SPIFAN Stakeholder Panel (March 15, 2017)

GB Analytical Methods (3)

• However, when updating the method or for a new analyte, GB will encourage international literature search; and internationally published or accepted methods are respected, such as by AOAC. • An AOAC adopted method will be the first consideration. • Published in Journal of AOAC is the next. • If an international standard is adopted, a full Chinese translation is needed. • CFSA (China national center for Food Safety risk Assessment) is in charge of method evaluation.

March 14, 2017

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GB Method Validation Guideline

• Specification • LOD : 3 x SD (blank) or 3 x S/N. • Linearity :

Cover at least 5 concentration points, including LOQ; Analytical range cover the analytical concentration; R 2 шϬ͘ϵϵ͘

• Accuracy :

Either: Trueness (known concentration reference standards); Or 3 levels of spike-recoveries, including LOQ, in sample concentration and highest concentration with at least 3 replicates for each level. • Precision :

Repeatability, 6 replicates for each concentration level; Reproducibility, 3 labs other than method submitting lab.

• Robust (optional) • Uncertainty (optional)

March 14, 2017

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