Proven Experience

With extensive experience in the Belgian market, we have successfully developed and delivered food supplements that comply with the stringent regulations set forth by the Federal Public Service (FPS) Health, Food Chain Safety and Environment. Our expertise encompasses every stage, from formulation to delivery, ensuring adherence to both European Directive 2002/46/EC and specific Belgian Royal Decrees governing nutrients, plants, and other substances.

Definition of Food Supplements

In Belgium, food supplements are defined as pre-dosed foodstuffs—such as capsules, tablets, or liquids—containing one or more nutrients, plants, or other substances with nutritional or physiological effects. They are intended to supplement the normal diet.

Notification Process.

Prior to marketing food supplements in Belgium, businesses are required to submit a notification file to the FPS Health. This file should include:

  • Ingredient Information.

    A complete qualitative and quantitative list of ingredients.

  • Nutritional Analysis.

    Details of the product's nutritional content.

  • Safety Data.

    Information regarding the presence and non-toxicity of active substances.

  • Product Labeling.

    The proposed labeling of the product.

The preferred method for submission is through the online application FOODSUP. Users must register online and request access as a local administrator for security purposes. Once access is granted, notifications can be created and submitted via FOODSUP. A user manual and additional forms are available to assist with the process.

Labeling Requirements

The labeling of food supplements must comply with general regulations applicable to pre-packaged foodstuffs, including those concerning labeling, advertising, and additives. Additionally, labels must include:

  • The term “food supplement”.
  • Reference intake (RI) information.
  • A warning not to exceed the recommended daily intake.
  • A statement that the product 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 per recommended daily portion, which may also be presented graphically.

Labels must not suggest that a balanced and varied diet cannot provide appropriate quantities of nutrients, nor attribute properties of preventing, treating, or curing human diseases to the product. All claims must adhere to Regulation 1924/2006. 

Evaluation and Approval

Upon submission, the FPS Health reviews the notification file, focusing on the declared composition and draft label. The notifier receives a letter with an administrative number and any remarks based on the review. This number does not constitute acknowledgment of compliance or product status and cannot be considered a marketing authorization. 

Additional Considerations

For products containing substances other than nutrients and plants, the Royal Decree of 12 February 2009 applies. This decree outlines specific requirements for such substances in food supplements.

We’re Certified.

Our company holds all necessary certifications, including BRC and NSF GMP, ensuring that our manufacturing processes meet the highest quality standards.

accreditation

Accreditations

Multi-language Labelling

To enhance product appeal in Belgium’s multilingual market, we offer assistance in creating labels in Dutch, French, and German, ensuring compliance with regional language requirements.