EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11249/2016 
(POOL/E2/2016/11249/11249 -EN.doc) 
D047571/03  
[…](2016) XXX  draft 
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 152/2009 as regards the methods for the determination of 
the levels of dioxins and polychlorinated biphenyls  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Regulation (EC) No 152/2009 as regards the methods for the determination of 
the levels of dioxins and polychlorinated biphenyls  
(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 882/2004 of the European Parliament and of the 
Council of 29 April 2004 on official controls performed to ensure the verification of 
compliance with feed and food law, animal health and animal welfare rules1, and in particular  
Article 11(4) thereof,  
Whereas:  
(1) Commission Regulation (EC) No 152/20092 includes methods for the determination of 
the levels of polychlorinated dibenzo -p-dioxins (PCDDs), polychlorinated 
dibenzofurans (PCDFs), dioxin -like polychlorinated biphenyls (PCBs) and non -
dioxin -like PCBs in feed . 
(2) EU reference laboratory for dioxins and PCBs in feed and food has provided evidence 
that analytical results for dioxins and PCBs in certain cases are not reliable when the 
performance criteria provided for in Part B of Annex V to Regulation  (EC) 
No 152/2009 are not applied by laboratories performing the analysis of s amples taken 
by feed business operators in accordance with Regulation (EC) No 183/2005 of the 
European Parliament a nd of the Council3. It is therefore appropriate to make the 
application of the performance criteria for the analysis of samples obligatory.  
(3) Given that the method of using a decision limit to ensure, with a certain probability, 
that an analytical result is above the maximum level, as provided for in Commission 
Decision 2002/657/EC4, is no longer applied for the analysis of dioxins, furans and 
PCBs in feed, it is appropriate to delete that method and to keep only the method of 
the expanded uncertainty using the coverage factor of 2, which gives a level of 
confidence of approximately 95 %.  
(4) Guidance documents for the measurement uncertainty and fo r the estimation of the 
Limit of Determination (LOD) and Limit of Quantification (LOQ) have been 
developed. It is appropriate to make reference to them.  
                                                 
1 OJ L 165, 30.4.2004, p. 1.  
2 Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling 
and analysis for the official control of feed  (OJ L 54, 26.2.2009, p. 1) . 
3 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying 
down requirements for feed hygiene (OJ L 35, 8.2.2005 , p. 1) . 
4 Commission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC 
concerning the performance of analytical methods and the interpretation of resu lts (OJ L 221, 
17.8.2002, p. 8) .  
EN 3   EN (5) In line with the reporting requirements for bioanalytical screening methods provided 
for in Part B of Annex V  to Regulation  (EC) No 152/2009 , it is appropriate to provide 
also for physico -chemical methods to be used for screening specific reporting 
requirements  in point 8.3 of  Chapter II of that Part  
(6) Given that the analysis of dioxins, dioxin -like PCBs and  non-dioxin -like PCBs are in 
most cases determined together, it is appropriate to align the performance criteria for 
the non -dioxin -like PCBs provided for in point 3.3 of Chapter III of Part B of Annex 
V to Regulation (EC) No 152/2009 to the performance cr iteria for dioxins and dioxin -
like PCBs. This is a simplification without substantial changes in practice as for non -
dioxin -like PCBs the relative intensity of qualifier ions compared to target ions is 
> 50 %. 
(7) Following experience gained, it is appropriate  to adapt some technical specifications 
such as recoveries of isotope -labelled standards provided for in points 7.3 and 7.5 of 
Chapter III of Part B of Annex V to Regulation (EC) No 152/2009.  
(8) Furthermore, there are several other minor modifications propos ed to the current  
provisions to improve the consistency in the terminology used, requiring replacing the 
whole Part B of Annex V to Regulation (EC) No 152/2009 to maintain the readability 
of the text.  
(9) Regulation (EC) No 152/2009 should therefore be amended  accordingly.  
(10) 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  
Part B of Annex V to Regulation (EC) No 152/2009 is 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 . 
This Regulation shall be binding in its entirety and dir ectly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER