AOAC SPIFAN Stakeholder Panel Meeting Book (March 12, 2020)

Conclusions/Recommendations (1)

• Some SPIFAN methods are not fit to demonstrate compliance with narrow nutritional regulatory limits of several countries ( C m <1). • Probability of finding a test result outside the regulatory requirements due to analytical variability alone can be as high as 19%. • Of particular concern are methods for vitamins A, B 12 , D, Folic acid for country/regional regulations in China, some EU member states, Pakistan, Russia, Singapore, South Africa and Thailand. As well as vitamins B 1 and B 6 in FSMP for Russian regulation.

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Conclusions/Recommendations (2)

• Situation could be improved by: • Developing analytical methods with less variability. • Changing/globally harmonizing regulatory limits to fit testing capabilities. • Consider implementing the concept of method capability to help set or evaluate performance requirements of future AOAC methods to deliver results which support the assessment of regulatory compliance.

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