Developing an Effective Allergen Management Program for SQF Compliance

Allergens pose a significant health issue in the United States, accounting for one-third of all product recalls. The primary reason for these recalls is incorrect labeling, which includes instances of products having the wrong labels or containing different items than ...

Allergen management program

Allergens pose a significant health issue in the United States, accounting for one-third of all product recalls. The primary reason for these recalls is incorrect labeling, which includes instances of products having the wrong labels or containing different items than what is indicated. As a result, it is essential to implement an effective Allergen Management Program to minimize the risk of cross-contamination.

This article outlines the necessary steps to establish an Allergen Management Program that complies with these mandatory requirements. The focus is on preventing allergen contamination and ensuring product safety.

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The SQF Code requires that companies develop and implement an Allergen Management program that outlines the responsibilities and methods for allergen control at the sites. The program must include:

  • A risk assessment of ingredients, processing aids, lubricants that contain food allergens.
  • An assessment of allergens that can be introduced into the facility through lunches, vending machines and personal items.
  • A list of allergens of the country where the product is being manufactured and the country where the product is going to be distributed.
  • The inclusion of allergens in the hazard analysis of the Food Safety Plan.
  • Management plan of identified allergens.

A thorough allergen verification procedure should be integrated into the entire labeling process, starting from its design phase through its application in the packaging stage.

The Allergen Management Program involves several stages of the process:

  • Receiving of ingredients and labels.
  • Storage of ingredients and labels.
  • Processing of products.
  • Labeling of products.
  • Storage of finished goods.

Segregation is an important requirement to avoid cross-contact. Ideally, allergens should be processed in a dedicated line. However, in practicality, this might not always be the case.

If allergens are processed in the same line as non-allergens or allergens of different kind, a thorough sanitation process of the processes equipment and lines must be conducted followed by a verification of allergen removal. Cleaning protocols must be validated for effectiveness to remove allergen from processing equipment.

In addition, traceability must be implemented to allergen materials and finished goods, If allergens are reworked back into production, it is essential to ensure they are correctly identified and traceable within the system.

When processing allergens, it is necessary to establish and execute written change over protocols. These protocols should encompass a comprehensive line clearance, entailing the removal of all materials involved in the production of the product containing the allergen.

Finally, if a site does not process allergens, the program must be written and implemented to prevent the cross-contact risk of allergens introduced unintentionally through materials, contracted manufacturing, site personnel and visitors.

This article underscores the crucial role of a comprehensive Allergen Management Program mitigating the significant health risk posed by allergens in the USA., a major cause of product recalls. Adhering to the SQF Code, the program spans various stages from ingredient handling to final product storage, emphasizing risk assessments, strict segregation, effective sanitation, and robust traceability to prevent cross-contact. This multifaceted approach is vital not only to regulatory compliance but also for maintaining consumer confidence in food safety.


Allergen management training should be conducted annually to ensure all employees are updated on the latest practices and regulatory requirements. Refresher sessions are advised whenever there are changes in production processes or the introduction of new allergens.
Best practices include regular audits of label design and printing processes, use of barcode systems to verify correct labels, and rigorous checks during packaging to ensure that every product is correctly labeled according to its content.
Improving traceability can be achieved by implementing advanced tracking systems that monitor ingredients from receipt through processing to final distribution. Employing digital tools to record and trace batch numbers and production dates ensures greater accuracy.
Strategies include dedicated production lines for allergen-containing products, rigorous cleaning and sanitation protocols between batches, and physical barriers to separate allergen and non-allergen processing areas. Scheduling production runs of allergenic foods at the end of the production cycle can also reduce risk.
Yes, testing finished products for allergens is crucial, especially when there is potential for cross-contact. Validated testing methods, like ELISA or PCR tests, should be used regularly to ensure that allergen levels are below regulatory thresholds and safe for consumption.

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Radojka Barycki

Radojka Barycki is an Award-Winning Quality Assurance, Food Safety, Training and Consulting Professional with 24+ years’ experience with demonstrated success in the development, implementation, and improvement of Quality and Food Safety Management Systems (SQF, BRCGS, FSSC2200)
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