Labelling of allergen traces: the VITAL concept
Is labelling necessary? How to evaluate allergen traces in your products
Dec 2020. 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 3.0 since 2019. It supports food manufacturers 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 reference doses
Reference doses base on clinical studies with allergenic consumers challenged with an allergic food. These reference doses are the core of the VITAL concept. Allergic persons were fed with food containing a known amount of allergen. Action values were developed from the lowest allergen concentration at which allergic symptoms still occurred. Over the years more and more clinical data from further challenge studies were compiled. A scientific board with experts from the clinical and analytical fields derived the reference doses from this data. In the version 3.0. of September 2019, even the most sensitive consumers are now taken into account: Statistically, 99% of allergic consumers would now not show any symptoms!
These are the recommendations of the VITAL Scientific Expert Panel (VESP):
Allergen |
No. of individuals |
VITAL 2.0 Ref Dose (mg protein) |
2019 VSEP Ref Dose (mg protein [ED01] |
Change |
2019 VSEP ED05
|
|
Egg |
431 |
0.03 |
0.2 |
▲ |
2.3 |
|
Hazelnut |
411 |
0.1 |
0.1 |
✓ |
3.5 |
|
Lupin |
25 |
4.0 |
2.6 |
▼ |
15.3 |
|
Milk |
450 |
0.1 |
0.2 |
▲ |
2.4 |
|
Mustard |
33 |
0.05 |
0.05 |
✓ |
0.4 |
|
Peanut |
1306 |
0.2 |
0.2 |
✓ |
2.1 |
|
Sesame |
40 |
0.2 |
0.1 |
▼ |
2.7 |
|
Shrimp |
75 |
10.0 |
25 |
▲ |
280 |
|
Soy (milk + flourl) |
87 |
1.0 (soy flour) |
0.5 |
▼ |
10.0 |
|
Wheat |
99 |
1.0 |
0.7 |
▼ |
6.1 |
|
Cashew |
245 |
|
0.05 |
+ |
0.8 |
|
Celery |
82 |
|
0.05 |
+ |
1.3 |
|
Fish (finfish) |
82 |
|
1.3 |
+ |
12.1 |
|
Walnut |
74 |
|
0.03 |
+ |
0.8 |
▲ Reference Dose increased | ✓ Reference Dose unchanged | ▼ Reference Dose decreased | + New Reference Dose
Source: Allergen Bureau, Summary of the 2019 VITAL Scientific Expert Panel Recommendations, page 8
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: 1 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 = 1.25 mg/kg milk protein - Calculation of action levels depending on the portion size
VITAL reference dose = 0.2 mg milk protein, therefore the action level is 0.2 mg per kg food portion
a) Action levels in 500 g ready-made meal:
< 0.4 mg/kg milk protein – no trace labelling
> 0.4 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:
< 4 mg/kg milk protein – no trace labelling
> 4 mg/kg milk protein – trace labelling necessary
Thus, for chocolate with the above-mentioned casein concentration, a precautionary trace labelling is not necessary!
The calculation shows: analytically a lower detection limit of the used tests is required, the larger the portion quantity is. It is therefore very important to clarify with the lab whether the method is suitable for implementing the VITAL concept in the defined portion sizes. From an analytical point of view, it is possible to achieve a sensitivity in the required order of magnitude for most products using ELISA, in some cases also PCR.
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.
