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))
Date: 1997-06-26
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: approximation of laws, classification, dangerous substance, labelling, packaging product













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51997AP0186

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))  


Official Journal C 222 , 21/07/1997 P. 0026 





A4-0186/97Proposal 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)>Text following EP vote>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)>Original text>1. This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States concerning:>Text following EP vote>1. This Directive aims at the approximation of the laws, regulations and administrative provisions of the Member States concerning:>Original text>- the classification, packaging and labelling of dangerous preparations,>Text following EP vote>- the classification, packaging and labelling of dangerous preparations,>Original text>- 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.>Text following EP vote>- 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)>Original text>3. The specific provisions set out:>Text following EP vote>3. The specific provisions set out:>Original text>- in Article 9 and defined in Annex IV,>Text following EP vote>- in Article 9 and defined in Annex IV,>Original text>- in Article 10 and defined in Annex V, and>Text following EP vote>- in Article 10 and defined in Annex V, and>Original text>- in Article 16>Text following EP vote>- in Article 16>Original text>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.>Text following EP vote>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)>Original text>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.>Text following EP vote>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)>Original text>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.>Text following EP vote>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>Original text>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.>Text following EP vote>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.>Original text>Furthermore, where it can be demonstrated that:>Text following EP vote>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)>Text following EP vote>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.)>Original text>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.>Text following EP vote>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.)>Original text>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.>Text following EP vote>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>Original text>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.>Text following EP vote>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.>Original text>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.>Text following EP vote>See amendment 13>Original text>The name of the substances which have given rise to the classification of the preparation in one or more of the following danger categories:>Text following EP vote>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:>Original text>- 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>Text following EP vote>- 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>Original text>shall be mentioned on the label.>Text following EP vote>shall be mentioned on the label.(Amendment 12)Article 10(2.3.4.)>Original text>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:>Text following EP vote>2. 3.4. The name of a substance which led to the classification of the preparation in the following dangerous categories:>Original text>- explosive- oxidizing- extremely flammable- highly inflammable- flammable- irritant- dangerous for the environment>Text following EP vote>- explosive- oxidizing- extremely flammable- highly inflammable- flammable>Original text>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.;>Text following EP vote>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)>Original text>See amendment 11>Text following EP vote>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>Original text>- 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);>Text following EP vote>- 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)>Original text>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.>Text following EP vote>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>Text following EP vote>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>Original text>- one substance posing health hazards, or>Text following EP vote>- one substance posing hazards to health or to the environment, or(Amendment 17)Article 20a (new)>Text following EP vote>Article 20aThe Commission shall be assisted by a committee composed of one representative per Member State and chaired by the representative of the Commission.>Text following EP vote>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.>Text following EP vote>The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.>Text following EP vote>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.>Text following EP vote>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)>Text following EP vote>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.>Text following EP vote>Part B gives the concentration limits to be used when applying the conventional method and the relevant symbols and R phrases for classification.>Text following EP vote>Part C gives the test methods for the evaluation of the hazards for the aquatic environment.>Text following EP vote>Part D gives the R phrases to use on the label.>Text following EP vote>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>Original text>concentration > 0,5%>Text following EP vote>concentration > 0,1%(Amendment 20)ANNEX III, Part C, 4th paragraph>Original text>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.>Text following EP vote>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)>Text following EP vote>This provision shall not apply to aerosols classified and labelled only as extremely flammable or highly flammable.(Amendment 22)ANNEX V, Part C(1)>Original text>1. Preparations containing at least one dangerous substance but not classified within the meaning of Articles 5, 6 and 7.>Text following EP vote>1. Preparations containing at least one dangerous substance but not classified within the meaning of Articles 5, 6 and 7.>Original text>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:>Text following EP vote>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:>Original text>'Contains 'name of sensitizing substance'. May produce an allergic reaction in persons already sensitized">Text following EP vote>'Contains 'name of sensitizing substance'". May produce an allergic reaction.(Amendment 24)ANNEX V, Part C(2)>Original text>2. Preparations not intended for the general public.>Text following EP vote>2. Preparations not intended for the general public.>Original text>The label on the packaging of the preparations referred to in Article 16.2 must bear the following inscription:>Text following EP vote>The label on the packaging of the preparations referred to in Article 16.2 must bear the following inscription:>Original text>'Safety data sheet available on request'>Text following EP vote>'Contains low concentrations of substances hazardous to health. Safety data sheet available on request.'(Amendment 25)ANNEX V, Part Ca (new)>Text following EP vote>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)>Text following EP vote>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)>Text following EP vote>- Directive 96/65/ECLegislative 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.