Is Melatonin legal in Croatia?

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

Formal status

There's no single EU rule on melatonin in food supplements: each member state has gone its own way, and the range of outcomes is wide.

Croatia sets 1 mg per day. The Ministry of Health's regulation on substances that may be added to food, issued on 31 December 2013 and in force from 1 January 2014, has capped melatonin in food supplements at that level ever since. Melatonin above 1 mg falls to be treated as a medicine, and the 2 mg prolonged-release melatonin medicine authorised across the EU sits above the supplement line.

A compliant supplement route is therefore fully available in Croatia, entirely separate from the cannabinoid position affecting the rest of the formula.

Do we sell here?

Yes: Sleep spray, Sleep capsules.

Melatonin is straightforward in Croatia. The national limit for food supplements is 1 mg a day and our dose is exactly that, with the 2 mg prescription medicines sitting above the line. This is the one ingredient in the formula with a clear, settled answer in this market.

Outlook

Croatia's 1 mg ceiling has been in place since the start of 2014 with no indication of movement, and it aligns with the dose EFSA assessed for the authorised sleep-onset claim. Any future change would most likely come from EU-level harmonisation of melatonin limits rather than from a Croatian initiative.

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The Ministry of Health's regulation on substances that may be added to food (Narodne novine 160/2013), issued on 31 December 2013 and in force from 1 January 2014, caps melatonin in food supplements at 1 mg per day. Products containing more than 1 mg that had already been notified were permitted on the Croatian market until 30 June 2014.

Narodne novine 160/2013