The VITAL approach
The VITAL program was developed by the Allergen Bureau in Australia and New Zealand and was designed as a tool to help businesses to decide whether PAL was appropriate (VITAL stands for Voluntary Incidental Trace Allergen Labelling). The tool uses VITAL test data relating to the user’s products and ingredients, and any levels of unintentional allergen protein they contain, to calculate whether these would equate to levels at or above the reference doses for those allergens. It is recommended that PAL is applied to the product if the recorded levels are at or above the VITAL test reference dose.
The reference doses used in the Allergen Bureau’s VITAL program are the doses of allergen at which 1% of the allergic population are likely to start to have a reaction and are reported as the ED01 levels (ED meaning Eliciting Dose and 01 meaning 1%). As these reference doses were published linked with the program, they became known as the VITAL reference doses.
If a business is adopting the VITAL approach and is using these reference doses to make decisions about whether to apply precautionary labelling, it is critical that the right sampling and VITAL testing approach is adopted. Sampling needs to be based on risk, and represent the worst-case scenario in order to capture the highest levels of contamination. The VITAL testing undertaken needs to be based on the detection of protein, so typically ELISA is the method of choice. Working with a laboratory that understands how reference doses can be applied will also be beneficial when it comes to interpreting the VITAL test results.
Many businesses have attempted to adopt the VITAL approach and perform calculations intended to assess contamination levels, only to discover that it is not as simple as it first appears. Many considerations are needed, including the source of the contamination, portion sizing, the proportion of contaminated ingredients, and the interpretation of analytical testing results.