The new testing methods will be mandatory from 1 July 2011 in all Member States. (Photo: Stock File/EC/FIS)
Chemical method replaces biological process for detecting marine biotoxins
Wednesday, January 12, 2011, 22:50 (GMT + 9)
The European Commission (EC) has established a new method for detecting marine biotoxins in bivalve molluscs, with techniques based on liquid chromatography/mass spectrometry. This method will replace the previous mouse bioassay and rat bioassay.
The Official Journal of the European Union (OJEU) published on 10 January, Regulation (EU) 15/2011, which amends the previously applicable rules on the subject, dating from 2005.
As detailed in the regulations, these methods have been established for the detection of marine biotoxins under new scientific evidence and also to meet the opinion of the Standing Committee on the Food Chain and Animal Health.
The regulations will take effect after 220 days have passed since its publication in the OJEU, and will be mandatory from 1 July 2011 in all Member States.
The legislation replaces the biological system from bioassay in mice and rats, the official method so far, because of reports from The Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA) which indicate that these tests have deficiencies.
The report details the mouse bioassay method is not suitable "because of the high variability in results." Moreover, this technique exhibits "insufficient detection capability and limited specificity."
For these reasons, the current official method will be replaced by a liquid chromatography-mass spectrometry (LC-MS/MS) method which has been successfully tested in pre-validation studies.
Following Regulation 15/2011, the chemical method is to be applied as a reference system for the detection of lipophilic toxins and self-monitoring of food business operators.
This method will determine, at a minimum, the following compounds:
- okadaic acid group toxins: OA, DTX1, DTX2, DTX3 including their esters
- pectenotoxins group toxins: PTX1 and PTX2
- yessotoxins group toxins: YTX, 45 OH YTX, homo YTX, and 45 OH homo YTX
- azaspiracids group toxins: AZA1, AZA2 and AZA3
Any other method may be applied, other than liquid chromatography-mass spectrometry, provided it meets the performance criteria set by the EU.
Of all methods, the Regulation stipulates that these methods should be validated between laboratories and successfully used as part of recognized proficiency testing. If the results are challenged, the reference method must be specified in the regulations.
For Member States to adapt their methods to the chemical system, they may continue to use biological methods for a limited period.
After this period, biological methods should not be used routinely, only during periodic inspections of production areas to detect new or unknown marine toxins.
The new method is the subject of a public consultation on the website of the European Union Reference Laboratory on marine biotoxins (EU-RL).
Click here to view the full text of Regulation 15/2011.
By Silvina Corniola