EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/2310 v2  
[…](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 denatonium 
benzoate, diuron, etoxazole, methomyl and teflubenzuron 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 denatonium 
benzoate, diuron, etoxazole, methomyl and teflubenzuron in or on certain products  
(Text with EEA relevan ce) 
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), Article 18(1) , point (b), and Article 49(2) thereof,  
Whereas:  
(1) For denatonium benzoate, diuron, etoxazole, methomyl and teflubenzuron , maximum 
residue levels ( ‘MRLs ’) were set in Annex II to Regulation (EC) No 396/2005.  
(2) The approval of the active substance  denatonium benzoate expired on 30 November 
20202 and no applicat ion for renewal of its approval  had been submitted . All existing 
authorisations for plant protection products containing th at active substance have been 
revoked.  No Codex maximum residue limits ( ‘CXLs ’) or import tolerances exist  for 
that substance . The MR Ls for denatonium benzoate on all products are set at the limit 
of determination (‘LOD’).  It is therefore appropriate to delete the MRLs set out for 
this substance  in Annex I 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 denatonium benzoate on all products should be set at the product 
specific LOD s in Annex V to Regulation (EC) No 396/2005  in accordance with 
Article  18(1) , point (b), of that Regulation . 
(3) The approval of the active substance diuron  expired on 30 September 2020 and no 
application for renewal of its approval had been submitted.  All existing authorisations 
for plant protection products containing th at active substance hav e been revoked.  No 
CXLs or import tolerances exist  for that substance . The MRLs  for diuron  on all 
products  are currently  set at the product specific LOD s. It is therefore appropriate to 
delete the MRLs set out for th is substance  in Annex I 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 diuron on all products 
should be set at the product specific LOD s in Annex V to Regulation (EC) No 
396/2005  in accordance with Article  18(1) , point (b), of that Regulation . Additionally, 
 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2020/1643 of 5 November 2020 amending Implementing 
Regulation (EU) No 540/2011 as regards the approval periods of the active substances calcium 
phosphide, denathonium benzoate, haloxyfop -P, imidacloprid, pencycuron a nd zeta -cypermethrin  
(OJ L 370, 6.11.2020, p.  18). EN 2  EN for the avoidance of doubt, the respective footnotes indicating lack of  information on 
residue trials should be deleted.  
(4) The approval of the active substance  etoxazol e was rene wed by Commission 
Implementing Regulation (EU) 2020/21053 with a specific provision that only uses  of 
plant protection products  on ornamental plants in permanent greenhouses shall be 
authorised  by Member States . All existing authorisations for plant prote ction products 
containing th at active substance for use on edible crops have been revoked . In the 
context of the  procedure for the  renewal of approval  of that active substance , the 
European Food Safety Authority (‘the Authority ’) published a conclusion4 on the peer 
review explaining  that risks for human health from consumption of edible crops  
treated with etoxazole  could not be excluded . Therefore, existing MRLs based on 
CXLs cannot be confirmed as being safe for consumers  and cannot be maintained . 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 A rticle 17 of Regulation (EC) 
No 396/2005 in conjunction with Article 14(1)  point (a) thereof . MRLs for  etoxazole 
on all pr oducts should be set at the product specific LOD s in Annex V to Regulation 
(EC) No 396/2005  in accordance with Article 18(1) , point (b), of that Regulation . 
Additionally,  for the avoidance of doubt , the footnote indicating lack of  information 
on analytical  methods  should be deleted . 
(5) The approval of the active substance methomyl  expired on 31 August 2019 as no 
application for renewal of its approval had been submitted . All existing authorisations 
for plant protection products containing th at active substance  have been revoked.  The 
MRLs for methomyl on kumquats and gherkins were based on CXLs that the 
Authority had confirmed are  safe for consumers5. Those MRLs should therefore be 
maintained in Annex II to Regulation (EC) No 396/2005  at the existing levels in 
accordance with Article 14(2), point (e), of Regulation (EC ) No  396/2005.  The 
existing MRLs  for methomyl  on lettuces, beans  (dry) , soyabeans, cotton seeds, 
maize/corn, and oat were based on  CXLs , for which  the Authority concluded that they  
are not sufficiently supported by data as data is missing on metabolism of methomyl in 
leafy crops, pulses and oilseeds5. Those MRLs  should therefore be lowered to product 
specific LODs in Annex II to Regulation (EC) No 3 96/2005 . For  all other products,  for 
which the MRLs were based on uses in the EU which are no longer authorized,  it is 
appropriate to lower the MRLs to product specific  LODs in Annex II to Regulation 
(EC) No 396/2005  in accordance with Article 17 of Regula tion (EC) No 396/2005 in 
conjunction with Article 14(1)  point (a) thereof . Additionally,  for the avoidance of 
doubt , the footnotes indicating lack of  information on residue trials and crop 
metabolism should be deleted.  
(6) The approval of the active substance teflubenzuron  expired on 30 November 2019 a s 
no application for renewal of its approval had been submitted . The MRLs for  
teflubenzuron on  grapefruits and mandarins are based on  import tolerance request s 
 
3 Commission Implementing Regulation (EU) 2020/2105 of 15 December 2020 renewing the approval of 
the active substance etoxazole as a candidate for substitution in accordance with Regulation (EC) No 
1107/2009 of the European Parliament and of the Council conc erning the placing of plant protection 
products on the market,  and amending the Annex to Commission Implementing Regulation (EU) No 
540/2011 (OJ L 425, 16.12.2020, p. 96).  
4 EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance etoxazole ; 
EFSA Journal 2017;15(10):4988.  
5 EFSA Reasoned Opinion on the r eview of the existing maximum residue levels for methomyl according 
to Article 12 of Regulation (EC) No 396/2005 ; EFSA Journal 2015;13(10):4277.  EN 3  EN from Brazil , which  the Authority had confirmed as  safe for consumers6. The MRLs for 
teflubenzuron  on citrus fruits, grapes, papayas, tomatoes, cucumbers, gherkins, 
melons, sunflower seeds, soyabeans, and coffee beans  result from the implementation 
of CXLs , which  the Authority had confirmed a s safe for consumers7. Those MRLs 
should therefore be maintained in Annex  II to Regulation (EC) No 396/2005  at the 
existing le vels in accordance with Article  14(2), point (e), of Regulation (EC) No 
396/2005. For all other products,  for which the MRLs were  based on uses in the EU 
which are no longer authorized,  it is appropriate to lower the MRLs to product specific  
LODs in Annex  II to Regulation (EC) No 396/2005  in accordance with A rticle 17 of 
Regulation (EC) No  396/2005 in conjunction with Article 14(1)  point  (a) thereof . 
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs. For all the active substances 
covered by this Regulation , those laboratories proposed product specific LODs that are 
analytically achievable.   
(8) 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.  
(9) Regulation (EC) N o 396/2005 should therefore be amended accordingly.  
(10) As regards the active substances  denatonium benzoate, diuron, methomyl and 
teflubenzuron , to allow for the normal marketing, processing and consumption of 
products, 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  and for 
which a high level of consumer protection is maintained.  
(11) A reasonable period should be allowed to elapse before the new MRLs become 
applic able in order to permit Member States, third countries and food business 
operators to adapt themselves to the requirements which result  from the modification 
of the MRLs .  
(12) The measures provided for in this Regulation are in accordance with the opinion of t he 
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 this Regulation.  
Article 2  
As regards the active substances  denatonium benzoate, diuron, methomyl and teflubenzuron 
in and on all products, 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 publications: please insert  date 6 months after the date of 
entry into force of this Regulation ].  
 
6 EFSA Reasoned Opinion on the setting of import tolerances for teflubenzuron in grapefruits, mandarins 
and broccoli ; EFSA Journal 2018;16(11):5474.  
7 EFSA Scientific support for preparing an EU position in the 49th Session of the Codex Committee on 
Pesticide Residues  (CCPR) ]; EFSA J ournal 2017;15(7):4929.  EN 4  EN Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journa l of the European Union .  
It shall apply from … [ Office of publications: please insert  date 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