The CJEU judgment (Case C-759/23) of 26 June 2025 legally upholds Delegated Directive 2022/2100 and, with it, the European Union’s strategy of aligning the regulatory treatment of all tobacco products. The CJEU rejected the arguments of the tobacco industry and endorsed the legitimacy of the Commission to adjust regulation in order to protect public health.

Directive 2014/40/EU regulates the manufacture, presentation, and sale of tobacco and related products in the European Union. That Directive contains provisions on the ban of characteristic flavours (menthol, vanilla, etc.) and on packaging with graphic and textual health warnings. In its original version, certain exemptions were granted for novel tobacco products, including heated tobacco products (HTPs). In 2022, the Commission adopted Delegated Directive (EU) 2022/2100, which removed those exemptions after concluding that substantial changes had occurred in the use of these products, such as significant market growth, increased appeal to young consumers, and the risk of undermining EU public health policies.

The tobacco companies PJ Carroll and Nicoventures Trading, supported by Philip Morris, brought an action before the High Court of Ireland, claiming that the European Commission lacked the competence to remove those exemptions by means of a delegated act, and that such a decision could only be taken by the Parliament and the Council through the ordinary legislative procedure. Their main argument was that Delegated Directive 2022/2100 violated the principle of legal certainty, as it radically altered the framework applicable to these products.

The Irish Government defended the validity of the delegated act, stressing that the Commission acted within the mandate conferred by Directive 2014/40/EU. The European Commission underlined that Article 7(12) and Article 11(6) of Directive 2014/40/EU explicitly grant it the power to adapt the rules in light of scientific and market developments.

The CJEU’s Second Chamber ruled that the Commission was indeed empowered to withdraw the exemptions by means of a delegated act, since this responded to a substantial change of circumstances, which fits within the flexible review mandate conferred on the Commission by the EU legislator. Therefore, the act is valid and in conformity with Union law.

This ruling entails important practical consequences, including the regulatory alignment of heated tobacco products, which are now subject to the same restrictions as cigarettes and other tobacco products. Furthermore, it reinforces public health policies by preventing these products, marketed as “innovative alternatives,” from becoming a gateway to tobacco consumption and by preventing the industry from exploiting legal loopholes to attract new consumers. Finally, it establishes a jurisprudential precedent confirming that the European Commission may intervene swiftly, through delegated acts, when significant changes occur in scientific evidence or in the market, thus consolidating the EU’s room for manoeuvre in tobacco control and prevention.