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Product Development

The Key Point of the New EFSA Novel Food Guidance

Entering the market with a novel food requires the submission of a scientific dossier that meets strict regulatory requirements and undergoes evaluation by the European Food Safety Authority (EFSA).

Bringing a novel food ingredient to the European market requires a scientific dossier that meets strict EFSA requirements. This white paper summarizes the key updates in the latest EFSA novel food guidance and what companies should expect when preparing an application. It also highlights recent guidance on the characterization of micro-organisms used in the food chain.

What you’ll learn in this white paper

  • How EFSA has strengthened expectations for identity and compositional data, including greater emphasis on whole genome sequencing for many natural-source ingredients and more robust analytical validation.

  • What the new guidance means for micro-organisms used in the food chain, including bacteria, yeasts, filamentous fungi, microalgae, postbiotics, probiotics, and precision fermentation strains.

  • Why nanoparticle assessment is now a critical early step, especially for non-soluble powders and products containing at least 10% nanoparticles.

  • How EFSA’s updated safety assessment raises the bar for genotoxicity, 90-day oral toxicity studies, nutrient source evaluation, and bioavailability.

  • How to approach allergenicity assessment based on EFSA’s four clarified categories of allergenic risk.

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