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Registration Procedure of Food Supplement in Belgium

Regulatory Authority:

Federal Agency for medicine and health Products

Regulatory Website:

https://www.famhp.be/en

Registration Timeline:

1 month

License validity:

5 years

Registration fee:

128,16.-€

A standardized list of vitamins and minerals that may be added to food supplements for nutritional reasons is outlined in Directive 2002/46/EC of June 10, 2002 (Annex I to the Directive). A list of approved sources (vitamin and mineral compounds) from which these supplements and minerals may be produced can be found in Annex II of the Directive.

Belgian laws pertaining to dietary supplements:

Depending on whether the dietary supplements in question contain nutrients, plants, or other substances, three distinct Royal Decrees govern them at the national level:

  • The Royal Decree dated March 3, 1992, governs the sale of nutrients and consumables enriched with nutrients.
  • The Royal Decree dated August 29, 1997, governs the production and distribution of food items made from or including plant materials.
  • The production and distribution of dietary supplements including materials other than minerals and plants or plant preparations are governed by the Royal Decree of February 12, 2009.

Registration:

Food supplements and fortified foods must first be marketed once the authority receives a notification filing.

Among other things, a notification file ought to include:

  • details regarding the 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.

There is a Dutch and French explanation note available on the legislation.

The web tool FOODSUP is used to customize the notifications based on user preferences.

Labelling:

Food supplements must be labeled with all necessary information, just like regular foods. In addition, food supplements must have the following extra information on their labels:

 

  • the reference intake (RI); the term “food supplement”;
  • a caution not to take more than the suggested daily amount;
  • a warning that young children should not be able to access the products when they are being stored;
  • a declaration that dietary supplements shouldn’t be utilized in place of a balanced diet;
  • the product’s nutritious contents divided by the suggested daily portion (this can also be shown graphically);

when available, the name of the plant or plants in the local language; otherwise, the scientific name (for dietary supplements including plants).

The advertising and labeling of dietary supplements:

  • must not state or imply that a balanced and varied diet cannot generally provideappropriate quantities of nutrients;
  • 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).

 

  • Food claims, both nutritional and health-related, must adhere to Regulation 1924/2006. Further details regarding claims are available on the advertising page and in the rules. The indicative list of claims that are not deemed therapeutic and/or preventive (available in Dutch and French) still applies to claims that are “on hold,” primarily those that are botanical in nature.