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Companies located in a European Union country other than Spain that wish to notify or register the market placement of food supplements must first be registered as food business operators in their respective country.

Once this step is satisfied, to market a food supplement in the EU, it must be notified either prior to or simultaneously in each country where it will be marketed. The pre-market authorisation procedure will be made to the competent Health Authority of each European Union country. As it happens in Spain at the level of Autonomous Communities, each EU country has established its own notification procedure, resulting in significant variability in the approach depending on the country.

Generally, in all EU countries, the food supplements pre-market authorisation is required, although there are some exceptions, such as Austria, Slovenia, the Netherlands, and Sweden, where this prior procedure does not currently exist.

Additionally, each country has developed its own national regulations based on the European Directive regulating food supplements in the European Union (Directive 2002/46 on food supplements). As a result, many countries have established maximum and minimum amounts for certain ingredients such as vitamins and minerals, lists of other substances with nutritional or physiological effects and their quantity limitations, positive and/or negative lists of plants or botanical species that can be used in the manufacture and marketing of food supplements, and safety warnings in many cases. Similarly, the notification fees applied in each EU country vary significantly, ranging from 0€ in countries like Portugal or France to 295€ imposed by Belgium.

The following map shows the different notification fees applicable for the current year for food supplements:

At LexSupplements Food Legal Consultancy, we specialize in the review and registration of food supplements in most European Union countries. Contact us for more information about our services.