Responsibility for correct nicotine declarations on e-cigarettes applies to the entire supply chain

On the occasion of a decision on nicotine declarations, the Court of Justice of the European Union (EuGH) also has clear words to say about the concept of placing on the market.

Strict Union law requirements for the protection of health and consumers

The European legislator attacheshealth and consumer protection in the field of tobacco and e-cigarette products outstanding importance for years. The decisive instrument here is theRichtlinie 2014/40/EU (Tabakproduktrichtlinie), the declared objective of which is toensure a high level of protection for human health, in particular forchildren and young people, and at the same time to create a uniform market environment in the European Union.

Electronic cigarettes andrefill containers with nicotine-containing liquids are not regarded as ordinary consumer goods under Union law. Due to theiraddictive potential and the associated health hazards, they are subject to strictlabelling, notification and control obligations. Nicotine declarations play a central role, in particular theaccurate declaration of the nicotine content on the packaging. This information is essential for consumers in order to assess risks and make informed decisions.

Member States are required under the Directive to ensure thatnon-compliant products are not placed on the market at any time. At the same time, they mustprovide for effective, proportionate and dissuasive sanctions in order to effectively penalise infringements.

The subject matter of the case: inaccurate nicotine declarations on refill containers

Thejudgment of the Court of Justice of the European Union of11.12.2025 (C‑665/24) was based on proceedings from the Netherlands. The national market surveillance authority hadexamined refill containers for electronic cigarettes that had been distributed through various sales outlets. It turned out that the nicotine declarations were incorrect: theactual nicotine content was lower than stated on the packaging.

The affected products had previously beensupplied by distributors (wholesalers) to sales outlets. These distributors had in turn obtained the goods from manufacturers or importers from other EU Member States. The competent authority imposedfines on the distributors on the ground that they had placed products with defective labelling 'on the market' because of the inaccurate nicotine declarations.

The companies defended themselves with the argument that they hadnot supplied the products directly to end consumers, but had merely delivered them to sales outlets. Furthermore, they argued that they were entitled to rely on the nicotine declarations of the manufacturers and importers, particularly since these had been consistent with the official notifications under the Directive. The national court subsequently referred several questions to the Court of Justice of the European Union concerning theinterpretation of the term 'placing on the market' and theadmissibility of fault-independent fines.

Clear words from the Court of Justice of the European Union: 'placing on the market' does not begin only with the sale to consumers

The Court of Justice of the European Union makes unmistakably clear in its decision that the Union law concept of'placing on the market' is to be interpreted broadly. It encompassesany supply of a product within the Union, whether for consideration or free of charge, regardless of which stage of the supply chain it takes place at.

This means that not only the sale to the end consumer is covered, but also thesupply of refill containers to a sales outlet. According to the Court of Justice of the European Union, a restriction to the final trading stage would endanger the objective of the Directive – to achievecomprehensive health and consumer protection – thereby endangering it. Only if all economic operators along the supply chain are held responsible can it be prevented thatunlawfully labelled products reach the market at all.

The Court of Justice of the European Union (EuGH) further emphasises that the supervisory obligations of the Member States span the entire supply chain. Every step that contributes to ultimately making a product available to consumers is subject to the requirements of the Directive.

Sanctions without fault – but not without due measure

On the question of sanctions, the EuGH also takes a differentiated position. In principle, it is permissible under EU law for Member States to provide for a system of strict liability. This means: An economic operator can be fined even without proof of personal fault if they place a non-conforming product on the market.

In the Court of Justice's view, such a system is particularly justified when – as in this case – a paramount public interest is being pursued, namely the protection of public health. The Directive is intended to encourage economic operators to actively monitor compliance and not to rely blindly on upstream market actors.

A sanction becomes impermissible, however, if it is disproportionate in design. The EuGH expressly objects to flat-rate fines that leave no room for consideration of the specific circumstances of the individual case. For example, it may be significant whether the actual nicotine content was higher or – as in the dispute at hand – lower than stated in the nicotine information, what role the affected economic operator played and whether they had realistic possibilities for monitoring.

Recommendation from a legal counsel perspective

The judgment has considerable practical significance. For companies in the field of e-cigarettes and refill containers: Consumer protection does not end with the manufacturer. Also importers, wholesalers and distributors bear an independent responsibility for the accuracy of labelling. Anyone who relies exclusively on the manufacturer for, among other things, nicotine information runs a legal risk.

From a legal counsel perspective, it is urgently recommended to establish contractual audit provisions and recourse arrangements, random product inspections as well as a reliable compliance system. At the same time, the judgment also shows clear limits for the authorities: Sanctions must be proportionate and must not be imposed schematically. Our law firm AVANTCORE Rechtsanwälte in Stuttgart advises companies on legally compliant market participation.