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Is Melatonin legal in Croatia?

Formal status

There is no EU-harmonised limit for melatonin in food supplements - each member state sets its own rule.

Croatia sets 1 mg per day. The Ministry of Health's regulation on substances that may be added to food, published in the official gazette in December 2013, caps melatonin in food supplements at that level; products containing more than 1 mg that had already been notified were given until 30 June 2014 to clear the market. Melatonin above that level 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?

Melatonin is straightforward in Croatia. The national limit for food supplements is 1 mg a day and our dose is exactly that - inside the limit, 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 2013 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.

Timeline

December 2013

The Ministry of Health's regulation on substances that may be added to food (Narodne novine 160/2013) 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

Ingredients

Browse legality of our other ingredients in Croatia.