EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11298/2021 Rev. 0  
[…](2021) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
renewing the approval of the active substance bifenazate 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 I mplementing Regulation (EU) No 540/2011    
EN 2  EN ANNEX I  
Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
Bifenazate  
149877 -41-8 
736 isopropyl 2 -(4-
methoxybiphenyl
-3-
yl)hydrazinoform
ate 980 g/kg  
 
Toluene is of  
toxicological 
concern and must 
not exceed 0.7 
g/kg in the 
technical 
material . 
 
 1 July 2022 30 June  July 2037 Only uses on non -edible crops in permanent greenhouses shall be 
authorised.  
 
For the implementation of the uniform principles, as referred to in 
Article  29(6) of Regulation (EC) No  1107/2009, the conclusions of 
the re newal  report on bifenazate , and in particular Appendices  I and II 
thereof, shall b e taken into account.  
 
In this overall assessment Member States shall pay particular attention 
to: 
- the protection of operators and workers, ensuring that conditions 
of use include the application of adequate personal protective 
equipment;  
- the risk to bees and bumble bees released for pollination in 
permanent greenhouses . 
Conditions of use shall include risk mitigation measures, where 
appropriate . 
The applicant shall submit by [publication office, insert date 
corresponding to two years from the date of entry  into force of this 
Regulation ] to the Commission, the Member States and the Authority 
confirmatory information as regards points 3.6.5 and 3.8.2 of Annex  II 
to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 
2018/605 , in particular an updated assessment of the information 
submitted  previously  and, where relevant, further information to 
confirm the absence of endocrine activity .  
                                                 
1 Further details on the identity and the specification of the active substance are provi ded in the re newal  report .   
EN 3  EN ANNEX II  
The Annex to Implementing Regulation (EU) No 540/2011  is amended as follows:  
(1) in Part A, entry  109 on bifenazate  is deleted;  
(2) in Part B, the following entry is added : 
 
 
No. Common 
Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of 
approval  Expiration of 
approval  Specific  provisions  
“XX Bifenazate  
149877 -41-8 
736 isopropyl 2 -(4-
methoxybipheny
l-3-
yl)hydrazinofor
mate  980 g/kg  
 
Toluene  is of 
toxicological 
concern and 
must not 
exceed 0.7 
g/kg in the 
technical 
material . 
 
 1 July 2022 30 June 2037 Only uses on non -edible crops  in permanent greenhouses shall be authorised.  
 
For the implementation of the uniform principles, as referred to in Article  29(6) of 
Regulation (EC) No  1107/2009, the conclusions of the re newal  report on 
bifenazate , and in particular Appendices I and II th ereof, shall be taken into 
account.  
 
In this overall assessment Member States shall pay particular attention to:  
- the protection of operators and workers, ensuring that conditions of use 
include the application of adequate personal protective equipment;  
- the risk to bees and bumble bees released for pollination in permanent 
greenhouses . 
Conditions of use shall include risk mitigation measures, where appropriate . 
 
The applicant shall submit by [publication office, please insert date corresponding 
to two years from the date of entry into force of this Regulation ] to the 
Commission, the Member States and the Authority confirmatory information as 
regards points  3.6.5 and 3.8.2 of Annex II to Regulation (EC) No  1107/2009, as 
amended by Regulation (EU) 2018/605 , in particular an  updated assessment of the 
information submitted  previously  and, where relevant, further information to 
confirm th e absence of endocrine activity.”  
                                                 
1 Further details on the identity and the specification of the active substance are provided in the re newal  report .   
EN 4  EN