Is Melatonin legal in Italy?

23 August 2026

A flag of Italy, next to the chemical structure of Melatonin

Situación formal

No EU-wide rule governs melatonin in food supplements; each member state decides independently, and the resulting positions vary widely.

Italy permits melatonin in food supplements up to 1 mg per day. The Ministry of Health set this ceiling by circular in 2013, reducing it from 5 mg to align with the EFSA-assessed dose supporting the authorised sleep-onset claim and to demarcate supplement use from the 2 mg prolonged-release melatonin medicines authorised in the EU. Above 1 mg per day the product falls to be treated as a medicine. Melatonin appears in the Ministry's "other substances" table with that intake limit, so a compliant supplement route is fully available - entirely separate from the cannabinoid prohibitions affecting the rest of the formula.

¿Vendemos aquí?

Not at the moment.

Melatonin is not the reason we don't sell 01 Sleep in Italy - our 1mg dose sits inside Italy's 1mg supplement ceiling, with no grey area. The product is unavailable there because of its CBD and CBN content.

Perspectivas

Italy's 1 mg ceiling has been stable since 2013 with no indication of movement. Given the reason it was set, described above, any future change would most likely follow EU-level harmonisation rather than an Italian initiative.

Timeline

June 2013

The Ministry of Health cuts the maximum melatonin content of food supplements from 5 mg to 1 mg per day, effective 30 September 2013, to align with the EFSA-assessed claim dose and to demarcate supplements from 2 mg melatonin medicines.

NutraIngredients