Is Melatonin legal in Germany?

Situación jurídica

There is no EU-harmonised limit for melatonin in food supplements - each member state sets its own rule.

Germany has no statutory maximum either, and the question is contested product by product rather than settled by rule. The federal medicines and risk-assessment institutes have held since 1996 that melatonin is a licensable medicinal product on a dose-independent basis, and melatonin authorised as a medicine in Germany is prescription-only.

The courts have not followed that position for low doses. The Frankfurt higher regional court considered a product dosed at 0.5 mg twice daily - exactly 1 mg per day - and held it a food supplement rather than a functional medicine, finding no appreciable effect on metabolism. The North Rhine-Westphalia higher administrative court reached a comparable conclusion. Classification decisions rest with each Land's food authority, not the federal bodies.

¿Vendemos aquí?

Sí, por ahora: Sleep spray, Sleep cápsulas.

Melatonin in Germany is less settled than in most of our markets, and we'd rather say so than imply otherwise. There's no German limit - instead each product is judged individually, and German courts have looked at a 1 mg daily dose, the same as ours, and treated it as a food supplement rather than a medicine. That's the closest thing to a direct answer available.

Germany's risk assessment body has since raised questions about melatonin supplements generally, which we're watching.

Perspectivas

The most likely source of movement is BfR's September 2024 opinion, which flags adverse effects at doses of 1 mg per day and below and declines to derive a safe reference value on the data available.

An opinion of that shape is the usual precursor to either a national maximum level or a renewed classification push, and Germany has been among the member states pressing the Commission for harmonised maximum levels.

Cronología

June 1996

BfArM and BgVV jointly hold that melatonin is a medicinal product requiring authorisation, and that this assessment is dose-independent. On that view melatonin is not marketable as a food supplement. The final classification decision is left to the food supervision authorities of the individual Laender.

Bundesinstitut fuer Risikobewertung (BfR)

March 2021

The Frankfurt Higher Regional Court (6 U 2/15) holds that a melatonin product dosed at 0.5 mg twice daily - 1 mg per day - is a food supplement rather than a functional medicinal product, finding no appreciable influence on metabolism at that dose.

SBS Legal

October 2021

The North Rhine-Westphalia Higher Administrative Court (13 A 1376/17) reverses the Cologne Administrative Court, finding no basis for treating the melatonin product before it as a functional medicinal product.

SBS Legal

Septiembre de 2024

BfR Stellungnahme 42/2024 warns against uncritical use of melatonin food supplements, notes undesirable effects reported at doses of 1 mg per day and below, and states that the available data are insufficient to derive a safe toxicological guidance value.

Bundesinstitut fuer Risikobewertung (BfR)