Ingredients

Melatonin

Melatonin has no single status in the EU. The same product can be a food supplement in one country, a medicine in another and unlawful as a supplement in a third, while EU law authorises two health claims for it.

At a glance

EU status

No harmonised rule. Not in Directive 2002/46/EC Annexes I or II; no binding EU action found

Nutrient reference value

None

EFSA upper level

None. The German BfR says no health-based guidance value could be derived

Authorised claims

Two, on jet lag and time taken to fall asleep

EU-authorised medicine

Circadin 2 mg prolonged-release, prescription only, for short-term treatment of primary insomnia in people aged 55 or over

Why the status varies

Whether a product is a food or a medicine is decided nationally, case by case, on its presentation and its function: see borderline products. Because melatonin has a pharmacological effect, regulators reach different answers, usually by reference to dose. In June 2024 a report from the Heads of Food Safety Agencies noted that many Member States urgently need to determine a maximum daily dose or restrict products aimed at children, but suggested putting submission of the issue to the Commission on hold because the topic is so complex.

National positions

These positions can change, and the French one has not been rechecked since 2018. Older figures for other countries circulate online, but we list only those we could trace to an official source.

Authorised health claims

Two claims appear in Regulation (EU) No 432/2012. "Melatonin contributes to the alleviation of subjective feelings of jet lag" may be used for food with at least 0.5 mg per quantified portion. "Melatonin contributes to the reduction of time taken to fall asleep" may be used for food with 1 mg per quantified portion. An authorised claim does not make a substance lawful as a supplement everywhere: the 1 mg condition is above the Dutch 0.3 mg line, and Ireland does not permit melatonin in supplements at all.

Who should avoid it

In 2018 France's food safety agency ANSES advised that melatonin food supplements should not be consumed by pregnant and breastfeeding women, children and adolescents, people with inflammatory or autoimmune diseases, and people doing any activity requiring sustained vigilance where drowsiness could pose a safety problem. It advised people with epilepsy, asthma, or mood, behaviour or personality disorders, and anyone taking medication, to seek medical advice first. It also called for a harmonised European framework.

In 2024 the German BfR likewise excluded children and adolescents from uncontrolled use, and cautioned people with reduced liver or kidney function, autoimmune disease or epilepsy, naming antihypertensives, anticoagulants and antidepressants among possible interactions. This page does not give dosing advice.

Frequently asked questions

Is melatonin a medicine or a food supplement in the EU?

It depends on the country and the dose. There is no harmonised EU rule: some countries accept low-dose supplements, some treat higher doses as medicines, and Ireland does not permit melatonin in supplements.

Can melatonin be sold in a parapharmacy?

Only where it is lawfully a food supplement. If a national authority classifies a product as a medicine, it stays in the pharmacy channel. Spain's AEMPS has withdrawn 3 mg products on this basis.

Which health claims are allowed for melatonin?

Two: that it contributes to the alleviation of subjective feelings of jet lag, and that it contributes to the reduction of time taken to fall asleep. Each has conditions on the amount per portion.

Last reviewed: November 2026.