The Innovation Research Programme (IRP) has worked with scientific experts to identify recurringly challenging areas for applicants when preparing dossiers for novel foods produced by precision (PF) or biomass fermentation. This document contains supplementary guidance for novel food PF and biomass fermentation applications. It complements the FSA/FSS guidance (https://www.food.gov.uk/business-guidance/regulated-products/novel-foods-guidance) and the EFSA novel foods guidance (https://www.efsa.europa.eu/en/efsajournal/pub/4594), clarifying how assessors interpret key principles and highlighting common shortcomings that delay assessments. The guidance is relevant to the identity, characterisation, manufacturing process, stability, conditions of use and allergenicity sections of the novel foods guidance. Special focus has been given to bioinformatics analysis and protein digestibility assays, recognising these as useful tools for the characterisation of novel food products produced through PF or biomass fermentation, particularly when used as a source of protein. This is not intended to be a comprehensive guide and the FSA/FSS may request information beyond the examples in this document depending on the product characteristics. Dossiers should tell a clear, product-specific narrative. Following this guidance does not necessarily guarantee that a product will be authorised. It is a matter for Ministers to determine whether or not to authorise a novel food produced by precision or biomass fermentation and there are a variety of case-specific factors which may inform that decision.
Food Standards Agency (Fri,) studied this question.