Food Authenticity NTT SMPR (Comments)

78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98

7. Validation Guidance

a) Data demonstrating method performance is required.

b) Samples: Complete documentation for the collection and use of authentic samples is must be supplied by the method authors. The scope of authentic samples used to construct the “authentic” profile must be applicable to the defined scope of the NTT method. Expansion of the scope is possible with the inclusion of additional authentic samples into the baseline calibration, and validation using the protocol listed in this SMPR. c) For single lab validation studies, the method will be evaluated using prescribed adulterated materials as shown in Table 1. Methods approved at this level will proceed to a second level of evaluation where blinded samples containing unknown adulterants will

be sent to participating laboratories.

d) Methods submitted based on these SMPRs must yield binary analytical results (i.e.

“Authentic” or “Not Authentic”). e) Available guidance documents :

a. AOAC INTERNATIONAL Guidelines for Validation of Botanical Identification Methods,

Journal of AOAC International Vol. 95, No. 1, 2012

b. Statistical analysis of interlaboratory studies. LII. Sample size needed to meet performance requirement on proportion. http://lcfltd.com/AOAC/tr347-SAIS-LII-

sample-size-needed-for-PR-for-proportion.pdf

99 100

8. Maximum Time-to-Results

None

9. Reference Materials 101 A detailed description of the process used to obtain and evaluate authentic samples, and of the 102 test protocol establishing the baseline fingerprint must be supplied. 103