Electronic cigarettes and refill containers with nicotine are subject to a notification procedure. As a result, the manufacturer or importer of electronic cigarettes and refill containers with nicotine must submit to the authorities, 6 months before the product is placed on the market, certain information such as:
the contact details of the manufacturer and importer,
a qualitative and quantitative list of all ingredients,
information on the dosage and inhalation of nicotine,
annual sales volumes,
Within the framework of this notification procedure, the FPS Public Health provides the public and economic operators with a positive list of all the products whose notification file has been received and validated.
The presence of a product on this positive list does not mean in any way that this product is safe for health. As the Superior Health Council states: "The long-term health effects of chronic use of e-cigarettes are currently insufficiently known". This simply means that the products on this positive list have fulfilled their administrative notification obligations and that this is confirmed by our services: the company has paid the fee of €165 per product and all the data that must legally be transmitted by the producer or importer has been provided to the FPS Health via the European notification system EU-CEG.
If a product is not on this positive list, then it does not meet the requirements for notification, and therefore cannot be marketed on the Belgian market. Only products on the positive list can be marketed and the label of the marketed product must bear a name identical to that on the positive list. However, this is only a necessary but not sufficient condition for placing the product on the market. Other provisions, such as those concerning labelling, are the full responsibility of the producer or importer. Retailers are also responsible for the conformity of the products they place on the market.
The FPS Health also makes available to the public a negative list containing all the products that have been negatively received by the Service of the FPS Health in charge of that matter. The products on this list do not meet the requirements of the Belgian legislation regarding notification: the data provided are not in conformity and/or the company has not paid the fee of €165 per product. These products cannot be placed on the Belgian market.
Products on the negative list and products not on any list, i.e. products for which no file has been submitted to the Service and products for which the dossier is still being processed, may not be sold under any circumstances.
Important remarks for economic operators:
The FPS Public Health provides companies wishing to notify e-cigarette products with recommendations on notification, instructions on how to bring notified products into compliance with the new Royal Decree and the list of recommendations on the name of notified products.