AOAC Gluten Qualitative Validation Guidance-FINAL (July 2023)

Gluten Public Comments (Responses)

This edit has been made, along with the subsequent change to the mg/kg and mg/g values. ------------------------------------------------------------------------------------------------------------------------------------------ Annex B, first paragraph "Add “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.” Under first paragraph in Annex B “Preparation of Materials For Gluten Method Validation”. Justification: Full understanding of the Codex gluten definition requires the inclusion of the note on oats." Per WG discussion, rather than add the Codex footnote here without the full definition, the following note was added under “Oats” in the list of conversion factors: “* 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.” ------------------------------------------------------------------------------------------------------------------------------------------ Annex B-Preparation Until such time as a reference materials are available, the gluten source for all prepared samples should be commercial, unbleached whole wheat, whole rye, whole barley or contaminated whole oat flour. Per WG discussion, changed the first paragraph so it reads “Until such time as a reference materials are available, the gluten source for all prepared test materials should be commercial, unbleached whole flours from each claimed gluten source.” ------------------------------------------------------------------------------------------------------------------------------------------ Annex C Pagination of Annex C needs repair. Page layout of the Excel document was adjusted ------------------------------------------------------------------------------------------------------------------------------------------ Annex D Guidance should state that experimental factors should be randomly assigned to factors in design. Added the following as the second paragraph under Study Design: “Robustness study designs can be large, and may need to be broken up across test kits, operators, days or other experimental conditions. The factorial treatment combinations (the Runs comprising specific combinations of parameters as shown in the tables below) should be assigned randomly to each set of conditions (test kit, day, operator, etc.).” ------------------------------------------------------------------------------------------------------------------------------------------ Annex D "Binomial" is the link used, the "Regression" is logistic regression by default.