— 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,

— contain at least one dangerous substance within the meaning of Article 2,

— and

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

— in Article 9 and defined in Annex IV,

— in Article 10 and defined in Annex V, and

— in Article 14

(a) medicinal products for human or veterinary use, as defined in Directive 65/65/EEC ( 12 );

(b) cosmetic products as defined in Directive 76/768/EEC ( 13 );

(c) mixtures of substances which, in the form of waste, are covered by Directives 75/442/EEC ( 14 ) and 78/319/EEC ( 15 );

(d) foodstuffs;

(e) animal feedingstuffs;

(f) preparations containing radioactive substances as defined by Directive 80/836/Euratom ( 16 );

(g) medical devices which are invasive or used in direct physical contact with the human body in so far as Community 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.

— the carriage of dangerous preparations by rail, road, inland waterway, sea or air,

— 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) (………);

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

(f) ‘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;

(g) ‘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;

(h) ‘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 Community 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 of 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.

— physico-chemical properties,

— properties affecting health,

— environmental properties.

— are listed in Annex I to Directive 67/548/EEC,

— are listed in Elincs in accordance with Article 21 of Directive 67/548/EEC,

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

— are classified and labelled in accordance with Article 7 of Directive 67/548/EEC and are not yet included in Elincs,

— are covered by Article 8 of Directive 67/548/EEC,

— are classified and labelled in accordance with Article 13 of Directive 67/548/EEC,

— 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,

— 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,

— preparations placed on the market in the form of aerosols satisfy the provisions of Article 9a of Directive 75/324/EEC ( 17 ).

(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. These properties shall be determined by means of the methods laid down in Part B of Annex V to Directive 67/548/EEC, unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.

— 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.

— 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 to this Directive;

(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. These properties shall be determined by means of the methods laid down in Part C of Annex V to Directive 67/548/EEC unless, in the case of plant protection products, other internationally recognised methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC. Without prejudice to the testing requirements set out in Directive 91/414/EEC, 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.

— the data used for the classification and labelling of the preparation,

— any pertinent information relating to packaging requirements in accordance with Article 9(1.3), including the test certificate issued in accordance with Part A of Annex IX to Directive 67/548/EEC,

— the data used for establishing the safety data sheet, in accordance with Article 14.

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

1.2. With respect to plant protection products subject to Directive 91/414/EEC, 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 16 of, and Annex V to, Directive 91/414/EEC.

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

5. Without prejudice to Article 16(4) of Directive 91/414/EC, 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.

(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 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;

(d) by way of derogation from Articles 10 and 11 permit the packaging of dangerous preparations which are not mentioned in (b) or (c) above 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.

1. The safety data sheet information is principally intended for use by professional users and must enable them to take the necessary measures as regards the protection of health, safety and the environment at the place of work.

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

2.2. The safety data sheet and its supply must comply with the provisions of Directive 91/155/EEC.

2.3. The necessary amendments required to adapt to technical progress Directive 91/155/EEC shall be adopted in accordance with the procedure laid down in Article 20 of this Directive.

In particular, the necessary amendments to take account of provisions in paragraph 2.1(b) shall be adopted before the date specified in Article 22(1).

2.4. The safety data sheet may be supplied on paper or electronically, provided that the addressee has the necessary means of receiving it.

— irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in point 2.3.4 of Article 10, or

— harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 presenting acute lethal effects alone

(a) to preparations not within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2002; and

(b) to preparations within the scope of Directive 91/414/EEC or Directive 98/8/EC as from 30 July 2004.

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.

1. Method for the determination of oxidising properties

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

2. Method for the determination of flammability properties

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

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.

(a) where the dangerous substances listed in Annex I to Directive 67/548/EEC 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 Annex I to Directive 67/548/EEC 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.

— 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.

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:

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

where:

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:

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;

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:

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

Where:

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:

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:

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;

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:

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

Where:

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 paragraph 3.2.3 of Annex VI to Directive 67/548/EEC. In applying the conventional method according to the above paragraph 3.1 no account shall be taken of the classification of a substance as R65;

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 ►M1  R68 ◄ /route of exposure.

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:

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:

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

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:

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 under 4.1.1(a) or (b) if:

where:

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

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:

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 under 4.2.1(a) or (b) if:

where:

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

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:

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 under 5.1.1(a) or (b) if:

where:

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

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:

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 under 5.2.1(a) or (b) if:

where:

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

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:

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 under 5.3.1(a) or (b) if:

where:

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

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:

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 under 5.4.1(a) or (b) if:

where:

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 under 5.4.1(a) or (b) if:

where:

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:

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:

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:

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:

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:

8.2. those of category 3 which are assigned the symbol ‘Xn’ and the phrase  ►M1  R68 ◄ .

Preparations containing at least one substance, producing such effects, classified as mutagenic and to which is assigned phrase  ►M1  R68 ◄ which denotes mutagenic substances in category 3, in individual concentrations equal to or greater than:

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:

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:

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:

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:

— 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.

— 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.

— the symbol Xn and phrase R42 if this effect can be produced by inhalation,

— the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

— the symbol Xn and phrase R42 if this effect can be produced by inhalation,

— the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

(a) Where the dangerous substances listed in Annex 1 to Directive 67/548/EEC 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 Annex I to Directive 67/548/EEC 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 shall be assigned in accordance with the specification in Part B of this Annex.

1. and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrases R50 and R53 (R50-53):

1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrases R50-53 in individual concentrations equal to or greater than:

1.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 in lower individual concentrations than the limits specified under I.1.1(a) or (b) if:

where:

2. and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrases R51 and R53 (R51-53) unless the preparation is already classified according to I.1 above;

2.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50-53 or R51-53 in individual concentrations equal to or greater than:

2.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R50-53 or R51-53 in lower individual concentrations than the limits specified under I.2. (a) or (b) if:

where:

3. and assigned the risk phrases R52 and R53 (R52-53) unless the preparation is already classified according to I.1 or I.2 above;

3.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrases R50-53 or R51-53 or R52-53 in individual concentrations equal to or greater than:

3.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrases R51-53 or R50-53 or R52-53 in lower individual concentrations than the limits specified under I.3.1(a) or (b) if:

where:

4. and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrase R50 unless the preparation is already classified according to I.1 above:

4.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R50 in individual concentrations equal to or greater than:

4.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R50 in lower individual concentrations than the limits specified under I.4.1(a) or (b) if:

where:

4.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R50 not meeting the criteria under I.4.1 or I.4.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 if:

where:

5. and assigned the risk phrase R52 unless the preparation is already classified according to I.1, I.2, I.3, or I.4 above:

5.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R52 in individual concentrations equal to or greater than:

5.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R52 in lower individual concentrations than the limits specified under I.5.1 (a) or (b) if:

where:

6. and assigned the risk phrase R53 unless the preparation is already classified according to I.1, I.2, or I.3 above:

6.1. preparations containing one or more than one substance classified as dangerous to the environment and to which is assigned phrase R53 in individual concentrations equal to or greater than:

6.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R 53 in lower individual concentrations than the limits specified under I.6.1(a) or (b) if:

where:

6.3. preparations containing one or more than one of the substances classified as dangerous for the environment and to which is assigned phrase R53 not meeting the criteria under I.6.2 and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 or R51-53 or R52-53 if:

where:

1. and assigned the symbol ‘N’, the indication of danger ‘dangerous for the environment’ and the risk phrase R59;

1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned the symbol ‘N’ and the risk phrase R59 in individual concentrations equal to or greater than:

1. Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic or corrosive in accordance with Article 10 and under the conditions laid down in Article 6 of this Directive, are to fitted with child-resistant fastenings.

2. Containers of whatever capacity containing preparations presenting an aspiration hazard (Xn, R65) and classified and labelled according to paragraph 3.2.3 of Annex VI to Directive 67/548/EEC with the exception of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment.

3. Containers of wathever capacity, having at least one of the substances mentioned below present in a concentration equal to or greater then the maximum individual concentration specified,

which are offered or sold to the general public are to be fitted with child-resistant fastenings.

1.1. The label on the packaging containing such preparations, in addition to the specific safety advice, must bear the relevant safety advice S1, S2, S45 or S46 in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

1.2. When such preparations are classified as very toxic (T+), toxic (T) or corrosive (C) and where it is physically impossible to give such information on the package itself, packages containing such preparations must be accompanied by precise and easily understandable instructions for use including, where appropriate, instructions for the destruction of the empty package.

‘Cyanoacrylate

Danger

Bonds skin and eyes in seconds

Keep out of the reach of children’.

‘Contains isocyanates.

See information supplied by the manufacturer’.

‘Contains epoxy constituents.

See information supplied by the manufacturer’.

‘Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions’.

— the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or R39/26,

— or the preparation is in a package not exceeding 125 ml.

A. Article 15 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality.

B. To avoid multiple requests for confidentiality relating to the same substance used in different preparations, a single request for confidentiality may suffice if a certain number of preparations have:

A single alternative denomination must be used to mask the chemical identity of the same substance in the preparations concerned. Furthermore, the request for confidentiality must contain all information indicated in the following request, without forgetting the name or the trade name of each preparation.

C. The alternative designation used on the label must be the same as that given under heading 2 ‘Composition/information on ingredients’ of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

This implies that the alternative designation used will contain enough information about the substance to ensure risk-free handling.

D. In making the request to use an alternative designation the person responsible for placing on the market must take into account the need to provide enough information for necessary health and safety precautions to be taken in the workplace and to ensure that risks from handling the preparation can be minimised.

1. Name and full address (including telephone number) of the person established in the Community who is responsible for placing the preparation on the market (manufacturer, importer or distributor).

2. Precise identification of the substance(s) for which confidentiality is proposed and the alternative designation.

3. Justification for confidentiality (probability — plausibility).

4. Designation(s) or commercial name(s) of the preparation(s).

5. Is the designation or commercial name the same for all the Community?

If no, specify the designation(s) or commercial name(s) used in the different Member States:

6. Composition of the preparation(s) defined in point 2 of the Annex to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

7. Classification of the preparation(s) according to Article 6 of this Directive.

8. Labelling of the preparation(s) according to Article 10 of this Directive.

9. Intended uses for the preparation(s).

10. Safety data sheet(s) conforming to Directive 91/155/EEC as last amended by Directive 93/112/EEC.

— inorganic or organic substances whose properties are identified by having a common chemical element as their chief characteristic. The family name is derived from the name of the chemical element. These families are identified as in Annex I by the atomic number of the chemical element (001 to 103),

— organic substances whose properties are identified by having a common functional group as their chief characteristics.

(i) identification of the functional groups and chemical elements present in the molecule;

(ii) determination of the extent to which account should be taken of the most important functional groups and chemical elements.

4.1. If the name of a family or sub-family is sufficient to characterise the chemical elements or important functional groups, this name will be chosen as the generic name.

Examples:

4.2. If the name of a family or sub-family is not sufficient to characterise the chemical elements of important functional groups, the generic name will be a combination of the corresponding different family or sub-family names:

Examples:

NB:

In the case of certain elements, notably metals, the name of the family or sub-family may be indicated by the words‘organic’ or ‘inorganic’.

Examples:

(The examples cited are substances taken from Annex I to Directive 67/548/EEC (19th adaptation) in respect of which requests for confidentiality may be submitted).

— Directive 78/631/EEC on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)

— Directive 88/379/EEC on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations and its following adaptations to technical progress:

— Directive 90/35/EEC defining in accordance with Article 6 of Directive 88/379/EEC the category of preparations the packaging of which must be fitted with child-resistant fastenings and/or carry a tactile warning of danger

— Directive 91/442/EEC on dangerous preparations the packaging of which must be fitted with child-resistant fastenings

1. Austria, Finland and Sweden do not transpose or apply Council Directive 78/631/EEC of 26 June 1978 on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides), as last amended by Council Directive 92/32/EEC of 30 April 1992.

2. Austria is to apply Council Directive 88/379/EEC of 7 June 1988 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations, as last amended by Directive 96/65/EC of 11 October 1996 under the following conditions:

The following provisions of Directive 88/379/EEC will not apply to Austria

3. Sweden is to apply Council Directive 88/379/EEC of 7 June 1988 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous preparations, as last amended by Directive 96/65/EC of 11 October 1996 under the following conditions:

The following provisions of Directive 88/379/EEC will not apply to Sweden: