EU - Amendment on the Conditions of Approval of the Active Substance
Business description
Commission Implementing Regulation (EU) No 22/2013 provides for the approval of the active substance cyflumetofen and the resulting insertion of cyflumetofen in the Annex to Commission Implementing Regulation (EU) No 540/2011. Implementing Regulation (EU) No 22/2013 also provides for the submission of further confirmatory information on the mutagenic potential of metabolite B3 and the dietary exposure thereof and on the risk from cyflumetofen to aquatic vertebrates.
The applicant submitted additional information with a view to rule out the mutagenic potential of metabolite B3 and to confirm an acceptable risk for aquatic vertebrates.
The European Food Safety Authority considered that according to the additional information provided by the applicant, an acceptable risk to aquatic vertebrates is confirmed on a life-cycle basis. Point (c) in the Annex to Implementing Regulation (EU) No 22/2013 should hence be considered addressed. However, concerning metabolite B3, a genotoxic potential could not be excluded from the additional data submitted in accordance with points (a) and (b) of the Annex to Implementing Regulation (EU) No 22/2013.
The Commission has concluded that the additional information provided is not sufficient to exclude the genotoxic potential of metabolite B3 and that the conditions of approval set out in the Annex to Implementing Regulation (EU) No 540/2011 should be restricted to ensure that the use of products containing cyflumetofen is acceptable, in particular concerning the exposure of groundwater to metabolite B3.
Therefore in accordance with Article 21(3) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof, it is necessary and appropriate to restrict the approval of cyflumetofen.
Disclaimer
The content of our website has been compiled with meticulous care and to the best of our knowledge. However, we cannot assume liability on the page content to be up-to-date, complete or accurate.