Grey area

The status of certain products is not always clear.

They belong to a “grey area”: products lying somewhere between medicinal products, food supplements, cosmetics, biocides, nutrients or daily consumer goods.

The Mixed Commission, set up by the Royal Decree of 28/10/2008 (French version) clarifies the status of these products.

The Mixed Commission is composed of representatives from:

• FAMHP
• FPS Health, Food Chain Safety and Environment: DG Animals, Plants and Food and DG Environment
• FPS Economy, SMEs, and Energy
• FASFC

Its mission is to express an opinion on product dossiers for which there is doubt about the status. The Minister or his representative takes a decision based on that opinion. The opinion may be requested by the relevant public services, by third parties or by a manufacturer who wants to be certain about the status of his product.

The Mixed Commission may also draw up opinions for the establishment of guidelines by the Minister pursuant to article 1, § 2, paragraph 7 of the law of 25 March 1964 on medicinal products. On the basis of these opinions, the Minister has established the following guidelines:

The following opinions have been prepared by the Mixed Commission and will be presented to the Minister for guidance:

  • Opinion on the use of N-acetylcysteine in food supplements (French).
  • Opinion on the use of alpha-lipoic acid in food supplements (French).
  • Opinion on the use of melatonin in food supplements (French).
  • Opinion on the use of nicotine pouches to be kept in the mouth : are considered as medicinal products.

The Mixed Commission consists of a Chamber for products for human use and a Chamber for products for veterinary use. Under the Royal Decree, these chambers have drawn up a Rule of Procedure which has been submitted to the Minister for approval.

Contact:

borderline.hum@fagg-afmps.be

borderline.vet@fagg-afmps.be

 

 

 

 

 

 

 

Last updated on 24/09/2021