A blank, fillable allergen matrix — every product you make against the nine major food allergens, the shared lines that create cross-contact, and the cleaning you validated to keep it out.
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An allergen matrix is the single page that says, for every product you make, which of the nine major food allergens it contains and which could reach it by cross-contact. Fill it in once for your whole line, keep it current as recipes and equipment change, and reach for it before anyone writes a "Contains" statement, answers a buyer's allergen questionnaire, or schedules a changeover.
FDA counts nine major food allergens — milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame — since sesame became the ninth on January 1, 2023 under the FASTER Act (21 U.S.C. 321(qq); FDA on the FASTER Act, verified July 2026). Every one of the nine gets a column, whether or not you use it today — an empty column is the record that you checked and it is absent.
Each cell answers one of two questions. Is the allergen an ingredient you add on purpose? Or is it something that could get into the product without being on the recipe — , the term FDA defines in 21 CFR 117.3? Mark each cell with the legend below.
| Mark | Meaning |
|---|---|
| I | Present as an intentional ingredient in this product |
| CC | Cross-contact risk — not an ingredient, but present in the facility or on a shared line and could reach the product |
| (blank) | Not present, and no cross-contact route |
Fill the product matrix first, then map the shared lines that explain every CC mark, then record the cleaning you validated to control that cross-contact. Download a blank copy of this matrix to fill in offline.
Crustacean shellfish, not all shellfish
Only Crustacean shellfish — crab, lobster, shrimp — is a major food allergen. Molluscan shellfish such as clams, mussels, oysters, and scallops is not one of the nine, so it gets no column here. If a molluscan allergen matters to a customer, track it in your notes, not as one of the Big 9.
One row per product or SKU. Work from the recipe for the I marks and from your line map, in the next section, for the CC marks. The I marks are the allergens your label must declare and your food safety plan must control — carry them into your HACCP plan as allergen hazards. The CC marks are the ones your changeover and cleaning have to keep out.
| Product / SKU | Milk | Egg | Fish | Crustacean shellfish | Tree nuts | Wheat | Peanuts | Soybeans | Sesame | Notes |
|---|---|---|---|---|---|---|---|---|---|---|
| (example) Classic Hummus / SKU-201 | CC | I | I | Tahini = sesame; soybean oil = soy; shares Mixing Line 2 with a walnut product | ||||||
Every CC mark in the matrix should trace back to a line, a room, or a piece of equipment on this map. List what each shared line handles, then the rule you follow to keep allergens from carrying over between products.
| Line / equipment / room | Allergens handled on it | Products that run on it | Changeover and sequence rule | Cleaning validation ref |
|---|---|---|---|---|
| (example) Mixing Line 2 | Sesame, soy, tree nuts | Hummus, walnut pesto, tahini dressing | Run the fewest-allergen product first; full wet clean before any allergen-free product | CV-2024-03 |
A CC mark you have controlled is only as good as the cleaning behind it. This is where you record, for each shared line, the evidence that your changeover cleaning actually removes the allergen before a different product runs — . Allergen controls under 21 CFR 117.135(c)(2) require you to protect food from cross-contact during handling and use; a validated cleaning record is how you show that protection is real, not assumed (verified July 2026).
| Validation ref | Line / equipment | Allergen removed | Cleaning procedure (SSOP ref) | How verified | Result / acceptance | Validated by, date | Revalidation due |
|---|---|---|---|---|---|---|---|
| (example) CV-2024-03 | Mixing Line 2 | Sesame | SSOP-07 full wet clean | Sesame lateral-flow swab after clean, 3 consecutive changeovers | Below detection, all 3 | ____ | Annually, or on any process change |
The matrix is a live record, not a one-time form. Update it whenever you add a product, change a recipe or a supplier, or move production to a different line — any of those can add or remove an allergen. The I marks feed the "Contains" statement on each product's label, so a stale matrix becomes a mislabeled product. Re-verify the nine against FDA before an audit or a label run, since the list can change — sesame was added in 2023.
| Field | Entry |
|---|---|
| Prepared by (name, role) | |
| Date prepared | |
| Last reviewed | |
| Next review due |