Launching food supplements in the European Union: the notification conundrum

The notification requirements for placing food supplement products on the market depend largely on which country in the European Union (EU) companies intend to launch their products. According to the 2002 EU Food Supplement Directive countries (Member States) can choose whether or not to require product notification, to facilitate the efficient monitoring of food supplements entering their market.

One thing to remember is that food supplement notification has generally nothing to do with having your product approved in your EU country of choice. It is simply a way of informing the authorities that you have introduced or intend to introduce the product into the market.

Countries such as Austria, the Netherlands, Sweden and the UK do not expect food supplement notification when entering the market, relying instead on post-marketing controls. In other countries where forms of notification do exist the procedures differ, but it is useful to know that the information needed does not differ that much for those food supplement products containing mainly vitamins and minerals. In Finland completing the required form, gathering some administrative information, submitting of a copy of the label and paying a 25 euro fee results in your company having completed the notification procedure. In other countries, notification requires submitting of a copy of the label and general product information, as well as proof that the product is legally sold in another EU Member State — a principle of mutual recognition/ free movement of goods whereby the Member State should normally accept the product notification. France operates on this principle and in 2006 included a provision in its food supplements Decree outlining such a notification/authorisation via mutual recognition.

Many Member States have introduced a notification system, and in principle (although there are exceptions) forwarding a model of the label fulfils the notification requirement. In practice however, this is often not sufficient due to, for example, the use of substances other than vitamins and minerals in food supplements, and the still used risk assessment/authorisation approach.

Other substances have not been harmonised across the EU and as a result notification especially for these substances may require completing a form, providing detailed product information, submitting safety data and so on. Additionally, Member States, many of whom used an authorisation procedure before the 2002 Food Supplement Directive came into force, continue to follow the product risk assessment/authorisation approach — a procedure primarily applied when a food supplement contains non-authorised ingredients or is not marketed in any other Member State. Countries applying this approach, such as Denmark and Latvia, will decide on a case by case basis whether or not the food supplement in question is acceptable in their market.

It is interesting to see how the different EU countries have applied notification procedures within their national laws. It is also clear that an analysis of the broad range of systems across the EU and an understanding of the different national requirements is imperative for companies considering a pan-EU launch of food supplement products.

Pieter Lagae, Regulatory Adviser, EAS, 50 Rue de l'Association, 1000 Brussels, Belgium. Tel: (+32 2) 218 14 70, Fax: (+32 2) 219 73 42, email [email protected], visit

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