The step-by-step procedure for applying the VITAL® Program 4.0: identifying allergens, quantifying cross contact, determining Action Levels from the ED₀₅-based Reference Doses, and deciding precautionary allergen labelling outcomes.
Published: August 2024 (Version 4)
Format: PDF, 20 pages
Cost: Free to download
About this guide
The Voluntary Incidental Trace Allergen Labelling (VITAL®) Program is a risk-based method for food manufacturers to assess the impact of allergen cross contact and decide when a precautionary allergen labelling (PAL) statement is appropriate. It aims to avoid the indiscriminate use of PAL, so that it keeps its value as a risk management tool, while still communicating effectively to consumers with food allergy.
This guide sets out how to apply the VITAL® Program 4.0, from identifying allergens and quantifying cross contact through to Action Levels and labelling outcomes. VITAL® Program 4.0 adopts the ED₀₅-based Reference Doses recommended by the FAO/WHO Expert Committee.
Who it’s for
- Food manufacturers assessing the impact of allergen cross contact on their products
- Anyone deciding whether a precautionary allergen labelling statement is appropriate
- Users of VITAL® Online and the interactive VITAL Action Level Grid
Important to know
- The VITAL® Program is designed for consistent risk communication. It is not designed to deliver total safety and does not guarantee that a consumer will not have an allergic response, so it must be supported by robust allergen management.
- It does not address risks from royal jelly or propolis, and it does not extend to infants or to foods for special medical purposes.
- The Action Level concept was not developed to assess “free from” claims.
- Reference Doses from VITAL 1.0 and 2.0 are no longer considered valid for best practice quantitative risk assessments.
What’s inside
| Section | What it covers |
|---|---|
| 1. Introduction | The VITAL science, how the program fits with the regulatory framework, its objective, and how and when to use it, including its limits. |
| 2. The VITAL procedure | Scope and pre-requisites; identifying intentionally added and cross contact allergens; quantifying particulate and readily dispersible cross contact and calculating the total in the finished product; determining Reference Amounts, Reference Doses and Action Levels; validating the assessment; labelling outcomes and precautionary allergen labelling; recording assumptions and ongoing monitoring. |
| 3. Information | Where to find support: VITAL® Online and the interactive Action Level Grid, the Allergen Risk Review website, the VITAL® Best Practice Labelling Guide, the VITAL Standard, VITAL training and other resources. Also how the program relates to allergen analysis, and a decision tree for cross contact allergens. |
| 4. Glossary | Definitions of key terms. |
| 5. References | Source references. |