The Belgian Official Journal (Belgisch Staatsblad / Moniteur belge) publishes today a Ministerial Decree of 12 February 2026 “approving the rules of procedure of the Committee for Borderline Products for Human Use” (Ministerieel Besluit van 12 februari 2026 tot goedkeuring van het huishoudelijk reglement van de Commissie voor Borderline producten voor menselijk gebruik / Arrêté ministériel du 12 février 2026 portant approbation du règlement d’ordre intérieur de la Commission pour les produits borderline à usage humain) (the Decree; see, attached copy). The Decree approves the internal rules of procedure which the Committee for Borderline Products for Human Use (the Committee) adopted on 17 December 2025.

The Committee was established in August 2024 within the Federal Agency for Medicines and Health Products (FAMHP) and replaced the so-called “Mixed Committee” (Gemengde Commissie / Commission Mixte) (see, Van Bael & Bellis Life Sciences News & Insights of 20 August 2024). It is tasked with issuing opinions on the legal status of borderline products, i.e., products of which it is not clear whether they qualify as a medicine, medical device, food supplement, cosmetic, nutrient or daily consumer good.

Opinions from the Committee on the legal status of specific products can be requested by:

1. manufacturers seeking clarification regarding the legal status of their products (both before and after their placing on the market);
2. third parties (e.g., competitors or consumer organisations); and
3. the public authorities which are represented in the Committee, i.e. (a) the FAMHP; (b) the Federal Public Service (FPS) Health, Food Chain Safety and Environment (both DG Animals, Plants and Food and DG Environment); (c) FPS Economy, SMEs, and Energy (both DG Economic Inspection and DG Economic Regulation); and (d) the Federal Agency for the Safety of the Food Chain.

The ultimate decision on the status of a product is taken by the Minister for Public Health or his/her representative.

The rules of procedure of the Committee clarify:

1. the procedure for adopting opinions (both in standard and in urgent cases);
2. the applicable professional ethics requirements, in particular with a view to preventing conflicts of interest;
3. the handling of complaints;
4. the procedure for convening members; and
5. the composition of the Bureau.

The Decree enters into force today.

In addition to the Committee, there is also a Committee for Borderline Products for Veterinary Use.