A summit held by the Commission last week has proposed ditching the flawed mouse bioassay (MBA) by early next year and replacing it with a chemical method. Until now, the MBA has been the reference method within the EU. It involves the injection of a shellfish tissue extract into the abdominal cavity of mice, with death of the animal signalling the positive detection of toxins.
EFSA concerns
The meeting on marine biotoxins was called in the wake of concerns raised by a European Food Safety Authority (EFSA) report last month that the MBA was not fit for purpose. The safety watchdog said the test method had “shortcomings and is not considered an appropriate tool for control purposes because of the high variability in results”.
Of particular concern was the MBA’s ability to detect OA- toxin groups at current EU limits, which was labelled as “inadequate, leading to false negative results in official controls”. The EFSA investigation concluded MBA was incapable of detecting concentrations considerably below EU levels and therefore could not be used to monitor the effects of commercial processing on lipophilic biotoxins.
Last week’s meeting saw food safety officials from member states, the Community Reference Laboratory (CRL) on marine biotoxins and representatives of the European producers associations look at ways of modifying the current law to authorise the use of certain chemical tests.
Consensus
There was a “general consensus on the use of a harmonised chemical test for the detection of lipophilic marine biotoxins”, said the Commission. The experts proposed the LC-MS test become the prescribed method within the EU bloc. This is due to be discussed at the upcoming Standing Committee of Food Chain and Animal Health (SCoFCAH) tomorrow and next week’s working group.
The practicalities of continuing to use the MBA during a yet to-be-decided “transitional phase” were also examined. It is hoped the new chemical method could come into force by spring 2010 – subject to consultation with Sanitary and Phytosanitary regulations.
The Commission confirmed to FoodProductionDaily.com that: “During this time, the CRL on marine biotoxins will validate the LC-MS method at European level to allow the application of a validated method in a harmonised way within EU.”
German support
The German Federal Institute for Risk Assessment (BfR) has backed the move to change test methods. The body said using chemical-analytical tests in place of the MBA will boost safety for consumers.
BfR President Professor Dr Andreas Hensel said: "Chemical-analytical methods can replace animal experiments. Furthermore, the methods help to improve consumer health protection because they can detect marine biotoxins more reliably.”
BfR said it had published a high performance chemical-analytical method this year which can detect marine biotoxins below the current regulatory limits. The body said it had recommended replacing animal tests with chemicals ones as far back as 2005 and would continue campaigning for the change.