EU tobacco rules face setback as proposal fails scrutiny
13th Nov 2026
The European Commission’s plans for new tobacco and nicotine regulations have hit a major obstacle. The Commission’s own scrutiny board has issued a negative opinion on the impact assessment for the proposed Tobacco Products Directive (TPD3). Delays now appear inevitable, forcing EU Health Commissioner Olivér Várhelyi back to the drawing board.
The EU’s efforts to tighten regulations on tobacco and nicotine products have suffered a setback. According to German news service Table.Briefings, the European Commission’s Regulatory Scrutiny Board (RSB) has issued a negative opinion on the impact assessment behind the planned revisions to the Tobacco Products Directive (TPD) and the Tobacco Advertising Directive (TAD).
This means the Commission must revise its assessment before the proposals can move forward through the normal legislative process.
Várhelyi’s plans put on hold
EU Health Commissioner Olivér Várhelyi has been leading efforts to introduce new rules for tobacco and nicotine products across the EU. The aim was to present a proposal before the end of the year. That deadline now looks unlikely to be met.
The Regulatory Scrutiny Board is responsible for checking whether proposed EU legislation is supported by sufficiently robust assessments of its economic and social impacts, among other factors.
A negative opinion means the board has identified serious shortcomings in the analysis. However, it does not mean the board has rejected the political objectives or the legislation itself.
Lindblad: EU must recognise differences between nicotine products
The issue is particularly important for Sweden, which has long argued that tobacco and nicotine regulations and taxes should reflect the differences in health risks between products.
Markus Lindblad, Head of Legal and External Affairs at Haypp Group, believes the Commission’s setback highlights the importance of proposals being based on solid evidence.
“It is remarkable that the European Commission’s work is once again facing such serious criticism. If you want to introduce new rules affecting millions of Europeans, those decisions must be based on facts. Ignoring the differences between cigarettes and smoke-free nicotine products is simply not acceptable,” says Markus Lindblad.
EU may have to revise its impact assessment
A negative opinion means the Commission must improve its impact assessment and submit it for another review. If the board issues a second negative opinion, moving the proposal forward becomes considerably more difficult. A special decision at political level would then be required for the process to continue.
According to Table.Briefings, the Commission’s Secretariat-General has also raised objections to plans to fast-track the proposal.
The European Commission has not confirmed a new timetable.
What is clear is that the EU’s planned overhaul of tobacco regulations has encountered a significant obstacle, leaving the timing of the next steps uncertain
