Abstract

Directive 2014/40 updated and repealed Directive 2001/37. As with the previous Directive, the new Tobacco Products Directive’s legal basis, proportionality, and subsidiarity were at issue in three recently decided cases, an action for annulment and two preliminary rulings, upholding the Directive’s validity, as well as in another pending preliminary reference. The new TPD once again raises questions of EU competence and recourse to the Article 114 TFEU general internal market legal basis for health measures. This article examines the dual nature of internal market legislation and interaction between internal market and public health objectives, analysing means of justifying the legal basis and proportionality of health-related internal market measures: the high level of health protection envisaged by mainstreaming provisions and the ‘decisive factor’ formula; the EU legislature's discretion as to the most appropriate method of approximation; and its broad discretion in areas involving complex assessments. This article examines the legal basis, proportionality, extent and relevance of labelling and packaging provisions on health warnings, TNCO labelling, misleading features and packet standardization. It suggests further adaptation of the public health legal basis, to reflect the evolution of EU competences in practice and avoid contrived reliance on the internal market objective, which should not, however, entail excessive risk-regulation.

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