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At a glance
The two authorised melatonin claims, quoted exactly
Under Regulation (EC) No 1924/2006, a health claim is lawful only if it appears on the Union list. Two melatonin claims appear in the Annex to Commission Regulation (EU) No 432/2012. Here they are, with their conditions of use, verbatim:
“Melatonin contributes to the reduction of time taken to fall asleep.”
Conditions of use: the claim may be used only for food which contains 1 mg of melatonin per quantified portion. Information shall be given to the consumer that the beneficial effect is obtained by consuming 1 mg of melatonin close to bedtime.
“Melatonin contributes to the alleviation of subjective feelings of jet lag.”
Conditions of use: the claim may be used only for food which contains at least 0,5 mg of melatonin per quantified portion. Information shall be given to the consumer that the beneficial effect is obtained with a minimum intake of 0,5 mg to be taken close to bedtime on the first day of travel and on the following few days after arrival at the destination.
Three consequences follow from that text and are frequently missed.
The sleep-onset claim requires exactly 1 mg per quantified portion, not “at least”. A 0.5 mg product may carry only the jet lag claim. The mandatory consumer information is part of the condition of use, so the claim is non-compliant without it on pack.
And no other melatonin claim is lawful in the EU. “Improves sleep quality”, “helps you stay asleep”, “supports deep sleep”, “regulates your body clock” and “antioxidant” are all unauthorised.
For CBD there is nothing to quote. No health claim for cannabidiol, hemp extract or any cannabinoid appears on the Union list, and Article 10(3) additionally prevents general wellbeing language in the absence of an authorised claim.
Melatonin is a clock, not a sedative
This is the misunderstanding that shapes everything else.
Melatonin is produced by the pineal gland on a daily rhythm, low in daylight and rising at night. That rhythm is set by the suprachiasmatic nucleus, the master clock in the brain, entrained by light. Melatonin then feeds back onto that clock, acting at two receptors, MT1 and MT2, which reduce firing in the clock nucleus and shift its phase.
So melatonin’s primary and best-evidenced action is signalling time of day rather than inducing sleep. This is why timing of a dose matters more than its size, and why the strongest evidence concerns situations where the internal clock is misaligned with the external one.
The jet lag evidence is genuinely good. A Cochrane review of ten trials found nine showed melatonin taken close to target bedtime reduced jet lag after crossing five or more time zones, with a number needed to treat of 2.
The effect size on ordinary sleep is modest
The most cited meta-analysis, published in PLOS ONE in 2013, found melatonin reduced time to fall asleep by roughly 7 minutes and increased total sleep time by roughly 8 minutes. A 2022 meta-analysis of 23 trials found a meaningful improvement in subjective sleep quality overall, with high heterogeneity, and no significant benefit in mental disorders or neurodegenerative disease.
Note that the authorised EU claim wording is carefully proportionate to that evidence. It says melatonin contributes to reducing the time taken to fall asleep. It does not say melatonin improves sleep, and it certainly does not say melatonin treats insomnia, which would be a medicinal claim taking the product out of food law entirely.
Taking them together
Combination products exist. CBD inhibits several cytochrome P450 enzymes. Melatonin is metabolised primarily by CYP1A2, which CBD affects less than the enzymes it strongly inhibits, so the specific interaction risk between these two is lower than for many combinations. If you take other medication, the CBD component is the part to raise with a prescriber.
Separately, if a product also contains CBN, preclinical work published in 2025 suggests a CBN and melatonin interaction that has not been characterised in humans.
The dose question
The EU claim conditions sit at 0.5 mg and 1 mg, close to that evidence. High-dose products sold in some other markets satisfy neither claim condition as drafted and have no efficacy justification.
CBD’s characterised pharmacology is not obviously sleep-related either, though one of its most potent actions, blocking the ENT1 adenosine transporter, is mechanistically interesting given adenosine’s role in sleep pressure. Interesting is not demonstrated.
Legal status and safety
Melatonin has a dual status in Europe. As a medicine, Circadin holds an EU-wide marketing authorisation, and Slenyto is authorised for specific paediatric indications. As a food supplement it is permitted in most member states, with the two authorised claims above.
CBD is an unauthorised novel food throughout the EU. No CBD novel food has been authorised. EFSA’s February 2026 provisional safe level of 0.0275 mg per kilogram of body weight per day, roughly 2 mg for a 70 kg adult, applies to CBD isolate of at least 98 percent purity, and safety could not be established for anyone under 25, for pregnant or breastfeeding women, or for people taking medication.
Frequently asked questions
Only in the exact authorised wording, at the exact dose, with the mandatory consumer information. Broader sleep claims are not permitted.
No. No cannabinoid claim is authorised, and general wellbeing language is also excluded.
The authorised claims sit at 1 mg for sleep onset and at least 0.5 mg for jet lag. The physiological evidence sits around 0.3 mg.
Timing matters more than dose. The authorised claims both specify close to bedtime.
Both, depending on dose and presentation. Circadin is an authorised medicine; lower-dose supplements are food.
References
Commission Regulation (EU) No 432/2012, Annex, melatonin entries.
Ferracioli-Oda E, Qawasmi A, Bloch MH. PLoS ONE 2013;8:e63773.
Herxheimer A, Petrie KJ. Cochrane Database Syst Rev 2002.
Liira J et al. Cochrane Database Syst Rev 2014.
Fatemeh G et al. J Neurol 2022;269:205-216.
Liu J et al. Annu Rev Pharmacol Toxicol 2016;56:361-383.
Erland LAE, Saxena PK. Melatonin Natural Health Products and Supplements: Presence of Serotonin and Significant Variability of Melatonin Content. J Clin Sleep Med 2017;13:275-281.
EFSA Journal 2026;24:9862.
Last reviewed 1 September 2026.
Educational information about published research and European regulation. Not a health claim.