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Food Allergen Matrix Worksheet (Product by Allergen)

An allergen matrix is the one-page view that production, QA and label reviewers all use. It lists, for every product and line, which major allergens are in the formula and which could be present through cross-contact.

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ProductLineMilkEggFishCrustacean shellfishTree nutsPeanutsWheatSoybeansSesameChangeover cleaning

The nine major allergens in the US are milk, egg, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame (added by the FASTER Act, effective 2023). Other markets differ: the EU list of 14 also includes cereals containing gluten, crustaceans, molluscs, celery, mustard, lupin and sulphites. Add columns for your market.

Add allergen checks to ERP work orders

Optional review of allergen attributes, formula change control and label checks in your ERP.

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How to use the worksheet

Add one row per product and line combination. For each allergen choose Contains if it is an ingredient or sub-ingredient, Cross-contact risk if the allergen is handled on the same line, equipment or in the same area without being in the formula, and None if it is neither. Use the changeover cleaning column to say what must happen before the line runs a product that does not contain that allergen. Review the matrix whenever you change a formula, a supplier or a line assignment, and export it for audits and customer questionnaires.

The logic behind it

Allergen control under FSMA preventive controls and most GFSI schemes begins with knowing which allergens are present, then deciding how to prevent unintended cross-contact and how to label correctly. Contains entries drive the ingredient statement and Contains line on the label. Cross-contact entries drive scheduling, cleaning validation and any precautionary label decision, which should be risk based, not a blanket practice. Sequencing runs from allergen free to allergen containing, and dedicating equipment for high-risk allergens like peanut, are standard controls.

  • Review every sub-ingredient's declaration
  • Check rework for allergen carryover
  • Verify cleaning with swab or visual tests
  • Keep matrix and labels under document control

Reading the matrix

Scan columns to find the allergens that are on a line, and scan rows to find a product's exposure. In the example, line 1 runs a tree nut bar with a peanut cross-contact risk, so a peanut-free product should not follow it without a validated clean. A column with Contains in several rows tells you where to schedule that allergen last in the week. A row with many cross-contact entries is a candidate for dedicated equipment or a different line.

Common mistakes

Forgetting rework is a leading cause of undeclared allergen recalls, followed by label mix-ups and ingredient supplier changes that were never reviewed. Another is treating sesame as optional now that it is a major US allergen. Keep the matrix tied to your ERP formula revision so a supplier or ingredient change triggers a review, and use the ERP allergen attribute on items to prevent a non-compliant substitution at the work order.

Frequently Asked Questions

What are the nine major food allergens in the US?

Milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added by the FASTER Act and applies to food labeled on or after January 1, 2023.

Is a precautionary allergen label required?

No US rule requires it, and FDA expects it not to replace good manufacturing practice. Decide based on a documented risk assessment, and follow your customer and scheme requirements.

How often should the matrix be reviewed?

At least annually and whenever a formula, ingredient, supplier, line or rework practice changes. Link the review to your change control process so it happens by default.

How is cleaning verified?

Common methods are visual inspection, ATP swabs for general cleanliness and allergen specific test kits such as ELISA or lateral flow on food contact surfaces. Validate the cleaning procedure first, then verify routinely.

If allergen data sits in spreadsheets apart from your ERP item master, we can help add allergen attributes and checks to formulas and work orders.