A4-0056/96

Proposal and amended proposal for a European Parliament and Council Directive on the placing of biocidal products on the market (COM(93)0351 - C3-0285/93 and COM(95)0387 - C4-0311/95 - 00/0465(COD))

The proposal was approved with the following amendments:

(Amendment 1)

Recital 12a (new)

>Text following EP vote>

Whereas current scientific data show that there are carcinogens for which no safety threshold can be defined (genotoxic carcinogens and specific non- genotoxic carcinogens); whereas there is no point in defining such a threshold for non-specific non-genotoxic carcinogens;

(Amendment 2)

Recital 13

>Original text>

Whereas it is necessary, at the time when biocidal products are authorized, to make sure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on their target species (i.e. they do not cause undesirable resistance and in the case of vertebrate animals unnecessary suffering), and have in the light of current scientific and technical knowledge no unacceptable adverse influence on the environment and, in particular, no harmful effect on human or animal health;

>Text following EP vote>

Whereas it is necessary, at the time when biocidal products are authorized, to make sure that, when properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on their target species (i.e. they do not cause undesirable resistance and in the case of vertebrate animals unnecessary suffering), and have in the light of current scientific and technical knowledge no unacceptable adverse influence on the environment and, in particular, no harmful effect on human or animal health; whereas there is a need for close coordination with other Community legislation, in particular the Directives on the protection of water 75/440/EEC1, 76/464/EEC2 and 80/68/EEC3 the drinking water Directive 80/778/EEC4, the Directives on the continued use and release into the environment of genetically modified organisms 90/219/EEC5 and 90/220/EEC6 and Directive 91/414/EEC on the placing of plant protection products on the market;

>Text following EP vote>

______________________

1 OJ L 194, 25.7.1975, p. 36.

2 OJ L 129, 18.5.1976, p. 23.

3 OJ L 20, 26.1.1980, p. 43.

4 OJ L 229, 30.8.1980, p. 11.

5 OJ L 117, 8.5.1990, p. 1.

6 OJ L 117, 8.5.1990, p. 15.

(Amendments 3 and 92)

Recital 19

>Original text>

Whereas Member States must be able to authorize biocidal products not complying with the above-mentioned conditions for a limited period of time, especially in case of an unforseen danger threatening man or the environment which cannot be contained by other means; whereas such authorization should be reviewed by the Commission in close cooperation with the Member States; whereas the Community procedure should not prevent Member States from authorizing for use in their territory for a limited period of time biocidal products containing an active substance not yet entered in the Community list, provided that a dossier meeting community requirements has been submitted and the Member State believes that the active substance and the biocidal products satisfy the Community conditions set in regard to them;

>Text following EP vote>

Whereas Member States must be able to authorize biocidal products not complying with the above-mentioned conditions for a limited period of time, especially in case of an unforseen danger threatening man or the environment which cannot be contained by other means, i.e. in cases where the requisite safety for man and the environment cannot be achieved by other means or with the aid of the products listed in Annex V of this Directive; whereas such authorization must accord with the principles laid down in Point 61 of Annex VI to this Directive and should be reviewed by the Commission in close cooperation with the Member States; whereas the Community procedure should not prevent Member States from authorizing for use in their territory for a limited period of time biocidal products containing an active substance not yet entered in the Community list, provided that a dossier meeting community requirements has been submitted and the Member State believes that the active substance and the biocidal products satisfy the Community conditions set in regard to them;

(Amendment 4)

Recital 19a (new)

>Text following EP vote>

Whereas the levying of green taxes in either the Union or its Member States could help limit and bring about change in the use of biocides;

(Amendment 5)

Recital 20a (new)

>Text following EP vote>

Whereas it is essential that this Directive helps to reduce the number of tests on animals, that the annexes are revised as satisfactory alternative methods of testing become available, that testing should be made dependent on the purpose and use of a product and that tests on animals can be conducted only if basic research shows it to be necessary;

(Amendment 6)

Recital 20b (new)

>Text following EP vote>

Whereas the Commission is to draw up technical notes for guidance on the implementation of Annex VI;

(Amendment 7)

Recital 23a (new)

>Text following EP vote>

Whereas Member States may, on the basis of environmental and health-related considerations, implement action plans aimed at reducing the use of biocidal products;

(Amendment 8)

Recital 24

>Original text>

Whereas the Council in its resolution of 1 February 19931 on a Community programme of policy and action in relation to the environment and sustainable development has approved the general approach and the strategy of the programme presented by the Commission which states that economic growth and environment quality must be viewed as mutually dependent; whereas therefore the strengthening of environmental protection requires the maintenance of the economic competitiveness of industry;

>Text following EP vote>

Deleted

>Original text>

1 OJ C 138, 17.5.1993, p. 1.

(Amendment 9)

Article 1(2)(aa) and (ab) (new) and (b)

>Text following EP vote>

(aa) Council Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products;1

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(ab) Council Directive 90/677/EEC on extending the scope of Directive 81/851/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products and laying down additional provisions for immunological veterinary medicinal products2;

>Original text>

(b) Council Directives 70/524/EEC and 82/471/EEC on additives and substances for exclusive use in animal feedingstuffs;

>Text following EP vote>

(b) Council Directives 70/524/EEC and 82/471/EEC on additives and substances for exclusive use in animal feedingstuffs and Directive 77/101/EEC3 on the marketing of straight feedingstuffs;

>Text following EP vote>

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1 OJ L 317, 6.11.1981, p. 82.

2 OJ L 373, 31.12.1990, p. 26.

3 OJ L 32, 3.2.1977, p. 1.

(Amendment 10)

Article 1(2)(fa) and (fb) (new)

>Text following EP vote>

(fa) Council Directive 90/385/EEC on the approximation of the laws of the Member States on active implantable medicinal devices1,

>Text following EP vote>

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1 OJ L 189, 20.7.1990, p. 17.

>Text following EP vote>

(fb) Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs2 and subsequent follow-up Directives.

>Text following EP vote>

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2 OJ L 40, 11.2.1989, p. 38.

(Amendment 11)

Article 1(3)(ea) (new)

>Text following EP vote>

(ea) Council Directive 84/450/EEC on the approximation of the laws, regulations or administrative provisions of the Member States relating to misleading advertising1.

>Text following EP vote>

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1 OJ L 250, 19.9.1984, p. 17.

(Amendment 12)

Article 2(1)(c)

>Original text>

(c) harmful organism

any organism which has an unwanted presence or a detrimental effect for man, his activities or the products he uses or produces, or for animals or for the environment;

>Text following EP vote>

(c) harmful organism

any organism which has a detrimental effect for man, his activities or the products he uses or produces, or for animals or for the environment;

(Amendment 13)

Article 2(1)(d)

>Original text>

(d) placing on the market

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(d) placing on the market

>Original text>

any supply, whether in return for payment or free of charge, other than for storage followed by consignment from the territory of the Community or disposal. Importation of a biocidal product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive;

>Text following EP vote>

any supply, whether in return for payment or free of charge. Importation of a biocidal product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive;

(Amendment 14)

Article 2(1)(ea) (new)

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(ea) framework formulations

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a group of biocidal products for the same purpose and the same user type. This product group must contain the same active ingredients, and its compositions may display only such differences, compared with a biocidal product authorized in the past, which have no effect on the associated risk and which do not impair effectiveness.

>Text following EP vote>

In this context a difference is deemed to be a lower percentage proportion of the active substance and/or a change in the percentage composition of one or more inactive substances and/or the replacement of one or more pigment, dyestuffs or aromatic agent with other substances with the same or a lower risk;

(Amendment 15)

Article 3(1)

>Original text>

1. Member States shall prescribe that a biocidal product shall not be placed on the market and used in their territory unless it has been authorized in accordance with this Directive.

>Text following EP vote>

1. Member States shall prescribe that a biocidal product shall not be placed on the market and used in their territory unless it has been authorized in accordance with this Directive. Member States shall establish control mechanisms to ensure that products containing biocidal products shall not be imported into, placed on the market or used in their territory unless the biocidal products used comply with the requirements of this Directive.

(Amendment 17)

Article 3(2)

>Original text>

2. Every application for authorization shall be decided upon within a reasonable period.

>Text following EP vote>

2. Every application for authorization shall be decided upon without undue delay.

(Amendment 18)

Article 3(3)

>Original text>

3. A biocidal product that has already been authorized in one Member state shall be authorized, in another Member State within 60 days of an application being received by the other Member State, providing that the active substance of the biocidal product conforms to the entry in Annex I.

>Text following EP vote>

3. Notwithstanding Articles 7 and 11, in cases where an application for authorization is made for a biocidal product based on a framework formulation, a decision shall be taken within 60 days.

(Amendment 19)

Article 3(4)

>Original text>

4. If in complying with Article 4 a Member State establishes that:

>Text following EP vote>

Deleted

>Original text>

(a) unacceptable resistance of the target organism to the biocidal product is proven or

>Original text>

(b) the relevant circumstances of use, such as climate or breeding period of the target species, differ significantly from those in the Member State where the biocidal product was first authorized, and an unchanged authorization may therefore present unacceptable risks to man or the environment,

>Original text>

the Member State may request that the directions for use and the dose rate referred to in Article 18(3)(e) are adjusted to the different circumstances or, if the risk cannot be prevented in any other way, the Member State may request changes to be made to the biocidal product itself so that conditions for issue of an authorization provided for in Article 4 are satisfied.

(Amendment 20)

Article 3(4a) and (4b)(new) and (5), 1st subparagraph

>Text following EP vote>

4a. Notwithstanding Article 11, a biocidal product which is already authorized in one Member State shall be authorized in another Member State within 60 days of receipt of application and sufficient documentation, if the active substance of the biocidal product is listed in Annex I and conforms to the requirements thereof. The application shall be accompanied by a summary of the dossiers pursuant to Article 7(2) (a) and Annex III, (X), and a certified copy of the authorisation.

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4b. If a Member State establishes pursuant to Article 4 that

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(a) the target species can be assured not to occur on its territory

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(b) unacceptable resistance of the target organism to the biocidal product is proven or

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(c) the relevant circumstances of use, such as climate or breeding period of the target species, differ significantly from those in the Member State where the biocidal product was first authorized, and an unchanged authorization may therefore present unacceptable risks to man or the environment,

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the Member State may request that specific requirements referred to in Article 18(3)(e), (h), (j) and (l) are adjusted to the different circumstances so that conditions for issue of an authorization provided for in Article 4 are satisfied.

>Text following EP vote>

The authorization may include requirements based on the implementation of other measures pursuant to Community law which are concerned with the sale and application of the biocidal products, taking into account protection of the health of the relevant sales enterprise, users and workers.

>Original text>

5. Notwithstanding paragraph 4 where a Member State believes a biocidal product cannot meet the conditions set out under Article 4 and consequently proposes to refuse authorization, it shall notify the Commission, other Member States and the applicant and shall provide them with an explanatory document giving details of the product and setting out the grounds on which it proposes to refuse the authorization.

>Text following EP vote>

5. Notwithstanding the provisions of the previous paragraph, where a Member State believes a biocidal product cannot meet the conditions set out under Article 4 and consequently proposes to refuse authorization, it shall notify the Commission, other Member States and the applicant and shall provide them with an explanatory document giving details of the product and setting out the grounds on which it proposes to refuse the authorization.

(Amendment 21)

Article 4(1)(b) (iii) and (iv)

>Original text>

(iii) has no harmful effects itself or as a result of its residues, on human or animal health, directly or indirectly (e.g. through drinking water, food or feed) or on groundwater;

>Text following EP vote>

(iii) has no harmful effects itself or as a result of its residues, on human or animal health, directly or indirectly (e.g. through air, drinking water, food or feed) or on groundwater and surface water;

>Original text>

(iv) has no unacceptable effect on the environment having particular regard to the following considerations:

>Text following EP vote>

(iv) has no unacceptable effect on the environment having particular regard to the following considerations:

>Original text>

- its fate and distribution in the environment; particularly contamination of water including drinking water and groundwater,

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- its fate and distribution in the environment; particularly contamination of water including drinking water, groundwater and surface water,

>Original text>

- its impact on non-target organisms;

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- its impact on non-target organisms;

(Amendment 22)

Article 4(1)(b)(va) (new)

>Text following EP vote>

(va) does not contain any substance belonging to the category of carcinogens for which no safety threshold can be set;

(Amendment 23)

Article 4(1)(c)

>Original text>

(c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co- formulants, and its residues of toxicological or environmental significance, which result from authorized uses, can be determined according to the relevant requirements in Annexes II, III and IV;

>Text following EP vote>

(c) the nature and quantity of its active substances and any toxicologically or ecotoxicologically significant impurities and co-formulants, and its residues of toxicological or environmental significance, which result from authorized uses, can be determined according to the relevant requirements in Annexes II, III and IV;

(Amendment 24)

Article 4(4)

>Original text>

4. Where other Community provisions impose requirements relevant to the conditions for the issue of an authorization and particularly where these are intended to protect the health of distributors, users, workers and consumers or animal health or the environment, the competent authority shall take these into account when issuing an authorization and where necessary shall issue the authorization subject to those requirements.

>Text following EP vote>

4. Where other Community provisions impose requirements relevant to the conditions for the issue of an authorization and for application and particularly where these are intended to protect the health of distributors, users, workers and consumers or animal health or the environment, the competent authority shall take these into account when issuing an authorization and where necessary shall issue the authorization subject to those requirements.

(Amendment 25)

Article 7(4)

>Original text>

4. Information, which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted.

>Text following EP vote>

Deleted

(Amendment 26)

Article 7a (new)

>Text following EP vote>

Article 7a

Fees

Member States shall charge a fee for the authorization of a biocidal product.

(Amendment 27)

Article 9(2), introduction and (i), introduction

>Original text>

2. Inclusion of an active substance in Annex I shall, where appropriate, be subject to the following:

>Text following EP vote>

2. Inclusion of an active substance in Annex I shall be subject to the following:

>Original text>

(i) requirements on:

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(i) requirements and/or information on:

(Amendment 28)

Article 9(2)(ii)(b)

>Original text>

(b) where relevant, an acceptable daily intake for man (ADI);

>Text following EP vote>

(b) an acceptable daily intake for man (ADI);

(Amendments 29 and 95)

Article 9(5)

>Original text>

5. The inclusion of an active substance in Annex I may be refused or reviewed, if there is another active substance in Annex I for the same product type, or another method of control exists, which in the light of scientific or technical knowledge presents significantly less risk to health or to the environment. When considering such a refusal, an evaluation of the alternative active substances or methods shall be produced in accordance with common principles for the evaluation of dossiers, to demonstrate they can be used with the same effect on the target organism without significant economic and practical disadvantages to the user. The evaluation shall be circulated in accordance with the procedures in Article 10(2) for decision in accordance with the procedures laid down in Articles 24 and 25(3).

>Text following EP vote>

5. The inclusion of an active substance in Annex I may be refused or reviewed, if there is another active substance in Annex I for the same product type, or another method of control exists, which in the light of scientific or technical knowledge presents significantly less risk to health or to the environment. When considering such a refusal, an evaluation of the alternative active substances or methods shall be produced to demonstrate they can be used with the same effect on the target organism without significant economic and practical disadvantages to the user. Substances which are to be removed from the annex may be granted a five-year phasing out period by using the procedure in Article 10. The evaluation shall be circulated in accordance with the procedures in Article 10(2) for decision in accordance with the procedures laid down in Articles 24 and 25(3).

(Amendment 31)

Article 14(3)

>Original text>

3. By way of further derogation from Article 4(1), Article 7(2) and Article 7(3) and without prejudice to paragraph 4 and paragraph 6, a Member State may, for a period of 10 years from the date of entry into force of this Directive, authorize the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I that are on the market on the date of entry into force of this Directive.

>Text following EP vote>

3. By way of further derogation from Article 3(1), Article 4(1), Article 7(2) and Article 7(3) and without prejudice to paragraph 4 and paragraph 6, a Member State may, for a period of 10 years from the date of entry into force of this Directive, authorize the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I, but which have been used in biocidal products and are on the market on the date of entry into force of this Directive.

(Amendment 32)

Article 14(4), first subparagraph

>Original text>

4. Following the adoption of this Directive, the Commission shall commence a 10 year programme of work for the systematic examination of active substances not on Annex I. A Regulation, adopted according to the procedure laid down in Article 25(2), will provide for all provisions necessary for the establishment and implementation of the programme. No later than two years before completion of the work programme, the Commission shall forward to the Council and the European Parliament a report on the progress achieved with the programme.

>Text following EP vote>

4. Following the adoption of this Directive, the Commission shall commence a 10 year programme of work for the systematic examination of active substances not on Annex I. A Regulation, adopted according to the procedure laid down in Article 25(3), will provide for all provisions necessary for the establishment and implementation of the programme. No later than two years before completion of the work programme, the Commission shall forward to the Council and the European Parliament a report on the progress achieved with the programme.

(Amendment 33)

Article 16(2a) (new)

>Text following EP vote>

2a. A biocidal product may not be authorized unless the Commission and the Member States believe they have the required information, including if necessary technical data as specified in Article 7. If agreement cannot be reached on authorization, a decision shall be taken pursuant to the procedure laid down in Article 25.

(Amendment 34)

Article 17(1)

>Original text>

1. Without prejudice to Council Directive 90/313/EEC on the freedom of access to information on the environment an applicant may indicate to the competent authority the information which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially and which he therefore wishes to be kept confidential from all persons other than the competent authorities and the Commission. Full justification will be required in each case.

>Text following EP vote>

1. Without prejudice to Council Directive 90/313/EEC on the freedom of access to information on the environment an applicant may indicate to the competent authority the information which he considers to be commercially sensitive and disclosure of which might harm him industrially or commercially and which he therefore wishes to be kept confidential from all persons other than the competent authorities and the Commission. Full justification will be required in each case. However, any request to treat the composition or product formulations as confidential shall be considered warranted.

(Amendment 35)

Article 18(2)(ba) (new)

>Text following EP vote>

(ba) products available to the general public shall be provided with safety lids.

(Amendment 36)

Article 18(3), introduction

>Original text>

3. Biocidal products shall be labelled according to the provisions of Directive 88/379/EEC concerning labelling. In addition the label must show clearly and indelibly the following:

>Text following EP vote>

3. Biocidal products shall be labelled according to the provisions of Directive 88/379/EEC concerning labelling. Labels shall not be misleading or give an exaggerated impression of the product. Labels shall not include claims or publicity for the product. In addition the label must show clearly and indelibly the following:

(Amendment 37)

Article 18(4)

>Original text>

4. By way of derogation from paragraphs 1 and 2 and the first sentence of paragraph 3 biocidal products authorised as insecticides, acaricides, rodenticides, avicides or molluscicides shall be classified, packaged and labelled in accordance with Directive 78/631/EEC on the approximation of the laws of the Member States relating to the classification, packaging and labelling of dangerous preparations (pesticides)1 insofar as there is no other Community provision specifically covering these matters for such products.

>Text following EP vote>

Deleted

>Original text>

1 OJ L 206, 29.7.1978, p. 13.

(Amendment 38)

Article 20(1), 1st and 2nd subparagraphs

>Original text>

1. Member States shall require that every advertisement for a biocidal product is accompanied by the sentences 'Use biocides safely. Always read the label and the product information before use.'

The sentences shall be clearly distinguishable in relation to the whole advertisement.

>Text following EP vote>

1. Member States shall require that every advertisement for a biocidal product is accompanied by the sentences 'Use biocides safely and moderately in the interests of your own health and a clean environment. Always read the label and the product information before use.'

The sentences shall be clearly distinguishable in relation to the whole advertisement, and clearly visible.

(Amendment 39)

Article 24(3)

>Original text>

3. The applicant or his authorized representative may be asked by the Commission to submit remarks to it, in particular whenever an unfavourable decision is envisaged.

>Text following EP vote>

3. The applicant or his authorized representative shall be asked by the Commission to submit remarks to it, in particular whenever an unfavourable decision is envisaged.

(Amendment 63)

Article 25(1)

>Original text>

1. The Commission shall establish a Standing Committee on Biocidal products (the Standing Committee) to assist it. The Standing Committee shall be composed of representatives of the Member States and chaired by a representative of the Commission. The Standing Committee shall adopt its own rules of procedure.

>Text following EP vote>

1. The Commission shall establish a Standing Committee on Biocidal Products (the Standing Committee) to assist it. The Standing Committee shall be composed of representatives of the Member States responsible for the environment, health or water management sectors and chaired by a representative from DG XI of the Commission. Interested parties shall be consulted by the Standing Committee when appropriate. The Standing Committee shall adopt its own rules of procedure.

(Amendment 41)

Article 29

>Original text>

Where a Member State has valid reasons to consider that a biocidal product which it has authorized or is bound to authorize under Article 3 constitutes an unacceptable risk to human or animal health or the environment, it may provisionally restrict or prohibit the use or sale of that product on its territory. It shall immediately inform the Commission and the other Member States of such action and give reasons for its decision. A decision shall be taken on the matter within 90 days in accordance with the procedure laid down in Article 25(3).

>Text following EP vote>

Where a Member State has valid reasons to consider that a biocidal product which it has authorized or is bound to authorize under Article 3 constitutes an unacceptable risk to human or animal health or the environment, it may provisionally restrict or prohibit the use or sale of that product on its territory. In order to safeguard health and the environment in other Member States, the Member State shall immediately inform the Commission and the other Member States of such action and give reasons for its decision. A decision as to whether authorization of the product in question should be cancelled throughout the market or only in the Member State concerned shall be taken within 90 days in accordance with the procedure laid down in Article 25(3).

(Amendment 42)

Article 29a (new)

>Text following EP vote>

Article 29a

Achieving the objectives of the Directive

>Text following EP vote>

The Council, taking a decision on the basis of the relevant articles of the Treaty, may adopt economic instruments aimed at ensuring that the objectives of this Directive are achieved. In the absence of such measures, Member States may, in accordance with the principles applicable to the Community's environmental policy, including the polluter-pays principle, and with due regard to the obligations arising from the Treaty, adopt measures designed to help achieve such objectives.

(Amendment 43)

Article 29b (new)

>Text following EP vote>

Article 29b

Action plans

Member States may draw up action plans designed to reduce consumption of biocidal products. Member States shall keep each other and the Commission informed of such action plans.

(Amendment 81)

Annex II(A) (1)

>Original text>

1. Dossiers on active substances are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data.

>Text following EP vote>

1. Dossiers on active substances are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data. The dossier requirements must be in line with technical development.

(Amendment 44)

Annex II(A) (2)

>Original text>

2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted.

>Text following EP vote>

Deleted

(Amendment 45)

Annex II(A) (IV) (4.2), introduction and (a), (b) and (c)

>Original text>

4.2. Analytical methods including recovery rates and the limits of determination for the active substance, and for residues thereof, and where relevant in/on the following:

>Text following EP vote>

4.2. Analytical methods including recovery rates and the limits of determination for the active substance, and for residues thereof in/on the following:

>Original text>

(a) soil;

>Text following EP vote>

(a) soil;

>Original text>

(b) air;

>Text following EP vote>

(b) air;

>Original text>

(c) water: the applicant should confirm that the substance itself and any of its degradation products which fall within the definition of pesticides given for parameter 55 in Annex I of Directive 80/778/EEC on the quality of water intended for human consumption (OJ L 229, 30.8.1980, p. 11) can be estimated with adequate reliability at the MAC specified in that Directive for individual pesticides;

>Text following EP vote>

(c) water: the applicant must prove that, without special treatment, the substance itself and any of its degradation products which fall within the parameters of Directive 80/778/EEC on the quality of water intended for human consumption (OJ L 229, 30.8.1980, p. 11) do not exceed the MAC specified in that Directive;

(Amendment 46)

Annex II(A) (VI) title

>Original text>

VI. TOXICOLOGICAL AND METABOLIC STUDIES

>Text following EP vote>

VI. TOXICOLOGICAL AND METABOLIC STUDIES OF THE ACTIVE SUBSTANCE AND DEGRADATION PRODUCTS

(Amendment 47)

Annex II(A) (VI) (6.2) 3rd paragraph

>Original text>

For the following studies 6.3 (where necessary), 6.4, 6.5, 6.7 and 6.8, the required route of administration is the oral route unless it can be justified that an alternative route is more appropriate.

>Text following EP vote>

For the following studies 6.3 (where necessary), 6.4, 6.5, 6.7 and 6.8, the required route of administration is the oral route and/or inhalatory exposure unless it can be justified that an alternative route is more appropriate.

(Amendment 48)

Annex II(A) (VI) (6.14)

>Original text>

6. 14 Summary of mammalian toxicology and conclusions, including no observable adverse effect level (NOAEL), no observable effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning active substance. Where possible any suggested worker protection measures should be included in summary form.

>Text following EP vote>

6. 14 Summary of mammalian toxicology, the results of the molecular experiments and conclusions, including no observable adverse effect level (NOAEL), no observable effect level (NOEL), overall evaluation with regard to all toxicological data and any other information concerning active substance. Where possible any suggested worker protection measures should be included in summary form.

(Amendment 49)

Annex II(A) (VII) title

>Original text>

VII. ECOTOXOLOGICAL STUDIES ON THE ACTIVE SUBSTANCE

>Text following EP vote>

VII. ECOTOXOLOGICAL STUDIES ON THE ACTIVE SUBSTANCE AND ON ITS DEGRADATION PRODUCTS

(Amendment 79)

Annex II(B) (1)

>Original text>

1. Dossiers on active organisms are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data.

>Text following EP vote>

1. Dossiers on active organisms are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data. The dossier requirements must be in line with technical development.

(Amendment 50)

Annex II(B) (2)

>Original text>

2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted.

>Text following EP vote>

Deleted

(Amendment 80)

Annex III(A) (1)

>Original text>

1. Dossiers on biocidal products are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data.

>Text following EP vote>

1. Dossiers on biocidal products are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data. The dossier requirements must be in line with technical development.

(Amendment 51)

Annex III(A) (2)

>Original text>

2. Information which is not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification, acceptable to the competent authority must be submitted.

>Text following EP vote>

Deleted

(Amendment 52)

Annex III(A) (VI) and (VII)

>Original text>

VI. Toxicology data for the biocidal products (additional to that for the active substance)

>Text following EP vote>

VI. Toxicology data for the biocidal products and their residues (additional to that for the active substance)

>Original text>

VII. Ecotoxicological data for the biocidal products (additional to that for the active substance)

>Text following EP vote>

VII. Ecotoxicological data for the biocidal products and their residues (additional to that for the active substance)

(Amendment 53)

Annex III(A) (VII) (7.1)

>Original text>

7. 1 The information provided must, where relevant, include that referred to in Annex II, points 7.1 to 7.4.

>Text following EP vote>

7. 1 The information provided must include that referred to in Annex II, points 7.1 to 7.4.

(Amendment 54)

Annex III(A) (VII) (7.3)

>Original text>

7. 3 The information provided must, where relevant, include that referred to in Annex II, point 7.6.

>Text following EP vote>

7. 3 The information provided must include that referred to in Annex II, point 7.6.

(Amendment 83)

Annex III(B) (1)

>Original text>

1. Dossiers on biocidal products are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data.

>Text following EP vote>

1. Dossiers on biocidal products are required to address at least all the points listed under 'Dossier requirements'. Responses are required to be supported by data. The dossier requirements must be in line with technical development.

(Amendment 55)

Annex VI (27)

>Original text>

27. For mutagenicity and carcinogenicity it shall be sufficient to determine whether the active substance of concern has an inherent capacity to cause such effects during use of the biocidal product. However, if it can be demonstrated that an active substance or a substance of concern identified as a carcinogen is non-genotoxic, it will be appropriate to identify a N(L)OAEL as described in paragraph 25.

>Text following EP vote>

27. For mutagenicity and carcinogenicity by genotoxic effect, it shall be sufficient to determine whether the active substance of concern has an inherent capacity to cause such effects during use of the biocidal product. If it can be demonstrated that an active substance or a substance of concern identified as a carcinogen is non-genotoxic, it will be appropriate to identify a N(L)OAEL as described in paragraph 25, provided that it is a non-specific carcinogen.

(Amendment 56)

Annex VI (51) introduction

>Original text>

51. Testing should be carried out according to European Union guide-lines if these are available and applicable. In the absence of these other methods can be used as shown in the list below which is in order of descending preference:

>Text following EP vote>

51. Testing should be carried out according to European Union guide-lines if these are available and applicable. Where appropriate other methods can be used as shown in the list below which is in order of descending preference:

(Amendment 57)

Annex VI (59), 2nd subparagraph

>Original text>

In the case of active substances not on the market on the implementation date of the Directive only those substances listed in Annex I of the Directive can be used in biocidal products.

>Text following EP vote>

Deleted

(Amendment 58)

Annex VI (61), indent 7a (new)

>Text following EP vote>

- alternative technologies.

(Amendment 59)

Annex VI (80), introduction

>Original text>

80. The Member State shall not authorize a biocidal product if, under the proposed conditions of use, the foreseeable concentration of the active substance or of any other substance of concern or relevant metabolites or breakdown or reaction products in the groundwater exceeds the lower of the following concentrations:

>Text following EP vote>

80. The Member State shall not authorize a biocidal product if, under the proposed conditions of use, the foreseeable concentration of the active substance or of any other substance of concern or relevant metabolites or breakdown or reaction products in the surface water or groundwater exceeds the lower of the following concentrations:

(Amendment 60)

Annex VI (81), first indent

>Original text>

- exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (OJ L 194, 25.7.1975, p. 34), or

>Text following EP vote>

- exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the lower of the following concentrations:

- the values fixed by Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (OJ L 194, 25.7.1975, p. 34),

- the maximum permissible concentration laid down by Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption,

or

(Amendment 96)

Annex VI(86), 2nd subparagraph (new)

>Text following EP vote>

Member States may, however, authorize anti-fouling products used on seagoing vessels of over 25 m for a period of up to 10 years from the date on which this Directive enters into force. This provision shall lapse if IMO rules are adopted within that period.

(Amendment 62)

Annex VI (92)

>Original text>

92. The Member State shall then take due consideration of any relevant unacceptable effects, the efficacy of the biocidal product and the benefits of using the biocidal product before taking an authorization decision on the biocidal product.

>Text following EP vote>

92. The Member State shall then take due consideration of any relevant unacceptable effects, the efficacy of the biocidal product and the environmental and economic benefits of using the biocidal product before taking an authorization decision on the biocidal product.

Legislative resolution embodying Parliament's opinion on the proposal and amended proposal for a European Parliament and Council Directive concerning the placing of biocidal products on the market (COM(93)0351 - C3-0285/93 and COM(95)0387 - C4-0311/95 - 00/0465(COD))

(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal, COM(93)0351 ((OJ C 239, 3.9.1993, p. 3.)), and the amended Commission proposal to Parliament and the Council, COM(95)0387 - 00/0465(COD) ((OJ C 261, 6.10.1995, p. 5.)),

- having regard to Articles 100a and 189b(2) of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C4-0311/95),

- 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 Economic and Monetary Affairs and Industrial Policy (A4-0056/96),

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. Should the Council intend to depart from the text approved by Parliament, calls on the Council to notify Parliament and requests that the conciliation procedure be initiated;

5. 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;

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