Before marketing, health supplements will have to be notified in Belgium. Common reasons for delays or rejection include ingredient restrictions, non-compliant claims, and labelling problems.
This document provides an overview of the Health Supplements Registration Process in Belgium, labelling, claims, import procedures, timelines, and compliance in Belgium.
Regulatory Authority for Health Supplements in Belgium
FPS Public Health regulates health supplements in Belgium, and FASFC is responsible for the inspection and compliance with the market. Prior to commercialisation, products need to be notified via the FOODSUP portal. Medicinal products can be categorised as medicines rather than supplements.
What Are Health Supplements Under Belgian Regulations?
Belgium considers health supplements to be food products with concentrated sources of nutrients, plants, or other substances, marketed in dose form, including:
- Capsules
- Tablets
- Powders
- Ampoules
- Liquids
Products with prohibited plants, nutrient levels > than recommended, or medicinal claims will be rejected or considered medicines.
Compliance Checklist for Health Supplement Approval in Belgium
Companies are required to verify prior to FOODSUP notification:
- The compliance of ingredients with Belgian Royal Decrees
- The highest limits of nutrients and botanicals are set
- Novel food status
- EFSA-authorised health claims
- Multilingual label compliance
- Mandatory warning statements
- Technical documentation completeness
Common causes for delays are incomplete labels, untested claims, and prohibited ingredients.
Health Supplements Registration Process in Belgium
Pre-market notification is a mandatory step for Belgium, which is done via the FOODSUP platform before commercialisation. Here is the step-by-step approval process.
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.
Products that are usually identified as medicines include:
- High-dose melatonin
- CBD products
- Hormonal ingredients
- Weight-loss products
- Products claiming to have therapeutic properties
Step 2: Review and Confirm Ingredient Compliance
Belgian legislation on supplements is based on Royal Decrees on the following aspects:
- Nutrients
- Plants and botanicals
- Other substances
Companies must review:
- Maximum nutrient levels
- Plants that are either restricted or prohibited
- Botanical uses or indications
- Novel food status
- Substance restrictions
Step 3: Check Novel Food Status
Nutrient material such as CBD, new extracts, fermented products, and exotic botanicals could be considered for new food authorisation prior to notification.
Step 4: Prepare Product Label
Labels must include:
- “Food supplement” designation
- Recommended daily intake
- Active ingredient quantities
- Mandatory warnings
- Ingredient list
- Net quantity
- Storage conditions
Labels must meet requirements for the Belgian language:
- Dutch
- French
- German
Mostly, labels in English are not accepted.
Step 5: Review Health Claims
Only EU-authorised health claims are allowed across:
- Labels
- Websites
- Product listings
- Social media
Claims for treatment or prevention of a disease may result in rejection.
Step 6: Compile the FOODSUP Dossier
Typically, the notification file will contain:
- Chemical composition: qualitative and quantitative
- Nutritional analysis
- Botanical details
- Safety information
- Product label/artwork
Step 7: Register on FOODSUP
Prior to submitting notifications, companies have to register an account on the FOODSUP portal.
Step 8: Submit the Notification
Authorities review:
- Ingredient legality
- Dosage levels
- Label compliance
- Claims
- Safety concerns
They can accept, suggest corrections, or turn it down.
Step 9: Pay the Notification Fee
FPS Public Health provides an invoice upon submission. The cost of the FOODSUP notification is about €295 per product at this moment.
Step 10: Receive the Notification Number
If it is compliant, the authority provides a notification number, e.g.:
- NUT
- PL
- AS
The number is required for products to be marketed.
Step 11: Maintain Post-Market Compliance
Once launched, companies need to continue compliance for:
- Formula changes
- Label updates
- Advertising
- Traceability
- FASFC inspections
Documents Required for Health Supplement Registration in Belgium
Typical documents that are required are:
- Chemical composition, both qualitative and quantitative
- The amount of active ingredient per dose per day
- Nutritional analysis
- Botanical information, such as Latin names and parts of the plant used
- Ingredient specifications
- Safety information
- Novel food status confirmation, if applicable
- Final product label/artwork
- Mandatory warnings and claims information
- GMP and/or HACCP documentation
- Free Sale Certificate
- Details of the manufacturer and importer
- Applicant contact information
Labelling Requirements for Health Supplements in Belgium
Belgian laws and European legislation demand compliant supplement labels.
Labels must include:
- “Food supplement” designation
- Recommended daily dose
- Active ingredient quantities
- Ingredient list
- Net quantity
- Expiry date
- Storage conditions
- Responsible operator details
- Mandatory warnings
Mandatory warnings include:
- “DON’T take more than the suggested amount per day”
- “Food supplements are not intended to be a substitute for a balanced and varied diet”
- “Avoid giving to children under the age of five”
Labelling should be in the appropriate regional language:
- Dutch in Flanders
- French in Wallonia
- Dutch and French in Brussels
- German in the German-speaking area
Only authorised EU health claims are allowed.
Licensing Requirements for Health Supplements in Belgium
Most supplements do not need a product licence in Belgium; however, a mandatory FOODSUP notification prior to sale is required.
All supplement importers, manufacturers, storers, and distributors are food business operators and must register with FASFC.
For other applications, the following approvals may apply:
- Novel foods
- CBD products
- Borderline medicinal products
- High-risk ingredients
GMP Requirements for Health Supplements in Belgium
EU food safety and hygiene legislation applying to supplement manufacturers is implemented in Belgium by FASFC.
Authorities may review:
- Raw material controls
- Batch records
- Traceability systems
- Recall procedures
- Contamination controls
Common standards include:
- GMP
- HACCP
- ISO 22000
- FSSC 22000
- BRCGS
Companies that do use third-party manufacturers are still accountable for product compliance.
Health Claims and Advertising Regulations in Belgium
Only health claims that have been authorised under Regulation (EC) No 1924/2006 are allowed in Belgium.
Permitted claims include:
- Authorised health claims
- Approved nutrition claims
- Claims that conform to EU conditions of use are permitted
Prohibited claims include:
- Claims that are made to prevent or treat a disease
- Statements that suggest medical benefits
- Promises of a ‘cure’ or ‘guaranteed results’
- Misleading weight-loss claims
Claims should be consistent with respect to:
- Product labels
- Websites
- Social media
- Influencer marketing
- Online marketplaces
Import Regulations for Health Supplements in Belgium
The imported supplements have to conform to the Belgian and EU food law before they are available on the market, which involves FOODSUP notification, labelling, check of ingredients, customs control, etc.
Belgium does not accept products that contain:
- Unauthorised novel foods
- Restricted botanicals
- Non-compliant CBD ingredients
- Medicinal claims
- Incorrect labeling
Non-EU companies are usually sold through an EU-based importer or responsible operator registered with FASFC.
Health Supplement Registration Timelines in Belgium
Belgium does not have a set notification approval time frame. FPS Public Health reviews FOODSUP compliant applications within about 4 weeks.
Timelines frequently are longer for:
- Botanical supplements
- Novel ingredients
- CBD products
- High-dose formulations
- Incomplete dossiers
Health Supplement Registration Costs in Belgium
The government imposes a fee for FOODSUP notifications in Belgium. The price for the product is around €295 at the moment.
Other compliance expenses can include:
- Label translation
- Claims review
- Laboratory testing
- Novel food assessment
- Botanical safety review
- Regulatory consulting
Conclusion
Any food supplement must undergo mandatory FOODSUP notification, compliant labelling, authorisation of 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
1. Is food supplement notification mandatory in Belgium??
Yes. Before supplements can be put on the market in Belgium, it is mandatory to notify FOODSUP.
2. Does Belgium require a NUT number?
Yes. Successful notification review results in notification numbers from Belgium, like NUT, PL, or AS.
3. Is it possible to sell supplements directly in Belgium that are already on the market in another EU country?
Not always. Notification, labelling, and ingredient requirements for products remain valid in Belgium.
4. Will the English-only labels be accepted in Belgium?
Generally, no. Labels must meet the language requirements of the region.
