Explanatory Memorandum to COM(1996)347 - Approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations

Please note

This page contains a limited version of this dossier in the EU Monitor.

dossier COM(1996)347 - Approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, ...
source COM(1996)347 EN
date 18-07-1996
Avis juridique important

|
51996PC0347

Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations /* COM/96/0347 FINAL - COD 96/0200 */

Official Journal C 283 , 26/09/1996 P. 0001


Proposal for a European Parliament and Council Directive concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (96/C 283/01) (Text with EEA relevance) COM(96) 347 final - 96/0200 (COD) (Submitted by the Commission on 18 July 1996)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100A thereof,

Having regard to the proposal of the Commission,

Having regard to the opinion of the Economic and Social Committee,

Acting in accordance with the procedure laid down in Article 189b of the Treaty,

Whereas Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations () has been amended on several occasions; whereas on the occasion of further amendments, the said Directive should, for reasons of clarity be recast;

Whereas, in spite of Community provisions, the rules applying to certain dangerous preparations in the Member States exhibit considerable differences as regards classification, packaging and labelling; whereas these differences constitute a barrier to trade, create unequal competition conditions and directly affect the functioning of the internal market; whereas it is therefore necessary to remove this barrier to trade by approximating the relevant legislation existing in the Member States;

Whereas measures for the approximation of the provisions of the Member States affecting the establishment and functioning of the internal market must, in so far as they concern health, safety and protection of man and the environment, adopt a high level of protection as a basis; whereas this Directive must, at the same time, ensure protection for the general public, and, in particular, of persons who come into contact with dangerous preparations in the course of their work or in the pursuit of a hobby, of consumers, and also for the environment;

Whereas 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; whereas certain preparations not falling within these categories of danger may nevertheless, due to their composition, present a danger for children; whereas the packaging of such preparations should therefore be equipped with child resistant fastening;

Whereas it is necessary to provide concentration limits in the case of preparations marketed in gaseous form; whereas concentration limits expressed as a volume/volume percentage are therefore inserted into Annex II;

Whereas Annex V to this Directive contains special labelling provisions applicable to certain preparations; whereas to ensure an adequate level of protection for man and the environment, special labelling provisions must also be introduced for certain preparations which although not dangerous within the meaning of Article 1 (3), may present a danger to the user;

Whereas in April 1992 the Council adopted Directive 92/32/EEC () amending for the seventh time Council Directive 67/548/EEC () on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances; whereas in April 1993 the Commission adopted Directive 93/21/EEC () adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances; whereas new criteria developed for classifying and labelling substances dangerous for the environment were introduced by these Directives with the appropriate symbols, indication of danger, risk phrases and safety advices for labelling requirement; whereas provisions should be adopted at Community level on the classification and labelling of preparations to take account of their effects on the environment; whereas it is, therefore, necessary to introduce a method for assessing the hazards of a preparation to the environment either by a calculation method, or by determining the ecotoxicological properties by test methods under certain conditions;

Whereas the number of animals used for experiments should be reduced to a minimum, in accordance with the provisions of Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (); whereas Article 7 (2) of the abovementioned Directive stipulates that an experiment shall not be performed if another scientifically satisfactory method of obtaining the results sought, not entailing the use of an animal, is reasonably and practically available; whereas, 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;

Whereas classification, packaging and labelling of plant protection products covered by 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) () require to be revised taking into account technical and scientific developments as well as regulatory developments following implementation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ();

Whereas Directive 91/414/EEC and Council Directive ../../EC on biocides, in contrast to chemical preparations covered by the present Directive, provides for an authorization 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, and furthermore that this authorization procedure includes a control relating specifically to the classification, packaging and labelling of each product before it is placed on the market; whereas it is appropriate, as part of a clear and transparent information process to classify plant protection products according to the provisions of this Directive, to label them by taking into account both the classification and labelling rules of the present Directive and the results of the evaluation carried out in the framework of Directive 91/414/EEC and to ensure that the labelling satisfies the high level of protection sought by both this Directive and Directive 91/414/EEC; whereas also a safety data sheet has to be established in accordance with this Directive but subject to the authorization procedure of the Directive on plant protection products;

Whereas 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; whereas it is, therefore, necessary as part of a transparent information process to classify them and assign to them a safety data sheet in accordance with the provisions of this Directive and also to label them in accordance with the international rules used for the transport of such preparations;

Whereas 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 to extend certain provisions of this Directive to those preparations;

Whereas the label constitutes a basic tool for users of the dangerous preparations by giving them the initial essential concise information; whereas it nevertheless needs to be supplemented by a two-fold system of more detailed information, one, the safety data sheet, intended for professional users as defined by Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Directive 88/379/EEC () and the other bodies appointed by the Member States and whose responsibility it is to give information reserved solely for medical purposes, both curative and preventive;

Whereas the confidentiality for certain substances contained in the preparations should be guaranteed; whereas it is, therefore, necessary to institute a system which allows the manufacturer to request confidentiality for such substances;

Whereas the provisions of this Directive are without prejudice to the commitment entered into by the Community and its Member States, in accordance with the goals set under Agenda 21, Chapter 10, at the Unced Conference of June 1992 in Rio de Janeiro, to strive for the future harmonization of systems for the classification of dangerous substances and preparations;

Whereas the Commission should be given the powers necessary to adapt all the Annexes to this Directive to technical progress;

Whereas the adoption of this Directive should not affect the obligations of the Member States concerning the deadlines for transposition into national law and for application of the Directives indicated in Annex VIII,

HAVE ADOPTED THIS DIRECTIVE:


Contents

1.

Article 1


Objectives and scope

1. This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States concerning:

- the classification, packaging and labelling of dangerous preparations,

- 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.

2. This Directive shall apply to preparations which:

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

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

3. The specific provisions set out:

- in Article 9 and defined in Annex IV,

- in Article 10 and defined in Annex V, and

- in Article 16,

of this Directive shall also apply to preparations which are not considered dangerous within the meaning of Articles 5, 6 or 7 but may nevertheless present a hazard to the user.

4. Without prejudice to the provisions of Directive 91/414/EEC concerning the placing of plant protection products on the market, the Articles on classification, packaging, labelling and safety data sheets of this Directive shall apply to plant protection products.

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

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

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

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

(d) foodstuffs,

(e) animal feedingstuffs,

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

(g) medical devices covered by Directives 90/385/EEC (), and 93/42/EEC (), which are intended to be implanted, invasive or used in direct contact with the body.

In addition, this Directive shall not apply to:

- 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.


2.

Article 2


Definitions

The definitions appearing in Article 2 of Directive 67/548/EEC, with the exception of the definition in paragraph 1 (d) thereof, shall apply to this Directive.


3.

Article 3


General principles for the determination of dangerous properties of preparations 1. The evaluation of the hazards of a preparation shall be based on the determination of:

- physico-chemical properties,

- properties affecting health,

- environmental properties.

These different properties shall be determined in accordance with the provisions laid down in Articles 5, 6, and 7 of this Directive.

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

2. Where the determination of dangerous properties is carried out in accordance with Articles 5, 6 and 7 of this Directive, all dangerous substances within the meaning of Article 2 of Directive 67/548/EEC and in particular those which:

- 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 labelled provisionally by the person responsible for 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 labelled in accordance with Article 13(2) of Directive 67/548/EEC,

must be taken into consideration in accordance with the provisions laid down in the method used.

3. For preparations covered by this Directive, dangerous substances such as defined in paragraph 2 which are classified dangerous on the basis of their health effects and 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 Annex I to Directive 67/548/EEC.

>TABLE>


4.

Article 4


General principles of classification and labelling

1. The classification of dangerous preparations according to the degree and the 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 according to the criteria in Annex VI to Directive 67/548/EEC save where alternative criteria referred to in Articles 5, 6 or 7 of this Directive are applied.


5.

Article 5


Evaluation of the hazards deriving from physico-chemical properties

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 Annex V to Directive 67/548/EEC, the physico-chemical properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria of Annex VI to that Directive.

By way of derogation from the preceding, the determination of the explosive, oxidizing, extremely flammable, highly flammable, or flammable properties is not necessary provided, however, that:

- 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 Council Directive 75/324/EEC (), as last amended by Directive 94/1/EC ().

2. For certain cases for which the methods of Part A of Annex V to Directive 67/548/EEC are not appropriate, alternative calculation methods are referred to in Annex I Part B to this Directive.

3. Some exemptions to the application of the methods of Part A of Annex V to Directive 67/548/EEC are referred to in Part A of Annex I to this Directive.

4. The hazards deriving from the physico-chemical properties of a preparation covered by Directive 91/414/EEC shall be assessed by determining the physico-chemical properties of the preparation necessary for appropriate classification in accordance with criteria of Annex VI to Directive 67/548/EEC. These physico-chemical properties will be determined by means of the methods laid down in Part A of Annex V to Directive 67/548/EEC unless other internationally recognized methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.


6.

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 the conventional method described in Annex II Parts A and B to this Directive using concentration limits;

(b) by determining, by means of the methods specified in point B of Annex V to Directive 67/548/EEC the toxicological properties of the preparation necessary for appropriate classification and labelling in accordance with the criteria in Annex VI to that Directive.

2. The health hazards of a preparation covered by Directive 91/414/EEC shall be assessed by one or more of the following procedures:

(a) by the conventional method described in Annex II Parts A and B to this Directive using concentration limits;

(b) by determining the health effect properties of the preparation necessary for appropriate classification in accordance with criteria of Annex VI to Directive 67/548/EEC. These health effect properties will be determined by means of the methods laid down in Part B of Annex V to Directive 67/548/EEC unless other internationally recognized methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.

3. When a toxicological property is established by method 1 (b) or 2 (b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Council Directive 87/18/EEC ()and with the provisions of Directive 86/609/EEC.

Any of the toxicological properties of the preparation which are not assessed by the method set out in 1 (b) or 2 (b) shall be assessed in accordance with the conventional method.

Where a toxicological property has been established by both the methods above, the result of method 1 (b) or 2 (b) shall be used for classifying the preparation except in the case of carcinogenic, mutagenic and toxic effects for reproduction for which only the conventional method described in Annex II applies.

Furthermore, where it can be demonstrated that:

- toxicological effects on man differ from those suggested by a toxicological determination or a conventional assessment, then the preparation shall be classified according to its effects on man,

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

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

4. For preparations of a known composition with the exception of those covered by Directive 91/414/EEC, classified in accordance with method 1 (b) a new evaluation of health hazard either by method 1 (a) or (b) 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:

>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 of this Directive, are introduced by the manufacturer.

This 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.

5. In accordance with paragraph 1 (a) and 2 (a), the health effects of a preparation shall be assessed by the conventional method described in Parts A and B of Annex II to this Directive, using individual concentration limits.

(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 Annex II to this Directive, 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 Annex II to this Directive, the concentration limits shall be assigned in accordance with the specifications in Part B of Annex II to this Directive.


7.

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 Parts A and B of Annex III to this Directive using concentration limits;

(b) by determining, by means of the methods specified in Part C of Annex V to Directive 67/548/EEC, the hazards of a preparation for the environment necessary for appropriate classification and labelling in accordance with the criteria defined in Annex VI to that Directive. The conditions of application of the test methods specified above shall be as described in Annex III Part C to this Directive.

2. The environmental hazards of a preparation covered by Directive 91/414/EEC shall be assessed by one or more of the following procedures:

(a) by a conventional method described in Parts A and B of Annex III to the present Directive using concentration limits;

(b) by determining the environmental effects of the preparation necessary for appropriate classification in accordance with criteria of Annex VI to Directive 67/548/EEC. These ecotoxicological properties will be determined by means of the methods laid down in Part C of Annex V to Directive 67/548/EEC unless other internationally recognized methods are acceptable in accordance with the provisions of Annexes II and III to Directive 91/414/EEC.

3. When an ecotoxicological property is established by method 1 (b) or 2 (b) to obtain new data, the test shall be conducted in compliance with the principles of good laboratory practice provided for in Directive 87/18/EEC and with the provisions of Directive 86/609/EEC.

Where the environmental hazards have been assessed by both the procedures mentioned above, the results of the methods referred to in 1 (b) or 2 (b) shall be used for classifying the preparation.

4. For preparations of a known composition with the exception of those covered by Directive 91/414/EEC classified in accordance with method 1 (b) above a new evaluation of environmental hazard either by method 1 (a) or 1 (b) 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:

>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 of this Directive, are introduced by the manufacturer.

This 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.

5. In accordance with paragraphs 1 (a) and 2 (a), the environmental hazards of a preparation shall be assessed by the conventional methods described in Parts A and B of Annex III to this Directive, using individual concentration limits.

(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 Annex III to this Directive, 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 Annex III to this Directive, the concentration limits shall be assigned in accordance with the specifications in Part B of Annex III to this Directive.


8.

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 therewith.

2. If there is any doubt with regard to the compliance referred to in paragraph 1, 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 it on the market.

3. Without prejudice to Article 8 (2), the Member States shall take all necessary measures to ensure that those responsible for placing the preparation on the market hold at the disposal of the authorities of the Member States:

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

- any pertinent information relating to packaging requirements according to 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 16 of this Directive.

4. The Member States shall inform the Commission of the name and full address of the national authorities responsible for communicating and exchanging information relating to the management of this Directive.

The Commission shall publish the list in the Official Journal of the European Communities.


9.

Article 9


Packaging

Member States shall take all necessary measures to ensure that:

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

- it shall be so designed and constructed that it contents cannot escape; this requirement shall not apply where special safety devices are prescribed,

- 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,

- 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,

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

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

- either a shape and/or graphic decoration likely to attract or arouse the active curiosity of children or to mislead consumers,

- or a presentation and/or a designation used for human and animal foodstuffs, or medicinal or cosmetic products;

3. containers which contain certain preparations offered or sold to the general public and defined in Annex IV to this Directive:

- are fitted with child-resistant fastenings,

10.

and/or


- 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.


11.

Article 10


Labelling

1.1. 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 Part A of Annex V to this Directive;

(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 paragraphs 2.1 and 2.2 hereunder and the specific provisions of Parts B and C of Annex V to this Directive.

1.2. Member States, through the authorities designated in Article 9 (1) of Directive 91/414/EEC, shall take all necessary measures to ensure that the preparations covered by the abovementioned Directive are labelled on the basis first of the classification criteria in this Directive and second, the assessment conclusions in accordance with the provisions of the abovementioned Directive, without reducing the level of protection.

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

2.1. the trade name or designation of the preparation;

2.2. the name, full address and telephone number of the person established in the Community who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor.

12.

2.3. Chemical name(s)


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

2.3.1. 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 Annex I to Directive 67/548/EEC or, failing that, Annex II B to this Directive have to be taken into consideration;

2.3.2. for preparations classified C in accordance with Article 6, only the substances C present in concentrations equal to or greater than the lowest limit (limit Xi) laid down in Annex I to Directive 67/548/EEC or, failing that, Annex II B to this Directive have to be taken into consideration;

2.3.3. for preparations classified as sensitizing, in accordance with Article 6 only the sensitizing substances present in concentrations equal to or greater than their respective limits laid down in Annex I to Directive 67/548/EEC or, failing that, Annex II B to this Directive have to be taken into consideration.

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.

The name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories:

- 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,

- sensitizing,

shall be mentioned on the label.

The chemical name shall be one of the designations listed in Annex I to Directive 67/548/EEC or an internationally recognized designation if it is not yet listed therein;

2.3.4. as a consequence of the above provisions the name of the substance(s) which led to the classification of the preparation in the following danger categories:

- explosive,

- oxidizing,

- extremely flammable,

- highly flammable,

- flammable,

- irritant,

- dangerous for the environment,

need not be mentioned on the label unless the substance(s) has (have) already been mentioned pursuant to 2.3.1 or 2.3.2;

2.3.5. where the disclosure on the label of the chemical identity of a harmful substance or harmful in combination with one of the properties mentioned in 2.3.4 presenting acute lethal effects alone will put at risk the confidential nature of this property, the person responsible for placing the preparation on the market may request the application of the procedure of Article 11 with a view to using an alternative name.

13.

2.4. 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 the wording of Annex II and the provisions of Annex VI to Directive 67/548/EEC and shall be applied in accordance with the evaluation of the hazards in accordance with Annexes I, II and III to this Directive.

Where more than one danger symbol has to be assigned to a preparation:

- the obligation to apply the symbol T shall make the symbols C and X optional unless otherwise specified in Annex I to Directive 67/548/EEC,

- the obligation to apply the symbol C shall make the symbol X optional,

- the obligation to apply the symbol E shall make the symbols F and O optional,

- if the symbol Xn and the indication of danger 'harmful` are assigned, the symbol Xi and indication of danger 'irritant` are optional.

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

14.

2.5. Risk phrases (R phrases)


The indications concerning special risks (R phrases) shall conform to the wording in Annex III and the provisions of Annex VI to Directive 67/548/EEC and shall be assigned, in accordance with the results of the hazards evaluation in accordance with Annexes I, II and III to this Directive.

The indications concerning special risks (R phrases) for preparations classified as dangerous for the environment shall conform to the wording of Annex III D to this Directive and shall be assigned in accordance with the results of the hazards evaluation in accordance with Annex III A, B and C 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, these standard phrases must 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 indicated where they describe an indication of danger used in accordance with paragraph 2.4.

15.

2.6. Safety advice (S phrases)


The indication giving safety advice (S phrases) shall conform to the wording in Annex IV and the provisions of Annex VI to Directive 67/548/EEC and shall be assigned in accordance with the results of the hazards evaluation in accordance with Annexes I, II and III to this Directive.

The indications giving safety advice (S phrases) for preparations classified as hazardous to the environment shall conform to the wording of Annex III E of the present Directive and shall be assigned in accordance with the results of the hazard evaluation in accordance with Annex III A, B and C 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.

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

3. By way of derogation from paragraphs 2.4, 2.5 and 2.6, exemptions to certain provisions on labelling in the Articles mentioned or specific provisions on labelling replacing those may be indicated in Annex V A and B for certain preparations classified as dangerous within the meaning of Article 7 and defined in Annex V to this Directive.

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

- in the case of irritant, highly flammable and oxidizing preparations with the exception of those assigned the phrase R41, there is no need to indicate the special risks (R phrases) or the safety advice (S phrases),

- in the case of flammable preparations there is no need to indicate the safety advice (S phrases).

5. Information such as 'non-toxic`, 'non-harmful` or any other statement indicating that the preparation is not dangerous must not appear on the packaging or labelling of the preparations subject to this Directive.


16.

Article 11


Confidentiality of the identity of a chemical: procedures and details 1. Where the person responsible for placing a dangerous preparation within the meaning of Article 1 (2) on the market avails himself of the provisions of Article 10 paragraph 2.3.5 he shall make a request for confidentiality to the competent authority of one of the Member States in which the preparation is to be placed on the market.

2. This request must provide the information required in the form in Part A of Annex VI to this Directive, without prejudice to further information requested by the competent authority from the person responsible for placing the preparation on the market if it appears necessary to evaluate the validity of the request.

It shall include a proposal of alternative generic name, using a generic name that identifies the most important chemical groups in accordance with the lexicon presented in Annex VI Part B to this Directive.

3. Member States shall designate to the Commission, at the latest by the date of entry into force of this Directive, the authority or authorities responsible for receiving requests for confidentiality and examining their conformity with this Directive.

4. The authority of the Member State receiving a request for confidentiality shall verify its admissibility and inform the applicant of its decision within a maximum of (45) days.

If the request is rejected or further information is required, the competent authority shall give its reasons therefor.

Confidential information brought to the knowledge of the authorities of the Member States or of the Commission shall be dealt with in accordance with Article 19 (4) of Directive 67/548/EEC.

5. Anyone other than the person responsible for placing the preparation on the market, who modifies only the designation or commercial name of a preparation the labelling of which contains one or more alternative designations protecting the chemical identity or identities, shall inform on the one hand the authorities of the Member States where this preparation, together with its new designation or commercial name, is placed on the market for the first time and on the other hand the Commission.

This information shall include:

- the old designation or commercial name,

- the new designation or commercial name,

- the alternative designation(s) employed.

The alternative designations shall not be modified.


17.

Article 12


Exchange of information concerning requests for confidentiality between the Commission and the Member States

1. In the event of a favourable decision, the responsible authority shall forward a copy of its decision and the request to the Commission as soon as possible.

2. The Commission shall forward this decision and the request file as soon as possible to the responsible authorities of the other Member States.

3. Where one or more authorities referred to in paragraph 2 enters an objection it shall inform the Commission thereof within one month. The Commission shall consult the Member States as soon as possible and shall take an appropriate decision in accordance with Article 21.

4. At the latest by the date of entry into force of this Directive, each Member State shall communicate to the Commission the list of commercial names of preparations in respect of which it has been informed under Directive 88/379/EEC of the use of an alternative name for a harmful substance.

5. The Commission shall communicate each of the lists to the other Member States.


18.

Article 13


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 the said 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 are intended solely for provision of the information required by this Directive and if necessary of any supplementary health or safety information.

2. A label is not 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 in their territories subject to the use of the official language or languages in respect of the labelling thereof.

6. For the purpose 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 preparations and the inner package or packages are labelled in accordance with this Directive;

(b) in the case of a single package:

- if such a package is labelled in accordance with international rules on the transport of dangerous preparations and with Article 10, paragraphs 2.1, 2.2, 2.3, 2.5 and 2.6, or;

- where appropriate, for particular types of packaging such as mobile gas cylinders, in accordance with the specific requirements referred to in Annex VI to Directive 67/548/EEC.

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 preparations.


19.

Article 14


Exemptions from the labelling and packaging requirements

1. Articles 9, 10 and 13 shall not apply to the provisions relating 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 13 shall not apply.

3. Member States may:

(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 13 (1) and (2);

(b) by way of derogation from Articles 10 and 13, permit the packaging of dangerous preparations which are not explosive, very toxic or toxic 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) where packages are too small for the labelling provided for in Articles 10 and 13 and there is no reason to fear any danger to persons handling such preparations or to other persons, by way of derogation from the above provisions, permit the packaging of explosive, very toxic or toxic preparations to be labelled in some other appropriate way.

This derogation does not permit use of symbols, indications of danger, risk (R) phrases or safety (S) phrases different from those laid down in this Directive.

4. If a Member State makes use of the options provided for in paragraph 3, it shall inform the Commission thereof forthwith.


20.

Article 15


Advertisements

Any advertisement for a preparation within the meaning of this Directive communicated exclusively by correspondence or catalogue which imposes an obligation on the buyer shall be prohibited if no mention is made therein of the type or types of hazard indicated on the label.


21.

Article 16


Safety data sheet

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

1. The person responsible for placing on the market a preparation within the meaning of Article 1 (2) must provide, at the latest on first delivery, a safety data sheet.

2. The person responsible for placing on the market a preparation provides on request a safety data sheet for preparations not classified as dangerous within the meaning of Articles 5, 6 and 7 but containing in an individual concentration of >= 1 % by weight for non-gaseous preparations and >= 0,2 % volume for gaseous preparations at least:

- one substance posing health hazards, or

- one substance for which there are Community exposure limits at the workplace.

3. By way of derogation from paragraphs 1 and 2, the applicant for authorization of a plant protection product must provide to the authorities designated in Article 9 (1) of Directive 91/414/EEC a safety data sheet attached to the application for authorization of the plant protection product.

4. Safety data sheets must comply with the provisions of Directive 91/155/EEC, as last amended by Directive 93/112/EEC.

5. This 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.

6. The necessary amendments required to adapt to technical progress Directive 91/155/EEC, as last amended by Directive 93/112/EEC, shall be adopted in accordance with the procedure laid down in Article 21 of this Directive.

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


22.

Article 17


Rights of the Member States regarding safety of workers

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


23.

Article 18


Bodies responsible for receiving information relating to health

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

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

Member States shall ensure that the appointed bodies shall 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.


24.

Article 19


Free movement clause

Member States may not prohibit, restrict or impede the placing on the market of preparations which comply with the requirements of this Directive.


25.

Article 20


Safeguard clause 1. Where a Member State has detailed evidence that a preparation, although satisfying the requirements 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.

3. The Commission shall take a decision in accordance with the procedure laid down in Article 21 of this Directive.


26.

Article 21


Procedure for adaptation to technical progress

Amendments required to adapt to technical progress the Annexes to this Directive shall be adopted in accordance with the procedure laid down in Article 29 of Directive 67/548/EEC.


27.

Article 22


The Directives listed in Annex VIII Part A, are hereby repealed, without prejudice to the obligation of the Member States concerning the deadlines for transposition into national law and for application of the Directives indicated in Annex VIII Part B.

References to the repealed Directives shall be constituted as reference to this Directive and should be read in accordance with the correlation table set out in Annex IX.


28.

Article 23


1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 2003 at the latest. They shall immediately inform the Commission thereof.

2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by the Member States.


29.

Article 24


This Directive shall enter into force on the third day following its publication in the Official Journal of the European Communities.


30.

Article 25


This Directive is addressed to the Member States.


OJ No L 187, 16. 7. 1988 p. 14. Directive as last amended by Commission Directive 93/18/EEC (OJ No L 104, 29. 4. 1993, p. 46).

OJ No L 154, 5. 6. 1992, p. 1.

OJ No 196, 16. 8. 1967, p. 1/67. Directive as last amended by Commission Directive 94/69/EC (OJ No L 381, 31. 12. 1994, p.

1).

OJ No L 110, 4. 5. 1993, p. 20.

OJ No L 358, 18. 12. 1986, p. 1.

OJ No L 206, 29. 7. 1978, p. 13. Directive as last amended by Directive 92/32/EEC.

OJ No L 230, 19. 8. 1991, p. 1. Directive as last amended by Commission Directive 94/79/EC (OJ No L 354, 31. 12. 1994, p. 16).

OJ No L 76, 22. 3. 1991, p. 35. Directive last amended by Directive 93/112/EEC (OJ No L 314, 16. 12. 1993, p. 38.

OJ No 22, 9. 2. 1965, p. 369/65. Directive last amended by Directive 93/39/EEC (OJ No L 214, 24. 8. 1993, p. 22).

OJ No L 262, 27. 9. 1976, p. 169. Directive last amended by Directive 93/47/EEC (OJ No L 203, 13. 8. 1993, p. 24).

OJ No L 194, 25. 7. 1975, p. 39.

OJ No L 84, 31. 3. 1978, p. 43.

OJ No L 46, 17. 9. 1980, p. 1.

OJ No L 189, 20. 7. 1990, p. 17 () OJ No L 169, 12. 7. 1993, p. 1.

OJ No L 147, 9. 6. 1975, p. 40.

OJ No L 23, 28. 1. 1994, p. 28.

OJ No L 15, 17. 1. 1987, p. 29.


31.

ANNEX I


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

PART A

Exemption to test methods of Annex V Part A to Directive 67/548/EEC

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

32.

PART B


Alternative calculation methods

B1. Non-gaseous preparations

Method for the determination of oxidizing properties of preparations containing organic peroxides

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

33.

B2. Gaseous preparations


34.

1. Method for the determination of oxidizing properties


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

35.

2. Method for the determination of flammability properties


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


36.

ANNEX II


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

PART A

Method of evaluation

Introduction

This conventional method 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. sensitizing effects;

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

The classification of the substance is 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 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 Annex I to Directive 67/548/EEC, the concentration limits to be taken into account for the application of the conventional method are those set out in Part B of this Annex.

37.

Conventional method for the evaluation of health hazards


1. The following preparations shall be classified as very toxic:

1.1. owing to their acute lethal effects and assigned the risk phrase R26, R27 or R28:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 1 in Part B of this Annex (Tables I and IA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.1.2. preparations containing more than one substance classified as very toxic in individual concentrations not exceeding the limits specified under 1.1.1(a) or (b) if:

>REFERENCE TO A FILM>

where:

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

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

1.2. owing to their non-lethal irreversible effects after a single exposure, and assigned 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 2 in Part B in this Annex (Tables II and IIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC 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 risk phrase R23, R24 or R25:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 1 in Part B of this Annex (Tables I and IA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.1.2. preparations containing more than one substance classified as very toxic or toxic in individual concentrations not exceeding the limits specified under 2.1.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

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

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

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

2.2. owing to their non-lethal irreversible effects after a single exposure, and assigned the risk phrases 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 2 in Part B of this Annex (Tables II and IIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

2.3. owing to their long-term effects and assigned the risk phrases R38/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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 3 in Part B of this Annex (Tables III and IIIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC 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 risk phrase R20, R21 or R22:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 1 in Part B of this Annex (Tables I and IA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

3.1.2. preparations containing more than one substance classified as very toxic, toxic or harmful in individual concentrations not exceeding the limits specified under 3.1.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

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

PT = the percentage by weight or by volume of each toxic substance in the preparation;

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

LXn = 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 risk phrase R65:

3.2.1. preparations containing one or more substances classified as harmful and assigned the risk phrase R65 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified at point 1 in Part B of this Annex (Table 1) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

3.2.2. preparations containing more than one substance classified as harmful and assigned the risk phrase R65 in individual concentrations not exceeding the limits specified under 3.2.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PXn, R65 = the percentage by weight of each harmful substance to which is assigned the risk phrase R65 in the preparation,

LXn, R65 = the respective harmful limit specified for each harmful substance to which is assigned the risk phrase R65, expressed as percentage by weight;

3.3. owing to their non-lethal irreversible effects after a single exposure, and assigned the risk phrases R40/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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 2 in Part B of this Annex (Tables II and IIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

3.4. owing to their long-term effects, and assigned the risk phrases 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 3 in Part B of this Annex (Tables III and IIIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

4. The following preparations shall be classified as corrosive:

4.1. and assigned the risk phrase R35:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 4 in Part B of this Annex (Tables IV and IVA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

4.1.2. preparations containing more than one substance classified as corrosive and to which is assigned phrase R35 in individual concentrations not exceeding the limits specified under 4.1.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

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

LC, R35 = 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 risk phrase R34:

4.2.1. preparations containing one or more substances classified 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 4 in Part B of this Annex (Tables IV and IVA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

4.2.2. preparations containing more than one of the substances classified as corrosive and to which is assigned phrase R35 or R34 in individual concentrations not exceeding the limits specified under 4.2.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

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

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

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

5. The following preparations shall be classified as irritants:

5.1. liable to cause serious eye damage and assigned the risk phrase R41:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 4 in Part B of this Annex (Tables IV and IVA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC 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 in individual concentrations not exceeding the limits specified under 5.1.1 (a) or (b) or classified as corrosive and to which is assigned phrase R35 or R34 if:

>REFERENCE TO A FILM>

where:

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

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

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

LXi,R41 = 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 risk phrase R36:

5.2.1. preparations containing one or more substances classified as corrosive and 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 4 in Part B of this Annex (Tables IV and IVA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

5.2.2. preparations containing more than one of the substances classified as irritant and to which is assigned phrase R41 or R36 in individual concentrations not exceeding the limits specified under 5.2.1 (a) or (b) or classified as corrosive and to which is assigned phrase R35 or R34 if:

>REFERENCE TO A FILM>

where:

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

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

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

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

LXi,R36 = 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 risk phrase R38:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 4 in Part B of this Annex (Tables IV and IVA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

5.3.2. preparations containing more than one of the substances classified as corrosive and to which is assigned phrase R35 or R34 or as irritant and to which is assigned phrase R38 in individual concentrations not exceeding the limits specified under 5.3.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

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

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

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

LXi,R38 = 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 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 4 in Part B of this Annex (Tables IV and IVA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC 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 individual concentrations not exceeding the limits specified under 5.4.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

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

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

6. The following preparations shall be classified as sensitizing:

6.1. by skin contact and assigned the risk phrase R43:

preparations containing at least one substance classified as sensitizing 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 5 in Part B of this Annex (Tables V and VA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

6.2. by inhalation and assigned the risk phrase R42:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 5 in Part B of this Annex (Tables V and VA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

Remark: if a preparation contains a substance to which is assigned phrases R42/R43 the effects are to be considered in accordance with 6.1 to 6.2 above.

7. The following preparations shall be classified as carcinogenic:

7.1. those of category 1 or 2, and assigned 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 categories 1 and 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

7.2. those of category 3, and assigned phrase R40:

preparations containing at least one substance reducing 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

8. The following preparations shall be classified as mutagenic:

8.1. those of category 1 or 2 and assigned phrase R46:

preparations containing at least one substance producing such effects, classified as mutagenic and to which is assigned phrase 46 which denotes mutagenic substances in categories 1 and 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

8.2. those of category 3 and assigned phrase R40:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

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

9.1. those of category 1 or 2 and assigned 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 categories 1 and 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.2. those of category 3 and assigned 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.3. those of category 1 or 2 and assigned 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 categories 1 and 2, in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

9.4 those of category 3 and assigned 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 Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified at point 6 in Part B of this Annex (Tables VI and VIA) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits.

38.

PART B


Concentration limits to be used in applying the conventional method of assessing health hazards in accordance with Article 6

An assessment must be made of all the health hazards that the use of a substance might entail. 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. sensitizing effects;

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

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 (Tables A) where they are expressed as a volume/volume percentage and in conjunction with the classification of a substance.

The classification of the substance is 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 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.

39.

1. Acute lethal effects


40.

1.1. Non-gaseous preparations


The concentration limits fixed in Table I, 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>

The R phrase 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.

41.

1.2. Gaseous preparations


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

>TABLE>

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.

42.

2. Non-lethal irreversible effects after a single exposure


43.

2.1. Non-gaseous preparations


For substances that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/route of exposure), the individual concentration limits specified in Table II, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

44.

2.2. Gaseous preparations


For gases that produce non-lethal irreversible effects after a single exposure (R39/route of exposure, R40/route of exposure), the individual concentration limits specified in Table IIA, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

45.

3. Severe effects after repeated or prolonged exposure


46.

3.1. Non-gaseous preparations


For substances that produce severe effects after repeated exposure (R48/route of exposure), the individual concentration limits specified in Table III, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

47.

3.2. Gaseous preparations


For gases that produce severe effects after repeated or prolonged exposure (R48/route of exposure), the individual concentration limits specified in Table IIIA, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

48.

4. Corrosive and irritant effects including serious damage to eye


49.

4.1. Non-gaseous preparations


For substances that produce corrosive effects (R34, R35) or irritant effects (R36, R37, R38, R41), the individual concentration limits specified in Table IV, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

50.

4.2. Gaseous preparations


For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual concentration limits specified in Table IVA, expressed as a volume/volume percentage determine, when appropriate, the classification of the preparation.

>TABLE>

51.

5. Sensitizing effects


52.

5.1. Non-gaseous preparations


Preparations that produce such effects are classified as sensitizing and assigned:

- 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 individual concentration limits specified in Table V, expressed as a weight/weight percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

53.

5.2. Gaseous preparations


Gaseous preparations that produce such effects are classified as sensitizing and assigned:

- the symbol Xn and phrase R42 if this effect can be produced by inhalation.

The individual concentration limits specified in Table VA, expressed as a volume/volume percentage, determine, when appropriate, the classification of the preparation.

>TABLE>

54.

6. Carcinogenic/mutagenic/toxic effects for reproduction


55.

6.1. Non-gaseous preparations


For substances which produce such effects, the concentration limits laid down in Table VI, expressed as a weight/weight percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:

56.

carcinogenic categories 1 and 2: T; R45, R49


carcinogenic category 3: Xn; R40

mutagenic categories 1 and 2: T; R46

mutagenic category 3: Xn; R40

toxic for reproduction fertility categories 1 and 2: T; R60

toxic for reproduction development categories 1 and 2: T; R61

toxic for reproduction fertility category 3: Xn; R62

toxic for reproduction development category 3: Xn; R63

>TABLE>

57.

6.2. Gaseous preparations


For gases which produce such effects, the concentration limits laid down in Table VIA, expressed as a volume/volume percentage, shall determine, where appropriate, the classification of the preparation. The following symbol and risk phrases are assigned:

58.

carcinogenic categories 1 and 2: T; R45, R49


carcinogenic category 3: Xn; R40

mutagenic categories 1 and 2: T; R46

mutagenic category 3: Xn; R40

toxic for reproduction fertility categories 1 and 2: T; R60

toxic for reproduction development categories 1 and 2: T; R61

toxic for reproduction fertility category 3: Xn; R62

toxic for reproduction development category 3: Xn; R63

>TABLE>


59.

ANNEX III


METHODS FOR THE EVALUATION OF THE ENVIRONMENTAL HAZARDS OF PREPARATIONS IN ACCORDANCE WITH ARTICLE 7

Introduction

The systematic assessment of all the dangerous properties for the environment 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 a substance.

60.

PART A


Methods of evaluation

(a) Aquatic environment

1. Conventional method for the evaluation of hazards to the aquatic environment The conventional method for the evaluation of hazards to the aquatic environment takes into account all the hazards that a substance may entail for this medium according to the following specifications.

The following preparations shall be classified as dangerous for the environment 1.1. and assigned the risk phrases R50 (R50-53): very toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment:

1.1.1. 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table I) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.1.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 in individual concentrations not exceeding the limits specified under 1.1.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PN,R50-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

LN,R50-53 = the limit R50-53 for each substance dangerous for the environment to which is assigned the phrases R50-53, expressed as percentage by weight

1.2. and assigned the risk phrases R51 and R53 (R51-53): toxic to aquatic organisms and may cause long-term adverse effects in the aquatic environment:

1.2.1. 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table I) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.2.2. 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 individual concentrations not exceeding the limits specified under 1.2.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PN,R50-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN,R51-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

LN,R51-53 = the respective limit R51-53 for each substance dangerous for the environment to which is assigned phrases R50-53 or R51-53, expressed as percentage by weight

1.3. and assigned the risk phrases R52 and R53 (R52-53): harmful to aquatic organisms and may cause long-term adverse effects in the aquatic environment:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table I) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.3.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrase R51-53 or R50-53 or R52-53 in individual concentrations not exceeding the limits specified under 1.3.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PN,R50-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

PN,R51-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R51-53 in the preparation,

PR,52-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R52-53 in the preparation,

LR,52-53 = the respective limit R52-53 for each substance dangerous for the environment to which is assigned phrases R50-53 or R51-53 or R52-53, expressed as percentage by weight;

1.4. and assigned the risk phrase R50: very toxic to aquatic organisms:

1.4.1. 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table II) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.4.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R50 in individual concentrations not exceeding the limits specified under 1.4.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PN,R50 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

LN,R50 = the limit R50 for each substance dangerous for the environment to which is assigned phrase R50, expressed as percentage by weight

1.4.3. 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 1.4.1 or 1.4.2, and containing one or more than one substance classified as dangerous for the environment and to which is assigned phrases R50-53 if:

>REFERENCE TO A FILM>

where:

PN,R50 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50 in the preparation,

PN,R50-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrases R50-53 in the preparation,

LN, R50 = the respective limit R50 for each substance dangerous for the environment to which is assigned phrase R50 or R50-53, expressed as percentage by weight;

1.5. and assigned the risk phrase R52: harmful to aquatic organisms:

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

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table III) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.5.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R52 in individual concentrations not exceeding the limits specified under 1.5.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PR52 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52 in the preparation,

LR52 = the limit R52 for each substance dangerous for the environment to which is assigned phrase R52, expressed as percentage by weight;

1.6. and assigned the risk phrase R53: may cause long-term adverse effects in the aquatic environment:

1.6.1. 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:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table IV) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.6.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase R53 in individual concentrations not exceeding the limits specified under 1.6.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PR53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

LR53 = the limit R53 for each substance dangerous for the environment to which is assigned phrase R53, expressed as percentage by weight;

1.6.3. 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 1.6.2 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:

>REFERENCE TO A FILM>

where:

PR53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R53 in the preparation,

PN,R50-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R50-53 in the preparation,

PN,R51-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R51-53 in the preparation,

PR52-53 = the percentage by weight of each substance dangerous for the environment to which is assigned phrase R52-53 in the preparation,

LR53 = the respective limit R53 for each substance dangerous for the environment to which is assigned phrase R53 or R50-53 or R51-53 or R52-53, expressed as percentage by weight.

(b) Non-aquatic environment

(b1) Ozone layer

61.

1. Conventional method for the evaluation of preparations dangerous for the ozone layer The following preparations shall be classified as dangerous for the environment


1.1. and assigned the symbol N, the indication of danger and the risk phrase R59: Dangerous for the ozone layer:

1.1.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase (N)R59 in individual concentration equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration; or

(b) the concentration specified in Part B of this Annex (Table V) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.1.2. preparations containing more than one substance classified as dangerous for the environment and to which is assigned phrase (N)R59 in individual concentrations not exceeding the limits specified under 1.1.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PN,R59 = the percentage by weight or by volume of each substance dangerous for the environment to which is assigned phrase (N)R59 in the preparation,

LN,R59 = the limit (N)R59 for each substance dangerous for the environment to which is assigned phrase (N)R59, expressed as percentage by weight or by volume;

62.

1.2. and assigned the risk phrase R59: Dangerous for the ozone layer


1.2.1. preparations containing one or more substances classified as dangerous to the environment and to which is assigned phrase (N)R59 or R59 in individual concentrations equal to or greater than:

(a) either the concentration specified in Annex I to Directive 67/548/EEC for the substance or substances under consideration, or

(b) the concentration specified in Part B of this Annex (Table V) where the substance or substances do not appear in Annex I to Directive 67/548/EEC or appear in it without concentration limits;

1.2.2. preparations containing more than one of the substances classified as dangerous for the environment and to which is assigned phrase (N)R59 or R59 in individual concentrations not exceeding the limits specified under 1.2.1 (a) or (b) if:

>REFERENCE TO A FILM>

where:

PN,R59 = the percentage by weight or by volume of each substance dangerous for the environment to which is assigned phrase (N)R59 in the preparation,

PR59 = the percentage by weight or by volume of each substance dangerous for the environment to which is assigned phrase R59 in the preparation,

LR59 = the respective limit R59 for each substance dangerous for the environment to which is assigned phrase (N)R59 or R59, expressed as percentage by weight or by volume.

(b2) Terrestrial environment

63.

1. Evaluation of preparations dangerous for the terrestrial environment


Classification of preparations using the risk phrases below will follow after the detailed criteria for use of the phrases have been incorporated in Annex VI to Directive 67/548/EEC.

R54 toxic to flora,

R55 toxic to fauna,

R56 toxic to soil organisms,

R57 toxic to bees,

R58 may cause long-term adverse effects in the environment.

64.

PART B


Table of concentration limits

I. For the aquatic environment

The concentration limits fixed in the following tables, 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>

>TABLE>

>TABLE>

>TABLE>

65.

II. For the non-aquatic environment


The concentration limits fixed in the following table expressed as weight/weight percentage or, for gaseous preparations as a volume/volume percentage, determine the classification of the preparation in relation to the individual concentration of the substance(s) present whose classification is also shown.

>TABLE>

66.

PART C


Test methods for the evaluation of the hazards for the aquatic environment

Normally, the classification of a preparation is made on the basis of the conventional method. However, for the determination of the acute aquatic toxicity, there may be cases for which it is appropriate to carry out tests on the preparation.

The result of these tests on the preparation may only modify the classification concerning acute aquatic toxicity which would have been obtained by the application of the conventional method.

If such tests are chosen by the person responsible for the placing on the market, it must be ensured that the quality criteria of the test methods in Part C of Annex V to Directive 67/548/EEC have been complied with.

Furthermore, the tests shall be carried out on the three species in conformity with the criteria of Annex VI to Directive 67/548/EEC (algae, daphnia and fish), unless the highest hazard classification relating to acute aquatic toxicity has been assigned to the preparation after testing on one of the species.

67.

PART D


Indications concerning special risks (R phrases)

Preparations classified as dangerous for the environment within the meaning of Article 7 and in accordance with the provisions of Annex III A, B and C shall be assigned the following risk phrases in accordance with the table below.

>TABLE>

68.

PART E


Indications concerning safety advice (S phrases)

Preparations classified as dangerous for the environment within the meaning of Article 7 and in accordance with the provisions of Annex III A, B and C shall be assigned the following safety advice.

69.

'Follow the manufacturer's instructions regarding use and disposal`


The following S phrases must also be taken into consideration:

70.

S56 Dispose this product and its container to a dangerous or special waste collection point


- Applicability:

preparations which are dangerous for the environment.

- Criteria for use:

recommended for preparations to which the symbol N has been assigned and which are likely to be used by the general public.

71.

S57 Use appropriate containment to avoid environmental contamination


- Applicability:

preparations to which the symbol N has been assigned.

- Criteria for use:

normally limited to preparations not likely to be used by the general public.

72.

S59 Refer to manufacturer/supplier on information on recovery/recycling


- Applicability:

preparations which are dangerous for the environment.

- Criteria for use:

- obligatory for substances dangerous for the ozone layer,

- recommended for preparations to which the symbol N has been assigned and for which recovery/recycling is recommended.

73.

S60 This material and/or its container must be disposed of as a hazardous waste


- Applicability:

preparations which are dangerous for the environment.

- Criteria for use:

recommended for preparations to which the symbol N has been assigned which are not likely to be used by the general public.

S61 Avoid discharge into the environment: consult the special instructions, safety data sheets - Applicability:

preparations which are dangerous for the environment.

- Criteria for use:

- normally used for preparations for which the symbol N has been assigned,

- recommended for all preparations classified as dangerous for the environment not covered above.


74.

ANNEX IV


SPECIAL PROVISIONS FOR CONTAINERS CONTAINING PREPARATIONS OFFERED OR SOLD TO THE GENERAL PUBLIC

PART A

Containers to be fitted with child-resistant fastenings

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, shall be fitted with child-resistant fastenings.

2. Containers of whatever capacity, containing liquid preparations having a cinematic viscosity measured by rotative viscosity in accordance with ISO 3219 (edition of 15 December 1977) of less than 7 x 10-6m2/sec at 40 °C and containing aliphatic and/or aromatic hydrocarbons in a total concentration equal to or greater than 10 % with the exception of preparations placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment, which are offered or sold to the general public shall be fitted with child-resistant fastening.

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

>TABLE>

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

75.

PART B


Containers to be fitted with a tactile warning of danger

Containers of whatever capacity, containing preparations offered or sold to the general public and labelled as very toxic, toxic, corrosive, harmful, extremely flammable or highly flammable in accordance with Article 10 and under the conditions laid down in Articles 5 and 6 of this Directive, shall carry a tactile warning of danger.


76.

ANNEX V


SPECIAL PROVISIONS CONCERNING THE LABELLING OF CERTAIN PREPARATIONS A. For preparations classified as dangerous within the meaning of Articles 5, 6 and 7 1. Preparations sold to the general public

1.1. The labels on packages 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.

77.

2. Preparations intended for use by spraying


The package label containing such preparations must compulsorily bear the safety advice S23 accompanied by safety advice S38 or S51 assigned to it in accordance with the criteria laid down in Annex VI to Directive 67/548/EEC.

3. Preparations containing a substance assigned phrase R33: Danger of cumulative effects When a preparation contains at least one substance assigned the phrase R33, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Annex I to Directive 67/548/EEC.

4. Preparations containing a substance assigned phrase R64: May cause harm to breastfed babies When a preparation contains at least one substance assigned phrase R64, the label of the preparation must carry the wording of this phrase as set out in Annex III to Directive 67/548/EEC, when the concentration of this substance present in the preparation is equal to or higher than 1 %, unless different values are set in Annex I to Directive 67/548/EEC.

78.

B. For preparations irrespective of their classification within the meaning of Articles 5, 6 and 7


79.

1. Preparations containing lead


80.

1.1. Paint and varnishes


Labels of packages of paints and varnishes containing lead in quantities exceeding 0,15 % (expressed as weight of metal) of the total weight of the preparation, as determined in accordance with ISO standard 6503/1984, must show the following particulars:

'Contains lead. Should not be used on surfaces liable to be chewed or sucked by children.` In the case of packages the contents of which are less than 12,5 millilitres, the particulars may be as follows:

81.

'Warning. Contains lead.`


82.

2. Preparations containing cyanoacrylates


83.

2.1. Adhesives


The immediate packaging of adhesives based on cyanoacrylate must bear the following inscriptions:

'Cyanoacrylate.

Danger.

Bonds skin and eyes in seconds.

84.

Keep out of the reach of children.`


Appropriate advice on safety must accompany the package.

85.

3. Preparations containing isocyanates


The package labels of preparations containing isocyanates (as monomers, oligomers, prepolymers, etc., or as mixtures thereof) must bear the following inscriptions:

'Contains isocyanates.

86.

See information supplied by the manufacturer.`


4. Preparations containing epoxy constituents with an average molecular weight <= 700 The package labels of preparations containing epoxy constituents with an average molecular weight <= 700 must bear the following inscriptions:

'Contains epoxy constituents.

87.

See information supplied by the manufacturer.`


88.

5. Preparations sold to the general public which contain active chlorine


The packaging of preparations containing more than 1 % of active chlorine must bear the following particular inscriptions:

'Warning! Do not use together with other products. May release dangerous gases (chlorine).`

6. Preparations containing cadmium (alloys) and intended to be used for brazing or soldering The packaging of the abovementioned preparations must bear the following inscription printed in clearly legible and indelible characters:

'Warning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

89.

Comply with the safety instructions.`


90.

7. Preparations available as aerosols


Without prejudice to the provisions of this Directive, preparations available as aerosols are also subject to the labelling provisions in accordance with points 2.2 and 2.3 of the Annex to Directive 75/324/EEC as last amended by Directive 94/1/EC.

91.

8. Preparations containing substances not yet tested completely


Where a preparation contains at least one substance which, in accordance with Article 13 (3) of Directive 67/548/EEC, bears the inscription 'Warning - substance not yet tested completely`, the label of the preparation must bear the inscription 'Warning - this preparation contains a substance not yet tested completely` if this substance is present in a concentration >= 1 %.

92.

C. For preparations not classified within the meaning of Articles 5, 6 and 7 but containing at least one dangerous substance


93.

1. Preparations containing at least one dangerous substance but not classified within the meaning of Articles 5, 6 and 7


The label on the packaging of preparations containing at least one substance classified as sensitizing and accompanied by a specific note under Annex I to Directive 67/548/EEC must bear the inscription:

'Contains 'name of sensitizing substance'. May produce an allergic reaction in persons already sensitized.`

94.

2. Preparations not intended for the general public


The label on the packaging of the preparations referred to in Article 16 (2) must bear the following inscription:

95.

'Safety data sheet available on request.`



ANNEX VI

REQUEST FOR CONFIDENTIALITY FOR THE CHEMICAL IDENTITY OF A HARMFUL SUBSTANCE PRESENTING ONLY ACUTE LETHAL EFFECTS

PART A

Information to be communicated in the request for confidentiality

Introductory notes

A. Article 10 paragraph 2.3.4 indicates the conditions in which the person responsible for placing a preparation on the market may avail himself of the confidentiality request, namely:

- the substance whose chemical identity he wishes to protect must be classified only harmful on the basis of its acute lethal effects (Xn, R20, R21, R23) possibly in combination with one or more of the properties referred to in Article 10 paragraph 2.3.4 of this Directive.

- the person responsible for placing the preparation on the market must demonstrate that the disclosure of the chemical identity of a harmful substance on the label of a preparation will put at risk the confidential nature of his property.

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:

- the same dangerous constituents present in the same concentration range,

- the same classification and labelling,

- the same expected uses.

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.

96.

Request for confidentiality


In accordance with Article 11, the request for confidentiality must obligatorily contain the following information:

97.

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)


98.

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


>TABLE>

99.

3. Justification for confidentiality (probability - plausibility)


100.

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


101.

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


YES NO

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

Austria:

Belgium:

Denmark:

Germany:

Greece:

Finland:

France:

Ireland:

Italy:

Luxembourg:

Netherlands:

Portugal:

Spain:

Sweden:

United Kingdom:

102.

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


103.

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


104.

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


105.

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.

106.

PART B


Lexicon guide for establishing the alternative designations (generic names)

107.

1. Introductory note


The lexicon guide is based on the procedure for the classification of dangerous substances (division of substances into families) which appears in Annex I to Directive 67/548/EEC.

The families are defined in the following manner:

- 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.

The family name is derived from the functional group name.

These families are identified by the conventional number found in Annex I (601 to 650).

Sub-families bringing together substances with a common specific character have been added in certain cases.

108.

2. Establishing the generic name


General principles

For the purposes of establishing the generic name, the following general approach, involving two successive stages, is adopted:

- identification of the functional groups and chemical elements present in the molecule,

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

The identified functional groups and elements taken into account are the names of the families and sub-families set out in point 3 below in the form of a non-restrictive list.

109.

3. Division of substances into families and sub-families


>TABLE>

110.

Practical application


After having conducted a search to see if the substance belongs to one or more families or sub-families on this list, the generic name can be established in the following way:

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

Examples:

- 1,4 dihydroxybenzen

family 604: phenols and derivatives

generic name: phenol derivatives

- butanol

family 603: alcohols and derivatives

sub-family: aliphatic alcohols

generic name: aliphatic alcohol

- 2-Isopropoxyethanol

family 603: alcohols and derivatives

sub-family: glycolethers

generic name: glycolether

- methacrylate

family 607: organic acids and derivatives

sub-family: acrylates

generic name: acrylate

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

Examples:

- chlorobenzene

family 602: halogenated hydrocarbons

sub-family: halogenated aromatic hydrocarbons

family 017: chlorine compounds

generic name: chlorinated aromatic hydrocarbon

- 2,3,6-trichlorophenylacetic acid

family 607: organic acids

sub-family: halogenated aromatic acids

family 017: chlorine compounds

generic name: chlorinated aromatic acid

- 1-chloro-1-nitropropane

family 610: chlorinitrated derivatives

family 601: hydrocarbons

sub-family: aliphatic hydrocarbons

generic name: chlorinated aliphatic hydrocarbon

- tetrapropyl dithiopyrophosphate

family 015: phosphorus compounds

sub-family: phosphoric esters

family: 016: sulphur compounds

generic name: triophosphoric ester

N.B.:

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:

- dimercury chloride

family 080: mercury compounds

generic name: inorganic mercury compound

- barium acetate

family 056: barium compounds

generic name: organic barium compound

- ethyl nitrite

family 007: nitrogen compounds

sub-family: nitrites

generic name: organic nitrite

- sodium hydrosulphite

family 016: sulphur compounds

generic name: inorganic sulphur compound

(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).


111.

ANNEX VII


PREPARATIONS COVERED BY ARTICLE 14 (2)

Examples of preparations classified within the meaning of Article 6:

- Alloys

- Preparations containing polymers

- Preparations containing elastomers


ANNEX VIII

PART A

REPEATED DIRECTIVES IN ACCORDANCE WITH ARTICLE 22

- Directive 78/361/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 law of the Member States relating to the classification, packaging and labelling of dangerous preparations and its following adaptations to technical progress:

- Directive 89/178/EEC

- Directive 90/492/EEC

- Directive 93/18/EEC

- 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

PART B

Deadlines for transposition and for application in accordance with Article 22

>TABLE>


112.

ANNEX IX


>TABLE>

>TABLE>