As many as 500,000 mice or rats were killed annually for the mouse bio-assay in order to detect of algae toxins in shellfish. The EFSA (European Food and Savety Association) committee for contaminants in the food chain concluded that these bio-assays are inadequate and not applicable because of considerable deviations in test results, insufficient detectability and restricted specificity. Shellfish can accumulate hardazous toxins in their organism by ingesting algae. Human consumption of contaminated shellfish can lead to paralysis and diarrhoea. Since the eighties, an animal-free method of detecting toxin contamination in shellfish has been known.

Nowadays, the toxin profile is determined via LC-MS/MS, a combination of liquid chromatography (LC resp. HPLC) and mass spectrometry (MS). The method has been validated by the EU reference laboratory in a year-long validation process. The validation protocol can be downloaded from (http://www.aesan.msps.es/CRLMB/docs/docs/ayuda_cientifica/CRLMB-BiologicalMethods-ValidationProtocol.pdf). Other accepted test methods can be used to verify of lipophile toxins, as long as they fullfill the evaluation criteria set out by the EU regulation. The EU member states have to implement the new method within a transitional period of three years.

Further information:
http://eur-lex.europa.eu/