Marine biotoxins in shellfish - Summary on regulated marine biotoxins Scientific Opinion of the Panel on Contaminants in the Food Chain

The European Commission (EC) has requested the European Food Safety Authority (EFSA) to summarise the outcome of the adopted opinions on marine biotoxins that are currently regulated in European Union (EU) legislation, namely the opinions on okadaic acid (OA) and analogues, azaspiracid (AZA)-group toxins, yessotoxin (YTX)-group toxins, saxitoxin (STX)-group toxins, pectenotoxin (PTX)-group toxins and domoic acid (DA). The EC asked EFSA to address the current EU limits with regard to human health and methods of analysis. This opinion provides an overview of the EU regulatory limits, the acute reference doses (ARfD) set by EFSA, the exposure levels resulting from consumption of shellfish on the EU market, the available methods of analysis, certified calibrants and reference materials, the influence of processing on the levels of the toxins and the relative potency of the analogues of the six regulated marine biotoxins. Based on the established ARfDs it is concluded that the current EU regulatory limit values for OA-, AZA-, STX-group toxins and DA are not sufficiently protective for high consumers. For YTX-and PTX-group toxins, the EU limit values are sufficiently protective. The mouse bioassay (MBA) is the official reference method for lipophilic biotoxins. The Panel on Contaminants in the Food Chain (CONTAM Panel) noted that this bioassay has shortcomings and is not considered an appropriate tool for control purposes because of the high variability in results, the insufficient detection capability and the limited specificity. Recently developed alternatives to the reference methods for the determination of the marine biotoxins with lower limits of detection (LOD) have successfully been tested in prevalidation studies. Method performance criteria should be stipulated where possible and validation by interlaboratory trials should be the long-term objective.