Update on European regulations on heated tobacco

Pending the revision of the European directive on tobacco products, an article in a legal journal takes stock of the current provisions, mainly aimed at US producers of heated tobacco.

To be introduced on the European market, tobacco products must comply with the European Tobacco Products Directive (TPD), the current version dating from 2014. However, some adjustments have been made to the current version of the TPD, in particular to take into account heated tobacco products or new herbal cigarettes. In an article published in The National Law Revue, the online resource center Packaging Law, a specialist in regulatory issues relating to packaging and from the independent firm Keller and Heckman, takes stock of the measures currently in force in Europe[1].

Heated tobacco is indeed a tobacco product.

Among the changes already made to the TPD is the expansion of the concept of tobacco products. The TPD now covers not only heated tobacco products[2], but also electronic cigarettes and herbal cigarettes. The latter two products do not contain tobacco, but are smoked or contain nicotine, which is sufficient to bring them under this directive.

It may seem obvious that heated tobacco products are tobacco products; however, this was denied by Philip Morris France (PMF), until a judgment confirmed that its IQOS device is indeed a tobacco product, just like the Heets refills without which it cannot function.[3].

Product characteristics must be detailed before placing on the market

Before any tobacco product is launched on the market, manufacturers must submit a notification to the Member State authorities. This application must include information on 1) the ingredients of the products, 2) the emissions from the use of the products, 3) studies and research conducted on the ingredients and emissions or among consumers, and 4) once a year, information on the sales volumes of the products. Additional information is required for cigarettes or rolling tobacco products containing certain listed additives. Manufacturers of e-cigarettes must also provide details on the ingredients and functioning of their products, and on the nicotine dosages contained and absorbed.

The TPD also sets emission thresholds and analysis methods, and prohibits ingredients that are carcinogenic, mutagenic or toxic to reproduction (CMR) or that are harmful to human health. It limits the volume of e-liquid containers, and prohibits the nicotine level of all e-cigarettes from exceeding 20 mg/ml. Flavourings, for their part, are now banned in cigarettes, rolling tobacco and will be for the heated tobacco by July 2023. The TPD also regulates packaging and requires the presence of health warnings on products. Finally, tobacco products must comply with a traceability system via a unique identification code and security marking intended to prevent smuggling and counterfeiting. Distance selling can be regulated by the Member States.

Transposition of the TPD at national level

As with all European directives, Member States must transpose these texts into their national legislation within a fixed time period. At the TPD level, they can also adopt provisions strengthening them by notifying the Commission and the other Member States. Some states, such as France, have thus been able to adopt a neutral and standardised pack for cigarettes and rolling tobacco, or to ban certain tobacco and nicotine products for public health reasons. In line with the European Beating Cancer Plan, a revision of the TPD is planned for 2024.

The European Union is generally speaking and in the tobacco field in particular often at the origin of protective regulations for consumers and in the health field. Also the lobby deployed by the tobacco sector at the level of the European institutions is major insofar as the standards and decisions applied in this region of the world are often imposed on others.

To learn more about heated tobacco, see our decryption.

Keywords: TPD, heated tobacco, tobacco products, IQOS

MF

[1] The EU's Tobacco Products Directive: Revisiting the Requirements and Updates on Heated Tobacco Products, The National Law Review, 2023, Volume XIII, Number 41, published February 7, 2023, accessed February 10, 2023.

[2] Commission Delegated Directive (EU) 2022/2100 of 29 June 2022 amending Directive 2014/40/EU of the European Parliament and of the Council as regards the withdrawal of certain exemptions in respect of heated tobacco products, Eur-Lex.

[3] CNCT, The CNCT has Philip Morris convicted for illegal advertising of its IQOS device, press release, published December 3, 2021, accessed February 10, 2023.