Strengthening Food Safety: The Role of Allergen Testing in Safe Food Production
December 27, 2024

In the food industry, improving product safety is a vital step, especially as food allergies become increasingly common worldwide. Approximately 33 million people in the United States have at least one food allergy (FARE, 2023). Accidental allergen contamination in food manufacturing, whether from cross-contact or mislabeling, can pose significant risks to consumers' health. To safeguard consumers and meet regulatory standards, allergen testing has become essential. By accurately detecting and quantifying allergens in food products, manufacturers can uphold safety standards, maintain regulatory compliance, and reinforce consumer trust in their products.
Source: Food and Drug Administration
Why test for food allergens?
Testing helps protect the public
Food manufacturers can help protect those with food allergies by clearly labeling their products with a list of ingredients. Food allergen testing, along with a robust allergen control program, can help food manufacturers confirm that an unlabeled, potentially dangerous ingredient did not make its way into a food product.
Testing helps protect a company’s reputation
Testing helps provide assurance that allergens present in a facility are being controlled and are compliant with a company’s food safety plan. Testing clean-in-place (CIP) solutions, final product, and equipment after cleaning is finished, can identify sources of cross-contact, and helps verify cleanliness before the changeover. Testing can help protect against staggering costs and damaged reputation associated with a recall of mislabeled product.
Testing can simplify product labels
Testing can assist with precautionary advisory labeling. This is a common, voluntary warning to consumers added after the ingredient list. Its goal is to indicate a product not intended to contain a specific allergen may sporadically contain that allergen due to unintentional and unavoidable cross-contact. For example, some companies put a precautionary statement such as, “may contain peanut and peanut products” on the ingredient label, even though there may be a small chance the product contains any peanut. If testing is done, in conjunction with a thorough risk evaluation, companies may be able to minimize the use of precautionary labels.
Testing helps improve efficiencies
For manufactures that use specific cleaning products to clean equipment between productions, testing can help determine how much cleaning solution is necessary to achieve the removal of food allergens. Allergen testing can help eliminate guesswork and save the final product from going to waste or from having to be reworked.
Testing can help ensure compliance with regulatory standards
Regulatory bodies have set strict guidelines for allergen labeling to help protect individuals with food allergies. These regulations mandate that food manufacturers clearly list common allergens on product labels, allowing consumers to make informed choices and avoid potentially life-threatening allergic reactions.
- FDA: In the United States, allergen labeling is governed by the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. This law mandates that food manufacturers clearly identify the nine major allergens on product labels. The FDA also requires that manufacturers take steps to prevent cross-contact between allergens and other food products during processing. Any allergen present in a product, even in trace amounts, must be listed on the label. In addition, the FDA oversees the enforcement of allergen control in food facilities to ensure compliance with these regulations.
- CFIA: The Canadian Food Inspection Agency (CFIA) enforces allergen labeling requirements in Canada. Under the Food Allergen Labelling Regulations, Canada follows similar guidelines to the U.S. in terms of identifying the nine major allergens, along with mustard, celery, and sulfites. These allergens must be clearly stated on food packaging. Furthermore, manufacturers are required to ensure proper labeling of ingredients that could be cross contaminated with allergens during production. The CFIA also oversees inspections and enforces regulations that require food businesses to implement allergen control plans to prevent contamination.
Types of Allergen Testing Methods
Qualitative Allergen Testing – Lateral Flow Tests
Lateral flow tests typically rely on immunoassay technology, where antibodies on the test strip bind to the target allergenic proteins. When a sample is applied, if the allergen is present, it will react with the antibodies, leading to a visual indication often in the form of a colored line on the strip. The tests provide a yes/no answer about whether the present at or above a certain threshold.
Lateral flow test benefits:
- Are commonly used during spot checks and routine monitoring on the product floor to help verify allergen presence or absence
- Operators can efficiently check surfaces or rinses after cleaning to help ensure they are free of specific allergens before resuming production
- Useful in facilities where cross-contact needs to be monitored closely but exact allergy quantification isn’t as critical
Quantitative Allergen Testing – ELISA Tests
ELISA (Enzyme Linked ImmunoSorbent Assay) testing is a method used to measure the concentration of specific allergenic protein present in testing samples. This is achieved by using antibodies that bind to the target allergen; the intensity of the color change produced during the assay correlates to the allergen concentration in the sample.
ELISA test benefits:
- Ideal for applications where quantified measurements are critical to validate the cleanliness of equipment or production lines
- Commonly used in final product testing to help verify allergen-free claims
- Often performed in a centralized, quality control lab setting, as they require more setup and technical skill to allow for more accurate quantitative testing
To get all your allergen testing questions answered, reach out to a Neogen representative.
Establishing a Robust Allergen Testing Process
Setting up allergen testing procedures in a manufacturing environment requires a systematic approach to help safeguard food safety, regulatory compliance, and protection against allergen contamination. Here are some key steps for establishing allergen testing procedures:
- Conduct a Risk Assessment: Evaluate potential allergen risk and identify critical control points (CCPs) in the production process where allergens could be introduced or cross-contaminated.
- Define Critical Control Points (CCPs): Identify and define key stages, such as raw material receiving, production, and packaging, where allergen testing should occur to help prevent
- Select Testing Methods: Choose appropriate allergen testing methods, such as ELISA or lateral flow, based on the target allergens and testing needs.
- Develop Sampling Protocols: Establish guidelines for sample collection and testing frequency, focusing on high-risk areas and maintaining consistency throughout the production process.
- Train Staff: Provide comprehensive training on allergen control, testing procedures, and the correct use of equipment, ensuring all personnel are knowledgeable and equipped to manage allergen risks.
- Implement Cleaning Protocols: Establish preventive cleaning procedures and verify their effectiveness with post-cleaning allergen testing to help ensure contamination is minimized.
- Set Up Documentation Systems: Maintain thorough records of allergen test results, cleaning logs, and corrective actions to support traceability and compliance with regulations.
- Create Corrective Action Plans: Define clear steps for responding to allergen contamination, such as product recalls or reworking batches, and ensure staff can implement these plans effectively.
- Monitor and Review: Regularly audit the allergen testing program to make sure it is functioning correctly, identifying areas for improvement and ensuring compliance with the latest standards.
Conclusion
Allergen testing is a crucial component of food safety in today’s industry, protecting both consumers and manufacturers. With the prevalence of food allergies rising, precise testing for allergens helps confirm products meet regulatory standards and help prevent cross-contact contamination. Methods such as ELISA and lateral flow offer reliable detection, giving manufacturers the tools to make informed decisions and reduce the risks associated with allergen exposure. A robust allergen testing program, combined with regular staff training and compliance with regulatory standards, reinforces consumer trust and demonstrates a company's commitment to safety.
Ready to take your allergen testing to the next level? Learn more about our full portfolio of allergen testing solutions today!
Resources
- Neogen Food Allergen Handbook
- Neogen Food Allergen Validation and Verification
- Food Allergy Research & Education - https://www.foodallergy.org/resources/what-food-allergy
- FARRP - www.farrp.org , https://farrp.unl.edu/3fcc9e7c-9430-4988-99a0-96248e5a28f7.pdf
- FDA - https://www.fda.gov/food/hfp-constituent-updates/fda-issues-guidances-food-allergen-labeling-requirements.
- Canadian Food Inspection Agency (CFIA) - https://inspection.canada.ca/en/food-labels
- FARE - https://www.foodallergy.org/sites/default/files/2024-07/FARE%20Food%20Allergy%20Facts%20and%20Statistics_April2024.pdf
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