There is no EU-harmonised rule on melatonin in food supplements. It is governed nationally, and member states differ widely: some set a maximum dose, some set none, and some treat it as a medicine at any strength.
Poland sets no national maximum. The advisory team on food supplements attached to the chief sanitary inspectorate has adopted a long series of resolutions on maximum levels, covering vitamins A, C, D, E and K and a range of minerals, and none of them concerns melatonin. Those resolutions are in any case opinions of an advisory body rather than law, which is why the national audit office has recommended that permitted and prohibited ingredients be set by regulation instead.
A figure of 1 milligram per daily portion circulates widely in Polish trade commentary. We could not trace it to any instrument, and on the evidence it is market convention reported as a rule rather than a published limit.
The boundary between supplement and medicine in Poland is not drawn by a dose line but by the general test of pharmacological effect and presentation. In practice the two channels overlap: melatonin food supplements are sold up to 1 milligram per daily portion, registered over-the-counter medicines are sold at 1, 3 and 5 milligrams, and prescription prolonged-release products exist at 2 and 3 milligrams.
Melatonin supplements at 1 milligram are openly and widely sold in both oral spray and capsule form, including own-brand products from a major national retailer and from pharmacy chains, carrying the authorised claim that melatonin helps reduce the time taken to fall asleep. No Polish agency position adverse to melatonin in supplements was found.
