APAC SPSFAM Mid Year 2016

3. VITAL reference doses 3.1 Voluntary Incidental Trace Allergen Labeling (VITAL) is a project of the Allergen Bureau based in Australia/New Zealand. There is also an EU-VITAL. VITAL is a voluntary consensus project to establish maximum levels of allergens for safe consumption by individuals with food allergies.

The maximum allergen concentrations are calculated using the specification provided by the commenter for a 200 g serving size of food.

serving size (g)

converted to kg

mg/kg

hazel nut

200 200 200

0.2 0.2 0.2

3.2

milk

15.2

peanut whole egg

4

200

0.2

1.2

As the commenter noted, the maximum permissible concentration of allergens are all below the proposed LOQ in the SMPR.

While the VITAL concentrations are not binding, they are based on scientific studies.

RECOMMENDATION: LOQ AND RANGES CONSISTENT WITH THE VITAL WOULD SEEM TO BE A BENEFIT FOR INTERNATIONAL TRADE, AND THEREFORE A GOOD REASON TO REVISE THE SMPR.

WORKING GROUP DECISION: VITAL IS NOT AN INTERNATIONALLY RECOGNIZED STANDARD. AGREED NOT REVISE THE SMPR.

3.2 VITAL values are based on amount of protein per service size. Therefore, the definition of the food allergens as “food commodities” without mentioning the protein content will establish a non-comparability between results obtained by an LC-MS/MS method and VITAL values.

Method developers can provide conversion factors in their methods for peptide to protein to “whole” allergen.

RECOMMENDATION: NO CHANGE RECOMMENDED.

WORKING GROUP DECISION: AGREED WITH RECIMMENDATION. NO CHANGE RECOMMENDED.