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.
From 1 February 2020 onwards, as soon as a product is positively received by the notification team, it will be added to the positive list of products that are compliant with the notification (compliant data and fee paid). As soon as a product appears on the positive list, it can be sold in Belgium (without waiting for the end of the 6-month period that follows submission of the data in EU-CEG).
"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.
Only the products included in the positive list may be put on the market. In addition, a name identical to that in the positive list must appear on the label of the marketed product. Products appearing on the negative list and products not appearing on any list, i.e. products for which no file has been submitted to the Department and products for which the dossier is still being processed, may not be sold under any circumstances.
Important remarks for economic operators :
- The FPS Health provides, to the compagny wishing to notify e-cigarettes, recommendations in the field of notification.
- As provided for in the legislation, the "Launch date" mentioned in all your files must match the date of submission in EU-CEG to which 6 months must be added.
- Files will be processed in the order of arrival without any other priority criteria.
- Any particular request for files may result in a longer processing time in compliance with the six-month maximum deadline.
To check the status of a product, please contact our department at the address firstname.lastname@example.org. Please provide as much information on the product and, if possible, enclose a picture. Our department will reply as soon as possible.
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
# Refill container/cartridge containing e-liquid
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