Toward Harmonization of Performance Criteria for Mycotoxin Screening Methods: The EU Perspective

Area of Science:

• Food Science
• Analytical Chemistry
• Regulatory Science

Background:

• Screening methods are crucial for detecting substances at specific levels, requiring high sample throughput.
• Demonstrating fitness-for-purpose through validation studies is essential before practical application of screening methods.
• Mycotoxin contamination in food poses a significant risk, necessitating reliable detection methods.

Purpose of the Study:

• To present and discuss new European Union guidelines for evaluating the fitness-for-purpose of mycotoxin screening methods in food.
• To review practical applications of these guidelines in validation studies and assess screening method performance.
• To examine the impact of real-world mycotoxin contamination on the fitness-for-purpose of screening tests.

Main Methods:

• Review of official European Union guidelines for evaluating screening method performance parameters.
• Analysis of single- and interlaboratory validation studies for mycotoxin detection methods.
• Discussion of validation follow-up, including scope extension and method verification.

Main Results:

• Established EU guidelines provide a framework for assessing the fitness-for-purpose of mycotoxin screening methods.
• The evaluation scheme is applicable to various validation scenarios, including interlaboratory studies.
• Real-world sample contamination impacts the fitness-for-purpose of screening tests, requiring careful consideration.

Conclusions:

• The presented guidelines are vital for ensuring the reliability and applicability of mycotoxin screening methods in food analysis.
• Effective validation and follow-up are critical for maintaining the integrity of food safety testing.
• The guidelines support the accurate detection of mycotoxins and modified mycotoxins in diverse food matrices.