EFSA is updating its guidance on the scientific principles and data needed to assess the safety and relative bioavailability of new substances proposed as micronutrient sources. Its scope includes food supplements, fortified foods and products for specific groups.

Relevant cases include new chemical forms, micronutrient metabolites and new molecules with vitamin activity, many of which may also enter the Novel Food pathway. Assessment therefore needs to connect identity, manufacturing, specifications, exposure, metabolic fate and nutritional contribution.

For R&D and regulatory affairs, the operational point is to prepare dossiers that establish not only source safety but also how the ingested amount translates into a bioavailable form comparable with known sources.

Until the revised guidance is final, companies should monitor its development and perform a gap analysis on active projects. The update does not by itself alter existing authorisations or support conclusions on a specific ingredient.

Why it matters

For ingredient developers, the update points to greater attention to characterisation, nutritional-equivalence conversion and dossier quality.

Evidence limit

The update process is ongoing. The EFSA page describes scope and objectives but does not replace the final guidance or an assessment of any individual ingredient.

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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