EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10176/2022 rev.2  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for benalaxyl, 
bromoxynil, chlorsulfuron, epoxiconazole and fenamiphos in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for benalaxyl, 
bromoxynil, c hlorsulfuron, epoxiconazole and fenamiphos 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)(a) and Article 18(1)(b) thereof,  
Whereas:  
(1) For benalaxyl, bromox ynil and fenamiphos, maximum residue levels ( ‘MRLs ’) were 
set in Annex  II to Regulation (EC) No  396/2005. For chlorsulfuron  and epoxiconazole,  
MRLs were set  in Part A  of Annex III to that Regulation .  
(2) The approval of the active substance benalaxyl  was not renewed by Commission 
Regulation (EU) 2020/12802 including for reasons related to  human health . That 
approval expired on 31  July 2021. All existing authorisations for  plant protection 
products containing this active substance have been revoked.   
(3) In the context of the non -renewal of the approval of benalaxyl, the European Food 
Safety Authority (‘the Authority’) could not conclude that the substance has no 
endocrine disrupting properties3. 
(4) Benalaxyl -M is an approved active substance for use in plant protection products. The 
residue definition for both benalaxyl and benalaxyl -M is ‘Benalaxyl including other 
mixtures of constituent isomers including benalaxyl -M (sum of isomers)’ . MRLs for 
benalaxyl on table grapes, potatoes, garlic, onions, shallots, watermelons, lettuces and 
leeks  are safe for consumers  and should be maintained to take account of the 
authorised uses of benalaxyl -M on th ose products . For wine grapes and melons, the 
existing MRLs correspond to the Codex maximum residue limits (‘CXLs’) . They are 
safe for consumers  and should also be maintained  in accordance with  Article 14(2) , 
point (e) of Regulation (EC) No 396/2005 . MRLs f or the author ised uses of benalaxyl -
M on aubergines/eggplants and tomatoes  are lowe r than MRLs  for benalaxyl. 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2020/1280 of 14 September 2020 concerning the non -
renewal of the approval of the active substance benalaxyl, in accordance with Regulation (EC) No 
1107/2009 of the European Parliament and of the Council concerning th e placing of plant protection 
products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 
540/2011  (OJ L301, 15.9.2020, p.4 -6). 
3  European Food Safety Authority, ‘ Conclusion on the peer review of the pesticide risk assessm ent of the 
active substance benalaxyl ’, EFSA Journal 2020;18(1):5985  EN 2  EN Therefore, MRLs for benalaxyl on these products should be lowered to th e current 
MRLs  for benalaxyl -M. For sweet peppers /bell peppers  and rapeseeds /canola seeds , 
no authorised use s for benalaxyl -M exist and there are no  CXLs or import tolerances .  
MRLs  for benalaxyl  on those products should be  lowered  in Annex II to Regulation 
(EC) No 396/2005 to the limit of letermination (‘LOD’) .  
(5) The approval of the active substance bromoxynil was not renewed by Commission 
Regulation (EU) 2020/12764 including for reasons  related to human health . The 
approval of the substance expired on 31 July 2021 . All existing authorisations for plant 
protection products containing bromoxynil  have been revoked  and no  CXLs or import 
tolerances exist  for that active substance . It is therefore appropriate to delete the MRLs 
set out for th is substance  in Annex II to Regulation (EC) No 396/2005 in accordance 
with Artic le 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1)  
point (a) thereof . MRLs for all products should be set at the LOD in Annex V to 
Regulation (EC) No 396/2005  in accordance with article 18  point (1) (b) of that 
Regulation .  
(6) The approval  of the active substance chlorsulfuron  expired on 31 December 2019 and 
the applicant has not submit ted an application for its renewal. All existing 
authorisations for plant protection products containing th at active substance have been 
revoked.  No CXLs or import tolerances exist for chlorsulfuron. It is therefore 
appropriate to delete the MRLs set out for th is substance  in part A of Annex II I to 
Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 
396/2005 in conjunction with Article 14(1)  point (a) thereof . MRLs for all products 
should be set at the LOD in Annex V to Regulation (EC) No 396/2005  in accor dance 
with ar ticle 18 point (1) (b) of that Regulation .  
(7) The approval of the active substance epoxiconazole expired on 30  April  2020 and the 
applicant withdrew the application for its renewal. All existing authorisations for plant 
protection products containing th at act ive substance  have been revoked.  No CXLs or 
import tolerances exist for epoxiconazole. It is therefore appropriate to delete the 
MRLs set out for this substance in part A of Annex III to Regulation (EC) No 
396/2005 in accordance with Article 17 of Regulati on (EC) No 396/2005 in 
conjunction with Article 14(1) point (a) thereof. MRLs for all products should be set at 
the LOD in Annex V to Regulation (EC) No 396/2005 in accordance wit h article 18 
point (1) (b) of that Regulation.   
(8) The approval of the active substance fenamiphos was not renewed by Commission 
Regulation (EU) 2020/12465, including  for reasons related to human health.  The 
approval of the substance  expired on 23  September  2020.  All existing authorisations 
for plant protection products containing fenamiphos  have been revoked.   
                                                 
4 Commission Implementing Regulation (EU) 2020/1276 of 11 September 2020 concerning the non -
renewal of the approval of the active substance bromoxynil, 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 L300, 14.9.2020, p.32 -34). 
5 Commission Implemen ting Regulation (EU) 2020/1246 of 2 September 2020 concerning the non -
renewal of the approval of the active substance fenamiphos, 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 L288, 3.9.2020, p.18 -20). EN 3  EN (9) In the context of the non -renewal of the approval of fenamiphos, the Authority 
identified a number of concerns6, relating to consumer health risk and missi ng data for 
the representative uses concerning fruiting vegetables.  
(10) The MRLs  for table grapes and wine grapes correspond to import tolerances , but since 
the data package for metabolites M01 and M02 on genotoxicity was incomplete  and a 
consumer risk assessm ent could not be finalised, a risk for consumers cannot be 
excluded.  The MRLs for tomatoes, sweet peppers/bell peppers, aubergines/eggplants , 
melons  and sugar beet roots are based on EU uses  of fenamiphos that have been  
revoked . It is therefore appropriate  to delete the MRLs set out for th is substance  in 
Annex II to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation 
(EC) No 396/2005 in conjunction with Article 14(1)  point (a) thereof . MRLs for all 
products should be set at the LOD in An nex V to Regulation (EC) No 396/2005  in 
accordance wit h article 18 point (1) (b) of that Regulation .  
(11) The Commission consulted the E uropean Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . For all the active substances 
covered by this Regulation t hose laboratories proposed product specific LODs that are 
analytically achievable.  
(12) 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.  
(13) Regulation (EC) No 396/2005 should therefore be amended accordingly.  
(14) For all active substances covered by this R egulation , in order to allow for the normal 
marketing, processing and consumption of products, and given that information shows 
that a high level of consumer protection is maintained, this Regulation should not 
apply to products which have been produced in the Union or imported into the Union 
before the new MRLs  become applicable . 
(15) A reasonable period should be allowed to elapse before the new MRLs become 
applicable in order to permit Member States, third coun tries and food business 
operators to adapt  themselves to the requirements which result from the amendments  
to the relevant MRLs . 
(16) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, F ood and Feed . 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II, III  and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth day following that of i ts 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 ]. 
                                                 
6  European Food Safety Authority, ‘ Conclusion on the peer review of the pesticide risk assessment of the 
active substance fenamiphos ’, EFSA Journal 2019;17(1):5557  EN 4  EN 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