EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10218/2021 Rev. 3  
[…](2021) 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 fluoride ion, 
oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride 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 fluoride ion, 
oxyfluorfen, pyroxsulam, quinmerac and sulfuryl fluoride 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 part icular 
Article 14(1)(a)  and Article 49(2) thereof,  
Whereas:  
(1) For fluoride ion, oxyfluorfen, pyroxsulam , quinmerac  and sulfuryl fluoride , maximum 
residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) 
No 396/2005.  
(2) For oxyfluorfen , 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 MRLs for citrus fruits, tree nuts, 
pome fruits, stone frui ts, grapes, table olives, kaki/Japanese persimmon s, granate 
apple s/pomegranates, onions, head brassicas and sunflower seeds.  For other products, 
the Authority recommended keeping the existing MRLs. As there is no risk for 
consumers, MRLs should be set in A nnex  II to Regulation (EC) No  396/2005 at the 
existing level or the level identified by the Authority.  
(3) For pyroxsulam , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20053. It rec ommended  
keeping the existing MRLs  at the specific limit of determination (LOD) or the default 
MRL. For some products , specific LODs require adaptations to higher values in the 
light of analytical feasibility.  These LOD s 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 oxyfluorfen  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18( 10):6269 . 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for pyroxsulam  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18( 10):6260. EN 2  EN (4) For quinmerac , the Authority submitted a reasoned opinion on the existing MRLs in 
accordance with Article 12(1) of Regulation (EC) No  396/20054. It proposed to 
change the residue definition.  It recommended lowering the MRL s for sugar beet 
roots , muscle (swine, bovine, sheep, goat, equine, poultry), fat (swine, bovine, sheep, 
goat, equine, poultry), liver (swine, poultry), swine kidney, m ilk (cattle, sheep, goat, 
horse) and birds’ eggs . For other products, it recommended raising or keeping the 
existing MRLs. 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. The Authority concluded that concerning the MRLs for liver and 
kidney from ruminant s and equine  some information was not available  and that further 
consideration by risk managers was required. 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 sulfuryl fluoride  the Authority submitted  a reasoned opinion on the existing MRLs 
in accordance with Article 12(1) of Regulation (EC) No  396/20055. It proposed to 
maintain the existing two residue definition s (sulfuryl  fluoride and fluoride ion) as 
tentative  given that further data are required t o confirm them.  It also concluded that 
concerning the MRLs for sulfuryl fluoride and fluoride ion for all the commodities  
listed in Annex I to Regulation (EC) No  396/2005  some information was not available 
and that further consideration by risk managers wa s required. Taking into account 
additional monitoring data provided by food business operators , as there is no risk for 
consumers fluoride ion MRLs for herbal infusions , rose hips, elderberries and “basil 
and edible flowers ” should be set in Annex II to Regulation (EC) No 396/2005 at the 
existing level.  These MRLs will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation.  
(6) As regards products on which the use of the plant protect ion 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 provided for in Article 18(1)(b) of Regulation (EC) No  396/2005.  
(7) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs . For all the subatnces covered by 
this Regulation , those laboratories concluded that for certain commodities techn ical 
development requires the setting of specific LODs . 
(8) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under consideration, the appropriate modifications to the MRLs 
fulfil the requirements Articl e 14(2) of Regulation (EC) No  396/2005.  
(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 accordin gly. 
(11) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional arrangement for products which have 
                                                 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for quinmerac  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2020;18( 10):6257. 
5 European  Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for sulfuryl fluoride  according to Article 12 of Regulation (EC ) No 396/2005. EFSA Journal 
2021;19(1):6390. EN 3  EN been produced before the modification of the MRLs and for which information shows  
that a high level of consumer protection is maintained.  
(12) 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.  
(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  
Annexes 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 were produced in the Union or imported into the Union 
before [ Office of Publication: please insert date 6 months after entry into force ]. 
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of t he European Union .  
 
It shall apply from [Office of Publication: please insert date 6 months after entry 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  