Avis juridique important

Commission Directive 2001/87/EC of 12 October 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substances Official Journal L 276 , 19/10/2001 P. 0017 - 0020

Commission Directive 2001/87/EC of 12 October 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substances THE COMMISSION OF THE EUROPEAN COMMUNITIES, 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), as last amended by Commission Directive 2001/49/EC(2), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive") France received on 15 October 1996 an application from Novartis (now Syngenta) for the inclusion of the active substance acibenzolar-s-methyl (CGA 245704) in Annex I to the Directive. By Commission Decision 97/865/EC(3) it was confirmed that the dossier was "complete" i.e. it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to the Directive. (2) Greece received a similar application on 27 March 1996 from Rhône Poulenc Agrochimie SA (now Aventis CropScience), concerning cyclanilide (RPA 090946). This application was declared complete by Commission Decision 97/137/EC(4). (3) On 27 August 1998, Germany received an application from W. Neudorff GmbH KG, concerning ferric phosphate. This application was declared complete by Commission Decision 1999/43/EC(5). (4) Germany also received on 4 September 1996 an application from Novartis concerning pymetrozine (CGA 215944). By Commission Decision 97/865/EC this application was declared complete. (5) On 16 June 1997, Belgium received an application from Nihon Nohyaku Co. Ltd, concerning pyraflufen-ethyl. This application was declared complete by Commission Decision 98/242/EC(6). (6) For these five active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the respective applicant. The nominated rapporteur Member States, submitted draft assessment reports concerning the substances to the Commission on 17 December 1998 (acibenzolar-s-methyl), 11 February 1998 (cyclanilide), 30 July 1999 (ferric phosphate), 28 May 1998 (pymethrozine) and 8 July 1999 (pyraflufen-ethyl), respectively. (7) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. The reviews were finalised on 29 June 2001 in the format of the individual Commission review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymethrozine and pyraflufen-ethyl. (8) The dossier and the information from each of the reviews were submitted to the Scientific Committee for Plants. As regards acibenzolar-s-methyl and ferric phosphate, no specific questions were addressed to the Committee. The Committee considered that there were no issues that it wished to raise regarding the active substances in the context of a possible inclusion in Annex I to the Directive(7). The Committee noted that absence of comment should only be interpreted as an indication of no obvious reasons necessitating comment. (9) In its opinion(8) concerning cyclanilide the Committee provided its interpretation of certain effects observed in mice and rabbits and recommended a reassessment of the degradation of the soil metabolite 2,4-dichloraniline. The recommendations of the Committee have been taken into consideration. (10) In its opinion(9) on pymetrozine the Committee assessed certain effects in the context of deriving an acceptable daily intake and an acute reference dose for consumers. (11) In its opinion(10) on pyraflufen-ethyl the Committee concluded that there is generally negligible risk of groundwater contamination for the parent compound and its breakdown products. However, under extreme conditions the fate of certain breakdown products should be assessed carefully. (12) It has appeared from the various examinations made that plant protection products containing any of the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined and detailed in the respective Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substances concerned can be granted in accordance with the provisions of the said Directive. (13) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive. A longer period may also be required for plant protection products containing any of the active substances concerned and other active substances included in Annex I. (14) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where those principles refer to the evaluation of the data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive. It is, therefore, appropriate to provide that the finalised review reports (except for confidential information in the meaning of Article 14 of the Directive) are kept available or made available by the Member States for consultation by any interested parties. If a review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of the active substance concerned in Annex I to the Directive should also be amended in accordance with the Directive. (15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health, HAS ADOPTED THIS DIRECTIVE: Article 1 The table in Annex I to Directive 91/414/EEC shall be amended as set out in the Annex hereto. Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 March 2002. They shall forthwith inform the Commission thereof. When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. However, with regard to evaluation and decision-making pursuant to the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto, the period laid down in the first paragraph is extended for existing provisional authorisations of plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl to 31 March 2003. 3. However for plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl together with another active substance which is in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive amending Annex I to Directive 91/414/EEC to include the substance in the Annex. 4. Member States shall keep available the review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request. Article 3 This Directive shall enter into force on 1 November 2001. Article 4 This Directive is addressed to the Member States. Done at Brussels, 12 October 2001. For the Commission David Byrne Member of the Commission (1) OJ L 230, 19.8.1991, p. 1. (2) OJ L 176, 29.6.2001, p. 61. (3) OJ L 351, 23.12.1997, p. 67. (4) OJ L 52, 22.2.1997, p. 20. (5) OJ L 14, 19.1.1999, p. 30. (6) OJ L 96, 28.3.1998, p. 45. (7) Minutes of the plenary meeting of the Scientific Committee for Plants from 7 March 2001 (acibenzolar-s-methyl). Minutes of the plenary meeting of the Scientific Committee for Plants from 4 June 2001 (ferric phosphate). (8) Opinion of the Scientific Committee for Plants regarding the evaluation of cyclanilide in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/CYCLAN/002-final dated 11 December 2000. (9) Opinion of the Scientific Committee for Plants regarding the evaluation of pymetrozine in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/PYMETR/002-final dated 31 January 2001. (10) Opinion of the Scientific Committee for Plants regarding the evaluation of pyraflufen-ethyl in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/PYRA/-final dated 7 March 2001. ANNEX ENTRIES TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC ">TABLE>"

Commission Directive 2001/87/EC

of 12 October 2001

amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl as active substances

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

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), as last amended by Commission Directive 2001/49/EC(2), and in particular Article 6(1) thereof,

Whereas:

(1) In accordance with Article 6(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive") France received on 15 October 1996 an application from Novartis (now Syngenta) for the inclusion of the active substance acibenzolar-s-methyl (CGA 245704) in Annex I to the Directive. By Commission Decision 97/865/EC(3) it was confirmed that the dossier was "complete" i.e. it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to the Directive.

(2) Greece received a similar application on 27 March 1996 from Rhône Poulenc Agrochimie SA (now Aventis CropScience), concerning cyclanilide (RPA 090946). This application was declared complete by Commission Decision 97/137/EC(4).

(3) On 27 August 1998, Germany received an application from W. Neudorff GmbH KG, concerning ferric phosphate. This application was declared complete by Commission Decision 1999/43/EC(5).

(4) Germany also received on 4 September 1996 an application from Novartis concerning pymetrozine (CGA 215944). By Commission Decision 97/865/EC this application was declared complete.

(5) On 16 June 1997, Belgium received an application from Nihon Nohyaku Co. Ltd, concerning pyraflufen-ethyl. This application was declared complete by Commission Decision 98/242/EC(6).

(6) For these five active substances, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the respective applicant. The nominated rapporteur Member States, submitted draft assessment reports concerning the substances to the Commission on 17 December 1998 (acibenzolar-s-methyl), 11 February 1998 (cyclanilide), 30 July 1999 (ferric phosphate), 28 May 1998 (pymethrozine) and 8 July 1999 (pyraflufen-ethyl), respectively.

(7) The draft assessment reports have been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. The reviews were finalised on 29 June 2001 in the format of the individual Commission review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymethrozine and pyraflufen-ethyl.

(8) The dossier and the information from each of the reviews were submitted to the Scientific Committee for Plants. As regards acibenzolar-s-methyl and ferric phosphate, no specific questions were addressed to the Committee. The Committee considered that there were no issues that it wished to raise regarding the active substances in the context of a possible inclusion in Annex I to the Directive(7). The Committee noted that absence of comment should only be interpreted as an indication of no obvious reasons necessitating comment.

(9) In its opinion(8) concerning cyclanilide the Committee provided its interpretation of certain effects observed in mice and rabbits and recommended a reassessment of the degradation of the soil metabolite 2,4-dichloraniline. The recommendations of the Committee have been taken into consideration.

(10) In its opinion(9) on pymetrozine the Committee assessed certain effects in the context of deriving an acceptable daily intake and an acute reference dose for consumers.

(11) In its opinion(10) on pyraflufen-ethyl the Committee concluded that there is generally negligible risk of groundwater contamination for the parent compound and its breakdown products. However, under extreme conditions the fate of certain breakdown products should be assessed carefully.

(12) It has appeared from the various examinations made that plant protection products containing any of the active substances concerned may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined and detailed in the respective Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substances concerned can be granted in accordance with the provisions of the said Directive.

(13) After inclusion, a reasonable period is necessary to permit Member States to implement the provisions of the Directive on plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive. A longer period may also be required for plant protection products containing any of the active substances concerned and other active substances included in Annex I.

(14) The review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where those principles refer to the evaluation of the data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive. It is, therefore, appropriate to provide that the finalised review reports (except for confidential information in the meaning of Article 14 of the Directive) are kept available or made available by the Member States for consultation by any interested parties. If a review report has to be updated to take account of technical and scientific developments, the conditions for the inclusion of the active substance concerned in Annex I to the Directive should also be amended in accordance with the Directive.

(15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The table in Annex I to Directive 91/414/EEC shall be amended as set out in the Annex hereto.

Article 2

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 March 2002. They shall forthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. However, with regard to evaluation and decision-making pursuant to the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto, the period laid down in the first paragraph is extended for existing provisional authorisations of plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl to 31 March 2003.

3. However for plant protection products containing acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine or pyraflufen-ethyl together with another active substance which is in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive amending Annex I to Directive 91/414/EEC to include the substance in the Annex.

4. Member States shall keep available the review reports for acibenzolar-s-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufen-ethyl (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.

Article 3

This Directive shall enter into force on 1 November 2001.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 12 October 2001.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 230, 19.8.1991, p. 1.

(2) OJ L 176, 29.6.2001, p. 61.

(3) OJ L 351, 23.12.1997, p. 67.

(4) OJ L 52, 22.2.1997, p. 20.

(5) OJ L 14, 19.1.1999, p. 30.

(6) OJ L 96, 28.3.1998, p. 45.

(7) Minutes of the plenary meeting of the Scientific Committee for Plants from 7 March 2001 (acibenzolar-s-methyl).

Minutes of the plenary meeting of the Scientific Committee for Plants from 4 June 2001 (ferric phosphate).

(8) Opinion of the Scientific Committee for Plants regarding the evaluation of cyclanilide in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/CYCLAN/002-final dated 11 December 2000.

(9) Opinion of the Scientific Committee for Plants regarding the evaluation of pymetrozine in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/PYMETR/002-final dated 31 January 2001.

(10) Opinion of the Scientific Committee for Plants regarding the evaluation of pyraflufen-ethyl in the context of Directive 91/414/EEC concerning the placing of plant protection products on the market. SCP/PYRA/-final dated 7 March 2001.

ANNEX

ENTRIES TO BE INSERTED IN THE TABLE IN ANNEX I TO DIRECTIVE 91/414/EEC

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