EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1960 v2  
[…](2023) 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 cyproconazole , 
and spirodiclofen 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 cyproconazole 
and spirodiclofen 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 cyproconazole and spirodiclofen , 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 cyproconazole expired on 31  May 2021 and no 
application for a renewal of its approval has been submitted . All authorisations for 
plant protection products containing cyproconazole have been revoked . The European 
Food Safety Authority (the ‘Authority’)  had submitted a reasoned opinion on the 
review of the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 
396/20052. The Authority  proposed to change the residue definition to cyproconazole 
(sum of isomers) . The Commission considers this new residue definition to be 
appropriate . 
(3) The MRLs for cyproconazole in or on rapeseeds/canola seeds , soyabeans,  liver and 
kidney of swine, bovine, sheep, goat and equine  result from the implementation of 
Codex MRLs (‘CXLs’), which the Authority had confirmed as safe for consumers. 
The MRLs for liver and kidney of swine, bovine, sheep, goat and equine  for should 
therefore be set in  Annex  II to Regulat ion (EC) No 396/2005  at the existing levels in 
accordance with Article  14(2), point (e), of Regulation (EC) No  396/2005 . As some 
information was not available  for rapeseeds/canola seeds  and soyabeans, further 
consideration by risk managers was required. While the se MRLs based on CXLs are 
considered safe, they will therefore be reviewed. The review will take into account the 
information available within two years from the publication of this Regulation. As 
there is no risk for consumers, it is appropriate to set the MRLs for those products in 
Annex II to Regulation (EC) No 396/2005 at the levels identified by the Authority.  
The MRLs for cyproconazole  in or on peas (without pods), beans, peas, barley, 
buckwheat and other pseudocereals , maize/corn, common millet/proso millet, oat, rye, 
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj . 
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for cyproconazole  according to Article 12 of Regulation (E C) No 396/2005. EFSA Journal 
2021;19(3):6483.  EN 2  EN wheat, coffee beans and sugar beet roots , muscle, fat  of swine, bovine, sheep, goat and 
equine and muscle, fat and liver of poultry , milk of cattle, sheep, goat an d horse  and 
birds’ eggs  were based on uses in the Union  which are no longer authori sed. There are 
CXLs for th ose products, which the Authority had confirmed as safe for consumers. 
However, as some information was not available, further consideration by ris k 
managers was required. While the MRLs  based on CXLs  are considered safe, they will 
therefore be reviewed. The review will take into account the information available 
within two years from the publication of this Regulation. As there is no risk for 
consum ers, it is appropriate to set the MRLs for those products in Annex II to 
Regulation (EC) No 396/2005 at the levels identified by the Authority.   
(4) For all other products, as the MRLs  for cyproconazole  were based on uses in the 
Union  which are no longer autho rised and there are no CXL s or import tolerances, it is 
appropriate to lower the MRLs to product -specific limit of determination ( ‘LOD ’) and 
set 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.  
(5) The approval of the active substance  spirodiclofen expired on 31 July 2020 a nd no 
application for a renewal of its approval has been submitted . All authorisations for 
plant protection products containing spirodiclofen  have been revoked. The Authority  
had submitted a reasoned opinion on the review of the existing MRLs in accordance 
with Article 12(1) of Regulation (EC) No 396/20053. It proposed to change the residue 
definition in food groups of animal origi n to spirodiclofen -enol (M01), expressed as 
spirodiclofen . The Commission considers this new residue definition to be appropriate .  
(6) The Authority concluded that the MRLs set for spirodiclofen  in or on grapefruits, 
oranges, lemons , limes , mandarins , almonds, Brazil nuts, cashew nuts, chestnuts, 
macadamias, pecans, pistachios, walnuts, table grapes, avocados, mangoes and 
papayas  were derived from import tolerances  and were  based on sufficient supporting 
data for the current GAPs  and are con sidered safe for consumers. The MRLs  for limes 
and mandarins should therefore be maintained at the existing level  and the MRLs for 
grapefruits, oranges, almonds, avocados, mangoes and papayas should be lowered and 
set in Annex II to Regulation (EC) No 396/ 2005 . Slightly different methodology  to 
calculate  MRLs has been  used compared to the MRLs previously set in Commission 
Regulation (EU) No 520/20114 for Brazil nuts, cashew nuts, chestnuts, macadamias, 
pecans, pistachios, walnuts  and table grapes . MRLs for those foods are therefore 
raised  and set in Annex II to Regulation (EC) No 396/2005 . The MRLs for 
spirodiclofen in or on coconuts, hazelnuts /cobnuts , pine nut  kernels , pome fruits, stone 
fruits , wine grapes, strawberries, bluebe rries, c urrants (black, red and white) , tomatoes, 
sweet peppers/bell peppers , hops and muscle, fat, liver and kidney of swine, bovine, 
sheep, goat and equine , milk of cattle, sheep, goat and horse  result from the 
implementation of CXLs, which the Authority  had confirmed as safe for consumers. 
Those MRLs should therefore be set 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.  
 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for spirodiclofen  according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2021;19( 11):6908. 
4  Commission Regulation (EU) No 520/2011 of 25 M ay 2011 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 benalaxyl, boscalid, buprofezin, carbofuran, carbosulfan, cypermethrin, fluopicolide, hexythiazox, 
indoxa carb, metaflumizone, methoxyfenozide, paraquat, prochloraz, spirodiclofen, prothioconazole and 
zoxamide in or on certain products  (OJ L 140, 27.5.2011, p. 2 ). EN 3  EN (7) The MRLs for spirodiclofen  in or on cucumbers  and gherkins  were based on uses in 
the Union  which are no longer authori sed. There are CXLs for th ose products, which 
the Authority had confirmed as safe for consumers. The MRLs for th ose 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.   
(8) For all other products,  as the MRLs for spirodiclofen  were based on uses in the U nion 
which are no longer authori sed and there are no CXL or import tolerances , 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 . 
(9) 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 analyt ically achievable.   
(10) 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.  
(11) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(12) To allow for th e normal marketing, processing and consumption of products, this 
Regulation should not apply to products which have been placed on the market in the 
Union  before the new MRLs become applicable  and for which a high level of 
consumer protection is maintained . 
(13) 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 .  
(14) 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  in the Union  before … 
[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 Journ al of the European Union .  EN 4  EN 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