To be placed on the European Union market, tobacco and related products must comply with specific requirements and procedures, harmonized at the European level by Directive 2014/40/EU concerning the manufacture, presentation, and sale of tobacco and related products (hereinafter the “Tobacco Products Directive” or the “Directive”). This article provides a general overview of the requirements and procedures necessary to comply with the Tobacco Products Directive. This is the first of a series of articles that we will publish on marketing tobacco and related products in the EU. Future articles will address specific insights on (i) ingredients requirements and flavor bans, (ii) notification and reporting obligations under the Directive, (iii) labeling and packaging of tobacco products, and (iv) implementation of the Directive by the European Member States.
I. Scope of the Directive: Heated Tobacco Products Now Included
The Directive applies to electronic cigarettes, herbal products for smoking, and tobacco products. Under the Directive, “tobacco products” include pipe tobacco, roll-your-own tobacco, smokeless tobacco, cigarettes, cigars, cigarillos, waterpipe tobacco, and novel tobacco products. ‘Novel tobacco products’ is a new and open category introduced by the Directive, which encompasses all tobacco products not falling under the one previously mentioned and that are placed on the market after May 19, 2014. Following the Commission Delegated Directive (EU) 2022/2100, which became effective on November 23, 2022, novel tobacco products include ‘Heated Tobacco Products,’ which are defined as a product “that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by user(s), and that, depending on its characteristics, is a smokeless tobacco product or a tobacco product for smoking.”
II. Notification and Reporting Obligations
Under the Tobacco Products Directive, prior to placing a product on the market, manufacturers and importers of tobacco products and e-cigarettes must submit to the Member State authorities specific information containing details on (i) ingredients, accompanied by relevant toxicological data, (ii) emissions resulting from the use of the products, (iii) studies and market research on smokers, ingredients and emissions, and (iv) on a yearly basis, information on the sales volumes of the products. Enhanced reporting obligations apply to cigarettes and roll-your-own tobacco products only if they contain additives on a priority list. For electronic cigarettes, additional information includes components of the product, a description of the production process, and the nicotine doses and the nicotine uptake (i.e., the body absorption). The above information must be submitted through an electronic entry gate, common for all Member States of the European Union (also known as “the EU Common Entry Gate”).
III. Product Requirements
Emission levels and ingredients
The Tobacco Products Directive sets forth requirements on maximum emission levels, measurement methods, and standards (the latter for cigarettes only) and prohibits the use of ingredients that (i) are listed in the Directive, (ii) have carcinogenic, mutagenic, or reprotoxic (CMR) properties, or (iii) pose a risk to human health (for tobacco products and electronic cigarettes). The use of flavorings is banned in cigarettes and roll-your-own tobacco. Importantly, the flavor ban will apply (as of October 23, 2023) to heated tobacco products as well, pursuant to recent Directive (EU) 2022/2100. Further to the above, the Directive also provides specific product requirements for electronic cigarettes, such as maximum nicotine levels (20 mg/mL), volume requirements for refill containers and cartridges, and mechanical requirements for electronic cigarettes and refill containers.
Labeling and packaging
The Directive also regulates certain aspects of the labeling, packaging, and presentation of tobacco products, electronic cigarettes, and herbal products for smoking. For each of these product categories, the mandatory health warnings required to be placed on the product packaging are provided in the Directive.
For tobacco products only, the Directive sets out a traceability system in order to address the issue of illicit trade. Under the traceability system, (i) all unit packets of tobacco products must be marked with a unique identifier and a tamper-proof security feature enabling authorities and consumers to verify their authenticity, and (ii) economic operators in the supply chain must maintain records of the traceability of the products and transmit the related information to an independent provider of a repository, approved by the EU Commission, that stores therein the data transmitted. The competent authorities of the Member States and the Commission have access to the data stored in the repositories to ensure compliance with the tobacco products legislation.
Cross-border distance sales of tobacco products
Specific requirements (i.e., registration and verification obligations) apply to cross-border distance sales of tobacco products and electronic cigarettes. Cross-border distance sales may also be prohibited by Member States.
IV. Implementation of the Directive by the EU Member States
In general, EU Directives only set forth the objectives that all EU countries must achieve. However, it is up to the individual Member States to devise their own laws on how to achieve the objectives within the Directive. It follows that (i) Directives need to be implemented in each EU Member State to be enforceable and that (ii) the Directives may be, in practice, implemented differently in each Member State. In this regard, we note that pursuant to the Tobacco Products Directive:
- Member States may maintain or introduce further requirements in relation to the standardization of the packaging of tobacco products when justified on the grounds of public health;
- Member States may also prohibit a certain category of tobacco or related products, provided again, the provisions are justified by the need to protect public health
V. Revision of the Tobacco Products Directive
The European Commission is currently reviewing the Tobacco Products Directive, aiming to address issues such as further enforcement of the current regime for cross-border distance sales, emerging novel tobacco products, regulatory challenges posed by heated tobacco products and electronic cigarettes, new herbal products entering the market, and options to increase tobacco manufacturers’ liability. According to the European Commission’s Implementation Roadmap of Europe’s Beating Cancer Plan, the Commission is expected to adopt a proposal for the revision of the Tobacco Products Directive in 2024.
In summary, the Tobacco Products Directive establishes numerous and detailed provisions that manufacturers must take into consideration when placing electronic cigarettes and tobacco products on the European Union market. Given the numerous requirements, differences in Member State implementation of the Directive, upcoming flavor bans, and anticipated revisions to the Directive, companies must take a careful approach and monitor developments closely to ensure compliance and avoid enforcement.
We will be covering EU regulation of tobacco products in detail at Keller and Heckman’s Annual E-Vapor and Tobacco Law Symposium on February 15 – 16, 2023, in Irvine, California. Details and registration information can be found here.
 Decision (EU) 2016/787 laying down a priority list of additives contained in cigarettes and roll-your-own tobacco subject to enhanced reporting obligations. This is a list containing the most commonly used additives, for which there are indications that they: a) contribute to/increase the toxicity or addictiveness of the products, or b) result in a characterizing flavor, or c) facilitate inhalation or nicotine uptake, or d) leads to the formation/increase of CMR substances/their quantities.
 The list is provided by Article 7.6 of the Tobacco Products Directive.
 See Par. 5 (Traceability and security features) of the Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products of May 20, 2021 (the “2021 Commission Report”).
 According to the 2021 Commission Report, more than half of the Member States banned cross-border distance sales of tobacco and/or related products to consumers in their countries (Par. 6 Cross-border distance sales).
 We note that aspects not harmonized by the Directive may be regulated autonomously by the Member States. For example, the Directive (recital 47) mentions that it does not harmonize all aspects of electronic cigarettes or refill containers and that the responsibility for adopting rules on flavors remains with the Member States.
 See the 2021 Commission Report.
 Europe’s Beating Cancer Plan: Implementation Roadmap was published in November 2021 and is available here: https://health.ec.europa.eu/latest-updates/europes-beating-cancer-plan-implementation-roadmap-2021-11-17_en.