Is Melatonin legal in France?

Formal status

There is no EU-harmonised limit for melatonin in food supplements - each member state sets its own rule.

France permits food supplements containing under 2mg melatonin per day via an ongoing DGCCRF administrative tolerance, underpinned by ANSES's 2018 safety opinion. At 2mg and above, melatonin is a medicinal product requiring a prescription (e.g. Circadin 2mg). This is long-standing and well-established, and entirely separate from the DGAL cannabinoid enforcement affecting CBD and CBN.

Do we sell here?

Yes: Sleep spray, Sleep capsules.

Melatonin is straightforward in France, unlike the cannabinoids in the same formula. Our 1mg dose sits comfortably inside the under-2mg supplement threshold, so there's no grey area here - at 2mg and above it would be a prescription medicine, and we're well clear of that line.

Outlook

No indication of tightening on melatonin specifically. ANSES has called for EU-level harmonisation of melatonin limits, which would be the most likely source of future change - worth a periodic check, but nothing pending.

Timeline

September 2011

Arrete removes 1mg melatonin from France's poisonous-substances list, opening the door to its sale as a food supplement

ANSES nutrivigilance opinion

March 2017

Conseil d'Etat annuls the 2015 arrete that had formally exempted melatonin supplements from poisonous-substances rules; current legal basis becomes DGCCRF administrative tolerance rather than a standing arrete

Le Moniteur des Pharmacies

June 2018

ANSES publishes opinion recommending food supplements stay under 2mg/day melatonin; this remains the basis of the current DGCCRF administrative tolerance for supplement-status sale

ANSES