AOAC Gluten Qualitative Validation Guidance-FINAL (July 2023)

Gluten Public Comments (Responses)

References AAFCO Good Samples and Good Test Portions: https://www.aafco.org/resources/guides-and manuals/good-test-portions-and-goodsamples-resources/ Reference added under section 3, Terms and Definitions ------------------------------------------------------------------------------------------------------------------------------------------ Annex A Table 1 "Please add the footnote “The allowance of oats that are not contaminated with wheat, rye or barley in foods covered by this standard may be determined at the national level.” to Annex A, Table 1 if the definition of gluten in section 3.11 has not already been amended to include this note from the original Codex document. Justification: Full understanding of the Codex gluten definition requires the inclusion of the note on oats. This can come either in section 3.11 or in Annex A, Table 1 as a footnote." Per WG discussion, the following note was added under Table 1, linked to Oat Flour “ # Oats are not regulated as a gluten source in all countries. Please see the definition of “gluten”, and the related footnote, in the main guidance document. If oats are not considered a gluten source for the test method undergoing validation, then oats should be moved to Table 2 and treated as a commodity for the cross reactivity and interference studies.” ------------------------------------------------------------------------------------------------------------------------------------------ Annex A Table 2 "Addition: Add oat flour to Annex A, Table 2. Include a footnote that oats may be omitted from the cross-reactivity study if oats are claimed as a gluten source for the test. Justification: In nations where oats are allowed in gluten free foods, manufacturers will find it useful to know if kits cross react to oats." This was addressed through the change to Table 1, above. ------------------------------------------------------------------------------------------------------------------------------------------ Annex B The data in the reference 1 paper by Schalk et al, may not pertain to this standard as flours in that paper were processed as sieved to 200 um to produce white flours, not whole grain flours as will be used here. The Wehling/Scherf paper (ref #2 here) used unseived whole-grain flours, so the gluten fractions in that paper will be more suitable for this standard. This change had already been incorporated during the previous round of working group comments. ------------------------------------------------------------------------------------------------------------------------------------------ Annex B Using the conversion factor for barley which is 0.78 instead of 0.75, the gluten content should be 6.83% instead of 6.56 as reported in the document.