The commission for borderline products, set up by the royal decree of 16 July 2024 (French version) clarifies the status of products whose status is not always clear.
The commission for borderline products 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
The members of the commission were appointed by the royal decree of 24 March 2023 (French version).
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 commission for borderline products 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:
- Indicative list of claims considered not to describe curative or preventive properties (update 13/01/2014).
- Guidelines on the borderline between biocides, cosmetics and medicinal products for human use.
- Guideline of the Mixed Commission on the classification of "Bach Flowers".
- Guideline for products containing red yeast rice.
- Guideline concerning the substance 1,3-dimethylamylamine (DMAA).
- Guideline for the use of D-mannose in food supplements
The following opinions have been prepared by the commission for borderline products 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 commission for borderline products 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