EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/326_Rev4  
[…](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 deltamethrin, metalaxyl, 
thiabendazole and trifloxystrobin 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 deltamethrin, metalaxyl, 
thiabendazole and trifloxystrobin 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 deltamethrin, metalaxyl, th iabendazole and trifloxystrobin , maximum residue 
levels ( ‘MRLs ’) were set in Annex  II to Regulation (EC) No  396/2005.  
(2) During the assessmen t of those MRLs  in accordance with Article 12 of Regulation 
(EC) No  396/20052, the European Food Safety Authority (‘the Authority ’) identified 
some information as unavailable for cer tain product s. The available information was 
sufficient for the Authority to propose MRLs that are safe for consumers and the data 
gaps were indicated in Annex II of that Regulation specifying  the date by which th e 
missing  information was to be submitted to the Authority in support of the proposed 
MRL s. 
(3) For deltamethrin , such information concerning the method of enforcement and residue 
trials was provide d to confirm the existing MRLs  for ‘tree nuts ’, melons, watermelons, 
other cucurbits with inedible peel, Chinese cabbages, rice and wheat . The Authority 
concluded that the data provided was  sufficien t to address the data gap identified . 
Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) 
No 396/2005 should be maintained .  
(4) The information provided on residue trials analysing simultaneously the residue 
definitions  for enforcement  and risk assessment was not sufficient to confirm the 
existing MRLs of deltamethrin  for quinces, medlars, loquats , apricots, cherries, 
peaches, ‘other small fruits and berries ’, beetroots, celeri ac, horseradishes, Jerusalem 
artichokes, parsley roots, radishes, salsifies, swedes, turnips, ‘other root and tuber 
vegetables ’, ‘bulb vegetables ’, aubergines, kales , kohlrabies, leeks, olives for oil 
production, ‘herbal infusions from roots ’ and chicory ro ots. However, the Authority 
was able to conclude that the current MRLs are safe for consumers  by using  a 
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj  . 
2 Reasoned opinion on the Evaluation  of confirmatory data following the Article 12 MRL review and 
modification of the existing maximum residue levels for deltamethrin in toma toes and okra/lady’s 
fingers. EFSA Journal 2022;20(3):7107.  EN 2  EN conversion factor for recalculating the results of the residue trials obtained  according 
to the residue definition for enforcement to the residue defin ition for risk assessment . 
Therefore, for these products, the existing MRLs in Annex II to Regulation (EC) 
No 396/2005 should be kept.  
(5) The current MRLs for apples, table olives, carrots, pumpkins, ‘flowering brassica ’, 
‘legume vegetables ’, ‘cereals (except rice and wheat) ’, root and rhizome spices, 
grapes, strawberries, ‘cucurbits with edible peel ’, lamb ’s lettuce, cresses, land cresses, 
Roman rocket, red mustards, baby leaf crops, grape leaves, watercresses, chervil, 
cultivated fungi, lentils, peas,  lupins, tea and ‘products of animal origin, including 
milk and eggs ’ are based on Codex maximum residue limits (CXLs) , which were 
included in Annex II to Commission Regulation (EC) No  396/20053. Despite  a 
discrepancy between  the U nion and the Codex resid ue definitions, the Authority 
concluded that the current MRLs are safe for consumers. Therefore, for these products 
the existing MRLs in Annex II to Regulation (EC) No  396/2005 should be kept.  
(6) For citrus fruits, kiwis, escaroles, spinaches and similar leaves, globe artichokes, 
beans, oils eeds, fruit spices, bud spices and flower pistil spi ces, the Authority 
concluded that the data gap previously identified was not addressed and that risk 
managers may consider replacing those MRLs either with alternative MRLs , available 
for ‘citrus fruits ’, or with the  product specific  Limit of Determination  (‘LOD’) . Lower 
MRL was available for ‘citrus fruits ’ based on (alternative) GAPs and with a view to 
setting MRLs at the lowest reasonable level , it is appropriate to set new lower MRLs 
for them in Annex  II to Regulation (EC) No  396/2005 . Since for the oth er products 
listed no fall-back GAPs were available, it is appropriate to set the levels at the 
product specific LOD .  
(7) Additional information provided on residue trials was combined with the existing data, 
enabling the Authority to derive lower MRLs for cane fruits, herbs and edible flowers 
(except chervil), herbal infusions from flowers, herbal infusions from leaves and 
herbs, sweet peppers /bell peppers  and head cabbages and higher MRL for plums . The 
Authority concluded that the new MRLs are safe for consumers. Therefore, for these 
products, new MRLs should be included in Annex II to Regulation (EC) No  396/2005 .  
(8) The Authority identified a risk for consumer s concerning the existing MRLs for pears, 
potatoes and lettuces  and concluded that risk managers may consider replacing those 
MRLs either with alternative lower MRLs, available for pears  and lettuces , or 
replacing those MRLs with the product specific LOD.  As a fall -back GAP leading to a 
lower MRL was available for pea rs and lettuces , but not for potatoes, it is appropriate 
to set a new, lower MRL s only for pears  and lettuces , but  lower the MRL to the 
product -specific LOD for potatoes.  For the sake of clarity , the footnotes indicating a 
lack of information concerning th ose products should be deleted from Annex  II to 
Regulation (EC) No  396/2005 .  
(9) The Authority received several applications pursuant to Article 6 of Regulation (EC) 
No 396/2005  to modify the existing MRLs for deltamethrin in tomatoes and 
 
3 Commission Regulation (EU) 2018/832 of 5 June 2018 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 cyantraniliprole, cymoxanil, deltamethrin, difenoconazole, fenamidone, flubendiamide, fluopicolide, 
folpet, fosetyl, mandestrobin, mepiquat, metazachlor, propamocarb, propargite, pyrimethanil, 
sulfoxaflor and trifloxystrobin in or on certain pro ducts  (OJ L 140, 6.6.2018, p. 38 , ELI: 
http://data.europa.eu/eli/reg/2018/832/oj ). EN 3  EN okra/lady ’s fingers2, carobs/Saint John ’s breads4 and maize5. Regarding tomatoes and 
okra/lady ’s the Authority recommended r aising the MRLs for those products2. 
Therefore, the MRLs for tomatoes and okra/lady ’s fingers should be set at the level 
identified by the Authority. For carobs/Saint John ’s breads , the Authority , after having 
initially identified a long-term consumer intake concern f or the proposed MRL4, in the 
subsequent confirmatory data assessment, co ncluded that the proposed value was safe 
for consumers2. It is therefore appropriate to set this MRL at the proposed level . 
Regarding maize,  the Authority  concluded that the data provided was sufficient to 
derive a new MRL but that this level was lower than the existing one that is based on a 
CXL , which  is safe for consumers5. The existing MRL should therefore be maintained .  
(10) In accordance with Article 6(2)  and (4) of Regulation (EC) No 396/2005 an 
application was submitted for  deltamethrin on mangos and papayas. The applicant 
claimed that the authorised uses of de ltamethrin on such crops in Brazil lead to 
residues exceeding the MRLs contained in Regulation (EC) No 396/2005 and that 
higher MRLs are necessary to avoid trade barriers for the importation of those crops. 
The Authority assessed the application and concluded  that the submitted data were 
sufficient to set new (higher) MRLs that were  considered/that are safe for consumers6. 
As there is no risk for consumers, it is appropriate to set the MRLs for mangoes and 
papayas in Annex  II to Regulation (EC) No  396/2005 at the level identified by the 
Authority.  
(11) For metal axyl, the European Union reference laborat ories recommended to change the 
residue definition for monitoring produc ts of animal origin to ‘sum of metalaxyl (sum 
of enantiomers) and metabolites (free + conjugated) M3 (N - (2,6-dimethylphenyl) -N-
(hydroxyacetyl)alanine methyl ester) and M8 (N -(2-hydrox ymethyl -6- methylphenyl) -
N-(methoxyacetyl)alanine methyl ester (sum of enantiomers), expressed as metalaxyl ’. 
The Commission considers this new residu e definition to be appropriate.  
(12) To address the data gaps identified during by the Authority  in the framework of the 
MRL review for metalaxyl under Article 12 of Regulation (EC) No 396/2005 , the 
applicant provided new data regarding analytical methods and residue trials. For cocoa 
beans and hops , the Authority concluded7 that the data provided was suffi cient to 
address the gap identified and that the additional residue trials for cocoa beans lead to 
a new (lower) MRL  as safe for consumers . The Authority concluded that the new 
MRL is safe for consumers. Therefore, for hops the existing MRL should be 
maint ained and for cocoa beans the new (lower) MRL should be included in Annex II 
to Regulation (EC) No  396/2005.  For lemons, limes, mandarins, apples, pears, grapes, 
onions, sweet peppers/bell peppers , melons, watermelons, globe artichokes , soyabeans 
and ‘products of animal origin ’ the Authority concluded that the data gap previously 
identified was not addressed and that risk managers may consider replacing those 
MRLs either with alternative MRLs , when available , or replacing those MRLs with 
the product specifi c LOD . As a fall -back GAP leading to a lower MRL was available 
for limes, mandarins, onions, sweet peppers/bell peppers , melons, watermelons and 
globe artichokes , it is appropriate to set new lower MRLs . For “herbs and edible 
 
4 Reasoned opinion on the modification of the existing maximum residue level for deltamethrin in 
carobs/Saint John’s breads. EFSA Journal 202 0;18(10):6271 . 
5 Reasoned opinio n on the modification of the existing maximum residue level for deltamethrin in 
maize/corn. EFSA Journal 202 2;20(7):7446 . 
6 Reasoned opinion on the setting of import tolerances for deltamethrin in mangoes and papayas. EFSA 
Journal 202 2;20(3):7198 . 
7 Reasoned opinion on the e valuation of confirmatory data following the Article 12 MRL review for 
metalaxyl -M. EFSA Journal 202 1;19(12):6996 . EN 4  EN flowers” it was possible to extrapolate indoor data from open -leaf varieties of lettuce 
and it is appropriate to maintain its MRLs . Since for lemons, apples, pears , and 
soyabeans  no fall -back GAP was available, it is appropriate to lower these MRLs to 
the product specific LOD. For ‘products of animal origin ’ the Authority reviewed the 
existing MRLs based on updated dietary burden calculations  and proposed new 
(lower) MRLs for kidney and edible offals from swine, sheep and goats and higher 
MRLs for liver kid ney and edible offals from bovine and  equine . As there is no risk 
for consumers, it is appropriate to set the MRLs for ‘products of animal origin ’ in 
Annex  II to Regulation (EC) No 396/2005 at the level identified by the Authority. For 
the sake of clarity, the respective footnotes indicating a lack of information concerning 
those products should be deleted from Annex II to Regulation (EC) No  396/2005.  
(13) In accordance with Article 6(2) and (4) of Regulation (EC) No 396/2005 an 
application w as submitted for metalaxyl -M used in oil palms fruits and peppercorn 
(black, green and  white). The applicant claimed that the authorised uses of 
metalaxyl -M in oil palms in Colombia and in peppercorn in Vietnam lead to residues 
exceeding the MRLs contained  in Regulation (EC) No 396/2005 and that higher 
MRLs are necessary to avoid trade barriers for the importation of those crops. The 
Authority  assessed the application and concluded that the submitted data were 
sufficient to set new MRLs that were safe for c onsumers8. As there is no risk for 
consumers, it is appropriate to set the MRLs for oil palms fruits and peppercorn in 
Annex  II to Regulation (EC) No  396/2005 at the level identified by the Authority.  
(14) On 13 December 2022, the Codex Alimentarius Commissio n adopted new CXLs for 
metalaxyl9. In accordance with Article 5(3) of Regulation (EC) No 178/2002 of the 
European Parliament and of the Council10, where international standards exist or their 
completion is imminent, they are to be taken into consideration in the development or 
adaptation of food law, except where such standards or relevant parts would be an 
ineffective or inappropriate means for the fulfilment of the legitimate objectives of 
food law or where there is a scientific justification, or where they would result in a 
different level of protection from the one determined as appropriate in the Union. 
Moreover, in accordance with Article  13, po int (e), of that Regulation, the Union is to 
promote consistency between international technical standards and food law while 
ensuring that the high level of protection adopted in the Union is not reduced. The 
Authority assessed the risks to consumers and produced a scientific report11. In cases 
where the Authority had identified a potential consumer health risk, the Union 
presented reservations12,13 to the Codex Committee on Pesticides Residues on the 
 
8 Reasoned opinion on the setting of import tolerances for metalaxyl -M in oil palms fruits and 
peppercorn. EFSA Journal 202 3;21(5):8008 . 
9 Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission. Appendix III. Forty -
fifth Session. Virtual, 21 -25 November, 12 -13 and 19 December 2022 and 6 February 2023. 
https://www.fao.org/fao -who-codexalimentarius/sh -
proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMe
etings%252FCX -701-
45%252FFinal%252520Report%252520CAC45%252FCompiled%2BREP22_CAC.pdf . 
10 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law , establishing the European Food Safety 
Authority and laying down  procedures in matters of food safety  (OJ L 31, 1.2.2002, p.  1, ELI: 
http://data.europa.eu/eli/reg/2002/178/oj ). 
11 Scientific support for preparing an EU position for the 53rd Session of the Codex Committee on 
Pesticide Residues (CCPR). EFSA Journal 2022;20(9):7521.  
12 European Union comments on Codex CX/PR 22/53/5 : https://www.fao.org/fao -who-
codexalimentarius/sh -EN 5  EN CXLs proposed. This was the case for metalaxyl in apple s, pears and head cabbages. 
Those CXLs , for which the Union did not present a reservation to the Codex 
Committee on Pesticides Residues since the Authority did not identify risks for 
consumers in the Union, can therefore be considered safe. This is the case for the 
CXLs for metalaxyl in grapes, onions , potatoes  and peppercorn . Those CXLs should 
therefore be included in Annex II to Regulation (EC) No  396/2005 . 
(15) For thiabendazole , information concerning the potential consumer exposure to the 
metabolite benzimidazole, residue tria ls and storage stability were provided to confirm 
the existing MRLs for apples, avocados and pot atoes. The Au thority concluded14 that 
the data provided was sufficient to address the gap identified and derived  a new 
(lower) MRL  based on additional residue trials that were submitted for avocado . The 
Authority concluded that the new MRLs are safe for co nsumers. Therefore, for apples 
and potatoes the existing MRLs should be maintained and for avocados the new MRL 
should be included in Annex II to Regulation (EC) No  396/2005 . The Authority 
identified a potential  short -term consumer intake concern f or the existing MRL for 
papayas . Therefore, for papayas  the existing MRL should be lowered to the product 
specific LOD.  For the sake of clarity , the respective footnotes indicating a lack of 
information concerning those products should be deleted from Annex  II to Regulation 
(EC) No  396/2005.   
(16) For trifloxystrobin, the European Union reference laboratories  recommended to 
change the residue definition for monitoring produ cts of animal origin to “ Sum of 
trifloxystrobin and [(E,E) -meth oxyimino -{2-[1-(3-
trifluoromethylphenyl)ethylideneamino -oxymethyl]phenyl}acetic acid] 
(CGA  32111 3), expressed as trifloxystrobin (F)”. The Commission considers this new 
residue definition to be appropriate.  
(17) Some of the data gaps identified during by the Authority  in the framework of the MRL 
review for trifloxystrobin  under Article 12 of Regulation (EC) No 396/2005  were 
addre ssed in Commission Regulation (EU) No 2018/8323, regarding analytical 
methods and the  commercial  availability of the metabolite CGA321113 . To address 
the remaining data gaps identified by the Authority, the applicant provided new data 
regarding residue trials for ‘herbs and edible flowers ’, bean s with pods and oats. The 
Authority concluded15 that the data provided was sufficient to address the  data gap 
identified and that the additional residue trials derived new  MRLs which  are safe for 
consumers. Therefore, those  new MRLs should be included in Annex II  to Regulation 
(EC) No  396/2005 . For passion  fruits/maracujas, cucumbers, gherkin s and Chinese 
cabbages/pe -tsai the Authority concluded that the data gap previously identified was 
not addressed and that risk managers may consider maintaining those MRLs with the 
existing CXLs , available for cucumbers  and gherkin s or replacing those MRLs with 
the product specific LOD. As a fall-back  GAP leading to a n MRL safe for the 
 
proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252 Fsites%252Fcodex%252FMe
etings%252FCX -718-53%252FCRDs%252Fpr53_crd13revx.pdf . 
13 Report of the 53rd session of the Codex Committee on Pesticide Residues REP2 2/PR53: 
https://www.fao.org/fao -who-codexaliment arius/sh -
proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMe
etings%252FCX -718-53%252FREPORT%252FFINAL%2BREPORT%252FREP22_PR53e.pdf . 
14 Reasoned opinion on the evaluation of confirmatory da ta following the Article 12 MRL review for 
thiabendazole . EFSA Journal 2022;20( 8):7539. 
15 Reasoned opinion on the modification of existing maximum residue levels in various crops and 
evaluation of confirmatory data following the Article 12 MRL review for t rifloxystrobin . EFSA Journal 
2022;20(1):7048 . EN 6  EN consumers was available at the same level for cucumbers  and gherkin s it is appropriate 
to maintain those  MRLs, w hile since for passion  fruits/maracujas  and Chinese 
cabbages/pe -tsai no fall -back GAP was available, then it is appropriate to lower these 
MRLs to the product specific LOD. For the sake of clarity , the respective footnotes 
indicating a lack of information concerning those products should be deleted from 
Annex  II to Regulation (EC) No  396/2005 .  
(18) Together with the confirmatory data , the applicant also submitted several application s 
to modify the existing MRLs for trifloxystrobin  in various crops  under Article 6 of 
Regulation (EC) No 396/2005. The Authority assessed the application s and concluded 
that the submitted data were sufficient to set new MRLs for sweet peppers /bell 
peppers , kales , chicory roots and honey that were safe for consumers15, 16. 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 level identified by the Authority. When 
assessing the data submitted on escaroles, the Authority identified a risk f or consumers 
concerning the proposed  (higher) MRL , while it confirmed that the current MRL is 
safe for consumers . It is therefore appropriate to maintain its MRL at th e existing 
level . Regarding witloofs/Belgian endives , the Authority concluded that the data 
provided was insufficient to derive a new MRL . It is therefore appropriate to maintain 
its MRL at the existing level which is the  product specific LOD.  
(19) The Commission consulted the European Union reference laborator ies as regards the 
need to adapt certain LODs. Those laboratories proposed product specific LOD that 
are analytically achivable for all products.  
(20) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and th eir comments have been taken into account.  
(21) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
(22) In order to allow for the normal marketing, processing and consumption of products, 
this Regulation should provide for a transitional measure fo r products which have been 
placed on the market in the Union before the modification of the MRLs and for which 
information shows that a high level of consumer protection is maintained.  
(23) A reasonable period should be allowed to elapse before the modified MR Ls 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.  
(24) The measures provided for in this Regulation are in a ccordance 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.  
 
16 Modification of the existing maximum residue level for trifloxystrobin in honey.  EFSA Journal 
2023;21(8):8189  EN 7  EN Article 2  
Regulation (EC) No  396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were placed on the market in the Union before … 
[6  months after date of entry into force  of this Regulation ], except for the MRLs for  
deltamet hrin on  pears, potatoes and lettuces  and for thiabendazole  in papayas . 
Article 3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journa l of the European Union . 
It shall apply from … [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