Member state objections and the UK response

Czechia, Greece, Italy, Slovakia, and Portugal used the TRIS procedure to object to applying the UK’s Tobacco and Vapes Act, specifically the smoke-free generation provision, to Northern Ireland. Despite variations in emphasis, the core of their argument is remarkably consistent: the generational sales ban amounts to a de facto prohibition on the sale of tobacco products in Northern Ireland. Because it bans products and does not create or sustain a market in them, it obviously conflicts with both EU internal market law/free movement of goods law and the harmonised regulatory framework established under the TPD.

Taken together, the Member States’ objections converge around four legal points:

1. 1. Article 24(1) TPD – The measure unlawfully restricts the marketing of compliant products and exceeds national competence.

2. 2. Article 24(3) TPD – Any ban on a category of product requires Commission approval.

3. 3. Article 34 TFEU – The measure is a de facto market access restriction.

4. 4. Proportionality – The UK has not demonstrated that the generational ban is necessary, evidence-based, or the least restrictive option.

Secondary EU law: either out of scope, or exempted from the TPD

Following the legislative priority rule, whereby EU legislation, rather than Article 34 TFEU, is the starting point (Ní Chaoimh, Reference Ní Chaoimh2023), our analysis starts with the TPD. The TPD regulates the manufacture, presentation, and sale of tobacco and related products, including cigarettes, at the EU level. The key question is whether the TPD allows Member States to adopt measures stricter than those provided for in the Directive. The relevant provision is Article 24 (Box 1).

Article 24(1) TPD bars Member States from enacting further measures that would restrict or prohibit the marketing of products complying with the Directive, but only ‘for considerations relating to aspects regulated by the Directive’. This raises a first question: whether the Directive even regulates the generational ban adopted in the UK Tobacco and Vapes Act?

As argued by the UK government and acknowledged by the Commission (European Parliament, 2022), the TPD does not regulate ‘domestic sales arrangements’ (European Union, 2014). A generational sales ban does not prohibit placing a product on the market; it regulates buyer eligibility. Article 1 TPD provides that the subject matter of the Directive does not include sales arrangements. This leads to the conclusion that a generational ban falls outside the TPD’s scope.

If we argue the opposite, one might say that a generational sales ban is not merely a ‘sales arrangement’ because its long-term effects are comparable to a ban on placing a product on the market. If we accept that argument, nonetheless, Article 24(3) authorises a Member State to ban ‘a certain category’ of products on public health grounds relating to the specific situation in that Member State, potentially rendering a duly notified generational sales ban lawful. Beyond proportionality, which will be analysed together with Article 34 TFEU below (Ní Chaoimh, Reference Ní Chaoimh2022), two points arise.

First is whether the precise wording of Article 24(3) – ‘may … prohibit a certain category of tobacco or related products’ – only permits Member States to adopt targeted bans and precludes the adoption of a general ban on all tobacco products. This interpretation is not supported by the Court, which, particularly in the context of the TPD, has accepted the need for Member States to protect public health in the context of free movement of tobacco and outlined that this Directive is ‘not intended to interfere with the policies of the Member States concerning the lawfulness of tobacco products as such’ (C-547/14 Philip Morris Brands 2016, para 88). Thus, Article 24 TPD means that only products legally permitted to be marketed in the country concerned are subject to the free movement clause under Article 24(1).

Second, Article 24(3) allows further measures on grounds relating to the specific situation of the Member State concerned. Opponents of the Act might argue that tobacco consumption rates in the UK are not specific to the UK. However, this condition has not been applied strictly in recent European Commission decisions. For instance, in the cases of Belgium (European Commission, 2024a), France (European Commission, 2024b), and Bulgaria (European Commission, 2026), the authorities merely highlighted that the products in question were gaining traction on their national markets and that consumption was increasing, without demonstrating that these developments differed from those in other Member States.

The UK law is therefore likely to fall outside the scope of the TPD and, even if within its scope, would be lawful under Article 24(3) of the TPD.

Primary EU law: prohibited, or justified for public health reasons?

Many Member State objections in the TRIS process begin from the broad principle articulated in Dassonville (Case 8/74, 1974): that any measure ‘capable of hindering, directly or indirectly, actually or potentially’ trade between Member States constitutes a measure having equivalent effect to a quantitative restriction. This broad formulation is routinely invoked when seeking to characterise national rules as internal market barriers.

Member States rely on Commission v Italy (C-270/02, 2004) to argue that the smoke-free generation policy is effectively a ban, obviously within the scope of Article 34. But the Court very rarely applies the Dassonville formula as such (Barnard and Peers, Reference Barnard and Peers2026; Craig and De Búrca, Reference Craig and De Búrca2024; Maduro, Reference Maduro and Barnard2001; Schütze, Reference Schütze2016). Rather, it distinguishes between rules about the characteristics of goods, and rules about selling arrangements – the conditions under which goods are marketed or sold. While product requirements typically fall within Article 34 TFEU, selling arrangements fall outside its scope if they apply equally, in law and in fact, to domestic and imported goods (C-267-268/91 Keck, 1993).

Thus, neutral rules governing how, when, or where sales occur are not automatically unlawful barriers to trade. The generational ban fits within this category: it regulates the ‘conditions under which goods may be lawfully marketed’, in particular, to whom a product may be sold, not product characteristics. The key question is whether it is a neutral rule. An advertising ban is non-neutral because it deprives non-national traders of a sales route that is not needed by national traders already established in the market (C-34-36/95 De Agostini, 1997). But the UK’s generational ban does not impose differential burdens. It applies equally to all traders, domestic and foreign, and does not vary by product origin.

Arguably, non-differential selling arrangements are subject to a residual market access test (C-108/09 Ker-Optika, 2010; C-142/09 Lahousse, 2010; Schütze, Reference Schütze2016), or consideration of whether a measure has ‘considerable influence on the behaviour of consumers’ (C-110/05 Italian Motorcycle Trailers 2009). If this is a correct interpretation of the Court’s case law, a selling arrangement rule, even if neutral, with significant economic consequences for the market, falls within Article 34 TFEU. However, there is ample older (C-292/92 Hünermund, 1993; C-69/93 & C-258/93 Punto Casa, 1994; C-401/92 & C-402/92 Tankstation, 1994) and more recent case law (Case C-221/15 Colruyt, 2016; Case C-147/21 CIHEF, 2023) where the Court has stuck to a classic non-discriminatory test for selling arrangements, with no reference to a market access test.

Thus, it is far from clear that market access or market contraction alone determines the applicability of Article 34 TFEU. Given that the Court has never been faced with a sales arrangement like the generational sales ban, uncertainty remains. Moreover, even if the Court were to apply a market access test, a generational sales ban would not necessarily breach EU law, as it could be justified under Article 36 TFEU, provided it serves a legitimate public interest and is proportionate.

Justification of a national barrier to free movement is to be judged against the backdrop of the constitutional embedding of health protection within the fabric of the market. Contemporary EU law embeds increasing aspects of health policy within lawful EU-level activity (Greer et al., Reference Greer, Rozenblum, Fahy, Panteli, Jarman, Brooks, de Ruijter, Rockwell and Wismar2024; Hervey et al., Reference Hervey, Bartlett, Cayón-De las Cuevas, Delhomme, den Exter, de Ruijter, Ðuković, Flear, Frischhut, Gennet, Goffin, Guy, Lau, Mahalatchimy, Michalak, Raposo, Slokenberga and Schrauwen2026), not merely leaving health to the national level. This approach inflects the reasoning in free movement case law, particularly where free movement impacts national healthcare systems (Frischhut, Reference Frischhut, Garben and Gormley2024; Hervey and McHale, Reference Hervey and McHale2015). Rather than a simple rule/exception approach, health has become constitutive of the type of market being created. Moreover, the COVID-19 pandemic showed that free movement can lawfully be restricted where health protection requires it (Delhomme, Reference Delhomme2024).

The ‘public interest objective pursued’ is the first element needed to justify restricting the free movement of goods under EU primary law. The Explanatory Notes accompanying the Tobacco and Vapes Act (UK Parliament, 2024) explain that the smoke-free generation measure’s objective is the protection of public health, with the UK aiming for a smoking prevalence rate in England of 5% by 2030 (Office for National Statistics, 2024). The protection of human health is an express derogation under Article 36 TFEU that can justify restrictions under Article 34 TFEU.

Public health protection as the ‘public interest objective pursued’ is further supported by the need to protect the functioning and sustainability of the National Health Service (NHS). The Court has endorsed three relevant NHS-protection objectives. The first is the need to maintain treatment capacity or medical competence within the national territory, insofar as this is essential for public health (C-158/96 Kohll, 1998). When national health systems across Europe are increasingly under strain, including in the UK, health issues caused by tobacco and related products consume the valuable treatment capacity of medical practitioners and establishments that could be redirected if a smaller portion of the population were exposed to these products.

Second, the Court has recognised the need to maintain a balanced medical and hospital service open to all as a legitimate objective, insofar as it contributes to achieving a high level of health protection (C-158/96 Kohll, 1998). This includes requirements aimed at controlling costs and avoiding wastage of financial, technical, and human resources (C-157/99 Smits/Peerbooms, 2001; C-372/04 Watts, 2006; C-173/09 Elchinov, 2010; C-50/14 CASTA, 2016; C-243/19 A, 2020). The WHO (2025a), UK (Department of Health and Social Care, 2025), the United States (National Cancer Institute, 2026) and the EU itself (European Commission, 2024c), amongst many others, affirm that all forms of tobacco are harmful, that tobacco consumption is a significant cause of avoidable death, and that there is no safe level of tobacco consumption. These substantial risks thus threaten the balance of healthcare systems and can be avoided through measures such as smoke-free generation legislation.

Finally, the Court has recognised the need to protect against risks to the financial balance of the social security system as an objective capable of justifying restrictions to the free movement of goods and services (C-158/96 Kohll, 1998). With the smoking-related cost to NHS England alone estimated to be £2.6 billion annually (NHS England, 2022), and the government already struggling to manage the NHS budget (Lee, Reference Lee2024), the use of tobacco and related products clearly represents such a risk.

Proportionality of the generational ban

Scotch Whisky Association is a key statement of the Court’s proportionality test for novel public health measures. It emphasises evidence-based reasoning, including consideration of less trade-restrictive alternatives. The UK has presented credible evidence, modelling, health data, and analysis of youth initiation patterns. In this regard, its justification could benefit from further evaluation of alternatives, particularly as to why fixed-age increases or enforcement-based measures would be insufficient, and especially in Northern Ireland. However, while the Court emphasises evidence-based reasoning, it has also confirmed that Member States have discretion when addressing major health risks, especially where predictive judgements are needed, drawing on the principle of precaution. The Court accepted modelling and behavioural projections even in the absence of definitive data, requiring only an assessment of ‘whether it may reasonably be concluded from the evidence’ that the chosen measure is suitable and that alternatives are unlikely to offer equivalent protection (C-333/14 Scotch Whisky Association, 2015, para 56).

Proportionality requires demonstrating that the restrictive measure is capable of achieving the objective pursued (C-456/10 ANETT, 2012). In assessing the appropriateness of the measure where the objective is public health, the Court has noted that ‘a Member State may take the measures that reduce, as far as possible, a public health risk’ (C-171-172/07 Apothekerkammer des Saarlandes, 2009), and it is up to the Member State to decide on the appropriate degree of protection, within the limits imposed by the Treaties (C-170/04 Rosengren, 2007; C-333/14 Scotch Whisky Association, 2015). Also here, Member States are afforded a wide margin of discretion, both as to the degree of protection and the way in which that degree of protection is to be achieved (C-222/18 VIPA, 2019). In scrutinising the exercise of a Member State’s discretion, the Court looks at the Member State’s particular social circumstances and the importance attached by the Member State to the relevant objective (C-221/15 Colruyt, 2016). In that respect, the UK has long been amongst the most assertive European countries in tobacco control (Willemsen et al., Reference Willemsen, Mons and Fernández2022) and is considered to have one of the most comprehensive tobacco control approaches in the world (Cairney, Reference Cairney, t’ Hart and Compton2019). Furthermore, the question of suitability requires that the objective must be pursued in a way that genuinely meets the relevant concern (C-390/12 Pfleger, 2014), consistently and systematically (C-243/01 Gambelli, 2003). In assessing the genuine capacity of the measure to achieve the objective, it is not necessary to ascertain this ‘empirically and definitely’ (C-464/15 Admiral Casinos, 2016, para 29). Rather, a global assessment of the circumstances surrounding the adoption of the legislation must be undertaken (C-390/12 Pfleger, 2014).

Based on the evidence indicating that raising the minimum age of sale has corresponded to reductions in smoking prevalence (Millett et al., Reference Millett, Lee, Gibbons and Glantz2011), as well as the simple logic that making tobacco and related products more difficult to access is likely to reduce their use, the UK measures are genuinely suitable to protect public health. One objection to the measure’s suitability concerns the claim advanced by the tobacco industry and certain Member States that it would increase illicit trade (Snowdon, Reference Snowdon2025; Tobacco Manufacturers’ Association, 2024). In that regard, it can be observed that ‘There is no evidence that the smoke-free generation measure will contribute to increases in the availability of illicit tobacco’ (Institute of Public Health, 2024). Moreover, the UK forwards evidence that is, in fact, available, indicating that, by curbing overall demand, tobacco control policies have been associated with declines in illicit tobacco use (Department of Health and Social Care, 2024a). Even if illicit trade were to increase, that would not ultimately render the measure unsuitable for protecting public health. So long as there is a decrease in the overall rate of tobacco and related product use, the measure remains appropriate (Davies et al., Reference Davies, Murray, Langley, Morling and Bains2025). As the UK has consistently adopted comprehensive tobacco control policies, the requirement to pursue the objective consistently and systematically is also met. The smoke-free generation measure is also in line with the objectives set by the EU, as expressed, in particular, in the EU Beating Cancer Plan, an aspect that the Court takes into account when assessing a measure’s suitability (C-128/22 Nordic Info, 2023).

Last, the necessity criterion requires that no less onerous means be available to achieve the relevant objective as effectively (C-347/89 Eurim-Pharm, 1991; C-121/00 Walter Hahn, 2002; C-170/04 Rosengren, 2007; C-456/10 ANETT, 2012; C-333/14 Scotch Whisky Association, 2015). Critics invoke Scotch Whisky to argue that the UK failed to assess less restrictive alternatives, such as raising the age of sale to 21 or 25, stronger enforcement, expanded cessation support, or tax measures, and therefore cannot show necessity under Article 36 TFEU. Yet, this overstates what Scotch Whisky requires. The UK’s evidence is broadly sufficient. Its impact assessment considers the age-of-sale alternatives, and its modelling shows that fixed thresholds cannot achieve the long-term structural reduction in smoking that a generational rule delivers. The UK could elaborate more explicitly on why alternatives fall short, but proportionality does not demand perfect proof; it requires only a plausible, evidence-supported rationale. The burden of proof does not go as far as requiring positive proof ‘that no other conceivable measure could enable the legitimate objective pursued to be attained under the same conditions’ (C-333/14 Scotch Whisky Association, 2015, para 55).

A final argument advanced by the Member States in the TRIS process is that less onerous means are available to achieve the public health objective. But the UK has already adopted restrictions on advertising, progressively increased taxation, raised the legal age of purchase, limited smoking in public places, restricted smoking in cars, and provided support for smoking cessation (Anyanwu et al., Reference Anyanwu, Craig, Katikireddi and Green2020; Association of Directors of Public Health, 2025). Still, 10.6% of UK adults are current cigarette smokers and 10% use vapes (Office for National Statistics, 2024), implying the need for bold measures if this figure is to be halved to meet the 2030 5% target. Increasing the minimum age for tobacco-related sales could foreseeably further reduce the use of such products. However, it cannot be said that a one-off increase in the minimum age would be as effective as a gradual, yearly increase in the legal age of sale.

The proportionality test is often understood as involving a third step, so-called ‘stricto sensu’ proportionality, according to which ‘the disadvantages caused must not be disproportionate to the aims pursued’ (C-50/14 CASTA, 2016, para 165). This third step is rarely applied in the context of the review of national measures, but even if it were applied, the generational ban could meet it. According to Advocate General Bot, this third stage ‘assumes the balancing of the interests involved’ and ‘consists in comparing the extent of the interference which the national measure causes to the freedom under consideration and the contribution which that measure could secure for the protection of the objective pursued’ (C-333/14 (Opinion) Scotch Whisky Association, 2015, para 76). In this regard, the Court has consistently held that ‘the objective of protection of health takes precedence over economic considerations, the importance of that objective being such as to justify even substantial negative economic consequences’ for economic operators (Case C-151/17 (Opinion) Swedish Match, 2018).