Explains the move to ED₀₅-based Reference Doses in VITAL® Program 4.0, including the expert panel and science behind them, a table comparing VITAL 3.0 and 4.0 doses, and answers to frequently asked questions.
Published: August 2024
Format: PDF, 15 pages
Cost: Free to download
About this guide
VITAL® Program 4.0 adopts new Reference Doses based on the ED₀₅, the dose of total allergen protein predicted to produce objective symptoms in 5% of the allergic population, replacing the ED₀₁ values used in VITAL 3.0. This guide explains the decision: who the VITAL Scientific Expert Panel (VSEP) are, how the FAO/WHO Expert Committee reviewed the science, and how the allergen thresholds are derived.
It includes a table of the recommended Reference Doses and Risk Management Values for each allergen, set side by side with the VITAL 3.0 values, followed by answers to frequently asked questions about what the change means for food businesses and consumers.
Who it’s for
- Food businesses using, or considering, the VITAL® Program
- Consumers with food allergy, and the people who care for them
- Anyone who wants to understand the science behind the ED₀₅-based Reference Doses
Statement of support
The guide includes a statement from Allergy & Anaphylaxis Australia (A&AA), who worked with the Allergen Bureau on clear and consistent allergen labelling. A&AA supports the use of ED₀₅-based Reference Doses rather than the more stringent ED₀₁, because the higher threshold gives consumers more choice with minimal impact on the risk to public health. They also suggest the thresholds be reviewed when more data becomes available.
What’s inside
| Section | What it covers |
|---|---|
| Acknowledgment and Statement of Support | Thanks to the VSEP and reviewers, and a statement of support from Allergy & Anaphylaxis Australia. |
| Section 1: Information on Reference Doses | The expert panel and purpose of the document, the methods used to derive allergen threshold levels, and the results. Table 1 sets out the recommended Reference Doses (mg protein) for each allergen, comparing VITAL 3.0 with VITAL 4.0. It also covers Risk Management Values for allergens where data are limited and the value set for molluscs. |
| Section 2: ED₀₅ based Reference Doses and the VITAL® Program (FAQs) | Answers to questions including why the VITAL® Program is adopting ED₀₅-based Reference Doses; what the change means for food businesses and for consumers and more. |