EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/1863 v2  
[…](2023) 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 cypermethrins 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 cypermethrins 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 2 3 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 cypermethrin , maximum residue levels (‘MRLs’) were set in Annex II and Part B 
of Annex III to Regulation (EC) No 396/2005.  
(2) The group of cypermethrins consists of cypermethrin  and its isomers  alpha -
cypermethrin, beta -cypermethrin, and zeta -cypermethrin, under the residue definition 
‘cypermethrin (cypermethrin including other mixtures of constituent isomers (sum of 
isomers)) ’. The European Food Safety Authority (‘the Authority ’) confirmed this 
residue definition as appropriate2. In accordance with Regulation (EC) No  1107/2009 
of the European Parliament and of the Council3, cypermethrin4 is approved in the 
Union , while a lpha-cypermethrin5, beta -cypermethrin6 and zeta -cypermethrin7 are not 
approved in the Union.  
 
1 OJ L 70, 16.3.2005, p. 1 , ELI: http://data.europa.eu/eli/reg/2005/396/oj  . 
2 European Food Safety Authority,  Reasoned opinion on the Review of the residue definitions for risk 
assessment of pyrethroids forming common metabolites ; EFSA Journal 2023;21(5):8022 . 
3 Regulation (EC) No 1107/2009 of the European Parliament and of the Council  concerning the placing 
of plant protection products on the market and repealing Council Directives 79/117/EEC  and 
91/414/EEC  (OJ L 309 , 24.11.2009, p. 1 , ELI: http://data.europa.eu/eli/reg/2009/1107/oj ). 
4 Commission Implementing Regulation (EU) 2021/2049 of 24  November 2021 renewing the approval of 
the active substance cypermethrin as a candidate for substitution in accordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection 
products on th e market, and amending the Annex to Commission Implementing Regulation (EU) No  
540/2011  (OJ L 420, 25.11.2021, p. 6 , ELI: http://data.europa.eu/eli/reg/2021/2049/oj ). 
5 Commission Implementing Regulation (EU) 2021/795 of 17 May 2021 withdrawing the approval of the 
active substance alpha -cypermethrin in accordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing o f plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011  (OJ L 174, 18.5.2021, 
p. 2, ELI: http://data.europa.eu/eli/reg/2021/795/oj ).  
6 Commission Implementing Regulation (EU) 2017/1526 of 6 September 2017 concerning the non -
approval of the active substance beta -cypermethrin in accordance with Regulation (EC) No 1107/2009 
of the European Parliament and of the Council  concerning the placing of plant protection products on 
the market  (OJ L 231, 7.9.2017, p. 1 , ELI: http://data.europa.eu/eli/reg/2017/1526/oj )  
EN 2  EN (3) The Authority submitted a reasoned  opinion on the review of the existing MRLs for 
cypermet hrins in accordance with Article 12(1) of Regulation (EC) No 396/20058. 
(4) The Authority concluded that the current MRLs for cypermethrins in or on sweet corn, 
borage seeds, gold of pleasure seeds and hempseeds , which are confirmed as being 
safe for consumers , should be maintained based on the current Good Agricultural 
Practices (‘GAPs’ ) authorised in the Union.  The MRLs for these products laid down in 
Annex II to Regulation (EC) No 396/2005 should therefore remain at the existing 
levels in accordance with Article 14(2), point (e), of Regulation (EC) No 396/2005 . 
(5) The Authority concluded that the current MRLs for cypermethrins in or on t ree nuts, 
straw berries, durians, okra/lady ’s fingers, beans, lentils, peas, lupins/lupini beans, 
peanuts/groundnuts, mustard seeds, buckwheat, maize/corn, millet, cardamom, root 
and rhizome spices, sugar canes, sheep fat, goat fat, equine fat, poultry 
fat/liver /kidney/ edible offals  and sheep/goat/horse milk , which are confirmed as being 
safe for consumers , should be maintained based on the current Codex MRLs ( ‘CXLs ’). 
The MRLs for these products , laid down in Annex  II to Regulation (EC) No 396/2005 
should therefore remain  at the existing levels in accordance with Article  14(2), point 
(e), of Regulation (EC) No  396/2005 . 
(6) The Authority  concluded that the current MRLs for cypermethrins in or on  table 
olives, horseradishes, Jerusalem  artichokes, parsley root, cresses, land cresses, baby 
leaf crops, celery leaves, rosemary, thyme, bay leaves, tarragon and olives for oil 
production  could be raised , based on the current GAPs  authorised in the Union , to a 
level which is confirmed as being  safe for consumers . The MRLs  for these products  
should therefore be set in Annex II to Regulation (EC) No 396/2005 at the level s 
identified by the Authority . 
(7) The Authority  concluded that the current MRLs for cypermethrins in or on  kumquats, 
grape leaves, soyabeans, herbal infusions from ginseng, allspice/pimento, sichuan 
pepper, caraway, juniper berry, peppercorn, vanilla and tamarind  could be raised , 
based on the current CXLs , to a level which is confirmed as being safe for consum ers. 
The MRLs  for these products  should therefore be set in Annex II to Regulation (EC) 
No 396/2005 at the level s identified by the Authority . 
(8) The Authority  concluded that the current MRL for cypermethrins in or on  sorghum  
could be raised , based on the current GAP authorised in the U nited States, to a level 
which is confirmed as being safe for consumers . The MRL  for sorghum  should 
therefore be set in Annex II to Regulation (EC) No 396/2005 at the level identified by 
the Authority . 
(9) The Autho rity recommended to lower the existing MRLs for cypermethrin s in or on  
sweet potatoes, aubergines/eggplants, garlic, shallots , and chicory roots , which is 
confirmed as being safe for consumers , based on the current GAPs  authorised in the 
Union and with a view to setting MRLs at levels as low as reasonably achievable . The 
MRLs  for these products  should therefore be set in Annex II to Regulation (EC) No 
396/2005 at the level s identified by the Authority . 
 
7 Commission Implemen ting Regulation (EU) 2020/1643 of 5 November 2020 amending Implementing 
Regulation (EU) No 540/2011 as regards the approval periods of the active substances calcium 
phosphide, denathonium benzoate, haloxyfop -P, imidacloprid, pencycuron and zeta -cypermethri n (OJ L 
370, 6.11.2020, p. 18 , ELI: http://data.europa.eu/eli/reg/2020/1643/oj ). 
8 European Food Safety Authority,  Reasoned opinion on the review of the existing maximum residue 
levels for cypermethrin s according to Article 12 of Regulation (EC) No 396/2005 ; EFSA Journal 
2023;21(3):7800.   
EN 3  EN (10) The Authority also recommended to lower the existing MRLs for cypermethrin s in or 
on grapefruits, lemons, limes, mandarins, gherkins, pumpkins, watermelons, cassava 
roots/manioc, yams, arrowroots, globe artichokes, linseeds, poppy seeds, sesame 
seeds, sunflower seeds, rape s eeds/canola seeds, coffee beans , sugar beet roots, swine 
liver/edible offals , bovine liver/kidney /edible offals , sheep muscle/liver/kidney /edible 
offals , goat muscle/liver/kidney /edible offals , equine muscle/liver/kidney /edible offals , 
poultry muscle, and birds’ eggs , which are confirmed as being safe for consumers , in 
line with the current CXL s and with a view to setting MRLs at levels as low as 
reasonably achievable . The MRLs  for these products  should therefore be set in 
Annex  II to Regulation (EC) No 396/2005 at the level s identified by the Authority . 
(11) The Authority recommended to lower the current MRL for cypermethrin s on cotton 
seeds , which is confirmed as being safe for consumers , based on the current GAP 
authorised in the U nited States and with a vi ew to setting MRLs at levels as low as 
reasonably achievable . The MRLs  for cotton seeds  should therefore be set in Annex  II 
to Regulation (EC) No 396/2005 at the level s identified by the Authority . 
(12) While CXLs exist for residues of some cypermethrin  isomers i n or on medlars, 
loquats/ Japanese  medlars, cucumbers, courgettes, cauliflowers, Brussels sprouts, 
Chinese cabbages/pe -tsai, kales, witloofs/Belgian endives, beans (fresh, without pods), 
peas (fresh, with pods), peas (fresh, without po ds), barley, oat, rye, wheat, swine 
muscle/fat, bovine muscle, bovine fat, and cattle milk, t he Authority could not confirm 
these CXLs as safe for consumers. The Authority recommended to lower the existing 
MRLs for cypermethrin s in or on  these products , which are confirmed as being safe 
for consumers , based on the current GAPs  authorised in the Union  and with a view to 
setting MRLs at levels as low as reasonably achievable . The MRLs  for these products  
should therefore be set in Annex  II to Regulation (EC) N o 396/2005 at the level s 
identified by the Authority . 
(13) The Authority identified unacceptable risks concerning the current MRLs  and CXLs  
of some  cypermethrin  isomers  for apples, pears, apricots, cherries, peaches, plums, 
blackberries, raspberries, litchis/lychees, mangoes, papayas, sweet peppers, kohlrabies, 
lettuces, escaroles/broad -leaves endives, spinaches, purslanes, chards/beet leaves, 
leeks, teas , and hops . The Authority consulted the Member States and requested them 
to report pot ential fall -back GAPs for these products , authorised in Member States or 
third countries and already evaluated at Member State level, which would not lead to 
an unacceptable risk for consumers. Fall -back GAPs were not identified. Therefore, 
MRLs of all cyp ermethrins  for these products should be lowered to the product -
specific  limits of determination  (‘LODs’ ) in Annex  II to Regulation (EC) No  
396/2005 . 
(14) The Authority identified potential risks regarding the current MRLs for cypermethrin s 
in or on oranges, quinces, table grapes, wine grapes, carambolas, potatoes, beetroots, 
carrots, celeriacs/turnip rooted celeries, parsnips, radishes, salsifies, swedes/rutabagas, 
turnips, onions, tomatoes, melons, broccoli, head cabbages, lamb's lettuces/corn 
salads, roman r ocket/rucola, red mustards, watercresses, chervil, chives, parsley, sage, 
basil and edible flowers, beans (fresh, with pods), lentils, asparagus, celeries, rhubarbs,  
and rice, in case residues would consist of only alpha -cypermethrin,  the more toxic  
compou nd. Further consideration by risk manager was thus required. Fall-back GAPs 
were identified for wine grapes, beetroots, carrots, celeriacs/turnip rooted celeries , 
parsnips , radishes , salsifies , swedes/rutabagas , turnips , onions , watercresses , chervil , 
bean s (with pod s) and asparagus . In order to protect consumers, it is appropriate to 
lower the MRLs for th ose commodities for which fall -back GAPs were available to  
EN 4  EN the levels identified by t he Authority . For those commodities where fall -back GAPs 
were not identified, it is appropriate to lower the MRLs to the product specific  LODs 
in Annex  II to Regulation (EC) No 396/2005 . 
(15) As the Authority identified that no residue trials were available to derive MRL v alues 
for cypermethrins in or on spring onions, cardoons, celeries, Florence fennels, 
rhubarbs, bamboo shoots, palm hearts,  and herbal infusions from leaves and herbs, 
further consideration by risk manager was required. In the absence of such trials, 
which  are necessary to derive a MRL value, the Commission considers it appropriate 
to set the MRLs for those products at the product -specific LODs set out in Annex II to 
Regulation (EC) No 396/2005.  
(16) For dewberries, wild fungi, safflower seeds, and commodities f rom other farmed 
terrestrial animals,  for which the MRLs were based on uses in the EU which are no 
longer authori sed and for which there are neither CXL s nor import tolerances, it is 
appropriate to lower the MRLs to the product specific LODs in Annex  II to Regulation 
(EC) No  396/2005 without seeking the opinion of the Authority in accordance with 
Article 17 of Regulation (EC) No  396/2005.  
(17) Additionally , some information was not available, and further consideration by risk 
managers was required . Since some information  on the analytical methods  for 
products of plant origin , residue trials for Brussels sprouts, cresses, and land cresses , 
and storage stability  for cotton seeds required to assess potential risks from residues of 
cypermethrin(s) in or on these pr oducts was not available , the new MRLs for these 
products  should be reviewed . That review should take into account the information 
available within two years from the publication of this Regulation .  
(18) As regards cypermethrin residues in or on products for which no  GAPs are authorised 
in the Union,  and neither CXLs nor import tolerances exist, MRLs should be set at the 
product -specific LOD s, or the default MRL s should apply, as provided for in Article  
18(1) , point (b), of Regulation (EC) No  396/2005.   
(19) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain LODs. Those laboratories proposed 
product specific LODs that are analytically achievable.   
(20) 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.  
(21) Annex es II and III  to Regulation (EC) No  396/2 005 should therefore be amended 
accordingly.  
(22) To allow for the normal marketing, processing and consumption of products, this 
Regulation should not apply to products which have been placed on the market  before 
the new MRLs for cypermethrin  become applicable  and for which a high level of 
consumer protection is maintained.  This is the case for most  products , except  for 
grapefruits, oranges, lemons, limes, mandarins, apples, pears, quinces, medlars, 
loquats/Japanese medlars, apricots, cherries (sweet), peaches,  plums, table grapes, 
wine grapes, blackberries, raspberries (red and yellow), carambolas, kaki/Japanese 
persimmons, kiwi fruits (green, red, yellow), litchis/lychees, American 
persimmons/Virginia kaki, avocados, bananas, mangoes, papayas, granate 
apples/p omegranates, pineapples , potatoes, yams, beetroots, carrots, celeriacs/turnip 
rooted celeries, parsnips, radishes, salsifies, swedes/rutabagas, turnips , onions, 
tomatoes, sweet peppers/bell peppers, aubergines/eggplants, cucumbers, courgettes, 
melons, pumkins, watermelons, broccoli, cauliflowers, Brussels sprouts, head  
EN 5  EN cabbages, Chinese cabbages/pe -tsai, kales, kohlrabies, lamb's lettuces/corn salads, 
lettuces, escaroles/broad -leaved endives, roman rocket/rucola, red mustard , spinaches, 
purslanes, chards/beet leaves, watercresses, witloofs/Belgian endives, chevil, chives, 
parsley, sage, basil and edible flowers, beans ( with pods and  without pods), peas ( with 
pods and  without pods), lentils, asparagus, celeries, globe artichokes, leeks, rhubarbs, 
wild fungi, barley, oat, rice, rye, wheat, teas, hops, swine  muscle , swine fat, bovine 
muscle, bovine fat and milk.  
(23) A reasonable period should be allowed to elapse  before the new MRLs become 
applicable in order to permit Member States, third countries and food business 
operators to adapt to the requirements which result from the modification of the MRLs 
for glufosinate.  
(24) 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 es 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 the products which were placed on the market  in the Union before … [6 
months after the date of entry into force of this Regulation ], except for grape fruits, oranges, 
lemons, limes, mandarins, apples, pears, quinces, medlars, loquats/Japanese medlars, apricots, 
cherries (sweet), peaches, plums, table grapes, wine grapes, blackberries, raspberries (red and 
yellow), carambolas, kaki/Japanese persimmons, k iwi fruits (green, red, yellow), 
litchis/lychees, American persimmons/Virginia kaki, avocados, bananas, mangoes, papayas, 
granate apples/pomegranates, pineapples, potatoes, yams, beetroots, carrots, celeriacs/turnip 
rooted celeries, parsnips, radishes, sal sifies, swedes/rutabagas, turnips, onions, tomatoes, 
sweet peppers/bell peppers, aubergines/eggplants, cucumbers, courgettes, melons, pumkins, 
watermelons, broccoli, cauliflowers, Brussels sprouts, head cabbages, Chinese cabbages/pe -
tsai, kales, kohlrabies , lamb's lettuces/corn salads, lettuces, escaroles/broad -leaved endives, 
roman rocket/rucola, red mustard, spinaches, purslanes, chards/beet leaves, watercresses, 
witloofs/Belgian endives, chevil, chives, parsley, sage, basil and edible flowers, beans ( with 
pods and  without pods), peas (fresh, without pods), lentils, asparagus, celeries, globe 
artichokes, leeks, rhubarbs, wild fungi, barley, oat, rice, rye, wheat, teas, hops, swine muscle, 
swine fat, bovine muscle, bovine fat and milk.  
Article 3  
This Regula tion 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 … [ 6 months after the date of entry into force of this Regulation ].  
EN 6  EN This Regulation shall be binding in i ts entirety  and directly applicable in all Member 
States.  
Done at Brussels,  
 For the Commission  
The President  
 Ursula VON DER LEYEN