AOAC GFA Stakeholder Program Meeting Book (March 17, 2021)

Food Allergen Working Group: Proposed Scope

X Initial Priorities:

1. Guidance document for validation criteria X Example elements: acceptance criteria, acceptable testing materials, standardization of units/define conversion factors 2. Guidance document for end users X Example elements: comparing methods, fit-for-purpose identification, guidance on implementation, sampling instructions 3. Criteria for testing and reference materials; testing materials for method developers for validation vs. materials for QC 4. New generation allergens/novel ingredients 5. Positioning methods in relation with health significance of results e.g. in relation with hazard characterization aspects - VITAL numbers, health needs vs. method practicality/standardized reporting units X Future priorities: 1. Identify need for new SMPRs 2. Review of new/updated regulatory requirements X Acceptable testing materials: X Criteria for testing materials for method developers X Practical guidance on in house preparation of incurred foods for use as testing materials X Reference materials vs. independently sourced materials X Homogeneity testing X Processing unit operations X Standardization of units/definition conversion factors for calibrants: X Reference materials vs. calibrant materials X Protein determinations X Acceptance criteria: X Cross-reactivity and LOD X LOQ and Recovery X Positioning methods in relation with health significance of results Proposed Outline for New Validation Guidance

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