Confusion Surrounding Allergen Labeling

Some businesses have adopted their own levels of an allergenic food protein that they consider would constitute little or no hazard to sensitive individuals (also known as reference dose). Reference doses have then been extrapolated to derive the action levels, i.e. the concentrations of allergenic food protein within the actual product that could be considered as being safe to the sensitive consumer. A lot of work has been carried out to reach a consensus on action levels for allergens of common concern and this has been coordinated by the New Zealand and Australia Allergen Bureau that have developed what is known as Voluntary Incidental Trace Allergen Labeling system, also known as VITAL. This is a risk management tool used to determine the concentrations of a food allergen present in a food product that could trigger the adoption of precautionary labeling.

Precautionary Labeling

The first question in the use of appropriate precautionary labeling is whether such warning is actually needed. General guidance for the use of precautionary labeling was published in 2006 by the Foods Standards Agency in the U.K. in the form of a decision tree. This included a series of questions that aimed to identify the likelihood under normal operating conditions for cross-contamination of a specific food to occur with any of the allergens of concern along with the role of such allergen(s) in the product recipe and its regulatory status—is it exempt from the country’s mandatory labeling or not. According to the above decision tree, if a probable likelihood for cross-contamination to occur exists, and the allergen is not already included in the product label as an ingredient and is not exempt from the mandatory labeling regulations either, i.e. it needs to be labeled if present, then hazard characterization needs to follow and the question whether the risk of cross-contamination can be managed or not answered. If the risk cannot be managed despite optimizing Good Manufacturing Practices, then a warning label, or precautionary label, is required.

The use of allergen action levels in precautionary labeling was further discussed within a recently published guidance document from Campden BRI entitled Food Allergens: Practical Risk Analysis, Testing, and Action Levels. According to the guide, actions levels should not be used in cases where the food allergen of concern is part of the product recipe, i.e. it is intentionally added. Instead, labeling of that allergen should be covered by the applicable legislation. The action level approach is not applicable in cases where the food containing the allergen of concern is targeted for consumption by infants or people allergic to the specific allergen; infants are generally thought to have higher sensitivity to food allergens than adults and at the same time clinical research has used observations made in adults. Action levels cannot be used in products that are labeled as free-from a specific allergen either.

Why Important

Whilst existing legislation requires food known to cause significant food allergies, when intentionally used as part of the recipe, to be declared, currently there is no legislation coving the unintentional presence of allergens in a product as a result of cross-contamination. It is for this reason that precautionary labeling has been extensively adopted by industry.

However, an increase in precautionary labeling being used in an inconsistent manner across different food types has significantly impaired its intended impact as an important risk reduction warning and therefore guidance on its appropriate use is necessary. During the 2014 Global Food Safety Conference, SGS discussed its industry survey and confirmed that lack of communication and interpretation of available guidance on the use of action levels and the implementation of precautionary labeling was a top challenge across industry. It was concluded that inconsistency in allergen risk assessment, management, and control is not necessarily a result of a specific knowledge gap in recommended practices, existing laws, or regulations governing allergen labeling. Instead such inconsistency could be attributed to uncertainty in the interpretation of such laws and regulations that would in turn affect their effective implementation.