A Guide to Risk Assessment Using Food Allergen Reference Doses

This paper, A Guide to Risk Assessment Using Food Allergen Reference Doses, details the Voluntary Incidental Trace Allergen Labeling version 3.0 (VITAL 3.0) exercise, which models human clinical data for probable reactions based on double-blinded placebo-controlled allergen challenge studies. This paper also briefly looks at using [ED₀₅] and [ED₀₁] when using milk as the tested allergen.

This is not a regulatory document but is a guidance document for best practices.

This paper is designed to provide:

• A brief explanation of VITAL 3.0
• An allergen reference dose table
• Differentiated details for using [ED₀₅] or [ED₀₁]
• A veratox method alignment table with VITAL 3.0 recommendations

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