Is Melatonin legal in Luxembourg?

Situación formal

Melatonin sits outside any EU-harmonised framework for food supplements. Member states set their own rules, and those rules differ considerably from one country to the next.

Luxembourg is unusual in having no list of its own. Its food safety authority states that there is no positive list in Luxembourg for plants and other substances that may be used in manufacturing food supplements, and that the lists established in other Member States serve as the reference for the competent authorities. Melatonin is an other substance in that sense, so Luxembourg sets no national maximum for it and no Luxembourg decision reclassifying it as a medicine was identified.

Which reference applies is unresolved, and it matters: Luxembourg's immediate neighbours diverge, with Belgium at 0.3 mg per day and France permitting below 2 mg.

¿Vendemos aquí?

Yes, for now: Espray para dormir, Cápsulas para dormir.

Luxembourg is unusual: it does not maintain its own list of permitted substances and maximum doses for food supplements. Its food safety authority says plainly that lists drawn up in other EU member states serve as the reference for Luxembourg's competent authorities. That leaves melatonin without a Luxembourg number.

We would rather set out the awkward part than leave it. Luxembourg's neighbours disagree sharply - Belgium caps melatonin at 0.3 mg, France allows up to 2 mg - and the melatonin supplements we can see on Luxembourg pharmacy shelves are formulated at 0.29 mg, which is the Belgian figure. Higher doses appear in Luxembourg as over-the-counter medicines rather than as supplements. We cannot rule out that a Luxembourg assessment would reach for the Belgian number, in which case our 1 mg would be over it.

We have found no Luxembourg enforcement against melatonin supplements at any dose, and no Luxembourg rule that our product breaches. That is the basis on which we currently ship. We are putting the question to the Luxembourg authorities directly, and we will say so here when we have an answer.

Perspectivas

This is the least settled part of our Luxembourg position and the one we most want an answer on. Because Luxembourg defers to other member states' lists rather than publishing its own figure, the position could be clarified at any time without any change in Luxembourg law - simply by an authority stating which reference it applies.

A direct written query to the Luxembourg food safety authority is the step that resolves it. Watch also for any move toward a national list, which several member states have made in recent years and which would replace the current ambiguity with a number.