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

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Regulatory Requirements

X Food Allergen Regulations: X Focus on intentional addition of ingredients derived from food allergens X Allergen cross-contact (unintentional presence): GMPs and/or allergen control plan requirements (vary by jurisdiction) X Precautionary Allergen Labeling and Risk Assessment X Precautionary allergen labeling largely voluntary X VITAL® Program: The Allergen Bureau X Largely no regulatory action limits X Exception 1: Japan X Exception 2: Proposed/internal action levels by individual EU member states X Big challenge for method validation Æ key difference from gluten methodology

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