On going regulations and positions

The tobacco and nicotine products regulatory landscape within the European Union is very fast-paced and permanently evolving. 
The tobacco and nicotine products regulatory landscape within the European Union is very fast-paced and permanently evolving.

Explore this tab to discover comprehensive resources to remain informed about the latest developments, Tobacco Europe’s views and positions, and gain valuable insights into the regulatory landscape of our sector.

Our objective is to provide our expertise and views necessary to make informed decisions and contribute to the ongoing dialogue surrounding these products within the EU.

Tobacco Europe is compliant with EU regulations, as we believe it is crucial for consumers and stakeholders looking for accurate and up-to-date information. With a focus on expertise, transparency, and science-based evidence, we act as a trusted policy partner for navigating the complexities of EU regulations pertaining to tobacco and nicotine products.

We aim to provide our knowledge, and views necessary to make informed decisions and contribute to the ongoing dialogue surrounding these products within the EU.
The Ombudsman’s inquiry on interaction between the Commission and the tobacco industry
In April 2023, the Ombudsman published a preliminary report pointing out “maladministration” coming from parts of the Commission. This inquiry is pursuant to the 2016 inquiry, which found maladministration “in light of the Commission’s refusal to apply DG SANTE’s proactive transparency policy across all of its departments”.

Following this publication in April 2023, Ombudsman asked the Commission to respond to preliminary inquiry findings about a lack of transparency in its interactions with tobacco lobbyists, following the examination of documents concerning Commission meetings with tobacco industry representatives in 2020 and 2021.

In this enquiry, the Ombudsman asked for the Commission to reply to these preliminary findings by mid-July, however the office of the Ombudsman confirmed they have not received an answer from the Commission at this stage.

Tobacco Europe adheres to and endorses compliance requirements set by the laws and regulations governing the industry, including the overarching Framework Convention for Tobacco Control. The association advocates for an open and transparent line of communication with all the interested parties when meeting with regulators and external stakeholders. To this end, Tobacco Europe is looking forward to reading the Commission's answer to the inquiry and to discovering the “necessity checks” that seem to be undertaken by the Commission when meeting with the tobacco industry.

Finally, we believe that the democratic rules and good governance principles require consultation with all affected parties, and generally do not allow for discrimination against one sector. In the tobacco control debate, each stakeholder has its role to play. It is then up to the relevant policymakers to take decisions in an inclusive, impartial and transparent way. Privileging one category of stakeholders can only undermine the legitimacy of the policy making process; it will not deliver informed decisions and good legislation.

The FCTC and Article 5.3

The Framework Convention on Tobacco Control (FCTC, entry into force in 2005) is the first treaty negotiated under the auspices of World Health Organisation (WHO) developing a regulatory strategy to reduce tobacco use and exposure to tobacco smoke.

The Article 5.3 of the Treaty requires that “in setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law”.

In 2008, the Conference of the Parties (COP) to the FCTC collectively adopted guidelines setting out 4 non-binding principles and 8 non-binding recommendations to support the implementation of Article 5.3. Among these 4 non-binding principles, one principle specifically addresses relations with the Tobacco Industry representatives and clearly states interactions shall be “accountable and transparent”.

The two sub-recommendations made for this principle request the “necessary interactions” to be “conducted transparently” but do not mandate or suggest the exclusion of the industry at any stage.

More importantly, Article 5.3 and its related principles seek to protect public health policies exclusively, and do not encompass other policies fields dealing with the Tobacco Industry. In this instance, no marginalization can be justified under Article 5.3 for dossiers unrelated to public health policies such as environmental, customs or financial dossiers.

All in all, Tobacco Europe believes that FCTC Article 5.3 provides an opportunity to improve transparency, inclusivity, and the integrity of a decision-making process – especially in conjunction with the EU and OECD principles of Better Regulation.

Tobacco Europe and its members are legitimate, transparent and accountable stakeholders in European regulatory debates. The tobacco industry is a legal and integral partner of the EU institutions when it comes to tobacco-related legislation in the EU and rightly expects to be part of the decision-making process, as any other stakeholder.

Importantly, this was further highlighted by the EU Court of Justice recently (February 2022), when delivering a judgement in the case C- 160/20 on the methods to measure the emission levels in which it clearly stressed that Article 5.3. of the FCTC does not prohibit all tobacco industry involvement in tobacco control policymaking but seeks to prevent tobacco control policies from being influenced by tobacco industry interests.

(Abstract of the ECJ judgement: It is clear from the very wording of that provision that it does not prohibit all participation of the tobacco industry in the establishment and implementation of rules on tobacco control but is intended solely to prevent the tobacco control policies of the parties to the convention from being influenced by that industry’s interests.)


Tobacco Europe is a trusted policy partner which is compliant with all laws and regulations governing our products and industry, including the overarching Framework WHO Convention for Tobacco Control.

Tobacco Europe and its members are registered on the Transparency Register and encourage transparency by clearly communicating and disclosing all necessary information to the authorities.

Whenever possible, Tobacco Europe cooperates with the competent authorities to ensure provisions applying to the industry are enforced. This is notably the case with the Track and Trace system, as provisioned in Article 15 of the Tobacco Products Directive.
Harm reduction
The goal of tobacco harm reduction is to prevent or reduce the health risk associated with smoking for people reluctant or unwilling to stop. Tobacco harm reduction is based on the well-established concept that smokers seek to obtain the effects of nicotine, while the real risks are produced by the toxic components generated by combustion process.

In practice, this primarily means encouraging smokers to adopt non-combustible tobacco and nicotine products such as HTP and e-cigs through regulations, fiscal measures and communications.

Smoking creates serious health risks, among which lung cancer, coronary heart disease, emphysema, and chronic bronchitis to the consumer; the use of combustible cigarettes is one of the leading causes of preventable morbidity and mortality globally. The higher health risks are associated to the combustion process, these products generating smoke; the smoke generated by a combustible cigarette contains chemical compounds, many of which are recognized as carcinogenic.

Although smokers are aware of the negative health impacts associated with smoking, some chose to continue to smoke, and others might not be able to quit. At the same time, there is a growing interest among tobacco users in potentially reduced risk products as an alternative to smoking cigarettes. These products include vaping products, tobacco heated products (THP), snus and tobacco-free nicotine pouches.

Tobacco Europe believes that public authorities and policies should support adult smokers who wish to move away from combustible tobacco to potentially less harmful alternatives. They should be evidence-based, provide a legal framework guaranteeing high quality standards and reassurance to consumers, whilst supporting technological developments and continued investment from economic operators.

While evidence-based, proportionate and effective regulation can help establish clear product standards and safeguard critical aspects of product contents and performance, public policies should nevertheless treat reduced risk products differently from cigarettes especially with regards to taxation, advertising and promotion, packaging.

Beating Cancer Plan

In 2021, the European Commission published its Beating Cancer plan to set out a new approach to prevention, treatment and care. The BECA plan tackles the entire disease pathway, from prevention to quality of life of cancer patients and survivors, focusing on actions where the EU can add the most value.

The third section of the BECA addresses cancer prevention, and the second chapter specifically concerns tobacco and the objective of achieving a “tobacco-free Europe”.

Smoke-Free Environment Council Recommendation

In 2009, the Council published a Recommendation on smoke-free environments aiming at protecting people within the European Union from exposure to secondhand smoke (inhalation of smoke by others than the user of the product).

As part of the Beating Cancer Plan published in 2021, the on-going update of the recommendation aims to bring it into line with the latest market developments as well as to include the use of tobacco and related products in certain outdoor spaces in its scope.

Tobacco Europe considers that the inclusion of emerging products within the scope of the Recommendation does not rely on scientific-based evidence. Together with our members, we believe in the development of reduced risk products (RRPs) such as HTPs and e-cigarettes as an alternative to tobacco products. Therefore, the right for adult consumers who have made the informed choice to use potentially reduced-risk products should be preserved, notably in public spaces. A counter-effect of such ban extension to emerging products must be carefully considered by the regulators.

Tobacco Europe considers that the assimilation of emerging products with regard to combustibles can have unintended consequences, including discouraging smokers from transitioning to reduced-risk products by giving the wrong signal, notably that the emissions from smoking are comparable to vapor aerosol, even for bystanders.

On the extension of the scope to outdoor spaces, Tobacco Europe considers it is its adult consumers’ duty to be courteous when smoking in public places, notably avoiding smoking around children, and it also believes that adult consumers should be able to use nicotine products responsibly indoors and outdoors with consideration and respect for others around them.

Tobacco Europe believes that measures to restrict smoking in outdoor public places such as outdoor terraces with bars and restaurants are not based on scientific rationale and do not have legitimacy. Additionally, the link between children seeing adult smoking and smoking initiation (by mimical behaviour) is not scientifically proven.

Considering the lack of science-based evidence and consistency used in the assessment methodology, Tobacco Europe does not support the extension of the Recommendation to emerging products nor the extension of its current scope to additional outdoor spaces.

The expected publication of the revised Recommendation initially scheduled for January 31 was delayed, until further notice.

Youth Access Prevention

Tobacco Europe and its member companies strongly believe that no underage person should have access to tobacco and/or nicotine products. As responsible manufacturers, it is our member companies’ duty to show good faith in this area and be pro-active on the public scene at policy level.

Underage Access Prevention
Tobacco Excise Directive
The Tobacco Excise Directive defines the impacted categories of products and the minimum rates and structures of excise duties they apply to.

Tobacco Europe is of the view that any decision on taxation should reflect the concerns and core interests of individual Member States. Therefore, any increase in the minimum rates must be limited as Member States should have full control over their fiscal policy and on how they generate revenue.

Should an increase to the minimum rate be deemed appropriate, this should be measured to preserve market stability and discourage growth of non-domestic duty-paid volumes (NDDP), especially in countries that fall below any proposed new thresholds. Ideally, any increase of the minimum should be gradual, e.g. every one or two years, to minimize market disruptions and allow Member States to realize their individual fiscal policy objectives.

Union Customs Code

The Union Customs Code defines the legal framework for customs rules and procedures within the EU customs territory.

In May 2023, the Commission presented its proposal to reform the Customs Union, and more precisely to simplify customs procedures and establish a new framework on risk management to protect EU common borders.

Among the proposed modifications made by the Commission, one suggests the removal of the customs duty “De Minimis” threshold, which Tobacco Europe supports. Indeed, e-commerce has created new distribution channels for illicit and counterfeit traded goods. A decrease of the customs duty ‘de Minimis threshold’ can contribute to the reduction of the illicit trade supply chains. We therefore welcome the EU Commission proposal to remove the EU ‘de-minimis’ threshold and we call on the EU Member States and the EU Commission to implement this recommendation as soon as possible.

The creation of the EU customs data hub and customs digitalization is also welcomed by Tobacco Europe. We believe the creation of the EU customs data hub is a huge step forward and look forward to the Commission’s proposal on smooth transition and collaboration with the industry players to achieve this objective.

Finally, Tobacco Europe believes the introduction of the 'Trust & Check Trader' is a promising development. It will benefit the EU companies and provide further simplifications from customs formalities. The concept of “self-assessment” and the change of EU customs approach from “transaction-based” to a “process-oriented” system can benefit EU companies.
Tobacco Product Directive
The Tobacco Product Directive regulates the sales and merchandising of tobacco and tobacco related products within the European Union. In 2014, a first revision of the Directive took place and “TPD 2” entered into force in 2016.

As set out in Article 28 of TPD2, a further review of the Directive began in 2021. This mandates the Commission to review the impact and the implementation of the TPD as well as to adapt it to market developments, i.e. new nicotine products.

In the course of 2023, the Commission therefore launched an evaluation of the legislative framework for tobacco control, to assess the extent to which the legislative framework has fulfilled its established goals and objectives and prior to launch an impact assessment in the course of 2024.

Overall, Tobacco Europe is supportive of the evaluation but believes it remains premature to properly assess the impact as not all measures of the framework have been fully implemented, which is contrary to the Better Regulation Guidelines.

Tobacco Europe encourages the Commission to pave the way for a new paradigm of tobacco harm reduction and support a genuine, open and objective policy debate to design a fit-for-purpose regulatory agenda.

We support reasonable, proportionate, and evidence-based regulation that respects adult freedom of choice and recognizes that tobacco and new nicotine products are consumed by more than a billion people worldwide. Economic operators have a role to play in supporting reasonable regulation that reduces illicit trade and prevents youth access to tobacco and nicotine products.

Public policies should also support adult smokers who wish to consider less harmful alternatives to combustible tobacco. A dialogue between governmental authorities and industry is essential if the regulation of the tobacco and related products industry is to be effective and proportionate. We want to be constructive and help deliver the EU’s desired policy outcomes. We believe our industry has the relevant expertise, knowledge and experience that can help improve policy. We welcome open dialogue with policymakers to help ensure effective measures.

Cigarette Testing Methods TE Position Paper
International marketing principles
Tobacco Europe and its member companies believe strong marketing principles are necessary to ensure products are being advertised and marketed in a responsible and compliant way.

All three member companies are committed to key international marketing principles to ensure only adult and legal of age consumers use their products, and that those adults receive clear and accurate information to make informed choices.

As responsible manufacturers, member companies are compliant with all laws and regulations and do not breach marketing or advertising codes.

Advertising regulatory framework

Tobacco Europe Members share the strong belief that tobacco and nicotine products should be marketed only to adult consumers who choose to use them. Tobacco Europe Members not only fully comply with legal restrictions, but in many cases go further by the application of responsible marketing principles.

Consumer communication and information are fundamental rights of both manufacturers and consumers. The Tobacco companies, which are members of Tobacco Europe, are committed to conducting their advertising and marketing in a responsible manner.

They believe that reasonable and responsible marketing of tobacco products and related products should continue to be permitted to enable companies to communicate to their adult consumers and to provide them with the information to choose from among the various tobacco and nicotine products with substantially different characteristics. Importantly, advertising of these products targets existing adult users of tobacco and nicotine products.

Tobacco Europe and its members believe that all marketing communication must comply with applicable laws and regulations, including those relating to general product safety, consumer protection and marketing.

Nicotine pouches

Nicotine Pouches are nicotine containing products placed on the market in various Member States of the European Union. They first emerged in the EU around 2016. A ‘nicotine pouch’ is mostly referred to as pre-portioned, tobacco-free consumer product that contains nicotine compounds, flavourings and other ingredients, that releases nicotine and flavours by placing the pouch between the upper lip and gum resulting in nicotine uptake via the oral mucosa.

As responsible manufacturers, in addition to marketing the nicotine pouches in compliance with all applicable laws we commit to applying the requirements set out in this document at all times. While preventing underage of any nicotine containing product is critical and we fully support regulatory actions in this regard, it is important that public health policy strikes a balance between protecting youth while allowing existing adult smokers and adult nicotine product users to have access to less harmful alternatives to smoking and be able to transition to such products.


Tobacco Europe members are committed to educating and informing public officials and the general public with the aim to prevent the underage use of vaping products.

The target consumers for vaping products are current adult users of tobacco products, vaping products or other nicotine products.

Vaping products are composed of a handheld battery-powered electronic device and a nicotine or non-nicotine containing e-liquid. The electronic device is used to heat up the e-liquid, creating a vapour that is consumed by the user. The e-liquid generally contains propylene glycol, vegetable glycerol, flavourings and nicotine (where applicable). It is contained within a pre-filled bottle or single use cartridge or pod, for use in an electronic cigarette. E-liquids without nicotine are also available. E-liquids do not contain tobacco. The nicotine ceiling for e-liquids in the European Union is 20mg/ml.

Vaping products fall into two broad types: closed or open systems. Closed systems are simple-to-use devices which feature a pre-filled cartridge or pod of e-liquid. Open systems require the user to refill the tank of the open system device with any commercially available e-liquid from a refill container.

Vaping products should only be sold to people above 18 years of age or above the legal age of purchase, where this is higher than 18 years. Vaping products are for adult consumption, this is clearly indicated on the packaging.

The EU’s Single-use Plastics Directive (SUPD), which entered into force in 2019, bans the placing on the market of specific single-use plastic items that are difficult to recycle and for which more environmentally friendly alternatives exist (e.g., cotton bud sticks, plates, straws etc.).

Single-use plastic items without alternatives have not been outlawed. One such item is tobacco products with filters containing plastic (TPF). The filters are made of cellulose acetate, an already renewable but only partially biodegradable material, which falls under the extended definition of plastic used by the EU.

The industry is constantly evaluating alternative filter materials with a more sustainable footprint, but to date, no alternative material without plastic has been found that meets both consumers’ expectations as well as performance requirements for cigarette filters.

As some of the products consumed in public are improperly disposed of by consumers (i.e., littered), the SUPD foresees specific measures for TPF. These include new marking requirements on product packaging and the obligation for Member States to establish extended producer responsibility (EPR) schemes. EPR means that producers participate in the waste management costs for TPF littered or disposed of in public.

Given the nature of the litter problem, we are convinced that the tobacco industry has a role to play in ensuring that TPF are kept from flowing into the environment. We, therefore, support measures designed to prevent littering and are committed to contributing financially to the associated costs.

Preventing littering requires awareness among consumers about disposing of products in an environmentally friendly way. Likewise, local authorities are responsible for providing the necessary waste infrastructure in public areas (e.g., bins and ashtrays).

To reduce littering, the industry cooperates with relevant stakeholders in establishing national EPR schemes whilst ensuring that core principles, as stipulated in the Directive, are respected (i.e., transparency, cost-efficiency, proportionality).

In the course of 2024, EU-level guidelines establishing a methodology for EPR costs will be published by the Commission.


In July 2023, the Council adopted a new regulation that strengthens sustainability rules for batteries and waste batteries. This regulation applies to all types of batteries, including starting, lighting, and ignition (SLI) batteries, light means of transport (LMT) batteries, as well as batteries designed to be added to other products are covered by the scope of the Regulation.

This regulation has an impact on our member companies’ product categories containing batteries, namely electronic cigarettes and tobacco heating products. According to Article 11, firms placing batteries on the market must ensure that waste batteries can be removed and replaced by either the end-user or independent operators. These provisions would apply 42 months after the proposal’s entry into force, hence in 3 years. However, battery replaceability by end consumers may not be an option in cases where electronic devices are equipped with customized batteries with functional technical specifications for which no safe equivalent alternative are readily available for purchase by end consumers. Moreover, it is not feasible for manufacturers to prove that there are no available alternatives on the market as this would require them to have a continuous, full-time overview of the global battery market.

Guidelines on the implementation of Article 11 have been drafted by the Joint Research Center and have been published in 2024.

Packaging and Packaging Waste Regulation

In November 2022, the Commission presented its proposal for revision of the Packaging and Packaging Waste Directive. The proposal was presented as part of the Commission’s second Circular Economy Action Plan, and its objective is to align with the European Green Deal by minimising packaging and packaging waste’s negative environmental impacts, whilst strengthening the internal market.

The three core objectives of the proposal would be to: reduce the current production of packaging waste; promote cost-effective circular economy principles across the industry; and increase the use of recycled materials in packaging.

Tobacco Europe welcomes the choice of a Regulation as a legal instrument, as we believe that to fully achieve a sustainable circular economy, a higher level of harmonisation of EU waste and packaging legislation across EU Member States is needed. We also support the choice of an internal market legal basis as the right step towards boosting packaging circularity across the EU. Tobacco Europe particularly believes that Member States should not be allowed to introduce further labelling requirements.

For the tobacco industry, the topic of labelling has a particular importance as our products are already subject to very strict and unique labelling requirements under the Directive 2014/40/EU which imposes the presence on our packaging of health warnings, combined health warnings (text and image), general warnings, cessation messages, a unique identifier aimed at granting the traceability of products and a security feature to ensure the integrity of the product. All dimensions and specifications related to the above elements are defined and mandated by the concerned Directive.

In addition to the above, in several Members States our products are also subject to National health related and/or commercial related marking and labelling requirements that complicates the overall scenario.

Moreover, tobacco products with filters are also subject to the Single-Use Plastic marking under the Directive 2019/904/EU aimed at indicating the presence of plastic in the filter.
As a result, the remaining space on our packaging is already almost non-existent, and it would be impossible to place other markings on almost the entirety of our primary packaging.

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