Tell Them What You Think ^beta

In the UK, the Food Standards Agency is the designated competent authority responsible for ensuring that the statutory monitoring programme for biotoxins in live bivalve molluscs (LBM) and other shellfish is in place using the methods of detection set out in Regulation (EC) No.2074/2005¹. Regulation (EC) 854/2004² stipulates that shellfish flesh is to be monitored routinely for three groups of marine biotoxins: paralytic shellfish poisoning, amnesic shellfish poisoning and lipophilic toxins. Mouse bioassay (MBA) is currently used in the UK as the reference method for detecting lipophilic toxins, including those belonging to the diarrhetic shellfish poisoning (DSP) group. However, while the MBA is currently prescribed in the EU Regulation as the reference method for detecting lipophilic toxins, it is recognised that it has scientific shortcomings and an alternative method for detecting these toxins is required. Furthermore, the use of animals in testing for scientific purposes is regulated under EU³ and national law⁴. These rules prohibit unnecessary animal testing and, in particular, require replacement of animal tests where a scientific alternative is available.

For the past few years, the Agency has commissioned research to develop an alternative, more effective method for the quantification of lipophilic toxins. Results from the Agency's funded research and similar initiatives at national and international level have shown that liquid chromatography-mass spectrometry (LC-MS), a chemical-based method, has an improved detection capability and is a highly specific method for the quantification of lipophilic toxins. As the LC-MS addresses the ethical and scientific concerns identified with the MBA, the method is now being proposed to replace the bioassay.

Following EFSA's review⁵ of the available data and recent advances in LC-MS methodology, the Commission has proposed an amendment to the legislation to adopt LCMS as the reference method for detecting lipophilic toxins. In order to allow member states time to adapt their monitoring programme and apply the validated LC-MS method, the proposed amendment to the legislation includes a transitional period of three years after which the MBA can only be used to detect new or unknown marine biotoxins. The Commission's proposal was accepted by the Standing Committee on the Food Chain and Animal Health (SCoFCAH) in November 2009 and is expected to be adopted before the end of 2010. The Agency's research on the LC-MS will soon provide a validated LC-MS method that would allow early implementation of the requirements of the Commission's proposal, and the method could be applied in the UK statutory monitoring programme early in 2011.

The replacement of the MBA with the more robust LC-MS method as the recognised testing method for lipophilic toxins will increase confidence in the results of the statutory monitoring programme. In addition, the implementation of the LC-MS will reduce the reliance on animal testing in the statutory biotoxin monitoring programme.

Endnotes
¹ Regulation (EC) No. 2074/2005 laying down implementing measures for certain products under the EU Food Hygiene Regulations and the Official Control Regulation (EC) No. 882/2004.
² Regulation (EC) No. 854/2004 laying down rules for the organisation of official controls on products of animal origin intended for human consumption
³ EU Council Directive 86/609/EEC
⁴ Animals (Scientific Procedures) Act 1986
⁵ Scientific Opinions of the Panel on Contaminants in the food chain - Marine biotoxins in shellfish: Okadaic acid and analogues (adopted on 27 November 2007); Azaspiracid group (adopted on 9 June 2008); Yessotoxin Group (adopted 2 December 2008); Pectenotoxin group (adopted 27 May 2009); Summary on regulated marine biotoxins (adopted on 13 August 2009)

This consultation started on 2nd September 2010 and ended on 24th November 2010.

Here are the documents we were able to locate that relate to this consultation: