Avis juridique important

Commission Directive 2000/49/EC of 26 July 2000 including an active substance (metsulfuron-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market Official Journal L 197 , 03/08/2000 P. 0032 - 0034

Commission Directive 2000/49/EC of 26 July 2000 including an active substance (metsulfuron-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market 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 2000/10/EC(2), and in particular Article 6(1) and the fourth subparagraph of Article 8(2) thereof, Whereas: (1) Commission Regulation (EEC) No 3600/92(3), as last amended by Regulation (EC) No 1972/1999(4), has laid down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive"). Pursuant to that Regulation, Commission Regulation (EC) No 933/94(5), as last amended by Regulation (EC) No 2230/95(6), lays down the list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to the Directive. (2) Those active substances should be included in that Annex when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment. (3) Such inclusions should be made for a period not exceeding 10 years. (4) Article 8(2) of the Directive provides that after inclusion of an active substance in its Annex I, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorisations of the plant protection products containing the active substance. In particular, Articles 4(1) and 13(1) of the Directive require that plant protection products are not authorised unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in Annex VI on the basis of a dossier satisfying the data requirements laid down in its Article 13. (5) For metsulfuron-methyl the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a number of uses proposed by the notifiers. France, acting as designated rapporteur Member State under Regulation (EC) No 933/94 submitted to the Commission on 25 June 1997 the relevant assessment report. (6) The said report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. This review was finalised on 16 June 2000 in the format of the Commission review report for metsulfuron-methyl. (7) The dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation. The Scientific Committee for Plants in its opinion(7), confirmed that the substance can be used without unacceptable risk but noted that Member States should assess the leaching potential to groundwater in particularly vulnerable locations and should apply risk mitigation measures to protect the aquatic environment. (8) It appears from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a) and (b) of the Directive, in particular with regard to the uses which were examined. Therefore it is appropriate to include the active substance concerned in Annex I, in order to ensure that in all Member States the granting, varying or withdrawing, as appropriate, of the authorisations of plant protection products containing metsulfuron-methyl can be organised in accordance with the provisions of the Directive. (9) Before inclusion, a reasonable deadline is necessary to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. Moreover, after inclusion, a reasonable period is necessary for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorisations or grant new authorisations in accordance with the provisions of Directive 91/414/EEC. A longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive. For plant protection products containing several active substances, the complete evaluation on the basis of the uniform principles can only be carried out when all the active substances concerned have been included in Annex I to the Directive. (10) It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties. (11) 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 these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive. (12) 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 Metsulfuron-methyl is hereby designated as an active substance in Annex I to Directive 91/414/EEC, 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 December 2001. In particular they shall, in accordance with the provisions of Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing metsulfuron-methyl as an active substance within such period. 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 plant protection products containing metsulfuron-methyl as the only active substance to four years from the entry into force of this Directive, - for plant protection products containing metsulfuron-methyl together with another active substance which is in Annex I to Directive 91/414/EEC, to four years from the entry into force of such Directive as shall include the last of those substances in Annex I. 3. Member States shall keep available the review report (except for confidential information in the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request. 4. When Member States adopt the provisions referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Article 3 This Directive shall enter into force on 1 July 2001. Article 4 This Directive is addressed to the Member States. Done at Brussels, 26 July 2000. For the Commission David Byrne Member of the Commission (1) OJ L 230, 19.8.1991, p. 1. (2) OJ L 57, 2.3.2000, p. 28. (3) OJ L 366, 15.12.1992, p. 10. (4) OJ L 244, 16.9.1999, p. 41. (5) OJ L 107, 28.4.1994, p. 8. (6) OJ L 225, 22.9.1995, p. 1. (7) Scientific Committee for Plants SCP/METSU/002-final, 5 April 2000. ANNEX Metsulfuron-methyl 1. Identity: >TABLE> 2. Particular conditions to be fulfilled: 2.1. The active substance as manufactured shall have a minimum purity of 960 g/kg. 2.2. Only uses as herbicide may be authorised. 2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metsulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 16 June 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 impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures. 3. Expiry date of the inclusion: 30 June 2011.

Commission Directive 2000/49/EC

of 26 July 2000

including an active substance (metsulfuron-methyl) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market

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 2000/10/EC(2), and in particular Article 6(1) and the fourth subparagraph of Article 8(2) thereof,

Whereas:

(1) Commission Regulation (EEC) No 3600/92(3), as last amended by Regulation (EC) No 1972/1999(4), has laid down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive"). Pursuant to that Regulation, Commission Regulation (EC) No 933/94(5), as last amended by Regulation (EC) No 2230/95(6), lays down the list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to the Directive.

(2) Those active substances should be included in that Annex when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment.

(3) Such inclusions should be made for a period not exceeding 10 years.

(4) Article 8(2) of the Directive provides that after inclusion of an active substance in its Annex I, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorisations of the plant protection products containing the active substance. In particular, Articles 4(1) and 13(1) of the Directive require that plant protection products are not authorised unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in Annex VI on the basis of a dossier satisfying the data requirements laid down in its Article 13.

(5) For metsulfuron-methyl the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a number of uses proposed by the notifiers. France, acting as designated rapporteur Member State under Regulation (EC) No 933/94 submitted to the Commission on 25 June 1997 the relevant assessment report.

(6) The said report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. This review was finalised on 16 June 2000 in the format of the Commission review report for metsulfuron-methyl.

(7) The dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation. The Scientific Committee for Plants in its opinion(7), confirmed that the substance can be used without unacceptable risk but noted that Member States should assess the leaching potential to groundwater in particularly vulnerable locations and should apply risk mitigation measures to protect the aquatic environment.

(8) It appears from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a) and (b) of the Directive, in particular with regard to the uses which were examined. Therefore it is appropriate to include the active substance concerned in Annex I, in order to ensure that in all Member States the granting, varying or withdrawing, as appropriate, of the authorisations of plant protection products containing metsulfuron-methyl can be organised in accordance with the provisions of the Directive.

(9) Before inclusion, a reasonable deadline is necessary to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. Moreover, after inclusion, a reasonable period is necessary for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorisations or grant new authorisations in accordance with the provisions of Directive 91/414/EEC. A longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive. For plant protection products containing several active substances, the complete evaluation on the basis of the uniform principles can only be carried out when all the active substances concerned have been included in Annex I to the Directive.

(10) It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties.

(11) 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 these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive.

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

HAS ADOPTED THIS DIRECTIVE:

Metsulfuron-methyl is hereby designated as an active substance in Annex I to Directive 91/414/EEC, 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 December 2001. In particular they shall, in accordance with the provisions of Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing metsulfuron-methyl as an active substance within such period.

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 plant protection products containing metsulfuron-methyl as the only active substance to four years from the entry into force of this Directive,

- for plant protection products containing metsulfuron-methyl together with another active substance which is in Annex I to Directive 91/414/EEC, to four years from the entry into force of such Directive as shall include the last of those substances in Annex I.

3. Member States shall keep available the review report (except for confidential information in the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.

4. When Member States adopt the provisions referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.

Article 3

This Directive shall enter into force on 1 July 2001.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 26 July 2000.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 57, 2.3.2000, p. 28.

(3) OJ L 366, 15.12.1992, p. 10.

(4) OJ L 244, 16.9.1999, p. 41.

(5) OJ L 107, 28.4.1994, p. 8.

(6) OJ L 225, 22.9.1995, p. 1.

(7) Scientific Committee for Plants SCP/METSU/002-final, 5 April 2000.

ANNEX

Metsulfuron-methyl

1. Identity:

>TABLE>

2. Particular conditions to be fulfilled:

2.1. The active substance as manufactured shall have a minimum purity of 960 g/kg.

2.2. Only uses as herbicide may be authorised.

2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metsulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 16 June 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 impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

3. Expiry date of the inclusion: 30 June 2011.