EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10521/2016 Rev. 2 
(POOL/E2/2016/10521/10521R2 -
EN.doc) D045998/04  
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
laying down methods of sampling and analysis for the control of levels of dioxins, dioxin -
like PCBs and non -dioxin -like PCBs in certain foodstuffs and repealing Regulation (EU) 
No 589/2014  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
laying  down methods of sampling and analysis for the control of levels of dioxins, dioxin -
like PCBs and non -dioxin -like PCBs in certain foodstuffs and repealing Regulation (EU) 
No 589/2014  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the T reaty 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 1881/20062 sets out the  maximum levels for non -
dioxin -like polychlorinated biphenyls (PCBs ) dioxins and furans and for the sum of 
dioxins, furans and dioxin -like PCBs in certain foodstuffs.   
(2) Commission Recommendation 2013/711/EU3 sets out action level s in order to 
stimulate a proactive approach to reduce the presence of polychlorinated dibenzo -para-
dioxins and polychlorinated dibenzo furans (PCDD/Fs) and dioxin -like PCBs in food. 
Those action level s are a tool used by  competent authorities and  operators to highlight 
those cases where it is appropriate to identify a source of contamination and to take the 
necessary measures  in order to reduce or eliminate it . 
(3) Commission Regulation (EC) No 589/20144 establishes specific provisions concerning 
the sampling procedure and the methods of analysis to be applied for the official 
control of levels of dioxins, dioxin -like PCBs and non -dioxin -like PCBs.  
(4) The provisions laid down in this Regulation relate only to the sampling and analysis of 
dioxins, dioxin -like PCBs  and non -dioxin -like PCBs  for the implementation of 
Regulation (EC) No 1881/2006 and Recommendation 2013/711/EU. They do not 
affect the s ampling strategy, sampling levels and frequency as set out  in Annexes III 
                                                 
1 OJ L 165, 30.4.2004, p. 1.  
2 Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain 
contaminants in foodstuffs  (OJ L 364, 20.12.2006, p. 5 ). 
3 Commission Recom mendation 2013/711/EU of 3 December 2013 on the reduction of the presence of 
dioxins, furans and PCBs in feed and food  (OJ L 323, 4.12.2013 , p. 37). 
4 Commission Regulation (EU) No 589/2014 of 2 June 2014 laying down methods of sampling and 
analysis for the official control of levels of dioxins, dioxin -like PCBs and non -dioxin -like PCBs in 
certain foodstuffs and repealing Regulation (EU) No 252/2012 ( OJ L 164, 3.6.2014, p. 1 8).  
EN 3   EN and IV to Council Directive 96/23/EC5. They do not affect the targeting criteria for 
sampling as laid down in Commission Decision 98/179/EC6.  
(5) It is appropriate to ensure that food b usiness operators applying the controls performed 
within the framework of Article 4 of Regulation (EC) No 852/2004 of the European 
Parliament and of the Council7 apply sampling procedures equivalent to the sampling 
procedures provided for by this Regulation  in order to ensure that samples take n for 
those controls are representative samples. Furthermore, the European Union Reference 
Laboratory for Dioxins and PCBs has provided evidence that analytical results in 
certain cases are not reliable when t he performance criteria as provided in this 
Regulation are not applied by laboratories performing the analysis of samples taken by 
food business operators within the framework of Article 4 of Regulation (EC) 
No 852/2004. It is therefore appropriate to make  the application of the performance 
criteria also obligatory for the analysis of those samples.  
(6) Given that the approach of the use of a decision limit to ensure that an analytical result 
is above the maximum level with a certain probability, as provided fo r in Commission 
Decision 2002/657/EC8, is no longer applied for the analysis of dioxins and PCBs in 
food, it is appropriate to delete this approach and to keep only the approach of the 
expanded uncertainty using the coverage factor of 2, giving a level con fidence of 
approximately 95 %.  
(7) In line with the reporting requirements for bioanalytical screening methods, it is 
appropriate to also provide for physico -chemical methods used for screening specific 
reporting requirements.  
(8) Given that the analysis of diox ins, 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 to the performance criteria for dioxins and dioxin -like PCBs. 
This is a simplification, wi thout substantial changes in practice as in the case of non -
dioxin -like PCBs the relative intensity of qualifier ions compared to target ions is 
> 50 %. 
(9) Furthermore there are several other minor modifications proposed to the current 
provisions, requiring t he repeal of Regulation (EU) No 589/2014 and its replacing by a 
new Regulation to maintain the readability of the text.  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on  Plants, Animals, Food and Feed , 
                                                 
5 Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain s ubstances and residues 
thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and 
Decisions 89/187/EEC and 91/664/EEC  (OJ L 125, 23.5.1996, p.  10). 
6 Commission Decision 98/179/EC of 23 February 1998 laying down deta iled rules on official sampling 
for the monitoring of certain substances and residues thereof in live animals and animal products  
(OJ L 65, 5.3.1998, p. 31 ). 
7 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on th e 
hygiene of foodstuffs  (OJ L 139, 30.4.2004, p. 1) . 
8 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 results  (OJ L 221, 
17.8.2002, p. 8) .  
EN 4   EN HAS ADOPTED THIS REGULATION:  
Article 1  
For the purpose s of this Regulation, the definitions and abbreviations set out in Annex I shall 
apply.  
Article 2  
Sampling for the official control of the levels of dioxins, furans, dioxin -like PCBs and non -
dioxin-like PCBs in foodstuffs listed in Section 5 of the Annex to Regulation (EC) No 
1881/2006 shall be carried out in accordance with the methods set out in Annex II to this 
Regulation.  
Article 3  
Sample preparation and analyses for the control of the levels of dioxins, furans and dioxin -
like PCBs in foodstuffs listed in Section 5 of the Annex to Regulation (EC) No 1881/2006 
shall be carried out in accordance with the methods set out in Annex III to this Regulation.  
Article 4  
Analyses for the control of the le vels of non -dioxin -like PCBs in foodstuffs listed in Section 5 
of the Annex to Regulation (EC) No 1881/ 2006 shall  be carried out in accordance with the 
requirements for analytical procedures set out in Annex IV to this Regulation.  
Article 5  
Regulation (EU)  No 589/2014 is repealed.  
References to the repealed Regulation shall be construed as references to this Regulation.  
Article 6  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the Eur opean Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 Jean -Claude JUNCKER  
 The President