EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX  
SANTE/10088/2022  
[…](2022) XXX draft 02 
 
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 calcium 
phosphide, cyromazine, topramezone and triflumizole 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 calcium 
phosphide, cyromazine, topramezone and triflumizole 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), point (a), and Article 18(1), point (b), thereof, 
Whereas: 
(1) For cyromazine, topramezone and triflumizole maximum residue levels ('MRLs') were 
set in Annex II and Part A of Annex III to Regulation (EC) No 396/2005 depending on 
the product. For calcium phosphide the default MRL of 0.01 mg/kg applies to all 
products in accordance with Art 18(1), point (b), to Regulation (EC) No 396/2005. 
(2) All applications for the renewal of the approval of the active substance calcium 
phosphide were withdrawn2 before the renewal procedure was completed. 
The approval of that active substance expired on 1 December 2020. All existing 
marketing authorisations for plant protection products containing calcium phosphide 
have now been revoked. It is appropriate to set all the MRLs  for calcium phosphide at 
the default MRL of 0.01 mg/kg and to list them in Annex V to Regulation (EC) 
No 396/2005 in accordance with Article 18(1)(b)  
(3) The approval of cyromazine as active substance for plant protection products expired 
on 31 December 2019 and no application for its renewal was submitted. However, 
cyromazine is also a pharmacologically active substance in veterinary medicines and 
MRLs for that substance in ovine products (except milk) were set based on the 
recommendations from the European Agency for the Evaluation of Medicinal 
Products3 in Commission Regulation (EU) No 37/20104. Those MRLs should be 
maintained at the existing levels to cover the exposure from use in veterinary 
                                                
1 OJ L 70, 16.3.2005, p. 1. 
2 Commission Implementing Regulation (EC) No 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 and zeta-
cypermethrin (OJ L 370, 6.11.2020, p. 18). 
3 Summary report of the Committee for veterinary medicinal products. The European Agency for the 
Evaluation of Medicinal Products, Veterinary Medicines and Inspections. EMEA/MRL/606/99-Final. 
June 1999. 
4 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active 
substances and their classification regarding maximum residue limits in foodstuffs of animal origin 
(OJ L 15, 20.1.2010, p. 1).   
EN 2  EN medicinal products in ovine animals. For all other products it is appropriate to delete  
the respective MRLs set out for cyromazine in Annex II of Regulation (EC) No 
396/2005 in accordance with Article 14(1)(a) in conjunction with Article 17 of that 
Regulation.   
(4) The European Food Safety Authority (‘the Authority’) performed a pesticide risk 
assessment of the active substance topramezone for the uses proposed by the applicant 
in 20145. In 2020, all applications for the renewal of the approval of the active 
substance topramezone were withdrawn and the renewal procedure concluded with the 
non-approval of topramezone6. All existing authorisations for plant protection 
products containing topramezone have been revoked. It is therefore appropriate to 
lower the MRLs set out for topramezone in Part A of Annex III to Regulation (EC) No 
396/2005 to the LOD and to list the respective LODs in Annex V to that Regulation in 
accordance with Article 14(1)(a).  
(5) The approval of triflumizole expired on 30 June 2020 and no application for its 
renewal was submitted. All existing authorisations for plant protection products 
containing triflumizole have been revoked. It is therefore appropriate to lower the 
MRLs set out for triflumizole in Annex II to Regulation (EC) No 396/2005 to the 
LOD.  
(6) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs. For cyromazine, topramezone 
and triflumizole those laboratories proposed product specific LODs that are 
analytically achievable.   
(7) 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. 
(8) Regulation (EC) No 396/2005 should therefore be amended accordingly. 
(9) For all active substances covered by this Regulation, to allow for the normal 
marketing, processing and comsuption of products, this Regulation should not apply to 
products which have been produced in the Union or imported into the Union before 
the modified MRLs star applying and for which information shows that a high level of 
consumer protection is maintained. 
(10) 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 adapt  to meet the requirements that result from the modification of the 
MRLs.  
(11) 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: 
                                                
5  European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment 
of the active substance topramezone. EFSA Journal 2014;12(2):3540, 82 pp. DOI: 
https://doi.org/10.2903/j.efsa.2014.3540 
6 Commission Implementing Regulation (EU) 2021/79 of 27 January 2021 concerning the non-approval 
of the active substance topramezone, 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 (OJ L 29, 28.1.2021, p. 8).  
EN 3  EN 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 produced in the Union or imported into the Union 
before [Office of Publications: please insert date 6 months after entry into force of this 
Regulation]. 
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 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