 
EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10574/2021  
[…](2021) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
Annex to Commission Implementing Regulation (EU)  .../... of XXX amending 
Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the 
active substance penflufen and repealing Implementing Regulation (EU) 2018/185  
        
   
EN 1  EN  
Annex  
to   
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of  approval of the 
active substance penflufen and repealing Implementing Regulation (EU) 2018/185  
   
EN 2  EN ANNEX  
In Part B of the Annex to Implementing Regulation (EU) No 540/2011 , the column ‘Specific provisions’ 
of entry 55, on penflufen , is replaced by the following:  
‘PART A  
Only uses to treat cereal seeds  before or during sowing may be authorised, limited to one application every 
third year on the same field.   
PART B  
For the implementation of the uniform principles as referred to in Article 29(6) of Regulat ion (EC) 
No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II 
thereof, shall be taken into account.  
In this overall assessment , Member States shall pay particular attention to:  
(a) the protection of operato rs; 
(b) the protection of birds;  
(c) the protection of groundwater, when the substance is applied to regions with vulnerable soil 
and/or climatic conditions;  
(d) to the residues in surface water abducted for drinking water purposes, in or from areas where 
products containing penflufen are used.  
Conditions of use shall include risk mitigation measures, where appropriate.’  