Allergen Labeling Compliance – Challenges and Solutions

Navigating the world of food allergens and labeling compliance can be challenging for any food manufacturer. Still, the accuracy of allergen labeling and the effectiveness of allergen controls are critical food safety issues. An estimated 33 million Americans have food allergies, including approximately 8 percent of children and 10 percent of adults, according to the National Institutes for Health (NIH)^[1]. While individuals afflicted with food allergies rely on the accuracy of allergen labeling on prepackaged food and beverages, the proliferation of precautionary statements such as “may contain” can be confusing.

A failure to properly declare food allergens on the labels of prepackaged food and beverage products has become a leading reason for food recalls in North America. In the United States, more than 1,100 recall alerts were attributed to allergens in the previous five years, according to Safety HUD data. For the year to date, approximately 50% of all U.S. FDA food recall events have been attributed to the Big Nine allergens. Beyond recalls, the annual total of FDA facility inspections is increasing, and the FDA has issued an average of 175 warning letters annually in recent years due to violations involving food^[2]. 

Compliance with the FDA rules for food allergens requires adherence to several mandates, including allergen labeling, good manufacturing practices, and preventive controls. Since enforcement of the allergen labeling rules for sesame began in January 2023, many food manufacturers have grappled with the challenge of preventing cross-contamination to comply with FDA regulations^[2]. 

Just Label It?

In recent warning letters, the FDA emphasized that allergens, even at “insignificant levels,” must be declared if they have a functional or technical effect on the finished product. In recent cases, the FDA concluded that some allergens provide technical functions, and in effect, these would not meet the definition of a processing aid^[2].

Sesame is a common food ingredient. Ensuring the absence of sesame from food processing facilities and products is difficult for many reasons. The small size of sesame seeds and the prevalence of sesame in various foods present a high risk for cross-contamination within food facilities. The challenge of preventing sesame cross-contamination has led some manufacturers to add sesame to products intentionally and then label products with a precautionary statement to declare their presence. 

The FDA considers precautionary labeling statements such as “may contain [allergen]” insufficient for protecting individuals with food allergies^[2]. 

The FDA’s current guidance for food allergen labeling states that labeling statements such as “may contain [allergen]” cannot replace current good manufacturing practices or implementing preventive measures for food allergens. Manufacturers must comply with applicable requirements to prevent allergen cross-contamination, including segregating allergen materials in storage, properly cleaning shared equipment, effective sanitation practices, use of dedicated equipment, production scheduling, and proper rework practices^[2].   

Beyond labeling compliance, food manufacturers must evaluate their food safety plans related to allergen controls, including employee training and sanitation controls. Under the Food Safety Modernization Act (FSMA), companies must consider allergens as potential hazards regarding preventive controls and a company’s food safety plan. In alignment with FSMA, the FDA implemented preventive controls and hazard analysis regulations, which mandated the control of all hazards, including food allergens. In September 2023, the FDA released guidance for developing and implementing a food allergen program, which will support industry compliance with the requirements of the FSMA preventive controls^[2].  

360° Solutions for Allergens 

Mérieux NutriSciences offers a full 360° Solutions Allergen Program for manufacturers and suppliers.  Our complete solutions approach offers a range of services, including allergen testing, consulting, auditing, training, labeling services, and digital tools for regulatory compliance.   

Our global labeling experts deeply understand food labeling regulations and know the potential repercussions of a mislabeled product. We understand how mislabeled products can impact a brand through a recall, brand reputation, and risks to public health.

To support regulatory compliance, we have offer comprehensive online resources, including:

• Safety HUD – a tool for efficiently monitoring food safety and fraud alerts worldwide.

• Regulatory Update - an efficient international regulatory watch covering 76 markets.
  
  
• Limit Detector – a database containing the legal limits of a substance and/or product in a specific country.