EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2927 R1  
[…](2024) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for isopyrazam in or 
on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for isopyrazam 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 49(2) thereof,  
Whereas:  
(1) For the active substance isopyrazam maximum residue levels ( ‘MRLs ’) were set in 
Part A of Annex II I to Regulation (EC) No 396/2005.  
(2) The approval of  the active substance  isopyrazam  was withdrawn by Commission 
Implementing Regulation (EU) 2022/7822. All author isations for plant protection 
products containing isopyrazam have been revoked.  
(3) The European Food Safety Authority (the ‘Authority’)  submitted a reasoned opinion 
on the review of the existing MRLs  for isopyrazam  in accordance with Article 12(1) of 
Regulation (EC) No 396/20053. The Authority proposed to change the residue 
definition to isopyrazam (sum of isomers). The Commission considers this new 
residue definition to be appropriate.  
(4) The MRLs for isopyrazam in o r on azaroles/Mediterranean medlars,  kaki/Japanese 
persimmons , sweet peppers/bell peppers, peanuts,  barley,  muscle, fat, liver and kidney 
of swine, bovine, sheep, goat and equine, milk of cattle, sheep, goat  and horse , and 
birds’  eggs result from the implementation of Codex MRLs (‘ CXLs’ ), which the 
Authority has confirmed as safe for consumers. 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 . 
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj . 
2 Commission Implementing Regulation (EU) 2022/782 of 18 May 2022 withdrawing the approval of the 
active substance isopyraz am 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, 
amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing 
Regu lation (EU) No 1037/2012   
(OJ L 140, 19.5.2022, p. 3 , ELI: http://data.europa.eu/eli/reg_impl/2022/782/oj ). 
3 European Food Safety Authority; Reasoned opinion o n the review of the existing maximum residue 
levels for isopyrazam  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2021;19( 7):6684. EN 2  EN (5) The MR Ls for isopyrazam in or on pome fruits, carrots, tomatoes, 
aubergines/eggplants, cucumbers, melons, rapeseeds/canola seeds, rye  and wheat were 
based on uses in the Union which are no longer authori sed. There are CXLs for th ose 
products, which the Authority  has confirmed as safe for consumers. The MRLs for 
those products should therefore be set in Annex II to Regulation (EC) No 396/2005 at 
the levels of the CXLs in accordance with Article 14(2), point (e), of Regulation (EC) 
No 396/2005.  
(6) The Authority concluded that the MRL set for isopyrazam in or on bananas was 
derived from import tolerance, which was supported by data and is  considered safe for 
consumers. However, t he calculation methodology to calculate MRLs has been 
changed since the MRL was first set for bananas , resulting in a higher MRL.  The 
MRL for bananas should therefore  be set  in Annex  II to Regulation (EC) No 396/2005  
at that new higher level in accordance with Article  14(2), point (e), of Regulation (EC) 
No 396/2005.  
(7) For all o ther products, as the MRLs were based on uses in the Union which are no 
longer authori sed and there are no CXL or import tolerances, it is appropriate to lower 
the MRLs and set  the MRLs  in Annex II to Regulation (EC) No 396/2005 to product -
specific  limit o f determination (‘LOD’)  in accordance with Article 17 of Regulation 
(EC) No 396/2005 in conjunction with Article  14(1) , point  (a) thereof.  
(8) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs.  Those laboratories proposed 
product -specific LODs that are analytically achievable.  
(9) 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.  
(10) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(11) To allow for the normal marketing, processing and consumption of products, this 
Regulation should not apply to products which have been placed on the market before 
the new MRLs become applicable  and for which a high level of consumer protection is 
maintaine d. 
(12) A reasonable period should be allowed to elapse before the new MRLs become 
applicable 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 .  
(13) 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  
Annex es II and III  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 have been placed on the market i n the Union  before EN 3  EN [Office of publications: please insert  date 6 months after the date of 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 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