Allergens ERP Book, Sept 17

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 Supporting Information 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 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? 3. Is there information demonstrating that the

Some precautions are missing. The authors should provide some info about safety measures while manipulating some irritant/toxic reagents or strong acids.

Yes. All the work described in the text has been supported by the documentation/figures attached.

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The method demonstrated its applicability only for certain combination allergen/matrices. The introduction of another confirmation peptide could be important and likely arising from another protein belonging to the same allergenic ingredient. Another limitation is the use of peanut butter in place of roasted peanuts. In the SPMR it is specified the use of peanuts seeds (from raw and roasted peanuts). The authors for hazelnuts referred infact to roasted samples in this case. It is more realistic to have contamination by roasted nuts along a production line or a contaminated raw material.

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