Selling supplements in the EU.
The strictest market. Navigable, but complex.
The EU is our most regulated export market — but it's also a €4B opportunity. Novel Food authorisation, EFSA health claims, and maximum levels apply to many ingredients. Here's exactly what's permitted and what's not.
Ashwagandha is NOT authorised for sale in the EU.
Under EU Novel Food Regulation (EU 2015/2283), ashwagandha (Withania somnifera) extract has not been granted Novel Food authorisation. It may not be placed on the market in EU member states as a food supplement. If you are building a range for the EU, focus on curcumin, spirulina, and CoQ10.
EU regulatory overview.
EU Novel Food Regulation (EU 2015/2283)
Any food or food ingredient not widely consumed in the EU before 15 May 1997 is classified as a "novel food" and requires EFSA safety assessment and European Commission authorisation before it can be placed on the EU market. Many Indian botanicals — including ashwagandha — do not yet have this authorisation.
EU Nutrition and Health Claims Regulation (NHCR — EC 1924/2006)
Health claims on EU food supplements must be on the EU Register of Authorised Claims. "Supports immunity," "reduces tiredness," or "antioxidant" claims are only permitted for specific nutrients listed on the register. Unauthorised claims are illegal.
Maximum Levels
The EU sets maximum permitted levels for many vitamins, minerals, and ingredients. CoQ10 is permitted up to 90mg/day. Curcumin has specific maximum levels per its Novel Food authorisation decision. Exceeding these limits is a compliance violation.
Traditional Food — Alternative Pathway
Ingredients with a documented history of safe food use in a third country (outside the EU) can enter the market via a "traditional food" notification under Article 14 of EU 2015/2283. Spirulina uses this pathway. Notification is faster than full Novel Food authorisation but still subject to EFSA review.
Our catalogue and EU authorisation status.
| Ingredient | EU Status | Maximum Level | Notes |
|---|---|---|---|
| Ashwagandha | ✗ Not authorised | N/A | Cannot be sold as food supplement in EU. No marketing authorisation granted. |
| Curcumin ≥95% curcuminoids |
✓ Novel Food auth. | Per authorisation decision | Authorised under EU 2015/2283 for food supplements and FSMP. Max level specified in the authorisation. |
| Spirulina A. platensis |
✓ Traditional food notif. | No maximum set | Traditional food notification submitted. Marketable during EFSA assessment under Art. 14. |
| CoQ10 Ubiquinone ≥98% |
✓ Authorised | 90mg/day | Authorised for food supplements. Must not exceed 90mg/day serving to remain compliant. |
What your EU label must include.
Product Name
Clear description of the supplement. "Curcumin Extract Food Supplement" or similar. Language requirements depend on the member state(s) of sale — multilingual labels required for multi-country distribution.
Nutrition Declaration
Per EU Regulation 1169/2011 (FIC). Per 100g and per recommended daily intake. Energy, fat, saturates, carbohydrate, sugars, protein, salt — plus the active ingredient(s).
Authorised Health Claims Only
Only EFSA-approved health claims from the EU register may be used. Structure/function claims not on the register are prohibited. No disease claims.
Recommended Daily Dose
Must state the recommended daily dose. Must not exceed the maximum authorised level for regulated ingredients (e.g. CoQ10 ≤90mg/day).
Warning Statement
Must include: "Food supplements should not be used as a substitute for a varied diet." Keep out of reach of children statement. Pregnancy/breastfeeding advice if relevant.
Responsible Operator
Name and address of the EU-based food business operator (FBO) responsible for placing the product on the market. This is typically your EU importer or distributor.
What ships with every EU-bound order.
| Document | Purpose | Included |
|---|---|---|
| NABL-accredited CoA | Potency, purity, heavy metals, microbial, pesticides | ✓ Standard |
| GMP Certificate | Manufacturing compliance (EU-recognised cGMP) | ✓ Standard |
| MSDS | Customs / import clearance | ✓ Standard |
| Certificate of Indian Origin | EU customs, origin declaration | ✓ Standard |
| EU Nutrition Declaration template | EU FIC-compliant label format | ✓ Standard |
| Novel Food / Traditional Food reference | Regulatory status evidence for authorised ingredients | ✓ Standard |
Building a range for the EU?
Curcumin, spirulina, and CoQ10 are all EU-authorised from our catalogue. Book a compliance call and we'll build your EU-ready formulation brief together.