EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11706/2016 Rev. 1  
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for fenpropidin and pymetrozin in or on 
certain products  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annex II to Regulation (EC) No 396/2005 of the European Parliament and of 
the Council as regards maximum residue levels for fenpropidin and pymetrozin 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 fenpropidin and pymetrozin maximum residue levels (MRLs) were set in Annex II  
to Regulation (EC) No 396/2005 . 
(2) For fenpropidin , the Authority, submit ted a reasoned opinion on the existing MRLs  in 
accordance with Article 12(1 ) of Regulation (EC) No 396/2005 and proposed to 
change the residue definition.2 By Regulation (EU) No 61/20143 the recommendations 
of the Authority on the review of the existing MRLs were implemented. As the EU 
reference labs identifi ed that t he reference standard for 2 -methyl -2-[4-(2-methyl -3- 
piperidin -1-yl-propyl) -phenyl]propionic acid  was not commercially available, the 
Commission added by means of Reg. (EU) No 61/2014 a footn ote to fenpropidin in 
annex II to Reg. (EC) No 396/2002 , stating that it will take into account the 
commercial availab ility of the reference standard  referred to in the previous sentence 
by 25 January 2015, or, if this  reference standard  is not commerciall y available by that 
date, the unavailability of it. In the meanwhile this deadline has expired  and the 
requested standard is still not commercially available. As this hampers the 
enforcement of the MRLs for commodities of animal origin that are established  in 
annex II to reg. (EC) No 396/2005, those MRLs should be lowered to the limit of 
determination (LOD).  In order to avoid residues exceeding the MRLs for commodities 
of animal origin, also the MRLs for plant commodities that can be used as feed should 
be lowered. Therefore th e MRLs for barley, oat, rye, wheat and sugar beet root should 
be lowered to the LOD. In order to allow the enforcement of the MRLs at the LOD for 
                                                 
1 OJ L 70, 16.3.2005, p. 1.  
 
2 European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for fenpropidin 
according to Article 12 of Regulation (EC) No 396/2005.  EFSA Journal 2011;9(8):2333. [42 pp.]  
 
3 Commission  Regulation (EU) No 61 /2014 of 24 January 2014  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 cyromazine, 
fenpropidin, formetanate, oxamyl and tebuconazole  in or on certain products ; OJ L22, 25.1.2014, p. 1.  
 EN 3   EN commodities of animal origin, the residue definition for those commodities should be 
chan ged to 'fenpropidin' . 
(3) For pymetrozine , the Authority, submitted a reasoned opinion on the existing MRLs  in 
accordance with Article 12(2 ) of Regulation (EC) No 396/2005 in conjunction with 
Article 12(1) thereof and proposed to change the residue definition.4 By Regulation 
(EU) No 398/20143 the recommendations of the Authority on the review of the 
existing MRLs were implemented. As the EU reference labs identifi ed that t he 
reference standard s for 6-hydroxymethylpymetrozine and its phosphate conjugate  
were not commercially avai lable, the Commission added by means of Reg. (EU) No 
398/2014 a footnote to pymetrozine in annex II to Reg. (EC) No 396/2002 , stating that 
it will take into account the commercial availability of the reference standards referred 
to in the  previous sentence by 25 April 2015, or, if these reference standards are  not 
commercially available by that date, the unavailability of them . In the meanwhile this 
deadline has expired  and the requested standards  are still not commercially available. 
As this hampers the enforcement of the MRLs for commodities of animal origin that 
are established in annex II to reg. (EC) No 396/2005, those MRLs should be lowered 
to the limit of determination (LOD).  In order to avoid re sidues exceeding the MRLs 
for commodities of animal origin, also the MRLs for plant commodities that can be 
used as feed should be lowered. Therefore the MRLs for citrus fruits, head cabbage, 
kale and cotton seed should be lowered to the LOD. In order to a llow the enforcement 
of the MRLs at the LOD for commodities of animal origin, the residue definition for 
those commodities should be changed to ''pymetrozine '. 
(4) Through the World Trade Organisation, the trading partners of the Union were 
consulted on the ne w MRLs and their comments have been taken into account.  
(5) Regulation (EC) No 396/2005  should therefore be amended accordingly.  
(6) In order to allow normal marketing, processing and consumption of products, this 
Regulation should provide for a transitional arran gement for products which have been 
lawfully produced before the modification of the MRLs and for which information 
shows that a high level of consumer protection is maintained.  
(7) A reasonable period should be allowed to elapse before the modified MRLs becom e 
applicable in order to permit Member States and interested parties  to prepare 
themselves to meet the new requirements which will result from the modification of 
the MRLs.  
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II Regulation (EC) No  396/2005 are amended in accordance with the Annex to this 
Regulation.  
                                                 
4 European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for pymetrozine 
according to Article 12 of Regulation (EC) No 396/20 05. EFSA Journal 2012; 10(10):2919. [67 pp.], revised 
version of 10 January 2013.  EN 4   EN Article 2  
As regards the active substances fenpropidin a nd pymetrozin  in and on all products, 
Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall 
continue to apply to products which were produced before [ Office of Publications please 
insert date 6 months after 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 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