The European Commission spent four years and roughly €3 million evaluating whether the EU's tobacco rules still work. A new assessment says the diagnosis is useful, but nowhere near enough to justify tougher regulation on its own.
In a report titled TPD2 Evaluation Assessment, the Brussels-based European Policy Innovation Council (EPIC) picks apart the Commission's April 2026 evaluation of the Tobacco Products Directive and the Tobacco Advertising Directive. Its verdict: the evaluation is a solid piece of diagnostic mapping, but it “does not yet provide a sufficiently robust analytical basis for major regulatory decisions without a comprehensive impact assessment.” EPIC is careful to say it is not challenging the public-health goals — cutting smoking, protecting minors. It is challenging whether the analysis behind the next legislative step holds up.
The strongest warning here isn't EPIC's. It's the Commission's. The draft evaluation went to the Regulatory Scrutiny Board — the Commission's internal quality-control body — on 10 November 2025. The Board discussed it on 9 December and issued a negative opinion on 12 December. The published evaluation sets out how officials addressed the Board's concerns: attribution, product scope, differences between member states, uncertainty, and conclusions running ahead of the evidence. But, EPIC points out, the revised document never went back for a second Board opinion. Whether those fixes went far enough is still an open question, and that question now sits at the centre of the debate.
EPIC scores the evaluation against six of the Commission's own Better Regulation criteria. Two come out “partially robust”: the definition of the problem, and the handling of a public consultation that drew more than 24,000 responses to the call for evidence and over 17,000 to the public consultation. Three are rated “constrained”: the causal evidence linking specific EU measures to falling smoking rates, the analysis of economic and value-chain costs, and the test of whether tougher rules would be proportionate. The final criterion — how the evaluation feeds the impact assessment — “requires further substantiation.”
The through-line is consistent. The evaluation is strong at describing what has changed in the market — the rise of vapes, nicotine pouches and other novel products, digital marketing, and national rules pulling in different directions. It is weak at proving that EU legislation, rather than taxation, national measures or shifting consumer habits, drove the results. On its own admission, the Commission cannot cleanly isolate the effect of the two directives from everything else acting on smokers.
EPIC's central procedural point is that an evaluation and an impact assessment do different jobs. An evaluation looks back and asks whether existing rules worked. An impact assessment looks forward: it defines the problem, weighs genuine options and tests proportionality before anyone drafts a law. EPIC's worry is that the Commission's evaluation already tilts toward a conclusion — that the framework has been “outpaced” and needs tightening — before that forward-looking work has been done. Blur the two, and the impact assessment risks becoming a rubber stamp rather than a real test of alternatives.
This is a fight about process, and in Brussels process is power. If the Commission carries the evaluation's directional narrative straight into a legislative proposal, it invites a bruising battle — a negative scrutiny-board opinion is exactly the kind of thing opponents will wave around in the Council, in Parliament and, eventually, in court. EPIC's prescription is that the coming impact assessment do the heavy lifting the evaluation didn't: pin down the problem, prove the causal chain, cost the impact on retailers, growers and smaller member states, and weigh tougher rules against alternatives such as better enforcement. The stakes cut both ways. A framework that fails to catch novel products leaves minors exposed; one built on thin analysis invites legal challenge and can push trade into illicit markets. Either way, EPIC's message to the Commission is blunt — the case for rewriting Europe's tobacco rules still has to be made.
