EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX 
SANTE/11371/2018 Rev. 1 
[…](2019) 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 myclobutanil, 
napropamide and sintofen 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 myclobutanil, 
napropamide and sintofen 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 myclobutanil maximum residue levels (MRLs) were set in Annex II and Part B 
of Annex III to Regulation (EC) No 396/2005. For napropamide MRLs were set in 
Part A of Annex III to Regulation (EC) No 396/2005. For sintofen no MRLs were set 
in Regulation (EC) No 396/2005, and as this active substance is not included in 
Annex IV to that Regulation, the default value of 0.01 mg/kg laid down in 
Article 18(1)(b) of Regulation (EC) No 396/2005 applies. 
(2) For myclobutanil the European Food Safety Authority ("the Authority"), submitted a 
reasoned opinion on the review of the existing MRLs in accordance with 
Article 12(1) of Regulation (EC) No 396/20052. It proposed to change the residue 
definition. It recommended raising or keeping the existing MRLs for apples, pears, 
quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), peaches, 
plums, table grapes and wines grapes. The Authority concluded that concerning the 
MRLs for hazelnuts/cobnuts, walnuts, strawberries, blackberries, raspberries, (red 
and yellow), currants (black, red and white), gooseberries (green, red and yellow), 
bananas, potatoes, cassava roots/manioc, sweet potatoes, yams, arrowroots, 
beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem 
artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, 
swedes/rutabagas, turnips, garlics, onions, shallots, spring onions/green onions, 
tomatoes, sweet peppers/bell peppers, aubergines/eggplants, cucumbers, gherkins, 
courgettes, melons, pumpkins, watermelons, broccoli, cauliflowers, Brussels sprouts, 
head cabbages, Chinese cabbages/pe-tsai, kales, kohlrabies, lamb's lettuces/corn 
salads, lettuces, escaroles/broad-leaved endives, cresses and other sprouts and shoots, 
land cresses, Roman rocket/rucola, red mustards, baby leaf crops (including brassica 
species), spinaches, purslanes, chards/beet leaves, grape leaves and similar species, 
                                                 
1 OJ L 070, 16.3.2005, p. 1. 
2 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(8):5392.  
EN 2  EN watercresses, witloofs/Belgian endives, chervil, beans (with pods), asparagus, 
Florence fennels, globe artichokes, leeks, borage seeds, hops, sugar beet roots, swine 
(muscle, fat, liver, kidney), bovine (muscle, fat, liver, kidney), sheep (muscle, fat, 
liver, kidney), goat (muscle, fat, liver, kidney) equine (muscle, fat, liver, kidney), 
poultry (muscle, fat, liver), milk (cattle, sheep, goat, horse) and birds’ eggs some 
information was not available and that further consideration by risk managers was 
required. As there is no risk for consumers, the MRLs for those products should be 
set in Annex II to Regulation (EC) No 396/2005 at the level identified by the 
Authority. These MRLs will be reviewed; the review will take into account the 
information available within two years from the publication of this Regulation. 
(3) For napropamide the Authority submitted a reasoned opinion on the review of the 
existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/20053. It 
proposed to change the residue definition. It recommended lowering the MRLs for 
almonds, chestnuts, hazelnuts/cobnuts, pecans, pine nut kernels, pistachios, walnuts, 
apples, pears, quinces, medlars, loquats/Japanese medlars, apricots, cherries (sweet), 
peaches, plums, potatoes, celeriacs/turnip rooted celeries, horseradishes, radishes, 
swedes/rutabagas, turnips, tomatoes, aubergines/eggplants, broccoli, cauliflowers, 
Brussels sprouts, head cabbages, lamb's lettuces/corn salads, Roman rocket/rucola, 
red mustards, baby leaf crops (including brassica species), beans (with pods), 
linseeds, poppy seeds, sesame seeds, sunflower seeds, rape seeds/canola seeds, 
soyabeans, mustard seeds, cotton seeds, pumpkin seeds, safflower seeds, borage 
seeds, gold of pleasure seeds, hemp seeds and castor beans. The Authority concluded 
that concerning the MRLs for table grapes, wine grapes, strawberries, blackberries, 
dewberries, raspberries (red and yellow), blueberries, cranberries, currants (black, red 
and white), gooseberries (green, red and yellow), rose hips, elderberries, figs, granate 
apples/pomegranates, sweet peppers/bell peppers, watermelons, Chinese 
cabbages/pe-tsai, kales, kohlrabies, chervil, chives, celery leaves, parsley, sage, 
rosemary, thyme, basil and edible flowers, laurel/bay leaves, tarragon, herbal 
infusions from flowers, herbal infusions from leaves and herbs, herbal infusions from 
roots and fruit spices some information was not available and that further 
consideration by risk managers was required. As there is no risk for consumers, the 
MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 
at the level identified by the Authority. These MRLs will be reviewed; the review 
will take into account the information available within two years from the 
publication of this Regulation.  
(4) For sintofen the European Food Safety Authority ("the Authority"), submitted a 
reasoned opinion on the review of the existing MRLs in accordance with 
Article 12(1) of Regulation (EC) No 396/20054. It concluded that concerning the 
MRL for wheat some information was not available and that further consideration by 
risk managers was required. No other authorisations exist for this substance. As there 
is no risk for consumers, this MRL should be set in Annex II to Regulation (EC) 
No 396/2005 at the level identified by the Authority. This MRL will be reviewed; the 
review will take into account the information available within two years from the 
publication of this Regulation.   
                                                 
3 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for napropamide according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(8):5394. 
4 European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue 
levels for sintofen according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 
2018;16(8):5406.  
EN 3  EN (5) As regards products on which the use of the plant protection product concerned is not 
authorised, and for which no import tolerances or Codex maximum residue limits 
(CXLs) exist, MRLs should be set at the specific limit of determination (LOD) or the 
default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) 
No 396/2005. 
(6) The Commission consulted the European Union reference laboratories for residues of 
pesticides as regards the need to adapt certain limits of determination. As regards 
several substances, those laboratories concluded that for certain commodities 
technical development requires the setting of specific limits of determination. 
(7) Based on the reasoned opinions of the Authority and taking into account the factors 
relevant to the matter under consideration, the appropriate modifications to the 
MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005. 
(8) 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. 
(9) Regulation (EC) No 396/2005 should therefore be amended accordingly. 
(10) 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 produced before the modification of the MRLs and for which information 
shows that a high level of consumer protection is maintained. 
(11) 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 will result from 
the modification of the MRLs. 
(12) 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 
Annexes 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 products which were produced in the Union or imported into the Union 
before [Office of Publication: please insert date 6 months after entry into force ]. 
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 shall be binding in its entirety and directly applicable in all Member States.  
EN 4  EN Done at Brussels, 
 For the Commission 
 The President 
Jean-Claude JUNCKER