EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10070/2018 Rev. 1 
[…](2018) XXX  draft 
 
COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annexes III and V to Regulation (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for diphenylamine 
and oxadixyl in or on certain products 
(Text with EEA relevance) 
  
EN 2  EN COMMISSION REGULATION (EU) …/… 
of XXX  
amending Annexes III and V to Regulati on (EC) No 396/2005 of the European 
Parliament and of the Council as regards maximum residue levels for diphenylamine 
and oxadixyl 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 leve ls of pesticides in or on food and feed 
of plant and animal origin and amending Council Directive 91/414/EEC
1, and in particular 
Article 14(1)(a), Arti cle 18(1)(b) and Article 49(2) thereof, 
Whereas: (1) For diphenylamine and oxadixyl, maximum re sidue levels (MRLs) were set in in 
Part A of Annex III to Re gulation (EC) No 396/2005.  
(2) The active substance diphenylamine was not approved by Commission Implementing 
Regulation (EU) No 578/2012
2. The active substance oxadi xyl was not included in 
Annex I to Directive 91/414/EEC by Commission Regulation (EC) No 2076/20023. 
All existing authorisations for plant pr otection products contai ning these active 
substances have been revoked. It is therefor e appropriate to delete the existing MRLs 
set out for these substances in Annex III in  accordance with Article 17 of Regulation 
(EC) No 396/2005 in conjunction with  Article 14(1)(a ) thereof.  
(3) For diphenylamine temporary MRLs we re set by Regulation (EU) No 772/20134 for 
apples and pears until 2 September 2015, to address an unavoidable cross-
contamination that affected untreated a pples and pears and wh ich was due to the 
presence of residues of diphenylamine in storage facilities. Commission Regulation 
(EU) 2016/675 extended the validity of those MR Ls until 22 January 2018 to provide 
                                                 
1 OJ L 70, 16.3.2005, p. 1. 
2 Commission Implementing Regulation (EU) No 578/2012 of 29 June 2012 concerning the non approval 
of the active substance diphenylam ine, 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 171, 30.6.2012, p. 2). 
3 Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred 
to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active 
substances in Annex I to that Directive and the withdrawal of authorisa tions for plant protection 
products containing these substances (OJ L 319, 23.11.2002, p. 3). 
4 Commission Regulation (EU) No 772/2013 of 8 August 2013 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 diphenylamine in or on certain products (OJ L 217, 13.8.2013, p. 1). 
5 Commission Regulation (EU) 2016/67 of 19 January 2016 amending Annexes II, III and V to 
Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum 
  
EN 3  EN the necessary time for business operators to completely remove the residues of 
diphenylamine in storage facilities. The European Food Safety Authority ('the 
Authority') and food business operators submitted recent monitoring data showing that residues of diphenylamine no longer occur at  levels above the relevant limit of 
determination (LOD).  
(4) For oxadixyl temporary MRLs were set by Regulation (EU) No 592/2012
6 for parsley, 
celeries and the group of lettuces and salad plants until 31 December 2014, to address an unavoidable cross-contamination that a ffected untreated crops and which was due 
to the presence of residues of oxadixyl in soil. Commission Regulation (EU) 2016/46
7 
extended the validity of those MRLs until 19 January 2018 in view of the persistence of that active substance in soil. The Au thority and food business operators submitted 
recent monitoring data showing that residue s of oxadixyl no longer occur at levels 
above the relevant LOD.  
(5) In view of the non-approval of the act ive substance diphenylamine and the non-
inclusion of the active substance oxadixyl  in Annex I to Dir ective 91/414/EEC, the 
MRLs for these substances should be set at  the LOD in accordance with Article 18 of 
Regulation (EC) No 396/2005. For the active substances for which all MRLs should 
be reduced to the relevant LOD, defau lt values should be listed in Annex V in 
accordance with Article 18(1)(b) of Regulation (EC) No 396/2005. 
(6) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the new MRLs and their co mments have been taken into account. 
(7) Regulation (EC) No 396/2005 should therefore be amended accordingly. 
(8) In order to allow for the normal marketi ng, processing and consumption of products, 
this Regulation should provide for a transi tional 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.  
(9) 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. 
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGULATION: 
                                                                                                                                                         
residue levels for ametoctradin, chlorothalonil, diphenylamine, flonicamid, fluazinam, fluoxastrobin, 
halauxifen-methyl, propamocarb, prothioconazole, thiacloprid and trifloxystrobin in or on certain products (OJ L 15, 22.1.2016, p. 2). 
6 Commission Regulation (EU) No 592/2012 of 4 July 2012 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 bifenazate, captan, cyprodinil, fluopicolide, hexythiazox, isoproth iolane, metaldehyde, oxadixyl and 
phosmet in or on certain products (OJ L 176, 6.7.2012, p. 1). 
7 Commission Regulation (EU) 2016/46 of 18 January 2016 amending Annex III to Regulation (EC) 
No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for 
oxadixyl and spinetoram in or on certain products (OJ L 12, 19.1.2016, p. 28).  
EN 4  EN Article 1 
Annexes III and V to Regulatio n (EC) No 396/2005 are amende d 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 produ ced in the Union or imported into the Union 
before [Office of Publications please insert date of application 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 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   Jean-Claude JUNCKER