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Allergenicity Evidence Checklist

Writing a GRAS notice for a new protein? Tick what your allergenicity section reports. You'll see how it compares with the 35 GRAS dossiers I coded for my study, and what reviewers look for that's still missing.

1. What kind of ingredient?

2. What does your notice report? A sequence screen, described: what was compared against what (your protein, host-cell proteins or the whole predicted proteome) The allergen database by name (e.g. AllergenOnline, COMPARE) …and the version or search date The thresholds used (e.g. more than 35% identity over 80 amino acids) …including an 8-amino-acid exact-match search The amount of host-cell or co-isolated proteins (e.g. % of total protein) An in vitro digestion test (pepsin or simulated gastric fluid, or a protein digestibility assay)

3. Also reported (not scored) A heat or thermal stability test (e.g. DSC or melt curve) Serum IgE, skin-prick or other human testing Cross-reactivity with the production organism's own allergens An allergen labeling statement (what the label will declare, or why none is needed) An explicit history-of-safe-use argument for the source food

Loaded with an example: A precision-fermentation protein with a described screen against a named database, but no thresholds, host-cell protein amounts or digestion test.

— —of 5 points

—of the 35 coded dossiers scored lower than yours

—mean score for this ingredient type

0 of 48FDA letters (with no public dossier) named the database or thresholds

What to add

The research behind this tool

Can Anyone Tell How Your New Protein Was Checked for Allergens?Plain-language guide: what 83 GRAS notices show, and what to put in your allergenicity section.

Technical report (PDF)Allergenicity Evidence in U.S. GRAS Notices for Novel Proteins: methods, results and limitations.

The dataset (CSV)All 83 notices with the 13 coded fields and each notice's transparency score.

Talk to a food scientist

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Based on 83 GRAS notices for proteins, precision-fermentation proteins and biomass ingredients in FDA's GRAS Notice Inventory, 35 of them with a dossier (Le, Mendocino Food Consulting, 2026). The score counts what a notice reports, one point each for a described screen, a named database, stated thresholds, quantified host-cell proteins and a digestion test. It does not judge whether a method is adequate, and it is not legal or regulatory advice.