As the concept of quantitative allergen risk assessment becomes legislated in some markets, is increasingly discussed by Codex, and continues to gather momentum globally, the Allergen Bureau would like to take this opportunity to clarify the distinction between the concept of quantitative risk assessment and the VITAL® Program.
Quantitative allergen risk assessment describes a scientific, risk-based approach to evaluating the likelihood and severity of unintended allergen presence in food to determine whether a Precautionary Allergen Labelling (PAL) statement is warranted. This approach may be reflected in regulatory frameworks, including legislation, guidance, and best-practice recommendations, in certain jurisdictions. Importantly, while these frameworks may reference or encourage the use of quantitative risk-based approaches, they do not prescribe the use of any specific proprietary methodology.
The VITAL® Program is a trademarked program developed, owned and administered by the Allergen Bureau, to translate emerging allergen risk science into a practical, consistent methodology that can be applied by food businesses. The VITAL® Program represents one established methodology that food businesses may choose to use to support quantitative allergen risk assessment and decisions relating to precautionary allergen labelling. Other scientifically justified approaches may also be used to meet regulatory or business needs.
To ensure accuracy, and to avoid confusion, references to regulatory or legislative requirements should use the term “quantitative allergen risk assessment”, rather than referring to VITAL®. The VITAL® Program should be referenced only when discussing the specific program, tools, training, or outputs developed by the Allergen Bureau, such as VITAL® Reference Doses.
The Allergen Bureau also reminds users and stakeholders that VITAL® is a registered trademark and should be identified as such on first mention. Referring to VITAL® as a generic system, regulatory standard, or mandatory framework may unintentionally misrepresent both the regulatory environment and the role of the program.
