Management of Allergens Procedure

Establish allergen status before materials enter routine use

Technical Management controls a raw-material allergen assessment for each raw material before approval and routine use. Approved supplier and specification information is used to identify allergens intentionally present, supplier-declared cross-contact or precautionary statements, allergens not present and, where supporting evidence is available, allergens confirmed absent.

The assessment also records the physical state or form of the material, such as powder, liquid, particulate or solid, because material characteristics are an input to subsequent control decisions. Where supplier or specification information is incomplete, unclear or insufficient, additional validated information is obtained before the allergen assessment is confirmed and the material is approved for use.

Quality Management also maintains the controlled list of allergen-containing raw materials, processing aids, intermediate products, finished products and relevant new product development materials handled on site.

Assess cross-contact risk through the process flow

A documented allergen risk assessment identifies the routes by which cross-contact could occur across site activities. Technical Management considers the physical state of allergenic materials and potential cross-contact points through the defined process flow, using the site’s movement routes and segregation arrangements as established by the Layout, Product Flow & Segregation Procedure.

Risk is assessed at each process step to determine whether existing controls remain acceptable or additional controls are required. The resulting handling methods and control measures address the relevant materials and process steps and align with the HACCP hazard-identification and analysis process.

Apply operational controls according to the assessed risk

Operations Management implements the allergen controls defined from the risk assessment, with Quality Management overseeing their application. Depending on the assessed risk and defined handling controls, these measures can include physical segregation, time-based separation, dedicated protective overclothing, dedicated equipment and utensils, and production scheduling to minimise transitions from products containing an allergen to products that do not contain it.

The procedure also addresses conditions in which airborne allergenic material may be generated, allergen spillages, allergen-containing waste, rework and site restrictions. Rework containing allergens is restricted to products that already contain the same allergen, while spillages and waste are managed through the relevant housekeeping, hygiene and waste-control procedures.

Use precautionary allergen statements only when justified

Precautionary allergen labelling is tied to the outcome of the allergen risk assessment. Where cross-contact from an allergen cannot be prevented through the defined handling controls and process conditions, Quality Management requires an appropriate warning statement before release of the affected product format.

The wording is determined with reference to applicable legislation, national guidelines or codes of practice, while label definition, verification, approval and amendment remain governed by the Product Labelling & Artwork Control Procedure. This preserves the distinction between the allergen-risk decision made under this procedure and the artwork-control process used to implement it.

Validate allergen-related suitability claims

Where a product carries a claim that it is suitable for individuals with a food allergy or food sensitivity, Technical Management ensures that the production process is validated before the claim is used. Validation can draw on relevant process controls, cleaning validation, analytical testing or other site verification activities.

Routine verification then provides evidence that the validated condition continues to be achieved during ongoing production. If that condition is not maintained, the claim cannot be used unless the validated condition is re-established, and affected product is controlled through the Non-Conforming Product Control Procedure.

Define, validate and verify allergen cleaning controls

Allergen-specific cleaning requirements are linked to the site’s wider housekeeping and hygiene system. A documented cleaning risk assessment defines cleaning methods and allergen-removal performance limits, with verification methods selected as appropriate to the assessed risk, including visual, analytical or allergen-specific techniques.

Quality Management validates allergen-removal methods before they are relied upon in routine operation. Validation is based on worst-case conditions, including relevant allergens, product types, equipment configuration and process conditions. Routine verification is then carried out against the defined methods and frequencies to confirm continued compliance with the cleaning performance limits.

Where cleaning effectiveness is not confirmed, the affected cleaning method is not used until effective performance has been re-established. Potentially impacted product is controlled as non-conforming product, and where released product poses a safety risk the response interfaces with the Incident Management, Product Withdrawal & Recall Procedure.

Allocate responsibility across technical, operational and hygiene controls

Senior Management provides the resources, infrastructure and organisational support needed for allergen control. Technical or Quality Management establishes and maintains the allergen management system, controls risk assessment and allergen data, defines control measures, and manages validation, verification and allergen-labelling decisions within the authority set by the procedure.

Operations Management implements the defined controls in storage, production and packing, including production sequencing, equipment use, rework and controls for airborne material, waste and spillage. Hygiene Management and cleaning personnel apply the defined cleaning methods and maintain control of cleaning equipment. Employees follow the controls relevant to their work and report deviations or conditions that may increase allergen cross-contact risk.

Connect allergen control with the wider FSQMS

The procedure makes allergen management an interface between approved supplier and specification information, HACCP assessment, layout and segregation, operational handling, housekeeping and hygiene, product labelling and product-status control. Each supporting procedure retains its own authority: this document defines the allergen-specific requirements and decisions that those wider controls support.

For technical and quality teams, that structure provides a clear route from material allergen status and process risk assessment through to operating controls, validated cleaning, verified product claims and defined responses where control or validated conditions are not maintained.