Short answer: if an ingredient wasn't eaten to any meaningful degree in the EU before 15 May 1997, it's probably a "novel food" — and that means it needs formal EU authorisation before you can sell it. No authorisation, no legal sale. For brands bringing newer or exotic ingredients into Europe, this is the single rule most likely to stop a launch dead.
What "novel food" actually means
Under Regulation (EU) 2015/2283 (in force since 1 January 2018), a novel food is any food that was not used for human consumption to a significant degree within the EU before 15 May 1997, and that falls into one of the regulation's defined categories. Those categories are broad, and that's the point — they're designed to catch anything genuinely new to the European diet, including:
- foods made from a new molecular structure;
- foods from microorganisms, fungi, algae, or cell/tissue culture;
- foods from plants or animals produced by non-traditional methods;
- foods produced using a new production process; and
- traditional foods from outside the EU (more on these below).
Insects are a well-known example — products like dried mealworm larvae have gone through this exact process to reach the EU market. CBD is another (and a cautionary one — see our CBD breakdown). The common thread: "new to Europe" triggers the rule, whether the food is high-tech or simply foreign.
Why it can block a launch
The mechanism is simple and strict: the EU maintains a Union list of authorised novel foods, and only foods on that list may be placed on the EU market. If your ingredient is a novel food and isn't on the list with your use covered, selling it is unlawful — full stop. There's no "notify and proceed" shortcut for a standard novel food. Until authorisation comes through, the product simply can't be sold legally, and enforcement (border stops, recalls, fines) varies by member state but is real.
How authorisation works
For a standard novel food, the route is centralised:
- You apply to the European Commission with a dossier of scientific and safety data.
- The European Food Safety Authority (EFSA) carries out the scientific risk assessment — and EFSA's bar for data quality is high; many applications fail not because the food is unsafe but because the dossier doesn't prove safety at realistic intake.
- If EFSA's opinion is positive, the Commission authorises the food and adds it to the Union list, with the conditions of use, labelling, and specifications that apply.
Authorisations are generally generic — once a food is on the Union list, anyone meeting the conditions can use it — unless the applicant secured time-limited data protection. The process is thorough and can take a long time, which is why "is this a novel food?" is a question to answer at the formulation stage, not after you've built a product around the ingredient.
The faster route: traditional foods from third countries
There's one important shortcut. If your ingredient has a history of safe food use of at least 25 years in a non-EU country — part of the customary diet of a significant number of people — it can use the traditional food notification route (Article 14). This is faster: the food can be placed on the market about four months after a valid notification, provided no member state or EFSA raises a reasoned safety objection. The catch is that the safety history has to match the exact food being notified — "people in that country have eaten this plant for generations" doesn't automatically cover a concentrated extract of it.
The practical takeaway
Before you build a product for the EU, ask:
- Was this ingredient eaten in the EU to a significant degree before May 1997? If not, assume it's a novel food until you've checked.
- Is it already on the Union list, with my intended use covered? If yes, you're working within an existing authorisation. If no, you're looking at an application — and a timeline.
- Does it qualify for the traditional-food route with a genuine 25-year third-country history? That can save a lot of time.
The brands that get caught are the ones who discover the novel food rule after committing to an ingredient. Regulave flags novel-food status as part of checking your formulation against EU requirements, so you know which route you're on before you launch.
Last reviewed: June 2026. This article is general information, not legal advice; novel food rules are detailed and evolve. Verify current requirements with the European Commission, EFSA, or a qualified professional. Check an ingredient's status across the EU and 21 other markets with Regulave →