EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11428/2020 Rev. 1  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for flupyradifurone 
and difluoroacetic acid in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for flupyradifurone 
and difluoroacetic acid 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) N o 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)(a) and Articl e 49(2) thereof,  
Whereas:  
(1) For flupyradifurone and difluoroacetic acid , maximum residue levels ( 'MRLs ') were 
set in Part A of Annex  III to Regulation (EC) No  396/2005.  
(2) In the context of a procedure for the authorisation of the use of a plant protection 
product containing the active substance flupyradifurone  on strawberries, table olives, 
cauliflowers, broccoli, Brussels sprouts, head cabbages, kales, kohlrabies, “lettuce s 
and salad plants”, “spinaches and similar (leaves)”, “herbs and edible flowers”,  beans, 
peas, rapeseeds/canola seeds , mustard seeds  and olives for oil production , an 
application was submitted in accordance with Article  6(1) of Regulation (EC) 
No 396/2005  for modification of the existing MRLs  for flupyradifurone and its main 
metabolite difluoroacetic acid . 
(3) In accordance with Article  6(2) and (4) of Regulation (EC) No  396/2005 an 
application  for import tolerance s was submitted for flupyradifurone  used in the Unites 
States  on citrus fruits, prickly pears/cactus fruits, cotton seeds, sweet corn, barley, 
maize/corn, sorghum and wheat,  in the United States and Canada on tree nuts, pome 
fruits, grapes, blueberries, “root and tuber vegetables”, tomatoes, sweet p eppers/bell 
peppers, aubergines/eggplants, melons, celeries, pulses, peanuts and soyabeans, in 
Brazil on coffee beans, and in Ghana and Ivory Coast on cocoa beans. The applicant s 
state that the authorised uses of that substance on such crops in those count ries lead to 
residues exceeding the MRLs contained in Regulation (EC) No 396/2005  for 
flupyradifurone and difluoroacetic acid  and that higher MRLs are necessary to avoid 
trade barriers for the import of those crops.  
                                                 
1 OJ L 70, 16.3.2005, p.  1. 
 EN 2  EN (4) In the context of these applications, the applicant submitted to the Rapporteur Member 
State, the Netherlands, the additional rotational crop field studies and livestock feeding 
studies within the deadline set under Commission Regulation (EU) 2016/4862. 
(5) In accordance with Article  8 of Regulation  (EC) No  396/2005, those applications were  
evaluated by the the Netherlands,  and the evaluation reports were forwarded to the 
Commission.  
(6) The European Food Safety Authority ('the Authority') assessed the applications and 
the evaluation reports, examining i n particular the risks to the consumer and, where 
relevant, to animals and gave reasoned opinions on the proposed MRLs3. It forwarded 
those opinions to the applicants, the Commission and the Member States and made 
them available to the public.  
(7) As regards a ll applications, the Authority concluded that all requirements with respect 
to data were met and that the modifications to the MRLs requested by the applicants 
were acceptable with regard to consumer safety on the basis of a consumer exposure 
assessment for 27  specific European consumer groups. It took into account the most 
recent information on the toxicological properties of the substances. Neither the 
lifetime exposure to these substances via consumption of all food products that may 
contain them, nor the short -term exposure due to high consumption of the relevant 
products showed that there is a risk that the acceptable daily intake or the acute 
reference dose is exceeded.  
(8) Following the assessment of the additional rotational crop field studies and live stock 
feeding studies , the Authority recommended raising , lowering  or keeping the existing 
MRLs  for flupyradifurone and difluoroacetic acid in rotational crops and products of 
animal origin . These MRLs should be set in Annex  II to Regulation (EC) No  396/20 05 
at the existing level s or the level s identified by the Authority.  
(9) Based on the reasoned opinions  of the Authority and taking into account the factors 
relevant to the matter under consideration, the respective modifications to the MRLs 
fulfil the require ments of Article  14(2) of Regulation (EC) No  396/2005.  
(10) 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.  
(11) Regulation (EC) No  396/2005 should therefore be a mended accordingly.  
(12) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional measure for products which have been 
produced before the modification of the MRLs and for which inform ation shows that a 
high level of consumer protection is maintained.  
                                                 
2 Commission Regulation (EU) 2016/486 of 29 March 2016 amending Annexes II and III to Regulation 
(EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels 
for cyazofamid, cycloxydim, difluoroacetic acid, fenoxycarb, flumetralin, fluopicolide, flupyradifurone, 
fluxapyroxad, kresoxim -methyl, mandestrobin, mepanipyrim, metalaxyl -M, pendimethalin an d 
tefluthrin in or on certain products  (OJ L 90, 6.4.2016, p.  1). 
3 EFSA scientific reports available online: http://www.efsa.europa.eu : 
Reasoned opinion on the setting of import tolerances, modification of existing maximum residue levels 
and evaluation of confirmatory data following the Article 12 MRL review for flupyradifurone and DFA . 
EFSA Journal 2020;18(6):6133 . 
Reasoned opinion on the  modification of the existing maximum residue levels for flupyradifuro ne and 
DFA in rapeseeds/canola seeds and mustard seeds . EFSA Journal 2020;18(11):6298 . EN 3  EN (13) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to prepare themsel ves to meet the new requirements which will result from 
the modification of the MRLs.  
(14) The measures provided 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 III to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
Regulation (EC) No  396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which wer e produced in the Union or imported  into the Union 
before [ Office of Publication: please insert date 6   months after entry into force ]. 
Article 3  
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 [ Office of Publication: please insert date 6 months after entry into force ]. 
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