Is Melatonin legal in Portugal?

Formal status

There is no EU-harmonised maximum for melatonin in food supplements. The question is governed nationally, and member state positions range from a prescription-only classification to caps of several milligrams.

Portugal sets a national maximum of 1 mg per daily dose, in a 2016 opinion of the food and veterinary directorate on the boundary between medicines and food supplements. The directorate accepts notifications only for supplements at or below that figure and not intended for children. This is a borderline-product classification under food law, not a medicines or narcotics measure, and it is an agency opinion rather than a decree. Melatonin is not prescription-only in Portugal at supplement doses; an authorised 2 mg melatonin medicine exists separately and does not close the food route.

Do we sell here?

Yes: Sleep spray, Sleep capsules.

Yes. Portugal sets a national maximum of 1 milligram of melatonin per daily dose in food supplements, and our Sleep formula contains exactly 1 milligram.

There is no grey area here. The dose sits inside the Portuguese rule, melatonin is freely sold at that strength in Portuguese pharmacies, and no prescription is required.

For the fuller picture on our hemp extract, see our CBD page for Portugal.

Outlook

Portugal's melatonin position has been stable since 2016 and there is no sign of it moving. Because the figure rests on an agency opinion rather than a decree, as noted above, it is in principle easier to change than a published regulation would be, so it is worth watching. The Portuguese retail market has settled firmly around the 1 mg figure.

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DGAV publishes its borderline-products opinion on melatonin, setting a maximum of 1 mg per daily dose in food supplements and accepting notifications only at or below that figure

DGAV, Parecer melatonina (via INFARMED)