Allergen test results: What the numbers mean for food safety
How much is too much?
An allergen test result is not a conclusion, it is a conversation. And as with any important conversation, you need to know how to listen, interpret and respond. That exchange begins with key questions:
- What is the purpose of the analysis?
- What is being measured, and in what units?
- How does the sample relate to the final product?
Every microgram has weight, and every assumption carries risk. Misunderstanding these details can lead to misinformed decisions; and ultimately, misjudged food-safety risk. It is time to move past guesswork, and become fluent in the language of data-driven allergen-risk assessment.
Responsible risk review and management
Why micrograms matter
Even small amounts – just a few milligrams – of protein from an allergen can trigger a mild to life-threatening reaction in sensitive individuals.
That is why manufacturers need to assess the risk of cross-contact allergens. If there is significant risk of cross-contact being present at levels that pose a risk to allergic consumers, precautionary allergen labelling (PAL) such as ‘may contain’ should be used to warn consumers.
Traditionally, potential allergen cross-contact information is simply passed along the supply chain until it reaches the consumer in the form of a PAL. However, using PAL as a blanket warning without a proper risk assessment limits allergic consumers’ choices, fuels label fatigue, and goes against the Regulations Relating to the Labelling and Advertising of Foodstuffs (R. 146/2010).
Globally, the industry is shifting away from a zero-tolerance approach towards a more harmonised, risk-based strategy for applying PAL.
Quantitative allergen information becomes particularly important when:
- Deciding whether PAL is necessary
- Validating key allergen controls
- Investigating cross-contact incidents or customer complaints
- Making product recall decisions
Whether in a proactive or reactive scenario, the goal of a quantitative risk assessment (QRA) is the same: estimating consumer exposure to the allergen, and assessing whether it poses a risk.
Responsible risk assessment
Tools for a smarter conversation
With the right tools, anyone can confidently engage in this conversation. There are multiple practical, user-friendly tools and guidelines available to help businesses make data-driven decisions (e.g. VITAL® and ILSI Europe Practical Guidance on the Application of Food Allergen Quantitative Risk Assessment within Food Operations). Even a basic QRA approach, grounded in sound inputs, can improve allergen risk management.
Unlike microorganisms, heavy metals or pesticides, allergens do not have defined limits (with the exception of gluten). Instead, we use reference doses, reference amounts and action levels to make informed decisions.
Reference Doses (RfDs): thresholds (in mg protein from the allergen) derived from low-dose oral challenge studies. Below these, only a small percentage, normally 5%, of allergic individuals are estimated to react, and usually mildly.
Reference Amounts (RAs): realistic estimates of how much of a product someone is likely to eat in one sitting.
Action Levels (ALs): allergen protein concentrations that serve as cutoffs, meaning concentrations above which PAL is warranted, based on a defined level of consumer protection. Action levels are calculated using reference dose and reference amount information.
Cross-contact Concentration (CC): the measured or calculated concentration of allergen protein cross-contact in a foodstuff.
Calculating the risk
Once the action level has been calculated, a simple risk factor (RF) can be determined by dividing the allergen cross-contact concentration (CC) by the action level.
A risk factor above 1 means exposure exceeds the RfD, indicating significant consumer risk and that PAL or further action is required. A risk factor below 1 suggests low consumer risk, often supporting the decision to omit PAL.
- The physical form of the allergen (e.g. particulate vs dispersed)
- The sample matrix and its effect on detection
- Actual concentration in the affected product
- Method suitability
- Sampling approach
Responsible risk communication
From doubt to data-driven decisions
Today’s allergen management is about more than just controlling cross-contact. It is about having a confident, evidence-based conversation that leads to informed, consistent decisions that protect allergic consumers without over-relying on PAL.
Once the conversation has led to a clear understanding of risk, and it is effectively managed, that message must be responsibly communicated to the consumer in line with R. 146. This means avoiding unsubstantiated PAL, ensuring the risk assessment process is well documented, and maintaining consistent, transparent messaging across all products and markets.
In allergen-risk management, silence is not safety. Speak up and join the conversation!
This article was originally written for and published in the November issue of the FST magazine, accessible here.