Allergen Bureau: How Do I Calculate Action Limits?

1. Intentionally added allergens must be declared on the product label (e.g. in the ingredient list).
2. Where cross-contact allergens cannot be eliminated, packaged products should be labelled according to the determined Action Levels.
3. Action Level calculations are only relevant for products which are intended for presentation to consumers. They cannot be made for bulk products (i.e. products intended for food service or further processing prior to presentation to a consumer) because a Reference Amount cannot be accurately determined for such products.
   • For bulk products, provide your customer with the following information about cross contact allergens:
     • the presence of any particulate cross contact allergen 
     • the total concentration of any readily dispersible cross contact allergens.
4. Packaged products where cross contact allergens are determined to be Action Level 1 do not require a precautionary allergen labelling statement.
5. Packaged products where cross contact allergens are determined to be Action Level 2 should be labelled with an appropriate precautionary allergen labelling statement if legally permitted in the country of sale.

Determine the Reference Amount for Packaged Products

The Reference Amount is the maximum amount of food eaten in a typical eating occasion.  This may or may not be the same as the nominal or declared serving size but it will not be less than the declared serving size.

• The determination of the Reference Amount is a business decision. It is recommended that where the serving size is used, the AFGC serving size principles (listed below) should be considered.

Determine the Reference Doses for Packaged Products

A Reference Dose is the protein level (total protein in milligrams from an allergenic food) below which only the most sensitive individuals (1%) of the allergic population are likely to experience an adverse reaction. 

• Select the relevant Reference Dose for each readily dispersible cross-contact allergen.

Reference Doses can be accessed within VITAL® Online vital.allergenbureau.net.

Establish Action Levels for each identified cross-contact allergen

Action Level 1: Low concentration of the relevant allergen under evaluation, low chance of adverse reaction and no precautionary allergen labelling statement is required 

Action Level 2: Significant concentration of relevant allergen under evaluation, significant chance of adverse reaction and a precautionary allergen labelling statement is required (if legally permitted in the country of sale or the country of further manufacture)

Determine the Action Levels for each identified cross-contact allergen in every packaged product.

The Action Level transition point *(ppm)
=
Reference Dose (mg) x (1000/Reference Amount (g))
(*except cereals containing gluten¹ where formula above is applicable or 20ppm, whichever is lower)

Example: The Reference Amount for a biscuit is 40g. 

Action Level transition for egg (40g Reference Amount) = 0.2 x (1000/40) = 5 ppm

For cross-contact egg in the biscuit, where the Reference Amount is 40g, Action Level 1 is < 5ppm and Action Level 2 is ≥ 5ppm. 

Action Level transition for soy (40g Reference Amount) = 0.5 x (1000/40) = 12.5ppm 

For cross contact soy in the biscuit, where the Reference Amount is 40g, Action Level 1 is < 12.5ppm and Action Level 2 is ≥ 12.5ppm.

Values given in this color are ED₀₁ Values from the Table Below

Laboratory analysis should verify the allergen is not detected at the ppm ranges you calculate.

Sources: Allergen Bureau. (2019). Summary of the 2019 VITAL Scientific Expert Panel recommendations. Allergen Bureau. https://www.allergenbureau.net

Allergen Bureau. (2023). The food industry guide to the Voluntary Incidental Trace Allergen Labelling (VITAL®) program (Version 3.1). Allergen Bureau. https://www.allergenbureau.net