Is Melatonin legal in Austria?

Formal status

There is no EU-harmonised rule on melatonin in food supplements. It is governed nationally, and member states have taken very different views, from an outright medicine classification to no rule at all. What is harmonised is the health claim: Regulation (EU) No 432/2012 authorises the statement that melatonin contributes to the reduction of time taken to fall asleep, and conditions it on the food containing exactly 1 mg of melatonin per quantified portion.

Austria has set no maximum. There is no legislative determination of permissible maximum quantities of melatonin in food supplements, and no figure has been published by the health ministry, the food safety agency or the medicines agency. Austria also requires no notification or registration of food supplements at all.

What Austria does have is a medicines-side entry: melatonin has been listed as prescription-only in the prescription-requirement ordinance since 23 June 2009, and unusually it carries no over-the-counter exception where comparable substances do. That ordinance governs medicinal products. Austria runs melatonin as a dual-status substance, and the market resolves the question in practice: melatonin food supplements are openly sold at 1 mg, 1.9 mg and 3 mg per daily dose, including an oral sleep spray at 1 mg per daily dose made by an Austrian manufacturer and labelled as a food supplement.

One Austrian threshold does exist, and it is a customs one. Austrian courts apply the EU combined nomenclature explanatory notes, under which a daily dose of 2 mg or more of melatonin has a therapeutic or prophylactic effect and brings the product within tariff position 3004. That classification matters because Austria prohibits private consumers receiving medicinal goods ordered at a distance.

Do we sell here?

Yes: Sleep spray, Sleep capsules.

Yes, and this one is straightforward.

Austria has set no maximum dose for melatonin in food supplements. There is no national figure to sit inside or outside, and no notification requirement for supplements either. Our 1 mg per daily dose is also exactly the amount the EU-authorised sleep claim is conditioned on, so it is the standard dose rather than an unusual one.

Austrian practice bears that out. Melatonin supplements are openly sold in Austria at 1 mg, 1.9 mg and 3 mg per daily dose, including an oral sleep spray at 1 mg per daily dose made by an Austrian manufacturer, in the same format as our Sleep Spray. We are inside established local practice, not testing its edge.

Austria does treat melatonin as prescription-only when it is sold as a medicine, which is a separate track from food supplements and is how several EU countries handle the same substance. It does not affect a 1 mg supplement.

Outlook

Austria has managed melatonin without a maximum dose for years and there is no sign of one being introduced. The market has settled around 1 mg to 3 mg per daily dose in supplement form, with an Austrian manufacturer selling an oral spray at the same 1 mg dose we use, so our position sits inside established domestic practice rather than at its edge.

The one Austrian figure to keep an eye on is the customs threshold of 2 mg per daily dose, above which melatonin is treated as a medicinal good for import purposes. That figure comes from EU explanatory notes rather than Austrian law, so it could move without any Austrian decision. We sit at half of it.

Timeline

June 2009

Melatonin is added to the Austrian prescription-requirement ordinance as prescription-only with no over-the-counter exception, an entry that governs medicinal products and sits alongside melatonin's continued sale as a food supplement.

BGBl. II Nr. 183/2009

October 2022

The Vienna Administrative Court quashes a penalty imposed on a consumer whose postal consignment of 5 mg melatonin tablets was seized under the Medicinal Goods Import Act, and discontinues the proceeding.

Verwaltungsgericht Wien, VGW-001/042/8466/2022

March 2023

The Lower Austria Administrative Court quashes, on formal grounds, a penalty imposed on a consumer over a seized consignment of 3 mg melatonin tablets.

Landesverwaltungsgericht Niederösterreich, LVwG-S-3059/001-2022

March 2024

The Vienna Administrative Court upholds the conviction and forfeiture of a consumer who imported 720 units of 5 mg melatonin from the United States, recording that a daily dose of 2 mg or more brings melatonin within customs tariff position 3004 and so within the Medicinal Goods Import Act.

Verwaltungsgericht Wien, VGW-001/032/13278/2023

September 2024

A joint customs, consumer-health and food-safety control action at the Vienna postal distribution centre examines 50 parcels of food supplements ordered from outside the EU; 44% were objected to and 21 were unauthorised novel foods, returned to sender under customs supervision with no penalty on the recipient.

BMF / BAVG / AGES press release

February 2025

The Tyrol Administrative Court upholds forfeiture and a reduced fine against a consumer whose consignment of 1,300 units of 10 mg melatonin from the United States was seized under the Medicinal Goods Import Act.

Landesverwaltungsgericht Tirol, LVwG-2024/37/2824-4

September 2025

The health ministry publishes its foreign-webshop control figures for 2024: 150 controls with a 62% objection rate, including 77 food supplements checked and 40 objected to, under a federal programme that expressly claims competence over sellers established in other EU and EEA states.

BMSGPK, Internetkontrolle (Stand 01.09.2025)