Strategies for Managing Complex Food Allergen Risks

This article first appeared in Sedgwick's Recall Index 2024 Edition 2.

Quantitative risk assessments, fail-safe technologies, and workforce training can help prevent the unintended presence of allergens

It has been nearly 20 years since Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). This law identifies major food allergens and requires that packaged foods and beverages be specifically labeled with the name of the allergen source. The current list includes milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Enforcement of sesame as an allergen began in January 2023 after the passage of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act in 2021. 

While the U.S. does not consider gluten a major allergen, FALCPA authorized the Food and Drug Administration to develop guidelines for labeling items as "gluten-free" to support individuals with gluten sensitivities. 

Marketing food without identifying potential allergens is hazardous for at-risk consumers. Mislabeled food products are deemed adulterated under the law and are subject to product recalls. Unfortunately, the food system fundamentally struggles with accuracy in allergen declarations — both on packaging to the final consumer and with restaurants and caterers. There are also challenges within the supply chain to downstream manufacturing customers. 

Undeclared allergens are a prevalent risk

From September 2009 to September 2022, about forty percent of notifications submitted to FDA through the Reportable Food Registry (RFR) as serious health risks involved undeclared allergens. Food allergen recalls also continue to be a predominant feature in the U.S. food system — with 445 undeclared allergen-related food recalls in the U.S. between Q1 2020 and Q2 2024.

According to a recent research study, 52% of allergen-related food recalls between 2013 and 2019 were classified as Class I recalls, indicating a high likelihood for serious adverse health consequences or death. These recall figures underestimate the true scale of food allergen declaration failures because supply chain errors can be caught in routine quality checks prior to placing the final packaged product in market. 

By following a consistent approach to gathering allergen information from their suppliers and delivering it to their customers, companies can help minimize confusion, avoid mistakes, and optimize efficiencies in information transfer and risk mitigation.

This critical safety issue creates significant disruption across the food and beverage sector and continues to put consumers at risk. Research shows that most undeclared allergen recalls are the result of labeling-related errors, including the wrong label, the wrong packaging, improper terminology, or no carry-through, which is when allergens from ingredients are not included on finished product labels. 

Challenges for producers 

Many food operations have a significant number of product changeovers per day. Some manufacturers change hundreds of times in a single day. This complexity will stretch even the best quality system unless deliberate fail-safe mechanisms are put in place to protect foods from cross-contact allergen risks.

Longer, more diverse supply chains can present challenges in allergen awareness because the mandatory lists of allergens differ across geographic regions and regulatory regimes. Supply chains are increasingly being disrupted due to geopolitical barriers and adverse climate event impacts. This requires rapid shifts in sourcing and supplier bases. Composition information on raw materials and recipes often falls behind actual live production. 

The food sector is made up of thousands of small and medium-sized operations. This structure affects the challenges around accurate allergen declaration. Underinvestment in both staff training and technology to support fail-safe systems can lead to inaccurate allergen declarations and mismatches in food product and packaging.

Allergen failures should be defined as "never occurring" events because they are wholly preventable. Guidance and best practice safety recommendations are readily available. Systematic fail-safe approaches like those used by other industries could be applied to manage this aspect of food risk management more effectively.

A global concern

Improvement and harmonization of allergen risk communication is a major topic of discussion for the Codex Alimentarius, a joint program of the World Health Organization and the United Nations' Food and Agriculture Organization (FAO). The WHO/FAO Codex is a collection of internationally recognized standards, codes of practice, and guidelines. 

The Codex Alimentarius' Code of Practice on Food Allergen Management for Food Business Operators (CXC 80-2020) was referenced in the EU's 2022/C 355/01 Commission Notice on the implementation of food safety management systems. The notice covered Good Hygiene Practices and procedures based on the Hazard Analysis and Critical Control Points (HACCP) principles and included the importance of lowering allergen risks.

Continuing this global initiative around food allergens, a WHO/FAO Ad Hoc Expert Working Group on food allergens was commissioned to debate and develop principles to identify allergens of public health importance. It was also tasked with establishing quantitative threshold doses for unintentional allergen cross-contact that require precautionary advisory labeling. Its published recommendations offer opportunities for harmonizing allergen risk communication across EU Member States so that there is a more consistent approach and the information is quantitatively pertinent to the risk presented to a consumer. 

The Codex Committee on Food Labeling (CCFL) is now taking these recommendations into account. CCFL is finalizing revisions to its General Standard for the Labeling of Pre-packaged Foods (CXS 1-1985) with provisions relevant to allergen labeling. It is also producing guidelines on the use of precautionary allergen labeling. Both were on the agenda for discussion at the 48th CCFL Session this past October. 

The new Codex review activity is likely to result in some changes to national mandatory allergen labeling lists in coming years. In addition, the CCFL revision will remove soya from their Codex standard as an allergenic food requiring mandatory labeling. This does not mean that all national governments will follow suit. Misinterpretation of global Codex activity versus national market requirements could cause confusion and mislabeling, resulting in product recalls.

Such high-profile global activity on food allergens is likely to result in greater attention being given to allergen risk management by food system stakeholders, including the regulators. National lists of which allergens require mandatory labeling differ among nations since they reflect local population allergy prevalence patterns. As an example, the FALCPA list of tree nuts is longer than the allergen labeling lists for many other nations.

No shortcuts 

Labeling is not a substitute for adherence to good manufacturing practices (GMPs). Food producers must still implement hazard analysis and preventive controls in the handling, processing, packing, and storage activities in their facilities. Allergen cross-contact should be addressed through risk assessment pertinent to the intended raw materials and recipe composition status, GMPs, and preventive controls.

The addition of allergen declarations such as "may contain" to labels when the allergen is not intentionally added is misleading. It has prompted direct regulatory actions in some markets to remove products from further sale until labels are corrected. Recent FDA warning letters regarding approaches to allergen declarations reinforce this position and demand action be taken to correct the allergen labeling on packaging.

What producers can do 

U.S. regulatory inspections and customer audits are likely to continue to focus on the use of precautionary allergen labeling only following quantitative risk assessment and removal of misleading or incorrect allergen labeling. Opportunities for new allergen labeling exemptions are also increasing. There are proposals that apply quantitative allergen risk assessment. 

Food business operators and supporting service industries, such as hygiene and cleaning services and labeling and systems information technology advisors, can undertake a full multi-level, in-depth review of their understanding and organizational competence with respect to allergen risk management. Implementing an approach of "never occurring" events and investing in fail-safe technologies will support compliance. However, it is still important to have human oversight. Technology can never fully compensate for a well-trained and aware workforce who care about food allergen risk management. 

Food allergies are not going away. The management of this critical food safety element is going to become more complex as lists of allergens requiring mandatory labeling and lists of exemptions to labeling lengthen and diversify across various global markets. 

Food businesses can better educate their supply chains about specific individual market needs. By following a consistent approach to gathering allergen information from their suppliers and delivering it to their customers, companies can help minimize confusion, avoid mistakes, and optimize efficiencies in information transfer and risk mitigation.