In this guide

Statement of advice on the risk to human health from consumption of bivalve molluscs (shellfish) harvested from UK waters associated with marine biotoxins

Conclusions

COT/2025/02

Last updated: 10 November 2025

In this guide

49.               The FSA is reviewing its current advice and monitoring programme for marine biotoxins to determine whether updates to existing legislative standards are necessary. To support this, the views of the COT were sought to ascertain the potential risks posed by emerging marine biotoxins to human health. The COT recommended using a numerical risk ranking method to provide the FSA with robust evidence to help inform any decisions on revising legislative standards.

50.               The risk ranking, which comprises numerical scores provided alongside a narrative, successfully distinguishes between higher risk biotoxins, notably TTX and PITX, and lower risk biotoxins such as SPX, BTX and GYM.  

51.               The risk ranking was subject to the following uncertainties: (1) the absence of routine monitoring, meaning that it was unclear whether emerging biotoxins are already present in UK waters or shellfish; (2) potential underreporting of human intoxications, especially in cases with only mild to moderate symptoms such as gastrointestinal effects; (3) a lack of detail on human reports such as complicating factors, co-occurrence of biotoxins and persistent symptoms; (4) the LD50s used to distinguish toxicity profiles were based on a limited number of studies (5) limited toxicological data precluded the derivation of HBGVs. The lack of a clear benchmark for estimated exposures limits the scope for drawing clear conclusions on current risks to public health.

52.               Despite these uncertainties the risk ranking, alongside the narrative, provides a priority list of emerging biotoxin groups to support decision making. It is important to note that the risk ranking was based on limited knowledge and that, as more information becomes available, knowledge concerning the risks associated with these marine biotoxins could change.

COT Statement

2025/02