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.
Before marketing food supplements and fortified foods, a notification file shall be submitted to the authority.
A notification file should contain amongst others:
- information about ingredients:
- for food supplements: a complete qualitative and quantitative list of ingredients;
- for fortified foods: a qualitative and quantitative list of the added nutrients (and if present, data on non-authorized plants from list 1 of the RD on plants);
- the nutritional analysis;
- data about the presence and non-toxicity of the active substances;
- the labelling of the product.
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 user has to register on line. In addition, the responsible person 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 the application a manual is available:
- User manual Front Office FOODSUP NEW
- Annex 1: Form "local admin"
- Annex 2: Modification of the "local admin"
- Annex 3: Delegations
- Annex 4: Transfer divisions
- Annex 5: Personal Data Protection - Foodsup Application
- link to FOODSUP (! optimized for Mozilla Firefox)
It is however still possible to submit a paper version of a Notification file (.WORD) through another procedure (available in Dutch and French).
In order to help you introducing your files, frequently asked questions are available on our FAQ-document.
In the processing of the notification file, verifications are performed on the declared composition of the product and on the draft label. The notifier receives a letter with an administrative number and remarks based on the review of the notification file.
There is no number on the letter but a code "b" when the file is incomplete or a code "a" for products outside de scope of the above-mentioned decrees on plants, nutrients or other substances.
The number will be temporarily assigned for six months (code "c") if a major infringement of the food legislation is found in the notification file or if further assessment is requiered.
The administrative number does not constitute an acknowledgement of the compliance nor of the status of the product and cannot be considered as a marketing authorization.
Labelling and advertising of food supplements
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 name "food supplement";
- the reference intake (RI);
- a warning not to exceed the recommended daily intake;
- a statement that the products should be stored out of the reach of young children;
- a statement that food supplements should not be used as a substitute for a varied diet;
- the amounts of nutrients present in the product per recommended daily portion (this may also be given in graphical form);
- the name of the plant(s) in the language of the region (when available), as well as the scientific name (for food supplements containing plants).
The labelling and advertising of food supplements:
- must not attribute to the product the property of preventing, treating or curing a human disease, or refer to such properties (the labelling must not contain any therapeutic and/or prophylactic statements);
- shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
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.
Marketing of food supplements
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.