# L_2007151EN.01004501.xml

| 13.6.2007 | EN | Official Journal of the European Union | L 151/45 |
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13.6.2007

EN

Official Journal of the European Union

L 151/45

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COMMISSION DECISION

of 12 June 2007

allowing Member States to extend provisional authorisations granted for the new active substance novaluron

(notified under document number C(2007) 2454)

(Text with EEA relevance)

(2007/404/EC)

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 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 March 2001 the United Kingdom received an application from Makhteshim Agan Ltd. for the inclusion of the active substance novaluron in Annex I to Directive 91/414/EEC. Commission Decision 2001/861/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 March 2001 the United Kingdom received an application from Makhteshim Agan Ltd. for the inclusion of the active substance novaluron in Annex I to Directive 91/414/EEC. Commission Decision 2001/861/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) | Confirmation of the completeness of the dossier was necessary in order to allow it 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 substance 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 substance and the plant protection product in the light of the requirements laid down by that Directive. |
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(2)

Confirmation of the completeness of the dossier was necessary in order to allow it 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 substance 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 substance and the plant protection product in the light of the requirements laid down by that Directive.

| (3) | For this active substance, 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 applicant. The rapporteur Member State submitted the draft assessment report to the Commission on 19 September 2005. |
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(3)

For this active substance, 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 applicant. The rapporteur Member State submitted the draft assessment report to the Commission on 19 September 2005.

| (4) | Following submission of the draft assessment report by the rapporteur Member State, it has been found to be necessary to request further information from the applicant and to have the rapporteur Member State examine that information and submit its assessment. Therefore, the examination of the dossier 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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(4)

Following submission of the draft assessment report by the rapporteur Member State, it has been found to be necessary to request further information from the applicant and to have the rapporteur Member State examine that information and submit its assessment. Therefore, the examination of the dossier is still ongoing and it will not be possible to complete the evaluation within the timeframe provided for in Directive 91/414/EEC.

| (5) | 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 substance 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 dossier to continue. It is expected that the evaluation and decision-making process with respect to a decision on possible Annex I inclusion for novaluron will have been completed within 24 months. |
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(5)

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 substance 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 dossier to continue. It is expected that the evaluation and decision-making process with respect to a decision on possible Annex I inclusion for novaluron will have been completed within 24 months.

| (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

Member States may extend provisional authorisations for plant protection products containing novaluron for a period not exceeding 24 months from the date of adoption of this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 12 June 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  
  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

1

(2)  
  OJ L 321, 6.12.2001, p. 34.

2

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