EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/946 v1  
[…](2023) 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 desmedipham, 
etridiazole, flurtamone, profoxydim, difenacoum and potassium permanganate in or on 
certain produ cts 
(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 desmedipham, 
etridiazole, flurtamone, profoxydim, difenacoum and potassium permanganate 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 Regu lation (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), Article 18(1), point (b), and Article 49(2) thereof , 
Whereas:  
(1) For the active substance s desmedipham, flurtamone and profoxydim,  maximum 
residue levels ( ‘MRLs ’) were set in  Annex II to Regulation (EC) No 396/2005. For the 
active substance etrid iazole, MRLs were set in Part A of Annex III to Regulation (EC) 
No 396/2005. For the active substances difenacoum and potassium permandanate, no 
specific MRLs were set in Regulation (EC) No 396/2005, and as these active 
substances are not included in Annex  IV to that Regula tion, the default value of 
0,01 mg/kg laid down in Article 18(1), point (b), of that Regulation applies . 
(2) The approval of the active substance desmedipham expired on 1  July 2019  and was 
non-renewed2. All authorisations for plant protection products containing that active 
substance have been revoked. No Codex maximum residue limits (‘CXLs’) or import 
tolerances exist for that substance. The MRLs for desmedipham on all products are set 
at the limit of determination (‘LOD’). In line with technical progress, lower levels of 
LODs are now achievable. It is therefore appropriate to lower the MRLs set out for 
desmedipham in Annex II to Regulation (EC) No  396/2005 to the current product 
specific LODs in accordance with Article 17 of Regulation (EC) No 396/2005 in 
conjunction with Article 14(1), point (a), thereof , and move them to Annex V to 
Regulation (EC) No 396/2005  in accordance with Article  18(1), point (b), of that 
Regulation . Additionally,  as the MRLs on all products are set at the product specific 
LODs, there is no longer a need for confirmatory data. Therefore, all footnotes 
containing requests for confirmatory data should be de leted.  
 
1 OJ L 70, 16.3.2005, p. 1.  
2 Commission Implementing Regulation (EU) 2019/1100 of 27 June 2019 concerning the non -renewal of 
approval of the active substance desmedipham, 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 175, 28.6.2019, p.  17). EN 2  EN (3) The approval of the active substance etridiazole expired on 31  May 2021 and no 
application for renewal of its approval had been submitted. All authorisations for plant 
protection products containing that active substance have been revoked. No CXLs  or 
import tolerances exist for that substance. It is therefore appropriate to delete the 
MRLs set for this substance in Part A to Annex III to Regulation (EC) No  396/2005  in 
accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with 
Article 14(1), point (a), thereof . MRLs for etridiazole on all products should be set at 
the product  specific LODs in An nex V to Regulation (EC) No 396/2005  in accordance 
with Article  18(1), point (b), of that Regulation . 
(4) The approval of the active substance flurtamone expired on 27  December  2018  and 
was non -renewed3. All authorisations for plant protection products containing that 
active substance have been revoked. No CXLs or import tolerances exist for that 
substance. The MRLs for flurtamone on all products are set at the product  specific 
LODs . It is therefore appropriate to move the MRLs set for flurtamone in Annex II to 
Regulation (EC) No  396/2005 to Annex V to Regulation (EC) No 396/2005  in 
accordance with Article  18(1), point (b), of that Regulation . 
(5) The approval of the active substance profoxydim expired on 31  July 2021 and no 
application for renewal of its approval had been submitted. All authorisations for plant 
protection products containing that active substance have b een revoked. No CXLs or 
import tolerances exist for that substance. The MRLs for profoxydim on all products 
are set at the product  specific LODs . It is therefore appropriate to move the MRLs set 
for profoxydim in Annex II to Regulation (EC) No  396/2005  to Annex V to 
Regulation (EC) No 396/2005  in accordance with Article  18(1), point (b), of that 
Regulation . 
(6) The approval of the active substance difenacoum expired on 30  December  2019 and 
no application for renewal of its approval had been submitted. All authorisations for 
plant protection products containing that acti ve substance have been revoked. No 
CXLs  or import tolerances exist for that substance . It is therefore appropriate to set the 
MRLs for difenacoum on all products at the product  specific LODs in Annex V to 
Regulation (EC) No 396/2005  in accordance with Article  18(1), point (b), of that 
Regulation . 
(7) The active substance p otassium permanganate is not approved4. No CXLs or import 
tolerances exist for that substance. It is therefore appropriate to set the MRLs for 
potassium permanganate on all products at the product  specific LODs in Annex  V to 
Regulation (EC) No 396/2005  in accordance with Article  18(1), point (b), of that 
Regulation . 
(8) 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.  
 
3 Commission Implementing Regulation (EU) 2018/1917 of 6 December 2018 concerning the non -
renewal of approval of the active substance flurtamone, in acc ordance with Regulation (EC) 
No 1107/2009 of the European Parliament and of th e Council concerning the placing of plant protection 
products on the market, and amending Commission Implementing Re gulation (EU) No 540/2011 
(OJ L 311, 7.12.2018, p. 27).  
4 Commission Decision of 30 September 2008 concerning the non -inclusion of Beauveria brongniartii 
and potassium permanganate in Annex I to Council Directive 91/414/EEC and the withdrawal of 
authorisations for plant protection products containing these substance s (OJ L 263, 2.10.2008, p.  12). EN 3  EN (9) 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.  
(10) Annexes II, III and V to Regulation (EC) No  396/2005 should therefore be amended 
accordingly.  
(11) To allow  for the normal marketing,  processing and consumption of products, this 
Regulation should not apply to products, which have been produced in the Union or 
imported into the Union before the new MRLs become applicable and for which a 
high level of consumer protection is maintained.  
(12) 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 themselves to the requirements which result  from the modification 
of the MRLs .  
(13) 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 , III and V to Regulation (EC) No  396/2005 are amended in accordance w ith 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 the date of entry into force 
of this Regulation ].  
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 publications: please insert  date 6  months after the 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 Commissi on 
The President  
 Ursula VON DER LEYEN