EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12078/2020 Rev. 6  
[…](2021) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for 2,4 -D, azoxystrobin, cyhalofop -butyl, 
cymoxanil, fenhexamid, flazasulfuron, florasulam, fluroxypyr, iprovalicarb and 
silthi ofam in or on certain products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the E uropean Parliament and of 
the Council as regards maximum residue levels for 2,4 -D, azoxystrobin, cyhalofop -butyl, 
cymoxanil, fenhexamid, flazasulfuron, florasulam, fluroxypyr, iprovalicarb and 
silthiofam in or on certain products  
(Text with EEA re levance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functio ning 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)(a) and Article 49(2) thereof,  
Whereas:  
(1) For 2,4-D, azoxystrobin, cyhalofop -butyl, cymoxanil, fenhexamid , flazasulfuron, 
florasu lam, fluroxypyr, iprovalicarb  and silthiofam maximum residue levels (MRLs) 
were set in Annex  II to Regulation (EC) No  396/2005.  
(2) During the review of  those MRL s in accordance with Article 12 of Regulation (EC) 
No 396/2005 , the European Food Safety Authority ("the Authority" ) identified some 
information as unavailable for cer tain produc ts. The available information was 
sufficient for the Authority to propose  MRL s that are safe for consumers and  the data 
gaps were indicated in Annex II of that  Regulation specifying  the date by which th e 
missing  information was to be submitted to the Authority in support of the proposed 
MRL s. 
(3) For 2,4 -D, such inform ation concerning  analytical methods  for almonds, brazil nuts, 
cashew nuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, 
pistachios, walnuts and other tree nuts was submitted  by the applicant  and the 
Authori ty concluded that this data gap was sufficiently addressed2. Therefore, for these 
products , the existing  MRLs in Annex II to Regulation (EC) No  396/2005 should be 
kept and the requirement to submit  additional information should be deleted from that 
Annex . However, for buckwheat and other pseudo -cereals such information  
concerning residue trials was not submitted  and the Authority concluded that the data 
gap was  thus not sufficiently addressed  and that risk managers may consider replacing 
those MRLs with the L imit of Determination (L OD)3. Therefore, for these products , it 
is appropriate to keep  the MRL  in Annex  II to Regulation (EC) No  396/2005  at the 
LOD  and to delete the requir ement to submit  additional information  from that Annex . 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance 2,4 -D. EFSA Journal 20 14;12(9):3812 . 
3 European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 
2,4-D, fenhexamid and iprovalicarb . EFSA Journal 20 21;19(10):6910 .  
EN 2  EN (4) For azoxystrobin , such information concerning  residue  trials for  lamb's lettuce s/corn 
salads , escarole s/broad -leaved endives , cress es and other sprouts and shoots , roman 
rocket/ rucola, red mustard s and baby leaf crops (including brassica species)  was 
submitted  by the applicant . The Authority concluded that t his data gap was sufficiently 
addressed4 and proposed lowering the MRLs  for those products  based on the new 
information . Therefore,  MRLs  for those products  should be set  in Annex II to 
Regulation (EC) No 396/2005 at the level identified by the Authority and the 
requirement to submit additional information should be deleted from that Annex . 
Together with the confirmatory data, pursuant to  Article 6  of Regulation (EC) 
396/2005 , the applicant also submitted an application to modify the existing MRLs for 
azoxystrobin in lettuces  and the Authority recommended4 lowering the MRL for that 
product . Therefore, the MRL for lettuces should  be set at the level identified by the 
Authority . During the Article 12 review, the Authority had identified a data gap 
concerning the toxicological profile of the metabolites L1, L4 and L9 for swine 
(muscle, fat, liver, kidney , edible offals ), bovine (muscle, fat, liver, kidney , edible 
offals ), sheep (muscle, fat, liver, kidney , edible offals ), goat (muscle, fat, liver, kidney , 
edible offals ), poultry (muscle, fat, liver, kidney, edible offals ), milk (cattle, sheep, 
goat, horse ) and birds'  eggs. Such information  was not submitted  by the applicant4. 
The Authority concluded4 that these metabolites do not occur on muscle, but that a full 
characterisation of the ir toxico logic al profile has not been provided by the applicant  
and that further  consideration by  risk manage rs was necessary , taking into account that 
the existing MRLs for these products  reflect Codex maximum residue limits (CXLs). 
Therefore, for  these products , the existing MRLs in Annex II to Regulation (EC) 
No 396/2005 should be kept and the requirement to submit  additional information 
should be maintained  in that Annex .     
(5) For cyhalofop -butyl , such information concerning analytical methods for rice was 
submitted  by the applicant and the Authority  concluded that this data gap was 
sufficiently addressed5. Therefore, for this product , the existing  MRL  in Annex II to 
Regu lation (EC) No  396/2005 should be kept and the requirement to submit additional 
information should be deleted from that Annex .  
(6) For cymoxanil, such information on residue trials for table grapes , wine grapes , 
lettuces and spinaches  was submitted  by the applicant . The Authority concluded that 
this data gap was sufficiently addressed6 and proposed keeping or lowering MRLs  for 
those products . Therefore, for tho se products , MRLs in Annex II to Regulation (EC) 
No 396/2005 should be set at the level identified by the Authority and the requirement 
to submi t additional information should be deleted from that Annex . The Authority 
concluded6 that the data gap s concerning analytical methods for herbal infusions and 
hops and storage stability for pulses , herbal infusions and hops have not been 
addressed and that MRLs for those products should be kept at the LOD.  Therefore,  
MRLs  for those products  in Annex  II to Regulation (EC) No 396/2005 shou ld be set  at 
the level identified by the Authority  and the requirement to submit additional 
information should be deleted from that Annex .  
                                                 
4 European Food Safety Authority; Evaluation of confirmatory data following the Article 12 MRL review 
and modification of the existing maximum residue levels for azoxystrobin . EFSA Journal 
2020;18(8):6231 . 
5 European Food Safety Authority; Conclusion on the pee r review of the pesticide risk assessment of the 
active substance cyhalofop (variant evaluated cyhalofop -butyl). EFSA Journal 2015; 13(1):3943.  
6 European Food Safety Authority; Evaluation of confirmatory data following the Article 12 review for 
cymoxanil. EFSA Journal 2019; 17(10):5823.   
EN 3  EN (7) For fenhexamid, such information concerning residue trials and Good Agricultural 
Practice (GAP) parameters  for kiwi fruits (green, red, yellow) was not submitted. 
However,  the Authority concluded that the requested information is no longer 
required7 as the evaluation was performed with older data req uirements thus  further  
residue trials  and inf ormation on GAP s are no longer required . There fore, for this 
product , the existing MRL  in Annex II to Regulation (EC) No  396/2005  should be 
kept and the requirement to submit  additional information should be deleted from  that 
Annex . 
(8) For flazasulfuron , such information concerning storage stability for table olives and 
olives for oil production was submitted  by the applicant and the Authority concluded 
that this data gap was sufficiently address ed8. Therefore, for these  products , the 
existing MRLs in Annex II to Regulation (EC) No  396/2005 should be kept and the 
requirement to submit additional information should be deleted from  that Annex . 
(9) For florasulam, such information concerning analytical methods for bovine (muscle, 
fat, liver, kidney, edible offals), sheep (muscle, fat, liver, kidney, edible offals), goat 
(muscle, fat, liver, kidney, edible offals) and milk (cattle, sheep, goat, horse)  was 
submitted  by the applicant  and the Authority concluded that this  data gap was 
sufficiently addressed9. Therefore, for th ose products , the existing MRLs in Annex II 
to Regulation (EC) No  396/2005 should be kept and the requirement to submit 
additional information should be deleted from  that Annex . 
(10) For fluroxypyr, such information concerning analytical methods, storage stability, pre -
harvest interval and residue trials for apples  and onions  was submitted  by the 
applicant . Additional information on the analytical method used in the residue trials 
for thyme was also submitted by the applicant. The Authority concluded that these  
data gap s were  sufficiently addressed10,11. Therefore, for th ese products , the MRL s in 
Annex II to Regulation (EC) No 396/2005 should be set at the level identified by the 
Authority and the requirement to submit additional information should be deleted from 
that Annex . The Authori ty concluded that the data gap concer ning the analytical 
method  for garlics, shallots , leeks, cereals, herbal infusions from flowers and sugar 
canes were only partially addressed or not addressed  at all  and that further risk 
management consideration is needed. It also concluded that the data gaps concerning 
storage stability and metabolism for swine (muscle, fat, liver, kidney , edible offals ), 
bovine (muscle,  fat, liver, kidney , edible offals ), sheep (muscle, fat, liver, kidney , 
edible offals ), goat (muscle, fat, liver, kidney , edible offals)  and milk (cattle, sheep, 
goat, horse ) were  only partially addressed and that further risk management 
consideration is needed . In the Final Review report12 for this substance , it was  
                                                 
7  European Food Safety Authority; Lack of confirmatory data following Article 12 MRL reviews for 2,4 -
D, fenhexamid and iprovalicarb . EFSA Journa l 2021;19(10):6910 . 
8 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance flazasulfuron . EFSA Journal 2016;1 4(8):4575 . 
9 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance florasulam . EFSA Journal 2015;13(1):3984 . 
10 European Food Safety Authority; Evaluation of confirmatory data following the Article 12 MRL review 
for fluroxypyr . EFSA Journal 20 19;17(9):5816 . 
11 European Food Safety Authority; Modification of the existing maximum residue levels for fluroxypyr 
in chives, celery leaves, parsley, thyme and basil and edible flowers . EFSA Journal 2020;18 (10):6273 . 
12 SANCO/11019/2011 rev.5, “ Final Review report for the active substance fluroxypyr finalised in the 
Standing Committee on the Food Chain and Animal Health at its meeting on 17 June 2011 in view of 
the approval  of fluroxypyr as active substance in accordance with Regulation (EC) No 1107/2009 ”, 
23 March  2017, https://ec.europa.eu/food/plant/pesticides/eu -pesticides -database/active -
substances/?event=as.details&as_id=734    
EN 4  EN concluded that the available data was sufficient to also address th ese data gap s. 
Therefore, for these products , MRLs in Annex II to Regulation (EC) No 396/2005 
should be kept and the requirement to submit additional information should be deleted 
from that Annex .      
(11) For iprovalicarb, such information concerning crop metabolism on lettuces, 
escaroles/br oad-leaved endives and roman rocket/rucola was not submitted  and the 
Authority  concluded that the data gap previously identified was thus not addressed13 
and that risk managers may consider replacing those MRLs with the LOD . Therefore, 
for these products , it is appropriate to set the MRLs in Annex  II to Regulation (EC) 
No 396/2005 at the specific LOD and to delete the requirement to submit additional 
information  from that Annex .    
(12) For silthiofam, such information concerning analytical methods  for barley, rye and 
wheat was submitted by the applicant and the Authority concluded that this data gap 
was sufficiently addressed14. Therefore, for these products , the existing MRLs in 
Annex II  to Regulation (EC) No  396/2005  should be kept and the requirements to 
submit additional information should be deleted from  that Annex . 
(13) The Commission consulted the European Union reference laboratories as regards the 
need to adapt certain LODs. Those laboratories concluded that for certain products 
technical development permits the setting of lower LODs.  
(14) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their com ments have been taken into account.  
(15) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(16) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional measure for produ cts which have been 
produced before the modification of the MRLs and for which information shows that a 
high level of consumer protection is maintained.  
(17) 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 themselves to meet the new requirements which will result from 
the modification of the MRLs.  
(18) The measures provided for in this Regulation are in accordance with the opinion of th e 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex  II to Regulation (EC) No  396/2005 is amended in accordance with the Annex to this 
Regulation.  
                                                 
13 European Food Safety Authority; Lack of confirmatory data following  Article  12 MRL reviews for 
2,4-D, fenhexamid and iprovalicarb . EFSA Journal 20 21;19(10):6910 . 
14 European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance silthiofam . EFSA Journal 2016;14(8):4574 .  
EN 5  EN Article 2  
Regulation (EC) No  396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced in the Union or imported  into the Union 
before [ Office of Publication: please insert date 6   months after entry into forc e]. 
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