Commission Decision of 15 October 2007 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of Adoxophyes orana granulovirus, amisulbrom, emamectin, pyridalil and Spodoptera littoralis nucleopolyhedrovirus in Annex I to Council Directive 91/414/EEC (notified under document number C(2007) 4647) (Text with EEA relevance) (2007/669/EC)
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Address https://gelex.eu/eli/EU/decision/2007/669@2007-10-15/en
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 on the market, and in particular Article 6(3) thereof,
Whereas:
(1) Directive 91/414/EEC provides for the development of a Community list of active substances authorised for incorporation in plant protection products.
(2) A dossier for the active substance Adoxophyes orana granulovirus was submitted by Andermatt Biocontrol GmbH to the authorities of Germany on 29 November 2004 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC. For amisulbrom a dossier was submitted by Nissan Chemical Europe S.A.R.L. to the authorities of the United Kingdom on 24 March 2006 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC. For emamectin a dossier was submitted by Syngenta Ltd. to the authorities of the Netherlands on 23 June 2006 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC. For pyridalil a dossier was submitted by Sumitomo Chemical Agro Europe SAS to the authorities of the Netherlands on 28 March 2006 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC. For Spodoptera littoralis nucleopolyhedrovirus a dossier was submitted by Andermatt Biocontrol GmbH to the authorities of Estonia on 2 January 2007 with an application to obtain its inclusion in Annex I to Directive 91/414/EEC.
(3) The authorities of Germany, the United Kingdom, the Netherlands and Estonia 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 substance concerned. In accordance with Article 6(2) of Directive 91/414/EEC, the dossiers were subsequently forwarded by the applicant to the Commission and other Member States, and were referred to the Standing Committee on the Food Chain and Animal Health.
(4) By this Decision it should be formally confirmed at Community 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 the active substance concerned, the requirements set out in Annex III to Directive 91/414/EEC.
(5) This Decision should not prejudice the right of the Commission to request the applicant to submit further data or information in order to clarify certain points in the dossier.
(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
Without prejudice to Article 6(4) of Directive 91/414/EEC, 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 that Directive, 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 that Directive in respect of one plant protection product containing the active substance, taking into account the uses proposed.
Article 2
The rapporteur Member States shall pursue the detailed examination for the dossiers referred to in Article 1 and shall communicate to the Commission the conclusions of their examination accompanied by a recommendation 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 those inclusions as soon as possible and at the latest within a period of one year from the date of publication of this Decision in the Official Journal of the European Union.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 15 October 2007. For the Commission Markos Kyprianou Member of the Commission
ANNEX
ANNEX ACTIVE SUBSTANCE CONCERNED BY THIS DECISION
Common Name, CIPAC Identification Number Applicant Date of application Rapporteur Member State Adoxophyes orana granulovirus CIPAC-No.: Not applicable Andermatt Biocontrol GmbH 29 November 2004 DE Amisulbrom CIPAC-No.: 789 Nissan Chemical Europe S.A.R.L. 24 March 2006 UK Emamectin CIPAC-No.: 791 Syngenta Ltd. 23 June 2006 NL Pyridalil CIPAC-No.: 792 Sumitomo Chemical Agro Europe SAS 28 March 2006 NL Spodoptera littoralis nucleopolyhedrovirus CIPAC-No.: Not applicable Andermatt Biocontrol GmbH 2 January 2007 EE
Versions
Cited by
- Commission Implementing Regulation (EU) No 828/2013 of 29 August 2013 approving the active substance emamectin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For emamectin the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC.
- Commission Implementing Regulation (EU) No 828/2013 of 29 August 2013 approving the active substance emamectin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands received on 23 June 2006 an application from Syngenta Crop Protection AG for the inclusion of the active substance emamectin in Annex I to Directive 91/414/EEC. Decision 2007/669/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Implementing Regulation (EU) No 193/2014 of 27 February 2014 approving the active substance amisulbrom, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For amisulbrom the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC.
- Commission Implementing Regulation (EU) No 193/2014 of 27 February 2014 approving the active substance amisulbrom, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 24 March 2006 an application from Nissan Chemical Europe S.A.R.L. for the inclusion of the active substance amisulbrom in Annex I to Directive 91/414/EEC. Decision 2007/669/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Implementing Decision of 2 August 2011 allowing Member States to extend provisional authorisations granted for the new active substances acequinocyl, Adoxophyes orana granulovirus, aminopyralid, flubendiamide, mandipropamid, metaflumizone, phosphane, pyroxsulam and thiencarbazone (notified under document C(2011) 5321) (Text with EEA relevance) (2011/490/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in November 2004 Germany received an application from Andermatt Biocontrol GmbH for the inclusion of the active substance Adoxophyes orana granulovirus in Annex I to Directive 91/414/EEC. Commission Decision 2007/669/EC 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.
- Commission Implementing Regulation (EU) No 143/2014 of 14 February 2014 approving the active substance pyridalyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For pyridalyl the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC.
- Commission Implementing Regulation (EU) No 143/2014 of 14 February 2014 approving the active substance pyridalyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC Austria received on 9 October 2006 an application from Sumitomo Chemical Agro Europe S.A.S. for the inclusion of the active substance pyridalyl in Annex I to Directive 91/414/EEC. Decision 2007/669/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Implementing Decision of 10 April 2012 allowing Member States to extend provisional authorisations granted for the new active substances amisulbrom, chlorantraniliprole, meptyldinocap, pinoxaden, silver thiosulphate and tembotrione (notified under document C(2012) 2259) (Text with EEA relevance) (2012/191/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in March 2006 the United Kingdom received an application from Nissan Chemical Europe SARL for the inclusion of the active substance amisulbrom in Annex I to Directive 91/414/EEC. Commission Decision 2007/669/EC 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.
- Commission Implementing Regulation (EU) No 746/2012 of 16 August 2012 approving the active substance Adoxophyes orana granulovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Adoxophyes orana granulovirus the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC.
- Commission Implementing Regulation (EU) No 746/2012 of 16 August 2012 approving the active substance Adoxophyes orana granulovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC Germany received on 29 November 2004 an application from Andermatt Biocontrol GmbH for the inclusion of the active substance Adoxophyes orana granulovirus in Annex I to Directive 91/414/EEC. Decision 2007/669/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Implementing Decision of 18 January 2013 allowing Member States to extend provisional authorisations granted for the new active substances emamectin and maltodextrin (notified under document C(2013) 51) (Text with EEA relevance) (2013/38/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in June 2006 the Netherlands received an application from Syngenta Ltd for the inclusion of the active substance emamectin in Annex I to Directive 91/414/EEC. Commission Decision 2007/669/EC 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.
- Commission Implementing Decision of 25 April 2013 allowing Member States to extend provisional authorisations granted for the new active substances acequinocyl, aminopyralid, ascorbic acid, flubendiamide, gamma-cyhalothrin, ipconazole, metaflumizone, orthosulfamuron, Pseudomonas sp. strain DSMZ 13134, pyridalil, pyroxsulam, spiromesifen, thiencarbazone and topramezone (notified under document C(2013) 2246) (Text with EEA relevance) (2013/205/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in March 2006 the Netherlands received an application from Sumitomo Chemical Agro Europe SAS for the inclusion of the active substance pyridalil in Annex I to Directive 91/414/EEC. Commission Decision 2007/669/EC 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.
- Commission Implementing Regulation (EU) No 367/2013 of 22 April 2013 approving the active substance Spodoptera littoralis nucleopolyhedrovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Spodoptera littoralis nucleopolyhedrovirus the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2007/669/EC.
- Commission Implementing Regulation (EU) No 367/2013 of 22 April 2013 approving the active substance Spodoptera littoralis nucleopolyhedrovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance) Regulation · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC Estonia received on 2 January 2007 an application from Andermatt Biocontrol GmbH for the inclusion of the active substance Spodoptera littoralis nucleopolyhedrovirus in Annex I to Directive 91/414/EEC. Decision 2007/669/EC confirmed that the dossier was complete in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.
- Commission Decision of 24 June 2010 allowing Member States to extend provisional authorisations granted for the new active substances amisulbrom, chlorantraniliprole, meptyldinocap and pinoxaden (notified under document C(2010) 4177) (Text with EEA relevance) (2010/353/EU) Decision · Grade B
In accordance with Article 6(2) of Directive 91/414/EEC, in March 2006 the United Kingdom received an application from Nissan Chemical Europe SARL for the inclusion of the active substance amisulbrom in Annex I to Directive 91/414/EEC. Commission Decision 2007/669/EC 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.