EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2853 Rev. 8  
[…](2023) 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 benomyl, 
carbendazim and thiophanate‐methyl 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 benomyl, 
carbendazim and thiophanate‐methyl 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 Parl iament 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), thereof,  
Whereas:  
(1) For the active substances carbendazim and thiophanate‐methyl , maximum residue 
levels (‘MRLs ’) were set in Annex  II and in Part B of Annex III to Regulation (EC) 
No 396/2005.  
(2) On 30 November 2014, the approval of the active substance carbendazim expired and 
no application for its renewal was submitted . 
(3) On 15 October 2020, the approval of the active substance thiophanate -methyl was not 
renewed by Commission Implementing Regulation (EU) 2020/14982. An application 
for the renewal of its approval had been submitted in accordance with Article  1 of 
Commission Implementing Regulation (EU) No  844/20123 within the set time period, 
and assessed in accordance with the procedure described by Regulation (EC) No 
1107/2009 of the European Parliament and of the Council4. However , the applica nt 
decided to withdraw the application . Nevertheless, based on the assessment of that 
application, the European Food Safety Authority (‘the Authority’) published its 
conclusion on the peer review of the pesticide risk assessment of the active substance 
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj . 
2 Commission Implementing Regulation (EU) 2020/1498 of 15 October 2020 concerning the non -
renewal of approval of the active substance thiophanate -methyl, 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 
540/20 11 (OJ L 342, 16.10.2020, p. 5 , ELI: http://data.europa.eu/eli/reg_impl/2020/1498/oj ). 
3 Commission Implementing Regulation (EU) No 844/2012 of 18 September 20 12 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products  on the market ( OJ L 252, 19.9.2012, p. 26 , ELI: 
http://data.europa.eu/eli/reg_impl/2012/844/oj ). 
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, 24.11.2009, p.  1, ELI: 
http://data.europa.eu/eli/reg/2009/1107/oj) . EN 2  EN thiophanate -methyl5, which identified a number of concerns and data gaps.  In 
particular, the Authority concluded that , given  the clastogenic potential of thiophanate -
methyl , toxicological reference values for consumer and operator risk as sessment 
could not be derived. Based on the dossier available on thiophanate -methyl , the 
Authority indicated that carbendazim might also have a clastogenic potential . 
(4) In its  earlier reasoned opinion on the review of all existing MRLs for carbendazim and 
thiophanate‐methyl  in accordance with Article 12 of Regulation (EC) No  396/20056, 
the Authority noted that the two substances share a common mode of action  and have 
similar metabolic patterns.  
(5) In view of the concerns about the potential cl astogenicity of carbendazim and 
thiophanate -methyl raised in the conclusions of the peer review , the Commission 
requested the Authority to provide a reasoned opinion  under Article 43 of Regulation 
(EC) No 396/2005 , assessing the toxicological properties of  carbendazim and 
thiophanate -methyl and, in light of the outcome of the assessment  under Article 12  of 
that Regulation , the risks that the current MRLs for these substances may pose to 
consumers.  
(6) Since  the two active substances were no longer approved for use in the Union and that 
all authorisations were withdrawn , the Authority invited Member  States to identify and 
submit possible Good Agricultural Practices ( ‘GAPs ’) in non -EU countries for which 
import tolerances were authorised. In the framework of that  consultation, one Member 
State informed the Authority that import tolerances for those two substances in ‘citrus 
fruits’, mangoes, papayas and okra/lady's fingers w ere currently in place . Those impo rt 
tolerances had already been  assessed in the framework of the review of all MRLs for 
carbendazim and thiophanate -methyl in accordance with Article  12 of Regulation (EC) 
No 396/2005 . The recommendations included in that r eview were  not yet 
implemented , pending t he further review under Article 43 of Regulation (EC) 
No 396/2005.  
(7) In its reasoned opinion7, the Authority concluded that there is evidence indicating that 
carbendazim and thiophanate -methyl are not clastogenic but aneugenic . It proposed 
toxicological reference values for both substances.  Based on that conclusion, the 
Authority also performed a combined risk assessment for the two active substances, 
and identified unacceptable risks concerning the cur rent MRLs , set based on import 
tolerances, for thiophanate -methyl in grapefruits, oranges, lemons, mandarins, 
mangoes, and papayas  and for carbendazim in oranges, grapefruits, mandarins, 
lemons, mangoes, and papayas . The Authority , however , noted  that the approach 
followed for the combined exposure assessment leads to an overestimation of the 
exposure in lemons  and mandarins, where residues  resulting from the use of 
carbendazim and thiophanate -methyl have been combined while co -occurrence of 
these residues is not expected in practice for these three crops . Therefore, the 
Authority  concluded that the current MRLs for carbendazim in mandarins and lemons 
and for thiophanate -methyl in lemons are safe for consumers, provided that residues 
 
5 European Food Sa fety Authority; Conclusion on the peer review of the pesticide risk assessment of the 
active substance thiophanate -methyl. EFSA Journal  2018;16(1):5133.  
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels (MRLs) for thiophanate -methyl and carbendazim according to Article 12 of Regulation (EC) 
No 396/2005. EFSA Journal 2014;12(12):3919 . 
7 European Food Safety Authority; Reasoned opinion on the toxicological properties and maximum 
residue levels (MRLs)  for the benzimidazole substances carbendazim and thiophanate -methyl. EFSA 
Journal 2021;19( 8):6773.  EN 3  EN do not co -occurr, while the MRLs for carbendazim in grapefruits, oranges, papayas 
and mangoes, and for thiophanate -methyl in grapefruits, oranges, mandarins, papayas 
and mangoes are of concern and MRLs should be set at the relevant product specific 
limit of determination ( ‘LOD ’). 
(8) For the other assessed import tolerances  for carbendazim in lemons, limes, mandarins 
and okra/lady ’s fingers and for thiophanate -methyl in lemons, limes and okra/lady ’s 
fingers , the Authority concluded that there is no risk for consu mers , provided that 
residues of both substances do not co -occurr . The MRLs should  therefore  be set at the 
level identified by the Authority, based on the GAPs from third countries that were 
assessed in the framework of the review of MRLs in accordance with  Article 12 of 
Regulation (EC) No 396/2005  and in the framework of the assessment of these two 
active substances under  Article 43 of Regulation (EC) No 396/2005 . Based on th ose 
GAPs , the MRLs for carbendazim in lemons, limes and mandarins and for 
thiophanate -methyl in limes should be raised and  those for carbendazim in o kra/lady ’s 
fingers  and for thiophanate -methyl  in lemons and o kra/lady ’s fingers  lowered.  
(9) Carbendazim and thiophanate -methyl are no longer approved in the U nion, and all 
authorisation s of plant protection products containing those active substances have 
been revoked in the U nion. Therefore, it is appropriate to lower all other  MRLs that 
are set out in Annex es II and III of Regulation (EC) No 396/2005 to the LODs without 
seeking the opinion of the Authority in accordance with Article  17 of that Regulation . 
(10) In addition, in its reasoned opinion s under Article s 12 and 43 of Regulation (EC) No 
396/2005 , the Authorit y proposed to modify  the residue definition s for carbendazim , 
which currently include s benomyl, and to set separate MRLs for both substances.  
(11) Benomyl is no t approved as an active substance in plant protection products under 
Regulation (EC) No 1107/2009  and was never assessed in the U nion. Therefore , no 
EU toxicological reference values are available and the safety of MRLs for this 
substance could not be assessed. The Authori ty concluded that further consideration 
from risk managers was required.  In the absence of such evidence on the safety of the 
substance , for all products, a risk for consumers cannot be ruled out.  As uses for 
benomyl  are not authorised in the Union, and as  no import tolerances or Codex 
maximum residue limits ( ‘CXLs ’) exist  for this substance , MRLs should be set in 
Annex V to Regulation (EC) No  396/2005  and the default MRL should apply, as 
provided for in Article  18(1) , point (b), of Regulation (EC) No  396/2 005. 
(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 Regulation, in order to allow for normal 
marketing, processing and consumption of products, this Regulation should provide 
for a transitional arrangement for products which have been placed on the market in 
the Union  before the m odification of the MRLs and for which information shows that 
a high level of consumer protection is maintained. This applies to  all products , except 
for carbendazim in grapefruits, oranges, papayas and mangoes, and for thiophanate -
methyl in grapefruits, or anges, mandarins, papayas and mangoes . 
(15) 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 to meet the new requirements result ing from the amendments.   EN 4  EN (16) 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 , III and V  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 were placed on the market in the Union  before … 
[6 months after date of entry into force of this Regulation ], except for carbendazim in 
grapefruit s, oranges, papayas and mangoes, and for thiophanate -methyl in grapefruits, 
oranges, mandarins, papayas and mangoes . 
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the Euro pean Union . 
It shall apply from … [6 months after date of entry into force ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member 
States.  
Done at Brussels,  
Done at Brussels,  
The President  
Ursula VON DER  LEYEN  