Developments in Allergen Thresholds: What it Means for Food Manufacturers and Consumers

Understanding allergen thresholds is essential for both food manufacturers and consumers with allergies or intolerances. An allergen threshold refers to the smallest amount of a food allergen that can cause an adverse reaction when consumed. However, for many of the 14 major allergens, no such thresholds exist today. This gap has led to the widespread use of precautionary allergen labelling (PAL) when there’s a possibility of cross-contamination during manufacturing, even when the allergen is not an ingredient in the product.

The importance of clear allergen labelling

According to current Food Standards Agency (FSA) UK guidelines, precautionary labelling should be used if a risk assessment determines a potential cross-contamination risk that cannot be managed. Unfortunately, research from the FSA has highlighted that the lack of clear thresholds and inconsistent labelling have led to confusion among consumers.

Real-world challenges faced by consumers

Our colleague Dr. Emma Ridley, General Manager of our Allergens Centre of Excellence in Hebden Bridge, has experienced this first-hand. Emma has a relative with gluten ataxia, a severe gluten intolerance that can affect motor control, and has noted how confusing current labelling can be. She recounts instances where products marked “Gluten-free” also included precautionary labels for gluten, creating uncertainty about the product's safety for those with gluten sensitivities.

The role of allergen management services in industry improvements

As a provider of allergen management services, including testing, regulatory compliance, and advisory support, we recognize the critical need to improve allergen labelling and provide clearer guidelines for manufacturers. One key solution would be the introduction of allergen thresholds that allow manufacturers to make better-informed decisions about whether PAL is necessary based on the actual risk of cross-contamination.

By establishing these thresholds, food producers can evaluate the presence of allergens by calculating the amount of allergen that may be present, and comparing with a reference dose to determine whether precautionary labelling is needed. These reference doses, ED01 and ED05, represent the amount of an allergen that would cause a reaction in 1% and 5% of the allergic population, respectively. During this assessment, the quantity of food consumed is also taken into consideration to determine whether the amount is above or below the reference dose. The adoption of these standard thresholds could significantly reduce consumer confusion.

Global efforts towards standardized allergen thresholds

On the global stage, progress is being made. Codex, an international food standards organization, has been working on a unified approach to precautionary allergen labelling, using expert consultation on allergen thresholds. Their draft proposal, which is still under review, recommends using action levels based on ED05 for labelling decisions. Meanwhile, the Allergen Bureau’s Voluntary Incidental Trace Allergen Labelling (VITAL^®) program has already implemented the ED05 reference dose in its recent update, VITAL 4.0, released in August 2024.

Supporting manufacturers with regulatory compliance

While a global standard and UK-specific guidance are still being discussed, progress is on the horizon. The UK Committee on Toxicity recently reviewed the Codex report on allergen thresholds and suggested that ED01 would offer greater protection to allergic individuals. However, reliable test methods must first be developed and validated before any final decisions are made.

As experts in allergen testing and regulatory advisory services, we are closely following these developments and are prepared to help manufacturers comply with future standards. By assisting with risk assessments, labelling compliance, and testing, we ensure that businesses stay ahead of regulatory changes while protecting consumer safety.

Looking ahead: Improving consumer confidence

As laboratories work to update testing methods to meet these new requirements, there is hope that more precise and standardized allergen labelling will soon be a reality. This will not only benefit food manufacturers by providing clear guidelines but also improve consumer confidence in the safety of the foods they buy.

Stay tuned as this important area of food safety continues to evolve. Our team remains committed to supporting businesses in navigating allergen thresholds and labelling requirements, ensuring compliance with both global and UK standards.

For further information, please contact:

Dr Emma Ridley
General Manager, Hebden Bridge
t: +44 (0) 151 350 6666