EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2307  rev.1  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for bifenazate in or 
on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for bifenazate in or 
on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty  on the Functioning of the European Union,  
Having regard to Regulation (EC) No  396/2005 of the European Parliament and of the 
Council of 23  February 2005 on maximum residue levels of pesticides in or on food and feed 
of plant and animal origin and amending  Council Directive 91/414/EEC1, and in particular 
Article  14(1) , point (a), and Article 18(1) , point (b), thereof,  
Whereas:  
(1) For bifenazate , maximum residue levels ( ‘MRLs ’) were set in Annex  II to Regulation 
(EC) No  396/2005.  
(2) The approval of the active substance bifenazate was renewed by Commission 
Implementing Regulation (EU) 2022/6982. The consumer risk assessment for edible 
crops could not be finalised,  as relevant information needed to ensure consumer safety 
was not provid ed and the toxicity of a relevant metabolite could not be determined, 
therefore  Regulation (EU) 2022/698  restrict ed the use of the active substance 
bifenazate  to non -edible crops  kept in permanent greenhouses . This was due to data 
gaps3 that could have an  impact on the assessment of residue levels in the different 
crops and due to missing toxicological reference values for metabolite D3598 
(bifenazate -diazene) included in the residue definition.  
(3) According to Article 46 of Regulation (EC) No 1107/20094, Member States can decide 
on the duration of the grace periods  for sale and distribution,  the disposal, storage,  and 
use of existing stocks of the plant protection product concerned . Maximum  grace 
period  granted by Member States  for bifenazate  will expire on  or before  
1 January  2024.  
 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2022/698 of 3 May 2022 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 Implementing Regulation (EU) No 540/2011  (OJ L 130, 4.5.2022, 
p. 3). 
3  European Food Safety Authority’s  conclusion on the u pdated peer review of the pesticide risk 
assessment of the  active substance bifenazate . EFSA Journ al 2021;19(8):6818 . 
4  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market and repealing Council Directives 
79/117/EEC and 91/414/EEC  (OJ L 309 24.1 1.2009, p. 1) . EN 2  EN (4) As b ifenazate based plant protection products  are only approved  to be used in non -
edible crops,  it is appropriate to lower  the MRLs set out for this substance in Annex II  
to Regulation (EC) No 396/2005 and list them in Annex V to by establishing them at 
the limit of determination (‘LOD’)  of that Regulation  once  the grace periods will have 
expired .  
(5) The Commissio n consulted the European Union R eference laboratories for resi dues of 
pesticides as regards the appropriate  LODs. Those laboratories proposed product 
specific LODs that are analytically achievable  for those products for which MRLs are 
established at the LOD . 
(6) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(7) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(8) A reasonable period should be allowed to elapse before the new MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to adapt themselves to the requirements which result from the amendments.  
(9) The measures prov ided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II  and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to t his Regulation.  
Article 2 
 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from … [6 months after the date of entry into force  of this Regulation ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member 
States.  
Done at Brussels,  
 For the Commission  
The President  
 Ursula VON DER LEYEN