FOOD SUPPLEMENTS NOTIFICATION PROCEDURE IN BELGIUM

Supplements notification en Belgium step by step: Belgian regulations, labeling requirements, FOODSUP online notification tool, notification fee for food supplements in Belgium, legal food consultancy in Belgium.

Belgium is one of the most advanced countries in the European Union in terms of food supplements regulations.

Its regulations on food supplements are not limited to a simple Royal Decree that transposes Directive 2002/46 of the European Commission on food supplements together with the rest of the harmonized European regulations on food supplements; but has also developed other Royal Decrees to regulate aspects such as certain nutrients that can be used in the manufacturing of food supplements and certain conditions or restrictions of use, a Royal Decree that regulates the use of plants or botannicals in food supplements and a Royal Decree that regulates the use of nutrients in food supplements, such as vitamins and minerals, setting maximum and minimum limits for this.

For example, it turns out that Belgium is one of the strictest countries regarding the maximum amount of caffeine allowed in dietary supplements, with the limit being 80 mg of caffeine per daily dose when most countries allow up to 200 mg per daily dose; as well as regarding the maximum allowed of melatonin in dietary supplements per daily dose, being 300 micrograms per daily dose.

Regarding plants or herbal preparations, its Royal Decree contains a series of annexes that include both a list of plants prohibited in food supplements, as well as a list of plants allowed to be used with their specific conditions of use, safety warnings or restrictions of use and finally a list of edible mushrooms allowed in food supplements.

All this must be considered when designing the labeling of dietary supplements to be marketed in Belgium and the food labeling information provided for these products.

In addition to the above, it was one of the first countries to develop a specific online tool so that Food Business Operators (FBO) could make an online notification or registration of dietary supplements in Belgium. This above all facilitates the process for companies outside Belgium, for which sending documentation by post was more difficult or expensive.

The tool in question is called FOODSUP and allows FBO to enter all the relevant information for the dietary supplement registration in Belgium such as exhaustive information about plants, having to indicate both the botanical name, the part used of the plant as a type of preparation, as well as the presence and amount of certain active substances of interest in said food supplement; and other nutrients indicating their sources and quantities.

Following the recent update and increase carried out in May 2023, the notification fee for dietary supplements in Belgium is 295€ per product,  (the previous notification fee was 180€ per product).

This fee must be paid by bank transfer after notification of placing on the market via FOODSUP, after the issuance of the corresponding invoice from the Belgian Federal Public Service (FPS).

Once the product has been notified, the FPS takes around 4 weeks to issue a report in which after the notification file of the food supplement has been reviewed, it can assign a notification registration number (this is the case in which no non-conformities in the labeling or notification dossier are found, or any risk situations due to the composition of the product), a provisional registration number, subject to the correction of some aspects of the labeling of the food supplement; or a rejection of the notification process for said food supplement due to the detection of a serious infringement, whether in the labeling, composition or information provided in the notification dossier.

It is therefore very important to be up to date with legislative developments that affect the rules and regulations of food supplements in Belgium, so that operators can develop formulas and labeling that result in successful notification files.

At LexSupplements Legal Food Consultancy in Belgium we are up to date on supplements regulations and dietary supplements notification procedure in Belgium to guarantee that our clients develop safe formulas and labels for the food supplements they market.

We carry out the labeling revision, composition revision, and further food supplement registration before the competent Belgian Health Authority (FPS Health, Food Chain Safety and Environment) as well as dietary supplements registration in other European countries.

Please get in contact with us for more information.