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Information | Belgium Electronic Cigarette Frequently Asked Questions Compilation

Author.

LCS

Source:

Post time:

2024-06-06

1、 Are all economic practitioners (manufacturers, importers, Belgian importers) required to notify?

No, a product can only be notified once by the relevant parties involved. Belgian importers are only responsible for notification when both the manufacturer and importer are not within the EU.

2、 Is contact information for relevant practitioners in Belgium mandatory?

Belgian importers must only notify the product if the manufacturer and EU importer have not submitted a notification. At this point, the information of the Belgian importer must be displayed on the instruction manual.

3、 If there are multiple importers of the same product in Belgium, must each importer (with their own packaging design and instructions) add a unique design?

If the same product is sold in different packaging, each product presentation must be notified in the EU-CEG. In this way, each design can be correctly identified. Different packaging designs match different product presentations but can have the same EC-ID.


4、 Is the annual fee announced for each product of 50 euros applicable to nicotine free products?

Regardless of the product type, sales figures for all notifications are required every year. The cost of notifying this data is 50 euros per notification.


5、 Will FPS Health inform manufacturers/importers if their product labels are compliant, or do they need to change the labels to avoid the need for packaging redesign in the future?

No, not really. Regarding packaging design, FPS Health verifies through notifications, focusing on two key points.

1) Has the notice submitted a packaging artwork

2) Is there any health warning information required for the Belgian market in the packaging.

The responsibility for ensuring packaging compliance will remain with relevant practitioners (manufacturers or importers) in Belgium. However, if violations are detected, they should be corrected through updated notices. If necessary, the official will reject the relevant products.


6、 There are some notes in the positive list that indicate containers with a capacity exceeding the specified 2ml limit. Is it allowed to have a capacity exceeding 2ml?

The capacity of the smoke bomb or liquid storage device is not allowed to exceed 2ml. However, in order to take into account the understanding and considerations of other member countries regarding the design of actual products, Belgium accepts a maximum tolerance of 5 milliliters for the reservoir. If the capacity exceeds 2 milliliters, all technical standards must comply with Belgian regulations. Any other non compliant behavior will result in the product being rejected. Please note that this tolerance only applies to refillable tanks or cartridges, and does not apply to non refillable nicotine containing cartridges.


7、 If the product is suitable for e-cigarettes that do not contain nicotine, is there a limit to its storage capacity?

The limit of 2 milliliters does not apply to nicotine free liquid cartridges or reservoirs. There is no limit of 10ml for the volume of supplementary containers


8、 Is different volumes of the same formula of tobacco oil considered as two different tobacco oils? If not, how do we prepare different packaging?

The same formula of nicotine free tobacco oil sold in different volumes should be submitted in the same notice (using the same EC-ID). The minimum volume unit should be filled in the volume column on the product details page. However, in the product presentation, an introduction should be added for each volume.

9、 What are the released substances that nicotine free liquid should contain?

There is no specific release substance that needs attention, as the release depends on the composition of the smoke liquid. In theory, all substances present in the analyte should be notified. Normally, nicotine should not be detected.


10、 Are the toxicological data required for products containing and not containing nicotine the same?

Yes, we need to provide data of the same type.

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