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As part of the marketing authorisation for Cruiser, the Directorate-General for Food put in place a national post-approval monitoring programme. This programme, which is intended to verify the absence of unintentional effects on pollinating insects, and particularly on domestic bees, runs from the 2008 sowing period until spring 2009, and is therefore still under way. Not all of the data have been gathered to date, and not all of the analytical results of samples already taken are available yet.

On 14 October 2008, Afssa received a request from the Ministry of Agriculture's Directorate-General for Food to find out whether the initial data obtained from this programme were likely to modify the conclusions of the previously issued Opinions. The response to this request was issued in an Opinion dated 23 October 2008.
Based on the data available, Afssa concluded that the initial findings of the monitoring programme did not highlight any concerns that would justify a review of the conclusions and recommendations issued in its previous Opinions.
Based on the findings presented, Afssa has also been able to add to the recommendations it had already issued by requiring additional technical measures be implemented without delay to reduce the emission and dispersal of dust when sowing.
All of this information prompted Afssa to issue an Opinion in favour of renewing Cruiser's marketing authorisation; this Opinion was sent to the competent authorities on 14 November 2008.

Reminder: Context

On 20 November 2007, Afssa issued an Opinion on the marketing authorisation application for the plant protection product "Cruiser", as part of a mutual recognition procedure between Member States. The Opinion considered that use of this product resulted in an acceptable short-term risk to bee colonies. However, the long-term risks could not be assessed in their entirety, pending the results of an ongoing study. On 20 December 2007, a second Opinion on the analysis of additional data completing the risk assessment for bees was issued. In this Opinion, Afssa upheld the favourable Opinion it had already issued as regards the marketing authorisation of the product, but developed the recommended precautionary measures to reduce bee exposure via the treated crop.
On 7 January 2008, the French Ministry of Agriculture granted a marketing authorisation for the insecticide Cruiser, with the conditions of use and restrictions put forward by the Agency.
On 13 June 2008, a third Opinion on the examination of data on the risk of groundwater becoming contaminated, supplemented the two earlier Opinions.


For more information

Afssa's Opinions

21 November 2007, Marketing authorisation application for the thiamethoxam-based insecticide Cruiser as part of a mutual recognition procedure

20 December 2007, Conclusions of the assessment of the insecticide Cruiser concerning the long-term risk to bee colonies

25 January 2008, Request for an Opinion on compliance with a management measure put forward for Cruiser

13 June 2008, Conclusions of the assessment of the insecticide Cruiser concerning the groundwater contamination risk

23 October 2008, Conclusions of the assessment of the insecticide Cruiser with regard to the monitoring plan results
Cruiser project: Afssa is examining the initial findings of the post-approval monitoring programme
19 November 2008
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