AOAC SPSFAM ERP for SELECTED FOOD ALLERGENS

2. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 3. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 4. Based on the supporting information, what are the pros/strengths of the method?

YES: There are information demonstrating that the method system suitability tests and control as specified in the SMPR worked appropriately and expected.

The method is well described and substantively prepared. The project of the method is well integrated and includes a clear and concise description.

The developed method was evaluated following the definitions of AOAC SMPR 2016.002 with respect to Method quantitation limit (MQL), Method detection limit (MDL), Linearity, Repeatability, Reproducibility, Recovery. Specificity is another important analytical parameter. Characteristic signature peptides were chosen for each allergen, and MRM transitions for each signature peptide were determined based on their uniqueness compared to background proteins and their sensitivity of detection. Page 49, Table (iv) Hazelnut commodity: For 10 ppm (10000 ppb), information is given that analyte concentrations are BQL (below method quantification limit). Does the procedure fulfil the method criteria? The cons/weakness of the method may be costs. But I think it is inevitable. Page 42, Table 9: Despite the fact that mean values of SD and RSD% are less than 16.7%, recovery values, as well as SD and RSD%, ought to be provided for all three spiking levels of 10, 100 and 1000 ppm separately. In my opinion, the Method #ALL-01 entitled: Detection and Quantitation of Selected Food Allergens using LC-MS/MS (Revision 2) described by Lee Sun New, Andre Schreiber and Hua-Fen Liu is applicable for the detection and quantitation of egg, milk, peanut, and hazelnut food allergens in finished food products and ingredients by LC- MS/MS. The revised (January 2017) Method #ALL-01 should be adopted in its present form as a First Action and recommended for publication in the Official Methods of Analysis of AOAC INTERNATIONAL.

5. Based on the supporting information, what are the cons/weaknesses of the method?

6. Any general comments about the method?

V. Final Recommendation

Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.