(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 (3) has been substantially amended several times (4). Since further amendments are to be made, that Directive 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.

(3)

Measures for the approximation of the provisions of the Member States affecting the functioning of the internal market should, 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 should, 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.

(4)

The number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of 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 (5). 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. 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.

(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 in accordance with this Directive and assign to them a safety data sheet in accordance with 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) and establishing a European Chemicals Agency (6), and also to label them in accordance with the international rules used for the transport of dangerous goods.

(6)

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 (7) 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 (8), 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 and biocidal products in accordance with this Directive, and also to provide instructions for use in accordance with the results of the evaluation carried out in the framework of Regulation (EC) No 1107/2009 and Directive 98/8/EC and to ensure that the labelling satisfies the high level of protection sought by both this Directive and Regulation (EC) No 1107/2009 or Directive 98/8/EC respectively . In addition, a safety data sheet has to be established for plant protection products and biocidal products in accordance with Regulation (EC) No 1907/2006.

(7)

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

(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.

(9)

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

(10)

Due to 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 (9) has been adapted and its rules on the notification and risk assessment of chemicals have been deleted. This Directive should be adapted accordingly.

(11)

Annex V to Directive 67/548/EEC, setting out methods for the determination of the physico-chemical properties, toxicity and ecotoxicity of substances and preparations, has been deleted by Directive 2006/121/EC of the European Parliament and of the Council (10) with effect from 1 June 2008. The references to that Annex in this Directive should be adapted accordingly.

(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 to that 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 (11) 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 that Regulation. By subjecting all future harmonisations of classifications to that Regulation, inconsistencies in harmonised classifications of the same substance under the existing and the new criteria should be avoided.

(13)

Preparations composed of more than one substance being classified in Table 3.2 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogenic, mutagenic and/or toxic for reproduction had to 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.

(14)

The references to R phrase R40 in Directive 67/548/EEC were amended by Commission Directive 2001/59/EC (12) when R phrase R40 was assigned to carcinogens of category 3. Consequently, the old wording of R phrase R40 became R68 and was used for mutagens of category 3 and for certain substances with non-lethal irreversible effects. The references to R phrase R40 in this Directive should be adapted accordingly.

(15)

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

(16)

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

(17)

Directive 67/548/EEC as amended by Commission Directive 98/98/EC (13) provides for new criteria and a new R phrase (R67) for vapours which may cause drowsiness and dizziness. Preparations should be classified and labelled accordingly.

(18)

Criteria developed for classifying and labelling substances dangerous for the environment were introduced together with the appropriate symbols, indications of danger, risk phrases and safety advice required to appear on labelling, by Council Directive 92/32/EEC of 30 April 1992 amending for the seventh time Directive 67/548/EEC (14) and by Commission Directive 93/21/EEC of 27 April 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC (15). Provisions are required at Union level on the classification and labelling of preparations to take account of their effects on the environment, and it is therefore necessary to provide for 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.

(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 that Annex, to which SCLs are applied, and those preparations containing substances not yet included in that 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.

(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. Preparations should be classified and labelled accordingly.

(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.

(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 as provided for in Regulation (EC) No 1907/2006 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.

(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.

(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 that certain provisions of this Directive cover such preparations.

(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 should also be laid down for certain preparations which, although not dangerous within the meaning of this Directive, may nevertheless present a danger to the user.

(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 Union level.

(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.

(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 to the 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 (16).

(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,

(a)

contain at least one dangerous substance within the meaning of Article 2; and

(b)

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

(a)

veterinary medicinal products and medicinal products for human use, as defined in Directives 2001/82/EC (17) and 2001/83/EC (18) of the European Parliament and of the Council respectively;

(b)

cosmetic products as defined in Council Directive 76/768/EEC (19);

(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 (20);

(d)

foodstuffs;

(e)

animal feedingstuffs;

(f)

preparations containing radioactive substances as defined by Council Directive 96/29/Euratom (21);

(g)

medical devices which are invasive or used in direct physical contact with the human body in so far as Union 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.

(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.

(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;

(d)

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

(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;

(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 Union market on 18 September 1981.

(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:

(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.

(a)

physico-chemical properties;

(b)

properties affecting health;

(c)

environmental properties.

(a)

substances listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008;

(b)

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

(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 (23).

(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 Regulations (EU) No 544/2011 and (EU) No 545/2011.

—

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.

—

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:

—

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.

(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 Regulations (EU) No 544/2011 and (EU) No 545/2011. Without prejudice to the testing requirements laid down in or pursuant to Regulation (EC) No 1107/2009 , the conditions for application of the test methods are described in Part C of Annex III to this Directive.

—

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:

—

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.

(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.

(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:

(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:

(c)

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

(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.

(a)

the trade name or designation of the preparation;

(b)

the name, full address and telephone number of the person established in the Union 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:

(d)

the danger symbol(s) and indication(s) of danger. 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:

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

(e)

the risk phrases (R phrases). 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)

the safety advice (S phrases). 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.

(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.

(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:

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.

(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 in accordance with 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;

(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.

—

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

—

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.