EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
PLAN/2023/2305 Rev. 3  
[…](2023) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for 1,4 -dimethylnaphthalene, 
difluoroacetic acid (DFA), fluopyram and flupyradifurone in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for 1,4 -dimethylnaphthalene, 
difluoroacetic acid (DFA), fluopyram and flupyradifurone 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), thereof,  
Whereas:  
(1) For the active substances 1,4-dimethylnaphthalene, difluoroacetic  acid (DFA), 
fluopyram and flupyradifurone , maximum residue levels ( ‘MRLs ’) were set in 
Annex  II to Regulation (EC) No  396/2005 . 
(2) As regards 1,4 -dimethylnaphthalene, an application was submitted pursuant to Article 
6(1) of Regulation (EC) No 396/2005  reques ting a modification of the existing MRL 
in potatoes . In addition, the applicant submitted information , previously unavailable 
during the review of the MRLs for this substance conducted pursuant to  Article 12 of 
Regulation (EC) No 396/2005 , on the nature of  the residue in processed commodities 
for potatoes and on analytical methods  for products of animal origin .  
(3) In accordance with Articles 8 and 9 of Regulation (EC) No  396/2005, the Member 
State concerned evaluated th at application and forwarded the evaluat ion report to the 
Commission. In the evaluation report, the Member State assessed the livestock dietary 
burden taking into account the livestock intake of commodities produced from 
potatoes and  proposed lowering  some of the existing MRLs for 1,4 -
dimethylna phthalene in products of animal origin  from mammals and raising the 
MRLs for th at substance in ‘commodities from poultry’ and ‘bird eggs’ . 
(4) The European Food Safety Authority (‘the Authority’) assessed the application and the 
evaluation report. It examined in particular the risks to consumers and, where relevant, 
to animals, and gave a reasoned opinion on the proposed MRLs2. It forwarded its 
reasoned opinion to the applicant, the Commission and the Member States and made it 
available to the public.  
(5) As regards the previously unavailable information submitted by the applicant on the 
nature of the residue in processed commodities for potatoes and on analytical methods 
 
1 OJ L 70, 16.3.2005, p.  1, ELI: http://data.europa.eu/eli/reg/2005/396/oj . 
2 EFSA 2023. Modification of the existing maximum residue levels for 1,4 -dimethylnaphthalene in 
potatoes. EFSA Journal, 21(8), 1 –37. https://doi.org/10.2903/j.efsa.2023.8190  EN 2  EN for products of animal origin, the Authority concluded that these data gaps were 
sufficiently addressed.  
(6) Therefore, for potatoes and products of animal origin , the requirement to submit 
additional information should be deleted from Annex  II to Regulation (EC) 
No 396/2005 .  
(7) As regards the modification s to the MRL s for 1,4-dimethylnaphthalen e in potatoes, 
swine fat, swine others, ‘commodities from bovine ’, sheep muscle, sheep fat, sheep 
liver, sheep edible offals (other than liver and kidney), sheep others, goat muscle, goat 
fat, goat liver, goat edible offals (other than liver and kidney), goat others, 
‘commodities from equine ’, ‘commodities from poultry ’, ‘milk’ and ‘bird eggs’ 
requested by the applicant, t he Authority concluded that all data requirements had 
been met and that such modifications were acceptable with regard to consumer safety  
on the basis of a consumer exposure assessment for 27  specific European consumer 
groups. The Authority took into account the most recent information on the 
toxicological properties of the substance. Neither the lifetime exposure to this 
substance via cons umption of all food products that may contain it nor the short -term 
exposure due to high consumption of the relevant products show a risk that the 
acceptable daily intake or the acute reference dose is exceeded.  
(8) In its reasoned opinion, the Authority did n ot recommend specific MRLs for the 
categories ‘edible offals (other than liver and kidney) ’ of the various groups of animal 
products.  
(9) To ensure that those MRLs are established at a realistic level, it is appropriate to set 
them  at the highest MRL applicable to one of the products within that same product 
group.  
(10) In its reasoned opinion, the Authority did not recommend specific MRLs for the group 
‘commodities from other farmed terrestrial animals’.  
(11) Since those MRLs are usually set at the same values as for the ruminant species group 
with the lowest MRLs,  it is appropriate to set those MRLs at the same level as the 
MRLs for the group ‘commodities from bovine’ . 
(12) As regards fluopyram , an application was submitted pursuant to Article 6(1) of 
Regulation (EC) No 396/2005 requesting a modification of the existing MRL for 
fluopyram in pumpkin seeds . 
(13) For that application, a Member State made a request to use the fast -track procedure,  
provided  for in the Technic al Guidelines on the MRL setting procedure3, to set an 
MRL based on residue trials on rapeseeds/canola seeds . 
(14) The Authority assessed residue trials on rapeseeds/canola seeds  in the framework of 
the review of the existing MRLs for fluopyram and g ave a reas oned opinion on the 
proposed MRL4. That opinion relies on the current scientific and technical knowledge 
on the subject. As it is appropriate to extrapolate from the residue trials on 
rapeseeds/canola seeds to pumpkin seeds , in line with  the Technical Gui delines on 
 
3 Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) 
No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1).  
4 EFSA 2 020. Reasoned opinion on the review of the existing maximum residue levels for  fluopyram  
according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(4):6059 . EN 3  EN extrapolation of MRL5, it is unnecessary to request the Authority to provide a reasoned 
opinion on pumpkin seeds  specifically.  
(15) It is therefore appropriate to set the MRL for fluopyram in pumpkin seeds at 0,4 mg/kg 
on the basis of the residue tr ials performed on rapeseeds/canola seeds . 
(16) As regards DFA and flupyradifurone , two application s were submitted pursuant to 
Article 6(1) of Regulation (EC) No 396/2005  requesting a modification of the existing 
MRL s for ‘citrus fruits ’, cherries (sweet), ‘cane fruits ’, ‘other small fruits and berries ’, 
‘leafy brassica ’, ‘herbs and edible flowers ’, sunflower seeds, barley, corn/maize, 
common millet/proso millet, oat, rye, wheat, sugar beet roots , chicory roots and honey . 
Those applicatio ns also requested setting import tolerances for those substances used 
in Australia, Brazil and the United States on other citrus fruits, macadamias, ‘stone 
fruits ’, avocados, mangoes, papayas, asparagus, sesame seeds, sunflower seeds, 
barley, corn/maize, c ommon millet/proso millet, oat, rye and wheat pursuant to Article 
6(2) and (4) of Regulation (EC) No 396/2005. The applicant s provided  data showing 
that the uses of DFA and flupyradifurone on those crop s that are authorised in 
Australia, Brazil and the Uni ted States lead to residues exceeding the MRLs set in 
Regulation (EC) No 396/2005 and that higher MRLs are needed to avoid trade barriers 
when importing these crops.  
(17) In accordance with Articles 8 and 9 of Regulation (EC) No 396/2005, the Member 
States con cerned evaluated th ose applications and forwarded the evaluation reports to 
the Commission . In the evaluation report, the Member State assessed the livestock 
dietary burden taking into account the livestock intake of commodities produced from 
those crops  and proposed raising  some of the existing MRLs for DFA and 
flupyradifurone in products of animal origin.  
(18) The Authority assessed the applications and the evaluation reports. It examined in 
particular the risks to consumers and, where relevant, to animals, and gave reasoned 
opinions on the proposed MRLs6. It forwarded its reasoned opinions to the applicants, 
the Commission and the Member States and made them available to the public.  
(19) In its reasoned opinion, the Authority concluded that the data submitted by the 
applicant s concerning flupyradifurone in grapefruit, oranges, lemons, limes, 
mandarins , macadamias, b lueberries, ‘cane fruits ’, avocados, asparagus, barley, 
maize/corn, wheat, sugar beet roots, and chicory roots and for DFA in grapefruit, 
oranges, blackberries, raspberries, ‘other small fruits and berries ’, ‘herbs and edible 
flowers ’, barley, common mille t/proso millet, wheat and honey  was insufficient to set 
new MRL s.  
(20) As regards DFA in rotational crops, the Authority concluded that further consideration 
by risk managers was required concerning the need to set MRLs taking into 
consideration not only the d irect treatment on those crops but also residues expected to 
be taken up via roots. As studies show  that in rotational crops the uptake of residues of 
 
5 Technical guidelines on data requirements for setting maximum residue levels, comparability of residue 
trials and extrapolation of residue data on products from plant a nd animal origin (SANTE/2019/12752 – 
Rev. 1  – 10 May 2023).  
6 EFSA 2023. Reasoned Opinion on the modification of the existing maximum residue levels and setting 
of import tolerances for flupyradifurone and DFA in various crops and animal commodities. EFSA 
Journal 2023;21(7):8081.  
 EFSA 2023. Reasoned Opinion on the modification of the existing maximum residue levels and setting 
import tolerances for flupyradifurone and difluoroacetic acid (DFA) in various plant commodities. 
EFSA Journal 2023; XX(X):XXX . EN 4  EN DFA  from soil, stemming from preceding  crops , cannot be fully avoided, it is 
appropriate to set MRLs that are reflecting  both direct treatment and  such uptake of 
residues  from soil . This is relevant fo r Chinese cabbages/pe -tsai, kales, ‘leafy brassica, 
others’, sesame seeds, sunflower seeds, maize/corn, oat, rye, sugar beet roots and 
chicory roots.  
(21) As regards  flupyradifurone in kales , the Authority concluded that further consideration 
by risk managers was required concerning the possibility to lower the existing MRL, 
in accordance with the applicant request, based on the new residue trials submitted. As 
the ne w residue trials provided  for flupyradifurone in kales are based on the same 
Good Agricultural Practices as the existing MRL, it is appropriate to lower the MRL 
from 5 mg/kg to 4 mg/kg based on the most recent and complete data provided . 
(22) As regards flupyradifurone in sunflower seeds, the Authority concluded that further 
consideration by risk managers was required concerning whether to establish the new 
MRL at the level of 0,8 mg/kg, as derived by the Authority based on the assessment of 
the residue trials on sunflower seeds submitted by the United States, or at the MRL of 
0,7 mg/kg, which is in force in the exporting country, the United States.  
(23) In accordance with the Technical Guidelines on the MRL setting procedure, an MRL 
established in the framework of an import tolerance application should  not exceed the 
one approved in the exporting country.  
(24) Therefore, it is appropriate to set the MRL at the level established in United States (0,7 
mg/kg ). 
(25) As regards the modification s to the MRL s for DFA in lemons, limes, mandarins, 
‘citrus fruits, others’, macadamias, ‘stone fruits ’, ‘cane fruits ’, avocados, mangoes, 
papayas, “leafy brassica”, asparagus, sesame seeds, sunflower seeds, maize/corn, oat, 
rye, sugar beet roots, chicory roots, swine fat, sw ine liver, sheep fat, goat fat, and 
poultry fat  and for flupyradifurone in ‘citrus fruits, others’, ‘stone fruits ’, ‘cane fruits ’, 
‘other small fruits and berries ’ (except blueberries), mangoes, papayas, ‘leafy 
brassica ’, ‘herbs and edible flowers ’, sesame  seeds, sunflower seeds, common 
millet/proso millet , oat, rye, ‘commodities from swine ’ (except swine muscle), and 
honey requested by the applicants, the Authority concluded that all the data 
requirements had been met and that the modifications to the MRLs  requested by the 
applicants were acceptable with regard to consumer safety on the basis of a consumer 
exposure assessment for 27 specific European consumer groups. In so concluding, the 
Authority took into account the most recent data on the toxicological  properties of the 
substances. Neither the long -term exposure to these substances via consumption of all 
food products that may contain them nor the short -term exposure due to high 
consumption of relevant products show a risk that the acceptable daily inta ke or the 
acute reference dose is exceeded.  
(26) Based on the reasoned opinions of the Authority and taking into account the relevant 
factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed 
modifications to the MRLs fulfil the requirements of that article.  
(27) 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.  
(28) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(29) For all active substances covered by this Regulation, 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 been placed on the market in EN 5  EN the Union  before the modification of the MRLs and for which information shows that 
a high level of consumer protection is maintained.  
(30) 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 result from the 
amendments.  
(31) 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  II to Regulation (EC) No 396/2005 is 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 sha ll 
continue to apply to products which were placed on the market in the Union  before [ 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 Offici al Journal of the European Union . 
It shall apply from … [6 months after 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 Presiden t  
 Ursula VON DER LEYEN