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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)

EU Regulation No 1272/2008 · Adopted 16 December 2008 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 Committeef1,

Acting in accordance with the procedure laid down in Article 251 of the Treatyf2,

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 productsf3, Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutritionf4, 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 productionf5, 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 consumptionf6, Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devicesf7, Council Directive 93/42/EEC of 14 June 1993 concerning medical devicesf8, Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devicesf9, 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 Councilf10, Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal productsf11, 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 usef12, 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 safetyf13 and Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionf14 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)f15, 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 substancesf16 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 preparationsf17. 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 purposesf18 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)f19 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 substancesf20.

(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 marketf21 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 marketf22 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 Unionf23.

(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 Commissionf24.

(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:

Annotations to the whole text

Footnotes

f1

OJ C 204, 9.8.2008, p. 47.

f2

Opinion of the European Parliament of 3 September 2008 (not yet published in the Official Journal).

f3

OJ L 262, 27.9.1976, p. 169.

f4

OJ L 213, 21.7.1982, p. 8.

f5

OJ L 184, 15.7.1988, p. 61.

f6

OJ L 40, 11.2.1989, p. 27.

f7

OJ L 189, 20.7.1990, p. 17.

f8

OJ L 169, 12.7.1993, p. 1.

f9

OJ L 331, 7.12.1998, p. 1.

f10

OJ L 84, 27.3.1999, p. 1.

f11

OJ L 311, 28.11.2001, p. 1.

f12

OJ L 311, 28.11.2001, p. 67.

f13

OJ L 31, 1.2.2002, p. 1.

f14

OJ L 268, 18.10.2003, p. 29.

f15

OJ L 396, 30.12.2006, p. 1. Corrected version in OJ L 136, 29.5.2007, p. 3.

f16

OJ 196, 16.8.1967, p. 1.

f17

OJ L 200, 30.7.1999, p. 1.

f18

OJ L 358, 18.12.1986, p. 1.

f19

OJ L 142, 31.5.2008, p. 1.

f20

OJ L 50, 20.2.2004, p. 44.

f21

OJ L 230, 19.8.1991, p. 1.

f22

OJ L 123, 24.4.1998, p. 1.

f23

OJ C 364, 18.12.2000, p. 1.

f24

OJ L 184, 17.7.1999, p. 23.

Contents

  1. Title I: GENERAL ISSUES
  2. 1Purpose and scope
  3. 2Definitions
  4. 3Hazardous substances and mixtures and specification of hazard classes
  5. 4General obligations to classify, label and package
  6. Title II: HAZARD CLASSIFICATION
  7. Chapter 1: Identification and examination of information
  8. 5Identification and examination of available information on substances
  9. 6Identification and examination of available information on mixtures
  10. 7Animal and human testing
  11. 8Generating new information for substances and mixtures
  12. Chapter 2: Evaluation of hazard information and decision on classification
  13. 9Evaluation of hazard information for substances and mixtures
  14. 10Concentration limits and M-factors for classification of substances and mixtures
  15. 11Cut-off values
  16. 12Specific cases requiring further evaluation
  17. 13Decision to classify substances and mixtures
  18. 14Specific rules for the classification of mixtures
  19. 15Review of classification for substances and mixtures
  20. 16Classification of substances included in the classification and labelling inventory Repealed
  21. Title III: HAZARD COMMUNICATION IN THE FORM OF LABELLING
  22. Chapter 1: Content of the label
  23. 17General rules
  24. 18Product identifiers
  25. 19Hazard pictograms
  26. 20Signal words
  27. 21Hazard statements
  28. 22Precautionary statements
  29. 23Derogations from labelling requirements for special cases
  30. 24Request for use of an alternative chemical name
  31. 25Supplemental information on the label
  32. 26Principles of precedence for hazard pictograms
  33. 27Principles of precedence for hazard statements
  34. 28Principles of precedence for precautionary statements
  35. 29Exemptions from labelling and packaging requirements
  36. 30Updating information on labels
  37. Chapter 2: Application of labels
  38. 31General rules for the application of labels
  39. 32Location of information on the label
  40. 33Specific rules for labelling of outer packaging, inner packaging and single packaging
  41. 34Report on communication on safe use of chemicals Repealed
  42. Title IV: PACKAGING
  43. 35Packaging
  44. Title V: MANDATORY CLASSIFICATION AND LABELLING OF SUBSTANCES ...
  45. Chapter 1: Establishing mandatory classification of substances
  46. 36Mandatory classification and labelling of substances
  47. 37Procedure for mandatory classification and labelling
  48. 37AProcedure for mandatory classification and labelling of substances where Article 37(1) does not apply Repealed
  49. 38Content of opinions and decisions for mandatory classification and labelling in the GB mandatory classification and labelling list; accessibility of information
  50. 38AGB mandatory classification and labelling list
  51. Chapter 2: GB notification database Repealed
  52. 39Scope Repealed
  53. 40Obligation to notify the Agency Repealed
  54. 41Agreed entries Repealed
  55. 42The GB notification database Repealed
  56. Title VI: HELPDESK AND APPOINTMENT OF BODIES
  57. 43Appointment of competent authorities and enforcement authorities and cooperation between authorities Repealed
  58. 44Helpdesk
  59. 45Appointment of bodies responsible for receiving information relating to emergency health response
  60. 46Enforcement and reporting Repealed
  61. 47Penalties for non-compliance Repealed
  62. Title VII: COMMON AND FINAL PROVISIONS
  63. 48Advertisement
  64. 49Obligation to maintain information and requests for information
  65. 50Tasks of the Agency
  66. 51Free movement clause Repealed
  67. 52Safeguard clause
  68. 53Adaptations to technical and scientific progress
  69. 53ARegulation making power
  70. 53BThe consent requirement
  71. 53aExercise of the delegation Repealed
  72. 53bUrgency procedure Repealed
  73. 53cSeparate delegated acts for different delegated powers Repealed
  74. 54Committee procedure Repealed
  75. 55Amendments to Directive 67/548/EEC
  76. 56Amendments to Directive 1999/45/EC
  77. 57Amendments to Regulation (EC) No 1907/2006 from the entry into force of this Regulation
  78. 58Amendments to Regulation (EC) No 1907/2006 from 1 December 2010
  79. 59Amendments to Regulation (EC) No 1907/2006 from 1 June 2015
  80. 60Repeal Repealed
  81. 61Transitional provisions Repealed
  82. 62Entry into force Repealed
  83. Signature
  84. Annex ICLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES
  85. PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING
  86. 1.0Definitions
  87. Classification of substances and mixtures
  88. 1.1.0Cooperation to meet the requirements in this Regulation
  89. The role and application of expert judgement and weight of evidence determination
  90. 1.1.1.1Division 1.1.1.1
  91. 1.1.1.2Division 1.1.1.2
  92. 1.1.1.3Division 1.1.1.3
  93. 1.1.1.4Division 1.1.1.4
  94. 1.1.1.5Division 1.1.1.5
  95. Specific concentration limits, M-factors and generic cut-off values
  96. 1.1.2.1Division 1.1.2.1
  97. 1.1.2.2Cut-off values
  98. 1.1.2.2.1Division 1.1.2.2.1
  99. 1.1.2.2.2The cut-off values referred to in Article 11 shall be the following:
  100. Note:
  101. 1.1.3Bridging principles for the classification of mixtures where test data are not available for the complete mixture
  102. 1.1.3.1Dilution
  103. 1.1.3.2Batching
  104. 1.1.3.3Concentration of highly hazardous mixtures
  105. 1.1.3.4Interpolation within one hazard category
  106. 1.1.3.5Substantially similar mixtures
  107. 1.1.3.6Review of classification where the composition of a mixture has changed
  108. 1.1.3.7Aerosols
  109. Labelling
  110. General rules for the application of labels required by Article 31
  111. 1.2.1.1Division 1.2.1.1
  112. 1.2.1.2Division 1.2.1.2
  113. 1.2.1.3Division 1.2.1.3
  114. 1.2.1.4Division 1.2.1.4
  115. 1.3Derogations from labelling requirements for special cases
  116. 1.3.1Transportable gas cylinders
  117. Gas containers intended for propane, butane or liquefied petroleum gas (LPG)
  118. 1.3.2.1Division 1.3.2.1
  119. 1.3.2.2Division 1.3.2.2
  120. 1.3.2.3Division 1.3.2.3
  121. 1.3.3Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard
  122. Metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers
  123. 1.3.4.1Division 1.3.4.1
  124. 1.3.4.2Division 1.3.4.2
  125. 1.3.5Explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect
  126. 1.3.6Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1)
  127. Request for use of an alternative chemical name
  128. 1.4.1Requests for use of an alternative chemical name under Article 24 may be granted only where
  129. 1.4.2The choice of the chemical name(s) for mixtures intended for the fragrance or perfume industry
  130. Exemptions from labelling and packaging requirements
  131. Exemptions from Article 31 [(Article 29(1))]
  132. 1.5.1.1Where Article 29(1) applies, the label elements mentioned in Article 17 may be provided in one of the following ways:
  133. 1.5.1.2Division 1.5.1.2
  134. Exemptions from Article 17 [(Article 29(2)]
  135. Labelling of packages where the contents do not exceed 125 ml
  136. 1.5.2.1.1The 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:
  137. 1.5.2.1.2The precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:
  138. 1.5.2.1.3The 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:
  139. 1.5.2.2Labelling of soluble packaging for single use
  140. 1.5.2.3Division 1.5.2.3
  141. Labelling of inner packaging where the contents do not exceed 10 ml
  142. 1.5.2.4.1The label elements required by Article 17 may be omitted from the inner packaging where:
  143. 1.5.2.4.2Division 1.5.2.4.2
  144. 1.5.2.5Division 1.5.2.5
  145. PART 2: PHYSICAL HAZARDS
  146. Explosives
  147. Definitions
  148. 2.1.1.1The class of explosives comprises
  149. 2.1.1.2For the purposes of this Regulation the following definitions shall apply:
  150. Classification criteria
  151. 2.1.2.1Division 2.1.2.1
  152. 2.1.2.2Substances, 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:
  153. 2.1.2.3Explosives, 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 RTDG, Manual of Tests and Criteria according to the results of the tests laid down in Table 2.1.1:
  154. 2.1.2.4Division 2.1.2.4
  155. 2.1.3Hazard Communication
  156. Division
  157. Division
  158. Additional Classification Considerations
  159. 2.1.4.1The 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 RTDG, Manual of Tests and Criteria is necessary.
  160. Figure 2.1.3Procedure for assignment to a division in the class of explosives (Class 1 for transport)
  161. ( 1 )Division ( 1 )
  162. 2.1.4.2Screening procedure
  163. Note:
  164. 2.1.4.3The acceptance procedure for the hazard class ‘explosives’ need not be applied if:
  165. 2.1.4.4Division 2.1.4.4
  166. Flammable gases
  167. 2.2.1Definitions
  168. Classification criteria
  169. 2.2.2.1A flammable gas is classified in Category 1A, 1B or 2 in accordance with Table 2.2.1. Flammable gases that are pyrophoric and/or chemically unstable are always classified in Category 1A.
  170. 2.2.3Hazard Communication
  171. Figure 2.2.1Flammable gases
  172. ( 1 )Division ( 1 )
  173. Additional Classification Considerations
  174. 2.2.4.1Division 2.2.4.1
  175. 2.2.4.2Division 2.2.4.2
  176. 2.2.4.3Division 2.2.4.3
  177. 2.2.4.4Division 2.2.4.4
  178. Aerosols
  179. 2.3.1Definitions
  180. Classification criteria
  181. 2.3.2.1Aerosols shall be classified in one of the three categories of this hazard class, depending on their flammable properties and their heat of combustion. They shall be considered for classification in Category 1 or 2 if they contain more than 1 % components (by mass) which are classified as flammable according to the following criteria set out in this Part:
  182. Division
  183. Division
  184. 2.3.2.2An 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.
  185. Note:
  186. 2.3.3Hazard Communication
  187. Additional Classification Considerations
  188. 2.3.4.1The chemical heat of combustion (ΔΗ c ), in kilojoules per gram (kJ/g), is the product of the theoretical heat of combustion (ΔΗ comb ), and a combustion efficiency, usually less than 1,0 (a typical combustion efficiency is 0,95 or 95 %).
  189. Oxidising gases
  190. 2.4.1Definitions
  191. Classification criteria
  192. 2.4.2.1An oxidising gas shall be classified in a single category for this class in accordance with Table 2.4.1.:
  193. Note:
  194. 2.4.3Hazard Communication
  195. 2.4.4Additional Classification Considerations
  196. Gases under pressure
  197. Definition
  198. 2.5.1.1Gases 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.
  199. 2.5.1.2Division 2.5.1.2
  200. Classification criteria
  201. 2.5.2.1Gases under pressure shall be classified, according to their physical state when packaged, in one of four groups in accordance with Table 2.5.1:
  202. 2.5.3Hazard Communication
  203. Note:
  204. 2.5.4Additional Classification Considerations
  205. Flammable liquids
  206. 2.6.1Definition
  207. Classification criteria
  208. 2.6.2.1A flammable liquid shall be classified in one of the three categories for this class in accordance with Table 2.6.1:
  209. Note:
  210. 2.6.3Hazard Communication
  211. Additional Classification Considerations
  212. 2.6.4.1Division 2.6.4.1
  213. 2.6.4.2In the case of mixtures containing known flammable liquids in defined concentrations, although they may contain non-volatile components e.g. polymers, additives, the flash point need not be determined experimentally if the calculated flash point of the mixture, using the method given in 2.6.4.3 below, is at least 5 °C greater than the relevant classification criterion and provided that:
  214. 2.6.4.3Division 2.6.4.3
  215. 2.6.4.4Possible test methods for determining the flash point of flammable liquids are listed in Table 2.6.3.
  216. 2.6.4.5Division 2.6.4.5
  217. 2.6.4.6Possible test methods for determining the initial boiling point of flammable liquids are listed in Table 2.6.4.
  218. Flammable solids
  219. Definition
  220. 2.7.1.1A flammable solid means a solid which is readily combustible, or may cause or contribute to fire through friction.
  221. Classification criteria
  222. 2.7.2.1Division 2.7.2.1
  223. 2.7.2.2Division 2.7.2.2
  224. 2.7.2.3A 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 UN RTDG, Manual of Tests and Criteria in accordance with Table 2.7.1:
  225. Note 1:
  226. Note 2:
  227. 2.7.3Hazard Communication
  228. Self-reactive substances and mixtures
  229. Definition
  230. 2.8.1.1Division 2.8.1.1
  231. 2.8.1.2Division 2.8.1.2
  232. Classification criteria
  233. 2.8.2.1Any self-reactive substance or mixture shall be considered for classification in this class as a self-reactive substance or mixture unless:
  234. 2.8.2.2Mixtures 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;
  235. 2.8.2.3Self-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:
  236. 2.8.2.4Criteria for temperature control
  237. 2.8.3Hazard Communication
  238. 2.8.4Additional Classification Considerations
  239. 2.8.4.1Division 2.8.4.1
  240. 2.8.4.2The classification procedures for self-reactive substances and mixtures need not be applied if:
  241. Pyrophoric liquids
  242. 2.9.1Definition
  243. Classification criteria
  244. 2.9.2.1A 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 UN RTDG, Manual of Tests and Criteria according to Table 2.9.1:
  245. 2.9.3Hazard Communication
  246. Additional Classification Considerations
  247. 2.9.4.1Division 2.9.4.1
  248. Pyrophoric solids
  249. 2.10.1Definition
  250. Classification criteria
  251. 2.10.2.1A 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 UN RTDG, Manual of Tests and Criteria in accordance with Table 2.10.1:
  252. Note
  253. 2.10.3Hazard Communication
  254. Additional Classification Considerations
  255. 2.10.4.1Division 2.10.4.1
  256. Self-heating substances and mixtures
  257. Definition
  258. 2.11.1.1Division 2.11.1.1
  259. 2.11.1.2Division 2.11.1.2
  260. Classification criteria
  261. 2.11.2.1A 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 UN RTDG, Manual of Tests and Criteria, Part III, sub-section 33.3.1.6:
  262. 2.11.2.2A 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 UN RTDG, Manual of Tests and Criteria, the result meets the criteria according to Table 2.11.1:
  263. Note
  264. 2.11.2.3Division 2.11.2.3
  265. 2.11.2.4Division 2.11.2.4
  266. 2.11.3Hazard Communication
  267. 2.11.4Additional Classification Considerations
  268. 2.11.4.1Division 2.11.4.1
  269. 2.11.4.2The 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:
  270. Substances and mixtures which in contact with water emit flammable gases
  271. 2.12.1Definition
  272. Classification criteria
  273. 2.12.2.1A 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 UN RTDG, Manual of Tests and Criteria, in accordance with Table 2.12.1:
  274. Note:
  275. 2.12.2.2Division 2.12.2.2
  276. 2.12.3Hazard Communication
  277. Additional Classification Considerations
  278. 2.12.4.1The classification procedure for this class need not be applied if:
  279. Oxidising liquids
  280. 2.13.1Definition
  281. Classification criteria
  282. 2.13.2.1An 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 UN RTDG, Manual of Tests and Criteria in accordance with Table 2.13.1:
  283. 2.13.3Hazard Communication
  284. Additional Classification Considerations
  285. 2.13.4.1For organic substances or mixtures the classification procedure for this class shall not apply if:
  286. 2.13.4.2Division 2.13.4.2
  287. 2.13.4.3Division 2.13.4.3
  288. 2.13.4.4Division 2.13.4.4
  289. Oxidising solids
  290. 2.14.1Definition
  291. Classification criteria
  292. 2.14.2.1An oxidising solid shall be classified in one of the three categories for this class using test O.1 in Part III, sub-section 34.4.1 or test O.3 in Part III, sub-section 34.4 3 of the UN RTDG, Manual of Tests and Criteria in accordance with Table 2.14.1:
  293. Note 1
  294. Note 2
  295. 2.14.3Hazard Communication
  296. Additional Classification Considerations
  297. 2.14.4.1For organic substances or mixtures the classification procedure for this class shall not apply if:
  298. 2.14.4.2Division 2.14.4.2
  299. 2.14.4.3Division 2.14.4.3
  300. Organic peroxides
  301. Definition
  302. 2.15.1.1Organic 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:
  303. 2.15.1.2Division 2.15.1.2
  304. Classification criteria
  305. 2.15.2.1Any organic peroxide shall be considered for classification in this class, unless it contains:
  306. Note
  307. 2.15.2.2Organic peroxides shall be classified in one of the seven categories of ‘Types A to G’ for this class, according to the following principles:
  308. 2.15.2.3Criteria for temperature control
  309. 2.15.3Hazard Communication
  310. 2.15.4Additional Classification Considerations
  311. 2.15.4.1Division 2.15.4.1
  312. 2.15.4.2Mixtures 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.
  313. Corrosive to metals
  314. 2.16.1Definition
  315. Classification criteria
  316. 2.16.2.1A 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 UN RTDG, Manual of Tests and Criteria, in accordance with Table 2.16.1:
  317. Note
  318. 2.16.3Hazard Communication
  319. Note:
  320. Additional Classification Considerations
  321. 2.16.4.1The corrosion rate can be measured according to the test method of Part III sub-section 37.4 of the UN RTDG, Manual of Tests and Criteria. The specimen to be used for the test shall be made of the following materials:
  322. Desensitised explosives
  323. Definitions and general considerations
  324. 2.17.1.1Division 2.17.1.1
  325. 2.17.1.2Division 2.17.1.2
  326. Classification criteria
  327. 2.17.2.1Division 2.17.2.1
  328. Division
  329. Division
  330. 2.17.2.2Division 2.17.2.2
  331. Division
  332. Division
  333. Division
  334. 2.17.3Hazard communication
  335. Additional classification considerations
  336. Figure 2.17.1Desensitised explosives
  337. 2.17.4.1Division 2.17.4.1
  338. 2.17.4.2Division 2.17.4.2
  339. PART 3: HEALTH HAZARDS
  340. Acute toxicity
  341. Definitions
  342. 3.1.1.1Division 3.1.1.1
  343. 3.1.1.2The hazard class Acute Toxicity is differentiated into:
  344. Criteria for classification of substances as acutely toxic
  345. 3.1.2.1Substances can be allocated to one of four hazard categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric cut-off criteria as shown in the table below. Acute toxicity values are expressed as (approximate) LD 50 (oral, dermal) or LC 50 (inhalation) values or as acute toxicity estimates (ATE). While some in vivo methods determine LD 50 /LC 50 values directly, other newer in vivo methods (e.g. using fewer animals) consider other indicators of acute toxicity, such as significant clinical signs of toxicity, which are used as a reference to assign the hazard category. Explanatory notes are shown following Table 3.1.1.
  346. Division
  347. Specific considerations for classification of substances as acutely toxic
  348. 3.1.2.2.1Division 3.1.2.2.1
  349. Specific considerations for classification of substances as acutely toxic by the inhalation route
  350. 3.1.2.3.1Division 3.1.2.3.1
  351. 3.1.2.3.2Division 3.1.2.3.2
  352. 3.1.2.3.3Division 3.1.2.3.3
  353. 3.1.3Criteria for classification of mixtures as acutely toxic
  354. 3.1.3.1Division 3.1.3.1
  355. 3.1.3.2Division 3.1.3.2
  356. 3.1.3.3In 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:
  357. Classification of mixtures where acute toxicity data are available for the complete mixture
  358. 3.1.3.4.1Division 3.1.3.4.1
  359. Classification of mixtures where acute toxicity data are available for the complete mixture: bridging principles
  360. 3.1.3.5.1Division 3.1.3.5.1
  361. 3.1.3.5.2Division 3.1.3.5.2
  362. Classification of mixtures based on ingredients of the mixture (Additivity formula)
  363. 3.1.3.6.1Data available for all ingredients
  364. 3.1.3.6.2Classification of mixtures when data are not available for all components
  365. 3.1.3.6.2.1Where 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.
  366. 3.1.3.6.2.2Division 3.1.3.6.2.2
  367. 3.1.3.6.2.3If 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:
  368. Note 1
  369. Hazard Communication
  370. 3.1.4.1Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.1.3. Without prejudice to Article 27, combined hazard statements may be used in accordance with Annex III.
  371. Note 1
  372. Note 2
  373. 3.1.4.2Division 3.1.4.2
  374. Skin corrosion/irritation
  375. Definitions and general considerations
  376. 3.2.1.1Division 3.2.1.1
  377. 3.2.1.2Division 3.2.1.2
  378. 3.2.2Classification criteria for substances
  379. Classification based on standard animal test data
  380. Skin corrosion
  381. 3.2.2.1.1.1Division 3.2.2.1.1.1
  382. 3.2.2.1.1.2Division 3.2.2.1.1.2
  383. 3.2.2.1.1.3Division 3.2.2.1.1.3
  384. 3.2.2.1.1.4Three sub-categories are provided within the corrosion category: sub-category 1A — where corrosive responses are noted following up to 3 minutes exposure and up to 1 hour observation; sub-category 1B — where corrosive responses are described following exposure greater than 3 minutes and up to 1 hour and observations up to 14 days; and sub-category 1C — where corrosive responses occur after exposures greater than 1 hour and up to 4 hours and observations up to 14 days.
  385. 3.2.2.1.1.5Division 3.2.2.1.1.5
  386. Skin irritation
  387. 3.2.2.1.2.1Division 3.2.2.1.2.1
  388. 3.2.2.1.2.2Division 3.2.2.1.2.2
  389. 3.2.2.1.2.3Division 3.2.2.1.2.3
  390. 3.2.2.1.2.4Animal irritant responses within a test can be variable, as they are with corrosion. A separate irritant criterion accommodates cases where there is a significant irritant response but less than the mean score criterion for a positive test. For example, a test material might be designated as an irritant if at least 1 of 3 tested animals shows a very elevated mean score throughout the study, including lesions persisting at the end of an observation period of normally 14 days. Other responses could also fulfil this criterion. However, it should be ascertained that the responses are the result of chemical exposure.
  391. 3.2.2.1.2.5Division 3.2.2.1.2.5
  392. Classification in a tiered approach
  393. 3.2.2.2.1Division 3.2.2.2.1
  394. 3.2.2.2.2Division 3.2.2.2.2
  395. 3.2.2.2.3Division 3.2.2.2.3
  396. 3.2.2.2.4Division 3.2.2.2.4
  397. 3.2.2.2.5Division 3.2.2.2.5
  398. 3.2.2.2.6Division 3.2.2.2.6
  399. 3.2.2.2.7Division 3.2.2.2.7
  400. Classification criteria for mixtures
  401. Classification of mixtures when data are available for the complete mixture
  402. 3.2.3.1.1Division 3.2.3.1.1
  403. 3.2.3.1.2Division 3.2.3.1.2
  404. Classification of mixtures when data are not available for the complete mixture: bridging principles
  405. 3.2.3.2.1Division 3.2.3.2.1
  406. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
  407. 3.2.3.3.1Division 3.2.3.3.1
  408. 3.2.3.3.2Division 3.2.3.3.2
  409. 3.2.3.3.3Division 3.2.3.3.3
  410. 3.2.3.3.4.1Division 3.2.3.3.4.1
  411. 3.2.3.3.4.2Division 3.2.3.3.4.2
  412. 3.2.3.3.4.3Division 3.2.3.3.4.3
  413. 3.2.3.3.5Division 3.2.3.3.5
  414. 3.2.3.3.6Division 3.2.3.3.6
  415. Note:
  416. Hazard Communication
  417. 3.2.4.1Division 3.2.4.1
  418. Serious eye damage/eye irritation
  419. Definitions and general considerations
  420. 3.3.1.1Division 3.3.1.1
  421. 3.3.1.2Division 3.3.1.2
  422. 3.3.2Classification criteria for substances
  423. Classification based on standard animal test data
  424. 3.3.2.1.1Serious eye damage (Category 1)
  425. 3.3.2.1.1.1Division 3.3.2.1.1.1
  426. 3.3.2.1.1.2Division 3.3.2.1.1.2
  427. 3.3.2.1.2Eye irritation (Category 2)
  428. 3.3.2.1.2.1Division 3.3.2.1.2.1
  429. 3.3.2.1.2.2Division 3.3.2.1.2.2
  430. 3.3.2.1.2.3Division 3.3.2.1.2.3
  431. Classification in a tiered approach
  432. 3.3.2.2.1Division 3.3.2.2.1
  433. 3.3.2.2.2Division 3.3.2.2.2
  434. 3.3.2.2.3Division 3.3.2.2.3
  435. 3.3.2.2.4Division 3.3.2.2.4
  436. 3.3.2.2.5Division 3.3.2.2.5
  437. 3.3.2.2.6Division 3.3.2.2.6
  438. Classification criteria for mixtures
  439. Classification of mixtures when data are available for the complete mixture
  440. 3.3.3.1.1Division 3.3.3.1.1
  441. 3.3.3.1.2Division 3.3.3.1.2
  442. Classification of mixtures when data are not available for the complete mixture: bridging principles
  443. 3.3.3.2.1Division 3.3.3.2.1
  444. 3.3.3.3Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
  445. 3.3.3.3.1Division 3.3.3.3.1
  446. 3.3.3.3.2Division 3.3.3.3.2
  447. 3.3.3.3.3Division 3.3.3.3.3
  448. 3.3.3.3.4.1Division 3.3.3.3.4.1
  449. 3.3.3.3.4.2Division 3.3.3.3.4.2
  450. 3.3.3.3.4.3Division 3.3.3.3.4.3
  451. 3.3.3.3.5Division 3.3.3.3.5
  452. 3.3.3.3.6Division 3.3.3.3.6
  453. Hazard Communication
  454. 3.3.4.1Division 3.3.4.1
  455. Respiratory or skin sensitisation
  456. Definitions and general considerations
  457. 3.4.1.1Division 3.4.1.1
  458. 3.4.1.2Division 3.4.1.2
  459. 3.4.1.3Division 3.4.1.3
  460. 3.4.1.4Division 3.4.1.4
  461. 3.4.1.5Division 3.4.1.5
  462. 3.4.1.6The hazard class Respiratory or Skin Sensitisation is differentiated into:
  463. Classification criteria for substances
  464. Respiratory sensitisers
  465. Hazard categories
  466. 3.4.2.1.1.1Division 3.4.2.1.1.1
  467. 3.4.2.1.1.2Division 3.4.2.1.1.2
  468. 3.4.2.1.1.3Division 3.4.2.1.1.3
  469. 3.4.2.1.1.4Division 3.4.2.1.1.4
  470. Human evidence
  471. 3.4.2.1.2.1Division 3.4.2.1.2.1
  472. 3.4.2.1.2.2Division 3.4.2.1.2.2
  473. 3.4.2.1.2.3Division 3.4.2.1.2.3
  474. 3.4.2.1.2.4Division 3.4.2.1.2.4
  475. 3.4.2.1.2.5Division 3.4.2.1.2.5
  476. Animal studies
  477. 3.4.2.1.3.1Division 3.4.2.1.3.1
  478. Skin sensitisers
  479. Hazard categories
  480. 3.4.2.2.1.1Division 3.4.2.2.1.1
  481. 3.4.2.2.1.2Division 3.4.2.2.1.2
  482. 3.4.2.2.1.3Division 3.4.2.2.1.3
  483. 3.4.2.2.1.4Division 3.4.2.2.1.4
  484. Human evidence
  485. 3.4.2.2.2.1Division 3.4.2.2.2.1
  486. 3.4.2.2.2.2Division 3.4.2.2.2.2
  487. Animal studies
  488. 3.4.2.2.3.1Division 3.4.2.2.3.1
  489. 3.4.2.2.3.2Division 3.4.2.2.3.2
  490. 3.4.2.2.3.3Division 3.4.2.2.3.3
  491. Specific considerations
  492. 3.4.2.2.4.1Division 3.4.2.2.4.1
  493. 3.4.2.2.4.2Division 3.4.2.2.4.2
  494. 3.4.2.2.4.3Division 3.4.2.2.4.3
  495. 3.4.2.2.4.4Immunological contact urticaria
  496. Classification criteria for mixtures
  497. Classification of mixtures when data are available for the complete mixture
  498. 3.4.3.1.1Division 3.4.3.1.1
  499. Classification of mixtures when data are not available for the complete mixture: bridging principles
  500. 3.4.3.2.1Division 3.4.3.2.1
  501. 3.4.3.3Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
  502. 3.4.3.3.1Division 3.4.3.3.1
  503. 3.4.3.3.2Division 3.4.3.3.2
  504. Note 1:
  505. Hazard communication
  506. 3.4.4.1Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.4.7.
  507. Germ cell mutagenicity
  508. Definitions and general considerations
  509. 3.5.1.1Division 3.5.1.1
  510. 3.5.1.2Division 3.5.1.2
  511. 3.5.1.3Division 3.5.1.3
  512. Classification criteria for substances
  513. 3.5.2.1Division 3.5.2.1
  514. 3.5.2.2For the purpose of classification for germ cell mutagenicity, substances are allocated to one of two categories as shown in Table 3.5.1.
  515. Specific considerations for classification of substances as germ cell mutagens
  516. 3.5.2.3.1Division 3.5.2.3.1
  517. 3.5.2.3.2Division 3.5.2.3.2
  518. 3.5.2.3.3Division 3.5.2.3.3
  519. 3.5.2.3.4In vivo heritable germ cell mutagenicity tests, such as:
  520. 3.5.2.3.5In vivo somatic cell mutagenicity tests, such as:
  521. 3.5.2.3.6Mutagenicity/genotoxicity tests in germ cells, such as:
  522. 3.5.2.3.7Genotoxicity tests in somatic cells such as:
  523. 3.5.2.3.8In vitro mutagenicity tests such as:
  524. 3.5.2.3.9Division 3.5.2.3.9
  525. Classification criteria for mixtures
  526. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
  527. 3.5.3.1.1The 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.
  528. Note
  529. Classification of mixtures when data are available for the complete mixture
  530. 3.5.3.2.1Division 3.5.3.2.1
  531. Classification of mixtures when data are not available for the complete mixture: bridging principles
  532. 3.5.3.3.1Division 3.5.3.3.1
  533. Hazard communication
  534. 3.5.4.1Label elements shall be used in accordance with Table 3.5.3, for substances or mixtures meeting the criteria for classification in this hazard class.
  535. 3.5.5Additional classification considerations
  536. Carcinogenicity
  537. Definition
  538. 3.6.1.1Carcinogenicity means the induction of cancer or an increase in the incidence of cancer occurring after exposure to a substance or mixture. Substances and mixtures 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.
  539. Classification criteria for substances
  540. 3.6.2.1For 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.
  541. Specific considerations for classification of substances as carcinogens
  542. 3.6.2.2.1Division 3.6.2.2.1
  543. 3.6.2.2.2Division 3.6.2.2.2
  544. 3.6.2.2.3Strength 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:
  545. 3.6.2.2.4Division 3.6.2.2.4
  546. 3.6.2.2.5Division 3.6.2.2.5
  547. 3.6.2.2.6Some important factors which may be taken into consideration, when assessing the overall level of concern are:
  548. 3.6.2.2.7Division 3.6.2.2.7
  549. 3.6.2.2.8Division 3.6.2.2.8
  550. 3.6.2.2.9Division 3.6.2.2.9
  551. Classification criteria for mixtures
  552. Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
  553. 3.6.3.1.1The 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.
  554. Note
  555. Note 1
  556. Classification of mixtures when data are available for the complete mixture
  557. 3.6.3.2.1Division 3.6.3.2.1
  558. Classification of mixtures when data are not available for the complete mixture: bridging principles
  559. 3.6.3.3.1Division 3.6.3.3.1
  560. Hazard Communication
  561. 3.6.4.1Label elements shall be used in accordance with Table 3.6.3, for substances or mixtures meeting the criteria for classification in this hazard class.
  562. Reproductive toxicity
  563. Definitions and general considerations
  564. 3.7.1.1Reproductive toxicity means adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring, occurring after exposure to a substance or mixture. 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 inheritable 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.
  565. 3.7.1.2For the purpose of classification the hazard class Reproductive Toxicity is differentiated into:
  566. 3.7.1.3Adverse effects on sexual function and fertility
  567. 3.7.1.4Adverse effects on development of the offspring
  568. 3.7.1.5Division 3.7.1.5
  569. Classification criteria for substances
  570. Hazard categories
  571. 3.7.2.1.1For 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.
  572. Basis of classification
  573. 3.7.2.2.1Classification 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.
  574. 3.7.2.2.2Division 3.7.2.2.2
  575. 3.7.2.2.3Division 3.7.2.2.3
  576. Weight of evidence
  577. 3.7.2.3.1Division 3.7.2.3.1
  578. 3.7.2.3.2Division 3.7.2.3.2
  579. 3.7.2.3.3Division 3.7.2.3.3
  580. 3.7.2.3.4Division 3.7.2.3.4
  581. 3.7.2.3.5Division 3.7.2.3.5
  582. Maternal toxicity
  583. 3.7.2.4.1Division 3.7.2.4.1
  584. 3.7.2.4.2Division 3.7.2.4.2
  585. 3.7.2.4.3Division 3.7.2.4.3
  586. 3.7.2.4.4Some 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.
  587. Animal and experimental data
  588. 3.7.2.5.1Division 3.7.2.5.1
  589. 3.7.2.5.2Division 3.7.2.5.2
  590. 3.7.2.5.3Division 3.7.2.5.3
  591. 3.7.2.5.4Division 3.7.2.5.4
  592. 3.7.2.5.5Division 3.7.2.5.5
  593. 3.7.2.5.6Division 3.7.2.5.6
  594. 3.7.2.5.7Division 3.7.2.5.7
  595. 3.7.2.5.8Division 3.7.2.5.8
  596. 3.7.2.5.9Division 3.7.2.5.9
  597. Classification criteria for mixtures
  598. 3.7.3.1Classification of mixtures when data are available for all ingredients or only for some ingredients of the mixture
  599. 3.7.3.1.1Division 3.7.3.1.1
  600. 3.7.3.1.2Division 3.7.3.1.2
  601. Classification of mixtures when data are available for the complete mixture
  602. 3.7.3.2.1Division 3.7.3.2.1
  603. Classification of mixtures when data are not available for the complete mixture: bridging principles
  604. 3.7.3.3.1Division 3.7.3.3.1
  605. Hazard Communication
  606. 3.7.4.1Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.7.3
  607. Specific target organ toxicity — single exposure
  608. Definitions and general considerations
  609. 3.8.1.1Division 3.8.1.1
  610. 3.8.1.2Division 3.8.1.2
  611. 3.8.1.3Division 3.8.1.3
  612. 3.8.1.4Division 3.8.1.4
  613. 3.8.1.5Division 3.8.1.5
  614. 3.8.1.6Specific 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:
  615. 3.8.1.7The hazard class Specific Target Organ Toxicity — Single Exposure is differentiated into:
  616. Classification criteria for substances
  617. Substances of Category 1 and Category 2
  618. 3.8.2.1.1Division 3.8.2.1.1
  619. 3.8.2.1.2Division 3.8.2.1.2
  620. 3.8.2.1.3Division 3.8.2.1.3
  621. 3.8.2.1.4Division 3.8.2.1.4
  622. 3.8.2.1.5Division 3.8.2.1.5
  623. 3.8.2.1.6In exceptional cases, based on expert judgement, it is appropriate to place certain substances with human evidence of target organ toxicity in Category 2:
  624. Effects considered to support classification for Category 1 and 2
  625. 3.8.2.1.7.1Division 3.8.2.1.7.1
  626. 3.8.2.1.7.2Division 3.8.2.1.7.2
  627. 3.8.2.1.7.3Evidence 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:
  628. 3.8.2.1.8Effects considered not to support classification for Category 1 and 2
  629. Guidance values to assist with classification based on the results obtained from studies conducted in experimental animals for Category 1 and 2
  630. 3.8.2.1.9.1Division 3.8.2.1.9.1
  631. 3.8.2.1.9.2Division 3.8.2.1.9.2
  632. 3.8.2.1.9.3The 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.
  633. Note
  634. Other considerations
  635. 3.8.2.1.10.1Division 3.8.2.1.10.1
  636. 3.8.2.1.10.2Division 3.8.2.1.10.2
  637. 3.8.2.1.10.3Division 3.8.2.1.10.3
  638. 3.8.2.1.10.4Division 3.8.2.1.10.4
  639. Substances of Category 3: Transient target organ effects
  640. 3.8.2.2.1Criteria for respiratory tract irritation
  641. 3.8.2.2.2Criteria for narcotic effects
  642. Classification criteria for mixtures
  643. 3.8.3.1Division 3.8.3.1
  644. Classification of mixtures when data are available for the complete mixture
  645. 3.8.3.2.1Division 3.8.3.2.1
  646. Classification of mixtures when data are not available for the complete mixture: bridging principles
  647. 3.8.3.3.1Division 3.8.3.3.1
  648. Classification of mixtures when data are available for all components or only for some components of the mixture
  649. 3.8.3.4.1Division 3.8.3.4.1
  650. 3.8.3.4.2Division 3.8.3.4.2
  651. 3.8.3.4.3Mixtures shall be classified for either or both single- and repeated-dose toxicity independently.
  652. Note 1
  653. 3.8.3.4.4Division 3.8.3.4.4
  654. 3.8.3.4.5Division 3.8.3.4.5
  655. 3.8.3.4.6Division 3.8.3.4.6
  656. Hazard Communication
  657. 3.8.4.1Label elements shall be used in accordance with Table 3.8.4., for substances or mixtures meeting the criteria for classification in this hazard class.
  658. Specific target organ toxicity — repeated exposure
  659. Definitions and general considerations
  660. 3.9.1.1Division 3.9.1.1
  661. 3.9.1.2Division 3.9.1.2
  662. 3.9.1.3Division 3.9.1.3
  663. 3.9.1.4Division 3.9.1.4
  664. 3.9.1.5Division 3.9.1.5
  665. 3.9.1.6Division 3.9.1.6
  666. Classification criteria for substances
  667. 3.9.2.1Substances are classified as specific target organ toxicants following repeated exposure 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 which take into account the duration of exposure and the dose/concentration which produced the effect(s), (see 3.9.2.9), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed (Table 3.9.1).
  668. Note
  669. 3.9.2.2Division 3.9.2.2
  670. 3.9.2.3Division 3.9.2.3
  671. 3.9.2.4Division 3.9.2.4
  672. 3.9.2.5Division 3.9.2.5
  673. 3.9.2.6In exceptional cases, based on expert judgement, it is appropriate to place certain substances with human evidence of specific target organ toxicity in Category 2:
  674. Effects considered to support classification for specific target organ toxicity following repeated exposure
  675. 3.9.2.7.1Division 3.9.2.7.1
  676. 3.9.2.7.2Division 3.9.2.7.2
  677. 3.9.2.7.3Evidence from appropriate studies in experimental animals can furnish much more detail, in the form of clinical observations, haematology, clinical chemistry, 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, shall be taken into consideration in the classification process, including but not limited to the following toxic effects in humans and/or animals:
  678. Effects considered not to support classification for specific target organ toxicity following repeated exposure
  679. 3.9.2.8.1It is recognised that effects may be seen in humans and/or animals that do not justify classification. Such effects include, but are not limited to:
  680. Guidance values to assist with classification based on the results obtained from studies conducted in experimental animals
  681. 3.9.2.9.1Division 3.9.2.9.1
  682. 3.9.2.9.2Division 3.9.2.9.2
  683. 3.9.2.9.3Division 3.9.2.9.3
  684. 3.9.2.9.4Division 3.9.2.9.4
  685. 3.9.2.9.5Division 3.9.2.9.5
  686. 3.9.2.9.6Thus classification in Category 1 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur at or below the guidance values (C) as indicated in Table 3.9.2:
  687. 3.9.2.9.7Classification in Category 2 is applicable, when significant toxic effects observed in a 90-day repeated-dose study conducted in experimental animals are seen to occur within the guidance value ranges as indicated in Table 3.9.3:
  688. 3.9.2.9.8Division 3.9.2.9.8
  689. 3.9.2.9.9Division 3.9.2.9.9
  690. Other considerations
  691. 3.9.2.10.1Division 3.9.2.10.1
  692. 3.9.2.10.2Division 3.9.2.10.2
  693. 3.9.2.10.3Division 3.9.2.10.3
  694. 3.9.2.10.4Division 3.9.2.10.4
  695. Classification criteria for mixtures
  696. 3.9.3.1Division 3.9.3.1
  697. Classification of mixtures when data are available for the complete mixture
  698. 3.9.3.2.1Division 3.9.3.2.1
  699. Classification of mixtures when data are not available for the complete mixture: bridging principles
  700. 3.9.3.3.1Division 3.9.3.3.1
  701. Classification of mixtures when data are available for all components or only for some components of the mixture
  702. 3.9.3.4.1Where there is no reliable evidence or test data for the specific mixture itself, and the bridging principles cannot be used to enable classification, then classification of the mixture is based on the classification of the ingredient substances. In this case, the mixture shall be classified as a specific target organ toxicant (specific organ specified), following repeated exposure when at least one ingredient has been classified as a Category 1 or Category 2 specific target organ toxicant (repeated exposure) and is present at or above the appropriate generic concentration limit as laid out in Table 3.9.4 for Category 1 and 2 respectively.
  703. Note 1
  704. 3.9.3.4.2Division 3.9.3.4.2
  705. 3.9.3.4.3Division 3.9.3.4.3
  706. 3.9.3.4.4Division 3.9.3.4.4
  707. Hazard Communication
  708. 3.9.4.1Label elements shall be used in accordance with Table 3.9.5 for substances or mixtures meeting the criteria for classification in this hazard class.
  709. Aspiration hazard
  710. Definitions and general considerations
  711. 3.10.1.1Division 3.10.1.1
  712. 3.10.1.2Division 3.10.1.2
  713. 3.10.1.3Division 3.10.1.3
  714. 3.10.1.4Division 3.10.1.4
  715. 3.10.1.5Division 3.10.1.5
  716. Specific considerations
  717. 3.10.1.6.1Division 3.10.1.6.1
  718. 3.10.1.6.2The classification criteria refer to kinematic viscosity. The following provides the conversion between dynamic and kinematic viscosity:
  719. 3.10.1.6.2aDivision 3.10.1.6.2a
  720. 3.10.1.6.3Classification of aerosol/mist products
  721. 3.10.2Classification criteria for substances
  722. Note:
  723. Classification criteria for mixtures
  724. 3.10.3.1Classification when data are available for the complete mixture
  725. Classification when data are not available for the complete mixture: bridging principles
  726. 3.10.3.2.1Division 3.10.3.2.1
  727. Classification when data are available for all components or only some components of the mixture
  728. Category 1
  729. 3.10.3.3.1.1Division 3.10.3.3.1.1
  730. 3.10.3.3.1.2Division 3.10.3.3.1.2
  731. 3.10.3.3.1.3Division 3.10.3.3.1.3
  732. Hazard Communication
  733. 3.10.4.1Label elements shall be used for substances or mixtures meeting the criteria for classification in this hazard class in accordance with Table 3.10.2.
  734. PART 4: ENVIRONMENTAL HAZARDS
  735. Hazardous to the aquatic environment
  736. Definitions and general considerations
  737. 4.1.1.1Definitions
  738. Basic elements
  739. 4.1.1.2.0Division 4.1.1.2.0
  740. 4.1.1.2.1Division 4.1.1.2.1
  741. 4.1.1.2.2Division 4.1.1.2.2
  742. Other considerations
  743. 4.1.1.3.1Division 4.1.1.3.1
  744. 4.1.1.3.2Division 4.1.1.3.2
  745. Classification criteria for substances
  746. 4.1.2.1Division 4.1.2.1
  747. 4.1.2.2Division 4.1.2.2
  748. 4.1.2.3Division 4.1.2.3
  749. 4.1.2.4Division 4.1.2.4
  750. 4.1.2.5Division 4.1.2.5
  751. 4.1.2.6Division 4.1.2.6
  752. Note 1:
  753. Note 2:
  754. Note 3:
  755. Note 4:
  756. Aquatic toxicity
  757. 4.1.2.7.1Division 4.1.2.7.1
  758. 4.1.2.7.2Division 4.1.2.7.2
  759. Bioaccumulation
  760. 4.1.2.8.1Division 4.1.2.8.1
  761. Rapid degradability of organic substances
  762. 4.1.2.9.1Division 4.1.2.9.1
  763. 4.1.2.9.2Division 4.1.2.9.2
  764. 4.1.2.9.3Division 4.1.2.9.3
  765. 4.1.2.9.4Division 4.1.2.9.4
  766. 4.1.2.9.5Division 4.1.2.9.5
  767. Inorganic compounds and metals
  768. 4.1.2.10.1Division 4.1.2.10.1
  769. 4.1.2.10.2Division 4.1.2.10.2
  770. Classification criteria for mixtures
  771. 4.1.3.1Division 4.1.3.1
  773. Division
  774. Figure 4.1.2Tiered approach to classification of mixtures for short-term (acute) and long-term (chronic) aquatic environmental hazards
  775. Classification of mixtures when toxicity data are available for the complete mixture
  776. 4.1.3.3.1Division 4.1.3.3.1
  777. 4.1.3.3.2Division 4.1.3.3.2
  778. 4.1.3.3.3Classification for category Acute 1
  779. 4.1.3.3.4Classification for categories Chronic 1, 2 and 3
  780. 4.1.3.3.5Classification for category Chronic 4
  781. Classification of mixtures when toxicity data are not available for the complete mixture: bridging principles
  782. 4.1.3.4.1Division 4.1.3.4.1
  783. 4.1.3.4.2Division 4.1.3.4.2
  784. 4.1.3.4.3Division 4.1.3.4.3
  785. Classification of mixtures when toxicity data are available for some or all components of the mixture
  786. 4.1.3.5.1Division 4.1.3.5.1
  787. 4.1.3.5.2Division 4.1.3.5.2
  788. 4.1.3.5.3Division 4.1.3.5.3
  789. 4.1.3.5.4Division 4.1.3.5.4
  790. Summation method
  791. Rationale
  792. 4.1.3.5.5.1.1Division 4.1.3.5.5.1.1
  793. 4.1.3.5.5.1.2Division 4.1.3.5.5.1.2
  794. Classification procedure
  795. 4.1.3.5.5.2.1Division 4.1.3.5.5.2.1
  796. Classification for category Acute 1
  797. 4.1.3.5.5.3.1Division 4.1.3.5.5.3.1
  798. 4.1.3.5.5.3.2Division 4.1.3.5.5.3.2
  799. Classification for the categories Chronic 1, 2, 3 and 4
  800. 4.1.3.5.5.4.1Division 4.1.3.5.5.4.1
  801. 4.1.3.5.5.4.2Division 4.1.3.5.5.4.2
  802. 4.1.3.5.5.4.3Division 4.1.3.5.5.4.3
  803. 4.1.3.5.5.4.4Division 4.1.3.5.5.4.4
  804. 4.1.3.5.5.4.5Division 4.1.3.5.5.4.5
  805. Mixtures with highly toxic components
  806. 4.1.3.5.5.5.1Division 4.1.3.5.5.5.1
  807. Classification of mixtures with components without any useable information
  808. 4.1.3.6.1Division 4.1.3.6.1
  809. Hazard communication
  810. 4.1.4.1Division 4.1.4.1
  811. PART 5: ADDITIONAL HAZARDS
  812. Hazardous to the ozone layer
  813. Definitions and general considerations
  814. 5.1.1.1Division 5.1.1.1
  815. Classification criteria for substances
  816. 5.1.2.1Division 5.1.2.1
  817. Classification criteria for mixtures
  818. 5.1.3.1Division 5.1.3.1
  819. Hazard communication
  820. 5.1.4.1Division 5.1.4.1
  821. Annex IISPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES
  822. 1PART 1: SUPPLEMENTAL HAZARD INFORMATION
  823. Physical properties
  824. 1.1.1EUH001 — ‘Explosive when dry’ Repealed
  825. 1.1.2EUH006 — ‘Explosive with or without contact with air’ Repealed
  826. 1.1.1EUH014 — ‘Reacts violently with water’
  827. 1.1.2EUH018 — ‘In use, may form flammable/explosive vapour-air mixture’
  828. 1.1.3EUH019 — ‘May form explosive peroxides’
  829. 1.1.4EUH044 — ‘Risk of explosion if heated under confinement’
  830. Health properties
  831. 1.2.1EUH029 — ‘Contact with water liberates toxic gas’
  832. 1.2.2EUH031 — ‘Contact with acids liberates toxic gas’
  833. 1.2.3EUH032 — ‘Contact with acids liberates very toxic gas’
  834. 1.2.4EUH066 — ‘Repeated exposure may cause skin dryness or cracking’
  835. 1.2.5EUH070 — ‘Toxic by eye contact’
  836. 1.2.6EUH071 — ‘Corrosive to the respiratory tract’
  837. 2PART 2: SPECIAL RULES FOR SUPPLEMENTAL LABEL ELEMENTS FOR CERTAIN MIXTURES
  838. 2.1Mixtures containing lead
  839. 2.2Mixtures containing cyanoacrylates
  840. 2.3Cements and cement mixtures
  841. 2.4Mixtures containing isocyanates
  842. 2.5Mixtures containing epoxy constituents with an average molecular weight ≤ 700
  843. 2.6Mixtures sold to the general public which contain active chlorine
  844. 2.7Mixtures containing cadmium (alloys) and intended to be used for brazing or soldering
  845. 2.8Mixtures containing at least one sensitising substance
  846. 2.9Liquid mixtures containing halogenated hydrocarbons
  847. 2.10Mixtures not intended for the general public
  848. 2.11Aerosols
  849. PART 3: SPECIAL RULES ON PACKAGING
  850. Provisions relating to child-resistant fastenings
  851. Packaging to be fitted with child-resistant fastenings
  852. 3.1.1.1Division 3.1.1.1
  853. 3.1.1.2Division 3.1.1.2
  854. 3.1.1.3Where a substances or mixture has at least one of the substances mentioned below present in a concentration equal to or greater than the maximum individual concentrations specified, which are supplied to the general public, the packaging of whatever capacity shall be fitted with child-resistant fastenings.
  855. 3.1.2Reclosable packages
  856. 3.1.3Non-reclosable packages
  857. Notes
  858. 3.1.4.1Division 3.1.4.1
  859. 3.1.4.2Specific cases
  860. Tactile Warnings
  861. Packaging to be fitted with a tactile warning
  862. 3.2.1.1Division 3.2.1.1
  863. 3.2.1.2Division 3.2.1.2
  864. 3.2.2Provisions relating to tactile warning
  865. 3.3Liquid consumer laundry detergents in soluble packaging for single use
  866. 4PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS
  867. 5PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES
  868. Annex III: LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS
  869. 1Part 1: hazard statements
  870. 2Part 2: supplemental hazard information
  871. 3Part 3: supplemental label elements/information on certain certain substances and mixtures
  872. Annex IVLIST OF PRECAUTIONARY STATEMENTS
  873. 1Part 1: Criteria for the selection of precautionary statements
  874. 2Part 2: precautionary statements
  875. Annex V: HAZARD PICTOGRAMS
  876. INTRODUCTION
  877. PART 1: PHYSICAL HAZARDS
  878. 1.1Symbol: exploding bomb
  879. 1.2Symbol: flame
  880. 1.3Symbol: flame over circle
  881. 1.4Symbol: gas cylinder
  882. 1.5Symbol: corrosion
  883. 1.6A pictogram is not required for the following physical hazard classes and hazard categories:
  884. PART 2: HEALTH HAZARDS
  885. 2.1Symbol: skull and crossbones
  886. 2.2Symbol: corrosion
  887. 2.3Symbol: exclamation mark
  888. 2.4Symbol: health hazard
  889. 2.5A pictogram is not required for the following health hazard categories:
  890. PART 3: ENVIRONMENTAL HAZARDS
  891. 3.1Symbol: environment
  892. PART 4: ADDITIONAL HAZARDS
  893. 4.1Symbol: exclamation mark
  894. Annex VIMandatory classification and labelling for certain hazardous substances
  895. PART 1: INTRODUCTION TO THE LIST OF MANDATORY CLASSIFICATIONS AND LABELLING
  896. Information listed for each entry
  897. Numbering of entries and identification of a substance
  898. 1.1.1.1Index numbers
  899. 1.1.1.2EC numbers
  900. 1.1.1.3CAS number
  901. 1.1.1.4Chemical name
  902. 1.1.1.5Entries for groups of substances
  903. Information related to the classification and labelling of each entry in the GB mandatory classification and labelling list
  904. Classification codes
  905. 1.1.2.1.1Hazard class and category codes
  906. 1.1.2.1.2Hazard statement codes
  907. 1.1.2.2Labelling codes
  908. 1.1.2.3Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE)
  909. 1.1.3Division 1.1.3
  910. 1.1.3.1Division 1.1.3.1
  911. 1.1.3.2Division 1.1.3.2
  912. Information related to the classification and labelling of each entry in Table 3.2 Repealed
  913. 1.1.4.1Classification codes Repealed
  914. 1.1.4.2Labelling codes Repealed
  915. 1.1.4.3Specific Concentration Limits Repealed
  916. 1.1.4.4Non-conformity with Table 3.1 for physical hazards Repealed
  917. Classifications and hazard statements in Table 3 arising from translation of classifications listed in Annex I to directive 67/548/EEC
  918. 1.2.1Minimum classification
  919. 1.2.2Route of exposure cannot be excluded
  920. 1.2.3Hazard statements for reproductive toxicity
  921. 1.2.4Correct classification for physical hazards could not be established
  922. 2PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING
  923. 3PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE
  924. Annex VIITranslation table from classification under Directive 67/548/EEC to classification under this Regulation
  925. 1Translation table
  926. Annex VIII: HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES Repealed
  927. Part A: GENERAL REQUIREMENTS Repealed
  928. APPLICATION Repealed
  929. 1.1Division 1.1 Repealed
  930. 1.2Division 1.2 Repealed
  931. 1.3Division 1.3 Repealed
  932. 1.4Division 1.4 Repealed
  933. 1.5Division 1.5 Repealed
  934. PURPOSE, SCOPE AND DEFINITIONS Repealed
  935. 2.1Division 2.1 Repealed
  936. 2.2This Annex shall not apply to mixtures for scientific research and development and to mixtures for product and process oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006. Repealed
  937. 2.2aDivision 2.2a Repealed
  938. 2.3Division 2.3 Repealed
  939. 2.4For the purposes of this Annex, the following definitions shall apply: Repealed
  940. SUBMISSION REQUIREMENTS Repealed
  941. 3.1Before placing mixtures on the market, submitters shall provide information relating to mixtures classified as hazardous on the basis of their health or physical effects to the bodies appointed under Article 45(1) (‘appointed bodies’), in the Member State or Member States where the mixture is placed on the market. Repealed
  942. 3.2Division 3.2 Repealed
  943. 3.3Division 3.3 Repealed
  944. 3.4Division 3.4 Repealed
  945. 3.5Division 3.5 Repealed
  946. GROUP SUBMISSION Repealed
  947. 4.1Division 4.1 Repealed
  948. 4.2Division 4.2 Repealed
  949. 4.3Division 4.3 Repealed
  950. 4.4Division 4.4 Repealed
  951. UNIQUE FORMULA IDENTIFIER (UFI) Repealed
  952. 5.1The submitter shall create a Unique Formula Identifier (‘UFI’) by electronic means made available by the Agency. The UFI is a unique alphanumeric code that unambiguously links the submitted information on the composition of a mixture or a group of mixtures to a specific mixture or group of mixtures. The assignment of a UFI is free of charge. Repealed
  953. 5.2Division 5.2 Repealed
  954. 5.3Instead of including the UFI in the supplemental information on the label, the submitter may opt to print or affix it on the inner packaging located with the other label elements. Repealed
  955. FORMATS AND TECHNICAL SUPPORT FOR SUBMISSION OF INFORMATION Repealed
  956. 6.1Division 6.1 Repealed
  957. 6.2Division 6.2 Repealed
  958. Part B: INFORMATION CONTAINED IN A SUBMISSION Repealed
  959. IDENTIFICATION OF THE MIXTURE AND OF THE SUBMITTER Repealed
  960. 1.1Product identifier of the mixture Repealed
  961. 1.2Details of the submitter and contact point Repealed
  962. 1.3Name, telephone number and email address for rapid access to additional product information Repealed
  963. 2HAZARDS IDENTIFICATION AND ADDITIONAL INFORMATION Repealed
  964. INFORMATION ON MIXTURE COMPONENTS Repealed
  965. 3.1General requirements Repealed
  966. 3.2Identification of mixture components Repealed
  967. 3.2.1Substances Repealed
  968. 3.2.2Mixture in mixture Repealed
  969. 3.2.3Identification by generic component identifiers Repealed
  970. 3.3Mixture components subject to submission requirements Repealed
  971. 3.4Concentration and concentration ranges of the mixture components Repealed
  972. 3.4.1Hazardous components of major concern for emergency health response and preventative measures Repealed
  973. 3.4.2Other hazardous components and components not classified as hazardous Repealed
  974. 3.5Grouping of components in an interchangeable component group Repealed
  975. 3.5.1Name of interchangeable component group and identification of grouped components Repealed
  976. 3.5.2Concentration and concentration ranges of grouped components Repealed
  977. 3.6Mixtures complying with standard formulas Repealed
  978. 3.7Fuels Repealed
  979. 3.8Classification of mixture components Repealed
  980. SUBMISSION UPDATE Repealed
  981. 4.1Conditions for submission update Repealed
  982. 4.2Content of the submission update Repealed
  983. Part C: SUBMISSION FORMAT Repealed
  984. SUBMISSION FORMAT Repealed
  985. 1.1Submission Format Repealed
  986. 1.2Identification of the mixture, submitter and contact point Repealed
  987. 1.3Classification of the mixture, label elements and toxicology Repealed
  988. 1.4Information on the mixture components and interchangeable component groups Repealed
  989. DSTANDARD FORMULAS Repealed