Allergens ERP Book, Sept 17

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 method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method? 6. Based on the supporting information, what are the cons/weaknesses of the method?


Not Clearly defined

System suitability not clearly defined


First let me first congratulate authors on their comprehensive research work in this area.

1. The method accuracy not established by analysis of other reference materials, or comparing its results with those obtained by other currently established methods. The method accuracy may be evaluated using available reference materials (CRMs) like IFAAN reference std. for peanut, and from Food Allergen Lab for egg, hazelnut and milk and other reference materials. 2. How the results provided by this method compare with the results provided by the current conventional methods, i.e., ELISA and other methods? 3. The method has not been applied to samples other than used for developing the method and calibrations. The method may be applied to different samples in matrices in scope.

4. The method meets SMPR parameters but still there are quite a few exceptions.

5. No internal std for Egg yolk transition Ey1 used for allergen marker. 6. EW2-J Used as a marker with No internal std in red and white wine matrices

7. Any general comments about the method?

An advanced method for the analysis. The next step is to correlate the results to the relevant meaning or information.

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