L_2005090EN.01000101.xml
| 8.4.2005 | EN | Official Journal of the European Union | L 90/1 |
COUNCIL DIRECTIVE 2005/25/EC
of 14 March 2005
amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EC 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:
| (1) | In accordance with Directive 91/414/EEC, Member States have to ensure that plant protection products are not authorised unless they comply with the requirements provided for in that Directive. |
| (2) | Directive 91/414/EEC provides for the establishment of Uniform Principles pursuant to which the Member States have to carry out the evaluation of plant protection products with a view to their authorisation. |
| (3) | Uniform Principles have been laid down for Member States to use in the evaluation and authorisation of chemical plant protection products only. However, there are no equivalent principles for Member States to apply in the evaluation and authorisation of plant protection products containing micro-organisms. It is appropriate to lay down additional Uniform Principles for this type of plant protection product. |
| (4) | Requirements for the dossiers to be submitted by applicants for the authorisation of plant protection products containing micro-organisms having been included in Directive 91/414/EEC by Commission Directive 2001/36/EEC (2), it is now necessary to lay down Uniform Principles for the evaluation of a dossier concerning plant protection products containing micro-organisms based on such data requirements. |
| (5) | The provisions of this Directive concerning the protection of water, including the provisions related to monitoring, are without prejudice to Member States' obligations under the Directives concerned, and in particular Council Directives 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 (3), 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (4), 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (5) and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (6). |
| (6) | The provisions of this Directive concerning genetically modified organisms are without prejudice to Member States' obligations under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (7). |
| (7) | The Scientific Committee on Plants has provided an opinion on this Directive, and this opinion has been taken into account. |
| (8) | Directive 91/414/EEC should therefore be amended accordingly, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex VI to Directive 91/414/EEC is hereby amended in accordance with the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 May 2006. They shall immediately forward to the Commission the text of those measures together with a correlation table between such measures and this Directive.
When Member States adopt those 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 Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 14 March 2005.
For the Council
The President
F. BODEN
(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2004/99/EC (OJ L 309, 16.10.2004, p. 6).
(2) OJ L 164, 20.6.2001, p. 1.
(3) OJ L 194, 25.7.1975, p. 26. Directive to be repealed from 22.12.2007 by Directive 2000/60/EC (OJ L 327, 22.12.2000, p. 1).
(4) OJ L 20, 26.1.1980, p. 43. Directive to be repealed from 22.12.2013 by Directive 2000/60/EC.
(5) OJ L 330, 5.12.1998, p. 32. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
(6) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).
(7) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).
ANNEX
Annex VI is hereby amended as follows:
| (1) | The title ‘Uniform Principles for evaluation and authorisation of plant protection products’ shall be replaced by ‘PART I UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS’; |
| (2) | The following Part shall be added after Part I ‘PART II UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS’ |
CONTENTS
| 2.1.1. | Identity of the micro-organism in the plant protection product | |
| 2.1.2. | Identity of the plant protection product | |
| 2.2. | Biological, physical, chemical and technical properties | |
| 2.2.1. | Biological properties of the micro-organism in the plant protection product | |
| 2.2.2. | Physical, chemical and technical properties of the plant protection product | |
| 2.3.1. | Quality control of the production of the micro-organism in the plant protection product | |
| 2.3.2. | Quality control of the plant protection product | |
| 2.5. | Identification/detection and quantification methods | |
| 2.5.1. | Analytical methods for the plant protection product | |
| 2.5.2. | Analytical methods for the determination of residues | |
| 2.6. | Impact on human and animal health | |
| 2.6.1. | Effects on human or animal health arising from the plant protection product | |
| 2.6.2. | Effects on human or animal health arising from residues | |
| 2.7. | Fate and behaviour in the environment | |
| 2.8. | Effects on and exposure of non-target organisms | |
| 2.9. | Conclusions and proposals | |
| 2.2. | Biological and technical properties | |
| 2.5. | Identification/detection and quantification methods | |
| 2.6. | Impact on human and animal health | |
| 2.6.1. | Effects on human or animal health arising from the plant protection product | |
| 2.6.2. | Effects on human or animal health arising from residues | |
| 2.7. | Fate and behaviour in the environment | |
| 2.8. | Effects on non-target organisms | |
A. INTRODUCTION
| |
1. | The principles developed in Part II of this Annex aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of Article 4(1)(b), (c), (d) and (e) of this Directive by all Member States at a high level of protection of human and animal health and the environment. |
| |
2. | In evaluating applications for granting authorisations Member States shall:
| (a) |
| — | ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of Annex IIIB, at the latest at the time of finalisation 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 IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism 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 metabolites/toxins. | |
| |
3. | Where, in the specific principles on evaluation, reference is made to Annex IIB data, this shall be understood as being the data referred to in point 2(b). |
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