Germany has no approval for food supplements — just a notification. That makes market entry look easy. The real risks sit in the ingredients, the claims and the line between a supplement and a medicine, where German authorities and courts are among the strictest in the EU.
A food supplement can be sold in Germany without approval, but the manufacturer or importer must notify the BVL no later than first placing on the market, with a label sample (§ 5 NemV). Since 1 July 2026 this works only online, it is free, and it is not an approval. Vitamins and minerals must come from the EU positive lists; there are still no binding maximum levels, so authorities apply BfR recommendations. Only authorised health claims may be used — botanical “on hold” claims are out since the CJEU’s April 2025 ruling — and disease claims are banned. A product with a relevant pharmacological effect is a medicine and needs a marketing authorisation.
A food supplement is a food: a concentrated source of nutrients or other substances with a nutritional or physiological effect, sold in dose form — capsules, tablets, powders in sachets, ampoules or drop bottles.
| Layer | What it governs |
|---|---|
| Directive 2002/46/EC → NemV | Definition, permitted vitamins and minerals, labelling, notification |
| Food and Feed Code (LFGB) | National framework: deception, official controls, import, penalties |
| Regulation (EU) No 1169/2011 (LMIV) | Food information and labelling; no disease claims |
| Regulation (EC) No 1924/2006 | Nutrition and health claims |
| Regulation (EC) No 1925/2006, Annex III | Prohibited and restricted substances |
| Regulation (EU) 2015/2283 | Novel foods, e.g. CBD |
| Medicinal Products Act (§ 2 AMG) | Where a product stops being food and becomes a medicine |
Only the vitamins and minerals in Annex I of Directive 2002/46/EC, in the chemical forms of Annex II, may be used (§ 3 NemV). There are still no legally binding maximum levels — neither in Germany nor at EU level. Control authorities assess products against the recommendations of the Federal Institute for Risk Assessment (BfR), which are not binding but are used in practice:
| Nutrient | BfR recommended maximum per daily dose in supplements |
|---|---|
| Vitamin D | 20 µg (confirmed in 2025, with a warning against high weekly or monthly bolus doses) |
| Vitamin B6 | 0.9 mg |
| Folic acid | 200 µg (400 µg where aimed at reducing neural-tube defect risk) |
| Selenium | 40 µg |
Harmonised EU maximum levels are back on the agenda: the Commission announced a call for evidence and consultation for 2026, and adoption is not expected before 2028.
These are not harmonised. The operator must assess safety case by case; the federal and Länder substance lists give non-binding orientation. Three EU rules cut across:
In Germany, most supplement disputes start with a competitor’s warning letter about a claim, not with an authority.
No. The manufacturer or importer must notify the BVL no later than first placing on the market, with a label sample. The notification is free and is not an approval; compliance remains the company’s responsibility.
Online through the federal administration portal (Verwaltungsportal Bund), which has been mandatory since 1 July 2026. Each product and each flavour needs its own notification; different pack sizes can be combined.
There are no legally binding maximum levels. German authorities use the BfR recommendations, for example 20 micrograms of vitamin D and 0.9 mg of vitamin B6 per daily dose. EU-wide limits are being prepared.
Generally not. Botanical claims awaiting EU assessment (“on hold”) may not be used outside narrow transitional rules, following the CJEU’s April 2025 ruling in case C-386/23.
When it is presented as treating or preventing disease, or when its composition and dose have a significant pharmacological, immunological or metabolic effect. It then needs a marketing authorisation under the Medicinal Products Act.
We check the regime, ingredients and claims for your product and map the route to market — fixed price, in writing.