Novel Food Regulation
EU and UK regulatory framework governing foods without significant consumption history before May 1997. Novel food status affects certain peptide-related products marketed as supplements that may require pre-market authorisation from EFSA (EU) or the FSA (UK) before sale.
Technical Context
EU Novel Food Regulation 2015/2283 requires: pre-market safety assessment by EFSA (European Food Safety Authority) and authorisation by the European Commission before novel foods can be sold. A 'novel food' is any food not used for human consumption to a significant degree within the EU before 15 May 1997. The authorisation process takes approximately 18 months and requires a dossier including: identity and characterisation, production process, compositional data, stability, proposed uses, toxicological data, and allergenicity assessment. For peptide-related products, novel food status may apply to: collagen peptide supplements with specific bioactive sequences, marine-derived peptides, insect-derived peptides, and fermented products containing novel peptide profiles. UK FSA operates a parallel novel food framework post-Brexit. The distinction between a novel food and a medicinal product depends on whether therapeutic claims are made.