Allergen risk calculation (VITAL)
A risk assessment of cross-contamination with allergens is carried out to determine whether a warning about possible cross-contamination is necessary or not. Such a warning is called Precautionary Allergen Labeling (PAL). With a quantitative risk assessment (Quantitative Risk Assessment or QRA for short), these risks are calculated and compared with safe limits. If the safe limit is exceeded, a PAL is used (e.g. "may contain xx"), but not below that.
Allergen risk assessments are increasingly applied internationally and is a legal obligation as of January 1, 2026 The Netherlands.
What is a VITAL calculation?
VITAL, from the Australian Allergen Bureau, is an example of a quantitative risk assessment. A quantitative risk assessment compares the total amount of allergenic protein that could be present in a product due to cross-contamination with a safe limit. Above this limit, cross-contamination with the allergen poses a risk of serious allergic reactions. A warning (PAL) is used on the label only if a risk exists.
QRA calculation and calculation tools
A QRA calculates what the maximum concentration of an allergen in the product can be if contamination occurs. This concentration can then be tested against the safe concentration, also known as the action limit. If the concentration remains below the action limit, no warning on the label is necessary. Above that, there is a risk for allergic consumers and a warning will have to be placed. The safe limits (see below) are scientifically substantiated.
Cross-contact can occur both in the own production process and at the supplier of the ingredients (? in the allergen list of a raw material specification). Both contamination routes must be calculated and then added together.
Our experience shows that a structured calculation tool significantly reduces the risk of calculation errors. There are several calculation tools in use, but only a few validated tools are available:
1. Allergen Risk Calculator (Excel) from Allergenen Consultancy
This calculation tool was developed by Allergenen Consultancy. This is provided for on-site advice and at the QRA/VITAL training and can then be used free of charge for six months. This Calculator can be used to carry out a risk assessment of cross-contamination for all fourteen legal allergens. With this tool cross-contamination from raw materials and from your own process can be calculated. Both point contamination and homogeneous contamination can be calculated.
The calculated cross-contamination is compared with different sets of safe limits, namely those of The Netherlands (VWS), Belgium (FAVV) values, VITAL 4.1 (ED05) and FAO/WHO. For companies that have already received the Calculator through previous training or advice, it is possible to obtain one for a small annual fee update service to close. A new license will then be automatically sent every year, as well as new versions of this calculation tool.
2. VITAL Online from the Allergen Bureau
VITAL Online is an online tool of the Allergen Bureau. A monthly or annual subscription can be taken out to use this tool. When using this tool, it is important to know that there are some differences compared to Dutch and Belgian policy. These differences are:
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- Sulfite is not included in the tool.
- Point contamination cannot be calculated. This will have to be done manually.
- The Dutch and Belgian reference doses differ for a few allergens VITAL (mustard, lupine and soy).
Approach to allergen risk calculation
A QRA / VITAL The calculation starts with collecting data: allergen protein levels in products, recipes, residual product in equipment, etc. Based on this, a calculation can be made. Download our free allergens template to request the information from suppliers.
A calculation tool, such as the Allergen Risk Calculator, can then be used to calculate whether action levels have been exceeded and whether a warning on the packaging is required.
Analyses are, however, not the starting point of a quantitative risk calculation, but are often used in a validation of a cleaning or for substantiation/proof that cross-contamination actually occurs.
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Download step-by-step plan for allergen risk calculation |
Safe limits (reference dose)
The basis of an allergen risk assessment is scientifically proven reference doses. A reference dose is the safe amount of protein from an allergen for consumers with that allergy. Mild reactions may occur in a minority of consumers, but the risk of severe reactions is negligible.
By the Dutch government reference doses determined on the basis of the advice of FAO/WHO (ED05). The ED05 choice is considered the optimal balance between safety and avoiding unnecessary restriction of food choices due to excessive use of a PAL. No countries have prescribed the ED01.
Most countries in Europe that have established safe limits for allergens also use the ED05 values, but there are differences.
Consumption size
A quantitative risk assessment can be used to calculate action limits in a product. This requires determining an appropriate consumption size for each product (group). This is generally not the serving size of the product. The Guidelines document and the Allergen Risk Calculator explain how to determine an appropriate consumption size.
Need training or advice?
Allergenen Consultancy is an official training partner of Allergen Bureau and even the first in Europe! Based on our years of experience, we can assist you in applying threshold values and calculating cross-contamination risks. With the risk calculation training for cross-contamination allergens (VITAL) you'll practice applying and calculating threshold values and work independently. The training is offered in various formats: classroom, web-based, or in-company. It's also possible to take this training in English. We can also create a QRA. We'll then go through all the steps of the QRA using your company data and complete the calculation tool together.