Templates and records · BRCGS · Clause 5.3
BRCGS allergen risk assessment
Which allergens are on site, how they could get into a product that does not declare them and what is done to prevent it. It is a fundamental requirement.
In one sentence
The BRCGS allergen risk assessment identifies the allergens present in raw materials, products and on site, assesses the risk of cross-contamination at each step and sets the measures — segregation, production scheduling, validated cleaning, label control and justified use of precautionary labelling — because clause 5.3 is a fundamental requirement.
- Where the standard requires it
- BRCGS · Clause 5.3 Clause references follow the numbering of BRCGS Food Safety Issue 9. If your audit is already against a later issue, check the correspondence on brcgs.com.
- Type of information
- Mandatory record Documented assessment and records to be retained (5.3, fundamental requirement)
- Who fills it in
- HACCP team and quality Production applies the measures; quality validates cleaning and verifies
- When
- At implementation and at every change New raw material, recipe or supplier change, new product; periodic review with the HACCP plan
- How long it is kept
- Shelf life plus 12 months, at least BRCGS requires a retention period to be set taking into account legislation, the customer and the product's shelf life, and as a minimum records must be kept for the shelf life plus twelve months (3.3).
What the standard requires
What BRCGS demands and what it leaves to your judgement
BRCGS requires the allergens in all raw materials to be known, including those arriving as traces, and a list of products containing them to be maintained. From there, a documented risk assessment identifies the routes of cross-contamination — shared equipment, air, staff, rework — and the measures to reduce them.
Cleaning that separates a product containing an allergen from one without it must be validated, and its effectiveness verified regularly. Precautionary "may contain" labelling is only used where the assessment shows the risk cannot be eliminated, not as blanket protection.
Control of labelling and packaging changeovers is part of the same requirement: the wrong label is behind a large share of allergen recalls.
Structure
Fields the template should include
- Allergens present in raw materials and products
- Cross-contamination routes by step
- Measures: segregation, production order, utensils, cleaning
- Validation of changeover cleaning and its results
- Periodic verification of cleaning
- Label control at every product changeover
- Justification for precautionary labelling, if used
- Review date and approval
Example
Example: shared line at a fictitious sauce plant
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Allergens on site | Egg, milk, mustard, celery |
| Line 1 | Mayonnaise (egg, mustard) and tomato sauce (no allergens) |
| Risk | Mayonnaise residues in the tank and filler when switching to tomato |
| Measures | Tomato first in the day · validated cleaning CI-12 before each changeover · colour-coded utensils by allergen |
| Validation | 3 trials of CI-12 with egg ELISA: < 0.5 ppm |
| Verification | Rapid protein strip at every changeover · quarterly ELISA |
| Labelling | Leftover labels removed and signed off at every product changeover |
| Precautionary labelling | Not used on the tomato sauce: the risk is controlled by the validation |
At the audit
Mistakes auditors commonly flag
- Supplier data sheets with allergen traces that never reach the matrix.
- Changeover cleaning not validated, or validated with a method that does not detect the allergen.
- Precautionary labelling on every product, with no assessment to justify it.
- Uncontrolled label changeovers: the product goes out with the previous one's label.
- Rework containing an allergen is fed back into a product that does not declare it.
In Kimobox
How this record is kept in Kimobox
- 1The allergen matrix by product is fed by the current technical data sheet of each raw material.
- 2If the supplier uploads a new version of its data sheet, a review of the products using it is triggered.
- 3Changeover cleaning and its verification are recorded on the terminal, and a nonconforming result blocks release of the line.
- 4Product allergen declarations are generated from the real data and travel with each batch certificate.
Frequently asked questions
What people ask us before getting started
Which allergens have to be managed?
At least the fourteen in Annex II to Regulation (EU) 1169/2011, plus any required by the law of the country of sale or by the customer.
When can "may contain traces" be used?
When the risk assessment shows that cross-contamination cannot be avoided with the measures available. BRCGS does not accept the warning as a substitute for managing the risk.
How is allergen cleaning validated?
With trials showing that, after cleaning, no detectable allergen remains in the next product or on surfaces, using a method capable of detecting it, such as ELISA or specific protein strips, repeated under real conditions.
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- BRCGS Global Standard for Food Safety, Issue 9 BRCGS · Published August 2022
- Regulation (EU) No 1169/2011 on the provision of food information to consumers (Annex II, allergens) EUR-Lex · 25 October 2011