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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 (Text with EEA relevance)

ELI: http://data.europa.eu/eli/reg/2008/1272/2015-06-01
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2008R1272 — EN — 01.06.2015 — 005.001


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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

(Text with EEA relevance)

(OJ L 353 31.12.2008, p. 1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION REGULATION (EC) No 790/2009 of 10 August 2009

  L 235

1

5.9.2009

►M2

COMMISSION REGULATION (EU) No 286/2011 of 10 March 2011

  L 83

1

30.3.2011

►M3

COMMISSION REGULATION (EU) No 618/2012 of 10 July 2012

  L 179

3

11.7.2012

►M4

COMMISSION REGULATION (EU) No 487/2013 of 8 May 2013

  L 149

1

1.6.2013

►M5

COUNCIL REGULATION (EU) No 517/2013 of 13 May 2013

  L 158

1

10.6.2013

►M6

COMMISSION REGULATION (EU) No 758/2013 of 7 August 2013

  L 216

1

10.8.2013

►M7

COMMISSION REGULATION (EU) No 944/2013 of 2 October 2013

  L 261

5

3.10.2013

►M8

COMMISSION REGULATION (EU) No 605/2014 of 5 June 2014

  L 167

36

6.6.2014

►M9

COMMISSION REGULATION (EU) No 1297/2014 of 5 December 2014

  L 350

1

6.12.2014


Corrected by:

►C1

Corrigendum, OJ L 016, 20.1.2011, p.  1 (1272/2008)

►C2

Corrigendum, OJ L 138, 26.5.2011, p.  66 (286/2011)




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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

(Text with EEA relevance)



THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee ( 1 ),

Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 2 ),

Whereas:

(1)

This Regulation should ensure a high level of protection of human health and the environment as well as the free movement of chemical substances, mixtures and certain specific articles, while enhancing competitiveness and innovation.

(2)

The efficient functioning of the internal market for substances, mixtures and those articles can be achieved only if the requirements applicable to them do not differ significantly between Member States.

(3)

A high level of human health and environmental protection should be ensured in the approximation of legislation on the criteria for classification and labelling of substances and mixtures, with the goal of achieving sustainable development.

(4)

Trade in substances and mixtures is an issue relating not only to the internal market, but also to the global market. Enterprises should therefore benefit from the global harmonisation of rules for classification and labelling and from consistency between, on the one hand, the rules for classification and labelling for supply and use and, on the other hand, those for transport.

(5)

With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling have been carefully developed over a period of 12 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as ‘the GHS’).

(6)

This Regulation follows various declarations whereby the Community confirmed its intention to contribute to the global harmonisation of criteria for classification and labelling, not only at UN level, but also through the incorporation of the internationally agreed GHS criteria into Community law.

(7)

The benefits for enterprises will increase as more countries in the world adopt the GHS criteria in their legislation. The Community should be at the forefront of this process to encourage other countries to follow and with the aim of providing a competitive advantage to industry in the Community.

(8)

Therefore it is essential to harmonise the provisions and criteria for the classification and labelling of substances, mixtures and certain specific articles within the Community, taking into account the classification criteria and labelling rules of the GHS, but also by building on the 40 years of experience obtained through implementation of existing Community chemicals legislation and maintaining the level of protection achieved through the system of harmonisation of classification and labelling, through Community hazard classes not yet part of the GHS as well as through current labelling and packaging rules.

(9)

This Regulation should be without prejudice to the full and complete application of Community competition rules.

(10)

The objective of this Regulation should be to determine which properties of substances and mixtures should lead to a classification as hazardous, in order for the hazards of substances and mixtures to be properly identified and communicated. Such properties should include physical hazards as well as hazards to human health and to the environment, including hazards to the ozone layer.

(11)

This Regulation should, as a general principle, apply to all substances and mixtures supplied in the Community, except where other Community legislation lays down more specific rules on classification and labelling, such as Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products ( 3 ), Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition ( 4 ), Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ( 5 ), Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption ( 6 ), Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices ( 7 ), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ( 8 ), Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ( 9 ), Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council ( 10 ), Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 11 ), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 12 ), Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( 13 ) and Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition ( 14 ) or except where substances and mixtures are transported by air, sea, road, rail or inland waterways.

(12)

The terms and definitions used in this Regulation should be consistent with those set out in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( 15 ), with those set out in the rules governing transport and with the definitions specified at UN level in the GHS, in order to ensure maximum consistency in the application of chemicals legislation within the Community in the context of global trade. The hazard classes specified in the GHS should be set out in this Regulation for the same reason.

(13)

It is especially appropriate to include those hazard classes defined in the GHS which specifically take account of the fact that the physical hazards which may be exhibited by substances and mixtures are to some extent influenced by the way in which they are released.

(14)

The term ‘mixture’ as defined in this Regulation should have the same meaning as the term ‘preparation’ previously used in Community legislation.

(15)

This Regulation should replace Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ( 16 ) as well as Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ( 17 ). It should maintain the overall current level of protection of human health and the environment provided by those Directives. Therefore, some hazard classes which are covered by those Directives but are not yet included in the GHS should be maintained in this Regulation.

(16)

Responsibility for the identification of hazards of substances and mixtures and for deciding on their classification should mainly lie with manufacturers, importers and downstream users of those substances or mixtures, regardless of whether they are subject to the requirements of Regulation (EC) No 1907/2006. In fulfilling their responsibilities for classification, downstream users should be allowed to use the classification of a substance or mixture derived in accordance with this Regulation by an actor in the supply chain, provided that they do not change the composition of the substance or mixture. Responsibility for classification of substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006 should mainly lie with the manufacturers, producers of articles and importers. However, there should be a possibility to provide for harmonised classifications of substances for hazard classes of highest concern and of other substances on a case-by-case basis which should be applied by all manufacturers, importers and downstream users of such substances and of mixtures containing such substances.

(17)

Where a decision has been taken to harmonise the classification of a substance for a specific hazard class or differentiation within a hazard class by including or revising an entry for that purpose in Part 3 of Annex VI to this Regulation, the manufacturer, importer and downstream user should apply this harmonised classification, and only self-classify for the remaining, non-harmonised hazard classes or differentiations within the hazard class.

(18)

To ensure that customers receive information on hazards, suppliers of substances and mixtures should ensure that they are labelled and packaged in accordance with this Regulation before placing them on the market, according to the classification derived. In fulfilling their responsibilities downstream users should be allowed to use the classification of a substance or mixture derived in accordance with this Regulation by an actor in the supply chain, provided that they do not change the composition of the substance or mixture, and distributors should be allowed to use the classification of a substance or mixture derived in accordance with this Regulation by an actor in the supply chain.

(19)

To ensure information on hazardous substances is available when they are included in mixtures containing at least one substance that is classified as hazardous, supplemental labelling information should be provided, where applicable.

(20)

While a manufacturer, importer or downstream user of any substance or mixture should not be obliged to generate new toxicological or eco-toxicological data for the purpose of classification, he should identify all relevant information available to him on the hazards of the substance or mixture and evaluate its quality. The manufacturer, importer or downstream user should also take into account historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure and effect data, and clinical studies. That information should be compared with the criteria for the different hazard classes and differentiations in order for that manufacturer, importer or downstream user to arrive at a conclusion as to whether or not the substance or mixture should be classified as hazardous.

(21)

While the classification of any substance or mixture may be carried out on the basis of available information, the available information to be used for the purposes of this Regulation should preferably have been generated in accordance with the test methods referred to in Regulation (EC) No 1907/2006, transport provisions or international principles or procedures for the validation of information, so as to ensure quality and comparability of the results and consistency with other requirements at international or Community level. The same test methods, provisions, principles and procedures should be followed where the manufacturer, importer or downstream user chooses to generate new information.

(22)

To facilitate hazard identification for mixtures, manufacturers, importers and downstream users should base this identification on the data for the mixture itself, where available, except for mixtures with carcinogenic, germ cell mutagenic or reproductive toxic substances, or where the biodegradation or bioaccumulation properties in the hazard class hazardous to the aquatic environment are evaluated. In those cases, as the hazards of the mixture cannot be sufficiently assessed in a manner that is based on the mixture itself, the data for the individual substances of the mixture should normally be used as a basis for the hazard identification of the mixture.

(23)

If sufficient information is available on similar tested mixtures, including relevant ingredients of the mixtures, it is possible to determine the hazardous properties of an untested mixture by applying certain rules known as ‘bridging principles’. Those rules allow characterisation of the hazards of the mixture without performing tests on it, but rather by building on the available information on similar tested mixtures. Where no or inadequate test data are available for the mixture itself, manufacturers, importers and downstream users should therefore follow the bridging principles to ensure adequate comparability of results of the classification of such mixtures.

(24)

Specific industry sectors may establish networks to facilitate exchange of data and bring together expertise in the evaluation of information, test data, weight of evidence determinations and bridging principles. Such networks may support manufacturers, importers and downstream users within those industry sectors, and in particular small and medium-sized enterprises (SMEs) in the fulfilment of their obligations under this Regulation. Those networks may also be used to exchange information and best practices with a view to simplifying fulfilment of the notification obligations. Suppliers making use of such support should remain fully responsible for the fulfilment of their classification, labelling and packaging responsibilities under this Regulation.

(25)

The protection of animals falling within the scope of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes ( 18 ) is of high priority. Accordingly, where the manufacturer, importer or downstream user chooses to generate information for the purposes of this Regulation, they should first consider means other than testing on animals within the scope of Directive 86/609/EEC. Tests on non-human primates should be prohibited for the purposes of this Regulation.

(26)

The test methods in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( 19 ) are regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved. The European Centre for the Validation of Alternative Methods (ECVAM) of the Commission's Joint Research Centre plays an important role in the scientific assessment and validation of alternative test methods.

(27)

The classification and labelling criteria set out in this Regulation should take the utmost account of promoting alternative methods for the assessment of hazards of substances and mixtures and of the obligation to generate information on intrinsic properties by means other than tests on animals within the meaning of Directive 86/609/EEC as laid down in Regulation (EC) No 1907/2006. Future criteria should not become a barrier to this aim and the corresponding obligations under that Regulation, and should under no circumstances lead to the use of animal tests where alternative tests are adequate for the purposes of classification and labelling.

(28)

For the purposes of classification, data should not be generated by means of testing on humans. Available, reliable epidemiological data and experience with regard to the effects of substances and mixtures on humans (e.g. occupational data and data from accident databases) should be taken into account and may be given priority over data derived from animal studies when they demonstrate hazards not identified from those studies. The results of animal studies should be weighed against the results of data from humans and expert judgement should be used to ensure the best protection of human health when evaluating both the animal and human data.

(29)

New information as regards physical hazards should always be necessary, except if the data are already available or if a derogation is provided for in this Regulation.

(30)

Testing that is carried out for the sole purpose of this Regulation should be carried out on the substance or 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. It should, however, be possible to use, for the purpose of this Regulation, the results of tests that are carried out to comply with other regulatory requirements, including those laid down by third countries, even if the tests were not carried out on the substance or mixture in the form(s) or physical state(s) in which it is placed on the market and in which it can reasonably be expected to be used.

(31)

If tests are performed, they should comply where appropriate with the relevant requirements for the protection of laboratory animals, set out in Directive 86/609/EEC, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances ( 20 ).

(32)

The criteria for classification in different hazard classes and differentiations should be set out in an annex, which should also contain additional provisions as to how the criteria may be met.

(33)

Recognising that the application of the criteria for the different hazard classes to information is not always straightforward and simple, manufacturers, importers and downstream users should apply weight of evidence determinations involving expert judgement to arrive at adequate results.

(34)

Specific concentration limits for substances should be assigned to a substance by a manufacturer, importer or downstream user in accordance with the criteria referred to in this Regulation, provided the manufacturer, importer or downstream user is able to justify the limits and informs the European Chemicals Agency (hereinafter referred to as ‘the Agency’) accordingly. However, specific concentration limits should not be set for harmonised hazard classes or differentiations for substances included in the harmonised classification and labelling tables annexed to this Regulation. Guidance should be provided by the Agency for the purpose of setting the specific concentration limits. In order to ensure uniformity, specific concentration limits should also be included, where appropriate, in cases of harmonised classifications. Specific concentration limits should take precedence over any other concentration limit for the purpose of classification.

(35)

Multiplying factors (M-factors) for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, should be assigned to a substance by a manufacturer, importer or downstream user in accordance with the criteria referred to in this Regulation. Guidance should be provided by the Agency for the purpose of setting the M-factors.

(36)

For reasons of proportionality and workability, generic cut-off values should be defined, both for identified impurities, additives and individual constituents of substances and for substances in mixtures, specifying when information on these should be taken into account in determining the hazard classification of substances and mixtures.

(37)

To ensure adequate classification of mixtures, available information on synergistic and antagonistic effects should be taken into account for the classification of mixtures.

(38)

Manufacturers, importers and downstream users should re-evaluate the classifications of substances or mixtures they place on the market if they become aware of new adequate and reliable scientific or technical information that may affect those classifications or if they change the composition of their mixtures, to ensure that the classification is based on up-to-date information, unless there is sufficient evidence that the classification would not change. Suppliers should update the labels accordingly.

(39)

Substances and mixtures classified as hazardous should be labelled and packaged according to their classification, so as to ensure appropriate protection and to provide essential information to their recipients, by drawing their attention to the hazards of the substance or mixture.

(40)

The two instruments foreseen by this Regulation to be used to communicate the hazards of substances and mixtures are labels and the safety data sheets provided for in Regulation (EC) No 1907/2006. Of these two, the label is the only tool for communication to consumers, but it may also serve to draw the attention of workers to the more comprehensive information on substances or mixtures provided in safety data sheets. Since the provisions on safety data sheets are included in Regulation (EC) No 1907/2006 which uses the safety data sheet as the main communication tool within the supply chain of substances, it is appropriate not to duplicate the same provisions in this Regulation.

(41)

To ensure proper and comprehensive information provision to consumers on the hazards and safe use of chemicals and mixtures, the use and dissemination of Internet sites and free-phone numbers should be promoted, particularly in connection with information provision on specific types of packaging.

(42)

Workers and consumers worldwide would benefit from a globally harmonised hazard communication tool in the form of labelling. Therefore, the elements to be included in labels should be specified in accordance with the hazard pictograms, signal words, hazard statements and precautionary statements which form the core information of the GHS. Other information included in labels should be limited to a minimum and should not call into question the main elements.

(43)

It is essential that the substances and mixtures placed on the market are well identified. However, the Agency should allow enterprises, upon their request and where necessary, to describe the chemical identity of certain substances in a way that does not put the confidential nature of their businesses at risk. Where the Agency refuses such a request, an appeal should be allowed in accordance with this Regulation. The appeal should have a suspensive effect, so that the confidential information with regard to which the request has been made, should not appear on the label while the appeal is pending.

(44)

The International Union of Pure and Applied Chemistry (IUPAC) is a long-standing global authority on chemical nomenclature and terminology. Identification of substances by their IUPAC name is widespread practice worldwide and provides the standard basis for identifying substances in an international and multilingual context. It is therefore appropriate to use these names for the purposes of this Regulation.

(45)

The Chemical Abstracts Service (CAS) provides a system whereby substances are added to the CAS Registry and are assigned a unique CAS Registry Number. Those CAS numbers are used in reference works, databases, and regulatory compliance documents throughout the world to identify substances without the ambiguity of chemical nomenclature. It is therefore appropriate to use the CAS numbers for the purposes of this Regulation.

(46)

To limit the information on the label to the most essential information, principles of precedence should determine the most appropriate label elements for cases in which substances or mixtures possess several hazardous properties.

(47)

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ( 21 ) and Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( 22 ) should remain fully applicable to any product within their scope.

(48)

Statements such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or other statements indicating that the substance or mixture is not hazardous or any other statements that are inconsistent with its classification should not appear on the label or packaging of any substance or mixture.

(49)

In general, substances and mixtures, especially those supplied to the general public, should be supplied in packaging together with the necessary labelling information. The supply of appropriate information between professionals, including for unpackaged substances and mixtures, is ensured by Regulation (EC) No 1907/2006. However, in exceptional circumstances, substances and mixtures may also be supplied to the general public unpackaged. Where appropriate, relevant labelling information should be supplied to the general public by other means, such as an invoice or bill.

(50)

Rules for the application of labels and the location of information on labels are necessary to ensure that the information on labels can be easily understood.

(51)

This Regulation should set general packaging standards, in order to ensure the safe supply of hazardous substances and mixtures.

(52)

The resources of the authorities should be focused on substances of the highest concern with regard to health and to the environment. Provision should therefore be made to enable competent authorities and manufacturers, importers and downstream users to submit proposals to the Agency for a harmonised classification and labelling of substances classified for carcinogenicity, germ cell mutagenicity or reproductive toxicity categories 1A, 1B or 2, for respiratory sensitisation, or in respect of other effects on a case-by-case basis. The competent authorities of Member States should also be able to propose harmonised classification and labelling for active substances used in plant protection products and biocidal products. The Agency should give its opinion on the proposal while interested parties should have an opportunity to comment. The Commission should submit a draft decision on the final classification and labelling elements.

(53)

In order to take full account of the work and experience accumulated under Directive 67/548/EEC, including the classification and labelling of specific substances listed in Annex I of Directive 67/548/EEC, all existing harmonised classifications should be converted into new harmonised classifications using the new criteria. Moreover, as the applicability of this Regulation is deferred and the harmonised classifications in accordance with the criteria of Directive 67/548/EEC are relevant for the classification of substances and mixtures during the ensuing transition period, all existing harmonised classifications should also be placed unchanged in an annex to this Regulation. By subjecting all future harmonisations of classifications to this Regulation, inconsistencies in harmonised classifications of the same substance under the existing and the new criteria should be avoided.

(54)

In order to achieve the efficient functioning of the internal market for substances and mixtures, while at the same time ensuring a high level of protection for human health and the environment, rules should be established for a classification and labelling inventory. The classification and labelling for any registered or hazardous substance placed on the market should therefore be notified to the Agency to be included in the inventory.

(55)

The Agency should study the possibilities for further simplification of the notification procedure in particular taking into account the needs of SMEs.

(56)

Different manufacturers and importers of the same substance should make every effort to agree on a single classification for that substance except for hazard classes and differentiations subject to a harmonised classification for that substance.

(57)

To ensure a harmonised level of protection for the general public, and, in particular, for persons who come into contact with certain substances, and the proper functioning of other Community legislation relying on classification and labelling, an inventory should record the classification in accordance with this Regulation agreed, if possible, by manufacturers and importers of the same substance, as well as decisions taken at Community level to harmonise the classification and labelling of some substances.

(58)

The information included in the classification and labelling inventory should benefit from the same degree of accessibility and protection as that afforded by Regulation (EC) No 1907/2006, especially with regard to information which, if disclosed, risks jeopardising the commercial interests of those concerned.

(59)

Member States should 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. Member States should put in place effective monitoring and control measures in order to ensure compliance with this Regulation.

(60)

It is important to provide advice to suppliers and any other interested parties, in particular SMEs, on their respective responsibilities and obligations under this Regulation. The national helpdesks already established under Regulation (EC) No 1907/2006 may act as the national helpdesks provided for under this Regulation.

(61)

In order for the system established by this Regulation to operate effectively, it is important that there should be good cooperation and coordination between the Member States, the Agency and the Commission.

(62)

In order to provide focal points for information on hazardous substances and mixtures, Member States should appoint bodies responsible for receiving information relating to health and to the chemical identity, components and nature of substances, including those for which the use of an alternative chemical name has been allowed in accordance with this Regulation, in addition to the competent authorities for the application and the authorities responsible for the enforcement of this Regulation.

(63)

The responsible bodies, where requested by a Member State, may undertake statistical analysis to identify where improved risk management measures might be needed.

(64)

Regular reports by the Member States and the Agency on the operation of this Regulation should be an indispensable means of monitoring the implementation of chemicals legislation as well as trends in this field. Conclusions drawn from findings in the reports should be useful and practical tools for reviewing the Regulation and, where necessary, for formulating proposals for amendments.

(65)

The Forum for the exchange of information on enforcement in the Agency, established by Regulation (EC) No 1907/2006, should also exchange information about the enforcement of this Regulation.

(66)

In order to ensure transparency, impartiality and consistency in the level of enforcement activities by Member States, it is necessary for Member States to set up an appropriate framework with a view to imposing effective, proportionate and dissuasive penalties for non-compliance with this Regulation, as non-compliance can result in damage to human health and the environment.

(67)

Rules should be laid down requiring advertisements for substances meeting the criteria for classification set out in this Regulation to mention the associated hazards, in order to protect recipients of substances, including consumers. Advertisements for mixtures classified as hazardous that allow a member of the general public to conclude a contract for purchase without first having sight of the label should mention the type or types of hazard indicated on the label, for the same reason.

(68)

A safeguard clause should be provided to address situations where a substance or a mixture constitutes a serious risk to human health or the environment, even if, in compliance with this Regulation, it is not classified as hazardous. Should such a situation occur, action at the UN level may be necessary in view of the global nature of trade in substances and mixtures.

(69)

While many of the obligations on enterprises laid down in Regulation (EC) No 1907/2006 are triggered by classification, this Regulation should not alter the scope and impact of that Regulation, except for its provisions on safety data sheets. To ensure this, that Regulation should be amended accordingly.

(70)

The application of this Regulation should be staggered to allow all parties involved, authorities, enterprises as well as stakeholders, to focus resources on preparing for new duties at the right times. Therefore, and because the classification of mixtures depends on the classification of substances, the provisions for the classification of mixtures should only be applied after the reclassification of all substances. Operators should be allowed to apply the classification criteria contained in this Regulation earlier on a voluntary basis, but in that case to avoid confusion the labelling and packaging should comply with this Regulation instead of Directives 67/548/EEC or 1999/45/EC.

(71)

To avoid unnecessary burdens on enterprises, substances and mixtures which are already in the supply chain when the labelling provisions of this Regulation become applicable to them may continue to be placed on the market without relabelling for a certain period of time.

(72)

Since the objectives of this Regulation, namely harmonising the classification, labelling and packaging rules, providing an obligation to classify and establishing a harmonised list of substances classified at Community level as well as a classification and labelling inventory, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

(73)

This Regulation observes the fundamental rights and principles which are acknowledged in particular in the Charter of Fundamental Rights of the European Union ( 23 ).

(74)

This Regulation should contribute to the fulfilment of the Strategic Approach to International Chemical Management (SAICM) adopted on 6 February 2006 in Dubai.

(75)

Subject to developments at UN level, the classification and labelling of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances should be included in this Regulation at a later stage.

(76)

The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( 24 ).

(77)

In particular, the Commission should be empowered to adapt this Regulation to technical and scientific progress, including incorporating amendments made at UN level to the GHS, in particular any such UN amendments relating to the use of information on similar mixtures. In carrying out such adaptations to technical and scientific progress the biannual working rhythm at UN level should be taken into account. Furthermore, the Commission should be empowered to decide on the harmonised classification and labelling of specific substances. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(78)

When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of adaptations to technical progress.

(79)

The Commission should also for the purposes of this Regulation be assisted by the Committee established by Regulation (EC) No 1907/2006, with a view to ensuring a consistent approach to the updating of chemicals legislation,

HAVE ADOPTED THIS REGULATION:



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:

(a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;

(b) providing an obligation for:

(i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market;

(ii) suppliers to label and package substances and mixtures placed on the market;

(iii) 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;

(c) 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;

(d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI;

(e) 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:

(a) 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 ( 25 );

(b) 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;

(c) non-isolated intermediates;

(d) 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 ( 26 ) 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:

(a) medicinal products as defined in Directive 2001/83/EC;

(b) veterinary medicinal products as defined in Directive 2001/82/EC;

(c) cosmetic products as defined in Directive 76/768/EEC;

(d) 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;

(e) food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used:

(i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC;

(ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC;

(iii) as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003;

(iv) 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:

1. ‘hazard class’ means the nature of the physical, health or environmental hazard;

2. ‘hazard category’ means the division of criteria within each hazard class, specifying hazard severity;

3. ‘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;

4. ‘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:

(a) ‘Danger’ means a signal word indicating the more severe hazard categories;

(b) ‘Warning’ means a signal word indicating the less severe hazard categories;

5. ‘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;

6. ‘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;

7. ‘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;

8. ‘mixture’ means a mixture or solution composed of two or more substances;

9. ‘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;

10. ‘producer of an article’ means any natural or legal person who makes or assembles an article within the Community;

11. ‘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) 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;

(b) 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;

12. ‘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;

13. ‘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;

14. ‘manufacturing’ means production or extraction of substances in the natural state;

15. ‘manufacturer’ means any natural or legal person established within the Community who manufactures a substance within the Community;

16. ‘import’ means the physical introduction into the customs territory of the Community;

17. ‘importer’ means any natural or legal person established within the Community who is responsible for import;

18. ‘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;

19. ‘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;

20. ‘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;

21. ‘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’);

22. ‘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;

23. ‘the Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;

24. ‘competent authority’ means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;

25. ‘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;

26. ‘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;

27. ‘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;

28. ‘UN RTDG’ means the United Nations Recommendations on the Transport of Dangerous Goods;

29. ‘notifier’ means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency;

30. ‘scientific research and development’ means any scientific experimentation, analysis or chemical research carried out under controlled conditions;

31. ‘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;

32. ‘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;

33. ‘differentiation’ means distinction within hazard classes depending on the route of exposure or the nature of the effects;

34. ‘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;

35. ‘package’ means the complete product of the packing operation, consisting of the packaging and its contents;

36. ‘packaging’ means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions;

37. ‘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:

(a) Articles 6, 7(1) or (5), 17 or 18 of Regulation (EC) No 1907/2006 provide for registration of a substance;

(b) 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:

(a) data generated in accordance with any of the methods referred to in Article 8(3);

(b) epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases;

(c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006;

(d) any new scientific information;

(e) 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:

(a) 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;

(b) 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;

(c) 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;

(d) 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:

(a) the test methods referred to in Article 13(3) of Regulation (EC) No 1907/2006;

or

(b) 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:

(a) adequate and reliable information demonstrates that in practice the physical hazards of a substance or a mixture differ from those shown by tests;

(b) 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;

(c) 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:

(a) one or more hazard categories for each relevant hazard class or differentiation;

(b) 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:

(a) 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;

(b) that the substances in the mixture react very slowly with other substances in the mixture to form different substances at low concentration;

(c) 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:

(a) 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;

(b) 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 —————

▼B

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) 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;

(b) 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:

(a) the name, address and telephone number of the supplier(s);

(b) 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;

(c) product identifiers as specified in Article 18;

(d) where applicable, hazard pictograms in accordance with Article 19;

(e) where applicable, signal words in accordance with Article 20;

(f) where applicable, hazard statements in accordance with Article 21;

(g) where applicable, the appropriate precautionary statements in accordance with Article 22;

(h) 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:

(a) if the substance is included in Part 3 of Annex VI, a name and an identification number as given therein;

(b) 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;

(c) 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

(d) 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:

(a) the trade name or the designation of the mixture;

(b) 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:

(a) transportable gas cylinders;

(b) gas containers intended for propane, butane or liquefied petroleum gas;

(c) aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard;

(d) metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers;

(e) 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;

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(f) substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes.

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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.

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▼B

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.

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:

(a) 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;

(b) if the hazard pictogram ‘GHS06’ applies, the hazard pictogram ‘GHS07’ shall not appear;

(c) if the hazard pictogram ‘GHS05’ applies, the hazard pictogram ‘GHS07’ shall not appear for skin or eye irritation;

(d) 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;

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(e) if the hazard pictogram «GHS02» or «GHS06» applies, the use of the hazard pictogram «GHS04» shall be optional.

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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.

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:

(a) the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

(b) 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;

(c) 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;

(d) 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.

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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 ( 27 ), is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply.

▼B

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:

(a) respiratory sensitisation, category 1 (Annex I, section 3.4);

(b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);

(c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);

(d) 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.  Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall, without undue delay, submit a draft decision concerning the 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.

That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4).

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:

(a) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;

(b) the classification of the substance referred to in Article 36, including a statement of reasons;

(c) the specific concentration limits or M-factors, where applicable;

(d) 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);

(e) 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:

(a) substances subject to registration in accordance with Regulation (EC) No 1907/2006;

(b) 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:

(a) 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;

(b) 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;

(c) the classification of the substance or substances in accordance with Article 13;

(d) 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;

(e) 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;

(f) 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:

(a) whether, in respect of the entry, there is harmonised classification and labelling at Community level by inclusion in Part 3 of Annex VI;

(b) 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;

(c) whether it is an agreed entry of two or more notifiers or registrants in accordance with Article 41;

(d) 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:

(a) to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency;

and

(b) 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.  By 20 January 2012 the Commission shall carry out a review to assess the possibility of harmonising the information referred to in paragraph 1, including establishing a format for the submission of information by importers and downstream users to appointed bodies. On the basis of this review, and following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT), the Commission may adopt a Regulation adding an Annex to this Regulation.

Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3).

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 ( 28 ).

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:

(a) provide industry with technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;

(b) 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 may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including 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. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4).

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 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.

3.  Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.  Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 55

Amendments to Directive 67/548/EEC

Directive 67/548/EEC shall be amended as follows:

1. in Article 1(2), the second subparagraph shall be deleted;

2. Article 4 shall be amended as follows:

(a) 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 ( 29 ), 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.

(b) paragraph 4 shall be deleted;

3. Article 5 shall be amended as follows:

(a) paragraph 1, second subparagraph shall be deleted;

(b) 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.’;

4. 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.’;

5. Article 22(3) and (4) shall be deleted;

6. Article 23(2) shall be amended as follows:

(a) in point (a), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;

(b) in point (c), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;

(c) in point (d), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;

(d) in point (e), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;

(e) in point (f), the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI of Regulation (EC) No 1272/2008’;

7. Article 24(4) second subparagraph shall be deleted;

8. Article 28 shall be deleted;

9. Article 31(2) and (3) shall be deleted;

10. 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.’;

11. Annex I shall be deleted.

Article 56

Amendments to Directive 1999/45/EC

Directive 1999/45/EC shall be amended as follows:

1. 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 ( 30 ).

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:

(a) Article 3(3);

(b) Article 10(2), points 2.3.1, 2.3.2, 2.3.3 and 2.4 first indent;

(c) Annex II, points (a) and (b) and the last paragraph of the Introduction;

(d) Annex II, Part A,

 point 1.1.1 (a) and (b),

 point 1.2 (a) and (b),

 point 2.1.1 (a) and (b),

 point 2.2 (a) and (b),

 point 2.3 (a) and (b),

 point 3.1.1 (a) and (b),

 point 3.3 (a) and (b),

 point 3.4 (a) and (b),

 point 4.1.1 (a) and (b),

 point 4.2.1 (a) and (b),

 point 5.1.1 (a) and (b),

 point 5.2.1 (a) and (b),

 point 5.3.1 (a) and (b),

 point 5.4.1 (a) and (b),

 point 6.1 (a) and (b),

 point 6.2 (a) and (b),

 point 7.1 (a) and (b),

 point 7.2 (a) and (b),

 point 8.1 (a) and (b),

 point 8.2 (a) and (b),

 point 9.1 (a) and (b),

 point 9.2 (a) and (b),

 point 9.3 (a) and (b),

 point 9.4 (a) and (b);

(e) Annex II, the introductory paragraph of Part B;

(f) Annex III, point (a) and (b) of the Introduction;

(g) Annex III, Part A, section (a) Aquatic environment

 point 1.1 (a) and (b),

 point 2.1 (a) and (b),

 point 3.1 (a) and (b),

 point 4.1 (a) and (b),

 point 5.1 (a) and (b),

 point 6.1 (a) and (b),

(h) Annex III, Part A, section (b) Non-aquatic environment point 1.1 (a) and (b);

(i) Annex V, section A points 3 and 4;

(j) Annex V, section B point 9;

(k) Annex VI, Part A, the third column of the table under point 2;

(l) Annex VI Part B point 1, first paragraph, and the first column of the table under point 3;

(m) Annex VIII, Appendix 1, second column of the table;

(n) Annex VIII, Appendix 2, second column of the table;

3. 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’;

4. 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:

1. Article 14(2) shall be amended as follows:

(a) point (b) shall be replaced by the following:

‘(b) 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 ( 31 );

(ba) 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;

(b) point (e) shall be replaced by the following:

‘(e) 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;

(ea) 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;’;

2. Article 31 shall be amended as follows:

(a) 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.’;

(b) 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.’;

3. Article 56(6)(b) shall be replaced by the following:

‘(b) 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.’;

4. Article 59(2) and 3 shall be amended as follows:

(a) 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.’;

(b) 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.’;

5. in Article 76(1)(c), the words ‘Title XI’ shall be replaced by ‘Title V of Regulation (EC) No 1272/2008’;

6. Article 77 shall be amended as follows:

(a) in paragraph 2, the first sentence of point (e) shall be replaced by the following:

‘(e) 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;’;

(b) in paragraph 3, point (a), the words ‘Titles VI to XI’ shall be replaced by ‘Titles VI to X’;

7. Title XI shall be deleted;

8. Annex XV, sections I and II shall be amended as follows:

(a) section I shall be amended as follows:

(i) the first indent shall be deleted;

(ii) 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,’;

(b) in section II, point 1 shall be deleted;

9. the table in Annex XVII shall be amended as follows:

(a) the column ‘Designation of the substance, of the groups of substances or of the preparation’, shall be amended as follows:

(i) 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:

 Carcinogen category 1A (Table 3.1)/carcinogen category 1 (Table 3.2) listed in Appendix 1

 Carcinogen category 1B (Table 3.1)/carcinogen category 2 (Table 3.2) listed in Appendix 2

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:

 Mutagen category 1A (Table 3.1)/mutagen category 1 (Table 3.2) listed in Appendix 3

 Mutagen category 1B (Table 3.1)/mutagen category 2 (Table 3.2) listed in Appendix 4

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:

 Reproductive toxicant category 1A adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 1 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 5

 Reproductive toxicant category 1B adverse effects on sexual function and fertility or on development (Table 3.1) or reproductive toxicant category 2 with R60 (May impair fertility) or R61 (May cause harm to the unborn child) (Table 3.2) listed in Appendix 6’;

(b) 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’;

10. Appendices 1 to 6 to Annex XVII shall be amended as follows:

(a) the Foreword shall be amended as follows:

(i) 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’;

(ii) 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’;

(iii) 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’;

(iv) 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.’;

(v) 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”.’;

(vi) Note E shall be deleted;

(vii) 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.’;

(viii) 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.’;

(ix) 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).’;

(b) in Appendix 1, the title shall be replaced by the following:

‘Point 28 — Carcinogens: category 1A (Table 3.1)/category 1 (Table 3.2)’;

(c) Appendix 2 shall be amended as follows:

(i) the title shall be replaced by ‘Point 28 — Carcinogens: category 1B (Table 3.1)/ category 2 (Table 3.2)’;

(ii) 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.’;

(d) in Appendix 3, the title shall be replaced by the following:

‘Point 29 — Mutagens: category 1A (Table 3.1)/category 1 (Table 3.2)’;

(e) in Appendix 4, the title shall be replaced by the following:

‘Point 29 — Mutagens: category 1B (Table 3.1)/category 2 (Table 3.2)’;

(f) 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)’;

(g) 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)’;

11. 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:

1. 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:

(a) 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;

(b) 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;

(c) hazard class 4.1;

(d) hazard class 5.1,

or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:’;

2. Article 31 shall be amended as follows

(a) paragraph 1(a) shall be replaced by the following:

‘(a) 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’;

(b) 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.’;

3. 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:

(a) 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;

(b) 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;

(c) hazard class 4.1;

(d) hazard class 5.1.’;

4. Article 57(a), (b) and (c) shall be replaced by the following:

‘(a) 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;

(b) 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;

(c) 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;’;

5. in Article 65 the words ‘Directive 67/548/EEC’ shall be replaced by ‘Directive 67/548/EEC and Regulation (EC) No 1272/2008’;

6. 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.’;

7. Article 119 shall be amended as follows:

(a) in paragraph 1, point (a) shall be replaced by the following:

‘(a) 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:

 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.’;

(b) paragraph 2 shall be amended as follows:

(i) point (f) shall be replaced by the following:

‘(f) 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;’

(ii) in point (g), the introductory phrase shall be replaced by the following:

‘(g) 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:’;

8. 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.’;

9. Annex III shall be amended as follows:

(a) point (a) shall be replaced by the following:

‘(a) 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;’;

(b) in point (b), point (ii) shall be replaced by the following:

‘(ii) 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.’;

10. in Annex V, point 8, the words ‘Directive 67/548/EEC’ shall be replaced by ‘Regulation (EC) No 1272/2008’;

11. 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.’;

12. Annex VIII shall be amended as follows:

(a) 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.’;

(b) 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.’;

13. 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.’;

14. Annex X shall be amended as follows:

(a) 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.’

(b) 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.’

(c) 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.’;

15. 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’;

16. 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:

(a) 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:

(a) 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;

(b) 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;

(c) hazard class 4.1;

(d) hazard class 5.1.’;

(b) 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:

1. 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

(a) the cut-off value referred to in Article 11, paragraph 3 of Regulation (EC) No 1272/2008;

(b) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to this Regulation.’;

2. Article 31 shall be amended as follows:

(a) in paragraph 1, point (a) shall be replaced by the following:

‘(a) where a substance or mixture meets the criteria for classification as hazardous in accordance with Regulation (EC) No 1272/2008; or’;

(b) 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:

(a) 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

(b) 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

(c) a substance for which there are Community workplace exposure limits’;

(c) 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.’;

3. Article 56(6)(b) shall be replaced by the following:

‘(b) 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.’;

4. in Article 65 the words ‘and Directive 1999/45/EC’ shall be deleted;

5. Annex II shall be amended as follows:

(a) 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.’;

(b) footnote 1 to point 3.3(a), first indent, shall be deleted;

(c) 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.’;

6. 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.’;

7. Annex XVII shall be amended as follows:

(a) 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;

(b) in the column ‘Conditions of restriction’ of the table, entry 28 shall be amended as follows:

(i) 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.’;

(ii) point 2 (d) shall be replaced by the following:

‘(d) 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:

(i) at 50 oC has a vapour pressure greater than 300 kPa (absolute); or

(ii) is completely gaseous at 20 oC at a standard pressure of 101,3 kPa;

Liquid means a substance or mixture which:

(i) at 50 oC has a vapour pressure of not more than 300 kPa (3 bar);

(ii) is not completely gaseous at 20 oC and at a standard pressure of 101,3 kPa; and

(iii) 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:

(a) For health and environmental hazards in Parts 3, 4 and 5 of this Annex:

(i) 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

(ii) 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

(iii) 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

(iv) 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.

(b) For aquatic environmental hazards in section 4.1 of this Annex:

(i) 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

(ii) 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.

▼M2

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.

▼B

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:

 the new mixture shall be classified as equivalent to the original mixture;

 the method explained in each section of Part 3 and in Part 4 for classification of mixtures when data are available for all components or only some components of the mixture;

 in the case of acute toxicity, the method for classification of mixtures based on ingredients of the mixture (additivity formula).

▼M2

1.1.3.2.   Batching

The hazard category of a tested production batch of a mixture can be assumed to be substantially equivalent to that of another untested production batch of the same commercial product, when produced by or under the control of the same supplier, unless there is reason to believe there is significant variation such that the hazard classification of the untested batch has changed. If the latter occurs, a new evaluation is necessary.

1.1.3.3.   Concentration of highly hazardous mixtures

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, if a tested mixture is classified in the highest hazard category or sub-category, and the concentration of the components of the tested mixture that are in that category or sub-category is increased, the resulting untested mixture shall be classified in that category or sub-category without additional testing.

1.1.3.4.   Interpolation within one toxicity category

In the case of the classification of mixtures covered by sections 3.1, 3.2, 3.3, 3.8, 3.9, 3.10 and 4.1, for three mixtures (A, B and C) with identical components, where mixtures A and B have been tested and are in the same hazard category, and where untested mixture C has the same hazardous components as mixture A and B but has concentrations of those hazardous components intermediate to the concentrations in mixtures A and B, then mixture C is assumed to be in the same hazard category as A and B.

▼B

1.1.3.5.   Substantially similar mixtures

Given the following:

(a) two mixtures each containing two ingredients:

(i) A + B

(ii) C + B;

(b) the concentration of ingredient B is essentially the same in both mixtures;

(c) the concentration of ingredient A in mixture (i) equals that of ingredient C in mixture (ii);

(d) 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.

▼M2

If mixture (i) or (ii) is already classified based on test data, then the other mixture shall be assigned the same hazard category.

▼B

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.

▼M2

1.2.   Labelling

1.2.1.   General rules for the application of labels required by Article 31

1.2.1.1.

Hazard pictograms shall be in the shape of a square set at a point.

1.2.1.2.

Hazard pictograms as laid down in Annex V shall have a black symbol on a white background with a red frame sufficiently wide to be clearly visible.

1.2.1.3.

Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by Article 17. The minimum area of each hazard pictogram shall not be less than 1 cm2.

1.2.1.4.

The dimensions of the label and of each pictogram shall be as follows:



Table 1.3

Minimum dimensions of labels and pictograms

Capacity of the package

Dimensions of the label (in millimetres) for the information required by Article 17

Dimensions of each pictogram (in millimetres)

Not exceeding 3 litres:

If possible, at least 52 × 74

Not smaller than 10 × 10

If possible, at least 16 × 16

Greater than 3 litres but not exceeding 50 litres:

At least 74 × 105

At least 23 × 23

Greater than 50 litres but not exceeding 500 litres:

At least 105 × 148

At least 32 × 32

Greater than 500 litres:

At least 148 × 210

At least 46 × 46

▼B

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) 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.

(b) 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.

▼M4

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

Substances or mixtures classified as corrosive to metals but not corrosive to skin and/or eyes which are in the finished state as packaged for consumer use do not require on the label the hazard pictogram GHS05.

▼B

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

(I) the substance has not been assigned a Community workplace exposure limit; and

(II) 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

(III) the substance is classified exclusively as one or more of the following hazard categories:

(a) any of the hazard categories referred to in Part 2 of this Annex;

(b) Acute toxicity, Category 4;

(c) Skin corrosion/irritation, Category 2;

(d) Serious eye damage/eye irritation, Category 2;

(e) Specific target organ toxicity — Single exposure, Category 2 or 3;

(f) Specific target organ toxicity — Repeated exposure, Category 2;

(g) 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:

(a) in fold-out labels; or

(b) on tie-on tags; or

(c) 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:

(a) the contents of the package do not exceed 125 ml; and

(b) the substance or mixture is classified in one or more of the following hazard categories:

1) Oxidising gases of category 1;

2) Gases under pressure;

3) Flammable liquids of category 2 or 3;

4) Flammable solids of category 1 or 2;

5) Self-reactive substances or mixtures Types C to F;

6) Self-heating substances or mixtures of category 2;

7) Substances and mixtures which, in contact with water, emit flammable gases of categories 1, 2 or 3;

8) Oxidising liquids of category 2 or 3;

9) Oxidising solids of category 2 or 3;

10) Organic peroxides Types C to F;

11) Acute toxicity of category 4, if the substances or mixtures are not supplied to the general public;

12) Skin irritation of category 2;

13) Eye irritation of category 2;

14) Specific target organ toxicity — single exposure of category 2 or 3, if the substance or mixture is not supplied to the general public;

15) Specific target organ toxicity — repeated exposure of category 2, if the substance or mixture is not supplied to the general public;

16) Hazardous to the aquatic environment — Acute of category 1;

17) 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:

(a) the contents of the package do not exceed 125 ml; and

(b) the substance or mixture is classified in one or more of the following hazard categories:

1) Flammable gases of category 2;

2) Reproductive toxicity: effects on or via lactation;

3) 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: ◄

(a) the contents of the package do not exceed 125 ml; and

(b) the substance or mixture is classified in one or more of the following hazard categories:

1) 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:

(a) The content of each soluble packaging does not exceed a volume of 25 ml;

▼M2

(b) The classification of the contents of the soluble packaging is exclusively one or more of the hazard categories in 1.5.2.1.1 (b), 1.5.2.1.2 (b) or 1.5.2.1.3 (b); and

▼B

(c) 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.

▼M4

1.5.2.4.    Labelling of inner packaging where the contents do not exceed 10 ml

1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where:

(a) the contents of the inner packaging do not exceed 10 ml;

(b) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis; and

(c) the inner packaging is contained within outer packaging that meets the requirements of Article 17.

1.5.2.4.2. Notwithstanding sections 1.5.1.2 and 1.5.2.4.1, the label on the inner packaging shall contain the product identifier and, where appropriate, the hazard pictograms “GHS01”, “GHS05”, “GHS06” and/or “GHS08”. Where more than two pictograms are assigned, “GHS06” and “GHS08” may take precedence over “GHS01” and “GHS05”.

1.5.2.5.

Section 1.5.2.4 shall not apply to substances or mixtures within the scope of Regulation (EC) No 1107/2009 or (EU) No 528/2012.

▼B

2.   PART 2: PHYSICAL HAZARDS

2.1.   Explosives

2.1.1.   Definitions

2.1.1.1. The class of explosives comprises

(a) explosive substances and mixtures;

(b) 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

(c) 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:

(a) 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);

(b) Division 1.2 Substances, mixtures and articles which have a projection hazard but not a mass explosion hazard;

(c) 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:

(i) combustion of which gives rise to considerable radiant heat; or

(ii) which burn one after another, producing minor blast or projection effects or both;

(d) Division 1.4 Substances, mixtures and articles which present no significant hazard:

 substances, mixtures and articles which present only a small hazard in the event of ignition or initiation. The effects are largely confined to the package and no projection of fragments of appreciable size or range is to be expected. An external fire shall not cause virtually instantaneous explosion of almost the entire contents of the package;

(e) Division 1.5 Very insensitive substances or mixtures which have a mass explosion hazard:

 substances and mixtures which have a mass explosion hazard but are so insensitive that there is very little probability of initiation or of transition from burning to detonation under normal conditions;

(f) Division 1.6 Extremely insensitive articles which do not have a mass explosion hazard:

 articles which contain only extremely insensitive ►M4  ————— ◄ substances or mixtures and which demonstrate a negligible probability of accidental initiation or propagation.

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 UN Recommendations on the Transport of Dangerous Goods, 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.

NOTE to Table 2.1.2: Unpackaged explosives or explosives repacked in packaging other than the original or similar packaging shall include all of the following label elements:

(a) the pictogram: exploding bomb;

(b) the signal word: ‘Danger’; and

(c) 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.



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

image

image

image

image

image

 

 

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 P202 ►M4   P280  ◄

P210

P230

P240

P250

P280

P210

P230

P240

P250

P280

P210

P230

P240

P250

P280

P210

P240

P250

P280

P210

P230

P240

P250

P280

No precautionary statement

Precautionary Statement

Response

P372

P373

P380

P370+P380

P372

P373

P370+P380

P372

P373

P370+P380

P372

P373

P370+P380

P372

P373

P370+P380

P372

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

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 UN Recommendations on the Transport of Dangerous Goods, 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) image ►(2) 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) image

Figure 2.1.3

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

image

Figure 2.1.4

Procedure for the classification of ammonium nitrate emulsion, suspension or gel (ANE)

image

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.

▼M2

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 ‘-’.

▼B

2.1.4.3. A substance or mixture shall not be classified as explosive if:

(a) 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

(b) 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;

(c) 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

(d) For mixtures of inorganic oxidising substances with organic material(s), the concentration of the inorganic oxidising substance is:

 less than 15 % by mass, if the oxidising substance is assigned to Categories 1 or 2;

 less than 30 % by mass, if the oxidising substance is assigned to Category 3.

2.1.4.4. In the case of mixtures containing any known explosives, the acceptance procedure has to be performed.

▼M4

2.2.    Flammable gases (including chemically unstable gases)

2.2.1.    Definitions

2.2.1.1. Flammable gas means a gas or gas mixture having a flammable range with air at 20 °C and a standard pressure of 101,3 kPa.

2.2.1.2. A chemically unstable gas means a flammable gas that is able to react explosively even in the absence of air or oxygen.

2.2.2.    Classification criteria

2.2.2.1. A flammable gas shall be classified in this class in accordance with Table 2.2.1:



Table 2.2.1

Criteria for flammable gases

Category

Criteria

1

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

(a)  are ignitable when in a mixture of 13 % or less by volume in air; or

(b)  have a flammable range with air of at least 12 percentage points regardless of the lower flammable limit.

2

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

Note:

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

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



Table 2.2.2

Criteria for chemically unstable gases

Category

Criteria

A

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

B

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

2.2.3.    Hazard Communication

Label elements shall be used for substances and mixtures meeting the criteria for classification in this hazard class in accordance with Table 2.2.3.



Table 2.2.3

Label elements for flammable gases (including chemically unstable gases)

Classification

Flammable gas

Chemically unstable gas

Category 1

Category 2

Category A

Category B

GHS Pictogram

image

No pictogram

No additional pictogram

No additional pictogram

Signal Word

Danger

Warning

No additional signal word

No additional signal word

Hazard Statement

H220: Extremely flammable gas

H221: Flammable gas

H230: May react explosively even in the absence of air

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

Precautionary Statement Prevention

P210

P210

P202

P202

Precautionary Statement Response

P377

P381

P377

P381

 

 

Precautionary Statement Storage

P403

P403

 

 

Precautionary Statement Disposal

 

 

 

 

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

Figure 2.2.1

Flammable gases

image

Figure 2.2.2

Chemically unstable gases

image

2.2.4.    Additional Classification Considerations

2.2.4.1. Flammability shall be determined by tests or, for mixtures where there are sufficient data available, by calculation in accordance with the methods adopted by ISO (see ISO 10156 as amended, Gases and gas mixtures — Determination of fire potential and oxidising ability for the selection of cylinder valve outlet). Where insufficient data are available to use these methods, test method EN 1839 as amended (Determination of explosion limits of gases and vapours) may be used.

2.2.4.2. Chemical instability shall be determined in accordance with the method described in Part III of the UN RTDG, Manual of Tests and Criteria. If the calculations in accordance with ISO 10156 as amended show that a gas mixture is not flammable it is not necessary to carry out the tests for determining chemical instability for classification purposes.

2.3.    Aerosols

2.3.1.    Definitions

Aerosols, this means aerosol dispensers, are any non-refillable receptacles made of metal, glass or plastics and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state or in a gaseous state.

2.3.2.    Classification criteria

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

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

 Flammable gases (see section 2.2);

 Flammable solids (see section 2.7).

Note 1:

Flammable components do not cover pyrophoric, self-heating or water-reactive substances and mixtures because such components are never used as aerosol contents.

Note 2:

Aerosols do not fall additionally within the scope of sections 2.2 (flammable gases), 2.5 (gases under pressure), 2.6 (flammable liquids) and 2.7 (flammable solids). Depending on their contents, aerosols may however fall within the scope of other hazard classes, including their labelling elements.

2.3.2.2. An aerosol shall be classified in one of the three categories for this Class on the basis of its components, of its chemical heat of combustion and, if applicable, of the results of the foam test (for foam aerosols) and of the ignition distance test and enclosed space test (for spray aerosols) in accordance with Figures 2.3.1(a) to 2.3.1(c) of this Annex and subsections 31.4, 31.5 and 31.6 of Part III of the UN RTDG, Manual of Tests and Criteria. Aerosols which do not meet the criteria for inclusion in Category 1 or Category 2 shall be classified in Category 3.

Note:

Aerosols containing more than 1 % flammable components or with a heat of combustion of at least 20 kJ/g, which are not submitted to the flammability classification procedures in this section shall be classified as aerosols, Category 1.

Figure 2.3.1 (a) Aerosols image

Figure 2.3.1 (b) Spray aerosols image

Figure 2.3.1 (c) Foam aerosols image

2.3.3.    Hazard Communication

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



Table 2.3.1

Label elements for flammable and non-flammable aerosols

Classification

Category 1

Category 2

Category 3

GHS Pictograms

image

image

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:

image

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).

▼B

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.

▼M4

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.

▼B

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

image

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

 

▼M4

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.

▼B

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.

▼M4

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.

▼B

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

image

image

image

image

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

 

 

 

 

▼M2

Note:

Pictogram GHS04 is not required for gases under pressure where pictogram GHS02 or pictogram GHS06 appears.

▼B

2.5.4.   Additional Classification Considerations

For this group of gases, the following information is required to be known:

 the vapour pressure at 50 oC;

 the physical state at 20 oC at standard ambient pressure;

 the critical temperature.

▼M4

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

▼B

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 o()

(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.

▼M2

Note:

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

▼B

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

image

image

image

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 ( 32 ) 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 ( 33 ) greater than the relevant classification criterion (23 °C and 60 °C, respectively) and provided that: ◄

(a) 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);

(b) 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 ◄ ;

(c) the temperature dependence of the saturated vapour pressure and of the activity coefficient is known for each component as present in the mixture;

(d) 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 —————

▼B

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)

▼M2

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.

▼M2

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.

▼B

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

image

image

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:

(a) they are explosives, according to the criteria given in 2.1;

(b) 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;

(c) they are organic peroxides, according to the criteria given in 2.15;

(d) their heat of decomposition is less than 300 J/g; or

(e) their self-accelerating decomposition temperature (SADT) is greater than 75 oC for a 50 kg package ( 34 ).

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:

(a) any self-reactive substance or mixture which can detonate or deflagrate rapidly, as packaged, shall be defined as self-reactive substance TYPE A;

(b) 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;

(c) 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;

(d) any self-reactive substance or mixture which in laboratory testing:

(i) detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or

(ii) does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or

(iii) 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;

(e) 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;

(f) 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;

(g) 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

GHS Pictograms

image

image image

image

image

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

P220

P234

P280

P210

P220

P234

P280

P210

P220

P234

P280

P210

P220

P234

P280

Precautionary Statement

Response

P370 + P378

P370 + P380 + P375

P370 + P378

P370 + P380 + P375

P370 + P378

P370 + P378

 

Precautionary Statement

Storage

P403 + P235

P411

P420

P403 + P235

P411

P420

P403 + P235

P411

P420

P403 + P235 P411

P420

 

Precautionary Statement

Disposal

P501

P501

P501

P501

 

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:

(a) 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

(b) 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

image

►(3) M2  

►(3) M2  

►(3) M2  

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

image

Signal Word

Danger

Hazard Statement

H250: Catches fire spontaneously if exposed to air

Precautionary Statement

Prevention

P210

P222

P280

Precautionary Statement

Response

P302 + P334

P370 + P378

Precautionary Statement

Storage

P422

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

image

Signal Word

Danger

Hazard Statement

H250: Catches fire spontaneously if exposed to air

Precautionary Statement

Prevention

P210

P222

P280

Precautionary Statement

Response

P335 + P334

P370 +P378

Precautionary Statement

Storage

P422

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).

▼M2

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.

▼B

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) a positive result is obtained using a 25 mm cube sample at 140 oC;

(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 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;

(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 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;

(d) 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

image

image

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 + P410

P280

P235 + P410

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:

(a) 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;

(b) 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

image

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 or mixtures which in contact with water emit flammable gases

Classification

Category 1

Category 2

Category 3

GHS Pictograms

image

image

image

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

P335 + P334

P370 + P378

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:

(a) the chemical structure of the substance or mixture does not contain metals or metalloids; or

(b) 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

(c) 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

image

image

image

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

P221

P280

P283

P210

P220

P221

P280

P210

P220

P221

P280

Precautionary Statement

Response

P306 + P360

P371 + P380 + P375

P370 + P378

P370 + P378

P370 + P378

Precautionary Statement

Storage

 

 

 

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:

(a) the substance or mixture does not contain oxygen, fluorine or chlorine; or

(b) 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. 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 of the ►M4  UN RTDG ◄ , Manual of Tests and Criteria in accordance with Table 2.14.1:



Table 2.14.1

Criteria for oxidising solids

Category

Criteria

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.

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.

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.

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’ (BC Code, Annex 3, Test 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

image

image

image

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

P221

P280

P283

P210

P220

P221

P280

P210

P220

P221

P280

Precautionary Statement

Response

P306 + P360

P371 + P380 + P375

P370 + P378

P370 + P378

P370 + P378

Precautionary Statement

Storage

 

 

 

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:

(a) the substance or mixture does not contain oxygen, fluorine or chlorine; or

(b) 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:

(i) be liable to explosive decomposition;

(ii) burn rapidly;

(iii) be sensitive to impact or friction;

(iv) 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:

(a) not more than 1,0 % available oxygen from the organic peroxides when containing not more than 1,0 % hydrogen peroxide; or

(b) 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:

image

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:

(a) any organic peroxide which, as packaged, can detonate or deflagrate rapidly shall be defined as organic peroxide TYPE A;

(b) 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;

(c) 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;

(d) any organic peroxide which in laboratory testing:

(i) detonates partially, does not deflagrate rapidly and shows no violent effect when heated under confinement; or

(ii) does not detonate at all, deflagrates slowly and shows no violent effect when heated under confinement; or

(iii) does not detonate or deflagrate at all and shows a medium effect when heated under confinement;

shall be defined as organic peroxide TYPE D;

(e) 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;

(f) 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;

(g) 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 ( 35 ), 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:

(a) Organic peroxide types B and C with an SADT ≤ 50 C;

(b) Organic peroxide type D showing a medium effect when heated under confinement ( 36 ) with an SADT ≤ 50 oC or showing a low or no effect when heated under confinement with an SADT ≤ 45 oC; and

(c) 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

image

image image

image

image

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

P220

P234

P280

P210

P220

P234

P280

P210

P220

P234

P280

P210

P220

P234

P280

Precautionary Statement

Response

 

 

 

 

 

Precautionary Statement

Storage

P411 + P235

P410

P420

P411 + P235

P410

P420

P411 + P235

P410

P420

P411 + P235

P410

P420

 

Precautionary Statement

Disposal

P501

P501

P501

P501

 

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

image

►(3) M2  

►(3) M2  

►(3) M2  

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

image

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

 

▼M4

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.

▼B

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:

(a) for the purposes of testing steel, steel types

 S235JR+CR (1.0037 resp.St 37-2),

 S275J2G3+CR (1.0144 resp.St 44-3), ISO 3574 as amended, Unified Numbering System (UNS) G 10200, or SAE 1020;

(b) 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:

 Acute oral toxicity;

 Acute dermal toxicity;

 Acute inhalation toxicity.

3.1.2.   Criteria for classification of substances as acutely toxic

▼M2

3.1.2.1. Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). Explanatory notes are shown following Table 3.1.1.



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:

(a) The acute toxicity estimate (ATE) for the classification of a substance is derived using the LD50/LC50 where available.

(b) The acute toxicity estimate (ATE) for the classification of a substance in a mixture is derived using:

 the LD50/LC50 where available,

 the appropriate conversion value from Table 3.1.2 that relates to the results of a range test, or

 the appropriate conversion value from Table 3.1.2 that relates to a classification category.

▼M4

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

▼M2

(d) 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: solid particles of a substance or mixture suspended in a gas (usually air),

 mist: liquid droplets of a substance or mixture suspended in a gas (usually air),

 vapour: the gaseous form of a substance or mixture released from its liquid or solid state.

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.

▼B

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. Of particular importance in classifying for inhalation toxicity is the use of well articulated values in the high toxicity 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.

▼M2

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.

▼B

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:

(a) 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).

(b) 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.

▼M2

(c) 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.

(d) 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.

▼B

Figure 3.1.1

Tiered approach to classification of mixtures for acute toxicity

image

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.

▼M2

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.

▼B

3.1.3.6.   Classification of mixtures based on ingredients of the mixture (Additivity formula)

3.1.3.6.1.    Data available for all ingredients

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:

(a) include ingredients with a known acute toxicity, which fall into any of the acute toxicity categories shown in Table 3.1.1;

(b) ignore ingredients that are presumed not acutely toxic (e.g., water, sugar);

▼M2

(c) 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.

▼B

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:

image

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.    Classification of mixtures when data are not available for all components

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:

(a) extrapolation between oral, dermal and inhalation acute toxicity estimates ( 37 ). Such an evaluation could require appropriate pharmacodynamic and pharmacokinetic data;

(b) evidence from human exposure that indicates toxic effects but does not provide lethal dose data;

(c) 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

(d) 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.

▼M4

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:

image

▼B



Table 3.1.2

▼M2

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

▼B

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

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. ◄

▼M4



Table 3.1.3

Acute toxicity label elements

Classification

Category 1

Category 2

Category 3

Category 4

GHS Pictograms

image

image

image

image

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

 

▼B

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.

▼M4

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’.

▼B

3.2.   Skin corrosion/irritation

3.2.1.   Definitions

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.

3.2.2.   Classification criteria for substances

3.2.2.1. Several factors need to be considered in determining the corrosion and irritation potential of substances before testing is undertaken. Solid substances (powders) may become corrosive or irritant when moistened or in contact with moist skin or mucous membranes. Existing human experience and animal data from single or repeated exposure shall be the first line of analysis, as they give information directly relevant to effects on the skin. In vitro alternatives that have been validated and accepted may also be used to help make classification decisions (see Article 5). In some cases enough information may be available from structurally related compounds to make classification decisions.

3.2.2.2. Likewise, pH extremes like ≤ 2 and ≥ 11,5 may indicate the potential to cause skin effects, especially when buffering capacity is known, although the correlation is not perfect. Generally, such substances are expected to produce significant effects on the skin. If consideration of alkali/acid reserve suggests the substance may not be corrosive despite the low or high pH value, then further testing shall be carried out to confirm this, preferably by use of an appropriate validated in vitro test.

3.2.2.3. If a substance is highly toxic by the dermal route, a skin irritation/corrosion 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 irritation/corrosion in acute toxicity studies and are observed up through the limit dose, additional testing is not needed, provided that the dilutions used and species tested are equivalent.

3.2.2.4. All the above information that is available on a substance shall be used in determining the need for in vivo skin irritation testing.

Although information might be gained from the evaluation of single parameters within a tier (see paragraph 3.2.2.5), e.g. caustic alkalis with extreme pH shall be considered as skin corrosives, there is merit in considering the totality of existing information and making an overall weight of evidence determination. This is especially true when there is information available on some but not all parameters. Generally, primary emphasis shall be placed upon existing human experience and data, followed by animal experience and testing data, followed by other sources of information, but case-by-case determinations are necessary.

3.2.2.5. A tiered approach to the evaluation of initial information shall be considered, where applicable, recognising that all elements may not be relevant in certain cases.

3.2.2.6.   Corrosion

3.2.2.6.1. On the basis of the results of animal testing a substance is classified as corrosive, as shown in Table 3.2.1. A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to a 4 hour duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at 14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars. Histopathology shall be considered to discern questionable lesions.

3.2.2.6.2. Three subcategories are provided within the corrosive category: subcategory 1A — where responses are noted following up to 3 minutes exposure and up to 1 hour observation; subcategory 1B — where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days; and subcategory 1C — where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days.

3.2.2.6.3. The use of human data is discussed in paragraphs 3.2.2.1 and 3.2.2.4 and also in paragraphs 1.1.1.3, 1.1.1.4 and.1.1.1.5.



Table 3.2.1

Skin Corrosive category and subcategories

 

 

Corrosive in > 1 of 3 animals

 

Corrosive subcategories

Exposure

Observation

Category 1: Corrosive

1A

≤ 3 minutes

≤ 1 hour

1B

> 3 minutes - ≤ 1 hour

≤ 14 days

1C

> 1 hour - ≤ 4 hours

≤ 14 days

3.2.2.7.   Irritation

3.2.2.7.1. Using the results of animal testing a single irritant category (Category 2) is presented in Table 3.2.2. The use of human data is discussed in paragraphs 3.2.2.1 and 3.2.2.4 and also in paragraphs 1.1.1.3, 1.1.1.4 and.1.1.1.5. The major criterion for the irritant category is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0 .



Table 3.2.2

Skin irritation category

Category

Criteria

Category 2: Irritant

(1)  Mean value of ≥ 2,3 - ≤ 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; 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.

3.2.2.8.   Comments on responses obtained in skin irritation tests in animals

3.2.2.8.1. Animal irritant responses within a test can be quite variable, as they are with corrosion. The major criterion for classification of a substance as irritant to skin, as shown in paragraph 3.2.2.7.1, is the mean value of the scores for either erythema/eschar or oedema calculated in at least 2 of 3 tested animals. A separate irritant criterion accommodates cases when 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.

3.2.2.8.2. Reversibility of skin lesions is another consideration 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.

3.2.3.   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 will be classified using the criteria for substances, and taking into account the testing and evaluation strategies to develop data for these hazard classes.

3.2.3.1.2. Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of substances and mixtures that can give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture, classifiers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and irritation (paragraph 3.2.2.5), to help ensure an accurate classification as well as avoid unnecessary animal testing. A mixture is considered corrosive to skin (Skin Corrosive Category 1) if it has a pH of 2 or less or a pH of 11,5 or greater. If consideration of alkali/acid reserve suggests the substance or mixture may not be corrosive despite the low or high pH value, then further testing shall be carried out to confirm this, preferably by use of 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 irritation/corrosion hazards, 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 components or only for some components of the mixture

3.2.3.3.1. In order to make use of all available data for purposes of classifying the skin irritation/corrosion hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

Assumption: 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 presumption (e.g., in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1 % can still be relevant for classifying the mixture for skin irritation/corrosion.

3.2.3.3.2. In general, the approach to classification of mixtures as irritant or corrosive to skin when data are available on the components, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant component contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive components 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 an irritant. The mixture is classified as corrosive or irritant when the sum of the concentrations of such components 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 an irritant or a corrosive 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 paragraphs 3.2.3.3.1 and 3.2.3.3.2 may not be applicable given that many of such substances are corrosive or irritant 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 paragraph 3.2.3.1.2) since pH is a better indicator of corrosion than the concentration limits of 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 Corrosive Category 1A, 1B or 1C if it contains ≥ 1 % of an ingredient classified in Category 1A, 1B or 1C respectively or as Category 2 when it contains ≥ 3 % of an 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.

▼M4

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 strategy shall be applied, as set out in section 3.2.2.5.

▼B

3.2.3.3.6. If there are data showing that (an) ingredient(s) is/are corrosive or irritant at a concentration of < 1 % (corrosive) or < 3 % (irritant), the mixture shall be classified accordingly.



Table 3.2.3

Generic concentration limits of ingredients classified for skin corrosive/irritant hazard (Category 1 or 2) that trigger classification of the mixture as corrosive/irritant to skin

Sum of ingredients classified as:

Concentration triggering classification of a mixture as:

 

Skin Corrosive

Skin Irritant

 

Category 1

(see note below)

Category 2

Skin Corrosive Categories 1A, 1B, 1C

≥ 5 %

≥ 1 % but < 5 %

Skin irritant Category 2

 

≥ 10 %

(10 × Skin Corrosive Category 1A, 1B, 1C) + Skin irritant Category 2

 

≥ 10 %

Note

The sum of all ingredients of a mixture classified as Skin Corrosive Category 1A, 1B or 1C respectively, shall each be ≥ 5 % respectively in order to classify the mixture as either Skin Corrosive Category 1A, 1B or 1C. If the sum of the Skin Corrosive Category 1A ingredients is < 5 % but the sum of Category 1A+1B ingredients is ≥ 5 %, the mixture shall be classified as Skin Corrosive Category 1B. Similarly, if the sum of Skin Corrosive Category 1A+1B ingredients is < 5 % but the sum of Category 1A+1B+1C ingredients is ≥ 5 % the mixture shall be classified as Skin Corrosive Category 1C.



Table 3.2.4

Generic concentration limits of ingredients of a mixture for which the additivity approach does not apply, that trigger classification of the mixture as corrosive/irritant to skin

Ingredient:

Concentration:

Mixture classified as: Skin

Acid with pH ≤ 2

≥ 1 %

Category 1

Base with pH ≥ 11,5

≥ 1 %

Category 1

Other corrosive (Categories 1A, 1B, 1C) ingredients for which additivity does not apply

≥ 1 %

Category 1

Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases

≥ 3 %

Category 2

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

Classification

Category 1 A/1 B/1 C

Category 2

GHS Pictograms

image

image

Signal Word

Danger

Warning

Hazard Statement

H314: Causes severe skin burns and eye damage

H315: Causes skin irritation

Precautionary Statement Prevention

P260

P264

P280

P264

P280

Precautionary Statement Response

P301 + P330 + P331

P303 + P361 + P353

P363

P304 + P340

P310

P321

P305 + P351 + P338

P302 + P352

P321

P332 + P313

P362 + P364

Precautionary Statement Storage

P405

 

Precautionary Statement Disposal

P501

 

3.3.   Serious eye damage/eye irritation

3.3.1.   Definitions

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.

3.3.2.   Classification criteria for substances

3.3.2.1. The classification system for substances involves a tiered testing and evaluation scheme, combining pre-existing information on serious ocular tissue damage and on eye irritation (including data relating to historical human or animal experience) as well as considerations on (Q)SAR and the output of validated in vitro tests in order to avoid unnecessary animal testing.

3.3.2.2. Before any in vivo testing for serious eye damage/eye irritation is carried out, all existing information on a substance shall be reviewed. Preliminary decisions can often be made from existing data as to whether a substance causes serious (i.e. irreversible) damage to the eyes. If a substance can be classified on the basis of these data, no testing is required.

3.3.2.3. Several factors need to be considered in determining the serious eye damage or irritation potential of a substance before testing is undertaken. Accumulated human and animal experience shall be the first line of analysis, as it gives information directly relevant to effects on the eye. In some cases enough information may be available from structurally related compounds to make hazard decisions. Likewise, pH extremes like ≤ 2 and ≥ 11,5 may produce serious eye damage, especially when associated with significant buffering capacity. Such substances are expected to produce significant effects on the eyes. Possible skin corrosion has to be evaluated prior to consideration of 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 damage to the eyes as well (Category 1), while skin irritant substances may be considered as leading to eye irritation (Category 2). In vitro alternatives that have been validated and accepted can be used to make classification decisions (see Article 5).

3.3.2.4. All the above information that is available on a substance shall be used in determining the need for in vivo eye irritation testing. Although information may be gained from the evaluation of single parameters within a tier (e.g. caustic alkalis with extreme pH shall be considered as local corrosives), the totality of existing information shall be considered in making an overall weight of evidence determination, particularly when there is information available on some but not all parameters. Generally, primary emphasis shall be placed upon expert judgement, considering human experience with the substance, followed by the outcome of skin irritation testing and of well-validated alternative methods. Animal testing with corrosive substances or mixtures shall be avoided whenever possible.

3.3.2.5. A tiered approach to the evaluation of initial information shall be considered where applicable, while recognising that all elements may not be relevant in certain cases.

3.3.2.6.   Irreversible effects on the eye/serious damage to eyes (Category 1)

3.3.2.6.1. Substances that have the potential to seriously damage the eyes are classified in Category 1 (irreversible effects on the eye). Substances are classified in this hazard category on the basis of the results of animal testing, in accordance with the criteria 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. Substances are also classified in Category 1 if they fulfil the criteria of corneal opacity ≥ 3 or iritis > 1,5 detected in a Draize eye test with rabbits, recognising that such severe lesions usually do not reverse within a 21-day observation period.



Table 3.3.1

Category for irreversible eye effects

Category

Criteria

Irreversible effects on the eye

(Category 1)

If, when applied to the eye of an animal, a substance produces:

— at least in 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

— at least in 2 of 3 tested animals, a positive response of:

— 

— corneal opacity ≥ 3 and/or

— iritis > 1,5

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

3.3.2.6.2. The use of human data is discussed in paragraphs 3.3.2.1, 3.3.2.4, and also in paragraphs 1.1.1.3, 1.1.1.4 and 1.1.1.5.

3.3.2.7.   Reversible effects on the eye (Category 2)

3.3.2.7.1. Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).



Table 3.3.2

Category for reversible eye effects

Category

Criteria

Irritating to eyes

(Category 2)

if, when applied to the eye of an animal, a substance produces:

— at least in 2 of 3 tested animals, a positive response of:

— 

— corneal opacity ≥ 1 and/or

— iritis ≥ 1, and/or

— conjunctival redness ≥ 2 and/or

— conjunctival oedema (chemosis) ≥ 2

— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days

3.3.2.7.2. For those substances where there is pronounced variability among animal responses, this information shall be taken into account in determining the classification.

3.3.3.   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 will be classified using the criteria for substances, and taking into account the testing and evaluation strategies used to develop data for these hazard classes.

3.3.3.1.2. Unlike other hazard classes, there are alternative tests available for skin corrosivity of certain types of mixtures that give an accurate result for classification purposes, as well as being simple and relatively inexpensive to perform. When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and serious eye damage and eye irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing. A mixture is considered to cause serious eye damage (Category 1) if it has a pH ≤ 2,0 or ≥ 11,5 . If consideration of alkali/acid reserve suggests the mixture may not have the potential to cause serious eye damage despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of 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 or 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 components or only for some components of the mixture

3.3.3.3.1. In order to make use of all available data for purposes of classifying the eye irritation/serious eye damaging properties of the mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:

Assumption: 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 presumption (e.g. in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1 % is still relevant for classifying the mixture for eye irritation/serious eye damage.

3.3.3.3.2. In general, the approach to classification of mixtures as eye irritant or seriously damaging to the eye when data are available on the components, but not on the mixture as a whole, is based on the theory of additivity, such that each corrosive or irritant component contributes to the overall irritant or corrosive properties of the mixture in proportion to its potency and concentration. A weighting factor of 10 is used for corrosive components when they are present at a concentration below the generic concentration limit for classification in Category 1, but are at a concentration that will contribute to the classification of the mixture as an irritant. The mixture is classified as seriously damaging to the eye or eye irritant when the sum of the concentrations of such components 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 irritant or as seriously damaging to the eye.

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 paragraphs 3.3.3.3.1 and 3.3.3.3.2 might not work given that many of such substances are corrosive or irritant at concentrations < 1 %.

3.3.3.3.4.2. For mixtures containing strong acids or bases the pH shall be used as classification criteria (see paragraph 3.3.2.3) since pH will be a better indicator of serious eye damage than the generic concentration limits of Table 3.3.3.

3.3.3.3.4.3. A mixture containing corrosive or irritant 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 Category 1 for effects on the eye if it contains ≥ 1 % of a corrosive ingredient and as Category 2 when it contains ≥ 3 % of an 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.

▼M4

3.3.3.3.5. On occasion, reliable data may show that the reversible/irreversible eye effects 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. On other occasions, when it is expected that the skin corrosion/irritation hazards or the reversible/irreversible eye effects 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 strategy shall be applied.

▼B

3.3.3.3.6. If there are data showing that (an) ingredient(s) may be corrosive or irritant at a concentration of < 1 % (corrosive) or < 3 % (irritant), the mixture shall be classified accordingly.



Table 3.3.3

Generic concentration limits of ingredients of a mixture classified as Skin corrosive Category 1 and/or eye Category 1 or 2 for effects on the eye that trigger classification of the mixture for effects on the eye (Category 1 or 2)

Sum of ingredients classified as:

Concentration triggering classification of a mixture as:

Irreversible Eye Effects

Reversible Eye Effects

Category 1

Category 2

Eye Effects Category 1 or Skin Corrosive Category 1A, 1B, 1C

≥ 3 %

≥ 1 % but < 3 %

Eye Effects Category 2

 

≥ 10 %

(10 × Eye Effects Category 1) + Eye effects Category 2

 

≥ 10 %

Skin Corrosive Category 1A, 1B, 1C + Eye effects Category 1

≥ 3 %

≥ 1 % but < 3 %

10 × (Skin Corrosive Category 1A, 1B, 1C + Eye Effects Category 1) + Eye Effects Category 2

 

≥ 10 %



Table 3.3.4

Generic concentration limits of ingredients of a mixture for which the additivity approach does not apply, that trigger classification of the mixture as hazardous to the eye

Ingredient

Concentration

Mixture classified as: Eye

Acid with pH ≤ 2

≥ 1 %

Category 1

Base with pH ≥ 11,5

≥ 1 %

Category 1

Other corrosive (Category 1) ingredients for which additivity does not apply

≥ 1 %

Category 1

Other irritant (Category 2) ingredients for which additivity does not apply, including acids and bases

≥ 3 %

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

Classification

Category 1

Category 2

GHS Pictograms

image

►M2  image  ◄

Signal Word

Danger

Warning

Hazard Statement

H318: Causes serious eye damage

H319: Causes serious eye irritation

Precautionary Statement

Prevention

P280

P264

P280

Precautionary Statement

Response

P305 + P351 + P338

P310

P305 + P351 + P338

P337 + P313

Precautionary Statement

Storage

 

 

Precautionary Statement

Disposal

 

 

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:

 Respiratory Sensitisation ►M2  and ◄ ;

 Skin Sensitisation.

▼M2

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

Category

Criteria

Category 1

Substances shall be classified as respiratory sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a)  if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity; and/or

(b)  if there are positive results from an appropriate animal test.

Sub-category 1A:

Substances showing a high frequency of occurrence in humans; or a probability of occurrence of a high sensitisation rate in humans based on animal or other tests (1). Severity of reaction may also be considered.

Sub-category 1B:

Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a low to moderate sensitisation rate in humans based on animal or other tests (1). Severity of reaction may also be considered.

(1)   At present, recognised and validated animal models for the testing of respiratory hypersensitivity are not available. Under certain circumstances, data from animal studies may provide valuable information in a weight of evidence assessment.

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.

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.

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

3.4.2.1.3.1.

Data from appropriate animal studies ( 38 ) which may be indicative of the potential of a substance to cause sensitisation by inhalation in humans ( 39 ) 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

3.4.2.2.1.1.

Skin sensitisers shall be classified in Category 1 where data are not sufficient for sub-categorisation.

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.

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.

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

Category

Criteria

Category 1

Substances shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a)  if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b)  if there are positive results from an appropriate animal test (see specific criteria in section 3.4.2.2.4.1).

Sub-category 1A:

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Sub-category 1B:

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

3.4.2.2.2.   Human evidence

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.

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

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.

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

Assay

Criteria

Local lymph node assay

EC3 value ≤ 2 %

Guinea pig maximisation test

≥ 30 % responding at ≤ 0,1 % intradermal induction dose or

≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose

Buehler assay

≥ 15 % responding at ≤ 0,2 % topical induction dose or

≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose

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

Assay

Criteria

Local lymph node assay

EC3 value > 2 %

Guinea pig maximisation test

≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or

≥ 30 % responding at > 1 % intradermal induction dose

Buehler assay

≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or

≥ 15 % responding at > 20 % topical induction dose

3.4.2.2.4.   Specific considerations

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.

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.

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.

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.

▼B

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

3.4.3.2.1. Where the mixture itself has not been tested to determine its sensitising properties, 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.

3.4.3.3.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.4.3.3.1. The mixture shall be classified as a respiratory or skin sensitiser when at least one ingredient has been classified as a respiratory or skin sensitiser and is present at or above the appropriate generic concentration limit as shown in ►M2  Table 3.4.5  ◄ for solid/liquid and gas respectively.

3.4.3.3.2. Some substances that are classified as sensitisers may elicit a response, when present in a mixture in quantities below the concentrations established in ►M2  Table 3.4.5 ◄ , in individuals who are already sensitised to the substance or mixture (see Note 1 to ►M2  Table 3.4.6 ◄ ).

▼M2



Table 3.4.5

Generic concentration limits of components of a mixture classified as either respiratory sensitisers or skin sensitisers that trigger classification of the mixture

Component classified as:

Generic concentration limits triggering classification of a mixture as:

Respiratory sensitiser

Category 1

Skin sensitiser

Category 1

Solid/liquid

Gas

All physical states

Respiratory sensitiser

Category 1

≥ 1,0 %

≥ 0,2 %

 

Respiratory sensitiser

Sub-category 1A

≥ 0,1 %

≥ 0,1 %

 

Respiratory sensitiser

Sub-category 1B

≥ 1,0 %

≥ 0,2 %

 

Skin sensitiser

Category 1

 

 

≥ 1,0 %

Skin sensitiser

Sub-category 1A

 

 

≥ 0,1 %

Skin sensitiser

Sub-category 1B

 

 

≥ 1,0 %

▼M2



Table 3.4.6

Concentration limits for elicitation of components of a mixture

Component classified as:

Concentration limits for elicitation

Respiratory sensitiser

Category 1

Skin sensitiser

Category 1

Solid/liquid

Gas

All physical states

Respiratory sensitiser

Category 1

≥ 0,1 % (Note 1)

≥ 0,1 % (Note 1)

 

Respiratory sensitiser

Sub-category 1A

≥ 0,01 % (Note 1)

≥ 0,01 % (Note 1)

 

Respiratory sensitiser

Sub-category 1B

≥ 0,1 % (Note 1)

≥ 0,1 % (Note 1)

 

Skin sensitiser

Category 1

 

 

≥ 0,1 % (Note 1)

Skin sensitiser

Sub-category 1A

 

 

≥ 0,01 % (Note 1)

Skin sensitiser

Sub-category 1B

 

 

≥ 0,1 % (Note 1)

▼M4

Note 1:

This concentration limit for elicitation is used for the application of the special labelling requirements of section 2.8 of Annex II to protect already sensitised individuals. A SDS is required for the mixture containing a component at or above this concentration. For sensitising substances with specific concentration limit lower than 0,1 %, the concentration limit for elicitation should be set at one tenth of the specific concentration limit.

▼B

3.4.4.   Hazard communication

▼M2

3.4.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.4.7.



Table 3.4.7

Respiratory or skin sensitisation label elements

Classification

Respiratory sensitisation

Skin sensitisation

Category 1 and subcategories 1A and 1B

Category 1 and subcategories 1A and 1B

GHS Pictograms

image

image

Signal Word

Danger

Warning

Hazard Statement

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled

H317: May cause an allergic skin reaction

Precautionary Statement Prevention

P261

P284

P261

P272

P280

Precautionary Statement Response

P304 + P340

P342 + P311

P302 + P352

P333 + P313

P321

P362 + P364

Precautionary Statement Storage

 

 

Precautionary Statement Disposal

P501

P501

▼B

3.5.   Germ cell mutagenicity

3.5.1.   Definitions and general considerations

3.5.1.1. A mutation means a permanent change in the amount or structure of the genetic material in a cell. The term ‘mutation’ applies both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations). The term ‘mutagenic’ and ‘mutagen’ will be used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms.

3.5.1.2. The more general terms ‘genotoxic’ and ‘genotoxicity’ apply to agents or processes which alter the structure, information content, or segregation of DNA, including those which cause DNA damage by interfering with normal replication processes, or which in a non-physiological manner (temporarily) alter its replication. Genotoxicity test results are usually taken as indicators for mutagenic effects.

3.5.2.   Classification criteria for substances

3.5.2.1. This hazard class is primarily concerned with substances that may cause mutations in the germ cells of humans that can be transmitted to the progeny. However, the results from mutagenicity or genotoxicity tests in vitro and in mammalian somatic and germ cells in vivo are also considered in classifying substances and mixtures within this hazard class.

3.5.2.2. For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories as shown in Table 3.5.1.



Table 3.5.1

Hazard categories for germ cell mutagens

Categories

Criteria

CATEGORY 1:

Substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans.

Substances known to induce heritable mutations in the germ cells of humans.

Category 1A:

The classification in Category 1A is based on positive evidence from human epidemiological studies.

Substances to be regarded as if they induce heritable mutations in the germ cells of humans.

Category 1B:

The classification in Category 1B is based on:

— positive result(s) from in vivo heritable germ cell mutagenicity tests in mammals; or

— positive result(s) from in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has potential to cause mutations to germ cells. It is possible to derive this supporting evidence from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells; or

— positive results from tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.

CATEGORY 2:

Substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans

The classification in Category 2 is based on:

— positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from:

— 

— somatic cell mutagenicity tests in vivo, in mammals; or

— other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.

Note: Substances which are positive in in vitro mammalian mutagenicity assays, and which also show chemical structure activity relationship to known germ cell mutagens, shall be considered for classification as Category 2 mutagens.

3.5.2.3.   Specific considerations for classification of substances as germ cell mutagens

3.5.2.3.1. To arrive at a classification, test results are considered from experiments determining mutagenic and/or genotoxic effects in germ and/or somatic cells of exposed animals. Mutagenic and/or genotoxic effects determined in in vitro tests shall also be considered.

3.5.2.3.2. The system is hazard based, classifying substances on the basis of their intrinsic ability to induce mutations in germ cells. The scheme is, therefore, not meant for the (quantitative) risk assessment of substances.

3.5.2.3.3. Classification for heritable effects in human germ cells is made on the basis of well conducted, sufficiently validated tests, preferably as described in Regulation (EC) No 440/2008 adopted in accordance with Article 13(3) of Regulation (EC) No 1907/2006 (‘Test Method Regulation’) such as those listed in the following paragraphs. Evaluation of the test results shall be done using expert judgement and all the available evidence shall be weighed in arriving at a classification.

3.5.2.3.4. In vivo heritable germ cell mutagenicity tests, such as:

 rodent dominant lethal mutation test;

 mouse heritable translocation assay.

3.5.2.3.5. In vivo somatic cell mutagenicicty tests, such as:

 mammalian bone marrow chromosome aberration test;

 mouse spot test;

 mammalian erythrocyte micronucleus test.

3.5.2.3.6. Mutagenicity/genotoxicity tests in germ cells, such as:

(a) mutagenicity tests:

 mammalian spermatogonial chromosome aberration test;

 spermatid micronucleus assay;

(b) Genotoxicity tests:

 sister chromatid exchange analysis in spermatogonia;

 unscheduled DNA synthesis test (UDS) in testicular cells.

3.5.2.3.7. Genotoxicity tests in somatic cells such as:

 liver Unscheduled synthesis test (UDS) in vivo;

 mammalian bone marrow Sister Chromatid Exchanges (SCE);

3.5.2.3.8. In vitro mutagenicity tests such as:

 in vitro mammalian chromosome aberration test;

 in vitro mammalian cell gene mutation test;

 bacterial reverse mutation tests.

3.5.2.3.9. The classification of individual substances shall be based on the total weight of evidence available, using expert judgement (See 1.1.1). In those instances where a single well-conducted test is used for classification, it shall provide clear and unambiguously positive results. If new, well validated, tests arise these may also be used in the total weight of evidence to be considered. The relevance of the route of exposure used in the study of the substance compared to the route of human exposure shall also be taken into account.

3.5.3.   Classification criteria for mixtures

3.5.3.1.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.5.3.1.1. The mixture shall be classified as a mutagen when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 mutagen and is present at or above the appropriate generic concentration limit as shown in Table 3.5.2 for Category 1A, Category 1B and Category 2 respectively.

▼M4



Table 3.5.2

Generic concentration limits of ingredients of a mixture classified as germ cell mutagens that trigger classification of the mixture

Ingredient classified as:

Concentration limits triggering classification of a mixture as:

Category 1 mutagen

Category 2 mutagen

Category 1A

Category 1B

Category 1A mutagen

≥ 0,1 %

Category 1B mutagen

≥ 0,1 %

Category 2 mutagen

≥ 1,0 %

▼B

Note

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).

3.5.3.2.   Classification of mixtures when data are available for the complete mixture

3.5.3.2.1. Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using concentration limits for the ingredients classified as germ cell mutagens. On a case-by-case basis, test data on mixtures may be used for classification when demonstrating effects that have not been established from the evaluation based on the individual ingredients. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations, sensitivity and statistical analysis of germ cell mutagenicity test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.

3.5.3.3.   Classification of mixtures when data are not available for the complete mixture: bridging principles

3.5.3.3.1. Where the mixture itself has not been tested to determine its germ cell mutagenicity hazard, but there are sufficient data on the individual ingredients and similar tested mixtures (subject to paragraph 3.5.3.2.1), to adequately characterise the hazards of the mixture, these data shall be used in accordance with the applicable bridging rules set out in section 1.1.3.

3.5.4.   Hazard communication

3.5.4.1. Label elements shall be used in accordance with Table 3.5.3, for substances or mixtures meeting the criteria for classification in this hazard class.

▼M4



Table 3.5.3

Label elements of germ cell mutagenicity

Classification

Category 1

(Category 1A, 1B)

Category 2

GHS Pictograms

image

image

Signal Word

Danger

Warning

Hazard Statement

H340: May cause genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

H341: Suspected of causing genetic defects (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

Precautionary Statement Prevention

P201

P202

P280

P201

P202

P280

Precautionary Statement Response

P308 + P313

P308 + P313

Precautionary Statement Storage

P405

P405

Precautionary Statement Disposal

P501

P501

▼B

3.5.5.   Additional classification considerations

It is increasingly accepted that the process of chemical-induced tumorigenesis in humans and animals involves genetic changes for example in proto-oncogenes and/or tumour suppresser genes of somatic cells. Therefore, the demonstration of mutagenic properties of substances in somatic and/or germ cells of mammals in vivo may have implications for the potential classification of these substances as carcinogens (see also Carcinogenicity, section 3.6, paragraph 3.6.2.2.6).

3.6.   Carcinogenicity

3.6.1.   Definition

3.6.1.1. Carcinogen means a substance or a mixture of substances which induce cancer or increase its incidence. Substances which have induced benign and malignant tumours in well performed experimental studies on animals are considered also to be presumed or suspected human carcinogens unless there is strong evidence that the mechanism of tumour formation is not relevant for humans.

3.6.2.   Classification criteria for substances

3.6.2.1. For the purpose of classification for carcinogenicity, substances are allocated to one of two categories based on strength of evidence and additional considerations (weight of evidence). In certain instances, route-specific classification may be warranted, if it can be conclusively proved that no other route of exposure exhibits the hazard.



Table 3.6.1

Hazard categories for carcinogens

Categories

Criteria

CATEGORY 1:

Known or presumed human carcinogens

A substance is classified in Category 1 for carcinogenicity on the basis of epidemiological and/or animal data. A substance may be further distinguished as:

Category 1A:

Category 1A, known to have carcinogenic potential for humans, classification is largely based on human evidence, or

Category 1B:

Category 1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence.

 

The classification in Category 1A and 1B is based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived from:

— human studies that establish a causal relationship between human exposure to a substance and the development of cancer (known human carcinogen); or

— animal experiments for which there is sufficient () evidence to demonstrate animal carcinogenicity (presumed human carcinogen).

 

In addition, on a case-by-case basis, scientific judgement may warrant a decision of presumed human carcinogenicity derived from studies showing limited evidence of carcinogenicity in humans together with limited evidence of carcinogenicity in experimental animals.

CATEGORY 2:

Suspected human carcinogens

The placing of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B, based on strength of evidence together with additional considerations (see section 3.6.2.2). Such evidence may be derived either from limited () evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies.

(1)   Note: See 3.6.2.2.4.

3.6.2.2.   Specific considerations for classification of substances as carcinogens

3.6.2.2.1. Classification as a carcinogen is made on the basis of evidence from reliable and acceptable studies and is intended to be used for substances which have an intrinsic property to cause cancer. The evaluations shall be based on all existing data, peer-reviewed published studies and additional acceptable data.

3.6.2.2.2. Classification of a substance as a carcinogen is a process that involves two interrelated determinations: evaluations of strength of evidence and consideration of all other relevant information to place substances with human cancer potential into hazard categories.

3.6.2.2.3. Strength of evidence involves the enumeration of tumours in human and animal studies and determination of their level of statistical significance. Sufficient human evidence demonstrates causality between human exposure and the development of cancer, whereas sufficient evidence in animals shows a causal relationship between the substance and an increased incidence of tumours. Limited evidence in humans is demonstrated by a positive association between exposure and cancer, but a causal relationship cannot be stated. Limited evidence in animals is provided when data suggest a carcinogenic effect, but are less than sufficient. The terms ‘sufficient’ and ‘limited’ have been used here as they have been defined by the International Agency for Research on Cancer (IARC) and read as follows:

(a) Carcinogenicity in humans

The evidence relevant to carcinogenicity from studies in humans is classified into one of the following categories:

 sufficient evidence of carcinogenicity: a causal relationship has been established between exposure to the agent and human cancer. That is, a positive relationship has been observed between the exposure and cancer in studies in which chance, bias and confounding could be ruled out with reasonable confidence;

 limited evidence of carcinogenicity: a positive association has been observed between exposure to the agent and cancer for which a causal interpretation is considered to be credible, but chance, bias or confounding could not be ruled out with reasonable confidence.

(b) Carcinogenicity in experimental animals

Carcinogenicity in experimental animals can be evaluated using conventional bioassays, bioassays that employ genetically modified animals, and other in-vivo bioassays that focus on one or more of the critical stages of carcinogenesis. In the absence of data from conventional long-term bioassays or from assays with neoplasia as the end-point, consistently positive results in several models that address several stages in the multistage process of carcinogenesis should be considered in evaluating the degree of evidence of carcinogenicity in experimental animals. The evidence relevant to carcinogenicity in experimental animals is classified into one of the following categories:

 sufficient evidence of carcinogenicity: a causal relationship has been established between the agent and an increased incidence of malignant neoplasms or of an appropriate combination of benign and malignant neoplasms in (a) two or more species of animals or (b) two or more independent studies in one species carried out at different times or in different laboratories or under different protocols. An increased incidence of tumours in both sexes of a single species in a well-conducted study, ideally conducted under Good Laboratory Practices, can also provide sufficient evidence. A single study in one species and sex might be considered to provide sufficient evidence of carcinogenicity when malignant neoplasms occur to an unusual degree with regard to incidence, site, type of tumour or age at onset, or when there are strong findings of tumours at multiple sites;

 limited evidence of carcinogenicity: the data suggest a carcinogenic effect but are limited for making a definitive evaluation because, e.g. (a) the evidence of carcinogenicity is restricted to a single experiment; (b) there are unresolved questions regarding the adequacy of the design, conduct or interpretation of the studies; (c) the agent increases the incidence only of benign neoplasms or lesions of uncertain neoplastic potential; or (d) the evidence of carcinogenicity is restricted to studies that demonstrate only promoting activity in a narrow range of tissues or organs.

3.6.2.2.4. Additional considerations (as part of the weight of evidence approach (see 1.1.1)). Beyond the determination of the strength of evidence for carcinogenicity, a number of other factors need to be considered that influence the overall likelihood that a substance poses a carcinogenic hazard in humans. The full list of factors that influence this determination would be very lengthy, but some of the more important ones are considered here.

3.6.2.2.5. The factors can be viewed as either increasing or decreasing the level of concern for human carcinogenicity. The relative emphasis accorded to each factor depends upon the amount and coherence of evidence bearing on each. Generally there is a requirement for more complete information to decrease than to increase the level of concern. Additional considerations should be used in evaluating the tumour findings and the other factors in a case-by-case manner.

3.6.2.2.6. Some important factors which may be taken into consideration, when assessing the overall level of concern are:

(a) tumour type and background incidence;

(b) multi-site responses;

(c) progression of lesions to malignancy;

(d) reduced tumour latency;

(e) whether responses are in single or both sexes;

(f) whether responses are in a single species or several species;

(g) structural similarity to a substance(s) for which there is good evidence of carcinogenicity;

(h) routes of exposure;

(i) comparison of absorption, distribution, metabolism and excretion between test animals and humans;

(j) the possibility of a confounding effect of excessive toxicity at test doses;

(k) mode of action and its relevance for humans, such as cytotoxicity with growth stimulation, mitogenesis, immunosuppression, mutagenicity.

Mutagenicity: it is recognised that genetic events are central in the overall process of cancer development. Therefore evidence of mutagenic activity in vivo may indicate that a substance has a potential for carcinogenic effects.

3.6.2.2.7. A substance that has not been tested for carcinogenicity may in certain instances be classified in Category 1A, Category 1B or Category 2 based on tumour data from a structural analogue together with substantial support from consideration of other important factors such as formation of common significant metabolites, e.g. for benzidine congener dyes.

3.6.2.2.8. The classification shall take into consideration whether or not the substance is absorbed by a given route(s); or whether there are only local tumours at the site of administration for the tested route(s), and adequate testing by other major route(s) show lack of carcinogenicity.

3.6.2.2.9. It is important that whatever is known of the physico-chemical, toxicokinetic and toxicodynamic properties of the substances, as well as any available relevant information on chemical analogues, i.e. structure activity relationship, is taken into consideration when undertaking classification.

3.6.3.   Classification criteria for mixtures

3.6.3.1.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.6.3.1.1. The mixture will be classified as a carcinogen when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 carcinogen and is present at or above the appropriate generic concentration limit as shown in Table 3.6.2 for Category 1A, Category 1B and Category 2 respectively.

▼M4



Table 3.6.2

Generic concentration limits of ingredients of a mixture classified as carcinogen that trigger classification of the mixture

Ingredient classified as:

Generic concentration limits triggering classification of a mixture as:

Category 1 carcinogen

Category 2 carcinogen

Category 1A

Category 1B

Category 1A carcinogen

≥ 0,1 %

Category 1B carcinogen

≥ 0,1 %

Category 2 carcinogen

≥ 1,0 % [Note 1]

▼B

Note

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).

Note 1

If a Category 2 carcinogen is present in the mixture as an ingredient at a concentration ≥ 0,1 % a SDS shall be available for the mixture upon request.

3.6.3.2.   Classification of mixtures when data are available for the complete mixture

3.6.3.2.1. Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using concentration limits for the ingredients classified as carcinogens. On a case-by-case basis, test data on mixtures may be used for classification when demonstrating effects that have not been established from the evaluation based on the individual ingredients. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations, sensitivity and statistical analysis of carcinogenicity test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.

3.6.3.3.   Classification of mixtures when data are not available for the complete mixture: bridging principles

3.6.3.3.1. Where the mixture itself has not been tested to determine its carcinogenic hazard, but there are sufficient data on the individual ingredients and similar tested mixtures (subject to paragraph 3.6.3.2.1) to adequately characterise the hazards of the mixture, these data shall be used in accordance with the applicable bridging rules set out in section 1.1.3.

3.6.4.   Hazard Communication

3.6.4.1. Label elements shall be used in accordance with Table 3.6.3, for substances or mixtures meeting the criteria for classification in this hazard class.



Table 3.6.3

Label elements for carcinogenicity

Classification

Category 1

(Category 1A, 1B)

Category 2

GHS Pictograms

image

image

Signal Word

Danger

Warning

Hazard Statement

H350: May cause cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

H351: Suspected of causing cancer (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

Precautionary Statement Prevention

P201

P202

P280

P201

P202

P280

Precautionary Statement Response

P308 + P313

P308 + P313

Precautionary Statement Storage

P405

P405

Precautionary Statement Disposal

P501

P501

3.7.   Reproductive toxicity

3.7.1.   Definitions and general considerations

3.7.1.1. Reproductive toxicity includes adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. The definitions presented below are adapted from those agreed as working definitions in IPCS/EHC Document No 225, Principles for Evaluating Health Risks to Reproduction Associated with Exposure to Chemicals. For classification purposes, the known induction of genetically based heritable effects in the offspring is addressed in Germ Cell Mutagenicity (section 3.5), since in the present classification system it is considered more appropriate to address such effects under the separate hazard class of germ cell mutagenicity.

In this classification system, reproductive toxicity is subdivided under two main headings:

(a) adverse effects on sexual function and fertility;

(b) adverse effects on development of the offspring.

Some reproductive toxic effects cannot be clearly assigned to either impairment of sexual function and fertility or to developmental toxicity. Nonetheless, substances with these effects, or mixtures containing them, shall be classified as reproductive toxicants.

3.7.1.2. For the purpose of classification the hazard class Reproductive Toxicity is differentiated into:

 adverse effects

 

 on sexual function and fertility, or

 on development;

 effects on or via lactation.

3.7.1.3.   Adverse effects on sexual function and fertility

Any effect of substances that has the potential to interfere with sexual function and fertility. This includes, but is not limited to, alterations to the female and male reproductive system, adverse effects on onset of puberty, gamete production and transport, reproductive cycle normality, sexual behaviour, fertility, parturition, pregnancy outcomes, premature reproductive senescence, or modifications in other functions that are dependent on the integrity of the reproductive systems.

3.7.1.4.   Adverse effects on development of the offspring

Developmental toxicity includes, in its widest sense, any effect which interferes with normal development of the conceptus, either before or after birth, and resulting from exposure of either parent prior to conception, or exposure of the developing offspring during prenatal development, or postnatally, to the time of sexual maturation. However, it is considered that classification under the heading of developmental toxicity is primarily intended to provide a hazard warning for pregnant women, and for men and women of reproductive capacity. Therefore, for pragmatic purposes of classification, developmental toxicity essentially means adverse effects induced during pregnancy, or as a result of parental exposure. These effects can be manifested at any point in the life span of the organism. The major manifestations of developmental toxicity include (1) death of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional deficiency.

3.7.1.5. Adverse effects on or via lactation are also included in reproductive toxicity, but for classification purposes, such effects are treated separately (see Table 3.7.1 (b)). This is because it is desirable to be able to classify substances specifically for an adverse effect on lactation so that a specific hazard warning about this effect can be provided for lactating mothers.

3.7.2.   Classification criteria for substances

3.7.2.1.   Hazard categories

3.7.2.1.1. For the purpose of classification for reproductive toxicity, substances are allocated to one of two categories. Within each category, effects on sexual function and fertility, and on development, are considered separately. In addition, effects on lactation are allocated to a separate hazard category.



Table 3.7.1(a)

Hazard categories for reproductive toxicants

Categories

Criteria

CATEGORY 1

Known or presumed human reproductive toxicant

Substances are classified in Category 1 for reproductive toxicity when they are known to have produced an adverse effect on sexual function and fertility, or on development in humans or when there is evidence from animal studies, possibly supplemented with other information, to provide a strong presumption that the substance has the capacity to interfere with reproduction in humans. The classification of a substance is further distinguished on the basis of whether the evidence for classification is primarily from human data (Category 1A) or from animal data (Category 1B).

Category 1A

Known human reproductive toxicant

The classification of a substance in Category 1A is largely based on evidence from humans.

Category 1B

Presumed human reproductive toxicant

The classification of a substance in Category 1B is largely based on data from animal studies. Such data shall provide clear evidence of an adverse effect on sexual function and fertility or on development in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of other toxic effects. However, when there is mechanistic information that raises doubt about the relevance of the effect for humans, classification in Category 2 may be more appropriate.

CATEGORY 2

Suspected human reproductive toxicant

Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1. If deficiencies in the study make the quality of evidence less convincing, Category 2 could be the more appropriate classification.

Such effects shall have been observed in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects.



Table 3.7.1(b)

Hazard category for lactation effects

EFFECTS ON OR VIA LACTATION

Effects on or via lactation are allocated to a separate single category. It is recognised that for many substances there is no information on the potential to cause adverse effects on the offspring via lactation. However, substances which are absorbed by women and have been shown to interfere with lactation, or which may be present (including metabolites) in breast milk in amounts sufficient to cause concern for the health of a breastfed child, shall be classified and labelled to indicate this property hazardous to breastfed babies. This classification can be assigned on the:

(a)  human evidence indicating a hazard to babies during the lactation period; and/or

(b)  results of one or two generation studies in animals which provide clear evidence of adverse effect in the offspring due to transfer in the milk or adverse effect on the quality of the milk; and/or

(c)  absorption, metabolism, distribution and excretion studies that indicate the likelihood that the substance is present in potentially toxic levels in breast milk.

3.7.2.2.   Basis of classification

3.7.2.2.1. Classification is made on the basis of the appropriate criteria, outlined above, and an assessment of the total weight of evidence (see 1.1.1). Classification as a reproductive toxicant is intended to be used for substances which have an intrinsic, specific property to produce an adverse effect on reproduction and substances shall not be so classified if such an effect is produced solely as a non-specific secondary consequence of other toxic effects.

The classification of a substance is derived from the hazard categories in the following order of precedence: Category 1A, Category 1B, Category 2 and the additional Category for effects on or via lactation. If a substance meets the criteria for classification into both of the main categories (for example Category 1B for effects on sexual function and fertility and also Category 2 for development) then both hazard differentiations shall be communicated by the respective hazard statements. Classification in the additional category for effects on or via lactation will be considered irrespective of a classification into Category 1A, Category 1B or Category 2.

3.7.2.2.2. In the evaluation of toxic effects on the developing offspring, it is important to consider the possible influence of maternal toxicity (see section 3.7.2.4).

3.7.2.2.3. For human evidence to provide the primary basis for a Category 1A classification there must be reliable evidence of an adverse effect on reproduction in humans. Evidence used for classification shall ideally be from well conducted epidemiological studies which include the use of appropriate controls, balanced assessment, and due consideration of bias or confounding factors. Less rigorous data from studies in humans shall be supplemented with adequate data from studies in experimental animals and classification in Category 1B shall be considered.

3.7.2.3.   Weight of evidence

3.7.2.3.1. Classification as a reproductive toxicant is made on the basis of an assessment of the total weight of evidence, see section 1.1.1. This means that all available information that bears on the determination of reproductive toxicity is considered together, such as epidemiological studies and case reports in humans and specific reproduction studies along with sub-chronic, chronic and special study results in animals that provide relevant information regarding toxicity to reproductive and related endocrine organs. Evaluation of substances chemically related to the substance under study may also be included, particularly when information on the substance is scarce. The weight given to the available evidence will be influenced by factors such as the quality of the studies, consistency of results, nature and severity of effects, the presence of maternal toxicity in experimental animal studies, level of statistical significance for inter-group differences, number of endpoints affected, relevance of route of administration to humans and freedom from bias. Both positive and negative results are assembled together into a weight of evidence determination. A single, positive study performed according to good scientific principles and with statistically or biologically significant positive results may justify classification (see also 3.7.2.2.3).

3.7.2.3.2. Toxicokinetic studies in animals and humans, site of action and mechanism or mode of action study results may provide relevant information which reduces or increases concerns about the hazard to human health. If it is conclusively demonstrated that the clearly identified mechanism or mode of action has no relevance for humans or when the toxicokinetic differences are so marked that it is certain that the hazardous property will not be expressed in humans then a substance which produces an adverse effect on reproduction in experimental animals should not be classified.

3.7.2.3.3. If, in some reproductive toxicity studies in experimental animals the only effects recorded are considered to be of low or minimal toxicological significance, classification may not necessarily be the outcome. These effects include small changes in semen parameters or in the incidence of spontaneous defects in the foetus, small changes in the proportions of common foetal variants such as are observed in skeletal examinations, or in foetal weights, or small differences in postnatal developmental assessments.

3.7.2.3.4. Data from animal studies ideally shall provide clear evidence of specific reproductive toxicity in the absence of other systemic toxic effects. However, if developmental toxicity occurs together with other toxic effects in the dam, the potential influence of the generalised adverse effects shall be assessed to the extent possible. The preferred approach is to consider adverse effects in the embryo/foetus first, and then evaluate maternal toxicity, along with any other factors which are likely to have influenced these effects, as part of the weight of evidence. In general, developmental effects that are observed at maternally toxic doses shall not be automatically discounted. Discounting developmental effects that are observed at maternally toxic doses can only be done on a case-by-case basis when a causal relationship is established or refuted.

3.7.2.3.5. If appropriate information is available it is important to try to determine whether developmental toxicity is due to a specific maternally mediated mechanism or to a non-specific secondary mechanism, like maternal stress and the disruption of homeostasis. Generally, the presence of maternal toxicity shall not be used to negate findings of embryo/foetal effects, unless it can be clearly demonstrated that the effects are secondary non-specific effects. This is especially the case when the effects in the offspring are significant, e.g. irreversible effects such as structural malformations. In some situations it can be assumed that reproductive toxicity is due to a secondary consequence of maternal toxicity and discount the effects, if the substance is so toxic that dams fail to thrive and there is severe inanition, they are incapable of nursing pups; or they are prostrate or dying.

3.7.2.4.   Maternal toxicity

3.7.2.4.1. Development of the offspring throughout gestation and during the early postnatal stages can be influenced by toxic effects in the mother either through non-specific mechanisms related to stress and the disruption of maternal homeostasis, or by specific maternally-mediated mechanisms. In the interpretation of the developmental outcome to decide classification for developmental effects it is important to consider the possible influence of maternal toxicity. This is a complex issue because of uncertainties surrounding the relationship between maternal toxicity and developmental outcome. Expert judgement and a weight of evidence approach, using all available studies, shall be used to determine the degree of influence that shall be attributed to maternal toxicity when interpreting the criteria for classification for developmental effects. The adverse effects in the embryo/foetus shall be first considered, and then maternal toxicity, along with any other factors which are likely to have influenced these effects, as weight of evidence, to help reach a conclusion about classification.

3.7.2.4.2. Based on pragmatic observation, maternal toxicity may, depending on severity, influence development via non-specific secondary mechanisms, producing effects such as depressed foetal weight, retarded ossification, and possibly resorptions and certain malformations in some strains of certain species. However, the limited number of studies which have investigated the relationship between developmental effects and general maternal toxicity have failed to demonstrate a consistent, reproducible relationship across species. Developmental effects which occur even in the presence of maternal toxicity are considered to be evidence of developmental toxicity, unless it can be unequivocally demonstrated on a case-by-case basis that the developmental effects are secondary to maternal toxicity. Moreover, classification shall be considered where there is a significant toxic effect in the offspring, e.g. irreversible effects such as structural malformations, embryo/foetal lethality, significant post-natal functional deficiencies.

3.7.2.4.3. Classification shall not automatically be discounted for substances that produce developmental toxicity only in association with maternal toxicity, even if a specific maternally-mediated mechanism has been demonstrated. In such a case, classification in Category 2 may be considered more appropriate than Category 1. However, when a substance is so toxic that maternal death or severe inanition results, or the dams are prostrate and incapable of nursing the pups, it is reasonable to assume that developmental toxicity is produced solely as a secondary consequence of maternal toxicity and discount the developmental effects. Classification is not necessarily the outcome in the case of minor developmental changes, when there is only a small reduction in foetal/pup body weight or retardation of ossification when seen in association with maternal toxicity.

3.7.2.4.4. Some of the end points used to assess maternal effects are provided below. Data on these end points, if available, need to be evaluated in light of their statistical or biological significance and dose response relationship.

Maternal mortality:

an increased incidence of mortality among the treated dams over the controls shall be considered evidence of maternal toxicity if the increase occurs in a dose-related manner and can be attributed to the systemic toxicity of the test material. Maternal mortality greater than 10 % is considered excessive and the data for that dose level shall not normally be considered for further evaluation.

Mating index

(no. animals with seminal plugs or sperm/no. mated × 100) ( 40 )

Fertility index

(no. animals with implants/no. of matings × 100)

Gestation length

(if allowed to deliver)

Body weight and body weight change:

Consideration of the maternal body weight change and/or adjusted (corrected) maternal body weight shall be included in the evaluation of maternal toxicity whenever such data are available. The calculation of an adjusted (corrected) mean maternal body weight change, which is the difference between the initial and terminal body weight minus the gravid uterine weight (or alternatively, the sum of the weights of the foetuses), may indicate whether the effect is maternal or intrauterine. In rabbits, the body weight gain may not be useful indicators of maternal toxicity because of normal fluctuations in body weight during pregnancy.

Food and water consumption (if relevant):

The observation of a significant decrease in the average food or water consumption in treated dams compared to the control group is useful in evaluating maternal toxicity, particularly when the test material is administered in the diet or drinking water. Changes in food or water consumption need to be evaluated in conjunction with maternal body weights when determining if the effects noted are reflective of maternal toxicity or more simply, unpalatability of the test material in feed or water.

Clinical evaluations (including clinical signs, markers, haematology and clinical chemistry studies):

The observation of increased incidence of significant clinical signs of toxicity in treated dams relative to the control group is useful in evaluating maternal toxicity. If this is to be used as the basis for the assessment of maternal toxicity, the types, incidence, degree and duration of clinical signs shall be reported in the study. Clinical signs of maternal intoxication include: coma, prostration, hyperactivity, loss of righting reflex, ataxia, or laboured breathing.

Post-mortem data:

Increased incidence and/or severity of post-mortem findings may be indicative of maternal toxicity. This can include gross or microscopic pathological findings or organ weight data, including absolute organ weight, organ-to-body weight ratio, or organ-to-brain weight ratio. When supported by findings of adverse histopathological effects in the affected organ(s), the observation of a significant change in the average weight of suspected target organ(s) of treated dams, compared to those in the control group, may be considered evidence of maternal toxicity.

3.7.2.5.   Animal and experimental data

3.7.2.5.1. A number of internationally accepted test methods are available; these include methods for developmental toxicity testing (e.g. OECD Test Guideline 414), and methods for one or two-generation toxicity testing (e.g. OECD Test Guidelines 415, 416).

3.7.2.5.2. Results obtained from Screening Tests (e.g. OECD Guidelines 421 — Reproduction/Developmental Toxicity Screening Test, and 422 — Combined Repeated Dose Toxicity Study with Reproduction/Development Toxicity Screening Test) can also be used to justify classification, although it is recognised that the quality of this evidence is less reliable than that obtained through full studies.

3.7.2.5.3. Adverse effects or changes, seen in short- or long-term repeated dose toxicity studies, which are judged likely to impair reproductive function and which occur in the absence of significant generalised toxicity, may be used as a basis for classification, e.g. histopathological changes in the gonads.

3.7.2.5.4. Evidence from in vitro assays, or non-mammalian tests, and from analogous substances using structure-activity relationship (SAR), can contribute to the procedure for classification. In all cases of this nature, expert judgement must be used to assess the adequacy of the data. Inadequate data shall not be used as a primary support for classification.

3.7.2.5.5. It is preferable that animal studies are conducted using appropriate routes of administration which relate to the potential route of human exposure. However, in practice, reproductive toxicity studies are commonly conducted using the oral route, and such studies will normally be suitable for evaluating the hazardous properties of the substance with respect to reproductive toxicity. However, if it can be conclusively demonstrated that the clearly identified mechanism or mode of action has no relevance for humans or when the toxicokinetic differences are so marked that it is certain that the hazardous property will not be expressed in humans then a substance which produces an adverse effect on reproduction in experimental animals shall not be classified.

3.7.2.5.6. Studies involving routes of administration such as intravenous or intraperitoneal injection, which result in exposure of the reproductive organs to unrealistically high levels of the test substance, or elicit local damage to the reproductive organs, including irritation, must be interpreted with extreme caution and on their own are not normally the basis for classification.

3.7.2.5.7. There is general agreement about the concept of a limit dose, above which the production of an adverse effect is considered to be outside the criteria which lead to classification, but not regarding the inclusion within the criteria of a specific dose as a limit dose. However, some guidelines for test methods, specify a limit dose, others qualify the limit dose with a statement that higher doses may be necessary if anticipated human exposure is sufficiently high that an adequate margin of exposure is not achieved. Also, due to species differences in toxicokinetics, establishing a specific limit dose may not be adequate for situations where humans are more sensitive than the animal model.

3.7.2.5.8. In principle, adverse effects on reproduction seen only at very high dose levels in animal studies (for example doses that induce prostration, severe inappetence, excessive mortality) would not normally lead to classification, unless other information is available, e.g. toxicokinetics information indicating that humans may be more susceptible than animals, to suggest that classification is appropriate. Please also refer to the section on maternal toxicity (3.7.2.4) for further guidance in this area.

3.7.2.5.9. However, specification of the actual ‘limit dose’ will depend upon the test method that has been employed to provide the test results, e.g. in the OECD Test Guideline for repeated dose toxicity studies by the oral route, an upper dose of 1 000 mg/kg has been recommended as a limit dose, unless expected human response indicates the need for a higher dose level.

3.7.3.   Classification criteria for mixtures

3.7.3.1.   Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture

3.7.3.1.1. The mixture shall be classified as a reproductive toxicant when at least one ingredient has been classified as a Category 1A, Category 1B or Category 2 reproductive toxicant and is present at or above the appropriate generic concentration limit as shown in Table 3.7.2 for Category 1A, Category 1B and Category 2 respectively.

3.7.3.1.2. The mixture shall be classified for effects on or via lactation when at least one ingredient has been classified for effects on or via lactation and is present at or above the appropriate generic concentration limit as shown in Table 3.7.2 for the additional category for effects on or via lactation.

▼M4



Table 3.7.2

Generic concentration limits of ingredients of a mixture classified as reproduction toxicants or for effects on or via lactation that trigger classification of the mixture

Ingredient classified as:

Generic concentration limits triggering classification of a mixture as:

Category 1 reproductive toxicant

Category 2 reproductive toxicant

Additional category for effects on or via lactation

Category 1A

Category 1B

Category 1A reproductive toxicant

≥ 0,3 %

[Note 1]

 

 

 

Category 1B reproductive toxicant

 

≥ 0,3 %

[Note 1]

 

 

Category 2 reproductive toxicant

 

 

≥ 3,0 %

[Note 1]

 

Additional category for effects on or via lactation

 

 

 

≥ 0,3 %

[Note 1]

Note:

The concentration limits in Table 3.7.2 apply to solids and liquids (w/w units) as well as gases (v/v units).

Note 1:

If a Category 1 or Category 2 reproductive toxicant or a substance classified for effects on or via lactation is present in the mixture as an ingredient at a concentration at or above 0,1 %, a SDS shall be available for the mixture upon request.

▼B

3.7.3.2.   Classification of mixtures when data are available for the complete mixture

3.7.3.2.1. Classification of mixtures will be based on the available test data for the individual ingredients of the mixture using concentration limits for the ingredients of the mixture. On a case-by-case basis, test data on mixtures may be used for classification when demonstrating effects that have not been established from the evaluation based on the individual components. In such cases, the test results for the mixture as a whole must be shown to be conclusive taking into account dose and other factors such as duration, observations, sensitivity and statistical analysis of reproduction test systems. Adequate documentation supporting the classification shall be retained and made available for review upon request.

3.7.3.3.   Classification of mixtures when data are not available for the complete mixture: bridging principles

3.7.3.3.1. Subject to paragraph 3.7.3.2.1, where the mixture itself has not been tested to determine its reproductive 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 applicable bridging rules set out in section 1.1.3.

3.7.4.   Hazard Communication

3.7.4.1. Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.7.3



Table 3.7.3

Label elements for reproductive toxicity

Classification

Category 1

(Category 1A, 1B)

Category 2

Additional category for effects on or via lactation

GHS Pictograms

image

image

No pictogram

Signal Word

Danger

Warning

No signal word

Hazard Statement

H360: May damage fertility or the unborn child (state specific effect if known)(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

H361: Suspected of damaging fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard)

H362: May cause harm to breast-fed children.

Precautionary Statement Prevention

P201

P202

P280

P201

P202

P280

P201

P260

P263

P264

P270

Precautionary Statement Response

P308 + P313

P308 + P313

P308 + P313

Precautionary Statement Storage

P405

P405

 

Precautionary Statement Disposal

P501

P501

 

3.8.   Specific target organ toxicity — single exposure

3.8.1.   Definitions and general considerations

3.8.1.1. Specific target organ toxicity (single exposure) is defined as specific, non lethal target organ toxicity arising from a single exposure to a substance or mixture. All significant health effects that can impair function, both reversible and irreversible, immediate and/or delayed and not specifically addressed in sections 3.1 to 3.7 and 3.10 are included (see also 3.8.1.6).

3.8.1.2. Classification identifies the substance or mixture as being a specific target organ toxicant and, as such, it may present a potential for adverse health effects in people who are exposed to it.

3.8.1.3. These adverse health effects produced by a single exposure include consistent and identifiable toxic effects in humans, or, in experimental animals, toxicologically significant changes which have affected the function or morphology of a tissue/organ, or have produced serious changes to the biochemistry or haematology of the organism, and these changes are relevant for human health.

3.8.1.4. Assessment shall take into consideration not only significant changes in a single organ or biological system but also generalised changes of a less severe nature involving several organs.

3.8.1.5. Specific target organ toxicity can occur by any route that is relevant for humans, i.e. principally oral, dermal or inhalation.

3.8.1.6. Specific target organ toxicity following a repeated exposure is classified as described in Specific target organ toxicity — Repeated exposure (section 3.9) and is therefore excluded from section 3.8. Other specific toxic effects, listed below, are assessed separately and consequently are not included here:

(a) Acute toxicity (section 3.1);

(b) Skin corrosion/irritation (section 3.2);

(c) Serious eye damage/eye irritation (section 3.3);

(d) Respiratory or skin sensitisation (section 3.4);

(e) Germ cell mutagenicity (section 3.5);

(f) Carcinogenicity (section 3.6);

(g) Reproductive toxicity (section 3.7); and

(h) Aspiration toxicity (section 3.10).

3.8.1.7. The hazard class Specific Target Organ Toxicity — Single Exposure is differentiated into:

 Specific target organ toxicity — single exposure, Category 1 and 2;

 Specific target organ toxicity — single exposure, Category 3.

See Table 3.8.1.



Table 3.8.1

Categories for specific target organ toxicity-single exposure

Categories

Criteria

Category 1

Substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following single exposure

Substances are classified in Category 1 for specific target organ toxicity (single exposure) on the basis of:

(a)  reliable and good quality evidence from human cases or epidemiological studies; or

(b)  observations from appropriate studies in experimental animals in which significant and/or severe toxic effects of relevance to human health were produced at generally low exposure concentrations. Guidance dose/concentration values are provided below (see 3.8.2.1.9) to be used as part of weight-of-evidence evaluation.

Category 2

Substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following single exposure

Substances are classified in Category 2 for specific target organ toxicity (single exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. Guidance dose/concentration values are provided below (see 3.8.2.1.9) in order to help in classification.

In exceptional cases, human evidence can also be used to place a substance in Category 2 (see 3.8.2.1.6).

Category 3

Transient target organ effects

This category only includes narcotic effects and respiratory tract irritation. These are target organ effects for which a substance does not meet the criteria to be classified in Categories 1 or 2 indicated above. These are effects which adversely alter human function for a short duration after exposure and from which humans may recover in a reasonable period without leaving significant alteration of structure or function. Substances are classified specifically for these effects as laid down in 3.8.2.2.

Note: Attempts shall be made to determine the primary target organ of toxicity and to classify for that purpose, such as hepatotoxicants, neurotoxicants. The data shall be carefully evaluated and, where possible, secondary effects should not be included (e.g. a hepatotoxicant can produce secondary effects in the nervous or gastro-intestinal systems).

3.8.2.   Classification criteria for substances

3.8.2.1.   Substances of Category 1 and Category 2

3.8.2.1.1. Substances are classified for immediate or delayed effects separately, by the use of expert judgement (see 1.1.1) on the basis of the weight of all evidence available, including the use of recommended guidance values (see 3.8.2.1.9). Substances are then placed in Category 1 or 2, depending upon the nature and severity of the effect(s) observed (Table 3.8.1).

3.8.2.1.2. The relevant route or routes of exposure by which the classified substance produces damage shall be identified (see 3.8.1.5).

3.8.2.1.3. Classification is determined by expert judgement (see section 1.1.1), on the basis of the weight of all evidence available including the guidance presented below.

3.8.2.1.4. Weight of evidence of all data (see section 1.1.1), including human incidents, epidemiology, and studies conducted in experimental animals, is used to substantiate specific target organ toxic effects that merit classification.

3.8.2.1.5. The information required to evaluate specific target organ toxicity comes either from single exposure in humans, such as: exposure at home, in the workplace or environmentally, or from studies conducted in experimental animals. The standard animal studies in rats or mice that provide this information are acute toxicity studies which can include clinical observations and detailed macroscopic and microscopic examination to enable the toxic effects on target tissues/organs to be identified. Results of acute toxicity studies conducted in other species may also provide relevant information.

3.8.2.1.6. In exceptional cases, based on expert judgement, it is appropriate to place certain substances with human evidence of target organ toxicity in Category 2:

(a) when the weight of human evidence is not sufficiently convincing to warrant Category 1 classification, and/or

(b) based on the nature and severity of effects.

Dose/concentration levels in humans shall not be considered in the classification and any available evidence from animal studies shall be consistent with the Category 2 classification. In other words, if there are also animal data available on the substance that warrant Category 1 classification, the substance shall be classified as Category 1.

3.8.2.1.7.    Effects considered to support classification for Category 1 and 2

3.8.2.1.7.1. Classification is supported by evidence associating single exposure to the substance with a consistent and identifiable toxic effect.

3.8.2.1.7.2. Evidence from human experience/incidents is usually restricted to reports of adverse health consequence, often with uncertainty about exposure conditions, and may not provide the scientific detail that can be obtained from well-conducted studies in experimental animals.

3.8.2.1.7.3. Evidence from appropriate studies in experimental animals can furnish much more detail, in the form of clinical observations, and macroscopic and microscopic pathological examination, and this can often reveal hazards that may not be life-threatening but could indicate functional impairment. Consequently all available evidence, and relevance to human health, must be taken into consideration in the classification process, including but not limited to the following effects in humans and/or animals:

(a) morbidity resulting from single exposure;

(b) significant functional changes, more than transient in nature, in the respiratory system, central or peripheral nervous systems, other organs or other organ systems, including signs of central nervous system depression and effects on special senses (such as sight, hearing and sense of smell);

(c) any consistent and significant adverse change in clinical biochemistry, haematology, or urinalysis parameters;

(d) significant organ damage noted at necropsy and/or subsequently seen or confirmed at microscopic examination;

(e) multi-focal or diffuse necrosis, fibrosis or granuloma formation in vital organs with regenerative capacity;

(f) morphological changes that are potentially reversible but provide clear evidence of marked organ dysfunction;

(g) evidence of appreciable cell death (including cell degeneration and reduced cell number) in vital organs incapable of regeneration.

3.8.2.1.8.    Effects considered not to support classification for Category 1 and 2

It is recognised that effects may be seen that does not justify classification. Such effects in humans and/or animals include, but are not limited to:

(a) clinical observations or small changes in bodyweight gain, food consumption or water intake that may have some toxicological importance but that do not, by themselves, indicate ‘significant’ toxicity;

(b) small changes in clinical biochemistry, haematology or urinalysis parameters and/or transient effects, when such changes or effects are of doubtful or minimal toxicological importance;

(c) changes in organ weights with no evidence of organ dysfunction;

(d) adaptive responses that are not considered toxicologically relevant;

(e) substance-induced species-specific mechanisms of toxicity, i.e. demonstrated with reasonable certainty to be not relevant for human health, shall not justify classification.

3.8.2.1.9.    Guidance values to assist with classification based on the results obtained from studies conducted in experimental animals for Category 1 and 2

3.8.2.1.9.1. In order to help reach a decision about whether a substance shall be classified or not, and to what degree it shall be classified (Category 1 or Category 2), dose/concentration ‘guidance values’ are provided for consideration of the dose/concentration which has been shown to produce significant health effects. The principal argument for proposing such guidance values is that all substances are potentially toxic and there has to be a reasonable dose/concentration above which a degree of toxic effect is acknowledged.

3.8.2.1.9.2. Thus, in animal studies, when significant toxic effects are observed that indicate classification, consideration of the dose/concentration at which these effects were seen, in relation to the suggested guidance values, provides useful information to help assess the need to classify (since the toxic effects are a consequence of the hazardous property(ies) and also the dose/concentration).

3.8.2.1.9.3. The guidance value (C) ranges for single-dose exposure which has produced a significant non-lethal toxic effect are those applicable to acute toxicity testing, as indicated in Table 3.8.2.



Table 3.8.2

Guidance value ranges for single-dose exposures a

 

Guidance value ranges for:

Route of exposure

Units

Category 1

Category 2

Category 3

Oral (rat)

mg/kg body weight

C ≤ 300

2 000 ≥ C > 300

Guidance values do not apply b

Dermal (rat or rabbit)

mg/kg body weight

C ≤ 1 000

2 000 ≥ C > 1 000

Inhalation (rat) gas

ppmV/4h

C ≤ 2 500

20 000 ≥ C > 2 500

Inhalation (rat) vapour

mg/l/4h

C ≤ 10

20 ≥ C > 10

Inhalation (rat) dust/mist/fume

mg/l/4h

C ≤ 1,0

5,0 ≥ C > 1,0

(a) The guidance values and ranges mentioned in Table 3.8.2 are intended only for guidance purposes, i.e. to be used as part of the weight of evidence approach, and to assist with decision about classification. They are not intended as strict demarcation values.

(b) Guidance values are not provided for Category 3 substances since this classification is primarily based on human data. Animal data, if available, shall be included in the weight of evidence evaluation.

3.8.2.1.10.    Other considerations

3.8.2.1.10.1. When a substance is characterised only by use of animal data (typical of new substances, but also true for many existing substances), the classification process includes reference to dose/concentration guidance values as one of the elements that contribute to the weight of evidence approach.

3.8.2.1.10.2. When well-substantiated human data are available showing a specific target organ toxic effect that can be reliably attributed to single exposure to a substance, the substance shall normally be classified. Positive human data, regardless of probable dose, predominates over animal data. Thus, if a substance is unclassified because specific target organ toxicity observed was considered not relevant or significant to humans, if subsequent human incident data become available showing a specific target organ toxic effect, the substance shall be classified.

3.8.2.1.10.3. A substance that has not been tested for specific target organ toxicity may, where appropriate, be classified on the basis of data from a validated structure activity relationship and expert judgement-based extrapolation from a structural analogue that has previously been classified together with substantial support from consideration of other important factors such as formation of common significant metabolites.

3.8.2.1.10.4. Saturated vapour concentration shall be considered, where appropriate, as an additional element to provide for specific health and safety protection

3.8.2.2.   Substances of Category 3: Transient target organ effects

3.8.2.2.1.    Criteria for respiratory tract irritation

The criteria for classifying substances as Category 3 for respiratory tract irritation are:

(a) respiratory irritant effects (characterised by localised redness, oedema, pruritis and/or pain) that impair function with symptoms such as cough, pain, choking, and breathing difficulties are included. This evaluation will be based primarily on human data;

(b) subjective human observations could be supported by objective measurements of clear respiratory tract irritation (RTI) (such as electrophysiological responses, biomarkers of inflammation in nasal or bronchoalveolar lavage fluids);

(c) the symptoms observed in humans shall also be typical of those that would be produced in the exposed population rather than being an isolated idiosyncratic reaction or response triggered only in individuals with hypersensitive airways. Ambiguous reports simply of ‘irritation’ shall be excluded as this term is commonly used to describe a wide range of sensations including those such as smell, unpleasant taste, a tickling sensation, and dryness, which are outside the scope of classification for respiratory irritation;

(d) there are currently no validated animal tests that deal specifically with RTI, however, useful information may be obtained from the single and repeated inhalation toxicity tests. For example, animal studies may provide useful information in terms of clinical signs of toxicity (dyspnoea, rhinitis etc) and histopathology (e.g. hyperemia, edema, minimal inflammation, thickened mucous layer) which are reversible and may be reflective of the characteristic clinical symptoms described above. Such animal studies can be used as part of weight of evidence evaluation;

(e) this special classification would occur only when more severe organ effects including in the respiratory system are not observed.

3.8.2.2.2    Criteria for narcotic effects

The criteria for classifying substances as Category 3 for narcotic effects are:

(a) central nervous system depression including narcotic effects in humans such as drowsiness, narcosis, reduced alertness, loss of reflexes, lack of coordination, and vertigo are included. These effects can also be manifested as severe headache or nausea, and can lead to reduced judgment, dizziness, irritability, fatigue, impaired memory function, deficits in perception and coordination, reaction time, or sleepiness;

(b) narcotic effects observed in animal studies may include lethargy, lack of coordination, loss of righting reflex, and ataxia. If these effects are not transient in nature, then they shall be considered to support classification for Category 1 or 2 specific target organ toxicity single exposure.

3.8.3.   Classification criteria for mixtures

3.8.3.1. Mixtures are classified using the same criteria as for substances, or alternatively as described below. As with substances, mixtures shall be classified for specific target organ toxicity following single exposure.

3.8.3.2.   Classification of mixtures when data are available for the complete mixture

3.8.3.2.1. 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 shall be classified by weight of evidence evaluation of these data (see 1.1.1.4). Care shall be exercised in evaluat