Is Melatonin legal in Hungary?

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. 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.

Hungary has set no maximum, and says so itself. The medicines and nutrition agency's published position records that neither the Hungarian food supplements decree nor any other national instrument contains a rule prohibiting or restricting the use of melatonin in food. Melatonin is also absent from Annex III of Regulation (EC) No 1925/2006.

What the agency does hold, in the same document, is a safety view with no numeric limb: that no minimum quantity of melatonin can be identified at which long-term regular consumption in a food supplement would be safe and free of side effects, and that marketing melatonin as a food supplement cannot therefore be regarded as safe and may present a public health risk. That is an agency opinion rather than a binding instrument, and it sets no figure.

Hungarian practice runs the other way. Melatonin food supplements at 1 mg per daily dose, made by a Hungarian manufacturer and carrying the EU-authorised sleep-onset claim, are stocked by Hungarian pharmacy and drugstore chains, while melatonin sold as a medicine in Hungary begins at 3 mg.

Do we sell here?

Not at the moment.

Hungary has no rule restricting melatonin in food supplements, and its own medicines agency says so: neither the Hungarian food supplements decree nor any other national instrument limits it. Our 1 mg per daily dose is also exactly the amount the EU-authorised sleep claim is conditioned on, and melatonin supplements at that same dose, made by a Hungarian manufacturer, are stocked by Hungarian pharmacy and drugstore chains today.

The same agency has separately published a view that selling melatonin as a food supplement cannot be considered safe. That view sets no figure and is not a binding rule, and the Hungarian market has plainly not followed it - but we would rather tell you it exists than leave it out.

We do not currently ship to Hungary, and melatonin is not the reason. See our CBD page for Hungary for the fuller country picture.

Outlook

Hungary's position on melatonin is unusual in being contested rather than settled: there is no national rule restricting it, and a published agency view that selling it as a supplement is not safe, with the market plainly following the first rather than the second. That tension has persisted since 2022 without resolving.

It could resolve in either direction. A national maximum would settle it, and if Hungary set one the natural place to look would be the 1 mg the EU-authorised claim is already conditioned on. Equally, the agency could act on its own opinion. We are watching for either.

Timeline

October 2022

The medicines and nutrition agency publishes its melatonin position, recording that neither the food supplement decree nor any other national instrument prohibits or restricts melatonin in food, while stating the agency's view that no minimum quantity can be identified at which long-term supplement use would be safe.

OGYÉI állásfoglalás (PDF creation date 2022-10-25; server last-modified 2022-10-26)