# L_2011049EN.01004001.xml

| 24.2.2011 | EN | Official Journal of the European Union | L 49/40 |
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24.2.2011

EN

Official Journal of the European Union

L 49/40

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COMMISSION DECISION

of 23 February 2011

recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of sedaxane and Bacillus firmus I-1582 in Annex I to Council Directive 91/414/EEC

(notified under document C(2011) 989)

(Text with EEA relevance)

(2011/123/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 Article 6(3) thereof,

Whereas:

| (1) | Directive 91/414/EEC provides for the development of a European Union list of active substances authorised for incorporation in plant protection products. |
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(1)

Directive 91/414/EEC provides for the development of a European Union list of active substances authorised for incorporation in plant protection products.

| (2) | The dossier for the active substance sedaxane was submitted by Syngenta Crop Protection AG to the authorities of France on 18 June 2010 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC. |
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(2)

The dossier for the active substance sedaxane was submitted by Syngenta Crop Protection AG to the authorities of France on 18 June 2010 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC.

| (3) | The dossier for the active substance Bacillus firmus I-1582 was submitted by Bayer CropScience SAS to the authorities of France on 29 September 2010 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC. |
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(3)

The dossier for the active substance Bacillus firmus I-1582 was submitted by Bayer CropScience SAS to the authorities of France on 29 September 2010 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC.

| (4) | The French authorities have indicated to the Commission that, on preliminary examination, the dossiers for the active substances concerned appear to satisfy the data and information requirements set out in Annex II to Directive 91/414/EEC. The dossiers submitted appear also to satisfy the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substances concerned. In accordance with Article 6(2) of Directive 91/414/EEC, the dossiers were subsequently forwarded by the applicants to the Commission and other Member States, and were referred to the Standing Committee on the Food Chain and Animal Health. |
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(4)

The French authorities have indicated to the Commission that, on preliminary examination, the dossiers for the active substances concerned appear to satisfy the data and information requirements set out in Annex II to Directive 91/414/EEC. The dossiers submitted appear also to satisfy the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substances concerned. In accordance with Article 6(2) of Directive 91/414/EEC, the dossiers were subsequently forwarded by the applicants to the Commission and other Member States, and were referred to the Standing Committee on the Food Chain and Animal Health.

| (5) | By this Decision it should be formally confirmed at European Union level that the dossiers are considered as satisfying in principle the data and information requirements set out in Annex II and, for at least one plant protection product containing one of the active substances concerned, the requirements set out in Annex III to Directive 91/414/EEC. |
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(5)

By this Decision it should be formally confirmed at European Union level that the dossiers are considered as satisfying in principle the data and information requirements set out in Annex II and, for at least one plant protection product containing one of the active substances concerned, the requirements set out in Annex III to Directive 91/414/EEC.

| (6) | 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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(6)

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

The dossiers concerning the active substances identified in the Annex to this Decision, which were submitted to the Commission and the Member States with a view to obtaining the inclusion of those substances in Annex I to Directive 91/414/EEC, satisfy in principle the data and information requirements set out in Annex II to that Directive.

The dossiers also satisfy the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substance, taking into account the uses proposed.

Article 2

The rapporteur Member State shall pursue the detailed examination for the dossiers referred to in Article 1 and shall communicate to the Commission the conclusions of its examination accompanied by any recommendations on the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substances referred to in Article 1 and any conditions for that inclusion as soon as possible and by 28 February 2012 at the latest.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 23 February 2011.

For the Commission

John DALLI

Member of the Commission

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

1

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ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

| Common name, CIPAC identification number | Applicant | Date of application | Rapporteur Member State |
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| Sedaxane
  CIPAC No: 833 | Syngenta Crop Protection AG | 18 June 2010 | FR |
| Bacillus firmus I-1582
  CIPAC No: not applicable | Bayer CropScience SAS | 29 September 2010 | FR |

Common name, CIPAC identification number

Applicant

Date of application

Rapporteur Member State

Sedaxane

CIPAC No: 833

Syngenta Crop Protection AG

18 June 2010

FR

Bacillus firmus I-1582

CIPAC No: not applicable

Bayer CropScience SAS

29 September 2010

FR

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