AOAC GFA Stakeholder Program Meeting Book (March 15, 2023)

4.1.1 Scope The method developer validation study is intended to determine the performance of a method under the controlled conditions of a laboratory. The study is designed to evaluate performance parameters including cross-reactivity, interference, POD at regulatory level(s), robustness, between-device variation, lot-to-lot variability and product stability. From a regulatory perspective, gluten has four potential sources – wheat, rye, barley and oat grains – and multiple regulatory levels. Developers must determine which of these sources and levels their method is intended to detect, and perform interference and POD studies for each claimed gluten source. Proposed New Text “Developers must determine which of the gluten sources listed in Annex A, Table 1 that their method is intended to detect, and they must perform interference and POD studies for each claimed gluten source.” Justification: Limiting the list of gluten sources to four is neither consistent with the codex definition nor with Annex A, Table 1. Triticale is a commercially important cross breed and does appear as a contaminant in food at times.

Note The term “wheat” is clarified in the definition of Gluten to refer to all Triticum species – but this section does not address crossbred varieties.

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