The European Commission’s planned overhaul of the European Union’s tobacco control laws has been delayed after its internal quality watchdog issued a negative opinion on the legislative impact assessment, according to reports in Brussels today.
The Regulatory Scrutiny Board (RSB), an independent body within the Commission tasked with reviewing the quality of impact assessments and evaluations underpinning draft legislation, delivered a negative verdict on the impact assessment prepared by the Directorate-General for Health and Food Safety (DG SANTE).
The decision affects Health Commissioner Olivér Várhelyi’s flagship legislative package, which seeks to revise both the Tobacco Products Directive (TPD), in a third iteration known as TPD3, and the Tobacco Advertising Directive (TAD).
This latest rejection deals a significant blow to the European Commission’s health directorate, which has now failed twice to clear its own internal quality watchdog.
Critics say the Commission’s flagship health initiative is being driven by political ambition rather than economic and regulatory analysis, causing the wheels to fall off.
Asked about the impact of the opinion, a Commission spokesperson told Brussels Signal that they are “working to deliver this important proposal as soon as possible”, but cannot share a precise timeline at this stage.
Asked how the matter might be resolved, they added that they “do not comment on internal procedures”.
First reported by the Brussels newsletter Europe.Table on November 12, the rejection means the Commission will be unable to present its legislative proposals before the end of the year as previously scheduled.
Under the Commission’s Better Regulation guidelines, a positive, or at least positive-with-reservations, opinion from the RSB is required before a draft law can advance to interservice consultation and formal adoption by the College of Commissioners, unless an explicit political derogation is granted.
With the negative opinion, DG SANTE must now revise its impact assessment and resubmit it to the Board.
According to the Brussels-based outlet Eunews, the Board adopted its opinion on November 9 and questioned the proportionality of the proposed measures, the lack of a specific assessment of their tax implications and the analysis of their socio-economic consequences.
The setback marks the second consecutive negative ruling from the scrutiny board on the tobacco file.
On December 12, 2025, the RSB issued a formal negative opinion on DG SANTE’s evaluation of the existing 2014 Tobacco Products Directive and 2003 Tobacco Advertising Directive.
In that opinion, made public alongside the evaluation in April 2026, the Board faulted officials for failing to adequately define how existing rules apply to new and emerging nicotine products, failing to analyse the interplay between national and EU-level measures, and neglecting coherence with the Tobacco Taxation Directive.
The procedural hurdle compounds broader political difficulties facing the Commission’s tobacco agenda across Brussels.
On November 9, EU finance ministers meeting at the Economic and Financial Affairs Council (ECOFIN) failed to reach the required unanimity to adopt a parallel revision of the Tobacco Taxation Directive.
While 26 member states backed a compromise text brokered by the Irish presidency of the Council of the European Union, Malta withheld its consent, insisting that taxation remains a national prerogative.
That has stalled the tax reform ahead of a further scheduled attempt on December 11.
Meanwhile, Commissioner Várhelyi has faced competing pressures from member states and industry over the scope of TPD3.
On October 6, health ministers from eight member states — the Netherlands, Belgium, Finland, France, Hungary, Latvia, Slovenia and Spain — wrote to Várhelyi urging the Commission to use the revised directive to bar new nicotine products from entering the EU market, reduce their attractiveness to young people, allow national bans on nicotine pouches (widely used in Sweden) and restrict advertising.
Conversely, on November 4, a coalition of more than 200 European business, retail, farming and manufacturing associations, coordinated by the industry group Tobacco Europe, sent an open letter to Commission President Ursula von der Leyen warning of job and revenue losses from disproportionate restrictions.
The signatories also raised procedural concerns over the preparation of the review, pointing to reports that the impact assessment had failed to clear RSB scrutiny.
Under Europe’s Beating Cancer Plan, the Commission has set a target of reducing tobacco use in the bloc to below 5 per cent of the population by 2040.
On November 12, the European Parliament approved a resolution assessing the EU’s action plan on beating cancer, by 447 votes to 66 with 91 abstentions, saying it wants to see EU tobacco legislation urgently updated to cover products such as electronic cigarettes, heated tobacco products and nicotine pouches.
The report was drafted by Romanian Renew Europe MEP Vlad Vasile-Voiculescu. MEPs rejected an amendment, tabled by several European People’s Party (EPP) members, that sought to postpone the revision of tobacco legislation.
The nicotine and tobacco industry opposes this, saying it would only lead to more illegal products and that it completely ignores principles of harm reduction.
The review could also include plain packaging requirements, restrictions on flavours that attract young consumers, the mandatory reporting of ingredients and a prohibition on the online sale of nicotine products to minors. At the same time, MEPs say an increase in minimum excise duties for all tobacco and nicotine products is needed.
