Before marketing, food supplements must comply with the applicable Belgian and EU food legislation and notification requirements. These cover their composition, notification, labelling, and advertising. Directive 2002/46/EC provides the EU framework for food supplements and has been transposed into Belgian national legislation through specific Royal Decrees.
This guide provides an overview of food supplement requirements in Belgium, including product classification, ingredients, notification, labelling, claims, food-business requirements, imports and ongoing compliance.
Regulatory Authority for Food Supplements in Belgium
Food supplements in Belgium are regulated within the Belgian food-law framework. The Federal Public Service (FPS) Health, Food Chain Safety and Environment administers the FOODSUP notification system for food supplements and fortified foods, while the Federal Agency for the Safety of the Food Chain (FASFC/AFSCA) carries out official controls within the food chain.
Belgium’s national rules operate alongside Directive 2002/46/EC, which establishes the EU framework for food supplements marketed as foodstuffs.
Belgian Legislation Governing Food Supplements
Belgium’s national framework is divided according to the type of substance used in the supplement.
| Belgian regulation | Main scope |
| Royal Decree of 30 May 2021 | Nutrients and foods to which nutrients have been added |
| Royal Decree of 31 August 2021 | Plants and plant preparations |
| Royal Decree of 29 August 2021 | Substances other than nutrients, plants or plant preparations |
According to FASFC, these decrees establish minimum and maximum vitamin/mineral amounts per daily portion, lists of prohibited plants and plants requiring notification, and specific requirements for certain other substances.
The same Belgian framework contains a notification procedure before products can be placed on the market, as well as labelling and advertising requirements.
What Are Food Supplements Under Belgian Regulations?
Belgium works under the EU Directive and classifies food supplements as foodstuffs. These aim to supplement the normal diet, as they have concentrated sources of nutrients, plants, or other substances. These nutrients/substances have nutritional or physiological effects and are marketed in dose form, like capsules, tablets, powders, ampoules, and liquids.
Products with prohibited plants, nutrient levels greater than recommended, or medicinal claims will be considered non-compliant and outside the food supplement framework. The Directive defines nutrients for its purposes as vitamins and minerals.
Compliance Checklist for Food Supplements in Belgium
Companies are required to verify prior to FOODSUP notification:
- The compliance of ingredients with Belgian Royal Decrees
- Maximum and minimum levels checked
- Novel food status
- Authorised health claims
- Multilingual label compliance
- Mandatory warning statements
- Technical documentation completeness
- Complete qualitative and quantitative composition for FOODSUP notification
Food Supplements Notification Process in Belgium
The step-by-step food supplement notification process in Belgium begins with confirming the product classification and preparing the required notification dossier. Before placing a food supplement on the Belgian market, a notification dossier must be submitted to the competent authority. FPS Public Health states that the notification procedure is preferably completed through the electronic FOODSUP application, although a paper notification procedure is also available.
Step 1: Confirm the Product is a Food Supplement
It is the responsibility of companies to confirm if the product is considered to be a supplement or a medicinal product. The product should fall under the applicable definition and expressly exclude medicinal products from its scope.
Step 2: Review and Confirm Ingredient Compliance
Review the formulation against the Belgian Royal Decrees applicable to the product’s ingredients. FASFC identifies separate Belgian rules for nutrients, plants/plant preparations and other substances.
For vitamins and minerals, Directive 2002/46/EC establishes the EU list of permitted vitamins and minerals and their authorised sources. It also provides maximum and, where appropriate, minimum amounts of vitamins and minerals per recommended daily portion.
A complete qualitative and quantitative list of the ingredients present is mandatory in the notification dossier for food supplements. Where an ingredient is not available in the FOODSUP ingredient database, the applicant should first check spelling and synonyms. If it still cannot be found, FPS Health can be contacted to consider adding it to the database.
Step 3: Check Novel Food Status
Companies should assess whether any ingredient qualifies as a novel food under Regulation (EU) 2015/2283 before marketing.
Step 4: Prepare Product Label
General food labelling rules under EU law should be followed. It should display the portion of the product to be consumed daily, along with mandatory warnings and statements.
Step 5: Review Health Claims
Nutrition and health claims should comply with Regulation (EC) No. 1924/2006. The claims should not mislead consumers and must meet the relevant conditions of use. Claims for treatment or prevention of a disease are prohibited.
Step 6: Compile the FOODSUP Dossier
According to FPS Public Health, a food supplement notification dossier must contain the list of documents mentioned below. Additional information may be required depending on the product. Other dossier items include the following:
- Company Name & Information
- Product Name
- Product Nature – form, presentation, packaging, recommended daily intake, net weight per daily dose
- List Of All Ingredients
- Information Regarding Nutrients
- Info Regarding Plants
- Other Substance Details
- Nutritional Analysis
- Toxicity
- Stability
- Analyses
- Payment for Initial Notification
- Signature
- Attachments
The attachments can include labelling (mandatory), package leaflet, analysis report, scientific dossier, novel food information, stability & toxicity info, and other to be specified.
Step 7: Obtain Access to FOODSUP
For electronic notification, the notifier must register before using FOODSUP. FPS Public Health also states that the person responsible for notification must request access as a local administrator through the prescribed procedure.
Step 8: Submit the Notification
Enter the required product information, upload the necessary documents and submit the notification through FOODSUP. Alternatively, the official paper notification procedure may be used.
Step 9: Receive the Reply Letter
If the submitted notification is compliant, the authority provides a NUT, PL, and/or AS notification number. These indicate no major breaches of legislation. Code (a) suggests that the file does not fall under the legislation of food supplements or fortified foods. Code (b) is an incomplete file, and Code (d) indicates a serious violation of the legislation.
Note: This number is not an authorisation or endorsement of the product.
Step 10: Maintain Post-Market Compliance
Changes to an existing product may require modification of the FOODSUP dossier. Where information in an existing notification needs to be corrected or updated, the applicable modification procedure should be followed.
Documents Required for Food Supplement Notification in Belgium
According to FPS Public Health, the notification dossier for a food supplement must contain at least:
- A complete qualitative and quantitative list of ingredients
- Nutritional analysis, where applicable
- Information concerning the presence and safety of active substances
- The final version of the product label as it will appear on the market
- An undertaking to conduct regular analyses
Depending on the composition of the supplement, additional supporting information may be necessary. For example, products involving certain plant ingredients may require further information for assessment by the Plant Preparations Advisory Commission.
Labelling Requirements for Food Supplements in Belgium
Belgian laws and European legislation demand compliant supplement labels. The product must be sold under the designation “food supplement”.
In addition to the general EU food-labelling requirements, food supplement labels must include the following supplement-specific information:
- The categories of nutrients or other substances characterising the product, or an indication of their nature.
- The portion recommended for daily consumption.
- Warning: not to exceed the recommended daily dose.
- A statement that food supplements should not be used as a substitute for a varied diet.
- A statement that the product should be stored out of reach of young children.
The quantities of nutrients or other substances with a nutritional or physiological effect must be declared numerically, using the applicable units. The declared amounts are based on the portion recommended for daily consumption.
Health Claims and Advertising Regulations for Food Supplements in Belgium
Nutrition and health claims used for food supplements must comply with Regulation (EC) No. 1924/2006, including the applicable conditions of use and substantiation requirements.
Prohibited claims include:
- Claims that a product can cure, prevent, or treat a disease
- Statements that suggest medical benefits
- Promises of a ‘cure’ or ‘guaranteed results’
- Misleading claims
- Statements suggesting that a balanced and varied diet cannot provide sufficient nutrients.
Claims should be consistent with respect to product labels, websites, social media, influencer marketing, or online marketplaces.
Food Supplement Notification Timelines & Costs in Belgium
FPS Public Health states that a food supplement notification dossier is processed within three months. The same processing period applies to both new notification dossiers and modifications of existing dossiers.
A notification fee must be paid when submitting a new food supplement dossier. According to the notification file provided on FPS Health, a payment of 350 Euros per product needs to be made after the departments send the business invoice. Proof of payment should also be provided within the deadlines, as it indicates the official submission of the complete dossier.
Modifications of existing files do not attract this notification fee. Businesses should verify the current applicable fee when preparing a new notification.
Mutual Recognition of Food Supplements in Belgium
Food supplements that do not comply with certain Belgian requirements but are lawfully marketed in another EU Member State may be eligible for mutual recognition in Belgium. This principle is based on the EU free-movement framework and Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State.
For food supplements, FPS Public Health states that an operator can request mutual recognition by completing a mutual recognition declaration and adding it to the product’s notification dossier.
The declaration must include:
- Product information and the relevant legislation of the EU Member State where the product is marketed;
- Evidence that the product is sold in that Member State on a specified date, identifying the product, suppliers and customers; and
- A reference to, or statement concerning, the legislation applicable in that Member State.
The dossier can be completed in Dutch, French, German or English. FPS Public Health states that without the required supporting information, the mutual-recognition request is incomplete.
Important distinction
Mutual recognition does not mean that every supplement legally sold elsewhere in the EU can automatically be placed on the Belgian market without notification. Belgium’s own FPS Health specifically instructs operators seeking mutual recognition to include the declaration in the Belgian notification dossier.
Conclusion
Any food supplement must undergo mandatory FOODSUP notification, compliant labelling, health claims, and regulation on ingredients before being released onto the market in Belgium. Developing classification, ingredient compliance, labelling, and claims pre-notification can help to minimise notification delay and mitigate post-market enforcement risk.
Artixio assists Belgium food supplement notification, FOODSUP submissions, and supplement manufacturers, importers, and regulatory teams with ingredient compliance review, food supplement labelling assessment, health claims evaluation, and EU market entry support. Contact Artixio today at info@artixio.com.
FAQs
Is food supplement notification mandatory in Belgium??
Yes. Before supplements can be put on the market in Belgium, it is mandatory to notify the authorities using FOODSUP or paper format.
Does a Belgian food supplement notification number mean the product is approved?
No. Following dossier review, FPS Public Health may issue a NUT, PL and/or AS notification number where no major infringement has been identified in the submitted dossier. However, FPS explicitly states that the notification number is not an approval or marketing authorisation for the product.
Is it possible to sell supplements directly in Belgium that are already on the market in another EU country?
Not automatically. Food supplements marketed in another EU Member State may be eligible for mutual recognition in Belgium if the applicable conditions are met. The operator must still follow the Belgian notification procedure and include the required mutual-recognition declaration in the notification dossier.
Does every change to a notified food supplement require a new notification?
Changes to an existing notified product may require a modification of the notification dossier. The applicable procedure should be followed through FOODSUP or the alternative notification procedure provided by FPS Public Health.
