When institutions design policy, they assume it will change behaviour. A more difficult matter to assess is whether all available evidence is truly used to challenge assumptions. This sits at the core of DG SANTE’s recent evaluation of the Tobacco Products Directive.
The Directive is the EU's main framework for tobacco and nicotine regulation, in force since 2014 and now under revision. An evaluation by the Commission, published this spring, is the formal starting point. The document returns, page after page, to the same answer. Ban. The word, and the policy reflex behind it, is applied often to the flavoured vapour products and nicotine pouches that adult smokers across Europe use to move away from cigarettes to smokeless alternatives.
Good rules tend to be written by paying close attention to those who see, in real time, what happens on the ground
At the same time, the agencies enforcing the existing rules are describing a different reality. Last December, OLAF and customs authorities in 23 EU member states concluded the first EU-wide joint operation against the illicit vape trade, seizing more than 94 million pieces. OLAF's Director-General, Petr Klement, described the illicit trade in tobacco and e-cigarettes as "a serious and growing threat to public health and public finances." Europol's 2025 Threat Assessment reaches the same conclusion, and the Council has placed illicit tobacco among its enforcement priorities for 2026 to 2029.
This is the picture from the front line. Independent estimates put around half of the EU vapour market in the illicit or non-compliant space. Member states collectively spend around €19.7 million a year enforcing the current Directive, while losing roughly €13 billion in unpaid taxes to the trade they cannot control.
The policy meant to keep young people away from flavoured vapes is the reason most of them now buy from unregulated channels
In the Netherlands, after the 2024 flavour ban, close to 90 per cent of the Dutch vape market moved underground, and underage vaping has increased by 15 per cent compared to the year before the ban. Two years on, around 90 per cent of Dutch underage vapers still use flavoured products. The policy meant to keep young people away from flavoured vapes is the reason most of them now buy from unregulated channels. Smart regulation and robust enforcement keeps control where it belongs – with government. Bans hand the market to criminal networks, where there are no age checks, no product safety standards, no taxes, and no accountability
This is an aspect that DG SANTE has not engaged with so far. And one which the next phase of the policy process has every opportunity to address. The Commission's own Better Regulation principles call for evaluations and assessments to weigh all the available evidence, including the parts that complicate the analysis. Good rules tend to be written by paying close attention to those who see, in real time, what happens on the ground.
Independent estimates put around half of the EU vapour market in the illicit or non-compliant space
World No Tobacco Day this year falls as the Commission's thinking on new tobacco rules is still taking shape and as the process has entered the Impact Assessment phase, accompanied by a Call for Evidence and Open Public Consultation. The opportunity now is for DG SANTE to heed the evidence on bans and extreme restrictions. Without it, it will be next to impossible to design smart rules that can be enforced on the ground, and to safeguard a regulated market that contributes €107 billion in annual tax revenue and supports 1.5 million jobs across Europe.
The evidence is there. I sincerely hope it will be reflected in the policymaking process.
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