Is Melatonin legal in Spain?

Situación jurídica

There is no EU-harmonised rule for melatonin. It sits outside the cannabinoid framework entirely and is governed nationally, with limits ranging from 0.3 mg in Belgium to 2 mg in Spain and no limit at all in several member states. The one EU-level figure is the authorised health claim in Regulation (EU) 432/2012, conditional on 1 mg per quantified portion.

Spain draws the line clearly and has done so for over a decade. 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 through ordinary notification. AESAN published those conditions of use on 4 July 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.

¿Vendemos aquí?

Sí: Sleep spray, Sleep cápsulas.

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 a higher-dose one in 2024. 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.

Perspectivas

Settled since 2013 and enforced only at the top end. AEMPS withdrew a 3 mg supplement in 2021 and AESAN alerted on a product above the limit in April 2024, with AEMPS ordering its withdrawal 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.

Cronología

July 2013

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

Abril de 2024

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.

AESAN alert 2024/15 and AEMPS