A4-0186/97

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 - C4-0426/96 - 96/0200(COD))

The proposal was approved with the following amendments:

(Amendment 1)

Recital 13a (new)

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Whereas the Commission will, on the basis of information to be supplied by the Member States and the various parties concerned, submit a report to the European Parliament and the Council within two years of the entry into force of this Directive on experience with the present overall approach to labelling of dangerous preparations and in particular on its understanding and application by users, experience with publicity campaigns and educational and training programmes; whereas on the basis of this report the Commission will, if appropriate, submit the necessary proposals;

(Amendment 2)

Article 1(1)

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

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

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- the classification, packaging and labelling of dangerous preparations,

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- the classification, packaging and labelling of dangerous preparations,

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- 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.

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- specific provisions for certain preparations which may present hazards, whether or not they are classified as dangerous within the meaning of this Directive,

when such preparations are placed on the market of the Member States.

(Amendment 3)

Article 1(3)

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3. The specific provisions set out:

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3. The specific provisions set out:

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- in Article 9 and defined in Annex IV,

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- in Article 9 and defined in Annex IV,

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- in Article 10 and defined in Annex V, and

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- in Article 10 and defined in Annex V, and

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- in Article 16

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- in Article 16

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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.

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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 specific hazard to the user.

(Amendment 4)

Article 3(3)

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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.

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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 normally be taken into consideration when their concentrations are equal to or greater than those defined in the following table, or when a lower value is given in Annex I to Directive 67/548/EEC. When several very toxic substances are contained in a preparation, they must be taken into account in the classification of the preparation if they, while individually not reaching the concentrations shown in the table below or contained in Annex I to Directive 67/548/EEC, in total reach the concentration laid down in the table. The same shall apply when a preparation contains low concentrations of several corrosive substances which, however, in total reach the concentration laid down in the following table.

(Amendment 5)

Article 4(2)

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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.

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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, 7 or 10 and the corresponding Annexes of this Directive are applied.

(Amendment 6)

Article 6(3), subparagraphs 1, 2, 3, 4, introduction

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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 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) above 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 effects and toxic effects for reproduction for which only the conventional method described in Annex II applies.

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3. When the methods 1(b) and 2(b) provide for tests on animals, they may be carried out and/or used for classification only if the toxicological properties of a preparation cannot be established in any other way, for example on the basis of the conventional method or validated alternative method not using tests on animals. The tests in question 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. Only the conventional method described in Annex II shall be used to assess carcinogenic and mutagenic effects and toxic effects for reproduction.

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Furthermore, where it can be demonstrated that:

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Furthermore, where it can be demonstrated by statistically-backed experience, such as the assessment of data from poison information units, that:

(Amendment 7)

Article 9, 2nd paragraph (new)

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Preparations shall be deemed to satisfy the requirements of point 1, first to third indents, if their packaging complies with the requirements for carriage by rail, road, inland waterway, sea or air.

(Amendment 8)

Article 10(2.3.1.)

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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 of this Directive have to be taken into consideration.

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2. 3.1. for preparations classified T+, T, Xn in accordance with Article 6, only the substances T+, T, Xn present in concentrations individually or in total 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 of this Directive have to be taken into consideration.

(Amendment 9)

Article 10(2.3.2.)

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2. 3.2. for preparations classified C in accordance with Article 6, only the substances C present in concentration equal to or greater than the lowest limit (limit Xi) laid down in Annex I of Directive 67/548/EEC, or, failing that, Annex II B of this Directive have to be taken into consideration.

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2. 3.2. for preparations classified C in accordance with Article 6, only the substances C present in concentration individually or in total equal to or greater than the lowest limit (limit Xi) laid down in Annex I of Directive 67/548/EEC, or, failing that, Annex II B of this Directive have to be taken into consideration.

(Amendment 11)

Article 10(2.3.3.), subparagraphs 1 to 3

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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 of this Directive have to be taken into consideration.

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2. 3.3. for preparations classified as sensitizing in accordance with Article 6, only the sensitizing substances present in concentrations individually or in total equal to or greater than their respective limits laid down in Annex I to Directive 67/548/EEC or, failing that, Annex II B of this Directive have to be taken into consideration.

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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.

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See amendment 13

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

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The names of all the substances (even if more than four in number) which have given rise or contributed to the classification of the preparation in one or more of the following danger categories:

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- 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

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- 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

- corrosive

- irritant

- dangerous for the environment

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shall be mentioned on the label.

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shall be mentioned on the label.

(Amendment 12)

Article 10(2.3.4.)

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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 dangerous categories:

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2. 3.4. The name of a substance which led to the classification of the preparation in the following dangerous categories:

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- explosive

- oxidizing

- extremely flammable

- highly inflammable

- flammable

- irritant

- dangerous for the environment

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- explosive

- oxidizing

- extremely flammable

- highly inflammable

- flammable

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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.;

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need not be mentioned on the label unless the substance has already to be mentioned pursuant to 2.3.1. to 2.3.3.;

(Amendment 13)

Article 10(2.3.4a) (new)

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See amendment 11

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2. 3.4a. as a general rule a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards if they gave 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 if only to designate the health hazards.

(Amendment 14)

Article 10(4), first indent

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

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

(Amendment 15)

Article 10(5)

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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.

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5. Information such as 'non-toxic', 'non-harmful', 'environmentally- friendly', 'eco' or any other statement indicating that the preparation is not dangerous or which might lead to an underestimation of the hazards of such preparations must not appear on the packaging or labelling of the preparations subject to this Directive.

(Amendment 16)

Article 15, new first paragraph

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If a preparation is advertised on television, radio, in the printed media, on posters, by mail shots or other marketing methods, there must be a clear reference to every hazardous property of the preparation as mentioned in Articles 5, 6 and 7 of this Directive.

(Amendment 40)

Article 16(2), first indent

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- one substance posing health hazards, or

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- one substance posing hazards to health or to the environment, or

(Amendment 17)

Article 20a (new)

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Article 20a

The Commission shall be assisted by a committee composed of one representative per Member State and chaired by the representative of the Commission.

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The representative of the Commission shall submit to the Committee a draft of the general measures to be taken. The Committee shall deliver its opinion on the draft within a time limit to be determined by the chairman according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

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The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

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If the measures envisaged are not in accordance with the opinion of the Committee, of if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

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If, within three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

(Amendment 19)

ANNEX III, Introduction, paragraphs 1a to 1e (new)

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Part A gives the calculation procedure according to Article 7(1)(a) and 7(2)(a) and gives the R phrases to be assigned to the classification of the preparation.

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Part B gives the concentration limits to be used when applying the conventional method and the relevant symbols and R phrases for classification.

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Part C gives the test methods for the evaluation of the hazards for the aquatic environment.

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Part D gives the R phrases to use on the label.

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Part E gives the indications concerning safety advice to put on the label.

(Amendment 18)

ANNEX III, Part B, Table V, second column, first line

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concentration > 0,5%

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concentration > 0,1%

(Amendment 20)

ANNEX III, Part C, 4th paragraph

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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.

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Furthermore, the tests shall be carried out on all 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, or unless a test result was already available before this Directive came into force.

(Amendment 21)

ANNEX IV, Part B, 2nd paragraph (new)

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This provision shall not apply to aerosols classified and labelled only as extremely flammable or highly flammable.

(Amendment 22)

ANNEX V, Part C(1)

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

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

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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:

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The label on the packaging of preparations containing at least one substance classified as sensitizing and mentioned in Annex I to Directive 67/548/EEC must bear the inscription:

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

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'Contains 'name of sensitizing substance'". May produce an allergic reaction.

(Amendment 24)

ANNEX V, Part C(2)

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2. Preparations not intended for the general public.

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2. Preparations not intended for the general public.

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The label on the packaging of the preparations referred to in Article 16.2 must bear the following inscription:

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The label on the packaging of the preparations referred to in Article 16.2 must bear the following inscription:

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'Safety data sheet available on request'

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'Contains low concentrations of substances hazardous to health. Safety data sheet available on request.'

(Amendment 25)

ANNEX V, Part Ca (new)

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Ca. Special provisions for preparations placed on the market solely as authorized plant protection products pursuant to Directive 91/414/EEC.

(Amendment 26)

ANNEX V, Part Cb (new)

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Cb. Special provisions for preparations placed on the market solely as authorized biocides pursuant to Directive ...

(Amendment 27)

ANNEX VIII, Part A, 2nd indent, 3rd subindent a (new)

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- Directive 96/65/EC

Legislative resolution embodying Parliament's opinion on the 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 - C4-0426/96 - 96/0200(COD))

(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal to Parliament and the Council, COM(96)0347 - 96/0200(COD) ((OJ C 283, 26.9.1996, p. 1.)),

- having regard to Articles 189b(2) and 100a of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C4-0426/96),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinion of the Committee on Budgets (A4- 0186/97),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to incorporate Parliament's amendments in the common position that it adopts in accordance with Article 189b(2) of the EC Treaty;

4. Points out that the Commission is required to submit to Parliament any modification it may intend to make to its proposal as amended by Parliament;

5. Instructs its President to forward this opinion to the Council and Commission.