Is melatonin permitted in food supplements?
Direct answer
In France, melatonin is covered by the supplement framework described by DGCCRF on 15 November 2022, with a boundary linked to medicinal classification: according to that text, a supplement cannot reach 2 mg per daily portion. This does not establish a harmonised status or dose throughout the EU. [dgccrf] [anses]
Regulatory status
The ANSES opinion dated 24 December 2024 reports a daily amount of 1.9 mg used in France and DGAL’s question about retaining it. The committee does not take a position on inclusion in the draft Order without a risk assessment. The draft is not presented as a new Order in force. [anses-2024]
Authority concern, specified context In its opinion of 23 February 2018, ANSES advises against these supplements notably for pregnant or breastfeeding women, children and adolescents, people with inflammatory or autoimmune diseases and those needing sustained alertness. It calls for medical advice for certain conditions and treatments, and recommends occasional use. These recommendations are those of the agency. [anses] [dgccrf]
Restrictions and conditions of use
Authorised claim: melatonin contributes to the alleviation of subjective feelings of jet lag. At least 0.5 mg per portion; information on the effect obtained with at least 0.5 mg close to bedtime on the first day of travel and the following few days after arrival. [eu-432]
Authorised claim: melatonin contributes to the reduction of time taken to fall asleep. Food containing 1 mg per quantified portion; information that the effect is obtained by consuming 1 mg close to bedtime. [eu-432]
Dated primary sources
DGCCRF, compléments alimentaires à base de mélatonine. Text : 2022-11-15. Consulted : 2026-10-31. Page 2, note 2 et recommandations ; page 1, deux allégations..
DGCCRF distinguishes food supplements from medicines by function and recalls claim conditions.
Un complément alimentaire ne peut pas apporter une dose équivalente à 2 mg de mélatonine par portion journalière (dose journalière correspondant à celle d’un médicament délivré sous prescription médicale) sous peine d’être qualifié de médicament par fonction.ANSES, avis 2016-SA-0209 sur la mélatonine. Text : 2018-02-23. Consulted : 2026-10-31. Conclusions, populations et usage ponctuel ; source officielle indexée et reprise intégrale des recommandations par la DGCCRF, page 2. Accès direct au PDF : 403..
The opinion distinguishes populations advised against use and those for whom medical advice is recommended.
les femmes enceintes ou allaitantes
les enfants et les adolescents
limiter la prise de ces compléments alimentaires à un usage ponctuelANSES, avis 2023-SA-0216 sur un projet de révision. Text : 2024-12-24. Consulted : 2026-10-31. Rubrique 3.1.12, mélatonine ; passage officiel indexé. Projet d’arrêté, pas acte adopté ; accès direct 403..
The opinion reports French practice at 1.9 mg/day and considers a draft; it is not a new regulatory authorisation.
la DJM actuellement utilisée en France (1,9 mg, fondée sur la dose pharmacologique de 2 mg/j)
ne se prononce pasRèglement (UE) n° 432/2012, mélatonine. Text : 2012-05-16. Consulted : 2026-10-31. Annexe, deux lignes Melatonin et leurs conditions ; texte anglais officiel indexé, traductions officielles es/de/it téléchargées..
Two claims are regulated; their authorisation does not generally authorise all melatonin products.
Melatonin contributes to the alleviation of subjective feelings of jet lag
The claim may be used only for food which contains at least 0,5 mg of melatonin per quantified portion. In order to bear the claim, 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.
Melatonin contributes to the reduction of time taken to fall asleep
The claim may be used only for food which contains 1 mg of melatonin per quantified portion. In order to bear the claim, information shall be given to the consumer that the beneficial effect is obtained by consuming 1 mg of melatonin close to bedtime.Limits of the data
The two claims and conditions are read from health_claim. The French substance limit table has no melatonin row; the French boundaries above are attributed to administrative documents, not invented in that table. No current national rule for another country is inferred from product declarations in the database. [dgccrf] [eu-432]
Last verification
2026-10-31