Evaluation of the new European Union reference method for paralytic shellfish toxins in shellfish: A review of twelve years regulatory monitoring using pre-column oxidation LC-FLD

Naturally-occurring saxitoxins periodically accumulate in shellfish giving rise to Paralytic Shellfish Poisoning. For decades a mouse bioassay has been used for public health protection, but in 2019 a precolumn oxidation LC-FLD method became the official reference method in the European Union. Laboratories are now required to use this method for regulatory monitoring, which will prove challenging. This paper reviews the development, validation and implementation of the method, having been used for over twelve years, successfully providing effective controls against human poisonings without resorting to contingency bioassay. The review describes the work conducted to refine, semi-automate and standardise the method, as well as modifications to cope with new analogues and shellfish species. Approaches for qualitative screening, semi-quantitation and full quantitation are also highlighted, as well as faster chromatography, quality assurance tools and interlaboratory studies. Recommendations for those laboratories new to the method are also described. Crown Copyright (c) 2019 Published by Elsevier B. V. All rights reserved.