SPSFAM Allergens ERP

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. 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. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the

Based on the presentation of information in the submission, it is tremendously unclear whether the authors are applying the definitions of “food allergens” from the SMPR appropriately throughout the document. All indications of concentrations of food allergens must have absolutely clear units applied. For example, several different milk- based ingredients are used in the method and supporting data. The use of “50 ppm milk” is insufficient and should be revised to indicate precisely what the authors mean. Does it mean 50 ppm fluid whole milk in a specific matrix/solution or 50 ppm lyophilized whole milk in a specific matrix/solution or 50 ppm nonfat dry milk in a specific matrix? The absence of clarity on these definitions of units makes it impossible to determine whether the method meets the requirements from the SMPR based on the data presented. The differences between fluid whole milk (the SMPR definition of “milk”), lyophilized whole milk, and nonfat dry milk make a highly significant impact on determining limits of detection and quantification. The authors used alternative sources of reference materials to evaluate the method performance, as there are few certified reference materials for food allergens. Instead of the actual materials being the primary issue, this section is yet again woefully lacking in concise, accurate information about the correct units for these reference materials and what units the authors are implementing for their own results. For example, the authors indicate that they utilized iFAAM peanut reference materials that contained 40 ppm peanut, but this is incorrect. The iFAAM reference material contains 40 ppm peanut protein in reconstituted dessert matrix. The descriptions of the other reference materials are similarly unclear or incorrect. Throughout this section of data, the authors then apply mystery correction factors, which are not sufficiently justified or explained, particularly given the misstatement of concentrations for some of the reference materials. The authors indicate that some of these correction factors are calculated based on Bradford assay protein determinations, but no information is given regarding how or when said protein determinations were performed. Also, the applicability of soluble protein concentrations as opposed to total protein concentrations (i.e. as determined by Kjeldahl or Duma methods) for these materials must be clearly justified. As noted above, the unclear presentation of information and particularly measurement units in the submission makes this reviewer unable to determine whether the method meets any of the SMPR specifications.

No.

The authors did not specifically indicate system suitability tests were performed.