EU Novel Food Rules for Supplement Brands
The single most common reason a US-style supplement cannot be sold in Europe is not claims or dosage — it is an ingredient that counts as a “novel food”. This guide explains the rule, the ingredients that cause problems, and what to check before you order for the EU or UK.
What “novel” means
Under Regulation (EU) 2015/2283, any food or ingredient not consumed to a significant degree in the EU before 15 May 1997 is “novel” and needs pre-market authorisation with a safety dossier — unless it is already authorised on the Union list. The rule applies to supplements exactly as to foods. The practical consequence: an ingredient that is legal and popular in the US can be unsellable in the EU, even though nothing about the product changed.
How to check an ingredient
- Novel Food Catalogue (European Commission website): a searchable list of ingredients with a status — not novel, novel (needs authorisation), or authorised. It is not legally binding but it is what authorities use.
- Union list of authorised novel foods: ingredients that have been authorised, with conditions (maximum dose, form, labeling).
- Form matters. The catalogue distinguishes fruiting body from mycelium, extract from powder, oil from seed. Read the exact entry, not the plant name.
Ingredients that trip up supplement brands
| Ingredient | EU status | Note |
|---|---|---|
| Shilajit (mumijo) | Novel — not authorised for supplements | Cannot be sold in the EU. US, Gulf and Asian markets only. |
| Mushroom mycelium powder (lion’s mane, cordyceps etc.) | Novel | Mycelium grown on grain is the problem. Fruiting-body extracts of lion’s mane, reishi, cordyceps are not novel. |
| NMN (nicotinamide mononucleotide) | Novel — not authorised | NAD+ products for the EU must use other forms (e.g. niacinamide); NR (nicotinamide riboside) has a limited authorisation. |
| CBD | Novel — applications pending | Not on our catalog in any case. |
| Soursop (graviola) leaf | Status varies by form; check catalogue | Check before quoting. |
| Sea moss (Chondrus crispus) | Not novel as a food; check extract forms | Also subject to iodine limits. |
| Astaxanthin | Authorised with a maximum daily dose (8 mg) | Dose on label must comply. |
| Melatonin | Not a Novel Food issue, but a medicines issue | Permitted in supplements in some states at ≤ 1 mg (Italy) or 1.9 mg (France); prescription-only in UK, restricted in Germany and Netherlands. |
| Ashwagandha | Not novel, but banned or restricted in Denmark, Netherlands and others on safety grounds | Country check. |
| Vitamin K2 (MK-7) | Authorised (synthetic and natto-derived forms) | Fine. |
| Creatine, collagen peptides, electrolytes, most vitamins and minerals | Not novel | Permitted forms and maximum levels still apply. |
Three other EU rules that matter
- Permitted forms of vitamins and minerals (Directive 2002/46/EC annexes): magnesium glycinate is permitted, some exotic forms are not.
- Health claims (Regulation 1924/2006): only authorised claims from the EU Register. “Vitamin C contributes to the normal function of the immune system” — yes. “Boosts immunity” — no.
- National botanical lists: France (DGCCRF list of authorised plants), Italy (Ministry of Health BELFRIT list), Belgium — a botanical allowed in one country may be restricted in another.
Notification: country by country
| Country | Procedure | Who files |
|---|---|---|
| Germany | Notification to BVL before first sale; no approval, but documentation on file | EU-established food business operator |
| France | Télédéclaration via DGCCRF Téléicare; botanicals checked against the French list | EU-established operator |
| Italy | Notification to Ministero della Salute; product listed in the national register | EU-established operator |
| Netherlands | No pre-notification; NVWA enforces | EU-established operator |
| United Kingdom | No notification; retained EU rules; FSA / Trading Standards enforce | UK food business operator |
In every case the responsible operator must be established in the EU (or UK). A Chinese factory cannot be the operator of record; your company or an EU importer / responsible-person service is.
What we do before quoting for Europe
We check every ingredient in the formula against the Novel Food Catalogue and the permitted-forms annexes, flag anything that is novel or restricted, and propose a compliant alternative — a fruiting-body extract instead of mycelium, a melatonin-free sleep blend, niacinamide instead of NMN. The label is supplied in EU format with the mandatory statements. Notification remains your job (or your importer’s); we supply the technical file it needs. See compliance and our Italian, German, French and Dutch pages.