What Is an Allergen Risk Assessment?
An allergen risk assessment is a documented review of where allergens enter your site, how cross contact could occur at each process step, how likely and how severe that would be, and which controls reduce the risk. It underpins your allergen management plan, cleaning, scheduling and labeling decisions.
In US regulation, "Allergen cross-contact means the unintentional incorporation of a food allergen into a food" (21 CFR 117.3), and food allergen controls are a named type of preventive control under 21 CFR 117.135(c)(2).
In the UK, 14 allergens are listed in retained Regulation 1169/2011, Annex II, "Substances or Products Causing Allergies or Intolerances", starting with cereals containing gluten. In the US, FDA lists "nine major food allergens identified by law", including "sesame as of January 1, 2023".
When You Need One (New Products, Line Changes, Supplier Changes)
Review your assessment whenever something changes that could alter where allergens are or how they move:
- A new product, recipe or ingredient
- A new or changed supplier, or a supplier changing its own site or recipe
- New equipment, a line change or a change in production schedule
- A change in cleaning method or chemicals
- A complaint, nonconformance or near miss involving allergens
- A scheduled periodic review
IFS Food Version 8 clause 4.19.1 requires a risk assessment "for all raw materials" to identify allergens requiring declaration, but does not set a review interval, so define one in your own procedure.
How to Score Allergen Risk: Likelihood and Severity Matrix
Score each allergen at each process step, then multiply likelihood by severity.
| Score | Likelihood of Cross Contact | Severity |
|---|---|---|
| 1 | Very unlikely: allergen not on site or fully segregated | Low: trace amounts, low hazard form |
| 2 | Unlikely: allergen on site, separate line and validated clean | Moderate |
| 3 | Possible: shared equipment with validated cleaning | Significant |
| 4 | Likely: shared equipment, airborne or particulate allergen | High |
| 5 | Almost certain: no effective barrier | Severe |
Example banding: 1 to 6 low, 8 to 12 medium, 15 to 25 high. These bands are an internal scoring convention, not a legal threshold; set and document your own.
Note: your scores support decisions; they do not on their own prove compliance.
Worked Example: One Line, Three Allergens
An illustrative bakery line producing a plain biscuit, a sesame biscuit and a hazelnut biscuit on shared equipment:
| Allergen | Step | Hazard | Likelihood | Severity | Score | Control |
|---|---|---|---|---|---|---|
| Sesame | Topping | Seeds carried on belt to next run | 4 | 4 | 16 (high) | Run sesame last; full validated clean before plain biscuit |
| Hazelnut | Mixing | Powder residue in mixer | 3 | 5 | 15 (high) | Dedicated mixer bowl; validated clean; pre start check |
| Milk | Ingoing ingredient | Present in all three recipes | n/a | n/a | Not scored: declared ingredient | Labeled as an ingredient, no cross contact risk to manage |
This example is illustrative only. Your own scores must reflect your site, data and validation evidence.
Controls: Segregation, Scheduling, Cleaning and Labeling
- Segregation: separate storage, dedicated utensils, color coding and controlled movement of allergen materials.
- Scheduling: run allergen products last, or group them, to limit changeovers.
- Cleaning: validate the clean that each control relies on (see our guide to allergen cleaning validation), and verify it at every changeover with a pre-operational inspection.
- Labeling: declare allergens present as ingredients, and only use precautionary labeling where your assessment shows a risk you cannot control.
- Supplier control: check suppliers' allergen information and change notifications as part of approval.
If a control fails, an undeclared allergen can lead to a withdrawal or recall, so make sure your recall procedure is ready.