AOAC SPSFAM ERP for SELECTED FOOD ALLERGENS

3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used. 4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s). III. Review of Info in Support of Method: 1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method. method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. IV. General Submission Package: 3. Is there information demonstrating that the

Yes.

No. Need to be added.

Yes.

Yes, but only for selected matrices and even those have not been repeatable in other samples, for example was applied on cookie type. Will method provide similar results in other cookies without using separate calibration curve. The method requires separate calibration curve for different samples even for the matrices for which the method has been demonstrated to be applicable. Reference materials are used to calibrate the method but not used to establish accuracy of the over all method. Other allergen reference materials may be used to establish accuracy of the method for specified matrices. The method accuracy may be established further.

Yes but for selected matrices. The method meets SMPR method performance requirements specifications but those have been demonstrated for selected matrices in only single sample for the matrix.

1.

Based on the supporting information, were there any

No

additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method?