Testing the TPD2 Revision Process
Does the Commission’s Evaluation and Public Consultation Provide a Robust Evidence Base for the Next Stage of EU Tobacco Policy?
Publication date: 2026
Category: Better Regulation | Public Health | EU Policy Assessment
Overview
The European Commission’s review of the EU tobacco control framework is progressing through a series of stages that may lead to the revision of the Tobacco Products Directive and the Tobacco Advertising Directive.
EPIC is examining this process through the lens of the EU Better Regulation framework, with particular attention to the quality of the evidence base, methodological robustness, proportionality, implementation and enforcement, and the role of the forthcoming Impact Assessment.
The assessment currently consists of two parts.
Part I examines the Commission’s Evaluation of the existing tobacco control framework and asks whether it provides a sufficiently robust analytical basis for future regulatory decisions.
Part II examines the Public Consultation questionnaire as the next stage in the evidence-to-regulation chain and asks whether the regulatory interventions it tests are supported by a clear evidence trail from the Evaluation.
Key Message
Taken together, the two parts identify a central Better Regulation challenge.
The Commission’s Evaluation provides a broad and useful diagnostic account of the existing framework, but important limitations remain in the evidence base, causal attribution, economic analysis and proportionality assessment.
The Public Consultation then moves, in several areas, from those broad findings towards specific and more ambitious regulatory interventions without always establishing a clear evidentiary bridge from the Evaluation.
The forthcoming Impact Assessment must therefore remain a substantive and independent stage of the policy process. It should establish, measure by measure, the evidence trail from the existing rule to the demonstrated problem, from the problem to the available policy options, and from the preferred option to a proportionate EU intervention.
Part I — Assessment of the Commission Evaluation
Does the Commission Evaluation Provide a Robust Basis for the Next Stage of EU Tobacco Policy?
The European Commission’s Evaluation provides a detailed account of market developments, implementation challenges, novel tobacco and nicotine products, digital promotion and divergent national approaches across the EU.
EPIC’s assessment examines whether that Evaluation provides a sufficiently robust analytical basis for the next stage of the policy cycle, particularly the forthcoming Impact Assessment.
What Part I Finds
| Assessment criterion | Assessment |
|---|---|
| Problem Definition and Intervention Logic | Partially robust |
| Evidence Base and Causal Attribution | Constrained |
| Stakeholder Consultation and Evidence Integrity | Partially robust |
| Economic Impacts and Value-Chain Considerations | Constrained |
| Proportionality and Options Logic | Constrained |
| Interface with the Impact Assessment Phase | Requires further substantiation |
The central conclusion of Part I is that the Evaluation is useful as a diagnostic document, but does not by itself provide a sufficiently robust basis for major regulatory decisions without a comprehensive Impact Assessment.
The distinction between retrospective evaluation and forward-looking policy design therefore remains essential. The Impact Assessment should independently test regulatory options, proportionality, implementation and enforcement questions, and economic, social, regional and value-chain impacts.
Part II — Assessment of the Public Consultation Questionnaire
Testing the Evidence Trail from Evaluation to Impact Assessment
The Public Consultation is an important procedural stage in the preparation of future legislation. The way questions are framed, the product categories used, the response options offered and the trade-offs explored influence the evidence the Commission receives and, ultimately, the quality of the future Impact Assessment.
Part II identifies what the report calls an Evaluation-to-Public Consultation leap.
In several areas, the questionnaire moves from broad diagnosis to specific regulatory interventions even though the Evaluation did not clearly establish whether the relevant existing TPD framework is ineffective, inadequately enforced or no longer fit for purpose.
The concern is not that these measures should be excluded from consideration. The concern is that their inclusion in the consultation should not itself be treated as evidence that intervention is necessary, effective or proportionate.
What Part II Finds
The assessment identifies five recurring risks for the forthcoming Impact Assessment:
| Risk identified | Requirement for the Impact Assessment |
|---|---|
| Specific interventions are tested without a clearly established Evaluation finding | Identify the existing rule, the proven shortcoming and the evidence of failure |
| Ineffective rules are not consistently distinguished from insufficient enforcement | Distinguish rule-design failure, enforcement failure and market or technological obsolescence |
| The questionnaire moves across different product categories | Assess each product category separately and justify any cross-category extension |
| Restrictive measures are tested without equivalent testing of alternatives | Compare less restrictive, targeted, enforcement-led and product-specific options |
| Agreement-scale responses may not explain why respondents support measures | Supplement consultation data with targeted evidence, technical analysis and stakeholder input |
The report illustrates these risks through five examples: pack inserts with cessation information; standardisation of vape tanks, refill containers and cartridges; standardised packaging formats for new-generation products; additional vape device-safety rules; and restrictions on device design and appeal.
Why This Matters
EU tobacco policy pursues major public health objectives, including reducing smoking-related harm and protecting minors.
At the same time, future regulation must be evidence-based, proportionate, enforceable, legally robust and attentive to economic, social, regional and market impacts.
The purpose of this series is not to determine the final policy outcome in advance, but to test whether the regulatory process meets the standards of evidence, neutrality, proportionality and analytical completeness required under the EU Better Regulation framework.
Each part examines a different stage of the policy cycle: evaluation, consultation, impact assessment and legislative proposal.
The central question for the next stage is therefore straightforward:
Will the forthcoming Impact Assessment supply the missing evidence trail and independently test whether proposed regulatory interventions are necessary, effective and proportionate?
