
The VITAL Program gives food businesses a risk-based methodology to manage allergen risk and assess unintended allergen presence due to cross contact to determine whether precautionary allergen labelling (PAL) is warranted.
A risk assessment, carried out following the VITAL principles and using tools such as VITAL® Online, helps food businesses thoroughly review the allergen status of all the ingredients and the processing conditions that contribute to the allergen status of the finished product.
VITAL Program Guides
We have developed a range of industry guides to support the implementation of the VITAL Program. These are free to access from our Allergen Resources section.
Where allergens come from
Allergenic foods may be present in a food through intentional inclusion as part of a recipe, or unintentionally due to cross contact. Cross contact can occur at any point in the food supply chain, from agricultural co-mingling of raw materials to the use of shared equipment and processes during manufacture.
Even under Good Manufacturing Practice (GMP), cross contact may be difficult to eliminate entirely, and some residual risk may remain. PAL is used to communicate this residual risk to consumers with food allergy or coeliac disease. It is not a substitute for effective allergen management.
What the VITAL® Program does
Using a quantitative methodology, the VITAL Program determines when a PAL statement is warranted. A statement is warranted only where the assessment shows the amount of unintended allergen presence is above the Action Level for that allergen. Action Levels are derived from Reference Doses aligned with those recommended by FAO/WHO and adopted by Codex.
The assessment covers:
- the likely sources of allergen cross contact from raw materials and the processing environment
- an evaluation of the amount of allergen protein that may be present, and a comparison with the Action Level for each allergen
- a review of the ability to eliminate cross contact from all contributing sources, or reduce it to the lowest practicable level
- ongoing monitoring and verification of the risk assessment process, so any changes to the level of risk are acted upon without delay
The VITAL® program outcome
The risk assessment produces a labelling outcome. It summarises the allergenic foods present due to intentional inclusion as part of a recipe. It also identifies which allergens present due to cross contact should be included on the label, in the form of the precautionary statement ‘May be present: allergen x, allergen y.’
This single, standardised statement is consistent with the Codex guidelines on PAL, and is applied where PAL is legally permitted in the country of sale.
Explore the VITAL® Program
VITAL® Science
The Reference Doses, Action Levels and expert review behind the labelling outcomes.
VITAL® and the Consumer
Why the program is needed, how it works, and what it means for consumers with food allergy.
VITAL® History
How the program has developed since 2005, from the first version to VITAL® Program 4.0.
VITAL® Standard
The supplementary certification program for food manufacturers.
VITAL®Training
Training from Allergen Bureau-endorsed providers.
VITAL® Resources
We have a range of guides to support inductry to implement the VITAL Program.
Put VITAL® into practice with VITAL® Online
VITAL® Online is the user-friendly, web-based VITAL Calculator. Store the allergen status of ingredients and processing profiles for use in multiple recipes, record the assumptions in your VITAL risk assessment, and create an Action Level report using the interactive VITAL Action Level Grid.
