EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10090/2022 Rev. 5  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for benzalkonium 
chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, 
metazachlo r, nicotine, profenofos, quizalofop -P, sodium aluminium silicate, 
thiabendazole and triadimenol in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III, IV and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for benzalkonium 
chloride (BAC), chlorpropham, didecyldimethylammonium chloride (DDAC), flutriafol, 
metazachlor, nicotine, profenofos, quizalofop -P, sodium aluminium silicate, 
thiabendazole and triadimenol 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 res idue 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 18(1) , point (b), thereof,  
Whereas:  
(1) For flutriafol, metazachlor, quizalofop -P, thiabendazole and triadimenol , maximum 
residue levels ('MRLs')  were set in Annex  II to Regulation (EC) No  396/2005. For 
profenofos , MRLs were set in Annex II and in Part B of Annex III to that Regulation . 
For benzalkonium chloride (BAC), chlorpropham, didecyldimethylammonium 
chloride (DDAC) and nicotine , MRLs were set in Part  A of Annex  III to Regulation  
(EC) No  396/2005 . Sodium aluminium silicate  is included  in Annex  IV to that 
Regulation.  
(2) BAC  is not an approved active substance in plant protection pro ducts under 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council2. 
DDAC was approved as an active substance in plant protection products for use on 
ornamental crops, but all authorisations for plant protection products containing 
DDAC  have been revoked following the withdrawal of its approval3. However, b oth 
substances are used as biocides for disinfection. That use may lead to detectable 
residues in food.  For both substances , temporary MRLs were therefore set b y 
Commission Regulation (EU) No  1119/20144 for all products , since food business 
operators showed that residues of those substances are present in food products at 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
2 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
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). 
3 Commission Implementing Regulation (EU) N o 175/2013 of 27 February 2013 amending 
Implementing Regulation (EU) No 540/2011 as regards the withdrawal of the approval of the active 
substance didecyldimethylammonium chloride (OJ L 56, 28.2.2013, p.  4). 
4 Commission Regulation (EU) No 1119/2014 of 16 October 2014 amending Annex III to Regulation 
(EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels 
for benzalkonium chloride and didecyldimethylammonium chloride in or on certain products  (OJ L  304, 
23.10 .2014, p . 43). EN 2  EN levels that frequently exceed the default MRL of 0.01  mg/kg due to their use as a 
biocide. Those  MRLs were to be rev ised based on monitoring data after 5  years.  
(3) The Commission analysed the monitoring data for BAC, which showed that residues 
of this substance still occur in several products, at levels higher than the limit of 
determination  (LOD) and similar to the existing  temporary MRL . The Commission 
also analysed the monitoring data for DDAC, which showed that residues of this 
substance still occur in some products  of animal origin , at levels higher than the LOD 
and similar to the existing  temporary MRL . In products of plant origin , the residue 
levels of DDAC have decreased and are consistently below the existing  temporary 
MRLs . It is therefore appropriate to lower the existing  temporary MRLs for DDAC in 
those products accordingly. The tempor ary MRLs  for BAC and DDAC  should be 
reviewed within seven years  from the  publication of this Regulation  to evaluate new 
data and information that will become available . 
(4) The active substance chlorpropham is not approved in the Union . A temporary MRL 
for chlorpropham in potatoes was set by Commission Regulation  (EU) 2021/1555 
since monitoring data showed potential contamination of potatoes above the LOD  
when stored in facilities with a history of chlorpropham use. That Regulation also 
required potato trade  organisations and manufacturers to develop  and implement new 
and more efficient cleaning practices to reduce such contamination, and to submit  to 
the Commission new monitoring data  that would allow the Commission to review th at 
temporary MRL.  
(5) The temporar y MRL for chlorpropham in potatoes was reviewed based on monitoring 
data submitted to the Commission by 31  December  2021. As recent monitoring data 
showed that a lower MRL than 0.4  mg/kg is currently achievable , this MRL should be 
set at 0.35  mg/kg.  
(6) This temporary MRL should be reviewed based on monitoring data submitted to the 
Commission by 31  December  2022 and thereafter by 31  December of each subsequent 
year. It will allow the Commission to regularly re -assess the situation and gradually 
reduce the MRL,  where appropriate, as implementation of better cleaning 
methodology progresses. A report on the progress and implementation of cleaning 
practices should be submitted to the Commission together with the monitoring data by 
31 December  2022, and updates to it in the subsequent year s. The relevant footnote  for 
potatoes in Annex III should be amended accordingly.  
(7) An application for import tolerance pursuant to Article  6(2) and (4) of Regulation 
(EC) No  396/2005 was submitted for flutriafol used in the United States on cucu rbits 
with inedible peel. The applicant provided data showing that the authorised uses of 
that substance on th ose crops in the United States 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 into the Union  of those crops. With  this 
application, t he applicant also submitted information previously unavailable during the 
review conducted in accordance with Article 12 of Regulation (EC) No  396/2005 on 
the nature of residues in process ed commodities for flutriafol in pome fruits and wine 
grapes, for residue trials in rice, and for storage conditions of the samples from the 
                                                 
5 Commission Regulation (EU) 2021/155 of 9 February 2021 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 carbon tetrachloride, chlorothalonil, chlorpro pham, dimethoate, ethoprophos, 
fenamidone, methiocarb, omethoate, propiconazole and pymetrozine in or on certain products  (OJ L 46, 
10.2.2021, p.  5). EN 3  EN feeding studies and storage stability for pig liver, bovine liver, sheep liver, goat liver, 
equine liver and other terrestrial animals liver .  
(8) In accordance with Article 8 of Regulation (EC) No 396/2005, the application for 
flutriafol was evaluated by the Member State concerned and the evaluation report was 
forwarded to the Commission. The European Food Safety Authority ('the Authority 
assessed the application and the evaluation report, examining in particular the risks to 
consumers and, where relevant, to animals, and gave a reasoned opinion on the 
proposed MRLs6. It forwarded this opinion to the applicant, the Commission and the 
Member States and made it available to the public. The Authority concluded that all 
requirements with respect to completeness of data submission were met and that the 
modification to the MRLs requested by the applicant was 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 toxicologic al properties of the substances. Neither the long -term 
exposure to the substance via consumption of all food products that may contain it, nor 
the short -term exposure due to high consumption of the relevant products showed a 
risk that the acceptable daily intake or the acute reference dose is exceeded.  
(9) For flutriafol in cucurbits with inedible peel, it is appropriate to set the MRL at the 
level identified by the Authority . The Authority  examined the supplementary dat a 
submitted and concluded that, for beetroots , a risk management considerat ion was 
needed , while all other  MRLs  for w hich data ga ps were identified  during the review 
conducted in accordance with Article 12 of Regulation (EC) No  396/2005 are now 
fully supported by data . For flutriafol in beetroots,  it is appropriate to extrapolate the 
data concerning res idue trials from sugar beet s, confirming the existing  MRL. 
Therefore, all respective footnote s in Annex II highlighting the need for additional 
data should  be deleted  and the MRL for beetroots should be maintained . Based on the 
reasoned opinion  of the  Authority and taking into account the relevant factors listed in 
Article 14(2) of Regulation (EC) No 396/2005, it is appropriate to  modify the MRLs 
as set forth in the Annex to this Regulation .  
(10) As regards metazachlor, t he applicant submitted information previously unavailable 
during the review conducted in accordance with Article 12 of Regulation (EC) 
No 396/2005 on residue trials  for metazachlor in head cabbages and kohlrabies , 
demonstrating that the MRLs are fully supported by data7. The applicant also 
submitted information previously unavailable during the review conducted in 
accordance with Article 12 of Regulation (EC) No  396/2005 on residue trials for  
metazachlor on  flowering brassica  and kales , that permit s the setting  of MRLs  lower 
than the currently established ones  and that are still fully supported by data. As regards 
metazachlor o n radishes, data concerning residue trials are still missing . The livestock 
dietary burden calculation was updated based on the new information. Based on th at 
updated  calculation, a lower MRL of 0.15 mg/kg for swine liver , which  is safe for 
consumers , can be set . 
(11) In accordance with Article 8 of Regulation (EC) No 396/2005, the application  for 
metazachlor was evaluated by the Member State concerned and the evaluati on report 
                                                 
6 EFSA 2020. Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL 
review and setting of an import tolerance for fl utriafol in cucurbits (inedible peel). EFSA Journal 
2020;18(12):6315.  
7 EFSA 20 19. Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL 
review and modification of the existing maximum residue levels for metazachlor in variou s 
commodities. EFSA Journal 2019;17(10):5819.  EN 4  EN was forwarded to the Commission.  The Authority assessed the application and the 
evaluation report, examining in particular the risks to consumers and, where relevant, 
to animals, and gave a reasoned opinion on the proposed MRLs8. The Authority  
forwarded that opinion to the applicant, the Commission and the Member States and 
made it available to the public.  The Authority concluded that all requirements with 
respect to completeness of data submission were met and that the modification to the 
MRLs re quested by the applicant was 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 prop erties of the substances. Neither the long -term exposure to th at 
substance via consumption of all food products that may contain it, nor the short -term 
exposure due to high consumption of the relevant products showed a risk that the 
acceptable daily intake  or the acute reference dose is exceeded.  
(12) For metazachlor in head cabbages and kohlrabies, it is appropriate  to maintain the 
MRL at the existing levels. For metazachlor in flowering brassica and kales , it is 
appropriate to lower the MRLs to t he level  recom mended by the Authority . For 
metazachlor on radishes, it is appropriate to lower th e MRL to the LOD. The 
respective footnotes in Annex II highlighting the need for additional data for those  
products should be deleted. For metazachlor in  swine liver, it is appropriate to lower 
the MRL to the level  recommended by the Authority . Based on the reasoned opinion 
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 MRL s fulfil th e 
requirements of Article 14(2) of that Regulation.  
(13) For nicotine, temporary MRLs were set by Commission Regulation (EU) 
No 812/20119 for rose hips, “herbs and edible flowers”, wild mushrooms (fresh), teas, 
“herbal infusions ” and “spices ” until 19  October  2021, pending the submission and 
evaluation of new data and information on the natural occurrence or formation of 
nicotine in th ose products. Scientific evidence is not conclusive to demonstrate that 
nicotine occurs naturally in those  products and to elucid ate the mechanism of 
formation. The Authority and food business operators submitted recent monitoring 
data showing that , while residues of this substance still occur in those products at 
levels higher than the LOD, the residue levels have decreased. In add ition, for rose 
hips, teas and capers, the Authority identified unacceptable risks  for consumers  from  
the existing  MRLs10. Therefore , taking into account EFSA’s opinion and based on 
monitoring data, it is appropriate to set  the MRL s for nicotine in rose hips  at 
0.2 mg/kg, for nicotine in “herbs and edible flowers” at 0.1 mg/kg, for nicotine in wild 
mushrooms (fresh) at 0.02  mg/kg, for nicotine in teas at 0.4 mg/kg,  for nicotine in 
“herbal infusions ” at 0.3  mg/kg, for nicotine in “seed spices ” and “root spices ” at 
0.01 mg/kg, and for all other spices at 0.07  mg/kg. For all other products , for which no 
specific M RL were set under Regulation (EC) No  396/2005, it is appropriate to 
indicate  that the LODs apply.  
                                                 
8 EFSA 20 19. Reasoned opinion on the evaluation of confirmatory data following the Article 12 MRL 
review and modification of the existing maximum residue levels for metazachlor in various 
commodities. EFSA Journal 2019;17(10):5819 . 
9 Commission Regulation (EU) No 812/2011 of 10 August 2011 amending Annex III to Regulation (EC) 
No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 
dimethomorph, fluopicolide, mandiprop amid, metrafenone, nicotine and spirotetramat in or on certain 
products (OJ L 208, 13.8.2011, p. 1 ). 
10 Reference to be added to EFSA Reasoned Opinion, when officially adopted.  EN 5  EN (14) It is appropriate to continue to monitor the levels of nicotine in rose hips, “herbs and 
edible flowers”, teas, “herbal infusions” and “spices”  and to review these MRLs based 
on monitoring data submitted to the Commission within  seven years from the 
public ation of this Regulation . Regarding  nicotine in wild mushrooms (fresh), it is 
appropriate to align the revision of this MRL with the revision of the temporary MRL 
for wild mushrooms (dry), that will be based on monitoring data submitted to the 
Commission within seven years from the publication of Regulation  (EU) …/…11, 
which is revising temporary MRLs for this substance in other products . 
(15) For profenofos, a temporary MRL was set by Commission Regulation (EU) 
No 1096/201412 for “herbs and edible flowers”  until 18  October  2021, pending the 
submission of monitoring data on the occurrence of this  active  substance in these 
product s. The Authority and food business operators submitted recent monitoring data 
showing that , while  residues of this active substance  higher than the LOD  still occur in 
“herbs and edible flowers”, the residue levels have decreased. Therefore, th e MRL  for 
“herbs and edible flowers”  should be set at 0. 03 mg/kg. It is appropriate to continue to 
monitor the levels of profenofos in “herbs an d edible flowers” and to review this MRL 
based on monitoring data submitted to the Commission  within  seven years from the 
publication of this Regulation.  
(16) An application pursuant to Article 6(1) of Regulation (EC) No 396/2005 , requesting a 
modification of the existing MRLs for quizalofop -P resulting from the use of 
quizalofop -P-ethyl on caraway , was submitted.  
(17) In accordance with Article  8 of Regulation (EC) No  396/2005, the application was 
evaluated by the Member State concerned and the evaluation report w as forwarded to 
the Commission.  The Authority assessed the application and the evaluation report, 
examining in particular the risks to consumers and, where relevant, to animals, and 
gave a reasoned opinion on the proposed MRL13. The Authority  forwarded this  
opinion to the applicant, the Commission and the Member States and made it available 
to the public.  The Authority concluded that all requirements with respect to 
completeness of data submission were met and proposed, based on the available data, 
setting a  lower MRL  that is 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 the relevant products showed a risk that the acceptable 
daily intake or th e acute reference dose is exceeded.  Based on the reasoned opinion of 
the Authority and taking into account the relevant factors listed in Article 14(2) of 
                                                 
11 Commission Regulation (EU) …/… of …  amending Annexes II, I II and IV to Regulat ion (EC) 
No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 
ametoctradin, chlormequat, dodine, nicotine, profenofos and Spodoptera exigua multicapsid 
nucleopolyhedrovirus (SeMNPV) isolate BV -0004 in or on certai n products  (OJ L xx, xx.xx.xxxx, 
p. x). 
12 Commission Regulation (EU) No 1096/2014 of 15 October 2014 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 carbaryl,  procymidone and profenofos in or on certain products  (OJ L 300, 
18.10.2014, p.  5). 
13 Reasoned Opinion on the modification of the existing maximum residue level for quizalofop (resulting 
from the use of quizalofop -P-ethyl) in caraway. EFSA Journal 2021;19( 12):6957, 32 pp. EFSA 
scientific reports available online: https://www.efsa.europa.eu . 
 EN 6  EN Regulation (EC) No 396/2005, it is appropriate to modify the MRLs as set forth in the 
Annex to this R egulation . 
(18) All applications for the renewal of the approval of the active substance sodium 
aluminium silicate  were withdrawn  and the renewal procedure was terminated before 
the EFSA risk assessment . The approval of sodium aluminium silicate  expired on 
31 August  201914. Sodium aluminium silicate was temporarily included in Annex IV  
pending the finalisation of its evaluation either under Directive 91/414/EEC, and 
pending its review according to Article 12 of Regulation (E C) No 396/2005.  
Following the expiratio n of the approval,  of this substance,  the Authority  included it in 
its statement on pesticide active substances that do not require a review of the existing 
MRLs under Article  12 of  Regulation  (EC) No  396/200515. In that statement , the 
Authority  stated that evidence to conclude on the safety of this substance is 
insufficient, since a complete toxicological data set is not available. Therefore, and 
also taking into consideration the fact that sodium aluminium silicate adds to the 
overall human diet ary exposure to aluminium, which already exceeds the Tolerable 
Weekly Intake for a significant part of the European population16, it is appropriate to 
set all MRLs  for that active substance  to the LOD and list them in Annex V in 
accordance with Article 14(1 )(a) in conjunction with Arti cle 17 of Regulation (EC) 
No 396/2005.  
(19) As regards thiabendazole, in the framework of the submission of several applications 
pursuant to Article 6(1)  and 6(4)  of Regulation (EC) No 396/2005, requestin g 
modification s of the existing MRLs for thiabendazole in several crops, one applicant 
submitted information previously unavailable during the review conducted in 
accordance with Article 12 of Regulation (EC) No  396/2005 on analytical methods for 
thiabendazole in  “produc ts of animal origin” .  
(20) In accordance with Article 8 of Regulation (EC) No 396/2005, the application s for 
thiabendazole  were evaluated by the Member State s concerned and the evaluation 
report s were forwarded to the Commission.  The Authority assessed the app lication s 
and the evaluation report s, examining in particular the risks to consumers and, where 
relevant, to animals, and gave a reasoned opinion on the proposed MRLs17. The 
Authority  forwarded this opinion to the applicant, the Commission and the Member 
States and made it available to the public.  The Authority concluded that all 
requirements with respect to completeness of data submission were met and that the 
modification s to the MRLs requested by the applicant w ere acceptable with regard to 
consumer safet y 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 substance. Neither the long -term 
exposure to this subst ance via consumption of all food products that may contain it, 
                                                 
14 Commission Implementing Regulation (EU) 2019/324 of 25 February 2019 amending Implementing 
Regulation (EU) No 540/2011 as r egards the approval periods of the active substances bifenthrin, 
carboxin, FEN 560 (also called fenugreek or fenugreek seed powder), pepper dust extraction residue 
and sodium aluminium silicate  (J L 57, 26.2.2019, p. 1 ). 
15 EFSA 2019. Statement on the pesti cide active  substances that do not require a review of the existing 
maximum residue levels under Article 12 of  Regulation (EC) No 396/2005. EFSA Journal 
2019;17(12):5954 . 
16 Scientific  Opinion  of the Panel  on Food  Additives,  Flavourings,  Processing  Aids  and Food  Contact  
Materials  on a request  from  European Commission on Safety of aluminium from dietary intake. Th e 
EFSA Journal (2008) 754, 1 -34. 
17 EFSA 20 21. Reasoned Opinion on the modification of the existing maximum residue levels and setting 
of import tole rances for thiabendazole in various crops. EFSA Journal 2021;19(5):6586 . EN 7  EN nor the short -term exposure due to high consumption of the relevant products showed 
a risk that the acceptable daily intake or the acute reference dose is exceeded.  
(21) Based on the reasoned opinio n of the Authority and taking into account the factors 
relevant to the matter under consideration, the respective modifications to the MRLs 
for products of plant origin were implemented by Commission Regulation (EU) 
2021/180718. 
(22) For thiabendazole in “commodities from bovine”, “commodities from goat”, cattle 
milk, and goat milk, the available data are sufficient to derive an MRL at the LOD of 
0.01 mg/kg on the basis of the updated EU livestock dietary burden. Therefore, it is 
appropriate to set lower MRL s corresponding to MRL s for veterinary medical 
products set by Commission Regulation No 37/20101920., because exposure from use 
in veterinary medicinal products is expected to be higher than from use in plant 
protection prod ucts. For poultry musc le, poultry fat and “bird eggs”, the existing 
MRLs correspond to CXLs which are not fully supported by data . Therefore, it is 
appropriate to lower  the existing  MRLs to the LOD.  For all other products of animal 
origin , the available data are su fficient to derive an MRL at the LOD of 0.01 mg/kg on 
the basis of the updated EU livestock dietary burden. I t is therefore appropriate to 
lower the existing MRLs to the LOD.  The respective footnotes  in Annex II 
highlighting the need for additional data for these prod ucts should  be deleted. Based 
on the reasoned opinion of the Authority and taking into account the relevant factors 
listed in Article 14(2) of Regulation (EC) No 396/2005, it is appropriate to modify the 
MRLs as set forth in the Annex to this Regulation . 
(23) All applications for the renewal of the approval of the active substance triadimenol  
were withdrawn  and the renewal procedure was terminated before the EFSA risk 
assessment . Therefore, the approval of triadimenol  expired on 31  August  2019. As 
regard s cucurb its with inedible peel and globe artichokes, the existing CXLs are not 
fully supported by data21 and as regards grapes, the existing CXL is not compatible 
with Union  residue definitions22. The MRLs for those products should therefore be 
lowered to the LOD. For all other products , it is appropriate to lower the existing 
MRLs set out in Annex II of Regulation (EC) No 396/2005 to the  LOD s in accordance 
with Article  14(1)(a) in conjunction with Article  17 of that Regulation  
(24) Through the World Trade Organisat ion, the trading partners of the Union were 
consulted on the new MRLs and their comments have been taken into account.  
(25) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
                                                 
18 Commission Regulation (EU) 2021/1807 of 13 October 2021 amending Annexes II, III and IV to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum 
residue levels for acibenzolar -S-methyl, aqueous extract from the germinated seeds of sweet Lupinus 
albus, azoxystrobin, clopyralid, cyflufenamid, fludioxonil, fluopyram, fosetyl, metazachlor, 
oxathiapiprolin, tebufenozide and thiabendazole in or o n certain products (OJ L 365, 14.10.2021, p. 1).  
19 Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active 
substances and their classification regarding maximum residue limits in foodstuffs of animal origin  (OJ 
L 15, 20.1.2010 , p. 1 ). 
20 EFSA 20 21. Reasoned Opinion on the modification of the existing maximum residue levels and setting 
of import tolerances for thiabendazole in various crops. EFSA Journal 2021;19(5):6586 . 
21 EFSA 2016. Reasoned opinion on the review of  the existing  maximum  residue  levels  for triadimenol 
according  to Article  12 of Regulation  (EC)  No 396/2005.  EFSA Journal 2016;14(1): 4377.  
22 EFSA 2016. Reasoned opinion on the review of  the existing  maximum  residue  levels  for triadimenol 
according  to Article  12 of Regulation  (EC)  No 396/2005.  EFSA Journal 2016;14(1): 4377.  EN 8  EN (26) For all active substances covered by this Regulation, in order to al low for the normal 
marketing, processing and consumption of products, this Regulation should provide 
for a transitional arrangement for products which have been produced before the 
modification of the MRLs and for which information shows that a high level of 
consumer protection is maintained. This is the case for all products  except nicotine in 
rose hips, teas and capers . 
(27) A reasonable period should be allowed to elapse before the modified MRLs become 
applicable in order to permit Member States, third countr ies and food business 
operators to prepare themselves to meet the new requirements which result from the 
amendments.   
(28) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Fee d, 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II, III , IV and V 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 Publications: please insert date 6  months after entry into force of this 
Regulation ], except for nicotine in rose hips, teas and capers . 
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: please insert date 6 months after entry into force ]. 
This Regulation sha ll be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
The President  
 Ursula VON DER LEYEN