Product Registration

No. Food supplements must be notified in the Member States where they are intended to be placed on the market. There is no harmonized notification system making it possible to notify a product one to be used in all European countries.

Most EU countries, except for the Netherlands, Sweden and Austria currently have a notification or registration procedure in place for food supplements. The procedure ranges from a mere submission of the label to a factual pre-market authorization. In some EU countries, the procedure includes a stand-still period after the notification before the product may be placed on the market, but this is not the case everywhere.

The procedure depends on the respective Member State. Most common is the notification through an online system where relevant information concerning the product such as ingredients or recommended daily dose must be entered. Other Member States such as Spain or Portugal require to send a form via e-mail.

The procedure of notification differs per country, in general we can say that notifications can be placed by the food business operators themselves or by consultants. In some countries it is necessary to have a local consultant to manage all administration and the procedure.

The cost of a notification differs from Member State to Member State. While countries like Germany, France or Portugal do not charge any fee, the costs for a first notification in other countries charge up to 200 € and Denmark charges an annual fee of 9382 DKK (1259 €) for companies whose turnover exceeds 50 000 DKK (6700 €) and an annual fee of 751 DKK (100,76 €) per registered product.

Strategically, the best choice is Belgium. The rules and practices are clear and the authorities have a high level of expertise recognized by other member states. This provides legal certainty. In addition, the Belgian legislation is permissive in terms of substances which can be used in food supplements (e.g. the maximum amounts of vitamins and minerals reach up to 300% of the RDAs, there is a long positive list of botanicals as well as lists of permitted other substances).

No.For the registration or notification it is not necessary to send a sample as proof or as example. Controls on the product market are performed by the respective competent enforcement authorities in the Member States.

The procedure of notification differs per Member State. Commonly, it is required to send a draft of the label or, like in Spain or Portugal, the finalized artwork label. In some countries it can be necessary to provide analysis results for certain substances. If a notification is made based on mutual recognition, the proof of registration in another member State must be submitted with the notification.

The procedure of notification differs per country. Some Member States, such as Germany or Portugal, provide a receipt upon submission, meaning that the food supplement may be placed on the market right away. The Belgian authorities issue a registration letter within a month. Only after this letter has been issued, the product may be placed on the market. Italy has a standstill period of three months and France has a standstill period of two months for products notified based on mutual recognition.

Changes to a product that has been notified must also be notified to the authorities, usually by means of a so-called re-notification. Belgium accepts a re-notification only for the change of authorized additives, aromas or chemical forms of nutrients. Further quantitative and qualitative changes as well as the change of the commercial name require a new notification.