# L_2010218EN.01002401.xml

| 19.8.2010 | EN | Official Journal of the European Union | L 218/24 |
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19.8.2010

EN

Official Journal of the European Union

L 218/24

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COMMISSION DECISION

of 17 August 2010

allowing Member States to extend provisional authorisations granted for the new active substances Candida oleophila strain O, potassium iodide and potassium thiocyanate

(notified under document C(2010) 5662)

(Text with EEA relevance)

(2010/457/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 July 2006 the United Kingdom received an application from Bionext SPRL for the inclusion of the active substance Candida oleophila strain O in Annex I to Directive 91/414/EEC. Commission Decision 2007/380/EC (2) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to that Directive. |
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(1)

In accordance with Article 6(2) of Directive 91/414/EEC, in July 2006 the United Kingdom received an application from Bionext SPRL for the inclusion of the active substance Candida oleophila strain O in Annex I to Directive 91/414/EEC. Commission Decision 2007/380/EC (2) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to that Directive.

| (2) | In accordance with Article 6(2) of Directive 91/414/EEC, in September 2004 the Netherlands received an application from Koppert Beheer BV for the inclusion of the active substance potassium iodide in Annex I to Directive 91/414/EEC. Commission Decision 2005/751/EC (3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to that Directive. |
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(2)

In accordance with Article 6(2) of Directive 91/414/EEC, in September 2004 the Netherlands received an application from Koppert Beheer BV for the inclusion of the active substance potassium iodide in Annex I to Directive 91/414/EEC. Commission Decision 2005/751/EC (3) confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to that Directive.

| (3) | In accordance with Article 6(2) of Directive 91/414/EEC, in September 2004 the Netherlands received an application from Koppert Beheer BV for the inclusion of the active substance potassium thiocyanate in Annex I to Directive 91/414/EEC. Decision 2005/751/EC confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to that Directive. |
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(3)

In accordance with Article 6(2) of Directive 91/414/EEC, in September 2004 the Netherlands received an application from Koppert Beheer BV for the inclusion of the active substance potassium thiocyanate in Annex I to Directive 91/414/EEC. Decision 2005/751/EC confirmed that the dossier was complete and could be considered as satisfying, in principle, the data and information requirements of Annexes II and 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 5 February 2008 (Candida oleophila strain O) and on 27 July 2007 (potassium iodide and potassium thiocyanate). |
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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 5 February 2008 (Candida oleophila strain O) and on 27 July 2007 (potassium iodide and potassium thiocyanate).

| (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 timeframe provided for in Directive 91/414/EEC. |
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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 timeframe provided for in Directive 91/414/EEC.

| (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 Candida oleophila strain O, potassium iodide and potassium thiocyanate 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 Candida oleophila strain O, potassium iodide and potassium thiocyanate 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 Candida oleophila strain O, potassium iodide or potassium thiocyanate for a period ending on 31 August 2012 at the latest.

Article 2

This Decision shall expire on 31 August 2012.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 17 August 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 141, 2.6.2007, p. 78.

2

(3)  
  OJ L 282, 26.10.2005, p. 18.

3

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