AOAC SPSFAM ERP for SELECTED FOOD ALLERGENS

the SMPR Method Performance REquirements table specifications for all analytes in the SMPR

unclear from the submission which data were used to generate these values. As noted in previous questions regarding definitions, the use of whole milk powder instead of whole liquid milk and spray dried whole egg instead of liquid whole egg affects the MQL, MDL, and quantitative range values for method performance in some cases. Also, as discussed in the summary and in later questions, there are issues around the clarity of the quantification strategy, which also impacts the method the authors used to determine Recovery performance.

applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 2. Is there information demonstrating that the method system suitability

No.

The choice of materials for the system suitability test (fractionated or partially purified versions of proteins from two foods) seems a bit unusual and requires more justification. Also, the levels at which these suitability samples were run does not correspond to the SMPR, which requires blank check samples and check standards at the lowest point and midrange point of the analytical range. Also, it’s unclear even how the given peptide peak areas would be obtained for Milk.Protein_2.Peptide_B, as this peptide is from beta-casein (see description in general comments), which is not specifically included in the system suitability test sample. No. One of the primary issues is with the quantification strategy. It is unclear from the submission how quantification would be conducted

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