About GINN. The Global Institute for Novel Nicotine (GINN) is a membership-based association and the responsible voice of the novel nicotine sector. GINN represents small and medium-sized European manufacturers and distributors of nicotine pouches and promotes an evidence-based, science-led approach to the regulation of reduced-risk products, with the goal of helping adult smokers move away from combustible tobacco towards demonstrably less harmful alternatives.
Every GINN member is bound by the association’s Core Principles enforceable commitments covering youth-access prevention, regulatory compliance, product quality and composition, responsible packaging and flavour naming, ethical marketing, environmental stewardship and fair sales practices.
Introduction
GINN welcomes the opportunity to contribute to the Commission’s Call for Evidence for an impact assessment on the revision of the Tobacco Products Directive (Directive 2014/40/EU) and the Tobacco Advertising Directive (Directive 2003/33/EC). We share the Commission’s twin objectives: a properly functioning internal market and a high level of human-health protection, including the goal of a tobacco-free generation by 2040.
This submission sets out the principles and the regulatory design that GINN considers essential to a proportionate and effective revision. At this stage our purpose is to identify, at the level of principle, where the revision can do best – and where a disproportionate approach would undermine both of the Commission’s objectives at once.
Our central message is straightforward. For the products GINN represents – oral nicotine pouches, which contain no tobacco and involve no combustion or inhalation the principal risk today is not the absence of regulation. It is the proliferation of divergent, and in several cases prohibitive, national measures that fragment the single market and remove a regulated, lower-risk alternative from the reach of adult smokers. The revision is the Commission’s opportunity to correct that fragmentation with a single, proportionate and risk-differentiated framework. Used well, it will advance the internal market and public health together. Used poorly by regulating a non-combustible oral product as though it were a cigarette it risks entrenching the very fragmentation it is meant to cure.
The problem: correcting fragmentation, not entrenching it
2.1 A fragmented internal market and the rise of de facto national bans
The Call for Evidence rightly identifies divergent national rules – including on nicotine products other than e-cigarettes, such as nicotine pouches as a barrier to the smooth functioning of the internal market. GINN agrees, and would put the point more strongly. In the absence of a harmonised European framework, Member States have adopted measures ranging from divergent nicotine-content limits to outright prohibition, and several of these national measures have already been challenged as disproportionate and as incompatible with the free movement of goods. The result is a patchwork in which an identical product may be freely sold in one Member State, capped at an unworkable level in a second, and banned in a third. For the small and medium-sized operators GINN represents, this is the single greatest barrier to lawful, compliant trade and every month without a harmonised framework allows that fragmentation to deepen.
2.2 Proportionality and the danger of treating very different products alike
GINN urges the Commission to resist a one-size-fits-all response. The concern that certain products may appeal to young people and draw a new generation into nicotine use may be a fair description of low-cost disposable e-cigarettes; applied indiscriminately to oral nicotine pouches, it does not hold.
A pouch produces no smoke, no tar, no carbon monoxide and none of the products of combustion that make cigarettes harmful. Regulation under a modernised framework must reflect that distinct profile.
Treating a non-combustible oral product on the same terms as combustible tobacco is not a neutral, cautious choice; it is a disproportionate one, and it is liable to fail the tests of necessity and proportionality that govern Union action under Article 114 TFEU.
2.3 The counter-productive effects of disproportionate measures
Where Member States have moved to ban or near-ban lower-risk products, the predictable consequences run directly against the Commission’s own objectives. Prohibition does not remove demand; it transfers it to an unregulated, untaxed and age-uncontrolled illicit market the supply channel least likely to verify a buyer’s age. And by closing off a regulated alternative, disproportionate measures push established adult users back towards combustible cigarettes. A revision designed to deliver a tobacco-free generation should not, in its own drafting, create incentives that return adults to smoking or hand the market to illicit trade. The proportionate response to a genuine youth-access concern is strict control of access, packaging and marketing – not the removal of a lawful, lower-risk category.
GINN’s binding Core Principles
GINN does not ask the Commission to take the responsible conduct of this sector on trust. Every GINN member is contractually bound by the association’s Core Principles, and breach results in termination of membership. They commit members to:
preventing youth access the first and overriding principle;
full compliance with applicable law and regulation in every market;
product quality and composition standards, including controls on ingredients;
responsible packaging and flavour naming that does not appeal to minors;
ethical marketing, including on social media, with no targeting of young people;
environmental stewardship across the product life cycle; and
fair and responsible sales practices.
These principles already align the conduct of GINN members with much of what a proportionate revision would require. They are offered to the Commission as a working template for what enforceable, industry-wide standards can look like in practice.
GINN’s views on the policy options
The Call for Evidence sets out the areas around which the Commission will develop policy options. GINN’s position on each follows.
A distinct, lower-risk legal category. GINN supports bringing nicotine pouches within a modernised, harmonised framework provided they are treated as a distinct category with proportionate requirements that differ from those applied to combustible tobacco.
GINN also supports building in the flexibility to address genuinely new products, on condition that this flexibility is exercised on an evidence basis and subject to proportionality, rather than as a standing power to restrict by default.
An evidence-based maximum nicotine content. If a maximum nicotine content is set, it must be calibrated to a level that remains genuinely effective as an alternative for established adult smokers – informed by the regulatory practice of Member States with functioning markets – rather than fixed at an arbitrarily low level that operates as a de facto ban. Member-State practice already diverges sharply, from meaningful per-pouch ceilings in some markets to no limit in others; this is precisely the divergence the revision should resolve. GINN’s indicative recommendation is a ceiling in the order of 16-20 mg per pouch.
Flavours: regulation by ingredient, not prohibition. GINN supports regulating flavours through a negative list of prohibited ingredients – those that are harmful, or that are objectively designed to appeal to minors, such as candy, cotton-candy, dessert and novelty descriptors rather than a blanket flavour ban. A blanket ban is the blunt instrument most likely to push consumers towards illicit supply and back to cigarettes, whereas a targeted negative list addresses the genuine youth-appeal concern without dismantling the category for the adults who rely on it.
Labelling and packaging. GINN supports clear and honest labelling: a proportionate health warning
stating that the product is not risk-free and contains nicotine; a clear statement that sale to persons under 18 is prohibited; and a prohibition on positive health claims, on imagery appealing to minors and on misleading descriptors as to risk. GINN cautions, however, against the wholesale extension to this distinct category of plain-packaging rules designed for combustible tobacco: standardised packaging removes the consumer’s ability to distinguish a regulated, compliant product from illicit supply, and erases the very signal that helps an adult smoker identify a lawful alternative.
Simplification and the burden on SMEs. GINN strongly supports the Commission’s objective of
simplifying provisions and reducing administrative burden. For the small and medium-sized operators GINN represents, a single harmonised regime is the most powerful simplification available: the heaviest burden of all is the obligation to navigate up to twenty-seven divergent national regimes. A clear, proportionate and harmonised framework lowers compliance costs, supports legitimate operators and strengthens, rather than weakens, market surveillance.
Coherence with the excise framework
The products within the scope of this revision are also the subject of the parallel revision of the rules on the structure and rates of excise duty on tobacco and related products (Council Directive 2011/64/EU). GINN urges the Commission to ensure that product rules and tax rules pull in the same direction. Nicotine pouches should sit in a distinct excise category set well below the rates applied to combustible tobacco, reflecting their lower-risk profile. Taxing a lower-risk product as though it were a cigarette removes the price incentive for an adult smoker to switch, and disproportionate taxation drives consumers towards the illicit market. A coherent revision is one in which the product framework and the fiscal framework reinforce the same harm-reduction objective rather than working against each other.
Conclusion
Nicotine pouches are a distinct, non-combustible, lower-risk oral product. Properly regulated, they can contribute to the Commission’s objective of a tobacco-free generation by 2040 rather than detract from it. The genuine problem the revision must address is the fragmentation of the single market by divergent and, in places, prohibitive national measures fragmentation that generates illicit trade and drives adult smokers back towards cigarettes.
The Commission has the instrument to correct this: a revised framework that gives nicotine pouches a dedicated, harmonised and risk-proportionate treatment in both product regulation and taxation, built on strict, enforceable controls on youth access, packaging and marketing. GINN stands ready to including through its provide market data, to take part in technical hearings, and to contribute Science and Standards Committee – to the design of that framework.
