Council Directive 94/43/EC of 27 July 1994 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market

• Published date: 01 September 1994
• Subject Matter: Plant health legislation,Approximation of laws
• Official Gazette Publication: Official Journal of the European Communities, L 227, 1 September 1994

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31994L0043

Council Directive 94/43/EC of 27 July 1994 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market

Official Journal L 227 , 01/09/1994 P. 0031 - 0055
Finnish special edition: Chapter 3 Volume 61 P. 0003
Swedish special edition: Chapter 3 Volume 61 P. 0003

COUNCIL DIRECTIVE 94/43/EC of 27 July 1994 establishing Annex VI to Directive 91/414/EEC concerning the placing of plant protection products on the market

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 18 (1) thereof,

Having regard to the proposal from the Commission,

Whereas Annex VI to Directive 91/414/EEC lays down uniform principles aiming to ensure that the Member States, in deciding on authorizations for plant protection products, apply the requirements of Article 4 (1) (b), (c), (d) and (e) of the Directive in an equivalent manner and at the high level of protection of human and animal health and the environment sought by the Directive;

Whereas it is therefore necessary to lay down detailed principles concerning the evaluation of information on plant protection products supplied by applicants and the decision to be made on authorization on the basis of the results of that evaluation;

Whereas such principles have to be laid down for each of the different requirements provided for in Article 4 (1) (b), (c), (d) and (e);

Whereas, initially, it is desirable to lay down uniform principles for chemical plant protection products only; whereas it therefore remains for the uniform principles for products containing micro-organisms to be laid down in accordance with the same procedure as provided for in Article 18 (1) of the Directive 91/414/EEC;

Whereas the provisions of this Directive on the protection of water are without prejudice to Member States' obligations under the Directives concerning the protection of water, and in particular Directives 75/440/EEC (2), 80/68/EEC (3) and 80/778/EEC (4);

Whereas a review of the abovementioned Directives is necessary and this should be carried out as soon as possible;

Whereas, pending such review, the provisions of this Directive concerning the protection of water are transitional in nature;

Whereas it is important to evaluate the impact of the use of plant protection products on groundwater, but whereas the models currently available do not enable a precise estimate to be made of the foreseeable concentration in such water; whereas it is therefore necessary to re-examine the provisions of Part C, point 2.5.1.2 (b) of Annex VI to Directive 91/414/EEC as soon as models validated at Community level enable such concentration to be estimated precisely,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex VI to Directive 91/414/EEC is hereby established as set out in the Annex to this Directive.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than one year after its entry into force.

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 reference shall be laid down by the Member States.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 27 July 1994.

For the Council,

The President

Th. WAIGEL

(1) OJ No L 230, 19. 8. 1991, p. 1. Directive as amended by Commission Directive 93/71/EEC (OJ No L 221, 31. 8. 1993, p. 27).(2) Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (OJ No L 194, 25. 7. 1975, p. 26. Directive as last amended by Directive 91/692/EEC (OJ No L 377, 31. 12. 1991, p. 48).(3) Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (OJ No L 20, 26. 1. 1980, p. 43). Directive as last amended by Directive 91/692/EEC (OJ No L 377, 31. 12. 1991, p. 48).(4) Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (OJ No L 229, 30. 8. 1980, p. 11). Directive as last amended by Directive 91/692/EEC (OJ No L 377, 31. 12. 1991, p. 48).

ANNEX

UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORIZATION OF PLANT PRODUCTION PRODUCTS

CONTENTS

A. INTRODUCTION

B. EVALUATION

1. General principles

2. Specific principles

2.1. Efficacy

2.2. Absence of unacceptable effects on plants or plant products

2.3. Impact on vertebrates to be controlled

2.4. Impact on human or animal health

2.4.1. arising from the plant protection product

2.4.2. arising from residues

2.5. Influence on the environment

2.5.1. Fate and distribution in the environment

2.5.2. Impact on non-target species

2.6. Analytical methods

2.7. Physical and chemical properties

C. DECISION-MAKING

1. General principles

2. Specific principles

2.1. Efficacy

2.2. Absence of unacceptable effects on plants or plant products

2.3. Impact on vertebrates to be controlled

2.4. Impact on human or animal health

2.4.1. arising from the plant protection product

2.4.2. arising from residues

2.5. Influence on the environment

2.5.1. Fate and distribution in the environment

2.5.2. Impact on non-target species

2.6. Analytical methods

2.7. Physical and chemical properties

A. INTRODUCTION

1. The principles developed in this Annex aim to ensure that evaluations and decisions with regard to authorization of plant protection products, provided they are chemical preparations, result in the implementation of the requirements of Article 4 (1) (b), (c), (d) and (e) of this Directive by all the Member States at the high level of protection of human and animal health and the environment.

2. In evaluating applications and granting authorizations Member States shall:

(a) - ensure that the dossier supplied is in accordance with the requirements of Annex III, at the latest at the time of finalization of the evaluation for the purpose of decision-making without prejudice, where relevant, to the provisions of Article 13 (1) (a), (4) and (6) of this Directive,

- ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,

- evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

(b) take into account the Annex II data concerning the active substance in the plant protection product, submitted for the purpose of inclusion of the active substance concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13 (1) (b), (2), (3) and (6) of this Directive;

(c) take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its residues.

3. Where in the specific principles on evaluation reference is made to Annex II data, this shall be understood as being the data referred to in point 2 (b).

4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.

Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for which the data gaps are such that it is not possible to finalize the evaluation and to make a reliable decision for at least one of the proposed uses.

5. During the process of evaluation and decision-making, Member States shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of this Directive.

Member States shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of Annex III.

6. The judgments made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognized at international level (for example, by the EPPO), and be made with the benefit of expert advice.

B. EVALUATION

1. General principles

1. Having regard to current scientific and technical knowledge, Member States shall evaluate the information referred to in Part A, point 2, and in particular:

(a) assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorization is sought; and

(b) identify the hazards arising, assess their significance and make a judgment as to the likely risks to humans, animals or the environment.

2. In accordance with the terms of Article 4 of this Directive, which inter alia specifies that Member States shall have regard to all normal conditions under which the plant protection product may be used, and to the consequences of its use, Member States shall ensure that evaluations...