# L_2010060EN.01002401.xml

| 10.3.2010 | EN | Official Journal of the European Union | L 60/24 |
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10.3.2010

EN

Official Journal of the European Union

L 60/24

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COMMISSION DECISION

of 9 March 2010

allowing Member States to extend provisional authorisations granted for the new active substances flonicamid, silver thiosulphate and tembotrione

(notified under document C(2010) 1255)

(Text with EEA relevance)

(2010/149/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

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 the fourth subparagraph of Article 8(1) thereof,

Whereas:

| (1) | In accordance with Article 6(2) of Directive 91/414/EEC, in December 2003 France received an application from ISK Biosciences Europe SA for the inclusion of the active substance flonicamid in Annex I to Directive 91/414/EEC. Commission Decision 2004/686/EC (2) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive. |
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(1)

In accordance with Article 6(2) of Directive 91/414/EEC, in December 2003 France received an application from ISK Biosciences Europe SA for the inclusion of the active substance flonicamid in Annex I to Directive 91/414/EEC. Commission Decision 2004/686/EC (2) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

| (2) | In accordance with Article 6(2) of Directive 91/414/EEC, in January 2003 the Netherlands received an application from Enhold BV for the inclusion of the active substance silver thiosulphate in Annex I to Directive 91/414/EEC. Commission Decision 2003/850/EC (3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive. |
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(2)

In accordance with Article 6(2) of Directive 91/414/EEC, in January 2003 the Netherlands received an application from Enhold BV for the inclusion of the active substance silver thiosulphate in Annex I to Directive 91/414/EEC. Commission Decision 2003/850/EC (3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

| (3) | In accordance with Article 6(2) of Directive 91/414/EEC, in November 2005 Austria received an application from Bayer CropScience AG for the inclusion of the active substance tembotrione in Annex I to Directive 91/414/EEC. Commission Decision 2006/586/EC (4) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive. |
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(3)

In accordance with Article 6(2) of Directive 91/414/EEC, in November 2005 Austria received an application from Bayer CropScience AG for the inclusion of the active substance tembotrione in Annex I to Directive 91/414/EEC. Commission Decision 2006/586/EC (4) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to that Directive.

| (4) | Confirmation of the completeness of the dossiers was necessary in order to allow them to be examined in detail and to allow Member States the possibility of granting provisional authorisations, for periods of up to three years, for plant protection products containing the active substances concerned, while complying with the conditions laid down in Article 8(1) of Directive 91/414/EEC and, in particular, the condition relating to the detailed assessment of the active substances and the plant protection products in the light of the requirements laid down by that Directive. |
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(4)

Confirmation of the completeness of the dossiers was necessary in order to allow them to be examined in detail and to allow Member States the possibility of granting provisional authorisations, for periods of up to three years, for plant protection products containing the active substances concerned, while complying with the conditions laid down in Article 8(1) of Directive 91/414/EEC and, in particular, the condition relating to the detailed assessment of the active substances and the plant protection products in the light of the requirements laid down by that Directive.

| (5) | For these 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 Directive 91/414/EEC, for the uses proposed by the applicants. The rapporteur Member States submitted the respective draft assessment reports to the Commission on 3 June 2005 (flonicamid), on 9 November 2005 (silver thiosulphate) and on 2 February 2007 (tembotrione). |
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(5)

For these 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 Directive 91/414/EEC, for the uses proposed by the applicants. The rapporteur Member States submitted the respective draft assessment reports to the Commission on 3 June 2005 (flonicamid), on 9 November 2005 (silver thiosulphate) and on 2 February 2007 (tembotrione).

| (6) | Following submission of the draft assessment reports by the rapporteur Member States, it has been found to be necessary to request further information from the applicants and to have the rapporteur Member States examine that information and submit their assessment. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the evaluation within the time-frame provided for in Directive 91/414/EEC, read in conjunction with Commission Decision 2008/353/EC (5) (flonicamid) and with Commission Decision 2008/56/EC (6) (silver thiosulphate). |
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(6)

Following submission of the draft assessment reports by the rapporteur Member States, it has been found to be necessary to request further information from the applicants and to have the rapporteur Member States examine that information and submit their assessment. Therefore, the examination of the dossiers is still ongoing and it will not be possible to complete the evaluation within the time-frame provided for in Directive 91/414/EEC, read in conjunction with Commission Decision 2008/353/EC (5) (flonicamid) and with Commission Decision 2008/56/EC (6) (silver thiosulphate).

| (7) | As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility of prolonging provisional authorisations granted for plant protection products containing the active substances concerned for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination of the dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on a possible inclusion in Annex I to that Directive for flonicamid, silver thiosulphate and tembotrione will have been completed within 24 months. |
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(7)

As the evaluation so far has not identified any reason for immediate concern, Member States should be given the possibility of prolonging provisional authorisations granted for plant protection products containing the active substances concerned for a period of 24 months in accordance with the provisions of Article 8 of Directive 91/414/EEC so as to enable the examination of the dossiers to continue. It is expected that the evaluation and decision-making process with respect to a decision on a possible inclusion in Annex I to that Directive for flonicamid, silver thiosulphate and tembotrione will have been completed within 24 months.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

Member States may extend provisional authorisations for plant protection products containing flonicamid, silver thiosulphate or tembotrione for a period ending on 31 May 2012 at the latest.

Article 2

This Decision shall expire on 31 May 2012.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 9 March 2010.

For the Commission

John DALLI

Member of the Commission

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

1

(2)  
  OJ L 313, 12.10.2004, p. 21.

2

(3)  
  OJ L 322, 9.12.2003, p. 28.

3

(4)  
  OJ L 236, 31.8.2006, p. 31.

4

(5)  
  OJ L 117, 1.5.2008, p. 45.

5

(6)  
  OJ L 14, 17.1.2008, p. 26.

6

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