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The European Commission is working on the proposal for TPD3. Photo credit: Sebastien Bertrand, CC2.0.
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It is expected that TPD3 will tackle illicit trade prevention. Photo credit: Piotr Drabik, CC2.0.
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TPD3 could expand plain packaging and graphic warning requirements.
The Tobacco Products Directive (TPD) is one of the most significant pieces of regulatory legislation for the tobacco and nicotine industries within the European Union. With TPD3—the third revision of this directive—now in the pipeline, the industry is watching closely to understand what changes it might bring and when these might take effect as it promises to bring new regulations impacting everything from product safety standards to marketing restrictions. The industry is expecting potentially substantial shifts that could influence product development, packaging, and environmental responsibilities across the EU.
TPD was initially introduced in 2001, with an updated version (TPD2) released in 2014. TPD2 aimed to curb smoking, especially among youth, and reduce health risks associated with tobacco. To that end, it introduced mandates such as pictorial health warnings, flavor restrictions, and controls on nicotine concentration for e-cigarettes. However, since TPD2 was implemented, the market has evolved dramatically. New products such as nicotine pouches, heat-not-burn (HNB) devices, and an increasingly diverse e-cigarette segment have emerged, creating regulatory gaps that authorities aim to address with TPD3.
Current status and the path forward
At this stage, TPD3 remains in the pre-drafting phase. The European Commission (EC) has been engaging in consultations and an impact assessment to evaluate the effectiveness of existing regulations under TPD2, aiming to identify both achievements and areas that need refinement. The impact assessment process includes input from a diverse set of stakeholders, especially public health advocates and consumer organizations.
The upcoming proposal is expected to attempt a balance between public health and market feasibility, with policymakers evaluating various regulatory options based on the feedback gathered. The industry is watching this process carefully, understanding that excessive restrictions might drive consumers toward illicit alternatives, while clear, harmonized standards could improve consumer confidence and enable responsible growth across the sector.
Key areas TPD3 may address
As EC continues its assessment, several key areas are expected to be central in TPD3:
1. E-cigarettes and vaping products
The popularity of e-cigarettes surged in recent years, but regulations on these products vary widely across EU member states. TPD3 will likely bring tighter, EU-wide rules, addressing flavor restrictions, nicotine concentrations, and advertising limitations.
2. Nicotine pouches and novel products
Nicotine pouches and other novel nicotine products remain largely unregulated under TPD2. TPD3 will likely introduce specific standards governing their marketing, age restrictions, nicotine content, and possibly even packaging requirements. It remains to be seen whether these policies will allow these products to grow as responsible alternatives while minimizing unnecessary regulatory hurdles that could limit market viability and increase production costs.
3. Health warnings and packaging
Pictorial health warnings, introduced under TPD2, were a landmark regulation for cigarette packaging. TPD3 could expand these requirements, potentially mandating plain packaging across more product categories. For example, plain packaging requirements—which eliminate all branding—could be extended to cover other nicotine and tobacco products. The directive could also explore standardized packaging for e-cigarettes and nicotine pouches, a move that may stifle brand identity and consumer information.
4. Illicit trade prevention
An estimated 10% of cigarettes in the EU originate from illicit sources, a significant concern for both the EU and the tobacco industry. TPD3 may strengthen track-and-trace requirements to better monitor product movement across the supply chain. However, there is a need to avoid imposing burdensome requirements that could hinder legitimate market operations. A balanced approach could safeguard the legal market while minimizing compliance costs and reducing the illicit trade’s impact on EU tax revenue.
5. Environmental regulations
With a growing emphasis on sustainability, TPD3 may also address the environmental impact of tobacco products. New regulations might require producers to manage the recycling and disposal of product waste, such as cigarette filters and electronic components from vaping products. While many companies are already implementing eco-friendly practices, any new requirements should be practical and scalable, allowing companies time to adjust their manufacturing and waste management practices.
What the industry might expect
Given EC’s dual goals of public health protection and harmonized regulation, the industry is bracing for a stricter regulatory landscape that may restrict marketing freedom and product innovation. Companies may be required to adapt to new labeling, packaging, and flavor restrictions that could impact the way they position their products in the market.
- Flavored product bans
Flavor bans remain a contentious issue, with public health groups arguing that flavors attract younger users. The industry counters by noting that flavors play an important role in encouraging adult smokers to switch to less harmful alternatives. An outright ban could lead consumers to illegal sources, defeating regulatory efforts. A more flexible approach that permits adult-friendly flavors could be beneficial, particularly for those seeking to transition away from traditional cigarettes.
- Increased compliance and r&d costs
Stricter product safety and quality standards could drive up r&d expenses, particularly for smaller companies that may not have all the necessary resources. Marketing strategies might also require substantial overhaul if new advertising limitations come into play, such as advertising on digital channels restrictions.
- Risk of market fragmentation
TPD3 will aim to harmonize regulations, but member states may opt to implement additional, stricter rules at the national level, resulting in a regulatory fragmentation that complicates market access. For industry players operating across multiple EU countries, this could complicate compliance efforts and increase costs.
Next steps and anticipated timeline for TPD3
EC’s impact assessment along with stakeholder consultations is likely to conclude with the release of a draft proposal in early to mid-2025. Once the proposal is published, it will enter a legislative process involving the European Parliament, the European Council, and EC itself. During this phase, there will be extensive debate, and revisions are likely as different interest groups provide input.
Given the complexity of the EU legislative process, TPD 3 may not be finalized until at least 2026. Following the adoption of the directive, a typical two-year transition period will be provided for member states to align their national laws with the new standards. Assuming this timeline holds, TPD3 could come into effect around 2028.
Navigating TPD3’s impact
The impending TPD 3 represents both a challenge and an opportunity for the tobacco and nicotine industries within the EU. As the directive seeks to modernize regulations to reflect the current landscape, companies will need to stay informed about the latest developments and adjust their strategies to align with the new requirements. While there is still uncertainty regarding the specifics of TPD3, the industry can anticipate stricter rules on product safety, marketing, and environmental responsibility. With TPD3 expected to bring transformative changes, the coming years will be pivotal for the tobacco and nicotine sectors as they adapt to the EU’s ever-evolving regulatory framework.