Is Melatonin legal in Spain?

Liquid error (blocks/custom-liquid line 4): The format option 'legality_date' is not a supported format.

A flag of Spain, next to the chemical structure of Melatonin

Formal status

There's no single EU rule on melatonin in food supplements — each member state has gone its own way, and the range of outcomes is wide.

Spain draws the line clearly and has done so for over a decade. The Spanish medicines agency considers melatonin a medicinal product when incorporated into supplements in quantities greater than 2 mg per day; at or below that level the food supplement route is available through ordinary notification. The food safety agency published those conditions of use in 2013, replacing a more restrictive dose-independent stance Spain had taken in 2010.

A 1 mg daily dose therefore sits at half the Spanish limit.

Do we sell here?

Yes: Sleep spray, Sleep capsules.

Spain treats melatonin as a medicine only above 2 mg per day. Below that it is an ordinary food supplement, and our 1 mg sits at half the limit - the most comfortable margin we have anywhere in Europe.

Spanish regulators do act in this area, but only against products above the line: a 3 mg supplement was pulled in 2021, and higher-dose products again in 2024 and 2026. That enforcement works in our favour rather than against it, because it clears out products that are not playing by the rules.

There is no grey area here for us.

Outlook

Settled since 2013 and enforced only at the top end. The Spanish medicines agency withdrew a 3 mg supplement in 2021, and in April 2024 the food safety agency alerted on a product above the limit which the medicines agency then ordered withdrawn as an unauthorised medicine - the pattern to expect, and one that works in favour of a compliant product by clearing out those that are not.

There is no sign of Spain moving the figure. If European practice continues to tighten - Greece to 1 mg in 2024, the Netherlands treating 0.3 mg and above as a medicine - Spain's 2 mg would become an outlier, and that is the direction worth watching rather than any Spanish proposal currently on the table.

Translation missing: en.legality.timeline.heading

Liquid error (sections/custom-liquid line 116): The format option 'legality_timeline_date' is not a supported format.

AESAN publishes the updated conditions of use for melatonin in food supplements: AEMPS considers melatonin a medicinal product when incorporated into supplements in quantities greater than 2 mg per day. At or below that level the food supplement route is available. Products already notified above the threshold were required to amend their labelling.

AESAN and AEMPS conditions of use, via Gobierno Vasco

Liquid error (sections/custom-liquid line 116): The format option 'legality_timeline_date' is not a supported format.

AESAN issues an alert for the presence of melatonin above the permitted limit in a food supplement, and AEMPS orders the withdrawal of the product Melatonin 7 capsulas as an unauthorised medicinal product because its melatonin content exceeds the dose permitted for a supplement.

AEMPS

Liquid error (sections/custom-liquid line 116): The format option 'legality_timeline_date' is not a supported format.

AESAN issues alert ES2026/543 over Melatonin Time Release by Haya Labs, a food supplement of United States origin containing 5 mg of melatonin per tablet. The product is withdrawn from distribution and consumers holding units are told not to consume them. The alert does not restate the 2 mg daily ceiling above which melatonin is treated as a medicine in Spain.

AESAN food alert ES2026/543

Ingredients

Browse legality of our other ingredients in Spain.