Food supplements are foodstuffs in a pre-dosed form. Therefore, the "horizontal" (general) regulation on labelling of pre-packaged foodstuffs, advertising and additives also applies to food supplements.
"Food supplements" means all pre-dosed foodstuffs (capsules, pastilles, drop dispensing bottles, …) containing one or more nutrients, plants or other substances with a nutritious or physiological effect. The purpose of food supplements is to supplement the normal diet.
At European level, there is a frame directive 2002/46/EC (.PDF) on food supplements. This directive is a first step towards full harmonization of the several national regulations.
The Royal Decree on nutrients is also applicable on normal foods to which nutrients have been added, the so called "fortified foods". On European level these foods are regulated by Regulation 1925/2006.
Food supplements and ordinary foodstuffs enriched with nutrients are regulated by Royal Decree of 3 March 1992 (available in Dutch and French).
This decree contains, among others, the following items:
The allowed chemical forms of vitamins and minerals are laid down in Ministerial Decree of 21 May 2003 (available in Dutch and French). For fortified foods they are laid down in the Regulation 1925/2006.
Food supplements containing plants are regulated by Royal Decree of 29 August 1997 (only available in Dutch and French).
This decree contains among others, the following items:
In the appendix to this decree, there are 3 lists:
1. a list of plants which are not allowed for use in or as foodstuffs. This means that any part, preparation or fruit of those plants must not be consumed as such and must not be used for preparing foodstuffs.
2. a list of eatable mushrooms;
3. a list of plants which are allowed in food supplements. For some of those plants, maximum amounts are laid down per daily portion, for which a list of recommended analysis methods has been drawn up (only available in Dutch and French).
On 4 April 2012, the Moniteur Belge published a decree modifying the royal decree of 29 August 1997. For more information you can consult the consolidated version, a presentation and overview of the changes.
Food supplements containing other substances are regulated by the Royal Decree of 12 February 2009 (available in Dutch and French).
This decree contains amoungst others, the following items:
For some other substances specific dispositions are foreseen in the Ministerial Decree of 19 February 2009 (available in Dutch and French).
Before marketing food supplements, a notification file shall be submitted to the authority.
A notification file should contain amoungst others:
An explanatory note about the legislation is available in Dutch and French.
The notification is done by preference with the online application FOODSUP.
Before FOODSUP can be used for the first time, the responsible for the notification has to request access as local admin by means of a form, this for safety reasons.
Once access has been granted, one can log into FOODSUP and create all notifications. For more information about application a manual is available:
It is however still possible to submit a paper version of a Notification file (.WORD) through another procedure (available in Dutch and French).
For food supplements in the form of capsules, tablettes, … containing essential oils of plants additional date on the safety of the product is necessary. The required data are collected in the “Data Sheet for Essential Oils and Concretes (.WORD)” that has to be annexed to the notification file.
Every notification file will be closely examined. In case of any breach of the foodstuffs legislation, the product will not receive a number and will not be allowed on the market. Examples of a breach of the legislation are: excessive maximum amounts, too high doses or use of prohibited additives.
The labelling of food supplements shall bear all mandatory indications as for ordinary foods. Besides that the labelling of food supplements shall bear a series of additional indications:
The labelling and advertising of food supplements:
The nutritional and health claims used on foods have to comply with the Regulation 1924/2006. More information about claims can be found in the guidelines and on the page about advertising. For claims "on hold", mainly relating to botanical, the indicative list of claims which are not considered as therapeutic and/or prophylactic (available in Dutch and French) is still applicable.
Given the large amount of food supplements sold through chemist's shops and due to several demands from chemists who are in charge of a dispensary, an information notice for shop pharmacists (available in Dutch and French) has been drawn up.
Federal Public Service (FPS) Health, Food Chain Safety and Environment
Place Victor Horta, 40 box 10
Contact Center: +32 (0)2 524.97.97
Published on 10/07/2013 – Page last updated on 10/07/2013