EU Novel Food Regulation (EC) 2015/2283

Regulation (EU) 2015/2283, in force since 1 January 2018, governs EU market authorisation of novel foods — food not used for human consumption to a significant degree within the Union before 15 May 1997. Ten novel-food categories include food from microorganisms/fungi/algae, food from cell or tissue culture, food from new production processes altering nutritional value or undesirable substances, engineered nanomaterials, and vitamins/minerals from novel production processes or nanomaterial forms. Standard authorisation (Articles 10-12) requires Commission submission with administrative and scientific dossier covering identity, characterisation, production, history, intake, ADME, toxicology, allergenicity and human studies; EFSA scientific opinion (9-18 months); Commission implementing act with Standing Committee vote; Union List publication. Total timeline 18-30 months with optional 5-year data protection (Article 26) for substantial newly-developed evidence. Traditional-food-from-third-country (Articles 14-20) accelerated pathway requires 25+ years documented safe customary use in a third country, 4-month EFSA/Member State objection window, no data protection — 12-18 month timeline if objection-free. Union List (Implementing Regulation 2017/2470) specifies authorised use conditions per ingredient (food category matrix, maximum levels, population restrictions, specifications, labelling). Use outside authorised scope requires variation. Novel Food Catalogue is the Commission's informal published reference of status determinations.