Allergen Management

Allergen Risk Assessments and Control Procedures

Allergen Management

I have considerable expertise in every aspect of allergen management, including allergen risk assessments, allergen-aware production planning, allergen testing allergen cleaning validation, verification and monitoring.

In many food manufacturing businesses, food allergens are a bigger food safety risk than pathogenic microorganisms. Only a few milligrams are required to cause an allergic reaction, anaphylaxis or even death, yet allergen management is rarely given as much attention as it requires, which is why specialist support can be so helpful.

I have worked at a “free-from” site with zero allergenic protein on site. I have worked at a nut/peanut site where almost every raw material was allergenic and many finished products contained multiple allergens. I have also worked at “normal” sites with a mixture of allergens and non-allergens.

Allergen Risk Assessments

An allergen management program always begins with a range of documented risk assessments, including:

Raw Materials: Which allergens do they intentionally contain and which may they unintentionally contain?
Raw Material Suppliers: Are their allergen control measures adequate to control the risk of cross-contamination?
Production Processes: Which allergens are present at each stage of the production process?
Work in Progress: Which WIPs are are at risk of allergen cross-contamination, where and why?
Finished Products: Which Finished Products are are at risk of allergen cross-contamination, where and why?
Allergen Risk Assessment: What are the significant risks and what controls can be put in place to reduce those risks, e.g. segregation, allergen-aware production planning and allergen cleaning?
Alibi Labelling: If any allergen cross-contamination risks cannot be adequately controlled, alibi labelling may be required, e.g. “May contain traces of …”
Other Allergen Investigations: Do hands, gloves, factory coats, pens, metal detector test pieces, etc. harbour allergens? And if so, control measures need to be implemented to minimise the risk of them cross-contaminating materials, WIP and finished products.

Allergen Validation, Verification & Monitoring

Validation: Allergen cleaning procedures (CICs) need to be validated to demonstrate that they are effective at removing all detectable traces of allergens. Allergen cleaning isn’t allergen-specific, i.e you don’t clean to just remove peanuts but not gluten. So there is no need to validate every CIC against every allergen used on site. Instead, a target allergen is selected based on prevalence, potency, and difficulty to clean, and the effectiveness of the cleaning validated against the target allergen(s). Validation must be completed in triplicate, and often involves a combination of in-house Rapid Tests and External Lab testing.

Verification: Once the initial validation has been conducted to demonstrate that the CICs are technically capable of removing all detectable traces of the target allergen(s), the cleaning needs to be periodically verified to demonstrate that it remains effective in practice. Verification is often conducted using Rapid Tests (Rapid Lateral Flow Devices or RFLDs).

Monitoring: In addition to routine monitoring, a quicker/cheaper method of monitoring the effectiveness of every allergen clean is often utilised, e.g. Protein Swabs (because all true allergens are proteins). ATP swabs are not recommended for allergen testing.

Pre-Validation of Test Methods: Lab Tests and Rapid Tests can be susceptible to “matrix interference”, where components in the food such as oil and spices can interfere with the tests. So product samples must be sent to the lab for “matrix checking” to ensure the target allergen(s) can be detected in your products.

Allergen Control Policy and Procedures

Once all the various risk assessments and allergen validation has been conducted, various policies, procedures and forms must be documented, issued, trained out and added to the internal audit schedule.
All of the risk assessment spreadsheets need to be document controlled and kept up-to-date.
Production schedules/plans should also include scheduled allergen cleans, and they need to be documented and archived so you have a record to demonstrate your “due diligence” with regard to allergen management.
Allergen management is such a complex and time-consuming process, and many technical teams don’t have sufficient knowledge or time to do the job properly. So bringing in an expert for a few months is becoming ever more necessary.