Allergen declaration

An allergen declaration is a document from a supplier that states which allergens are intentionally present in a specific material they supply, and which allergens are present elsewhere in their factory and therefore carry a cross contact risk. It is issued on the supplier's own paper, attributed to a named person or a technical mailbox, and it is tied to a material and a manufacturing site rather than to the supplier as a company.

It is not the same thing as a specification, a label artwork proof, or a test result. A specification describes what the material should be. A test result says what one batch was. The allergen declaration is the supplier's positive statement of what their site handles, which is the only way you can assess cross contact risk you cannot see or sample for.

An example

A flavour house supplies a seasoning blend. Its declaration names mustard as an intentional ingredient, states that sesame is handled on the same site with a cleaning step between runs, and confirms no peanut is present on site. Your specification, your label copy and your allergen risk assessment all rest on that one page. If the declaration was signed two years ago and the supplier has since taken on a new contract, the paper on your file is answering last year's question.

Wording varies by standard, by customer and by supplier template, so check what your own scheme and your own customers ask for. In practice the fields that make a declaration usable in front of an auditor are:

• The supplier name and the specific manufacturing site, not just the head office.
• The material name and code, matched to what appears on your goods in records.
• Allergens present as intentional ingredients, listed explicitly.
• Allergens handled elsewhere on the site, with a note on segregation or cleaning between products.
• A clear statement where an allergen is absent from the site altogether.
• A date of issue and a named signatory or role.

One quiet problem: unlike an audit certificate, an allergen declaration often carries no expiry date at all. Most plants therefore assign their own review date, commonly a year from issue, and chase a fresh declaration on that cycle or whenever the supplier changes a recipe, a line or a site. That review date is what turns the document from a filing decision into a due date somebody owns.

• CoA, certificate of analysis: a per batch statement of test results against specification. Batch specific, where an allergen declaration is site and material specific.
• Audit certificate: the third party certificate showing a supplier holds a scheme certification, with a real expiry date printed on it.
• Approved supplier list: the register of suppliers you have assessed and accepted, and the place the required document set per supplier is defined.
• Supplier questionnaire: the broader self assessment a supplier completes at approval, which usually asks about allergen handling but does not replace a signed declaration per material.
• Document control: the discipline of knowing which version is current, who issued it and when it is due for review.
• Non-conformance: the finding raised when the document on file is missing, unsigned or out of date at the point an auditor asks for it.