Labelling of allergen traces: the VITAL concept
Is labelling necessary? How to evaluate allergen traces in your products
Aug 2024 (update). Founded in 2005 as a non-profit organisation, the Australian-New Zealand Allergen Bureau developed a standardised process for risk assessment of unintended allergen traces based on threshold values. This process, known as VITAL concept (Voluntary Incidental Trace Allergen Labelling) was published in 2007 and is available in version 4.0 since summer 2024. It supports food manufacturers to manage allergens and thus also to decide whether trace labelling is necessary or not.
While the labelling of allergenic ingredients is clearly regulated, many questions arise in the case of unintentional entry of allergens through cross-contamination (cross contacts). In the production of food this can occur in many places; e.g. due to "contaminated" raw materials, shared production facilities, during transport etc. Since some allergen traces cannot be avoided even with careful allergen management, many food manufacturers indicate these allergen traces on their products. Thus, food labels contain precautionary warnings such as "may contain" or "contains traces of ...". The use of precautionary warnings significantly limits the choice of allergic consumers. Moreover, the wording does not say anything about the level of risk. The VITAL concept developed in Australia and New Zealand is a useful tool for evaluating traces of allergens. The wording of the respective allergen information is also precisely specified and uniform.
New Allergen reference doses
In 2019, FAO and WHO were mandated by the Codex Committee on Food Labelling (CCFL) to provide scientific advice to the Codex Committee on allergen labelling. In the following years, an expert committee, including members of the VITAL Scientific Expert Panel (VSEP), held several meetings and published the results in 2022-2024. The recommended reference doses were now based on the ED05 (Eliciting Dose 05) values. This dose was considered safe because only 5% of the allergic population was likely to react.
As early as March 2024, the German ALS and ALTS expert committees updated their assessment values for undeclared allergens and adapted them to the ED05 dose recommended by the FAO and WHO. The allergen legislation in the Netherlands has also been adapted.
Now the Allergen Bureau Australia/New Zealand has adopted the reference doses recommended by FAO and WHO with the new version VITAL 4.0. These reference doses are now included in the online VITAL calculator. The VITAL experts also recommend a risk management value for the allergen molluscs to support users in the EU region.
Recommended Reference doses
| Allergen | VITAL 3.0 Ref Dosis (mg Protein)* | VITAL 4.0 Ref Dosis (mg protein)# |
Änderung |
| Priority Allergens (RfD) | |||
| Almond | 0.1 | 1.0 | ↑ |
| Cashew (and Pistachio) | 0.05 | 1.0 | ↑ |
| Egg | 0.2 | 2.0 | ↑ |
| Fish | 1.3 | 5.0 | ↑ |
| Hazelnut | 0.1 | 3.0 | ↑ |
| Milk | 0.2 | 2.0 | ↑ |
| Peanut | 0.2 | 2.0 | ↑ |
| Sesame | 0.2 | 2.0 | ↑ |
| Shrimp | 25 | 200 | ↑ |
| Walnut (and Pecan) | 0.03 | 1.0 | ↑ |
| Wheat | 0.7 | 5.0 | ↑ |
| Non-Priority Allergens (RfD) | |||
| Soy | 0.5 | 10 | ↑ |
| Celery | 0.05 | 1.0 | ↑ |
| Non-Priority Allergens (Risik Management Value) | |||
| Lupin | 2.6 | 10 | ↑ |
| Mustard | 0.05 | 1.0 | ↑ |
| Brazil nuts, Macadamia nuts, Pine nuts | 0.1 | 1.0 | ↑ |
| Buckwheat | - | 10 | + |
| VSEP Risik Management Value | |||
| Mollusc | - | 20 | + |
* based on ED01 | # rounded from ED05 | + new Reference dose or Risk Management Value
Source: Allergen Bureau. 2024, VITAL 4.0 Summary and FAQs (Page 6)
Portion sizes
The reference dose is given as total protein in the unit mg (milligram). To assess the risk to the allergic consumer, the portion size, i.e. the amount of food usually consumed, must be considered. This can be a chocolate bar weighing 50g or a ready-made meal weighing 500g. The concentration, usually given in the unit mg/kg (milligram per kilogram, also known as ppm part per million), can therefore vary considerably.
Action levels
If traces of an allergen are found in a product, action levels are calculated depending on the portion size. Action Level 1 refers to a very small amount of allergen in the food portion, which is below the reference dose. This means that this food is most likely harmless for allergic consumers, and trace labelling is therefore not necessary. In Action level 2, the amount of allergen is higher than the reference dose. This means that there is a significant risk of an allergic reaction, trace labelling is required.
A calculation example
Laboratory result: 10 mg/kg casein - Is precautionary trace labelling necessary according to VITAL?
- Conversion to mg protein (total milk protein; 80% of milk proteins are casein)
Laboratory result = 12.5 mg/kg milk protein - Calculation of action levels depending on the portion size
VITAL reference dose = 2 mg milk protein, therefore the action level is 2 mg per kg food portion
a) Action levels in 500 g ready-made meal:
< 4 mg/kg milk protein – no trace labelling
> 4 mg/kg milk protein – trace labelling required
For the finished product with the above-mentioned casein concentration, precautionary trace labelling is therefore necessary!
b) Action levels in 50 g of chocolate:
< 40 mg/kg milk protein – no trace labelling
> 40 mg/kg milk protein – trace labelling necessary
Thus, for chocolate with the above-mentioned casein concentration, a precautionary trace labelling is not necessary!
Please contact us
Do you have any questions about trace labelling of food? Are you interested in implementing the VITAL concept for your food products? Feel free to contact your personal account manager or our experts for allergens, directly.
