Is Melatonin legal in the Netherlands?

Situación jurídica

There is no EU-harmonised rule for melatonin. It sits outside the cannabinoid framework entirely and is governed nationally, with limits ranging from 0.3 mg in Belgium to 2 mg in Spain and no limit at all in several member states. The one EU-level figure is the authorised health claim in Regulation (EU) 432/2012, conditional on 1 mg per quantified portion.

The Netherlands sets the lowest threshold in the EU, and it is conjunctive. The Minister for Medical Care set the position out in October 2019: melatonin may be marketed as a food supplement if the dose is below 0.3 mg and no health claim whatsoever appears on the packaging. Both conditions must hold.

On 1 April 2026 the Raad van State, the highest Dutch administrative court, upheld the Minister's appeals and confirmed that products whose dosing advice leads to an intake of 0.3 mg or more are regarded as medicinal products. The ruling preserves case-by-case assessment against the Court of Justice criteria rather than making the threshold mechanical.

The interaction with the EU health claim is worth noting: the authorised sleep claim requires at least 1 mg, which is more than three times the Dutch threshold, so a product formulated to make that claim is above the Dutch line by design.

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We don't sell to the Netherlands, and melatonin is a second and quite separate reason why.

The Netherlands sets the lowest melatonin threshold in Europe. A product may be sold as a food supplement only if the dose is below 0.3 mg and the packaging carries no health claim at all - both conditions, not either. Above that, Dutch law treats it as a medicine, and the highest Dutch administrative court confirmed that position in April 2026.

Our dose is 1 mg. That is more than three times the Dutch threshold, so our product would be a medicine there rather than a supplement - and the EU-authorised sleep claim that we can make in most of Europe needs at least 1 mg, which means the claim itself pushes a product over the Dutch line. There is no version of this product that works in the Netherlands without being a different product.

The main reason we don't ship there concerns CBD, and it is set out on our CBD page for the Netherlands.

Perspectivas

This position hardened rather than softened in 2026, and the regulator won at the highest administrative court, so expect continued confidence and activity rather than retreat.

The one nuance worth watching is that the ruling preserves case-by-case assessment, and records that one company was permitted to keep selling above the threshold while a marketing authorisation application was pending. That is a route through the medicines system rather than around it, and it is not a route a food supplement can take.

There is no sign of the Netherlands moving toward the levels used elsewhere in Europe. If anything, other member states have been moving toward the Dutch end.

Cronología

October 2019

The Minister for Medical Care answers parliamentary questions setting out the Dutch position on melatonin: Melatonine mag als voedingssupplement in de handel worden gebracht als de dosering lager is dan 0,3 mg en er op de verpakking geen enkele gezondheidsclaim wordt gevoerd. Melatonin may be marketed as a food supplement if the dose is below 0.3 mg and no health claim whatsoever appears on the packaging. The two conditions are conjunctive.

Aanhangsel Handelingen II 2019-2020 nr. 297

April 2026

Raad van State (ECLI:NL:RVS:2026:1846) upholds the Minister's appeals and confirms that producten met een doseeradvies die leidt tot inname van 0,3 mg melatonine of meer worden daarom beschouwd als een geneesmiddel - products whose dosing advice leads to an intake of 0.3 mg melatonin or more are therefore regarded as medicinal products. The ruling preserves case-by-case assessment against the Court of Justice criteria, and records that one company was permitted to continue selling above 0.3 mg pending the outcome of a marketing authorisation application to the CBG.

Raad van State