EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12108/2020 Rev. 3  
[…](2021) 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 amisulbrom, 
flubendiamide, meptyldinocap, metaflumizone and propineb  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 amisulbrom, 
flubendiamid e, meptyldinocap, metaflumizone and  propineb  in or on certain products  
(Text with EEA relevance)  
THE EUROPEAN COMMISS ION,  
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 plan t and animal origin and amending Council Directive 91/414/EEC1, and in particular 
Article  14(1)(a) , Article 18(1)(b ) and Article 49(2) thereof,  
Whereas:  
(1) For amisulbro m, flubendiamide, meptyldinocap and  metaflumizone, maximum 
residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) 
No 396/2005. For propineb, MRLs were set in Annex II and Part B of Annex III  to 
Regulation (EC) No  396/2005 . 
(2) For amisulbrom  the European Food Safety Authority ("the Authority" ), submitted a 
reasoned opinion on the existing MRLs in accordance with Article 12(1) of 
Regulation (EC) No  396/20052. It recommended lowering the MRL s for table grapes 
and wine grapes . For  other products, the Authority recommended keeping the 
existing MRLs. As there is no risk for consumers, MRLs should be set in Annex  II to 
Regulation (EC) No  396/2005 at the existing level or the le vel identified by the 
Authority .  
(3) For flubendiamide the  Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article 12(1) of Regulation (EC) No  396/20053. It identified a 
risk for consumers concerning the MRL s for head cabbages and lettuces . It is 
therefore appropriate to lower th ese MRL s in Annex  II to Regulation (EC) 
No 396/2005 to the limit of determination (LOD). For other products , the Authority 
recommended raising or keeping the existing MRLs.  Those MRLs should be set in 
Annex  II to Regulation (EC) No  396/2005 at the existing level or the level identified 
by the Authority.  
                                                 
1 OJ L 070, 16.3.2005 , p. 1.  
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for amisulbrom  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18(7):6170 . 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for flubendiamide  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18(6):6150 . EN 2  EN (4) For meptyldinocap the Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article 12(1) of Regulation (EC) No  396/20054. It recommended 
lowering the MRL s for cucumbers and courgette s. For other products, it 
recommended raising or keeping the existing MRLs. The Authority concluded that 
concerning the MRLs for table grapes, wine grapes, strawberries, melons and 
watermelons  some information was not available and that further considerati on by 
risk managers was required.  As there is no risk for consumers, those MRLs should 
be set in Annex  II to Regulation (EC) No  396/2005 at the existing level or the level 
identified by the Authority.  These MRLs will be reviewed; the review will take into 
account the information available within two years from the publication of this 
Regulation.  
(5) For metaflumizone  the Authority submitted a reasoned opinion on the existing MRLs 
in accordance with Article  12(1) of Regulation (EC) No  396/20055. It identified a 
risk for consumers concerning the MRLs for broccoli and escaroles (broad -leaved 
endives) . It is therefore appropriate to lower these MRLs in Annex  II to Regulation 
(EC) No  396/2005 to the LOD. The Aut hority recommended  lowering the MRL s for 
potatoes, head cabbages , cotton seeds  and milk (cattle, sheep, goat, horse) . For other 
products, it recommended  raising or keeping the existing MRLs.  The Authority 
concluded that concerning the MRLs for tomatoes, sweet peppers, g herkins, 
cauliflowers, Chinese cabbages, lamb’s lettuces/corn salads, lettuces, cresses and 
other sprouts and shoots, land cresses, Roman rocket/rucola, red mustards and baby 
leaf crops (including brassica species) some information was not available and th at 
further consideration by risk managers was required.  As there is no risk for 
consumers, those MRLs should be set in Annex  II to Regulation (EC) No  396/2005 
at the existing level or the level identified by the Authority.  These MRLs will be 
reviewed; the review will take into account the information available within two 
years from the publication of this Regulation .  
(6) For propineb  the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20056. It proposed t o 
change the residue definition . As propineb is no longer approved in the EU and all 
authorisations for th is substan ce have been revoked,  MRLs  for that  active substance  
should be set  in Annex  V to Regulation (EC) No  396/2005 to the LOD .  
(7) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or Codex maximum residue limits 
(CXLs) exist, MRLs should be set at the specific LOD or the default MRL should 
apply, as provi ded for in Article 18(1)(b) of Regulation (EC) No  396/2005.  
(8) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determination. As regards 
several substances, those laboratories concluded that for certain commodities 
technical development requires the setting of specific limits of determination.  
                                                 
4 European Food Safety Authority; Reasoned opinion  on the review of the existing maximum residue 
levels for meptyldinocap (DE -126) according to Article 12 of Regulation (EC ) No 396/2005. EFSA 
Journal 2020;18(6):6157 . 
5 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for metaflumizone  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18(6):6123 . 
6 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for propineb  according to Article  12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18(8):6233 . EN 3  EN (9) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under considerati on, the appropriate modifications to the 
MRLs fulfil the requirements of Article  14(2) of Regulation (EC) No  396/2005.  
(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) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional period  for products which have been 
produced before the modification of the MRLs and for which information shows that 
a high level of consumer protection is maintained.  
(13) 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 themselves to meet the new requirements which will 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  
Annexes II , III and V  to Regulation (EC) No 396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
As regards amisulbrom in and on all products, flubendiamide in and on all products except 
head cabbages and lettuces, meptyldinocap in and on all products, metaflumizone in and on 
all products except broccoli and escarole s (broad -leaved endives) and propineb  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 entry into for ce 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 Publication: please insert date 6 months after e ntry into force] . 
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  