Compulsory notification of e-cigarette products

The royal decree of 28 October 2016 on the manufacturing and marketing of electronic cigarettes requests that the manufacturers/importers selling electronic cigarettes and refill bottles in Belgium supply the authorities, 6 months before the planed marketing date, with specific information such as: contact details of the manufacturer and importer, a qualitative and quantitative list of all ingredients, information on the dosage and inhalation of nicotine, annual sale volumes... It is an administrative procedure aiming at informing public authorities, the sector stakeholders and the consumers.

In this context, the FPS Public Health makes available to the public a list of all products that have been received and controlled what regards the notification legal obligations by the FPS Public Health. On this list appear the products that may be introduced on the market and their effective date of marketing.

"Received and controlled" means that all the data that the producer or importer is legally obliged to supply the Belgian authorities with were provided to the FPS Public Health through the European notification system EUCEG (explicative link : https://ec.europa.eu/health/euceg/introduction_en ) and that the company has paid the €165 fee for each product.

The presence of a product on this list doesn't in any way mean that the product is without danger to the health. This only indicates that the producer or the importer has fulfilled his administrative obligations and that this has been confirmed by our services. As the Superior Health Council shows, "Long-term health effects of chronic e-cigarette use are not well known enough at the present time."

So, the FPS Public Health recommends not to use electronic cigarettes if you are non-smoker and to consult your doctor, a tobaccologist or to call 0800/11100 if you are a smoker and that you would like to stop consuming tobacco.

The FPS Public Health also makes available to the public a second list containing all products that have been negatively received by the FPS Public health. The products appearing on this list don’t meet the demands of the Belgian legislation on notification: the information supplied is not compliant and/or the company didn’t pay the €165 fee per product. These products may not be marketed in Belgium.

Products not present on any of the two lists are presently being processed by the FPS Public Health. The absence of a product on those list doesn’t mean it is not compliant. It is possible that the case hasn’t been received yet (notification submitted) or that it is still being processed.

To check the status of a product, please contact our department at the address enottab@health.belgium.be. Please provide as much information on the product and, if possible, enclose a picture. Our department will reply as soon as possible.

 

Lexicon:

Submitter Name : name of the company that have submitted the dossier to the authorities

Submitter Country : company’s country origin

Submitter Type : company type (manufacturer or importer)

Product id : single number ascribed to the product and enabling its identification

Brand Name(s) & Brand Sub Type Name(s) : product’s name(s) and sub-name(s). These two fields give basic information on the product. For instance, for eLiquid, it will give the brand, the flavor and the level of nicotine

Launch date(s) : date when the product can be launched on the Belgian market. The notification must be submitted at least 6 months before entry on the market.

Product Type :
# Electronic cigarette – Rechargeable, device only 
# Electronic cigarette – Refillage, device only 
# Individual part of electronic cigarette 
# Kit – Pack containing more than one different e-cigarette device 
# Other 
# Refill container/cartridge containing e-liquid 

 

Last update : 07/12/2018
The date of the last update appears in the top left corner of both lists (positive & negative).

Email contact :
enottab@sante.belgique.be