approach explained in Sections 3.3.3.3.1 and 3.3.3.3.2 might not work given that many such substances are seriously damaging to the eye/eye irritant at concentrations < 1 %. |
|
3.3.3.3.4.2. |
For mixtures containing strong acids or bases the pH shall be used as classification criterion (see Section 3.3.3.1.2) since pH will be a better indicator of serious eye damage (subject to consideration of acid/alkali reserve) than the generic concentration limits in Table 3.3.3. |
|
3.3.3.3.4.3. |
A mixture containing skin corrosive or serious eye damaging/eye irritating ingredients that cannot be classified based on the additivity approach (Table 3.3.3) due to chemical characteristics that make this approach unworkable, shall be classified as Serious Eye Damage (Category 1) if it contains ≥ 1 % of a skin corrosive or serious eye damaging ingredient and as Eye Irritation (Category 2) when it contains ≥ 3 % of an eye irritant ingredient. Classification of mixtures with ingredients for which the approach in Table 3.3.3 does not apply is summarised in Table 3.3.4. |
|
3.3.3.3.5. |
On occasion, reliable data may show that the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4 in Section 3.3.3.3.6. In these cases the mixture shall be classified according to those data (see also Articles 10 and 11). On other occasions, when it is expected that the skin corrosion/irritation hazards or the effects of serious eye damage/eye irritation of an ingredient will not be evident when present at a level at or above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered. In those cases, the tiered weight of evidence approach shall be applied. |
|
3.3.3.3.6. |
If there are data showing that (an) ingredient(s) may be corrosive to the skin or seriously damaging to the eye/eye irritating at a concentration of < 1 % (corrosive to the skin or seriously damaging to the eye) or < 3 % (eye irritant), the mixture shall be classified accordingly. |
Table 3.3.3
Generic concentration limits of ingredients classified as skin corrosion (Category 1, 1A, 1B or 1C) and/or serious eye damage (Category 1) or eye irritation (Category 2) that trigger classification of the mixture as serious eye damage/eye irritation where the additivity approach applies
|
Sum of ingredients classified as: |
Concentration triggering classification of a mixture as: |
|
|
Serious eye damage |
Eye irritation |
|
|
Category 1 |
Category 2 |
|
|
Skin corrosion Sub-Category 1A, 1B, 1C or Category 1 + Serious eye damage (Category 1) () |
≥ 3 % |
≥ 1 % but < 3 % |
|
Eye irritation (Category 2) |
|
≥ 10 % |
|
10 × (Skin corrosion Sub-Category 1A, 1B, 1C or Skin corrosion Category 1 + Serious eye damage (Category 1)) + Eye irritation (Category 2) |
|
≥ 10 % |
|
(1) If an ingredient is classified as both Skin Corrosion Sub-Category 1A, 1B, 1C or Category 1 and Serious Eye Damage (Category 1), its concentration is considered only once in the calculation. |
||
Table 3.3.4
Generic concentration limits of ingredients that trigger classification of the mixture as serious eye damage (Category 1) or eye irritation (Category 2), where the additivity approach does not apply
|
Ingredient |
Concentration |
Mixture classified as: |
|
Acid with pH ≤ 2 |
≥ 1 % |
Serious eye damage (Category 1) |
|
Base with pH ≥ 11,5 |
≥ 1 % |
Serious eye damage (Category 1) |
|
Other ingredient classified as skin corrosion (Sub-Category 1A, 1B, 1C or Category 1) or serious eye damage (Category 1) |
≥ 1 % |
Serious eye damage (Category 1) |
|
Other ingredient classified as eye irritation (Category 2) |
≥ 3 % |
Eye irritation (Category 2) |
3.3.4. Hazard Communication
|
3.3.4.1. |
Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.3.5.
Table 3.3.5 Label elements for serious eye damage/eye irritation ()
|
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3.4. Respiratory or skin sensitisation
3.4.1. Definitions and general considerations
3.4.1.1. Respiratory sensitiser means a substance that will lead to hypersensitivity of the airways following inhalation of the substance.
3.4.1.2. Skin sensitiser means a substance that will lead to an allergic response following skin contact.
3.4.1.3. For the purpose of section 3.4, sensitisation includes two phases: the first phase is induction of specialised immunological memory in an individual by exposure to an allergen. The second phase is elicitation, i.e. production of a cell-mediated or antibody-mediated allergic response by exposure of a sensitised individual to an allergen.
3.4.1.4. For respiratory sensitisation, the pattern of induction followed by elicitation phases is shared in common with skin sensitisation. For skin sensitisation, an induction phase is required in which the immune system learns to react; clinical symptoms can then arise when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). As a consequence, predictive tests usually follow this pattern in which there is an induction phase, the response to which is measured by a standardised elicitation phase, typically involving a patch test. The local lymph node assay is the exception, directly measuring the induction response. Evidence of skin sensitisation in humans normally is assessed by a diagnostic patch test.
3.4.1.5. Usually, for both skin and respiratory sensitisation, lower levels are necessary for elicitation than are required for induction. Provisions for alerting sensitised individuals to the presence of a particular sensitiser in a mixture can be found ►M2 in Annex II, section 2.8. ◄ .
3.4.1.6. The hazard class Respiratory or Skin Sensitisation is differentiated into:
3.4.2. Classification criteria for substances
3.4.2.1. Respiratory sensitisers
3.4.2.1.1. Hazard categories
|
3.4.2.1.1.1. |
Respiratory sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation. |
|
3.4.2.1.1.2. |
Where data are sufficient a refined evaluation according to 3.4.2.1.1.3 shall allow the allocation of respiratory sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other respiratory sensitisers. |
|
3.4.2.1.1.3. |
Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for respiratory sensitisers. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table 3.4.1 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals. |
|
3.4.2.1.1.4. |
Substances shall be classified as respiratory sensitisers in accordance with the criteria in Table 3.4.1:
Table 3.4.1 Hazard category and sub-categories for respiratory sensitisers
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3.4.2.1.2. Human evidence
|
3.4.2.1.2.1. |
Evidence that a substance can lead to specific respiratory hypersensitivity will normally be based on human experience. In this context, hypersensitivity is normally seen as asthma, but other hypersensitivity reactions such as rhinitis/conjunctivitis and alveolitis are also considered. The condition will have the clinical character of an allergic reaction. However, immunological mechanisms do not have to be demonstrated. |
|
3.4.2.1.2.2. |
When considering the human evidence, it is necessary for a decision on classification to take into account, in addition to the evidence from the cases:
(a)
the size of the population exposed;
(b)
the extent of exposure. The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5. |
|
3.4.2.1.2.3. |
The evidence referred to above could be:
(a)
clinical history and data from appropriate lung function tests related to exposure to the substance, confirmed by other supportive evidence which may include:
(i)
in vivo immunological test (e.g. skin prick test);
(ii)
in vitro immunological test (e.g. serological analysis);
(iii)
studies that indicate other specific hypersensitivity reactions where immunological mechanisms of action have not been proven, e.g. repeated low-level irritation, pharmacologically mediated effects;
(iv)
a chemical structure related to substances known to cause respiratory hypersensitivity;
(b)
data from one or more positive bronchial challenge tests with the substance conducted according to accepted guidelines for the determination of a specific hypersensitivity reaction. |
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3.4.2.1.2.4. |
Clinical history shall include both medical and occupational history to determine a relationship between exposure to a specific substance and development of respiratory hypersensitivity. Relevant information includes aggravating factors both in the home and workplace, the onset and progress of the disease, family history and medical history of the patient in question. The medical history shall also include a note of other allergic or airway disorders from childhood, and smoking history. |
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3.4.2.1.2.5. |
The results of positive bronchial challenge tests are considered to provide sufficient evidence for classification on their own. It is however recognised that in practice many of the examinations listed above will already have been carried out. |
3.4.2.1.3. Animal studies
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3.4.2.1.3.1. |
Data from appropriate animal studies ( 12 ) which may be indicative of the potential of a substance to cause sensitisation by inhalation in humans ( 13 ) may include:
(a)
measurements of Immunoglobulin E (IgE) and other specific immunological parameters in mice;
(b)
specific pulmonary responses in guinea pigs. |
3.4.2.2. Skin sensitisers
3.4.2.2.1. Hazard categories
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3.4.2.2.1.1. |
Skin sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation. |
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3.4.2.2.1.2. |
Where data are sufficient a refined evaluation according to section 3.4.2.2.1.3 allows the allocation of skin sensitisers into sub-category 1A, strong sensitisers, or sub-category 1B for other skin sensitisers. |
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3.4.2.2.1.3. |
Effects seen in either humans or animals will normally justify classification in a weight of evidence approach for skin sensitisers as described in section 3.4.2.2.2. Substances may be allocated to one of the two sub-categories 1A or 1B using a weight of evidence approach in accordance with the criteria given in Table 3.4.2 and on the basis of reliable and good quality evidence from human cases or epidemiological studies and/or observations from appropriate studies in experimental animals according to the guidance values provided in sections 3.4.2.2.2.1 and 3.4.2.2.3.2 for sub-category 1A and in sections 3.4.2.2.2.2 and 3.4.2.2.3.3 for sub-category 1B. |
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3.4.2.2.1.4. |
Substances shall be classified as skin sensitisers in accordance with the criteria in Table 3.4.2:
Table 3.4.2 Hazard category and sub-categories for skin sensitisers
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3.4.2.2.2. Human evidence
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3.4.2.2.2.1. |
Human evidence for sub-category 1A can include:
(a)
positive responses at ≤ 500 μg/cm2 (HRIPT, HMT — induction threshold);
(b)
diagnostic patch test data where there is a relatively high and substantial incidence of reactions in a defined population in relation to relatively low exposure;
(c)
other epidemiological evidence where there is a relatively high and substantial incidence of allergic contact dermatitis in relation to relatively low exposure. |
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3.4.2.2.2.2. |
Human evidence for sub-category 1B can include:
(a)
positive responses at > 500 μg/cm2 (HRIPT, HMT — induction threshold);
(b)
diagnostic patch test data where there is a relatively low but substantial incidence of reactions in a defined population in relation to relatively high exposure;
(c)
other epidemiological evidence where there is a relatively low but substantial incidence of allergic contact dermatitis in relation to relatively high exposure. The use of human data is discussed in sections 1.1.1.3, 1.1.1.4 and 1.1.1.5. |
3.4.2.2.3. Animal studies
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3.4.2.2.3.1. |
For Category 1, when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive. For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive. For Category 1, a stimulation index of three or more is considered a positive response in the local lymph node assay. Test methods for skin sensitisation are described in the OECD Guideline 406 (the Guinea Pig Maximisation test and the Buehler guinea pig test) and Guideline 429 (Local Lymph Node Assay). Other methods may be used provided that they are well-validated and scientific justification is given. For example, the mouse ear swelling test (MEST) could be a reliable screening test to detect moderate to strong sensitisers, and could be used as a first stage in the assessment of skin sensitisation potential. |
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3.4.2.2.3.2. |
Animal test results for sub-category 1A can include data with values indicated in Table 3.4.3
Table 3.4.3 Animal test results for sub-category 1A
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3.4.2.2.3.3. |
Animal test results for sub-category 1B can include data with values indicated in Table 3.4.4 below:
Table 3.4.4 Animal test results for sub-category 1B
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3.4.2.2.4. Specific considerations
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3.4.2.2.4.1. |
For classification of a substance, evidence should include any or all of the following using a weight of evidence approach:
(a)
positive data from patch testing, normally obtained in more than one dermatology clinic;
(b)
epidemiological studies showing allergic contact dermatitis caused by the substance. Situations in which a high proportion of those exposed exhibit characteristic symptoms are to be looked at with special concern, even if the number of cases is small;
(c)
positive data from appropriate animal studies;
(d)
positive data from experimental studies in man (see section 1.3.2.4.7);
(e)
well documented episodes of allergic contact dermatitis, normally obtained in more than one dermatology clinic;
(f)
severity of reaction may also be considered. |
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3.4.2.2.4.2. |
Evidence from animal studies is usually much more reliable than evidence from human exposure. However, in cases where evidence is available from both sources, and there is conflict between the results, the quality and reliability of the evidence from both sources must be assessed in order to resolve the question of classification on a case-by-case basis. Normally, human data are not generated in controlled experiments with volunteers for the purpose of hazard classification but rather as part of risk assessment to confirm lack of effects seen in animal tests. Consequently, positive human data on skin sensitisation are usually derived from case-control or other, less defined studies. Evaluation of human data must therefore be carried out with caution as the frequency of cases reflect, in addition to the inherent properties of the substances, factors such as the exposure situation, bioavailability, individual predisposition and preventive measures taken. Negative human data should not normally be used to negate positive results from animal studies. For both animal and human data, consideration should be given to the impact of vehicle. |
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3.4.2.2.4.3. |
If none of the abovementioned conditions are met, the substance need not be classified as a skin sensitiser. However, a combination of two or more indicators of skin sensitisation as listed below may alter the decision. This shall be considered on a case-by-case basis.
(a)
Isolated episodes of allergic contact dermatitis;
(b)
epidemiological studies of limited power, e.g. where chance, bias or confounders have not been ruled out fully with reasonable confidence;
(c)
data from animal tests, performed according to existing guidelines, which do not meet the criteria for a positive result described in section 3.4.2.2.3, but which are sufficiently close to the limit to be considered significant;
(d)
positive data from non-standard methods;
(e)
positive results from close structural analogues. |
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3.4.2.2.4.4. |
Immunological contact urticaria Substances meeting the criteria for classification as respiratory sensitisers may in addition cause immunological contact urticaria. Consideration should be given to classifying these substances also as skin sensitisers. Substances which cause immunological contact urticaria without meeting the criteria for respiratory sensitisers should also be considered for classification as skin sensitisers. There is no recognised animal model available to identify substances which cause immunological contact urticaria. Therefore, classification will normally be based on human evidence which will be similar to that for skin sensitisation. |
3.4.3. Classification criteria for mixtures
3.4.3.1. Classification of mixtures when data are available for the complete mixture
3.4.3.1.1. When reliable and good quality evidence from human experience or appropriate studies in experimental animals, as described in the criteria for substances, is available for the mixture, then the mixture can be classified by weight of evidence evaluation of these data. Care shall be exercised in evaluating data on mixtures, that the dose used does not render the results inconclusive.
3.4.3.2. Classification of mixtures when data are not available for the complete mixture: bridging principles