Meaningful allergen quantitative risk assessment
Food safety management systems place a lot of emphasis on managing allergen cross-contact (cross-contamination) that leads to unintended allergen presence (UAP). And rightfully so, as undeclared allergens are one of the primary culprits behind food product recalls internationally.
Most countries require that common allergens are declared when intentionally added to a product. On the other hand, most regulations (except for our own) do not specifically address the management and declaration of UAP using precautionary allergen labelling (PAL). Therefore, international stakeholders are now advocating for PAL to be applied to product labels, based on risk and using transparent and consistent decision-making criteria.
The historical approach to allergen risk assessment is simply to pass ‘potential’ allergen cross-contact information along the supply chain until it reaches the consumer in the form of a PAL. This approach is not sustainable. It is not considered adequate to state, for example, that an ingredient may be contaminated with a specific allergen, without establishing and appropriately communicating the expected levels of cross-contact.
It is a formal and systematic risk analysis approach to quantify risks and determine the action levels associated with UAP. In June 2022, ISLI Europe published an extensive practical guidance document on the application of food allergen quantitative risk assessment with the aim to assist the food industry.
What is the objective of an allergen QRA?
It establishes whether a contaminated product is likely to be a risk to allergic consumers. Therefore the risk assessment must be approached with purpose, and provide meaningful information.
ALLERGEN QUANTITATIVE RISK ASSESSMENT RESOURCES
- ILSI Europe Practical Guidance on the Application of Food Allergen Quantitative Risk Assessment within Food Operations – click here
- The Allergen Bureau’s VITAL® Risk Assessment Programme – click here
UAP in food products is normally due to allergen cross-contact that occurred at a single stage or at multiple stages in the supply chain, including agricultural practices, storage, transportation and production processes. When a UAP or cross-contact incident has occurred or is a known risk, but the risk to the allergic consumer is not immediately clear, the QRA helps you to determine what type of additional controls must be implemented, or which corrective actions need to be taken.
Types of allergen QRAs?
Depending on the quality of information available and the time available, a QRA can take two forms:
Proactive Assessment
A proactive QRA is done to understand the risk associated with cross-contact that may occur under normal conditions – for example, establishing whether UAP could occur in raw materials, or whether it could be introduced during the various stages of processing and manufacturing in a food production facility.
Additionally, you may also want to calculate the risks associated with atypical conditions – for example, ascertaining the risk should a raw material contain more than the usual amount of UAP, or if an atypical cross-contact incident had to occur during processing and manufacturing.
Reactive Assessment
A reactive QRA is done in response to an allergen cross-contact or UAP incident – for example, if new information comes to light indicating that a product (possibly already at market) contains undeclared allergens.
Gathering accurate, high-quality input information will determine the value of a QRA in both proactive and reactive scenarios. An allergen QRA is multifaceted, and in its simplest form (where possible and feasible) should consider the following:
Step 1: Exposure Assessment
The objective is to determine how much allergenic protein consumers will be exposed to or consume. The exposure amount is typically influenced by the following:
- the form of the cross-contact (e.g. homogenous, particulate, etc.) and its concentration;
- the amount of the specific product that consumers will eat on a single eating occasion (derived from reputable consumption data);
- the likelihood that the cross-contact incident will occur.
Step 2: Hazard Identification and Characterisation
The objective is to identify the following:
- how much allergenic protein sensitive individuals need to consume to elicit an adverse reaction, and
- how severe the reaction is likely to be.
Therefore, it is necessary to consider recognised allergen reference doses (RfDs).
Step 3: Risk Characterisation
The goal is to predict whether the allergic population is at risk of experiencing an adverse reaction. It compares the exposure dose (mg of protein from the allergenic source that will be consumed on a single eating occasion), established in step 1, to the RfD for the allergen of concern, established in step 2.
If the exposure dose is less than the RfD of interest, there is little to no predicted risk of an allergic reaction. However, if the exposure dose is equal to or more than the RfD of interest, there is an expected risk.
What do I do with the QRA output information?
The actions taken after a QRA will depend on whether it was a proactive or a reactive assessment.
In a proactive scenario, a QRA may:
- identify whether and where additional allergen controls need to be implemented.
- inform acceptable levels for cross-contact and raw materials, work in progress and final products.
- identify whether PAL for specific allergens is required – only when all possible allergen controls have been considered and implemented, and the risk remains.
In a reactive scenario, a QRA may:
- inform whether a recall or withdrawal is required.
- Identify whether and where additional allergen controls need to be implemented.
- indicate whether labels need to be amended to include a PAL.
Ultimately it is important to bear in mind that allergen QRA should be viewed as a supplementary tool that complements existing controls to identify and mitigate allergen cross-contact. It should not be employed in the absence of a robust allergen management plan, Good Manufacturing Practices (GMPs) and Prerequisite Programmes (PRPs).
FORM OF CROSS-CONTACT
- Amorphous homogenous: UAP does not have a discrete structure, and is uniformly distributed within the affected product.
- Amorphous heterogeneous: UAP does not have a discrete structure, but is isolated (clumped) in one or more regions of the affected product.
- Particulate homogenous: UAP has a discrete structure and is uniformly distributed within the affected product at a specific density per unit volume.
- Particulate heterogeneous: UAP has a discrete structure and is not uniformly distributed within the affected product.
SINGLE EATING OCCASION
Food allergic reactions generally develop within a very short time frame, and thus the intake amounts should reflect what is consumed on a single eating occasion. Exposure assessments should consider consumption data; they should not be based on recommended serving size, because it has been shown that the serving size is not representative of the actual amount eaten by individuals.
NORTH-WEST EUROPE CONSUMPTION DATA
Consumption datasets, designed specifically for allergen risk assessment and reporting, provide mean and P75 consumption values that consider maximum consumption on a single eating occasion. They are presented in a study by Birot, Madsen et al. (2018) https://doi.org/10.1016/j.fct.2018.05.042.
REFERENCE DOSES (RFDS) FOR ALLERGENS
Clinical threshold data is gathered from food-allergic individuals through low-dose food challenges, to establish recognised RfDs.
RfDs frequently used by the industry due to the volume and quality of data available are:
- The Allergen Bureau’s VITAL® 4.0 (2024) recommended RfDs (ED05).
- The joint FAO/WHO Expert Committee (2021) recommended RfDs (ED05).
ELICITING DOSEs (ED)
The concept of eliciting doses is explained as a predicted population eliciting dose (ED), where EDp refers to the dose of allergen that is predicted to produce a reaction in p% of the allergic population.
- ED01 doses can be defined as: mg of protein (from an allergenic food) below which only the most sensitive individuals (estimated at 1%) in the allergic population are likely to experience mild, transitory, non-fatal adverse reactions.
- ED05 doses can be defined as: mg of protein (from an allergenic food) below which only the most sensitive individuals (estimated at 5%) in the allergic population are likely to experience mild, transitory, non-fatal adverse reactions.
Available data from Patel, Adelman et al. 2021 indicates that these modelled ED values (ED01 and ED05) do not underpredict the proportion of reactions, and reactions experienced at these doses have not been shown to be severe.
A large amount of work has advanced the field of allergen risk assessment and risk management, to the point where practical, easy-to-use tools are available. But an alignment between governmental bodies and the food industry is required to facilitate the consistent application of allergen risk assessment and risk management.
Avoid a crisis response to allergen management – contact FACTS today to assist with a proactive QRA.
To view the full reference list of this article, please contact us.
Other articles, resources and videos you may be interested in:
Codex Expert panel recommendations on food allergen labelling
Allergen Bureau – Partners for best-practice allergen management