EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10482/2020  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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, chlorpropham, dimethoate, ethoprophos, fenamidone, 
methiocarb, omethoate , propiconazole and pymetrozine in or on certain products  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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, chlorpropham, dimethoate, ethoprophos, fenamidone, 
methiocarb, omethoate, propiconazole and pymetrozine 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 a nimal origin and amending Council Directive 91/414/EEC1, and in particular 
Article 14(1)(a) and Article 18(1)(b) thereof , 
Whereas:  
(1) For chlorothalonil, chlorpropham, dimethoate, fenamidone, omethoate, propiconazole 
and pymetrozine maximum residue levels (MR Ls) were set in Annex  II to Regulation 
(EC) No  396/2005. For carbon tetrachloride , MRLs were set in Annex II and Part B of 
Annex III to that Regulation. For ethoprophos and methiocarb , MRLs were set in 
Part A of Annex  III to that Regulation.  
(2) The approval of the active substance chlorothalonil  was not renewed  by Commission 
Implementing Regulation (EU) 2019/6772. The approval of the active substance 
chlorpropham  was not renewed by  Commission Implementing Regulation (EU) 
2019/9893. The approval o f the active substance dimethoate  was not renewed by  
Commission Implementing Regulation (EU) 2019/10904. The approval of the active 
substance ethoprophos  was not renewed by  Commission Implementing Regulation 
                                                 
1 OJ L 70, 16.3.2005, p. 1. 
2 Commission Implementing Regulation (EU) 2019/677 of 29 April 2019 concerning the non -renewal of 
the approval of the active substance chlorothalonil, 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, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 114, 
30.4.2019, p.  15).  
3 Commission Implementing Regulation (EU) 2019/989 of 17 June 2019 concerning the non -renewal of 
approval o f the active substance chlorpropham, 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, and amending the Annex to Commission Implementing Regulati on (EU) No 540/2011 (OJ L 
160, 18.6.2019, p.  11). 
4 Commission Implementing Regulation (EU) 2019/1090 of 26 June 2019 concerning the non -renewal of 
approval of the active substance dimethoate, 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 
173, 27.6.2019, p.  39). EN 2  EN (EU) 2019/3445. The approval of the active subst ance fenamidone  was not renewed by  
Commission Implementing Regulation (EU) 2018/10436. The approval of the active 
substance methiocarb  was not renewed by  Commission Implementing Regulation 
(EU) 2019/16067. The approval of the active substance propiconazole  was not 
renewed by  Commission Implementing Regulation (EU) 2018/18658. The approval of 
the active substance pymetrozine was not renewed by  Commission Implementing 
Regulation (EU) 2018/15019.  
(3) The active substances carbon tetrachloride and omethoate were never approved in the 
Union for the use in plant protection products. Temporary MRLs were set for carbon 
tetrachloride in cereals by Regulation (EC) No  149/200810 and omethoate  in several 
products by Regulation  (EU) 2017/113511. 
(4) All existing authorisations for plant protection products containing th ose active 
substances have been revoked. It is therefore appropriate to delete the  MRLs set out 
for th ose substances in Annexes II and III of Regulation (EC) No 396/2005 in 
accordance with Article 17 of that Regulation in conjunctio n with Article   14(1)(a) 
thereof .  
(5) The Commission consulted the European Union reference laboratories as regards the 
need to adapt certain limits of determinat ion ( LOD s). Those laboratories concluded 
that for certain products technical development permits the setting of lower LODs. For 
the active substances for which all MRLs should be reduced to the relevant LOD s, 
default values should be listed in Annex  V in a ccordance with Article  18(1)(b) of 
Regulation (EC) No  396/2005.   
                                                 
5 Commission Implementing Regulation (EU) 2019/344  of 28 February 2019 concerning the non -renewal 
of approval of the active substance ethoprophos, 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 , and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 
62, 1.3.2019, p.  7). 
6 Commission Implementing Regulation (EU) 2018/1043 of 24 July 2018 concerning the non -renewal of 
approval of the active substance fenamidone, in acc ordance with Regulation (EC) No 1107/2009 of the 
European Parliament and of the Council concerning the placing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011  (OJ L 188, 25.7.2018, 
p. 9). 
7 Commi ssion Implementing Regulation (EU) 2019/1606 of 27 September 2019 concerning the non -
renewal of the approval of the active substance methiocarb, in accordance with Regulation (EC) No 
1107/2009 of the European Parliament and of the Council concerning the pl acing of plant protection 
products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 
540/2011  (OJ L 250, 30.9.2019, p.  53). 
8 Commission Implementing Regulation (EU) 2018/1865 of 28 November 2018 concerning the non -
renewal  of approval of the active substance propiconazole, 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, and amending Commission Implementing Regula tion (EU) No 540/2011  (OJ L 
304, 29.11.2018, p.  6). 
9 Commission Implementing Regulation (EU) 2018/1501 of 9 October 2018 concerning the non -renewal 
of approval of the active substance pymetrozine, in accordance with Regulation (EC) No 1107/2009 of 
the European Parliament and of the Council concerning the pla cing of plant protection products on the 
market, and amending Commission Implementing Regulation (EU) No 540/2011 (OJ L 254, 
10.10.2018, p.  4). 
10 Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) 
No 396/2005 of the European  Parliament and of the Council by establishing Annexes II, III and IV 
setting maximum residue levels for products covered by Annex I thereto (OJ L 58, 1.3.2008, p.  1). 
11 Commission Regulation (EU) 2017/1135 of 23 June 2017 amending Annexes II and III to Re gulation 
(EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels 
for dimethoate and omethoate in or on certain products (OJ L 164, 27.6.2017, p. 28 ). EN 3  EN (6) In accordance with Article  6(2) of Regulation (EC) No  396/2005 , an application  was 
submitted  for modification of the existing MRL for potatoes together with  residue 
trials and monitoring data. The request  was made  to account for potential 
contamination of potatoes above the default MRL of 0.01 mg/kg when stored in 
facilities with a history of chlorpropham use . The applicant  claim s that, due to the 
specific pr operties of chlorpropham,  with the current  cleaning operations of these 
storage facilities remaining r esidues cannot be fully avoided. The submitted  
monitoring data confirm the presence of residues of chlorpropham in untreated 
potatoes . 
(7) The Netherlands eva luated that application i n accordance with Article  8 of Regulation 
(EC) No  396/2005 and forwarded the evaluation report to the Commission.  
(8) The European Food Safety Authority ('the Authority') assessed the application and the 
evaluation report, examining in  particular risks to consumers and, where relevant, to 
animals and gave a scientific opinion  on the proposed MRL12. It forwarded that 
opinion  to the applicant, the Commission and the Member States and made it available 
to the public.  
(9) The Authority concluded  in its scientific opinion  that the MRL s recommended  by the 
Netherlands  either at 0.3  mg/kg or at 0.4  mg/kg  were  acceptable with regard to 
consumer safety on the basis of a consumer exposure assessment for 27  specific 
European consumer groups. The Authority took into account the most recent 
information on the toxicological properties of the substance  and considered the 
presence of 3-chloroaniline , which is formed at conditions reflecting oven -baking of 
potato es. Neither the lifetime exposure to chlorpropham  via consumption of all food 
products that may contain it, nor the short -term exposure  to chlorpropham and its 
major metabolite 3 -chloroaniline , due to high consumption of potatoes , showed that 
there is a risk that the acceptable daily intake or the acute reference dose is exceeded.  
(10) In light of the Authority's conclusions on risk to consumers , and taking into accoun t 
that the levels should be set as low as reasonably achievable , the MRL for potatoes  
should be set at a level of 0. 4 mg/kg  resulting from the Good Laboratory Practice  
(GLP) trials and  corresponding to the 9 7.5th percentile of all the sample results. 
Moreo ver, as the Authority concluded that the current cleaning practices are 
inadequate , it is appropriate to provide  food business operators with sufficient  time to 
develop and introduce a new cleaning methodology.  
(11) This temporary MRL will be reviewed based on monitoring data submitted to the 
Commission by 31  December  2021 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 development and implementation of cleaning 
practices should be submitted to the Commission together with the monitoring data by 
31 December  2021,  and updates to it in the subseque nt years.  
(12) 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.  
(13) Regulation (EC) No  396/2005 should therefore be amended accordingly.  
                                                 
12 EFSA scientific reports available online: http://www.efsa.europa.eu : 
Reasoned Opinion on the setting of temporary maximum residue levels for chlorpropham in potatoes. 
EFSA Journal 2020;18(6 ):6061 . EN 4  EN (14) A reasonable period shoul d 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.  
(15) The meas ures 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, III  and V to Regulation (EC) No  396/2005 are amended in accordance with the 
Annex to this Regulation.  
Article 2  
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.  
Done at Brussels,  
 For the Commission  
The President  
 Ursula VON DER LEYEN