# Allergen Matrix

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. 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 (mark it I)? Or is it a cross-contact risk — present in the facility or on a
shared line and able to reach the product without being on the recipe (mark it CC)?
Leave the cell blank when the allergen is not present and has no cross-contact route.
Only Crustacean shellfish (crab, lobster, shrimp) is a major allergen; molluscan
shellfish such as clams, mussels, oysters, and scallops is not one of the nine.

Legend: I = intentional ingredient · CC = cross-contact risk · blank = not present.

- Nine major food allergens defined, 21 U.S.C. 321(qq): https://www.law.cornell.edu/uscode/text/21/321
- FASTER Act — sesame the ninth allergen, effective January 1, 2023: https://www.fda.gov/food/food-allergies/faster-act-sesame-ninth-major-food-allergen
- Allergen cross-contact defined, 21 CFR 117.3: https://www.law.cornell.edu/cfr/text/21/117.3
- Allergen preventive controls, 21 CFR 117.135(c)(2): https://www.law.cornell.edu/cfr/text/21/117.135

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## Allergen matrix

One row per product or SKU. Work from the recipe for the I marks and from your line
map for the CC marks. The I marks are the allergens your label must declare and your
food safety plan must control; 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 |
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## Shared-production-line map

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 |
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## Cleaning-validation reference

A CC mark you have controlled is only as good as the cleaning behind it. 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.

| 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 |
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## Keep it current

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 | |