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In preparation for replacement of the mouse bioassay by chemical tests within the framework of EU regulations, AFSSA has acquired the necessary tools for detecting, identifying and measuring all regulated lipophilic toxins in shellfish as of January 2010. The methods used are stringent and validated.
The agency is also actively involved in the implementation of a safeguard plan, as found in its Opinion of 4 December 2009, which will make it possible to anticipate the consequences of atypical toxicities that would not be fully assessed using regulatory monitoring.


Community-level talks have been under way for several months in view to replacing the mouse bioassy, which is the current benchmark method for monitoring shellfish safety, by chemical tests for direct detection of 13 regulated lipophilic marine biotoxins in shellfish.

For a number of years, AFSSA's Laboratory for study and research on quality of foods and food processes, the designated
national reference laboratory (NRL) for the monitoring of marine biotoxins, has worked in close cooperation with the European reference laboratory network for the development of a chemical method of lipophilic toxin analysis as an alternative to the mouse bioassay. Through the NRL's efforts, the method was validated in summer 2009. The NRL and Ifremer conducted a methods comparison test during the second half of 2009 in order to verify the comparability of their results. With the support of the ministry in charge of food, and within the context of the expected regulatory modifications, the agency has acquired the equipment and manpower needed for immediate implementation of the chemical test method for official shellfish analyses prior to commercialisation.


Recommendations for boosting consumer safety

Chemical test methods have the advantage of enabling
a much more detailed analysis of regulated lipophilic toxins than the mouse bioassay while also providing reliable quantitative results. However, such methods favour detection within a predetermined list of chemical substances, making it impossible to detect possible emerging toxins or new analogs of known toxins.

Within this context, AFSSA, in its opinion dated 4 December 2009, recommended that in the event of a switch over to the chemical test method for biotoxin monitoring, an additional safeguard should be implemented in order to provide very early detection of emerging sources of toxicity to humans, and not just the 13 currently regulated toxins.

The agency recommends
basing the new monitoring system on continued used of the mouse bioassay but with modified frequency of its use. This would provide data for a safeguard unit that could supply additional investigations, warning measures and/or management measures in certain cases, especially in the event of a positive mouse test result unexplained by chemical analysis.

The agency points out that the system should be rapidly modified to take into account the risks related to phycotoxins produced by various species of the genus
Ostreopsis found on the Mediterranean coast.
This combination of monitoring and safeguarding will mean that both the chemical tests and the mouse bioassay will be used to their fullest advantage, since the latter provides highly specific and detailed analysis of known toxins while the former, less precise, provides a more global view of possible sources of toxicity.
Together they can ensure that stringent requirements for consumer protection are maintained.
And finally, current
research work, in particular that of the Archachon research programme, will serve to boost our knowledge and understanding of the various factors involved in shellfish health and safety, as well as of the causes of certain atypical toxicity episodes that have occurred over the last few years.



Find out more

> Opinion of 4 December 2009

> Our close-up
New surveillance methods for lipophilic marine biotoxins
11 January 2010
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