Novel food
In the EU and the UK, a novel food is a food that was not used for human consumption to a significant degree there before May 15, 1997. It needs authorization before it can be sold.
What it means in practice
The European Commission defines novel food as food "that had not been consumed to a significant degree by humans in the EU before May 15, 1997" and says pre-market authorization based on an evaluation is necessary [1]. Its examples include new sources of vitamin K (menaquinone) and krill oil rich in phospholipids [1].
Great Britain kept the same rule in its assimilated version of Regulation (EU) 2015/2283, where the test is use "within the EU or the United Kingdom before May 15, 1997" [2]. The categories include food consisting of, isolated from or produced from microorganisms, fungi or algae [2]. The Food Standards Agency (FSA) says novel foods need to be authorized before they can be placed on the market in Great Britain [3]. EU decisions on novel food status made before January 1, 2021, still apply in Great Britain, and the FSA can give legal verification of status only through its Article 4 consultation process [3]. In Northern Ireland, novel foods must undergo a safety assessment and authorization before sale [3].
Why it matters when reading nootropics research
Status attaches to a specific food in a specific form, not to a species or a compound name. The European Commission's status list records "Hericium erinaceus dehydrated mycelium powder" as "Novel Food" (October 29, 2019) and "Hericium erinaceus powder extract from the fruiting body" as "Not novel" (September 10, 2026) [4]. Two lion's mane products can therefore sit on opposite sides of the line in the EU.
A novel food decision is also a food-safety and market-access decision, not a finding about effects in trials. And it covers the EU and the UK only; the US, Canada and Australia use other systems, described under DSHEA (including its new dietary ingredient rule for supplements), GRAS, NPN and ARTG.
NootropicsWork compound pages state EU and UK status only from a dated regulator source and never infer a status from a missing entry.
References
- European Commission. Novel food. not shown in fetched text.
- legislation.gov.uk. Regulation (EU) 2015/2283 on novel foods, Article 3 (assimilated law, latest available revised version). revised version incorporating the 01/04/2025 amendment.
- Food Standards Agency. Novel foods authorisation guidance. Published 30 May 2018; updated since (date not captured).
- European Commission. Consultation process on novel food status. not shown in fetched text.