1991L0414 — EN — 01.02.2007 — 016.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B COUNCIL DIRECTIVE of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (OJ L 230, 19.8.1991, p.1)

Amended by:





Corrected by:









▼B

COUNCIL DIRECTIVE

of 15 July 1991

concerning the placing of plant protection products on the market

(91/414/EEC)







THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission ( 1 ), Having regard to the opinion of the European Parliament ( 2 ), Having regard to the opinion of the Economic and Social Committee ( 3 ), Whereas plant production has a very important place in the Community; Whereas plant production yields are continually affected by harmful organisms including weeds; whereas it is absolutely essential to protect plants against these risks to prevent a decline in yields and to help to ensure security of supplies; Whereas one of the most important ways of protecting plants and plant products and of improving agricultural production is to use plant protection products; Whereas these plant protection products can have non-beneficial effects upon plant production; whereas their use may involve risks and hazards for humans, animals and the environment, especially if placed on the market without having been officially tested and authorized and if incorrectly used; Whereas, in view of the hazards, there are rules in most Member States governing the authorization of plant health products; whereas these rules present differences which constitute barriers not only to trade in plant protection products but also to trade in plant products, and thereby directly affect the establishment and operation of the internal market; Whereas it is therefore desirable to eliminate such barriers by harmonizing the provisions laid down in the Member States; Whereas uniform rules on the conditions and procedures for the authorization of plant protection products must be applied by the Member States; Whereas such rules should provide that plant protection products should not be put on the market or used unless they habe been officially authorized and should be used properly having regard to the principles of good plant protection practice and of integrated pest control; Whereas the provisions governing authorization must ensure a high standard of protection, which, in particular, must prevent the authorization of plant protection products whose risks to health, groundwater and the environment and human and animal health should take priority over the objective of improving plant production; Whereas it is necessary, at the time when plant protection products are authorized, to make sure that, when properly applied for the purpose intended, they are sufficiently effective and have no unacceptable effect on plants or plant products, no unacceptable influence on the environment in general and, in particular, no harmful effect on human or animal health or on groundwater; Whereas authorization should be limited to plant protection products containing certain active substances specified at Community level on the basis of their toxicological and ecotoxicological properties; Whereas it is therefore necessary to establish a Community list of authorized active substances; Whereas a Community procedure must be laid down for assessing whether an active substance can be entered on the Community list; whereas the information that interested parties must submit with a view to admission of a substance to the list should be specified; Whereas the Community procedure should not prevent Member States from authorizing for use in their territory for a limited period plant protection products containing an active substance not yet entered on the Community list, provided that the interested party has submitted a dossier meeting Community requirements and the Member State has concluded that the active substance and the plant protection products can be expected to satisfy the Community conditions set in regard to them; Whereas, in the interests of safety, substances on the Community list should be reviewed periodically, to take account of developments in science and technology and of impact studies based on the actual use of plant protection products containing the said substances; Whereas it is in the interests of free movement of plant products as well as of plant protection products that authorization granted by one Member State, and tests carried out with a view to authorization, should be recognized by other Member States, unless certain agricultural, plant health and environmental (including climatic) conditions relevant to the use of the products concerned are not comparable in the regions concerned; whereas to this end there is a need to harmonize the methods of experimentation and control applied by the Member States for the purpose of granting authorization; Whereas it is therefore desirable that a system for the mutual supply of information should be established and that Member States should make available to each other on request the particulars and scientific documentation submitted in connection with applications for authorization of plant protection products; Whereas, however, Member States must be enabled to authorize plant protection products not complying with the abovementioned conditions when it is necessary to do so because of an unforeseeable danger threatening plant production which cannot be countered by other means; whereas such authorization should be reviewed by the Community in close cooperation with the Member States in the framework of the Standing Committee on Plant Health; Whereas this Directive complements Community provisions on the classification, packaging and labelling of pesticides; whereas together with these provisions it considerably improves the protection of users of plant protection products and consumers of plants and plant products; whereas it also contributes to the protection of the environment; Whereas it is necessary to maintain consistency between this Directive and Community rules on the residues of plant protection products in agricultural products and the free movement of the latter in the Community; whereas this Directive complements Community provisions relating to maximum permissible levels for pesticide residues and will facilitate the adoption of such levels in the Commission; whereas together with the latter provisions it considerably improves the protection of consumers of plants and plant products; Whereas resources devoted to the conduct of tests on vertebrate animals should not be dissipated as a result of the differences in the laws of the Member States and whereas considerations of public interest and 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 ( 4 ) militate against needless repetition of tests on animals; Whereas, in order to ensure that the requirements laid down are satisfied, Member States must make provision for appropriate control and inspection arrangements with regard to the marketing and use of plant protection products; Whereas the procedures provided for by this Directive for the evaluation of the risks to the environment presented by plant protection products containing or composed of genetically modified organisms correspond in principle to those laid down in Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms ( 5 ); whereas in future however the supply of data in accordance with Part B of Annexes II and III is likely to be subject to specific requirements, provision should be made to amend this Directive accordingly; Whereas the implementation of this Directive and the adaptation of its Annexes to advances in technical and scientific knowledge necessitate close cooperation between the Commission and the Member States, and whereas the procedure of the Standing Committee on Plant Health offers a suitable basis for this cooperation, HAS ADOPTED THIS DIRECTIVE:







Scope

Article 1

1. This Directive concerns the authorization, placing on the market, use and control within the Community of plant protection products in commercial form and the placing on the market and control within the Community of active substances intended for a use specified in Article 2 (1).

2. This Directive shall apply without prejudice to 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) ( 6 ), as last amended by Directive 84/291/EEC ( 7 ) and, where active substances are concerned, without prejudice to the provisions concerning classification, packaging and labelling of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ( 8 ), as last amended by Directive 90/517/EEC ( 9 ).

3. This Directive applies to the authorization to place on the market plant protection products containing or composed of genetically modified organisms, provided that authorization to release them into the environment has been granted after the risk to the environment has been assessed in accordance with the provisions of Parts A, B and D and the relevant provisions of Part C of Directive 90/220/EEC.

The Commission shall submit to the Council, in sufficient time for the latter to be able to act not later than two years after the date of notification of this Directive, a proposal for an amendment with a view to including in this Directive ( 10 ) a specific procedure for evaluating the risk to the environment analogous to that provided for the Directive 90/220/EEC, and enabling this Directive to be placed on the list provided for in Article 10 (3) of Directive 90/220/EEC in accordance with the procedure laid down in the said Article 10.

Within five years of the date of notification of this Directive, the Commission, on the basis of experience gained, shall provide the European Parliament and the Council with a report on the operation of the arrangements described in the first and second subparagraphs.

4. This Directive shall apply without prejudice to Council Regulation (EEC) No 1734/88 of 16 June 1988 concerning export from and import into the Community of certain dangerous chemicals ( 11 ).







Definitions

Article 2

For the purposes of this Directive the following definitions shall apply:

1. ‘plant protection products’ active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

1.1. protect plants or plant products against all harmful organisms or prevent the action of such organisms, in so far as such substances or preparations are not otherwise defined below;

1.2. influence the life processes of plants, other than as a nutrient, (e.g. growth regulators);

1.3. preserve plant products, in so far as such substances or products are not subject to special Council of Commission provisions on preservatives;

1.4. destroy undesired plants; or

1.5. destroy parts of plants, check or prevent undesired growth of plants;

2. ‘residues of plant protection products’ one or more substances present in or on plants or products of plant origin, edible animal products or elsewhere in the environment and resulting from the use of a plant protection product, including their metabolites and products resulting from their degradation or reaction;

3. ‘substances’ chemical elements and their compounds, as they occur naturally or by manufacture, including any impurity inevitable resulting from the manufacturing process;

4. ‘active substances’ substances or micro-organisms including viruses, having general or specific action:

4.1. against harmful organisms; or

4.2. on plants, parts of plants or plant products;

5. ‘preparations’ mixtures or solutions composed of two or more substances of which at least one is an active substance, intended for use as plant protection products;

6. ‘plants’ live plants and live parts of plants, including fresh fruit and seeds;

7. ‘plant products’ products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined in point 6;

8. ‘harmful organisms’ pests of plants or plant products belonging to the animal or plant kingdom, and also viruses, bacteria and mycoplasmas and other pathogens;

9. ‘animals’ animals belonging to species normally fed and kept or consumed by man;

10. ‘placing on the market’ 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 plant protection product into the territory of the Community shall be deemed to constitute placing on the market for the purposes of this Directive;

11. ‘authorization of a plant protection product’ administrative act by which the competent authority of a Member State authorizes, following an application submitted by an applicant, the placing on the market of a plant protection product in its territory or in a part thereof;

12. ‘environment’ water, air, land, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms;

13. ‘integrated control’ the rational application of a combination of biological, biotechnological, chemical, cultural or plant-breeding measures whereby the use of chemical plant protection products is limited to the strict minimum necessary to maintain the pest population at levels below those causing economically unacceptable damage or loss.







General provisions

Article 3

1. Member States shall prescribe that plant protection products may not be placed on the market and used in their territory unless they have authorized the product in accordance with this Directive, except where the intended use is covered by Article 22.

2. Member States shall not, on the grounds that a plant protection product is not authorized for use in their territory, impede the production, storage or movement of such products intended for use in another Member State, provided that:

— the product is authorized in another Member State, and

— the inspection requirements laid down by the Member States in order to ensure compliance with paragraph 1 are satisfied.

3. Member States shall prescribe that plant protection products must be used properly. Proper use shall include compliance with the conditions established in accordance with Article 4 and specified on the labelling, and the application of the principles of good plant protection practice as well as, whenever possible, the principles of integrated control.

4. Member States shall prescribe that active substances may not be placed on the market unless:

— they are classified, packaged and labelled in accordance with Directive 67/548/EEC, and

— where the active substance was not on the market two years after notification of this Directive, a dossier has been forwarded to the Member States and to the Commission, in accordance with Article 6, with the declaration that the active substance is intended for a use specified in Article 2 (1). This condition shall not apply to active substances intended for a use under Article 22.







Granting, review and withdrawal of authorizations of plant protection products

Article 4

1. Member States shall ensure that a plant protection product is not authorized unless:

(a) its active substances are listed in Annex I and any conditions laid down therein are fulfilled, and, with regard to the following points (b), (c), (d) and (e), pursuant to the uniform principles provided for in Annex VI, unless:

(b) it is established, in the light of current scientific and technical kowledge and shown from appraisal of the dossier provided for in Annex III, that when used in accordance with Article 3 (3), and having regard to all normal conditions under which it may be used, and to the consequences of its use: (i) it is sufficiently effective; (ii) it has no unacceptable effect on plants or plant products; (iii) it does not cause unnecessary suffering and pain to vertebrates to be controlled; (iv) it has no harmful effect on human or animal health, directly or indirectly (e.g. through drinking water, food or feed) or on groundwater; (v) it has no unacceptable influence on the environment, having particular regard to the following considerations: — its fate and distribution in the environment, particularly contamination of water including drinking water and groundwater, — its impact on non-target species;

(c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants can be determined by appropriate methods, harmonized according to the procedure provided in Article 21, or, if not, agreed by the authorities responsible for the authorization;

(d) its residues, resulting from authorized uses, and which are of toxicological or environmental significance, can be determined by appropriate methods in general use;

(e) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product;

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(f) where appropriate, the MRLs for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005 ( 12 ).

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2. The authorization must stipulate the requirements relating to the placing on the market and use of the product or at least those aimed at ensuring compliance with the provisions of paragraph 1 (b).

3. Member States shall ensure that compliance with the requirements set out in paragraph 1 (b) to (f) is established by official or officially recognized tests and analyses carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of these prevailing where the product is intended to be used, within the territory of the Member State concerned.

4. Without prejudice to paragraphs 5 and 6, authorizations shall be granted for a fixed period of up to 10 years only, determined by the Member States; they may be renewed after verification that the conditions imposed in paragraph 1 are still satisfied. Renewal may be granted for the period necessary to the competent authorities of the Member States, for such verification, where an application for renewal has been made.

5. Authorizations may be reviewed at any time if there are indications that any of the requirements referred to in paragraph 1 are no longer satisfied. In such instances the Member States may require the applicant for authorization or party to whom an extension of the field of application was granted in accordance with Article 9 to submit further information necessary for the review. The authorization may, where necessary, be extended for the period necessary to complete a review and provide such further information.

6. Without prejudice to Decisions already taken pursuant to Article 10, an authorization shall be cancelled if it is established that:

(a) the requirements for obtaining the authorization are not or are no longer satisfied;

(b) false or misleading particulars were supplied concerning the facts on the basis of which the authorization was granted;

or modified if it is established that:

(c) on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified.

It may also be cancelled or modified at the request of the holder of the authorization, who shall state the reasons therefor; amendments can be granted only if it is established that the requirements of Article 4 (1) continue to be satisfied.

Where a Member State withdraws an authorization, it shall immediately inform the holder of the authorization; moreover, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length in accordance with the reason for the withdrawal, without prejudice to any period provided for by decision taken under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances ( 13 ), as last amended by Directive 90/533/EEC ( 14 ), or Article 6 (1) or Article 8 (1) or (2) of this Directive.







Inclusion of active substances in Annex I

Article 5

1. In the light of current scientific and technical knowledge, an active substance shall be included in Annex I for an initial period not exceeding 10 years, if it may be expected that plant protection products containing the active substance will fulfil the following conditions:

(a) their residues, consequent on application consistent with good plant protection practice, do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, and the said residues, in so far as they are of toxicological or environmental significance, can be measured by methods in general use;

(b) their use, consequent on application consistent with good plant protection practice, does not have any harmful effects on human or animal health or any anacceptable influence on the environment as provided for in Article 4 (1) (b) (iv) and (v).

2. For inclusion of an active substance in Annex I, the following shall be taken into particular account:

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

(b) an acceptable operator exposure level if necessary;

(c) where relevant, an estimate of its fate and distribution in the environment as well as its impact on non-target species.

3. For the first inclusion of an active substance which was not yet on the market two years after notification of this Directive, the requirements shall be deemed to be satisfied where this has been established for at least one preparation containging the said active substance.

4. Inclusion of an active substance in Annex I may be subject to requirements such as:

— the minimum degree of purity of the active substance,

— the nature and maximum content of certain impurities,

— restrictions arising from evaluation of the information referred to in Article 6, taking account of the agricultural, plant health and environmental (including climatic) conditions in question,

— type of preparation,

— manner of use.

5. On request, the inclusion of a substance in Annex I may be renewed once or more for periods not exceeding 10 years; such inclusion may be reviewed at any time if there are indications that the criteria referred to in paragraphs 1 and 2 are no longer satisfied. Renewal shall be granted for the period necessary to complete a review, where an application has been made for such renewal in sufficient time, and in any case not less than two years before the entry is due to lapse, and shall be granted for the period necessary to provide information requested in accordance with Article 6 (4).

Article 6

1. Inclusion of an active substance in Annex I shall be decided in accordance with the procedure laid down in Article 19.

The following shall also be decided in accordance with that procedure:

— any conditions for inclusion,

— amendements to Annex I, where necessary,

— removal of an active substance form Annex I if it no longer satisfies the requirements of Article 5 (1) and (2).

2. A Member State receiving an application for the inclusion of an active substance in Annex I shall without undue delay ensure that a dossier which is believed to satisfy the requirements of Annex II is forwarded by the applicant to the other Member States and to the Commission together with a dossier complying with Annex III on at least one preparation containing that active substance. The Commission shall refer the dossier to the Standing Committee on Plant Health referred to in Article 19 for examination.

3. Without prejudice to the provisions of paragraph 4, at the request of a Member State, and within three to six months after the date of referral to the committee mentioned in Article 19, it shall be established by the procedure laid down in Article 20 whether the dossier has been submitted in accordance with the requirements of Annexes II and III.

4. If the assessment of the dossier referred to in paragraph 2 shows that further information is necessary, the Commission may ask the applicant to submit such information. The applicant or his authorized representative may be asked by the Commission to submit his remarks to it, in particular whenever an unfavourable decision is envisaged.

These provisions shall also apply if, after inclusion of an active substance in Annex I, facts emerge that cast doubt on its conformity with the requirements indicated in Article 5 (1) and (2), or if renewal in accordance with Article 5 (5) is being considered.

5. The procedure concerning the submission and appraisal of applications for inclusion in Annex I and setting or varying any conditions for inclusion shall be adopted in accordance with the procedure laid down in Article 21.







Information on potentially harmful effects

Article 7

Member States shall prescribe that the holder of an authorization or those to whom an extension of the field of application has been granted in accordance with Article 9 (1) must immediately notify the competent authority of all new information on the potentially dangerous effects of any plant protection product, or of residues of an active substance on human or animal health or on groundwater, or their potentially dangerous effects on the environment. Member States shall ensure that the parties concerned immediately notify this information to the other Member States and to the Commission, which shall refer the information to the committee referred to in Article 19.







Transitional measures and derogations

Article 8

1. By way of derogation from Article 4, a Member State may, to enable a gradual assessment to be made of the properties of new active substances and to make it easier for new preparations to be made available for use in agriculture, authorize, for a provisional period not exceeding three years, the placing on the market of plant protection products containing an active substance not listed in Annex I and not yet available on the market two years after notification of this Directive, provided that:

(a) following application of Article 6 (2) and (3) it is found that the dossier on the active substance satisfies the requirements of Annexes II and III in relation to the projected uses;

(b) the Member State establishes that the active substance can satisfy the requirements of Article 5 (1) and that the plant protection product may be expected to satisfy the requirements of Article 4 (1) (b) to (f).

In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorization, giving at least the information provided for in Article 12 (1).

Following the evaluation of the dossier as provided for in Article 6 (3), it may be decided, in accordance with the procedure laid down in Article 19, that the active substance does not satisfy the requirements specified in Article 5 (1). In such cases the Member States shall ensure that the authorizations must be withdrawn.

By way of derogation from Article 6, if, on expiry of the three-year period, a decision has not been taken concerning the inclusion of an active substance in Annex I, a further period may be ordered by the procedure referred to in Article 19 to enable a full examination to be made of the dossier and, where appropriate, of any additional information requested in accordance with Article 6 (3) and (4).

The provisions of Article 4 (2), (3), (5) and (6) shall apply to authorizations granted under the terms of this paragraph without prejudice to the foregoing subparagraphs.

2. By way of derogation from Article 4 and without prejudice to paragraph 3 or to Directive 79/117/EEC, a Member State may, during a period of 12 years following the notification of this Directive, authorize the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this Directive.

After the adoption of this Directive, the Commission shall commence a programme of work for the gradual examination of these active substances within the 12-year period referred to in the foregoing subparagraph. This programme may require interested parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme. A Regulation, adopted according to the procedure laid down in Article 19, will set out all the provisions necessary for the implementation of the programme.

Ten years following notification of this Directive the Commission shall present to the European Parliament and the Council a progress report on the programme. Depending upon the conclusions of the report, it may be decided, according to the procedure laid down in Article 19, whether, for certain substances, the 12-year period referred to in the first subparagraph is to be extended for a period to be determined.

During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorizations are granted, withdrawn or varied, as appropriate, within a prescribed period.

3. Where they review plant protection products containing an active substance in accordance with paragraph 2, and before such review has taken place, Member States shall apply the requirements laid down in Article 4 (1) (b) (i) to (v), and (c) to (f) in accordance with national provisions concerning the data to be provided.

4. By way of further derogation from Article 4, in special circumstances a Member State may authorize for a period not exceeding 120 days the placing on the market of plant protection products not complying with Article 4 for a limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States and the Commission of its action. It shall be decided without delay, in accordance with the procedure laid down in Article 19, whether and under which conditions the action taken by the Member State may be extended for a given period, repeated, or revoked.







Application for authorization

Article 9

1. Application for authorization of a plant protection product shall be made by or on behalf of the person responsible for first placing it on the market in a Member State to the competent authorities of each Member State where the plant protection product is intended to be placed on the market.

Official or scientific bodies involved in agricultural activities or professional agricultural organizations and professional users may request that the field of application of a plant protection product already authorized in the Member State in question be extended to purposes other than those covered by this authorization.

Member States shall grant an extension of the field of application of an authorized plant protection product and shall be obliged to grant such an extension when it is in the public interest to the extent that:

— the documentation and information to support an extension of the field of application has been submitted by the applicant,

— they have established that the conditions referred to in Article 4 (1) (b) (iii), (iv) and (v) are satisfied,

— the intended use is minor in nature,

— users are fully and specifically informed as to instructions for use, by means of an addition to the labelling or, failing that, by means of an official publication.

2. Every applicant shall be required to have a permanent office within the Community.

3. Member States may require that applications for authorization be submitted in their national or official languages or one of those languages. They may also require that samples of the preparation and of its ingredients be provided.

4. Each Member State shall agree to consider any application for authorization made to it and shall decide thereon within a reasonable period, provided that it has the necessary scientific and technical structures at its disposal.

5. Member States shall ensure that a file is compiled on each application. Each file shall contain at least a copy of the application, a record of the administrative decisions taken by the Member State concerning the application and concerning the particulars and documentation laid down in Article 13 (1) together with a summary of the latter. Member States shall on request make available to the other Member States and to the Commission the files provided for in this paragraph; they shall supply to them on request all information necessary for full comprehension of applications, and shall where requested ensure that applicants provide a copy of the technical documentation laid down in Article 13 (1) (a).







Mutual recognition of authorizations

Article 10

1. At the request of the applicant, who must substantiate the claim to comparability with documentary evidence, a Member State to which an application is made for the authorization of a plant protection product already authorized in another Member State must:

— refrain from requiring the repetition of tests and analyses already carried out in connection with the authorization of the product in that Member State, and to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned, and

— to the extent that the uniform principles have been adopted in accordance with Article 23, where the product contains only active substances listed in Annex I, also authorize the placing of that product on the market in its territory, to the extent that agricultural, plant health and environmental (including climatic) conditions relevant to the use of the product are comparable in the regions concerned.

Authorization may be subject to conditions resulting from the implementation of other measures in accordance with Community law, relating to the conditions for distribution and use of plant protection products intended to protect the health of the distributors, users and workers concerned.

Subject to compliance with the Treaty, authorization may also be accompanied by restrictions on use arising from differences in dietary patterns and necessary in order to avoid exposure of consumers of treated products to the risks of dietary contamination in excess of the acceptable daily intake of the residues concerned.

Authorization may be subject, with the agreement of the applicant, to changes in the conditions of use in order to render, in the regions concerned, any non-comparable agricultural, plant health or environmental (including climatic) conditions irrelevant for the purpose of comparability.

2. Member States shall inform the Commission of cases where they have required repetition of a test and of cases where they have refused to authorize a plant protection product already authorized in another Member State, in respect of which the applicant had claimed that the agricultural, plant health and environmental (including climatic) conditions relevant to use of the product in the regions concerned in the Member State where the test was carried out or for which authorization was granted were comparable to those in their own territory. They shall notify the Commission of the grounds on which repetition of the test was required or authorization was refused.

3. Without prejudice to Article 23, in cases where a Member State refuses to recognize comparability and accept tests and analyses or authorize the placing on the market of a plant protection product in the relevant regions of its territory, the decision as to whether or not comparability exists shall be taken in accordance with the procedure laid down in Article 19 and, if the decision is negative, it shall also specify the conditions of use under which the non-comparability may be deemed irrelevant. In this procedure account shall be taken, inter alia, of the serious ecological vulnerability problems that may arise in certain Community regions or zones thereby requiring, if they do arise, specific protection measures. The Member State shall without delay accept the tests and analyses or authorize the placing of the plant protection product on the market, subject in the latter case to any terms which the above decision may set.

Article 11

1. Where a Member State has valid reasons to consider that a product which it has authorized or is bound to authorize under Article 10 constitutes a risk to human or animal health or the environment, it may provisionally restrict or prohibit the use and/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.

2. A decision shall be taken on the matter within three months in accordance with the procedure laid down in Article 19.







Exchange of information

Article 12

1. Within a period of one month at the end of each quarter at least, Member States shall inform each other and the Commission in writing of any plant protection products authorized or withdrawn, in accordance with the provisions of this Directive, indicating at least:

— the name or business name of the holder of the authorization,

— the trade name of the plant protection product,

— the type of preparation,

— the name and amount of each active substance which it contains,

— the use or uses for which it is intended,

— the maximum residue levels provisionally established where they have not already been set by Community rules,

— where relevant, the reasons for withdrawal of an authorization,

— the dossier needed for the evaluation of the maximum residue levels provisionally established.

2. Each Member State shall draw up an annual list of the plant protection products authorized in its territory and shall communicate that list to the other Member States and the Commission.

In accordance with the procedure laid down in Article 21 a standardized information system shall be set up to facilitate the application of paragraphs 1 and 2.







Data requirements, data protection and confidentiality

Article 13

1. Without prejudice to Article 10, Member States shall require that applicants for authorization of a plant protection product submit with their application:

(a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and

(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II.

2. By way of derogation from paragraph 1, and without prejudice to the provisions of paragraphs 3 and 4, applicants shall be exempted from supplying the information required under paragraph 1 (b) except for that identifying the active substance if the active substance is already listed in Annex I, taking into account the conditions of inclusion in Annex I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the dossier accompanying the original application.

3. In granting authorizations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:

(a) unless the applicant has agreed with the first applicant that use may be made of such information; or

(b) for a period of 10 years from first inclusion in Annex I of an active substance not on the market two years after the date of notification of this Directive; or

(c) for periods not exceeding 10 years from the date of the decision in each Member State and provided for in existing national rules, concerning an active substance on the market two years after the date of notification of this Directive; and

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(d) for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Annex I, or to vary the conditions for, or to maintain the inclusion of an active substance in Annex I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I, unless the five-year period expires before the period provided for in paragraphs 3 (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.

▼B

4. In granting authorizations, Member States shall not make use of the information referred to in Annex III to the benefit of other applicants:

(a) unless the applicant has agreed with the first applicant that use may be made of such information; or

(b) for a period of 10 years from first authorization of the plant protection product in any Member State, where authorization follows the inclusion in Annex I of any active substance contained in the product; or

(c) for periods not exceeding 10 years and provided for in existing national rules after the first authorization of the plant protection product in each Member State, where that authorization precedes inclusion in Annex I of any active substance contained in the product.

5. Member States, on examination of an application for authorization, shall inform the Commission of instances ►C1 where they consider an active substance as listed ◄ in Annex I, which has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which the active substance was first included in Annex I. They shall transmit to it all data regarding the identify and impurities of the active substance.

6. By way of derogation from paragraph 1, for active substances already on the market two years after notification of this Directive, Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such substances are not included in Annex I.

7. Notwithstanding paragraph 1, and without prejudice to Article 10, where the active substance is listed in Annex I:

(a) applicants for authorization of plant protection products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority of the Member State to which they intend making application: — whether the plant protection product for which an application is to be made is the same as a plant protection product for which authorization has been granted, and — as to the name and address of the holder or holders of the authorization or authorizations. The enquiry shall be supported by evidence that the prospective applicant intends to apply for authorization on his own behalf and that the other information specified in paragraph 1 is available;

(b) the competent authority of the Member State, if satisfied that the applicant intends to apply, shall provide the name and address of the holder or holders of previous relevant authorizations and shall at the time inform the holders of the authorizations of the name and address of the applicant.

The holder or holders of previous authorizations and the applicant shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

Where data is requested with a view to inclusion in Annex I of an active substance already on the market two years after notification of this Directive, the competent authorities of the Member State shall encourage data holders to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals.

If, nevertheless, the applicant and holders of previous authorizations of the same product can still not reach an agreement on the sharing of data, Member States may introduce national measures obliging the applicant and holders of previous authorizations located within their territory to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilizing information, and the reasonable balance of the interests of the parties concerned.

Article 14

Member States and the Commission shall, without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment ( 15 ), ensure that information submitted by applicants involving industrial and commercial secrets is treated as confidential if the applicant wishing to have an active substance included in Annex I or the applicant for authorization of a plant protection product so requests, and if the Member State or the Commission accepts that the applicant's request is warranted.

Confidentiality shall not apply to:

— the names and content of the active substance or substances and the name of the plant protection product,

— the name of other substances which are regarded as dangerous under Directives 67/548/EEC and 78/631/EEC,

— physico-chemical data concerning the active substance and plant protection product,

— any ways of rendering the active substance or plant protection product harmless,

— a summary of the results of the tests to establish the substance's or product's efficacy and harmlessness to humans, animals, plants and the environment,

— recommended methods and precautions to reduce handling, storage, transport, fire or other hazards,

— methods of analysis referred to in Articles 4 (1) (c) and (d) and 5 (1),

— methods of disposal of the product and of its packaging,

— decontamination procedures to be followed in the case of accidential spillage or leakage,

— first aid and medical treatment to be given in the case of injury to persons.

If the applicant subsequently discloses previously confidential information, he shall be required to inform the competent authority accordingly.







Packaging and labelling of plant protection products

Article 15

Article 5 (1) of Directive 78/631/EEC shall apply to all plant protection products not covered by Directive 78/631/EEC.

Article 16

Member States shall take all necessary measures to ensure that the packaging of plant protection products satisfies the following requirements as to labelling.

1. All packaging must show clearly and indelibly the following: (a) the trade name or designation of the plant protection product; (b) the name and address of the holder of the authorization and the authorization number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market; (c) the name and amount of each active substance expressed as provided for in Article 6 of Directive 78/631/EEC and ◄ in particular paragraph (2) (d) of that Article. The name must be as given in the list contained in Annex I to Directive 67/548/EEC or, if not included therein, its ISO common name. If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules; (d) the net quantity of plant protection product given in legal units of measurement; (e) the formulation batch number or some means of identifying it; (f) the particulars required under Article 6 of Directive 78/631/EEC, in particular those mentioned in paragraph 2 (d), (g), (h) and (i), and paragraphs 3 and 4 of that Article and information on first aid; (g) the nature of any special risks for humans, animals or the environment, by means of standard phrases selected as appropriate from those given in Annex IV; (h) safety precautions for the protection of humans, animals or the environment, in the form of standard phrases selected as appropriate from those given in Annex V; (i) the type of action of the plant protection product (e.g. insecticide, growth regulator, weedkiller, etc.); (j) the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc.); (k) the uses for which the plant protection product has been authorized and any specific agricultural, plant health and environmental conditions under which the product may be used or should not be used; (l) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorization; (m) where necessary, the safety interval for each use between application and: — sowing or planting of the crop to be protected, — sowing or planting of succeeding crops, — access by humans or animals, — harvesting, — use or consumption; (n) particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of: — the crop in question, or — subsequent crops; (o) if accompanied by a leaflet, as provided for in paragraph 2, the sentence ‘Read accompanying instructions before use’; (p) directions for safe disposal of the plant protection product and of the packaging; and (q) the expiry date relevant to normal conditions of storage where the shelf life of the product is limited to less than two years.

2. Member States may permit the requirements in paragraph 1 (l), (m) and (n) to be indicated on a separate leaflet accompanying the package if the space available on the package is too small. Such a leaflet shall be regarded as part of the label for the purposes of this Directive.

3. Taking account of the rules in force within their territories regarding the supply of certain plant protection products to certain categories of users, pending Community harmonization, the Member States shall require that it be indicated on the label whether a product is restricted to certain categories of users.

4. In no circumstances may the label of the packaging of a plant protection product bear the indications ‘non-toxic’, ‘harmless’, or similar indications. However, information to the effect that the plant protection product may be used when bees or other non-target species are active, or when crops or weeds are in flower or other such phrases to protect bees or other non-target species may be given on the label, if the authorization relates explicitly to use during the season for bees or other specified organisms and presents minimal hazard to them.

5. Member States may make the placing of plant protection products on the market in their territories subject to their being labelled in their national language or languages, and may require that samples, models or drafts of the packaging, labelling and leaflets referred to in this Article be submitted. By way of derogation from paragraph 1 (g) and (h), Member States may require additional phrases to be clearly and indelibly marked on packaging where they are deemed to be necessary for the protection of human beings, animals or the environment; in that event they shall notify the other Member States and the Commission forthwith of each derogation granted and shall forward the additional phrase or phrases and the reasons for these requirements. In accordance with the procedure laid down in Article 19, a decision shall be taken that the additional phrase or phrases is or are justified and hence that Annexes IV and V must be amended accordingly, or that the Member States concerned must no longer require such phrase(s). The Member State shall be entitled to maintain its requirement until such time as a decision has been taken.







Control measures

Article 17

Member States shall make the necessary arrangements for plant protection products which have been placed on the market and for their use to be officially checked to see whether they comply with the requirements of this Directive and in particular with the requirements of the authorization and information appearing on the label.

The Member States shall report annually before 1 August to the other Member States and the Commission on the results of the inspection measures taken in the previous year.







Administrative provisions

Article 18

1. The Council, acting by a qualified majority on a proposal from the Commission, shall adopt the ‘uniform principles’ referred to in Annex VI.

2. In accordance with the procedure laid down in Article 19 and having regard to current scientific and technical knowledge, the necessary amendments to Annexes II, III, IV, V and VI shall be adopted.

▼M39

Article 19

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health set up pursuant to Article 58 of Regulation (EC) No 178/2002 ( 16 ).

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC ( 17 ) shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its Rules of Procedure.

Article 20

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at 15 days.

Article 21

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

2. Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC shall apply.

▼B







Research and development

Article 22

1. The Member States shall prescribe that any experiment or test for research or development purposes involving the release into the environment of an unauthorized plant protection product may only be carried out after authorization for trial purposes has been granted and under controlled conditions and for limited quantities and areas.

2. The persons concerned shall submit an application to the competent authority of the Member State in whose territory the experiment or test is to be conducted, within time periods prescribed by the Member State before the commencement of the experiment or test, together with a dossier containing all the available data to permit an assessment to be made of possible effects on human or animal health or the possible impact on the environment.

If the proposed experiments or tests referred to in paragraph 1 are liable to have harmful effects on human or animal health or to have an unacceptable adverse influence on the environment, the Member State concerned may either prohibit them or permit them subject to such conditions as it considers necessary to prevent those consequences.

3. Paragraph 2 shall not apply if the Member State has granted the person concerned the right to undertake certain experiments and tests and has determined the conditions under which the experiments and tests have to be undertaken.

4. Common conditions for the application of this Article, in particular the maximum quantities of pesticides that may be released during experiments covered by paragraph 1, and the minimum data to be submitted in accordance with paragraph 2, shall be adopted in accordance with the procedure laid down in Article 19.

5. This Article shall not apply to experiments or tests covered by Part B of Directive 90/220/EEC.







Implementation of the Directive

Article 23

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years following notification thereof. They shall immediately inform the Commission thereof. The uniform principles shall be adopted one year after the date of notification.

When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.

2. Paragraph 1 notwithstanding, Member States need not bring into force laws, regulations and administrative provisions implementing Article 10 (1), second indent, until one year at the latest following adoption of the uniform principles, and only in relation to the requirements of Article 4 (1) (b) to (e) which are covered by the uniform principles thus adopted.

Article 24

This Directive is addressed to the Member States.

▼M22









ANNEX I







ACTIVE SUBSTANCES AUTHORISED FOR USE IN PLANT PROTECTION PRODUCTS Number Common name, identification numbers IUPAC name Purity (1) Entry into force Expiration of inclusion Specific provisions 1 Imazalil CAS No 73790-28-0, 35554-44-0 CIPAC No 335 (±)-1-(β-allyloxy-2,4-dichlorophenylethyl)imidazole or (±)-allyl 1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether 975 g/kg 1.1.1999 31.12.2008 Only uses as fungicide may be authorised For the following uses the following particular conditions apply: — post harvest fruit, vegetable and potato treatments may only be authorised when an appropriate decontamination system is available or a risk assessment has demonstrated to the authorising Member State that the discharge of the treatment solution does not have an unacceptable risk to the environment and in particular to aquatic organisms, — post harvest treatment of potatoes may only be authorised when a risk assessment has demonstrated to the authorising Member State that the discharge of the processing waste from treated potatoes does not have an unacceptable risk to aquatic organisms, — outdoor foliar uses may only be authorised when a risk assessment has demonstrated to the authorising Member State that the use has no unacceptable effects on human and animal health and the environment Date of Standing Committee on Plant Health at which the review report was finalised: 11.7.1997. 2 Azoxystrobin CAS No 131860-33-8 CIPAC No 571 Methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy] phenyl}-3-methoxyacrylate 930 g/kg (Z isomer max. 25 g/kg) 1.7.1998 1.7.2008 Only uses as fungicide may be authorised In the decision-making according to the uniform principles, particular attention should be given to the impact on aquatic organisms. Authorisation conditions should include appropriate risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 22.4.1998 3 Kresoxim-methyl CAS No 143390-89-0 CIPAC No 568 Methyl (E)-2-methoxyimino-2-[2-(o-tolyloxymethyl) phenyl] acetate 910 g/kg 1.2.1999 31.1.2009 Only used as fungicide may be authorised In their decision-making according to the uniform principles, Member States shall pay particular attention to the protection of groundwater under vulnerable conditions Date of Standing Committee on Plant Health at which the review report was finalised: 16.10.1998 4 Spiroxamine CAS No 1181134-30-8 CIPAC No 572 (8-tert-Butyl-1,4-dioxa-spiro [4.5] decan-2-ylmethyl)-ethyl-propylamine 940 g/kg (diastereomers A and B combined) 1.9.1999 1.9.2009 Only uses as a fungicide may be authorised In their decision-making according to the uniform principles, Member States: — must pay particular attention to operator safety and must ensure that the conditions of authorisation include appropriate protective measures, and — must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 12.5.1999 5 Azimsulfuron CAS No 120162-55-2 CIPAC No 584 1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea. 980 g/kg 1.10.1999 1.10.2009 Only uses as herbicide may be authorised Aerial application may not be authorised In their decision making according to the uniform principles, Member States must pay particular attention to the impact on aquatic organisms and terrestrial non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures (e. g. in rice cultivation minimum holding periods for water prior to discharge) Date of Standing Committee on Plant Health at which the review report was finalised: 2.7.1999 6 Fluroxypyr CAS No 69377-81-7 CIPAC No 431 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid 950 g/kg 1.12.2000 30.11.2010 Only uses as herbicide may be authorised In their decision-making according to the uniform principles, Member States: — shall take into account the additional information requested in point 7 of the review report, — must pay particular attention to the protection of groundwater, — must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Member States shall inform the Commission if the requested additional trials and information as outlined in point 7 of the review report were not submitted by 1.12.2000 Date of Standing Committee on Plant Health at which the review report was finalised: 30.11.1999 7 Metsulfuron-methyl CAS No 74223-64-6 EEC No 441 Methyl-2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl)benzoate 960 g/kg 1.7.2001 30.6.2011 Only uses as herbicide may be authorised In their decision making according to the uniform principles, Member States: — must pay particular attention to the protection of groundwater, — must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 16.6.2000 8 Prohexadione-calcium CAS No 127277-53-6 CIPAC No 567 Calcium 3,5-dioxo-4-propionylcyclohexanecarboxylate 890 g/kg 1.10.2000 1.10.2010 Only uses as plant growth regulator may be authorised Date of Standing Committee on Plant Health at which the review report was finalised: 16.6.2000 9 Triasulfuron CAS No 82097-50-5 CIPAC No 480 1-[2-(2-chloroethoxy)phenylsulfonyl]-3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea 940 g/kg 1.8.2001 31.7.2011 Only uses as herbicide may be authorised In their decision making according to the uniform principles, Member States: — must pay particular attention to the protection of groundwater, — must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 13.7.2000 10 Esfenvalerate CAS No 66230-04-4 CIPAC No 481 (S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate 830 g/kg 1.8.2001 31.7.2011 Only uses as insecticide may be authorised In their decision making according to the uniform principles, Member States: — must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Date of Standing Committee on Plant Health at which the review report was finalised: 13.7.2000 11 Bentazone CAS No 25057-89-0 CIPAC No 366 3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide 960 g/kg 1.8.2001 31.7.2011 Only uses as herbicide may be authorised In their decision-making according to the uniform principles, Member States must pay particular attention to the protection of groundwater Date of Standing Committee on Plant Health at which the review report was finalised: 13.7.2000 ▼M22 12 Lambda-cyhalothrin CAS No 91465-08-6 CIPAC No 463 A 1:1 mixture of: (S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate, and (R)-α-cyano-3-phenoxybenzyl (Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate 810 g/kg 1.1.2002 31.12.2011 Only uses as insecticide may be authorised In their decision-making according to the uniform principles, Member States: — must pay particular attention to operator safety, — must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures, — must pay particular attention to the residues in food and especially the acute effects thereof Date of Standing Committee on Plant Health at which the review report was finalised: 19.10.2000 ▼M24 13 Fenhexamid CAS No 126833-17-8 CIPAC No 603 N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexanecarboxamide ≥ 950 g/kg (2) 1 June 2001 31 May 2011 Only uses as a fungicide may be authorised. In decision making according to the Uniform Principles Member States must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000 ▼M23 14 Amitrole CAS No 61-82-5 CIPAC No 90 H-[1,2,4]-triazole-3-ylamine 900 g/kg 1.1.2002 31.12.2011 Only uses as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on amitrole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of operators — must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses — must pay particular attention to the protection of beneficial arthropods — must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures 15 Diquat CAS No 2764-72-9 (ion), 85-00-7 (dibromide) CIPAC No 55 9,10-Dihydro-8a,10a-diazoniaphenanthrene ion (dibromide) 950 g/kg 1.1.2002 31.12.2011 On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures — must pay particular attention to operator safety as related to non-professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures 16 Pyridate CAS No 55512-33.9 CIPAC No 447 6-Chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate 900 g/kg 1.1.2002 31.12.2011 Only uses as herbicide may be authorised For the implementation of the uniform priciples of Annex VI, the conclusions of the review report on pyridate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater — must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures 17 Thiabendazole CAS No 148-79-8 CIPAC No 323 2-Thiazol-4-yl-1H-benzimidazole 985 g/kg 1.1.2002 31.12.2011 Only uses as fungicide may be authorised. Foliar spray applications shall not be authorised For the implementation of the uniform priciples of Annex VI, the conclusions of the review report on thiabendazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater ▼M26 18 Paecilomyces fumosoroseus Apopka strain 97, PFR 97 or CG 170, ATCC20874 Not applicable The absence of secondary metabolites should be checked in each fermentation broth by HPLC 1 July 2001 30 June 2011 Only uses as an insecticide may be authorised Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001 ▼M27 19 DPX KE 459 (flupyrsulfuron-methyl) CAS No 144740-54-5 CIPAC No 577 2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt 903 g/kg (3) 1 July 2001 30 June 2011 Only uses as a herbicide may be authorised. In decision-making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater. Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001. ▼M28 20 Acibenzolar-s-methyl CAS No 135158-54-2 CIPAC No 597 Benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester 970 g/kg 1 November 2001 31 October 2011 Only uses as a plant activator may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. 21 Cyclanilide CAS No 113136-77-9 CIPAC No 586 Not available 960 g/kg 1 November 2001 31 October 2011 Only uses as a plant growth regulator may be authorised. The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. 22 Ferric phosphate CAS No 10045-86-0 CIPAC No 629 Ferric phosphate 990 g/kg 1 November 2001 31 October 2011 Only uses as a molluscicide may be authorised. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001 23 Pymetrozine CAS No 123312-89-0 CIPAC No 593 (E)-6-methyl-4-[(pyridin-3-ylmetylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one 950 g/kg 1 November 2001 31 October 2011 Only uses as an insecticide may be authorised. In decision-making according to the uniform principles Member States must pay particular attention to the protection of aquatic organisms. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. 24 Pyraflufen-ethyl CAS No 129630-19-9 CIPAC No 605 Ethyl-2-chloro-5-(4-chloro-5-difluoromethoxy-1-mhypyrazol-3-yl)-4-fluorophenoxyacetate 956 g/kg 1 November 2001 31 October 2011 Only uses as a herbicide may be authorised. In decision-making according to the uniform principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures. Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001. ▼M29 25 Glyphosate CAS No 1071-83-6 CIPAC No 284 N-(phosphonomethyl)-glycin 950 g/kg 1 July 2002 30 June 2012 Only uses as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crops uses 26 Thifensulfuron-methyl CAS No 79277-27-3 CIPAC No 452 Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl) thiophene-2-carboxylate 960 g/kg 1 July 2002 30 June 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of groundwater, — must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures ▼M30 27 2,4-D CAS No 94-75-7 CIPAC No 1 (2,4-dichlorophenoxy) acetic acid 960 g/kg 1.10.2002 30.9.2012 Only uses as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions — must pay particular attention to the dermal absorption — must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures ▼M31 28 Isoproturon CAS No 34123-59-6 CIPAC No 336 3-(4-isopropylphenyl)-1,1-dimethylurea 970 g/kg 1 January 2003 31 December 2012 Only uses as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on isoproturon, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate, — must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures ▼M32 29 Ethofumesate CAS No 26225-79-6 CICAP No 223 (±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate 960 g/kg 1 March 2003 28 February 2013 Only uses as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethofumesate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States may pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and must apply risk mitigation measures, where appropriate. ▼M33 30 Iprovalicarb CAS No 140923-17-7 CICAP No 620 {2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl] propyl}-carbamic acid isopropylester 950 g/kg (provisional specification) 1 July 2002 30 June 2011 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment: — the specification of the technical material as commercially manufactured must be confirmed and supported by apporpriate analytical data. The test material used in the toxicity dossier should be compared and verified against this specification of the technical material, — Member States must pay particular attention to the protection of operators. 31 Prosulfuron CAS No 94125-34-5 CICAP No 579 1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea 950 g/kg 1 Juli 2002 30 June 2011 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate, — must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. 32 Sulfosulfuron CAS No 141776-32-1 CICAP No 601 1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea 980 g/kg 1 July 2002 30 June 2011 Only uses as a herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulforsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to the protection of aquatic plants and algae. Where apporpriate, risk mitigation measures should be applied, — Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditons. ▼M34 33 Cinidon-ethyl CAS No 142891-20-1 CIPAC No 598 (Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate 940 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions, — should pay particular attention to the protection of aquatic organisms. Conditions of authorisation must include risk-mitigation measures, where appropriate. 34 Cyhalofop butyl CAS No 122008-85-9 CIPAC No 596 Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate 950 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cyhalofop butyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — Member States must carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate, — Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk-mitigation measures, where appropriate. 35 Famoxadone CAS No 131807-57-3 CIPAC No 594 3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione 960 g/kg 1 October 2002 30 September 2012 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms, — Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk-mitigation measures, — Member States should pay particular attention to the protection of operators. 36 Florasulam CAS No 145701-23-1 CIPAC No 616 2′, 6′, 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide 970 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk-mitigation measures, where appropriate. 37 Metalaxyl-M CAS No 70630-17-0 CIPAC No 580 Methyl(R)-2-{[(2,6-dimethylphenyl)methoxy-acetyl] amino} propionate 910 g/kg 1 October 2002 30 September 2012 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment: — particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk-mitigation measures should be applied, where appropriate. 38 Picolinafen CAS No 137641-05-5 CIPAC No 639 4′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide 970 g/kg 1 October 2002 30 September 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk-mitigation measures, where appropriate. ▼M35 39 Flumioxazine CAS No 103361-09-7 CICAP No 578 N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide 960 g/kg 1 January 2003 31 December 2012 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States: — must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate. ▼M36 40 Deltamethrin CAS No 52918-63-5 CIPAC No 333 (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropane carboxylate 980 g/kg 1 November 2003 31 October 2013 Only uses as insecticide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on deltamethrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 18 October 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the operator safety and must ensure that the conditions of authorisation include appropriate protective measures, — should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels, — must pay particular attention to the protection of aquatic organisms, bees and non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate. ▼M37 41 Imazamox CAS No 114311-32-9 CIPAC No 619 (±)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-(methoxymethyl) nicotinic acid 950 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on imazamox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate. 42 Oxasulfuron CAS No 144651-06-9 CIPAC No 626 Oxetan-3-yl 2[(4,6-dimethylpyrimidin-2-yl) carbamoyl-sulfamoyl] benzoate 960 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on oxasulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. — Member States must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied, where appropriate. 43 Ethoxysulfuron CAS No 126801-58-9 CIPAC No 591 3-(4,6-dimethoxypyrimidin-2-yl)-1-(2-ethoxyphenoxy-sulfonyl)urea 950 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethoxysulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. Member States should pay particular attention to the protection of non-target aquatic plants and algae in drainage canals. Risk mitigation measures should be applied where appropriate. 44 Foramsulfuron CAS No 173159-57-4 CIPAC No 659 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea 940 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on foramsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of aquatic plants. Risk mitigation measures should be applied, where appropriate. 45 Oxadiargyl CAS No 39807-15-3 CIPAC No 604 5-tert-butyl-3-(2,4-dichloro-5-propargyloxyphenyl)-1,3,4 oxadiazol-2-(3H)-one 980 g/kg 1 July 2003 30 June 2013 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on oxadiargyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States should pay particular attention to the protection of algae and aquatic plants. Risk mitigation measures should be applied where appropriate. 46 Cyazofamid CAS No 120116-88-3 CIPAC No 653 4-chloro-2cyano-N,N-dimethyl-5-P-tolylimidazole -1-sulfonamide 935 g/kg 1 July 2003 30 June 2013 Only uses as fungicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cyazofamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment — Member States must pay particular attention to the protection of aquatic organisms; — Member States must pay particular attention to the degradation kinetics of the metabolite CTCA in soil, especially for Northern European regions. Risk mitigation measures or use restrictions should be applied where appropriate. ▼M38 47 2,4-DB CAS No 94-82-6 CIPAC No 83 4-(2,4-dichlorophenoxy) butyric acid 940 g/kg 1 January 2004 31 December 2013 Only use as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,4-DB, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: must pay particular attention to the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. 48 Beta-cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 482 (1RS,3RS;1RS,3SR)-3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylic acid (SR)-α-cyano- (4-fluoro-3-phenoxy-phenyl)methyl ester 965 g/kg 1 January 2004 31 December 2013 Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by Annex VI. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures. 49 Cyfluthrin CAS No 68359-37-5 (unstated stereochemistry) CIPAC No 385 (RS),-α-cyano-4-fluoro-3-phenoxybenzyl-(1RS,3RS;1RS,3SR)-3-(2,2-dichlorovinyl)-2,2-dimethycyclopropanecarboxylate 920 g/kg 1 January 2004 31 December 2013 Only use as insecticide may be authorised Uses other than ornamental in greenhouses and seed treatment are currently not adequately supported and have not shown to be acceptable under the criteria required by Annex VI. To support authorisations for such uses, data and information to prove their acceptability to human consumers and the environment will have to be generated and submitted to the Member States. This will be the case in particular for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of foliar treatment in edible crops. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment: Member States must pay particular attention to the protection of non-target arthropods. Conditions of authorisation should include adequate risk mitigation measures. 50 Iprodione CAS No 36734-19-7 CIPAC No 278 3-(3,5-dichlorophenyl)-N-isopropyl-2,4-dioxo-imidazolidine-1-carboximide 960 g/kg 1 January 2004 31 December 2013 Only use as fungicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprodione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment, Member States: — should pay particular attention to the potential for ground water contamination when the active substance is applied at high use rates (in particular use in turf) on acidic soils (pH below 6) under vulnerable climatic conditions, — must carefully consider the risk to aquatic invertebrates if the active substance is applied directly adjacent to surface waters. Risk mitigation measures should be applied, where appropriate. 51 Linuron CAS No 330-55-2 CIPAC No 76 3-(3,4-dichlorophenyl)-1-methoxy-1-methylurea 900 g/kg 1 January 2004 31 December 2013 Only use as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on linuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of wild mammals, non-target arthropods and aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate, — must pay particular attention to the protection of operators. 52 Maleic hydrazide CAS No 123-33-1 CIPAC No 310 6-hydroxy-2H-pyridazin-3-one 940 g/kg The active substance shall comply with Council Directive 79/117/EEC (4), as amended by Council Directive 90/533/EEC (5). 1 January 2004 31 December 2013 Only use as growth regulator may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on maleic hydrazide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include risk mitigation measures, where appropriate, — must pay particular attention to the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate. 53 Pendimethalin CAS No 40487-42-1 CIPAC No 357 N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidene 900 g/kg 1 January 2004 31 December 2013 Only use as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pendimethalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health 3 December 2002 shall be taken into account. In this overall assessment Member States: — must pay particular attention to the protection of aquatic organisms and non-target terrestrial plants. Conditions of authorisation must include risk mitigation measures, where appropriate, — must pay particular attention to the possibility of short-range transport of the active substance in air. ▼M40 54 Propineb CAS No: 12071-83-9 (monomer), 9016-72-2 (homopolymer) CIPAC No: 177 Polymeric zinc 1,2-propylenebis(dithiocarbamate) The technical active substance should comply with the FAO specification 1 April 2004 31 March 2014 Only uses as fungicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on propineb, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the potential for ground water contamination when the active substance is applied in regions with vulnerable soils and/or extreme climatic conditions — Member States should pay particular attention to the protection of small mammals, aquatic organisms and non-target arthropods. Conditions of authorisation should include risk mitigation measures, where appropriate — Member States should observe the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels 55 Propyzamide CAS No: 23950-58-5 CIPAC No: 315 3,5-dichloro-N-(1,1-dimethyl-prop-2-ynyl)benzamide 920 g/kg 1 April 2004 31 March 2014 Only uses as herbicide may be authorised For the implementation of the uniform principles of Annex VI, the conclusions of the review report on propyzamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health 26 February 2003 shall be taken into account. In this overall assessment, Member States: — must pay particular attention to the protection of operators and must ensure that conditions of authorisation include risk mitigation measures, where appropriate — must pay particular attention to the protection of birds and wild mammals in particular if the substance is applied during the breeding season. Conditions of authorisation should include risk mitigation measures, where appropriate ▼M42 56 Mecoprop CAS No 7085-19-0 CIPAC No 51 (RS)-2-(4-chloro-o-tolyloxy)-propionic acid 930 g/kg 1 June 2004 31 May 2014 Only uses as herbicide may be authorised. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on mecoprop, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment: — Member States should pay particular attention to the po