COMMISSION REGULATION (EU) No 589/2014
of 2 June 2014
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 252/2012
(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 rules (1), and in particular Article 11(4) thereof,
Whereas:
(1)
Commission Regulation (EC) No 1881/2006 (2) provides for maximum levels for non-dioxin-like PCBs, dioxins and furans and for the sum of dioxins, furans and dioxin-like PCBs in certain foodstuffs.
(2)
Commission Recommendation 2013/711/EU (3) sets out action levels in order to stimulate a pro-active approach to reduce the presence of polychlorinated dibenzo-para-dioxins and polychlorinated dibenzofurans (PCDD/Fs) and dioxin-like PCBs in food. Those action levels are a tool for competent authorities and operators to highlight those cases where it is appropriate to identify a source of contamination and to take measures for its reduction or elimination.
(3)
Commission Regulation (EU) No 252/2012 of 21 March 2012 (4) establishes specific provisions concerning the sampling procedure and the methods of analysis to be applied for the official control.
(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) 1881/2006 and Recommendation 2013/711/EU. They do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV to Council Directive 96/23/EC (5). They do not affect the targeting criteria for sampling as laid down in Commission Decision 98/179/EC (6).
(5)
A screening method of analysis with widely acceptable validation and high throughput can be used to identify the samples with significant levels of PCDD/Fs and dioxin-like PCBs (preferably selecting samples exceeding action levels and ensuring the selection of samples exceeding maximum levels). The levels of PCDD/Fs and dioxin-like PCBs in these samples need to be determined by a confirmatory method of analysis. It is therefore appropriate to establish appropriate requirements for the screening method making sure that the false-compliant rate with respect to maximum levels is below 5 % and strict requirements for the confirmatory methods of analysis. Furthermore, confirmatory methods with sufficient sensitivity allow the determination of levels also in the low background range. That is important for to follow time trends, exposure assessment and for the re-evaluation of maximum and action levels.
(6)
For the sampling of very large fish, it is necessary that the sampling is specified in order to ensure a harmonised approach throughout the Union.
(7)
In fish of the same species originating from the same region, the level of dioxins, dioxin-like PCBs and non-dioxin-like PCBs can be different depending on the size and/or the age of the fish. Moreover, the level of dioxins, dioxin-like PCBs and non-dioxin-like PCBs is not necessarily the same in all parts of the fish. Therefore, it is necessary that the sampling and sample preparation is specified in order to ensure a harmonised approach throughout the Union.
(8)
It is important that analytical results are reported and interpreted in a uniform way in order to ensure a harmonised enforcement approach throughout the Union.
(9)
In addition to the gas chromatography/high resolution mass spectrometry (GC-HRMS), technical progress and developments have shown that also gas chromatography/tandem mass spectrometry (GC-MS/MS) can be used as a confirmatory method for checking compliance with the maximum level (ML). Regulation (EU) No 252/2012 should therefore be replaced by a new Regulation providing for the use of gas chromatography/tandem mass spectrometry (GC-MS/MS) as an appropriate confirmatory method for checking compliance with the maximum level.
(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
For the purposes 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 levels 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 methods of analysis set out in Annex IV to this Regulation.
Article 5
Regulation (EU) No 252/2012 is hereby 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 European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 2 June 2014.