If you manufacture food supplements outside Europe and want to sell them here, the first thing to understand about food supplements in the EU is counter-intuitive: there is no single European licence, and no EU authority that «approves» your product before it reaches the market. Food supplements are regulated as food, not as medicines, so the responsibility to place a legal product on the market sits with you and your EU-based operator — and it is verified after launch, not before. That freedom is also the trap: a product that is perfectly legal in the United States, Brazil or China can be illegal in the EU on day one, and you often find out only when a customs inspection or a national authority stops it.
Food supplements in the EU: no EU-wide licence, only national notification
Food supplements are governed at EU level by Directive 2002/46/EC. Because it is a directive and not a regulation, it is transposed into national law by each Member State, and several key points are left to national discretion. In practice there is no «EU registration»: you notify each country where you sell, in the way that country requires. In Spain, for example, the marketing company must be listed in the national food-business register (RGSEAA) and file a market notification when the product is first placed on the market; sell the same product in France, Italy or Belgium and you face a different procedure each time. Planning the route country by country — usually starting from the Member State where your EU operator is established — is the single most important decision of the whole project.
Which vitamins, minerals and substances you may use
The Directive harmonises two things across the EU: the list of vitamins and minerals that may be used, and the chemical forms in which they are allowed. Those permitted forms are set out in Regulation (EC) No 1170/2009. If your formula relies on a vitamin salt or a mineral source that is not on that list, the product is not legal, however common that ingredient may be elsewhere. What the EU has not harmonised matters just as much: there are still no EU-wide maximum levels for vitamins and minerals in supplements, so the safe upper amounts are set nationally and differ from country to country. Botanicals, amino acids and other substances beyond vitamins and minerals are also governed nationally, which is why a botanical extract accepted in one Member State can be restricted in another.
Novel food: the question that stops most launches
Before anything else, check whether any ingredient is a «novel food». Under Regulation (EU) 2015/2283, any food or ingredient not consumed to a significant degree in the EU before 15 May 1997 needs a specific EU authorisation before it can be sold — and that authorisation is granted to the applicant, not to the ingredient in general. The European Commission’s Novel Food Catalogue is the first place to look, though it is a guide and not an exhaustive legal list. Many market-entry projects for exotic botanicals, new peptides or fermentation-derived ingredients stop precisely here: without novel-food clearance the supplement cannot be placed on the EU market at all. We treat this as the gate everything else depends on, and cover it in detail in our guide on importing supplement ingredients and novel food.
Labelling: what every pack must show
Food-supplement labels must satisfy both the specific rules of Directive 2002/46/EC and the general food-information rules of Regulation (EU) No 1169/2011. That means, among other things, the name «food supplement», the amount of nutrients or substances per recommended daily dose, a warning not to exceed that dose, a statement that supplements do not replace a varied diet, and a warning to keep the product out of the reach of children. Crucially, all mandatory information must appear in a language easily understood by consumers in the country of sale — a Spanish label is not automatically valid in Germany. Adapting the artwork market by market is part of the work, not an afterthought.
Health and nutrition claims: only what is authorised
Whatever you say about what the product «does» is tightly controlled by Regulation (EC) No 1924/2006. Only nutrition and health claims listed in the EU Register of authorised claims may be used, in the approved wording or a clear equivalent. Any claim that a supplement prevents, treats or cures a disease is forbidden outright — that language turns the product into an unlicensed medicine and is one of the fastest ways to trigger a market withdrawal. Marketing copy written for another market almost always needs rewriting before it is safe to use for food supplements in the EU.
Frequently asked questions
Do I need EU approval before selling a food supplement?
There is no pre-market approval of the product itself, but you must notify each Member State as its law requires and make sure every ingredient — especially novel foods — is legal. The legal responsibility rests with the EU operator placing the product on the market.
Can I use my existing US or Asian label in Europe?
Rarely without changes. Ingredient forms, permitted claims, mandatory warnings and the language requirement usually differ, so labels normally have to be rebuilt to EU rules.
Who can act as my responsible operator in the EU?
Any business established in the EU that places the product on the market — an importer, a distributor or a partner such as ASC Services acting on your behalf. Someone established in the EU must hold that responsibility.
How ASC Services helps you enter the EU market
We take a food supplement from a formula and a foreign label to a product that can be sold legally in Spain and the wider EU: novel-food screening, verification of vitamin and mineral forms, national notification, EU-compliant labelling and a claims review, plus the customs side when you import. If you are bringing supplements across the border, our guide on importing food supplements into Spain explains the customs and health-control steps. To discuss your product, use our contact page or see our advisory services; you can also follow regulatory updates in our news section.
