Allergen Recalls Remain a Problem for Food Producers. Here’s How to Help Mitigate Risk.

Editor’s note: This article was written by Don Milne, director of U.S. certification operations, FoodChain ID.

© FoodChain ID

Allergen management programs are integral to commercial food production. These programs are intended to protect the 33 million Americans living with food allergies from exposure to allergens that could trigger harmful — and sometimes life-threatening — immune responses.

Despite the severe consequences of failing to control allergens, recalls caused by undeclared allergens unfortunately still occur. In 2022, Ingredient Risk Identification by HorizonScan reported 213 recall alerts for undeclared allergens in the United States. Not only do undisclosed allergens jeopardize the safety of consumers, but they can have dire consequences for brand reputation as a consequence of the resulting lawsuits, negative publicity and loss of consumer trust.

With sesame recently introduced this year as the ninth major allergen under The Food Allergy Safety, Treatment, Education & Research (FASTER) Act, more challenges for food producers may lie ahead. Many believe that this expansion of the FASTER Act may increase scrutiny from regulators to ensure preventive controls are in place. Considering this evolving legislative environment, proactively preventing allergen recalls by improving current allergen management programs is a hot topic for many food safety professionals.

KEY CHALLENGES IN ALLERGEN MANAGEMENT. Any systematic gaps in allergen controls could allow an error to occur. Some of the most common issues that lead to allergen recalls include difficulty tracking allergen risks with new products or formulation changes, labeling mistakes, ineffective verification procedures and poor organizational culture surrounding allergens.

When new ingredients are introduced to a product, allergen risk profiles can change. When this change occurs without adequate cross-functional visibility across innovation and QA teams, allergen risk assessments may not be properly conducted. A lack of oversight is also problematic for labeling, which is one of the main sources of allergen recalls. Weak controls around label design, inventory, storage and version control may allow potentially serious errors to occur. Even in instances where strong allergen management programs exist on paper, verification procedures to test those controls could have weaknesses in practice. Typical audits and checks may not be as thorough as required to adequately challenge the system and uncover issues with cross-contact, identification and declaration procedures.

Many errors that result in recalls can be remediated by improving institutional knowledge around compliance requirements. Training should be comprehensive to prevent knowledge gaps that negatively impact a team’s ability to make sound judgements when process failures are exposed. Happily, food producers can address critical allergen risk challenges with the right expertise, proactive planning and institutional knowledge enrichment.

HOW TO MITIGATE RECALL RISK. At its most basic, mitigating recall risk involves implementing adequate procedures and preventive controls to protect consumers living with allergies. This requires building an organizational culture focused on allergen control at every stage of the product development pipeline and within the production environment, one in which cross-functional visibility on compliance risks is enshrined in the innovation process to champion accountability at all times. Allergen control programs should always be unique to the specific product and process within each food production facility and formulated based on the level of risk substantiated by the food safety plan (HACCP plan) as well as the broader food safety system.

Improving education across functions is critical to successful control programs as allergen decisions inevitably cross departments. Marketing, R&D, production and other teams must understand allergens and how proposed changes to products and processes could increase risk. Data and software solutions can support food producers to enhance cross-functional visibility around allergen controls earlier in the process. Instead of allowing product development to proceed with possible undetected errors, front-loading allergen compliance means that procedures like screening and validation are in place early enough to address any issues promptly.

Identifying issues at the concept stage allows developers to reformulate long before non-compliant products reach production. Software tools that screen recipes and labels against known allergen data also facilitate continuous checks, which can identify areas vulnerable to process failures before they occur. Intelligent compliance software establishes a proactive approach to mitigating allergen risk and reducing common causes of recalls such as improper allergen labelling or ingredient usage.