Is Melatonin legal in Belgium?

Formal status

There is no EU-harmonised rule on melatonin in food supplements. It is governed nationally, and member states differ widely - from outright medicine-only treatment to permitted doses of several milligrams. That absence of a common rule is itself the correct starting point.

Belgium sits at the restrictive end. The mixed commission on borderline products, which advises the medicines agency, has published an opinion that products delivering an oral daily dose of 300 micrograms of melatonin or more may be regarded as medicines on the basis of their pharmacological activity. Where a product is specifically presented for trans-mucosal absorption in the mouth or pharynx, bioavailability is higher and the figure falls to 200 micrograms. The opinion also advises against use in food supplements for children under 12.

The opinion carries no publication date, and the agency confirms it remains an advisory opinion rather than a ministerial guideline, so it has not been formally adopted as binding guidance.

Melatonin is separately available in Belgium as a registered medicine: at 3 mg over the counter for short-term jet lag, and at 2 mg prolonged-release on prescription.

Do we sell here?

Not at the moment.

We do not currently ship to Belgium, and melatonin is a large part of the reason.

Belgium treats melatonin as a medicine at doses most countries consider ordinary. The threshold is 0.3 mg a day for a swallowed product, and 0.2 mg where a product is designed to be absorbed in the mouth, as a spray is. Our formula delivers 1 mg, which sits above both. The Belgian market reflects this closely: supplements there top out around 0.29 mg, and above that melatonin is sold as a registered medicine.

We would rather say that plainly than quietly ship a product that Belgian rules would classify differently. A lower-dose formulation would be a real option if we chose to enter the market, and it is not something we can fix by reformulating around the edges - the threshold is well below where our formula works.

If the Belgian position changes, or if we bring a compliant formulation to that market, we will update this page.

Outlook

The Belgian threshold has been stable for years and the market has organised itself around it, which makes movement unlikely in either direction in the near term.

One institutional change is worth watching. The mixed commission that issued the opinion has been superseded by a new commission for borderline products, created by royal decree in July 2024. A newly constituted body reviewing an inherited, undated opinion is the most plausible route to the figure being revisited, confirmed or formally adopted as a ministerial guideline.

The distinction between the oral and trans-mucosal figures is also worth watching, because it is unusual: few countries set a separate, lower threshold for sprays and sublingual formats, and how strictly that limb is applied would matter to any spray product.

Ingredients

Browse legality of our other ingredients in Belgium.