EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2190 R2  
[…](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 napropamide, pyridaben and 
tebufenpyrad 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 napropamide, pyridaben and 
tebufenpyrad 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)(a) and Article 49(2) thereof,  
Whereas:  
(1) For napropamide, pyridaben and tebufenpyrad , maximum residue levels ( ‘MRLs ’) 
were set in Annex  II to Regulation (EC) No  396/2005.  
(2) During the review of  those MRLs  pursuant to  Article 12 of Regulation (EC) 
No 396/2005, the European Food Safety Authority (‘the Authority ’) identified some 
information as unavailable for cer tain product s. The available info rmation was 
sufficient for the Authority to propose MRLs that are safe for consumers . Data gaps 
were indicated in Annex II to that Regulation specifying  the date by which th e missing  
information was to be submitted to the Authority , by the applicant in support of the 
proposed MRL s. 
(3) For napropamide  in or  on the food groups of  citrus fruits , cane fruits and strawberries,  
the applicant submitted the missing information concerning  storage stability . The 
Authori ty concluded that the data gap  indicated in A nnex II to Regulation (EC) 
No 396/2005  was sufficiently addressed2. Therefore, for th ose products , it is 
appropriate  to maintain  existing MRLs and to delete the respective  footnote s requiring 
the submission of additional information in Annex II to Regulation (EC) No  396/2005 .  
(4) For napropamide  in or on  blueberries, cranberries, currants (black, red and white), 
gooseberries (green, red and yellow), rose hips and elderberries, the applicant 
submitted the missing in formation concerning storage stability . The applicant , 
however, hasn’t  submitted  the missing information on crop metabolism for those 
products . The Authority concluded that the data gap previously identified on crop 
metabolism has not been addressed an d recommended that risk managers consider 
lowering th e MRLs  for that substance in or on those products  to the limit of 
determination ( ‘LOD ’). Therefore, for those products , it is appropriate to set the MRLs  
for napropamide at  the product -specific LOD and  to delete  respective footnotes 
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj . 
2 European Food Safety Authority; “Evaluation of confirmatory data following the Article 12  MRL 
review for napropamide”, EFSA Journal, 2023;21(7):8125 . EN 2  EN requiring the submission of additional information in Annex II to Regulation (EC) No 
396/2005 . 
(5) For napropamide  in or on  the food group of herbs and edible flowers, the  applicant did 
not submit the  missing information concerning residue trials. The Authority concluded 
that the data gap previously identified has not been addressed and  recommended that 
risk managers consider lowering the MRLs in or on those products  to the LOD. 
Therefore,  for these pr oducts, it is appropriate to set the MRLs for napropamide at the 
product -specific LOD and  to delete  the respective footnotes requiring the submission 
of additional information in Annex II to Regulation (EC) No 396/2005 . 
(6) For napropamide in or on the food gr oups of herbal infusions from flowers, leaves and 
herbs, roots, herbal infusions from any other part of the plant , and fruit spices , the 
applicant did not submit the missing information concerning analytical method for 
matrices difficult to analyse.  The Au thority concluded that although th at data gap was 
not addressed , the MRLs for those food groups should be maintained as they are 
already at the LOD. Therefore, for th ose food groups , it is appropriate to maintain the 
MRLs  for napropamide  at the LOD and to delete footnotes requiring the submission of 
additional information  in Annex II to Regulation (EC) No 396/2005 . 
(7) For pyridaben  in or on  apples, pears, quinces, medlars, loquats/Japanese medlars, and 
other pome fruits , the applicant did not submit the missing information concerning  
residue trials. However, the new residue data were submitted in support  of alternative 
Good Agricultural Practices  for apples . The Authority concluded that the provided 
residue  trials are considered sufficient3 to derive a  lower  MRL  for apples which can be 
extrapolated to the whole group of pome fruits.  Therefore, for pome fruits , it is 
appropriate to set the MRL s for pyridaben  at the level  proposed by the Authority  and 
to delete  the respective footnotes  requiring the submission of additional information  in 
Annex II to Regulation (EC) No 396/2005.  
(8) For pyridaben  in or on apricots, peaches and beans (with pods), the applicant did not 
submit  the missing information concerning residue trials. The Authority co ncluded 
that the data gap previously identified was not addressed and recommended that risk 
managers consider lowering th e MRLs for those products to the LOD. Therefore, for 
these products, it is appropriate to set the MRLs  for pyridaben  at the product -specific 
LOD and to delete  the respective  footnotes requiring the submission of additional 
information  in Annex II to Regulation (EC) No 396/2005 . 
(9) For pyridaben in or on bovine (muscle, fat, liver, kidney), sheep (muscle, fat, liver, 
kidney), goat (muscle, fa t, liver, kidney), equine (muscle, fat, liver, kidney), and milk 
(cattle, sheep, goat, horse) , the applicant submitted the  missing information concerning 
storage stability, feeding studies and analytical methods. The Authority concluded that 
the data gap i ndicated in Annex II to Regulation (EC) No 396/2005 was sufficiently 
addressed. Since a lower LOD of 0.01  mg/kg in th e products  of animal origin (except 
honey and other apiculture products ) is now achievable using the analytical method 
provided by the applicant, it is appropriate to lower the current LOD of 0.05  mg/kg to 
the LOD of 0.01  mg/kg  and set MRLs at  that LOD and to delete respective footnotes 
requiring the submission of additional information  in Annex II to Regulation (EC) No 
396/2005 . 
 
3 European Food Safety Authority; “Evaluation of confirmatory data following Article 12 MRL  review 
and modification of the existing MRLs in pome fruits for pyridaben”, EFSA Journal, 202 3;21(4):7970.  EN 3  EN (10) For tebufenpyrad  in or on  apricots, peaches, blackberries and dewberries , the applicant 
submitted the missing information concerning residue trials for and  the Authority 
concluded that the data gap indicated in Annex II to Regulation (EC) No  396/2005 
was sufficien tly addressed4. Based on the information provided  the existing MRLs can 
be lowered  for apricots and peaches  but can be maintained  for blackberries and 
dewberries , Therefore, it is appropriate to set MRLs for  tebufenpyrad  at a lower level 
for apricots and peaches  and maintain for blackberries and dewberries  and to delete the 
respective  footnote s requiring the submission of additional information  in Annex II to 
Regulation (EC) No 396/2005 .  
(11) For tebufenpyrad  in or on beans ( with pods) and hops, t he applicant did not submit the 
missing information on resid ue trials for beans (with pods) and on analytical methods 
for hops . The Authority concluded that the data gap previously identified was not 
addressed  and recommended that ris k managers consider lowering the MRLs for those 
products  to the LOD . Therefore, for th ose products, it is appropriate to set the MRLs  
for tebufenpyrad  at the product -specific LOD and  to delete footnotes requiring the 
submission of additional information  in Annex II to Regulation (EC) No 396/2005 . 
(12) For tebufenpyrad  in or on products of animal origin , except honey and other apiculture 
products , the applicant submitted the missing information . The Authority concluded 
that the data gap indicated in Annex II to Regulation (EC) No 396/2005 was 
sufficiently addressed. Therefore, for th ose products , it is appropriate to maintain the  
existing MRL s for tebufenpyrad , and to delete the footnote s requiring the submission 
of additional information  in Annex II to Regulatio n (EC) No 396/2005 . 
(13) For tebufenpyrad in or on honey and other apiculture products , the applicant did not 
submit the missing information on specific analytical methods for honey . The 
Authority concluded that the data gap previously identified was not addres sed and 
recommended to maintain the current MRL  which is at the LOD . Therefore, for th ose 
products, it is appropriate to maintain the MRL  for tebufenpyrad  at the LOD and 
delete footnotes requiring the submission of additional information  in Annex II to 
Regulation (EC) No 396/2005 . 
(14) For tebufenpyrad , the Authority found that it could not be excluded that the acute 
reference dose would be exceeded for table grapes. It is therefore appropriate to lower  
the MRL  to the LOD  for tebufenpyrad in Annex II to Regulation (EC) No 396/2005 in 
accordance with Article  17 of Regulation (EC) No 396/2005 in conjunction with 
Article  4(1), point  (a), thereof.  
(15) The Commission consulted the European Union reference laboratories as regards the 
need to adapt certain LODs  for napropamide, pyridaben and tebufenpyrad . Those 
laboratories concluded that for certain products technical development s permit the 
setting of lower LODs.  
(16) 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.  
(17) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(18) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should not apply to products which hav e been placed on the market in 
 
4  European Food Safety Authority; “ Evaluation of confirmatory data following the Article 12 MRL 
review for tebufenpyrad ” EFSA Journal 2023;21(2):7774.  EN 4  EN the Union before the new MRLs become applicable and for which a high level of 
consumer protection is maintained  except for tebufenpyrad in or on table grapes . 
(19) 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 adapt themselves to the requirements which result from the modification 
of the MRLs.   
(20) 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 shall 
continue to apply to all products which have been placed on the market in the Union before 
[Office of Publication s: please insert date 6   months after date of entry into force  of this 
regulation ] except for tebufenpyrad in or on table grapes . 
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 s: please insert date 6 months after 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