A few months after being suspended, a Royal Decree published on 28th October 2016 has finally transposed the European Tobacco Products Directive (TPD) – but with a very important change in the classification of vaping products in Belgium. From 17th January 2017, when the law comes into force, e-cigarettes and e-liquids containing nicotine will be considered consumer products, according to the latest ECigIntelligence regulatory report.
This will end e-cigs’ classification as medical devices included in the Act of 25th March 1964 on Medicines, and the Royal Decree of 14th December 2006 on Medicines for Human Use and Veterinary Use (part I and part II). None of them referred explicitly to e-cigarettes, but the Federal Agency for Medicines and Health Products (FAMHP) interpreted it that these existing laws covered vaping products.
After transposition of the TPD at national level, e-cigarettes will no longer be exclusively sold by pharmacists, as retailers required a medical license. However, e-cigarettes that do not contain nicotine or tobacco extracts were exempt from this and were not treated as medical devices.
The new product-specific regulation also includes severe restrictions on retail, including an online sales ban, as well as product, packaging, labeling, health warnings and advertising restrictions. The new law also includes the 2 ml maximum tank size, which also applies to open systems without nicotine.
Vapers ready for legal action
The Belgian Association of Vapers (Union Belge pour la Vape/Belgische Damp Bond) considers this new legal framework contrary to the interest of the population and they warn that with the transposition of the TPD rules, vaping will come under tobacco laws.
“We believe that, in the long term, this law, if implemented as it is, will put a major strain on the expansion of the e-cig in the Belgian market”, Yves Woot de Trixhe, VP of the Belgian Association of Vapers, told ECigIntelligence. Some of Belgium’s vaping industry figures have already introduced legal action to the Conseil d’État (Council of State, the supreme administrative court of the country) that will need to deliver a verdict by 13th December 2017. The Belgian Association of Vapers has already had meetings with the Federal Government to tackle this situation. If the authorities don’t change this law, the association “will continue our consultations with lawyers to see how we can attack this Royal Decree”, added Woot de Trixhe.
According to a recent ECigIntelligence Belgian market report, Belgium is potentially one of the most interesting countries for the e-cig sector. In 2016 the Belgian market was worth around €33m and the vaping population was around 210,000 (February 2016).
What This Means: The TPD will make significant changes in the Belgian vaping regulations. From January 2017, e-cigarettes will not be treated as medical devices, but restrictions for use will be enforced. Belgian Vaping associations think that with this new regulation, expansion of the e-cig industry in the country will be very difficult, especially for retailers. Vaping industry professionals are having meetings with federal health authorities, hoping to modify the law. If this is not achieved before the TPD rules are introduced in early 2017, this battle could end up in court.
– David Palacios ECigIntelligence staff
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