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. 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 the EU list of substances whose use in foods is prohibited, restricted or under scrutiny.
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.
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.
