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, in particular Article 11(4) thereof,
Whereas:
(1)
Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs 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 2011/516/EU of 23 August 2011 on the reduction of the presence of dioxins, furans and PCBs in feed and food 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 (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-like PCBs in certain foodstuffs establishes specific provisions concerning the sampling procedure and the methods of analysis to be applied for the official control.
(4)
The application of new maximum levels for non-dioxin-like PCBs, established following the availability of a scientific opinion from the European Food Safety Authority (EFSA) on non-dioxin-like PCBs and also to provide a harmonisation at Union level and the update of the criteria for screening methods require significant amendments. Therefore, for reasons of clarity, it is appropriate to replace Regulation (EC) No 1883/2006 by this Regulation.
(5)
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. They do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances 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. They do not affect the targeting criteria for sampling as laid down in Commission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products.
(6)
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 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.
(7)
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.
(8)
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.
(9)
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.
(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 and neither the European Parliament nor the Council have opposed them,
HAS ADOPTED THIS REGULATION: