EXPLANATORY MEMORANDUM

1. On 1 April 1987 the Commission decided[1] to instruct its staff that all acts should be codified after no more than ten amendments, stressing that this is a minimum requirement and that departments should endeavour to codify at even shorter intervals the texts for which they are responsible, to ensure that their provisions are clear and readily understandable.

2. The codification of 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[2] has been initiated by the Commission. The new Directive was to have superseded the various acts incorporated in it[3].

3. In the meantime the Lisbon Treaty entered into force. Article 290 of the Treaty on the Functioning of the European Union (TFEU) allows the legislator to delegate to the Commission the power to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act. Acts adopted by the Commission in this way are referred to in the terminology used by the TFEU as "delegated acts" (Article 290(3)).

4. Directive 1999/45/EC contains a provision with regard to which such a delegation of power would be opportune. It is therefore appropriate to transform the codification of Directive 1999/45/EC into a recast in order to incorporate the necessary amendments.

5. The recast proposal was drawn up on the basis of a preliminary consolidation, in 22 official languages, of Directive 1999/45/EC and the instruments amending it, carried out by the Publications Office of the European Union, by means of a data‑processing system. Where the Articles have been given new numbers, the correlation between the old and the new numbers is shown in a table set out in Annex IX to the recast Directive.

ê 1999/45/EC (adapted)

2012/0007 (COD)

Proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on the classification, packaging and labelling of dangerous preparations

(Recast)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article Ö 114 Õ thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national Parliaments,

Having regard to the opinion of the European Economic and Social Committee[4],

Acting in accordance with the ordinary legislative procedure[5],

Whereas:

ò new

(1) 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[6] has been substantially amended several times[7]. Since further amendments are to be made, it should be recast in the interests of clarity.

(2) The approximation of the rules existing in the Member States relating to classification, packaging and labelling of certain dangerous preparations is essential for setting equal competition conditions and the functioning of the internal market.

ê 1999/45/EC recital 3 (adapted)

(3) Measures for the approximation of the provisions of the Member States affecting the functioning of the internal market Ö should Õ, in so far as they concern health, safety and protection of man and the environment, adopt a high level of protection as a basis. This Directive Ö should Õ, at the same time, ensure protection for the general public, and, in particular, persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, protection for consumers and for the environment.

ê 1999/45/EC recital 8 (adapted)

(4) The number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of Ö Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes Õ[8]. Ö Pursuant to Article 4(1) of that Directive Member States are to ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, are used instead of a procedure within the meaning of that Directive, defined as any use, invasive or non-invasive, of an animal for experimental or other scientific purposes, with known or unknown outcome, or educational purposes, which may cause the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. Õ Therefore, this Directive makes use of the results of assessments of toxicological and ecotoxicological properties only when these are already known and entails no obligation to conduct further experiments on animals.

ê 1999/45/EC recital 14 (adapted)

(5) Although munitions are not covered by this Directive, explosives marketed to produce an explosive or pyrotechnic effect may, through their chemical composition, present dangers to health. It is therefore necessary as part of a transparent information process to classify them Ö in accordance with this Directive Õ and assign to them a safety data sheet in accordance with Ö 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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC[9], Õ and also to label them in accordance with the international rules used for the transport of dangerous goods.

ê 1999/45/EC recital 12 (adapted)

(6) Ö Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC Õ[10] 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[11], in contrast to the provisions applicable to chemical preparations covered by this Directive, provide for an authorisation procedure for each product on the basis of a dossier presented by the applicant and an assessment carried out by the competent authority in each Member State. Furthermore, that authorisation procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market. It is appropriate, as part of a clear and transparent information process, to classify and label plant protection products Ö and biocidal products Õ according to the provisions of this Directive, and also to provide instructions for use in accordance with the results of the evaluation carried out in the framework of Ö Regulation (EC) No 1107/2009 and Directive 98/8/EC Õ and to ensure that the labelling satisfies the high level of protection sought by both this Directive and Ö Regulation (EC) No 1107/2009 or Directive 98/8/EC respectively Õ. In addition, a safety data sheet has to be established for plant protection products Ö and biocidal products Õ in accordance with Ö Regulation (EC) No 1907/2006 Õ.

ê 1999/45/EC recital 5 (adapted)

(7) It is necessary to provide Ö for Õ concentration limits expressed as a volume/volume percentage in the case of preparations marketed in gaseous form.

ê 1999/45/EC recital 9

(8) It is necessary to define what human experience might be considered for the evaluation of the health hazards of a preparation. If clinical studies may be accepted, it is taken as given that such studies comply with the Helsinki Declaration and the Guidelines for Good Clinical Practice of the Organisation for Economic Co-operation and Development.

ê Corrigendum 1907/2006 recital 57 (OJ L 136, 29.5.2007, p. 3) (adapted)

(9) As the existing safety data sheet is already being used as a communication tool within the supply chain of substances and preparations, Ö has been developed Õ further and Ö has been made Õ an integral part of the system established by Regulation Ö (EC) No 1907/2006, it should be removed from this Directive Õ.

ê Corrigendum 2006/121/EC recital 1 (OJ L 136, 29.5.2007, p. 281) (adapted)

(10) Ö Due to Õ the adoption of Regulation (EC) No 1907/2006, 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[12] Ö has been Õ adapted and its rules on the notification and risk assessment of chemicals Ö have been Õ deleted. Ö This Directive should be adapted accordingly. Õ

ê 440/2008 recital 2 (adapted)

(11) Annex V to Directive 67/548/EEC, Ö setting out methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations, Õ has been deleted by Directive 2006/121/EC of the European Parliament and of the Council[13] with effect from 1 June 2008. Ö The references to that Annex in this Directive should be adapted accordingly. Õ

ê 1272/2008 recital 53 (adapted)

(12) 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 Ö to that Õ Directive, all existing harmonised classifications should be converted into new harmonised classifications using the new criteria. Moreover, as the applicability of 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[14] 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 Ö that Õ Regulation. By subjecting all future harmonisations of classifications to Ö that Õ Regulation, inconsistencies in harmonised classifications of the same substance under the existing and the new criteria should be avoided.

ê 2006/8/EC recital 1 (adapted)

(13) Preparations composed of more than one substance being classified in Ö Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 Õ as carcinogenic, mutagenic and/or toxic for reproduction Ö had to Õ be labelled with risk phrases (R phrases) to indicate both category 1 or 2 and category 3 classification. However, providing both R phrases sends a conflicting message. Preparations should therefore only be classified and labelled with the higher category.

ê 2001/60/EC recital 2 (adapted)

(14) Ö The references to R phrase R40 in Directive 67/548/EEC were amended by Õ Commission Directive 2001/59/EC[15] when Ö R phrase R40 was Õ assigned to carcinogens of category 3. Consequently, the old wording of R phrase R40 Ö became Õ R68 and Ö was used Õ for mutagens of category 3 and for certain substances with non-lethal irreversible effects. Ö The references to R phrase R40 in this Directive should be adapted accordingly. Õ

ê 2001/60/EC recital 3 (adapted)

(15) Annex VI to Directive 67/548/EEC Ö as amended by Directive 2001/59/EC gives Õ clear advice on the classification of substances and preparations for corrosive effects. Ö In this Directive, preparations should therefore be classified Õ accordingly.

ê 2001/60/EC recital 4 (adapted)

(16) It is known that cement preparations containing chromium (VI) may cause allergic reactions in certain circumstances. Such preparations Ö should Õ display Ö the relevant Õ warning label.

ê 2001/60/EC recital 1 (adapted)

(17) Ö Directive 67/548/EEC as amended by Õ Commission Directive 98/98/EC[16] provides for new criteria and a new R phrase (R67) for vapours which may cause drowsiness and dizziness. Ö Preparations should be classified and labelled accordingly Õ.

ê 1999/45/EC recital 7 (adapted)

(18) Criteria developed for classifying and labelling substances dangerous for the environment were introduced Ö together with the appropriate symbols, indications of danger, risk phrases and safety advice required to appear on labelling, Õ by Ö Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC on the approximation of the laws, regulation and administrative provisions relating to the classification, packaging and labelling of dangerous substances[17] and by Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulation and administrative provisions relating to the classification, packaging and labelling of dangerous substances[18]. Õ Provisions Ö are required Õ at Ö Union Õ level on the classification and labelling of preparations to take account of their effects on the environment, and it is therefore necessary to Ö provide for Õ a method for assessing the hazards of a given preparation for the environment either by a calculation method, or by determining the ecotoxicological properties by test methods under certain conditions.

ê 2006/8/EC recital 2 (adapted)

(19) For substances very toxic to the aquatic environment (classified as N) and assigned the R phrases R50 or R50/53, specific concentration limits (SCLs) are applied to substances listed in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 in order to avoid an underestimation of the hazard. This measure creates distortions between preparations containing substances listed in Ö that Õ Annex, to which SCLs are applied, and those preparations containing substances not yet included in Ö that Õ Annex, but classified and labelled provisionally in accordance with Article 6 of Directive 67/548/EEC and to which no SCLs are applicable. It is therefore necessary to ensure that SCLs are applied in the same way to all preparations containing substances very toxic to the aquatic environment.

ê 2006/8/EC recital 3 (adapted)

(20) Directive 2001/59/EC revised the criteria in Annex VI to Directive 67/548/EEC for the classification and labelling of ozone depleting substances. The revised Annex III now only provides for the assignment of the symbol N in addition to R phrase R59. Ö Preparations should be classified and labeled accordingly. Õ

ê 1999/45/EC recital 20

(21) The confidentiality of certain substances contained in the preparations should be guaranteed, and it is therefore necessary to institute a system which allows the person responsible for placing the preparation on the market to request confidentiality for such substances.

ê 1999/45/EC recital 16 (adapted)

(22) The label constitutes a basic tool for users of the dangerous preparations in so far as it provides them with the initial essential concise information. It nevertheless needs to be supplemented by a two-fold system of more detailed information, consisting firstly of the safety data sheet intended for professional users Ö as provided for in Regulation (EC) No 1907/2006 Õ and secondly of the bodies appointed by the Member States which are responsible for the provision of information solely for medical purposes, both preventive and curative.

ê 1999/45/EC recital 4

(23) Containers containing certain categories of dangerous preparations offered or sold to the general public must be fitted with child-resistant fastenings and/or carry a tactile warning of danger. Certain preparations not falling within these categories of danger may nevertheless, owing to their composition, present a danger for children. The packaging of such preparations should therefore be equipped with child-resistant fastenings.

ê 1999/45/EC recital 15 (adapted)

(24) In order to take account of certain preparations which, although they are not considered dangerous under this Directive, may nevertheless present a danger for users, it is necessary Ö that Õ certain provisions of this Directive cover such preparations.

ê 1999/45/EC recital 6 (adapted)

(25) This Directive contains special labelling provisions applicable to certain preparations. To ensure an adequate level of protection for man and the environment, special labelling provisions Ö should Õ also be Ö laid down Õ for certain preparations which, although not dangerous within the meaning of this Directive, may nevertheless present a danger to the user.

ê 1999/45/EC recital 19 (adapted)

(26) In the case of preparations classified as dangerous within the meaning of this Directive, it is appropriate to permit Member States to allow certain derogations with respect to labelling where the packaging is too small, or otherwise unsuitable for labelling, or where such small packaging or such small quantities are involved that there is no reason to fear any danger to man or the environment. In such cases appropriate consideration should also be given to the approximation of the relevant provisions at Ö Union Õ level.

ê 1999/45/EC recital 13

(27) It is appropriate to provide, in relation to environmental labelling, that specific exemptions or specific provisions may be decided upon in specific cases where it can be demonstrated that the overall environmental impact of the product types in question is lower than that of corresponding product types.

ò new

(28) In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of determining exemptions to certain provisions on environmental labelling, deciding on measures in the framework of the special provisions on the labelling of certain preparations and adapting the Annexes to technical progress. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

(29) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers[19].

(30) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex VIII, Part B,

ê 1999/45/EC

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Objectives and scope

1. This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, and to the approximation of specific provisions for certain preparations which may present hazards, whether or not they are classified as dangerous within the meaning of this Directive, when such preparations are placed on the market of the Member States.

2. This Directive shall apply to preparations which:

ê 1999/45/EC (adapted)

(a) contain at least one dangerous substance within the meaning of Article 2; Ö and Õ

ê 1999/45/EC

(b) are considered dangerous within the meaning of Article 5, 6 or 7.

ê 1999/45/EC (adapted)

3. The specific provisions set out in Article 9 and Annex IV, Ö and those set out Õ in Article 10 and Annex V shall also apply to preparations which are not considered dangerous within the meaning of Article 5, 6 or 7 but which may nevertheless present a specific hazard.

4. Without prejudice to Ö Regulation (EC) No 1107/2009 Õ, the articles on classification, packaging Ö and Õ labelling of this Directive shall apply to plant protection products.

ê 1999/45/EC

5. This Directive shall not apply to the following preparations in the finished state, intended for the final user:

(a) veterinary medicinal products and medicinal products for human use, as defined in Directives 2001/82/EC[20] and 2001/83/EC[21] of the European Parliament and of the Council respectively;

(b) cosmetic products as defined in Council Directive 76/768/EEC[22];

(c) mixtures of substances which, in the form of waste, are covered by Directive 2008/98/EC of the European Parliament and of the Council[23];

(d) foodstuffs;

(e) animal feedingstuffs;

(f) preparations containing radioactive substances as defined by Council Directive 96/29/Euratom[24];

ê 1999/45/EC (adapted)

(g) medical devices which are invasive or used in direct physical contact with the human body in so far as Ö Union Õ measures lay down provisions for the classification and labelling of dangerous substances and preparations which ensure the same level of information provision and protection as this Directive.

ê 1999/45/EC

6. This Directive shall not apply to:

(a) the carriage of dangerous preparations by rail, road, inland waterway, sea or air;

(b) preparations in transit which are under customs supervision, provided they do not undergo any treatment or processing.

Article 2

Definitions

ê 1999/45/EC (adapted)

1. For the purposes of this Directive Ö , the following definitions shall apply Õ:

ê 1999/45/EC

(a) ‘substances’ means chemical elements and their compounds in the natural state or obtained by any production process, including any additive necessary to preserve the stability of the products 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;

(b) ‘preparations’ means mixtures or solutions composed of two or more substances;

(c) ‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant and consists of less than a simple weight majority of molecules of the same molecular weight. 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. In the context of this definition a ‘monomer unit’ means the reacted form of a monomer in a polymer;

ê 1999/45/EC (adapted)

(d) ‘placing on the market’ means making available to third parties. Importation into the customs territory Ö of the Union Õ shall be deemed to be placing on the market for the purposes of this Directive;

ê 1999/45/EC

(e) ‘scientific research and development’ means scientific experimentation, analysis or chemical research carried out under controlled conditions; it includes the determination of intrinsic properties, performance and efficacy as well as scientific investigation related to product development;

(f) ‘process-orientated research and development’ means the further development of a substance in the course of which pilot plant or production trials are used to test the fields of application of the substance;

ê 1999/45/EC (adapted)

(g) ‘Einecs’ means the European Inventory of Existing Commercial Chemical Substances. This inventory contains the definitive list of all chemical substances deemed to be on the Ö Union Õ market on 18 September 1981.

ê 1999/45/EC

2. The following are ‘dangerous’ within the meaning of this Directive:

(a) explosive substances and preparations: solid, liquid, pasty or gelatinous substances and preparations which may also react exothermically without atmospheric oxygen thereby quickly evolving gases, and which, under defined test conditions, detonate, quickly deflagrate or upon heating explode when partially confined;

(b) oxidising substances and preparations: substances and preparations which give rise to a highly exothermic reaction in contact with other substances, particularly flammable substances;

(c) extremely flammable substances and preparations: liquid substances and preparations having an extremely low flash-point and a low boiling-point and gaseous substances and preparations which are flammable in contact with air at ambient temperature and pressure;

(d) highly flammable substances and preparations:

(i) substances and preparations which may become hot and finally catch fire in contact with air at ambient temperature without any application of energy; or

(ii) solid substances and preparations which may readily catch fire after brief contact with a source of ignition and which continue to burn or to be consumed after removal of the source of ignition; or

(iii) liquid substances and preparations having a very low flash-point; or

(iv) substances and preparations which, in contact with water or damp air, evolve extremely flammable gases in dangerous quantities;

(e) flammable substances and preparations: liquid substances and preparations having a low flash-point;

(f) very toxic substances and preparations: substances and preparations which in very low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

(g) toxic substances and preparations: substances and preparations which in low quantities cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

(h) harmful substances and preparations: substances and preparations which may cause death or acute or chronic damage to health when inhaled, swallowed or absorbed via the skin;

(i) corrosive substances and preparations: substances and preparations which may, on contact with living tissues, destroy them;

(j) irritant substances and preparations: non-corrosive substances and preparations which, through immediate, prolonged or repeated contact with the skin or mucous membrane, may cause inflammation;

(k) sensitising substances and preparations: substances and preparations which, if they are inhaled or if they penetrate the skin, are capable of eliciting a reaction of hypersensitisation such that on further exposure to the substance or preparation, characteristic adverse effects are produced;

(l) carcinogenic substances and preparations: substances or preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence;

(m) mutagenic substances and preparations: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence;

(n) substances and preparations which are toxic for reproduction: substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity;

(o) substances and preparations which are dangerous for the environment: substances and preparations which, were they to enter the environment, would or could present an immediate or delayed danger for one or more components of the environment.

Article 3

Determination of dangerous properties of preparations

1. The evaluation of the hazards of a preparation shall be based on the determination of:

(a) physico-chemical properties;

(b) properties affecting health;

(c) environmental properties.

ê 1999/45/EC (adapted)

Those different properties shall be determined in accordance with Articles 5, 6 and 7.

ê 1999/45/EC

Where laboratory tests are conducted, they shall be carried out on the preparation as placed on the market.

ê 1999/45/EC (adapted)

è1 1272/2008 Art. 56 pt. 1 (adapted)

2. Where the determination of dangerous properties is carried out in accordance with Articles 5, 6 and 7, all dangerous substances within the meaning of Article 2 and in particular Ö the following shall be taken into consideration in accordance with the provisions laid down in the method used Õ:

(a) Ö substances Õ listed in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç;

(b) Ö substances Õ classified and labelled provisionally by the person responsible for the placing on the market in accordance with Article 6 of Directive 67/548/EEC.

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(a)

3. For preparations covered by this Directive, dangerous substances as referred to in paragraph 2 which are classified as dangerous on the basis of their health and/or environmental effects, whether they are present as impurities or additives, shall be taken into consideration when their concentrations are equal to, or greater than, those defined in the following table unless lower values are given in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç, or in Part B of Annex II to this Directive or in Part B of Annex III thereto, unless otherwise specified in Annex V to this Directive.

Category of danger of the substance || Concentration to take into consideration for

gaseous preparations % vol/vol || other preparations % w/w

Very toxic || ≥ 0,02 || ≥ 0,1

Toxic || ≥ 0,02 || ≥ 0,1

Carcinogenic Category 1 or 2 || ≥ 0,02 || ≥ 0,1

Mutagenic Category 1 or 2 || ≥ 0,02 || ≥ 0,1

Toxic for reproduction Category 1 or 2 || ≥ 0,02 || ≥ 0,1

Harmful || ≥ 0,2 || ≥ 1

Corrosive || ≥ 0,02 || ≥ 1

Irritant || ≥ 0,2 || ≥ 1

Sensitising || ≥ 0,2 || ≥ 1

Carcinogenic Category 3 || ≥ 0,2 || ≥ 1

Mutagenic Category 3 || ≥ 0,2 || ≥ 1

Toxic for reproduction Category 3 || ≥ 0,2 || ≥ 1

Dangerous for the environment N || || ≥ 0,1

Dangerous for the environment ozone || ≥ 0,1 || ≥ 0,1

Dangerous for the environment || || ≥ 1

Article 4

General principles of classification and labelling

1. The classification of dangerous preparations according to the degree and specific nature of the hazards involved shall be based on the definitions of categories of danger laid down in Article 2.

2. The general principles of the classification and labelling of preparations shall be applied in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC, save where alternative criteria referred to in Article 5, 6, 7 or 10 and the relevant Annexes of this Directive are applied.

Article 5

Evaluation of the hazards deriving from physico-chemical properties

ê 1999/45/EC (adapted)

1. The hazards of a preparation deriving from its physico-chemical properties shall be assessed by determining, by means of the methods specified in Part A of the Annex to Council Regulation (EC) No 440/2008[25], the physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria laid down in Annex VI to Directive Ö 67/548/EEC Õ.

ê 1999/45/EC

2. By way of derogation from paragraph 1, the determination of the explosive, oxidising, extremely flammable, highly flammable, or flammable properties is not necessary provided that:

(a) none of the constituents possesses such properties and that, on the basis of the information available to the manufacturer, the preparation is unlikely to present hazards of this kind;

(b) in the event of a change in the composition of a preparation of known composition, scientific evidence indicates that a reassessment of the hazards will not lead to a change in classification;

(c) preparations placed on the market in the form of aerosols satisfy the provisions of Article 8(1a) of Council Directive 75/324/EEC[26].

3. For certain cases for which the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 are not appropriate, alternative calculation methods are laid down in Part B of Annex I to this Directive.

4. Certain exemptions from the application of the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 are referred to in Part A of Annex I to this Directive.

ê 1999/45/EC (adapted)

5. The hazards deriving from the physico-chemical properties of a preparation covered by Ö Regulation (EC) No 1107/2009 Õ shall be assessed by determining the physico-chemical properties of the preparation necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part A of the Annex to Regulation (EC) No 440/2008 unless other internationally recognised methods are acceptable in accordance with the provisions of Ö Commission Regulations (EU) No 544/2011[27] and (EU) No 545/2011[28] Õ.

Article 6

Evaluation of health hazards

1. The health hazards of a preparation shall be assessed by one or more of the following procedures:

(a) by a conventional method described in Annex II;

(b) by determining the toxicological properties of the preparation necessary for appropriate classification in accordance with the criteria in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part B of the Annex to Regulation (EC) No 440/2008, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Ö Regulations (EU) No 544/2011 and (EU) No 545/2011 Õ.

2. Without prejudice to the requirements of Ö Regulation (EC) No 1107/2009 Õ, only where it can be scientifically demonstrated by the person responsible for placing the preparation on the market that the toxicological properties of the preparation cannot correctly be determined by the method outlined in point (a) of paragraph 1, or on the basis of existing test results on animals, the methods outlined in point (b) of paragraph 1 may be used, provided they are justified or specifically authorised under Article 12 of Directive 86/609/EEC.

When a toxicological property is established by the methods outlined in point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC of the European Parliament and the Council[29] and the provisions of Directive 86/609/EEC, in particular Articles 7 and 12 thereof.

Subject to the provisions of paragraph 3, where a toxicological property has been established on the basis of both the methods outlined in points (a) and (b) of paragraph 1, the results from the methods outlined in point (b) of paragraph 1 shall be used for classifying the preparation, except in the case of carcinogenic, mutagenic or toxic effects for reproduction for which only the method outlined in point (a) of paragraph 1 shall be used.

Any of the toxicological properties of the preparation which are not assessed by the method outlined in point (b) of paragraph 1 shall be assessed in accordance with the method outlined in point (a) of paragraph 1.

3. Furthermore, where it can be demonstrated by epidemiological studies, by scientifically valid case studies as specified by Annex VI to Directive 67/548/EEC or by statistically backed experience, such as the assessment of data from poison information units or concerning occupational diseases:

– that toxicological effects on man differ from those suggested by the application of the methods outlined in paragraph 1, then the preparation shall be classified according to its effects on man,

– that, owing to effects such as potentiation, a conventional assessment would underestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation,

– that, owing to effects such as antagonism, a conventional assessment would overestimate the toxicological hazard, those effects shall be taken into account in classifying the preparation.

4. For preparations of a known composition, with the exception of those covered by Ö Regulation (EC) No 1107/2009 Õ, classified in accordance with point (b) of paragraph 1, a new evaluation of health hazard by the methods outlined in either point (a) or point (b) of paragraph 1 shall be performed whenever:

– changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:

Initial concentration range of the constituent || Permitted variation in initial concentration of the constituent

≤ 2,5 % || ± 30 %

> 2,5 ≤ 10 % || ± 20 %

> 10 ≤ 25 % || ± 10 %

> 25 ≤ 100 % || ± 5 %

– changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.

This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

Article 7

Evaluation of environmental hazards

1. The hazards of a preparation for the environment shall be assessed by one or more of the following procedures:

(a) by a conventional method described in Annex III ;

(b) by determining the hazardous properties of the preparation for the environment necessary for appropriate classification in accordance with the criteria set out in Annex VI to Directive 67/548/EEC. Those properties shall be determined by means of the methods laid down in Part C of the Annex to Regulation (EC) No 440/2008 unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Ö Regulations (EU) No 544/2011 and (EU) No 545/2011 Õ. Without prejudice to the testing requirements Ö laid down in or pursuant to Regulation (EC) No 1107/2009 Õ, the conditions for application of the test methods are described in Part C of Annex III to this Directive.

2. Where an ecotoxicological property is established by one of the methods outlined in point (b) of paragraph 1 to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC and with the provisions of Directive 86/609/EEC.

Where the environmental hazards have been assessed in compliance with both of the procedures mentioned above, the results of the methods referred to in point (b) of paragraph 1 shall be used for classifying the preparation.

3. For preparations of a known composition, with the exception of those covered by Ö Regulation (EC) No 1107/2009 Õ, classified in accordance with the method outlined in point (b) of paragraph 1, a new evaluation of environmental hazard either by the method outlined in point (a) of paragraph 1 or that outlined in point (b) of paragraph 1 shall be performed whenever:

– changes of composition of the initial concentration, as a weight/weight or volume/volume percentage, of one or more of the dangerous constituents are introduced by the manufacturer, in accordance with the following table:

Initial concentration range of the constituent || Permitted variation in initial concentration of the constituent

≤ 2,5 % || ± 30 %

> 2,5 ≤ 10 % || ± 20 %

> 10 ≤ 25 % || ± 10 %

> 25 ≤ 100 % || ± 5 %

– changes of composition involving the substitution or addition of one or more constituents, which may or may not be dangerous within the meaning of the definitions set out in Article 2, are introduced by the manufacturer.

This new evaluation will apply unless there is valid scientific justification for considering that a re-evaluation of the hazard will not result in a change of classification.

ê 1999/45/EC

Article 8

Obligations and duties of the Member States

1. Member States shall take all necessary measures to ensure that the preparations covered by this Directive cannot be placed on the market unless they comply with it.

2. In order to ensure compliance with this Directive, the authorities of the Member States may request information on the composition of the preparation and any other pertinent information from any person responsible for placing the preparation on the market.

3. Member States shall take all necessary measures to ensure that those responsible for placing the preparation on the market keep at the disposal of the authorities of the Member States:

(a) the data used for the classification and labelling of the preparation;

(b) any pertinent information relating to packaging requirements in accordance with point (c) of Article 9, including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC;

(c) the data used for establishing the safety data sheet, in accordance with Article 31 of Regulation (EC) No 1907/2006.

4. Member States and the Commission shall exchange information concerning the name and full address of the national authority or authorities responsible for communicating and exchanging information relating to the practical application of this Directive.

Article 9

Packaging

1. Member States shall take all necessary measures to ensure that:

(a) preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) cannot be placed on the market unless their packaging satisfies the following requirements:

(i) it shall be so designed and constructed that its contents cannot escape; this requirement shall not apply where special safety devices are prescribed;

(ii) the materials constituting the packaging and fastenings must not be susceptible to adverse attack by the contents, or liable to form dangerous compounds with the contents;

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

(iv) containers fitted with replaceable fastening devices shall be so designed that the packaging can be refastened repeatedly without the contents escaping;

(b) containers which contain preparations within the meaning of Article 1(2) and preparations covered by Annex IV pursuant to Article 1(3) offered or sold to the general public do not have:

(i) either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers; or

(ii) a presentation and/or a designation used for foodstuffs or animal feedingstuffs or medicinal or cosmetic products;

ê 1999/45/EC (adapted)

è1 1272/2008 Art. 56 pt. 2(b)

(c) containers which contain certain preparations offered or sold to the general public covered by Annex IV :

(i) are fitted with child-resistant fastenings; Ö and/or Õ

(ii) carry a tactile warning of danger.

The devices must conform to the technical specifications given in Parts A and B of Annex IX to Directive 67/548/EEC.

2. The packaging of preparations shall be deemed to satisfy the requirements of points (a)(i), (ii) and (iii) of paragraph 1 if it complies with the requirements for carriage of dangerous goods by rail, road, inland waterway, sea or air.

Article 10

Labelling

1. Member States shall take all necessary measures to ensure that:

(a) preparations within the meaning of Article 1(2) cannot be placed on the market unless the labelling on their packaging satisfies all the requirements of this Article and the specific provisions of Parts A and B of Annex V;

(b) preparations within the meaning of Article 1(3) as defined in Parts B and C of Annex V cannot be placed on the market unless the labelling on their packaging satisfies the requirements of points (a) and (b) of paragraph 3 of this Article and the specific provisions of Parts B and C of Annex V.

2. With respect to plant protection products subject to Ö Regulation (EC) No 1107/2009 Õ, the labelling requirements in accordance with this Directive shall be accompanied by the following wording:

‘To avoid risks to man and the environment, comply with the instructions for use.’

This labelling shall be without prejudice to the information required in accordance with Article Ö 65 Õ of Ö Regulation (EC) No 1107/2009 Õ and Ö Annexes I and III Õ to Ö Commission Regulation (EU) No 547/2011[30] Õ.

3. The following information shall be clearly and indelibly marked on any package:

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

(b) the name, full address and telephone number of the person established in the Ö Union Õ who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;

(c) the chemical name of the substance or substances present in the preparation in accordance with the following detailed rules:

(i) for preparations classified T+, T, Xn in accordance with Article 6, only the substances T+, T, Xn present in concentrations equal to, or greater than, the lowest limit (limit Xn) for each of them laid down in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or, failing that, Part B of Annex II to this Directive have to be taken into consideration;

(ii) for preparations classified C in accordance with Article 6, only C substances present in concentrations equal to, or greater than, the lowest limit (limit Xi) laid down in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or, failing that, Part B of Annex II to this Directive have to be taken into consideration;

(iii) the name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories Ö shall be mentioned on the label Õ:

– carcinogen category 1, 2 or 3,

– mutagen category 1, 2 or 3,

– toxic for reproduction category 1, 2 or 3,

– very toxic, toxic or harmful due to non-lethal effects after a single exposure,

– toxic or harmful due to severe effects after repeated or prolonged exposure,

– sensitising.

The chemical name shall be one of the designations listed in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or an internationally recognised chemical nomenclature if no corresponding designation is yet listed in that Annex;

(iv) the name of any substance which led to the classification of the preparation in the following danger categories Ö need not be mentioned on the label, unless the substance has to be mentioned pursuant to points (i), (ii) or (iii) Õ:

– explosive,

– oxidising,

– extremely flammable,

– highly flammable,

– flammable,

– irritant,

– dangerous for the environment;

(v) as a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding phrases referring to the risk involved. In some cases, more than four chemical names may be necessary;

(d) Ö the danger symbol(s) and indication(s) of danger. Õ The danger symbols, where specified in this Directive, and indications of the dangers involved in the use of the preparation, shall be in accordance with Annexes II and VI to Directive 67/548/EEC and shall be applied in accordance with the evaluation of the hazards carried out in accordance with Annexes I, II and III to this Directive.

Where more than one danger symbol must be assigned to a preparation the obligation to apply the symbol:

(i) T shall make the symbols C and X optional unless otherwise specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç;

(ii) C shall make the symbol X optional;

(iii) E shall make the symbols F and O optional;

(iv) Xn shall make the symbol Xi optional.

The symbol(s) shall be printed in black on an orange-yellow background;

(e) Ö the risk phrases (R phrases). Õ The indications concerning special risks (R phrases) shall comply with Annexes III and VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II, and III to this Directive.

As a general rule, a maximum of six R phrases shall suffice to describe the risks; for this purpose, the combined phrases listed in Annex III to Directive 67/548/EEC shall be regarded as single phrases. However, if the preparation falls within more than one danger category, those standard phrases shall cover all the principal hazards associated with the preparation. In some cases more than six R phrases may be necessary.

The standard phrases ‘extremely flammable’ or ‘highly flammable’ need not be used where they describe an indication of danger used in accordance with point (d) of this paragraph;

(f) Ö the safety advice (S phrases). Õ The indications giving safety advice (S phrases) shall comply with Annex IV and with Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazard evaluation carried out in accordance with Annexes I, II and III to this Directive.

As a general rule, a maximum of six S phrases shall suffice to formulate the most appropriate safety advice; for this purpose the combined phrases listed in Annex IV to Directive 67/548/EEC shall be regarded as single phrases. However, in some cases more than six S phrases may be necessary.

Where it is physically impossible to include the advice on the label or package itself, the package shall be accompanied by safety advice on the use of the preparation;

(g) the nominal quantity (nominal mass or nominal volume) of the contents in the case of preparations offered or sold to the general public.

ê 1999/45/EC (adapted)

è1 1137/2008 Art. 1 and Annex, point 3.5.1 (adapted)

ð new

4. è1 In relation to certain preparations classified as dangerous within the meaning of Article 7, by way of derogation from points (d), (e) and (f) of paragraph 3 of this Article, the Commission may ð shall be empowered to adopt delegated acts in accordance with Article 20 for the purpose of determining ï determine exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling, where it can be demonstrated that there would be a reduction in the environmental impact. Those measures, designed to amend non-essential elements of this Directive by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20a(3). ç Those exemptions or specific provisions are defined and laid down in Part A or B of Annex V.

ê 1999/45/EC

5. If the contents of the package do not exceed 125 ml:

(a) in the case of preparations that are classified as highly flammable, oxidising, irritant, with the exception of those assigned R41, or dangerous for the environment and assigned the N symbol it shall not be necessary to indicate the R phrases or the S phrases;

(b) in the case of preparations that are classified as flammable or dangerous for the environment and not assigned the N symbol it shall be necessary to indicate the R phrases but it shall not be necessary to indicate the S phrases.

ê 1999/45/EC (adapted)

6. Without prejudice to Ö point 3 of Annex I to Regulation (EU) No 547/2011 Õ, indications such as ‘non-toxic’, ‘non-harmful’, ‘non‑polluting’, ‘ecological’ or any other statement indicating that the preparation is not dangerous or likely to lead to underestimation of the dangers of the preparation in question shall not appear on the packaging or labelling of any preparation subject to this Directive.

ê 1999/45/EC

Article 11

Implementation of the labelling requirements

1. Where the particulars required by Article 10 appear on a label, that label shall be firmly affixed to one or more surfaces of the packaging so that those particulars can be read horizontally when the package is set down normally. The dimensions of the label are laid down in Annex VI to Directive 67/548/EEC and the label is intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information.

2. A label shall not be required when the particulars are clearly shown on the package itself, as specified in paragraph 1.

3. The colour and presentation of the label – or, in the case of paragraph 2, of the package – shall be such that the danger symbol and its background stand out clearly from it.

4. The information required on the label under Article 10 shall stand out clearly from its background and shall be of such size and spacing as to be easily read.

Specific provisions regarding the presentation and format of this information shall be laid down in Annex VI to Directive 67/548/EEC.

5. Member States may make the placing on the market of preparations covered by this Directive within their territories subject to the use of their official language or languages in respect of the labelling thereof.

6. For the purposes of this Directive, labelling requirements shall be deemed to be satisfied:

(a) in the case of an outer package containing one or more inner packages, if the outer package is labelled in accordance with international rules on the transport of dangerous goods and the inner package or packages are labelled in accordance with this Directive;

(b) in the case of a single package:

(i) if such a package is labelled in accordance with international rules on the transport of dangerous goods and with points (a), (b), (c), (e) and (f) of Article 10(3); for preparations classified according to Article 7, the provisions of Article 10(3)(d) shall additionally apply with respect to the property in question when it has not been so identified on the label; or

(ii) where appropriate, for particular types of packaging such as mobile gas cylinders, if the specific requirements referred to in Annex VI to Directive 67/548/EEC are complied with.

Where dangerous preparations do not leave the territory of a Member State, labelling may be permitted which complies with national rules instead of with international rules on the transport of dangerous goods.

Article 12

Exemptions from the labelling and packaging requirements

1. Articles 9, 10 and 11 shall not apply to explosives placed on the market with a view to obtaining an explosive or pyrotechnic effect.

2. For certain dangerous preparations within the meaning of Article 5, 6 or 7 defined in Annex VII which, in the form in which they are placed on the market, do not present any physico-chemical risk, or risk to health or to the environment, Articles 9, 10 and 11 shall not apply.

3. Member States may also:

(a) permit the labelling required by Article 10 to be applied in some other appropriate manner on packages which are either too small or otherwise unsuitable for labelling in accordance with Article 11(1) and (2);

(b) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are classified as harmful, extremely flammable, highly flammable, flammable, irritant or oxidising to be unlabelled or to be labelled in some other way, if they contain such small quantities that there is no reason to fear any danger to persons handling such preparations or to other persons;

(c) by way of derogation from Articles 10 and 11, for preparations classified according to Article 7, permit the packaging of dangerous preparations to be unlabelled or labelled in some other way if they contain such small quantities that there is no reason to fear any dangers to the environment;

ê 1999/45/EC (adapted)

è1 1137/2008 Art. 1 and Annex, point 3.5.2 (adapted)

ð new

(d) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are not mentioned in points (b) or (c) to be labelled in some other appropriate way, if the packages are too small for the labelling provided for in Articles 10 and 11 and there is no reason to fear any danger to persons handling such preparations or to other persons.

Where this paragraph is applied, the use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different to those laid down in this Directive shall not be permitted.

4. If a Member State makes use of the options provided for in paragraph 3, it shall forthwith inform the Commission and Member States thereof. è1 The Commission may decide ð shall be empowered to adopt delegated acts in accordance with Article 20 for the purpose of amending ï upon measures in the framework of Annex V ð on the basis of such information ï. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20a(3). ç

Article 13

Distance selling

Any advertisement for a preparation within the meaning of this Directive which enables a member of the general public to conclude a contract for purchase without first having sight of the label for that preparation Ö shall Õ make mention of the type or types of hazard indicated on the label. This requirement is without prejudice to Directive 97/7/EC of the European Parliament and of the Council[31].

Article 14

Confidentiality of chemical names

Where the person responsible for placing the preparation on the market can demonstrate that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as:

– irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in point (c)(iv) of Article 10(3), or

– harmful or harmful in combination with one or more of the properties mentioned in point (c)(iv) of Article 10(3) presenting acute lethal effects alone

will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Annex VI, be permitted to refer to that substance either by means of a name that identifies the most important functional chemical groups or by means of an alternative name. This procedure may not be applied where the substance concerned has been assigned a Ö Union Õ exposure limit.

Where the person responsible for placing a preparation on the market wishes to take advantage of confidentiality provisions, he shall make a request to the competent authority of the Member State in which the preparation is to be first placed on the market.

This request Ö shall Õ be made in accordance with the provisions of Annex VI and Ö shall Õ provide the information required in the form in Part A of that Annex. The competent authority may nevertheless request further information from the person responsible for placing the preparation on the market if such information appears necessary in order to evaluate the validity of the request.

The authority of the Member State receiving a request for confidentiality shall notify the applicant of its decision. The person responsible for placing the preparation on the market shall forward a copy of this decision to each of the Member States where he wishes to market the product.

Confidential information brought to the attention of the authorities of a Member State or of the Commission shall be Ö kept secret Õ.

ò new

In all cases such information:

– may be brought to the attention only of the competent authority or authorities responsible for receiving the information necessary for evaluating the foreseeable risks which the preparations may entail for man and the environment, and examining its conformity with the requirements of this Directive,

– may, however, be divulged to persons directly involved in administrative or legal proceedings involving sanctions which are undertaken for the purpose of controlling substances placed on the market and to persons who are to participate or be heard in legislative proceedings.

ê 1999/45/EC

Article 15

Rights of Member States regarding safety of workers

This Directive shall not affect the right of Member States to specify, in compliance with the Treaty, the requirements they deem necessary to ensure that workers are protected when using the dangerous preparations in question, provided that this does not mean that the classification, packaging, and labelling of dangerous preparations are modified in a way not provided for in this Directive.

Article 16

Bodies responsible for receiving information relating to health

Member States shall appoint the body or bodies responsible for receiving information, including chemical composition, relating to preparations placed on the market and considered dangerous on the basis of their health effects or on the basis of their physico-chemical effects.

Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet any medical demand by formulating preventive and curative measures, in particular in case of emergency.

Member States shall ensure that the information is not used for other purposes.

Member States shall ensure that the appointed bodies have at their disposal all the information required from the manufacturers or persons responsible for marketing to carry out the tasks for which they are responsible.

ê 1999/45/EC (adapted)

Article 17

Free movement clause

Without prejudice to the provisions set out in other Ö Union Õ legislation, Member States may not prohibit, restrict or impede the placing on the market of preparations because of their classification, packaging Ö and Õ labelling if such preparations comply with the provisions laid down in this Directive.

ê 1999/45/EC

Article 18

Safeguard clause

1. Where a Member State has detailed evidence that a preparation, although satisfying the provisions of this Directive, constitutes a hazard for man or the environment on grounds relating to the provisions of this Directive, it may provisionally prohibit the placing on the market of that preparation or subject it to special conditions in its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision.

2. In the case referred to in paragraph 1, the Commission shall consult the Member States as soon as possible.

ê 1137/2008 Art. 1 and Annex, point 3.5.3

ð new

3. The Commission shall ð decide by means of implementing acts. ï take a decision ð Those implementing acts shall be adopted ï in accordance with the ð examination ï regulatory procedure referred to in Article 21(2).

ê 1137/2008 Art. 1 and Annex, point 3.5.4 (adapted)

ð new

Article 19

Ö Adaptation to technical progress Õ

The Commission shall ð adopt delegated acts in accordance with Article 20 for the purpose of adapting ï adapt Annexes I to VII to technical progress. Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20a(3).

ò new

Article 20

Exercise of the delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Article 10(4), Article 12(4) and Article 19 shall be conferred for an indeterminate period of time from the [date of entry into force of this Directive]

ê 1137/2008 Art. 1 and Annex, point 3.5.4 (adapted)

ð new

3. The delegation of powers referred to in Article 10(4), Article 12(4) and Article 19 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5. A delegated act adopted pursuant to Article 10(4), Article 12(4) and Article 19 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by one month at the initiative of the European Parliament or of the Council.

ê 1137/2008 Art. 1 and Annex, point 3.5.5 (adapted)

ð new

Article 21

Ö Committee Õ

1. The Commission shall be assisted by the committee established by Article 29(1) of Directive 67/548/EEC. ð That Committee shall be a Committee within the meaning of Regulation (EU) No 182/2011. ï

2. Where reference is made to this paragraph, ð Article 5 of Regulation (EU) No 182/2011 shall apply. ï Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

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

ò new

Article 22

Repeal

Directive 1999/45/EC, as amended by the Acts listed in Part A of Annex VIII, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex VIII to the repealed Directive and in Part B of Annex VIII to this Directive.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IX.

ê 1999/45/EC (adapted)

Article 23

Entry into force

This Directive shall enter into force on the Ö twentieth Õ day Ö following that Õ of its publication in the Official Journal of the European Union.

Article 24

Addressees

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament For the Council

The President The President

ê 1999/45/EC

ANNEX I

METHODS FOR THE EVALUATION OF PHYSICO-CHEMICAL PROPERTIES OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 5

PART A

Exemptions to test methods of Part A of the Annex to Regulation (EC) No 440/2008

See point 2.2.5 of Annex VI to Directive 67/548/EEC.

PART B

Alternative calculation methods

B.1. Non-gaseous preparations

1. Method for the determination of oxidising properties of preparations containing organic peroxides.

See point 2.2.2.1 of Annex VI to Directive 67/548/EEC.

B.2. Gaseous preparations

1. Method for the determination of oxidising properties

See point 9.1.1.2 of Annex VI to Directive 67/548/EEC.

2. Method for the determination of flammability properties

See point 9.1.1.1 of Annex VI to Directive 67/548/EEC.

_____________

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(c)

ANNEX II

METHODS FOR THE EVALUATION OF HEALTH HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 6

Introduction

An assessment must be made for all the health effects corresponding to the health effects of substances contained in a preparation. This conventional method described in Parts A and B of this Annex is a calculation method which is applicable to all preparations and which takes into consideration all the health hazards of substances contained in the preparation. For that purpose the dangerous health effects have been subdivided into:

1. acute lethal effects;

2. non-lethal irreversible effects after a single exposure;

3. severe effects after repeated or prolonged exposure;

4. corrosive effects, irritant effects;

5. sensitising effects;

6. carcinogenic effects, mutagenic effects, toxic effects for reproduction.

The health effects of a preparation are to be assessed in accordance with Article 6(1)(a) by the conventional method described in Parts A and B of this Annex using individual concentration limits:

(a) where the dangerous substances listed in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç are assigned concentration limits necessary for the application of the method of assessment described in Part A of this Annex, these concentration limits must be used;

(b) where the dangerous substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear there without the concentration limits necessary for the application of the method of evaluation described in Part A of this Annex, the concentration limits must be assigned in accordance with the specifications in Part B of this Annex.

The procedure for classification is set out in Part A of this Annex.

The classification of the substance(s) and the resulting classification of the preparation are expressed:

– either by a symbol and one or more risk phrases, or

– by categories (category 1, category 2 or category 3) also assigned risk phrases when substances and preparations are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is important to consider, in addition to the symbol, all the phrases denoting specific risks which are assigned to each substance under consideration.

The systematic assessment of all the dangerous health effects is expressed by means of concentration limits, expressed as a weight/weight percentage except for gaseous preparations where they are expressed as a volume/volume percentage and in conjunction with the classification of the substance.

Where they are not given in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç, the concentration limits to be taken into account for the application of this conventional method are those set out in Part B of this Annex.

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), first indent

PART A

Procedure for evaluation of health hazards

The evaluation proceeds stepwise as follows:

1. The following preparations are to be classified as very toxic:

1.1. owing to their acute lethal effects and assigned the symbol ‘T+’, the indication of danger ‘very toxic’ and the risk phrases R26, R27 or R28:

1.1.1. preparations containing one or more substances classified as very toxic that produce such effects, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

1.1.2. preparations containing more than one substance classified as very toxic in lower individual concentrations than the limits specified in point 1.1.1(a) or (b) if:

where:

PT+ || = || is the percentage by weight or by volume of each very toxic substance in the preparation,

LT+ || = || is the very toxic limit specified for each very toxic substance, expressed as a percentage by weight or by volume;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), second indent

1.2. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘T+’, the indication of danger ‘very toxic’ and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

2. The following preparations shall be classified as toxic:

2.1. owing to their acute lethal effects and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrases R23, R24 or R25;

ê 1999/45/EC

è1 1272/2008 Art. 56 pt. 2(d), third indent

2.1.1. preparations containing one or more substances classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

2.1.2. preparations containing more than one substance classified as very toxic or toxic in lower individual concentrations than the limits specified in point 2.1.1(a) or (b) if:

where:

PT+ || = || is the percentage by weight or by volume of each very toxic substance in the preparation,

PT || = || is the percentage by weight or by volume of each toxic substance in the preparation,

LT || = || is the respective toxic limit specified for each very toxic or toxic substance, expressed as a percentage by weight or by volume;

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è1 1272/2008 Art. 56 pt. 2(d), fourth indent

2.2 owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrase R39/route of exposure.

Preparations containing at least one dangerous substance classified as very toxic or toxic that produce such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), fifth indent

2.3. owing to their long-term effects and assigned the symbol ‘T’, the indication of danger ‘toxic’ and the risk phrase R48/route of exposure.

Preparations containing at least one dangerous substance that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

3. The following preparations shall be classified as harmful:

3.1. owing to their acute lethal effects and assigned the symbol ‘Xn’ and the indication of danger ‘harmful’ and the risk phrases R20, R21 or R22;

ê 1999/45/EC (adapted)

è1 1272/2008 Art. 56 pt. 2(d), sixth indent

3.1.1. preparations containing one or more substances classified as very toxic, toxic or harmful and that produce such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table 1 and 1a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

3.1.2. preparations containing more than one substance classified as very toxic, toxic or harmful in lower individual concentrations than the limits specified in point 3.1.1(a) or (b) if:

where:

PT+ || = || is the percentage by weight or by volume of each very toxic substance in the preparation,

PT || = || is the percentage by weight or by volume of each toxic substance in the preparation,

PXn || = || is the percentage by weight or by volume of each harmful substance in the preparation,

LXn || = || is the respective harmful limit specified for each very toxic, toxic or harmful substance, expressed as percentage by weight or by volume;

3.2. owing to their acute effects to the lungs if swallowed and assigned the symbol ‘Xn’, and the indication of danger ‘harmful’ and the risk phrase R65.

Preparations classified as harmful according to the criteria specified in point 3.2.3 of Annex VI to Directive 67/548/EEC. In applying the conventional method according to point 3.1 Ö of this Part Õ no account shall be taken of the classification of a substance as R65;

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è1 2001/60/EC Art. 1 pt. 1, first indent

3.3. owing to their non-lethal irreversible effects after a single exposure and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase è1 R68 ç/route of exposure.

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è1 1272/2008 Art. 56 pt. 2(d), seventh indent

Preparations containing at least one dangerous substance classified as very toxic, toxic or harmful that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 2 in Part B of this Annex (Table 2 and 2a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), eighth indent

3.4. owing to their long-term effects and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R48/route of exposure.

Preparations containing at least one dangerous substance classified as toxic or harmful that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 3 in Part B of this Annex (Table 3 and 3a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

4. The following preparations are to be classified as corrosive:

4.1. and assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R35;

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è1 1272/2008 Art. 56 pt. 2(d), ninth indent

4.1.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

4.1.2. preparations containing more than one substance classified as corrosive to which is assigned phrase R35 in lower individual concentrations than the limits specified in point 4.1.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance which is assigned phrase R35 in the preparation,

LC, R35 || = || is the corrosive limit R35 specified for each corrosive substance to which is assigned phrase R35, expressed as a percentage by weight or by volume;

4.2. and assigned the symbol ‘C’, the indication of danger ‘corrosive’ and the risk phrase R34;

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è1 1272/2008 Art. 56 pt. 2(d), tenth indent

4.2.1. preparations containing one or more substances classified as corrosive to which is assigned the phrase R35 or R34 in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

4.2.2. preparations containing more than one of the substances classified as corrosive to which is assigned the phrase R35 or R34 in lower individual concentrations than the limits specified in point 4.2.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

LC, R34 || = || is the respective corrosive limit R34 specified for each corrosive substance to which is assigned phrase R35 or R34, expressed as a percentage by weight or by volume.

5. The following preparations are to be classified as irritants:

5.1. liable to cause serious eye damage and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R41;

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è1 1272/2008 Art. 56 pt. 2(d), eleventh indent

5.1.1. preparations containing one or more substances classified as irritant to which is assigned phrase R41 in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

5.1.2. preparations containing more than one of the substances classified as irritant and to which is assigned phrase R41, or classified as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in point 5.1.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

LXi, R41 || = || is the respective irritant limit R41 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, expressed as percentage by weight or by volume;

5.2. irritant to eyes and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R36;

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è1 1272/2008 Art. 56 pt. 2(d), twelfth indent

5.2.1. preparations containing one or more substances classified as corrosive to which is assigned phrase R35 or R34 or as irritant and to which is assigned phrase R41 or R36 in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

5.2.2. preparations containing more than one substance classified as irritant to which is assigned phrase R41 or R36, or as corrosive and to which is assigned phrase R35 or R34, in lower individual concentrations than the limits specified in point 5.2.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R41 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R41 in the preparation,

PXi, R36 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R36 in the preparation,

LXi, R36 || = || is the respective irritant limit R36 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R41, or R36 expressed as percentage by weight or by volume;

5.3. irritant to skin and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R38;

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è1 1272/2008 Art. 56 pt. 2(d), thirteenth indent

5.3.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R38 or as corrosive and to which is assigned phrase R35 or R34 in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

5.3.2. preparations containing more than one of the substances classified as irritant and to which is assigned phrase R38, or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified in point 5.3.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by weight or by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R38 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R38 in the preparation,

LXi, R38 || = || is the respective irritant limit R38 specified for each corrosive substance to which is assigned phrase R35 or R34 or irritant substance to which is assigned phrase R38, expressed as percentage by weight or by volume;

5.4. irritant to respiratory system and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R37;

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è1 1272/2008 Art. 56 pt. 2(d), fourteenth indent

5.4.1. preparations containing one or more substances classified as irritant and to which is assigned phrase R37 in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 4 in Part B of this Annex (Table 4 and 4a) where the substance or the substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

5.4.2. preparations containing more than one substance classified as irritant and to which is assigned phrase R37 in lower individual concentrations than the limits specified in point 5.4.1(a) or (b) if:

where:

PXi, R37 || = || is the percentage by weight or by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37 || = || is the irritant limit R37 specified for each irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume;

5.4.3. gaseous preparations containing more than one of the substances classified as irritant to which is assigned phrase R37 or as corrosive and to which is assigned phrase R35 or R34 in lower individual concentrations than the limits specified in point 5.4.1(a) or (b) if:

where:

PC, R35 || = || is the percentage by volume of each corrosive substance to which is assigned phrase R35 in the preparation,

PC, R34 || = || is the percentage by volume of each corrosive substance to which is assigned phrase R34 in the preparation,

PXi, R37 || = || is the percentage by volume of each irritant substance to which is assigned phrase R37 in the preparation,

LXi, R37 || = || is the respective irritant limit R37 specified for each gaseous corrosive substance to which is assigned phrase R35 or R34 or gaseous irritant substance to which is assigned phrase R37, expressed as percentage by weight or by volume.

6. The following preparations are to be classified as sensitising:

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è1 1272/2008 Art. 56 pt. 2(d), fifteenth indent

6.1. by skin contact and assigned the symbol ‘Xi’, the indication of danger ‘irritant’ and the risk phrase R43.

Preparations containing at least one substance classified as sensitising and to which is assigned phrase R43 that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), sixteenth indent

6.2. by inhalation and assigned the symbol ‘Xn’, the indication of danger ‘harmful’ and the risk phrase R42.

Preparations containing at least one substance classified as sensitising to which is assigned phrase R42 that produces such effects in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 5 in Part B of this Annex (Table 5 and 5a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

7. The following preparations are to be classified as carcinogenic:

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è1 1272/2008 Art. 56 pt. 2(d), seventeenth indent

7.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R45 or R49.

Preparations containing at least one substance producing such effects, classified as carcinogenic and to which is assigned phrase R45 or R49 which denotes carcinogenic substances in category 1 and category 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), eighteenth indent

7.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase R40.

Preparations containing at least one substance producing such effects classified as carcinogenic and to which is assigned phrase R40 which denotes carcinogenic substances in category 3, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

8. The following preparations are to be classified as mutagenic:

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è1 1272/2008 Art. 56 pt. 2(d), nineteenth indent

8.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R46.

Preparations containing at least one substance producing such effects, classified as mutagenic and to which is assigned phrase R46 which denotes mutagenic substances in category 1 and category 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 2001/60/EC Art. 1 pt. 1, second indent

8.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase è1 R68 ç.

Preparations containing at least one substance, producing such effects, classified as mutagenic and to which is assigned phrase è1 R68 ç which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than:

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è1 1272/2008 Art. 56 pt. 2(d), twentieth indent

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

9. The following preparations are to be classified as toxic for reproduction:

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è1 1272/2008 Art. 56 pt. 2(d), twenty-first indent

9.1. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R60 (fertility).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R60 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), twenty-second indent

9.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase R62 (fertility).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R62 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), twenty-third indent

9.3. those of category 1 or 2 which are assigned the symbol ‘T’ and the phrase R61 (development).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R61 which denotes substances toxic for reproduction of category 1 and category 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits;

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è1 1272/2008 Art. 56 pt. 2(d), twenty-fourth indent

9.4. those of category 3 which are assigned the symbol ‘Xn’ and the phrase R63 (development).

Preparations containing at least one substance producing such effects, classified as toxic for reproduction and to which is assigned phrase R63 which denotes substances toxic for reproduction of category 3, in individual concentrations equal to or greater than:

(a) either the concentration specified in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç for the substance or substances under consideration, or

(b) the concentration specified at point 6 in Part B of this Annex (Table 6 and 6a) where the substance or substances do not appear in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç or appear in it without concentration limits.

ê 1999/45/EC (adapted)

è1 1272/2008 Art. 56 pt. 2(e)

PART B

Concentration limits to be used in evaluation of health hazards

For each health effect, the first table (Tables 1 to 6) sets out the concentration limits (expressed as a weight/weight percentage) to be used for non-gaseous preparations and the second table (Tables 1a to 6a) sets out the concentration limits (expressed as a volume/volume percentage) to be used for gaseous preparations. These concentration limits are used in the absence of specific concentration limits for the substance under consideration in è1 Part 3 of Annex VI to Regulation (EC) No 1272/2008 ç.

1. Acute lethal effects

1.1. Non-gaseous preparations

The concentration limits fixed in Table 1, expressed as a weight/weight percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

Table 1

Classification of the substance || Classification of the preparation

T+ || T || Xn

T+ with R26, R27, R28 || concentration ≥ 7 % || 1 % ≤ concentration < 7 % || 0,1 % ≤ concentration < 1 %

T with R23, R24, R25 || || concentration ≥ 25 % || 3 % ≤ concentration < 25 %

Xn with R20, R21, R22 || || || concentration ≥ 25 %

The R phrases denoting risk are to be assigned to the preparation in accordance with the following criteria:

– the label shall include one or more of the abovementioned R phrases according to the classification used,

– in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.

1.2. Gaseous preparations

The concentration limits expressed as a volume/volume percentage in Table 1a determine the classification of the gaseous preparations in relation to the individual concentration of the gas(es) present whose classification is also shown.

Table 1a

Classification of the substance (gas) || Classification of the gaseous preparation

T+ || T || Xn

T+ with R26, R27, R28 || concentration ≥ 1 % || 0,2 % ≤ concentration < 1 % || 0,02 % ≤ concentration < 0,2 %

T with R23, R24, R25 || || concentration ≥ 5 % || 0,5 % ≤ concentration < 5 %

Xn with R20, R21, R22 || || || concentration ≥ 5 %

The R phrases denoting risk shall be assigned to the preparation in accordance with the following criteria:

– the label shall include one or more of the abovementioned R phrases according to the classification used,

– in general, the R phrases selected should be those applicable to the substance(s) present in the concentration which gives rise to the most severe classification.

ê