# L_2011106EN.01001101.xml

| 27.4.2011 | EN | Official Journal of the European Union | L 106/11 |
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27.4.2011

EN

Official Journal of the European Union

L 106/11

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COMMISSION IMPLEMENTING DECISION

of 26 April 2011

allowing Member States to extend provisional authorisations granted for the new active substances ascorbic acid, ipconazole, spiromesifen, topramezone, and Pseudomonas sp. strain DSMZ 13134

(notified under document C(2011) 2668)

(Text with EEA relevance)

(2011/252/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 September 2004 the Netherlands received an application from Citrex Nederland BV for the inclusion of the active substance ascorbic acid in Annex I to Directive 91/414/EEC. Commission Decision 2005/751/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 September 2004 the Netherlands received an application from Citrex Nederland BV for the inclusion of the active substance ascorbic acid in Annex I to Directive 91/414/EEC. Commission Decision 2005/751/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 March 2007 the United Kingdom received an application from Kureha GmbH for the inclusion of the active substance ipconazole in Annex I to Directive 91/414/EEC. Commission Decision 2008/20/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 March 2007 the United Kingdom received an application from Kureha GmbH for the inclusion of the active substance ipconazole in Annex I to Directive 91/414/EEC. Commission Decision 2008/20/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 April 2002 the United Kingdom received an application from Bayer CropScience AG for the inclusion of the active substance spiromesifen in Annex I to Directive 91/414/EEC. Commission Decision 2003/105/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 April 2002 the United Kingdom received an application from Bayer CropScience AG for the inclusion of the active substance spiromesifen in Annex I to Directive 91/414/EEC. Commission Decision 2003/105/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) | In accordance with Article 6(2) of Directive 91/414/EEC, in May 2003 France received an application from BASF SE for the inclusion of the active substance topramezone in Annex I to Directive 91/414/EEC. Commission Decision 2003/850/EC (5) 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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(4)

In accordance with Article 6(2) of Directive 91/414/EEC, in May 2003 France received an application from BASF SE for the inclusion of the active substance topramezone in Annex I to Directive 91/414/EEC. Commission Decision 2003/850/EC (5) 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.

| (5) | In accordance with Article 6(2) of Directive 91/414/EEC, in August 2008 the Netherlands received an application from Sourcon-Padena GmbH & Co KG for the inclusion of the active substance Pseudomonas sp. strain DSMZ 13134 in Annex I to Directive 91/414/EEC. Commission Decision 2008/599/EC (6) 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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(5)

In accordance with Article 6(2) of Directive 91/414/EEC, in August 2008 the Netherlands received an application from Sourcon-Padena GmbH & Co KG for the inclusion of the active substance Pseudomonas sp. strain DSMZ 13134 in Annex I to Directive 91/414/EEC. Commission Decision 2008/599/EC (6) 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.

| (6) | 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 3 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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(6)

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 3 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.

| (7) | 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 10 September 2007 (ascorbic acid), on 29 May 2008 (ipconazole), on 9 March 2004 (spiromesifen), on 26 July 2007 (topramezone) and on 3 November 2009 (Pseudomonas sp. strain DSMZ 13134). |
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(7)

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 10 September 2007 (ascorbic acid), on 29 May 2008 (ipconazole), on 9 March 2004 (spiromesifen), on 26 July 2007 (topramezone) and on 3 November 2009 (Pseudomonas sp. strain DSMZ 13134).

| (8) | 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, read in conjunction with Commission Decisions 2009/579/EC (7) (ascorbic acid) and 2009/311/EC (8) (topramezone). |
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(8)

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, read in conjunction with Commission Decisions 2009/579/EC (7) (ascorbic acid) and 2009/311/EC (8) (topramezone).

| (9) | 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 ascorbic acid, ipconazole, spiromesifen, topramezone, and Pseudomonas sp. strain DSMZ 13134 will have been completed within 24 months. |
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(9)

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 ascorbic acid, ipconazole, spiromesifen, topramezone, and Pseudomonas sp. strain DSMZ 13134 will have been completed within 24 months.

| (10) | 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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(10)

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 ascorbic acid, ipconazole, spiromesifen, topramezone, or Pseudomonas sp. strain DSMZ 13134 for a period ending on 30 April 2012 at the latest.

Article 2

This Decision shall expire on 30 April 2012.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 26 April 2011.

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 282, 26.10.2005, p. 18.

2

(3)  
  OJ L 1, 4.1.2008, p. 5.

3

(4)  
  OJ L 43, 18.2.2003, p. 45.

4

(5)  
  OJ L 322, 9.12.2003, p. 28.

5

(6)  
  OJ L 193, 22.7.2008, p. 14.

6

(7)  
  OJ L 198, 30.7.2009, p. 80.

7

(8)  
  OJ L 91, 3.4.2009, p. 25.

8

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