Bioanalytical screening for Dioxins and PCBs in EU-regulated foods: new analytical criteria adopted by the European Union in Commission Regulation (EU) 2017/644-Part 1: Introduction

摘要

Sensitive, efficient and high-throughput bioanalytical screening methods compliant with European Union (EU) legal requirements for the official control of the levels of dioxins and dioxin-like PCBs in food provide additional analytical capacities and reduce turnaround times and costs per sample. The authors describe concepts and procedures developed at the Bioassay Research Laboratory of the EU Reference Laboratory (EU-RL) for Dioxins and PCBs in Feed and Food, Freiburg (DE), in co-operation with the Department of Environmental Toxicology at the University of California Davis (US) and bioassay experts from National Reference Laboratories and independent research labs. New approaches to matrix-based calibration, validation and quality control provide an effective framework for cell-based bioanalytical screening applied within official control for checking compliance of foods for which legally binding maximum levels and voluntary action levels (an early warning system) were established by the EU. A new statistical concept ensures evaluation of reliable cut-off concentrations using authentic sample material. Bioassay scores now facilitate performance evaluation of bioanalytical screening methods within the scope of proficiency testing. Analytical performance criteria and requirements laid down in Commission Regulation (EU) 2017/644 of 5 April 2017 are discussed in detail, and practical guidance and the necessary mathematical formulae are presented.