From 20 July 2026, new food-additive applications must be prepared under EFSA’s updated guidance. It sets out more detailed data expectations for identity and characterisation, manufacturing, specifications, stability, proposed uses and dietary exposure.

The assessment also integrates genotoxicity, toxicological evidence and environmental safety where relevant. A dossier therefore cannot be assembled as independent chapters: composition, analytical methods, use conditions and exposure must describe the same material.

For companies, the practical response is an early gap analysis. Regulatory, analytical, manufacturing and toxicology teams should determine together which data exist, which can be bridged and which studies must be generated before submission.

Application of the guidance is not a judgement on any individual additive. Data requirements remain proportionate to the substance, process and requested uses, while EFSA’s application page remains the operational reference for current documents.

Why it matters

For regulatory and R&D teams, the change calls for early dossier gap analysis and more coordinated collection of analytical, toxicological and environmental data.

Evidence limit

The guidance concerns food additives and does not replace assessment of an individual dossier. Applicable data depend on the substance and requested uses.

Editorial note. This content is intended for industry professionals. It does not constitute medical advice, therapeutic guidance or regulatory advice. Read our editorial method.

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