31.12.2008   

EN

Official Journal of the European Union

L 353/1

(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

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

(13)

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

(14)

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

(15)

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

(16)

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

(17)

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

(18)

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

(19)

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

(20)

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

(21)

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

(22)

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

(23)

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

(24)

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

(25)

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

(26)

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

(27)

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

(28)

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

(29)

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

(30)

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

(31)

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

(32)

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

(33)

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

(34)

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

(35)

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

(36)

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

(37)

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

(38)

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

(39)

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

(40)

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

(41)

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

(42)

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

(43)

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

(44)

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

(45)

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

(46)

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

(47)

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

(48)

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

(49)

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

(50)

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

(51)

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

(52)

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

(53)

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

(54)

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

(55)

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

(56)

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

(57)

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

(58)

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

(59)

Member States should appoint the competent authority or competent authorities responsible for proposals for harmonised classification and labelling and the authorities responsible for the enforcement of the obligations set out in this Regulation. Member States should put in place effective monitoring and control measures in order to ensure compliance with this Regulation.

(60)

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

(61)

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

(62)

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

(63)

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

(64)

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

(65)

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

(66)

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

(67)

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

(68)

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

(69)

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

(70)

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

(71)

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

(72)

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

(73)

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

(74)

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

(75)

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

(76)

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

(77)

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

(78)

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

(79)

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

(a)

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

(b)

providing an obligation for:

(c)

providing an obligation for manufacturers and importers of substances to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006;

(d)

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

(e)

establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d).

(a)

radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation (25);

(b)

substances and mixtures which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit;

(c)

non-isolated intermediates;

(d)

substances and mixtures for scientific research and development, which are not placed on the market, provided they are used under controlled conditions in accordance with Community workplace and environmental legislation.

(a)

medicinal products as defined in Directive 2001/83/EC;

(b)

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

(c)

cosmetic products as defined in Directive 76/768/EEC;

(d)

medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;

(e)

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

1.

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

2.

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

3.

‘hazard pictogram’ means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned;

4.

‘signal word’ means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:

5.

‘hazard statement’ means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard;

6.

‘precautionary statement’ means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal;

7.

‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

8.

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

9.

‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

10.

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

11.

‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:

In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;

12.

‘monomer’ means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

13.

‘registrant’ means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006;

14.

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

15.

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

16.

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

17.

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

18.

‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

19.

‘downstream user’ means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user;

20.

‘distributor’ means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

21.

‘intermediate’ means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as ‘synthesis’);

22.

‘non-isolated intermediate’ means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

23.

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

24.

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

25.

‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

26.

‘supplier’ means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;

27.

‘alloy’ means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation;

28.

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

29.

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

30.

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

31.

‘cut-off value’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified;

32.

‘concentration limit’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively;

33.

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

34.

‘M-factor’ means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present;

35.

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

36.

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

37.

‘intermediate packaging’ means packaging placed between inner packaging, or articles, and outer packaging.

(a)

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

(b)

Articles 7(2) or 9 of Regulation (EC) No 1907/2006 provide for notification.

(a)

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

(b)

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

(c)

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

(d)

any new scientific information;

(e)

any other information generated under internationally recognised chemical programmes.

(a)

data generated in accordance with any of the methods referred to in Article 8(3) on the mixture itself or the substances contained in it;

(b)

epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it, such as occupational data or data from accident databases;

(c)

any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it;

(d)

any other information generated under internationally recognised chemical programmes for the mixture itself or the substances contained in it.

(a)

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

or

(b)

sound scientific principles that are internationally recognised or methods validated according to international procedures.

(a)

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

(b)

conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;

(c)

adequate and reliable scientific information demonstrates the potential occurrence of synergistic or antagonistic effects among the substances in a mixture for which the evaluation was decided on the basis of the information for the substances in the mixture.

(a)

one or more hazard categories for each relevant hazard class or differentiation;

(b)

subject to Article 21, one or more hazard statements corresponding to each hazard category assigned in accordance with (a).

(a)

that the substances in the mixture react slowly with atmospheric gases, in particular oxygen, carbon dioxide, water vapour, to form different substances at low concentration;

(b)

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

(c)

that the substances in the mixture may self-polymerise to form oligomers or polymers, at low concentration.

(a)

none of the substances in the mixture possesses any of those properties and, on the basis of the information available to the supplier, the mixture is unlikely to present hazards of this kind;

(b)

in the event of a change in the composition of a mixture, scientific evidence indicates that an evaluation of the information on the mixture will not lead to a change in classification;

(c)

where a mixture is placed on the market in the form of an aerosol dispenser, it satisfies Article 8(1a) of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (27).

(a)

a change in the composition of the initial concentration of one or more of the hazardous constituents in concentrations at or above the limits in Table 1.2 of Part 1 of Annex I;

(b)

a change in the composition involving the substitution or addition of one or more constituents in concentrations at or above the cut-off value referred to in Article 11(3).

(a)

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

(b)

the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;

(c)

product identifiers as specified in Article 18;

(d)

where applicable, hazard pictograms in accordance with Article 19;

(e)

where applicable, signal words in accordance with Article 20;

(f)

where applicable, hazard statements in accordance with Article 21;

(g)

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

(h)

where applicable, a section for supplemental information in accordance with Article 25.

(a)

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

(b)

if the substance is not included in Part 3 of Annex VI, but appears in the classification and labelling inventory, a name and an identification number as given therein;

(c)

if the substance is not included in Part 3 of Annex VI nor in the classification and labelling inventory, the number provided by the CAS (hereinafter referred to as ‘the CAS number’), together with the name set out in the nomenclature provided by the IUPAC (hereinafter referred to as ‘the IUPAC Nomenclature’), or the CAS number together with another international chemical name(s); or

(d)

if the CAS number is not available, the name set out in the IUPAC Nomenclature or another international chemical name(s).

(a)

the trade name or the designation of the mixture;

(b)

the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard.

(a)

transportable gas cylinders;

(b)

gas containers intended for propane, butane or liquefied petroleum gas;

(c)

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

(d)

metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers;

(e)

explosives, as referred to in section 2.1 of Annex I, placed on the market with a view to obtaining an explosive or pyrotechnic effect.

(a)

the hazard pictogram shall not be included on the label;

(b)

the signal words, hazard statements and precautionary statements shall be placed in the supplemental information section of the label.

(a)

if the hazard pictogram ‘GHS01’ applies, the use of the hazard pictograms ‘GHS02’ and ‘GHS03’ shall be optional, except in cases where more than one of these hazard pictograms are compulsory;

(b)

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

(c)

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

(d)

if the hazard pictogram ‘GHS08’ applies for respiratory sensitisation, the hazard pictogram ‘GHS07’ shall not appear for skin sensitisation or for skin and eye irritation.

(a)

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

(b)

the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

(c)

the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

(d)

packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

(a)

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

(b)

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

(c)

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

(d)

reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7).

(a)

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

(b)

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

(c)

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

(d)

the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);

(e)

any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.

(a)

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

(b)

substances within the scope of Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this Regulation or Directive 1999/45/EC, where relevant, which results in the classification of the mixture as hazardous.

(a)

the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;

(b)

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

(c)

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

(d)

where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;

(e)

specific concentration limits or M-factors, where applicable, in accordance with Article 10 of this Regulation together with a justification using the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;

(f)

the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1).

(a)

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

(b)

whether, in respect of the entry, it is a joint entry between registrants of the same substance as referred to in Article 11(1) of Regulation (EC) No 1907/2006;

(c)

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

(d)

whether the entry differs from another entry on the inventory for the same substance.

(a)

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

and

(b)

where requested by the Member State, to undertake statistical analysis to identify where improved risk management measures may be needed.

(a)

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

(b)

provide competent authorities with technical and scientific guidance on the operation of this Regulation and provide support to the helpdesks established by Member States under Article 44.

1.

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

2.

Article 4 shall be amended as follows:

3.

Article 5 shall be amended as follows:

4.

Article 6 shall be replaced by the following:

‘Article 6

Obligation to carry out investigations

Manufacturers, distributors and importers of substances which appear in the EINECS but for which no entry has been included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label dangerous substances according to the rules laid down in Articles 22 to 25 of this Directive and the criteria in Annex VI to this Directive.’;

5.

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

6.

Article 23(2) shall be amended as follows:

7.

Article 24(4) second subparagraph shall be deleted;

8.

Article 28 shall be deleted;

9.

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

10.

the following Article shall be inserted after Article 32:

‘Article 32a

Transitional provision regarding labelling and packaging of substances

Articles 22 to 25 shall not apply to substances from 1 December 2010.’;

11.

Annex I shall be deleted.

1.

in Article 3(2), first indent, the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (30).

2.

the words ‘Annex I to Directive 67/548/EEC’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’ in:

3.

in Annex VI, Part B, point 1, paragraph 3 first indent and paragraph 5, the words ‘Annex I’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’;

4.

in Annex VI, Part B, point 4.2, final paragraph, the words ‘Annex I to Directive 67/548/EEC (19th adaptation)’ shall be replaced by ‘Part 3 of Annex VI to Regulation (EC) No 1272/2008’.

1.

Article 14(2) shall be amended as follows:

2.

Article 31 shall be amended as follows:

3.

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

4.

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

5.

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

6.

Article 77 shall be amended as follows:

7.

Title XI shall be deleted;

8.

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

9.

the table in Annex XVII shall be amended as follows:

10.

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

11.

the word ‘preparation’ or ‘preparations’ within the meaning of Article 3 (2) of Regulation (EC) 1907/2006 shall be replaced by ‘mixture’ or ‘mixtures’ respectively throughout the text.

1.

in Article 14(4), the introductory sentence shall be replaced by the following:

‘4.   If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008:

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

2.

Article 31 shall be amended as follows

3.

Article 40(1) shall be replaced by the following:

‘1.   The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances above 100 tonnes per year with uses resulting in widespread and diffuse exposure, provided they fulfil the criteria for any of the following hazard classes or categories set out in Annex I of Regulation (EC) No 1272/2008:

4.

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

5.

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

6.

Article 68(2) shall be replaced by the following:

‘2.   For a substance on its own, in a mixture or in an article which meets the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, and could be used by consumers and for which restrictions to consumer use are proposed by the Commission, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4). Articles 69 to 73 shall not apply.’;

7.

Article 119 shall be amended as follows:

8.

in Article 138(1), the second sentence of the introductory phrase shall be replaced by the following:

‘However, for substances meeting the criteria for classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity, category 1A or 1B, in accordance with Regulation (EC) No 1272/2008, the review shall be carried out by 1 June 2014.’;

9.

Annex III shall be amended as follows:

10.

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

11.

in Annex VI, sections 4.1, 4.2 and 4.3 shall be replaced by the following:

12.

Annex VIII shall be amended as follows:

13.

in Annex IX, column 2, point 8.7, the second and third paragraphs shall be replaced by the following:

‘If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered.

If a substance is known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered.’;

14.

Annex X shall be amended as follows:

15.

in Annex XIII, the second and third indents of point 1.3 shall be replaced by the following:

16.

in the table in Annex XVII, the column ‘Designation of the substance, of the groups of substances or of the mixture’ shall be amended as follows:

1.

Article 14(2) shall be replaced by the following:

‘2.   A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a mixture if the concentration of the substance in the mixture is less than

2.

Article 31 shall be amended as follows:

3.

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

4.

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

5.

Annex II shall be amended as follows:

6.

in Annex VI section 4.3 shall be replaced by the following:

7.

Annex XVII shall be amended as follows: