Key Points
- Spain’s Council of Ministers approved a draft tobacco law on September 9.
- The draft includes a ban on non-tobacco vape flavors, a 0.99 mg cap on nicotine pouches, and a prohibition on disposable e-cigarettes.
- The EU internal market review (TRIS) has been completed. 2Firsts confirmed this development with Spanish government sources.
- Despite objections from the European Commission and seven member states, Spain did not amend the main provisions.
- Next steps: The bill moves to Parliament for debate and possible amendments; if passed, the Commission or member states may pursue legal challenges.
2Firsts, September 30, 2025 — Spain’s proposed reform of its tobacco law, which includes a ban on non-tobacco flavored e-cigarettes, a cap of 0.99 milligrams of nicotine per pouch, and a prohibition on disposable e-cigarettes, has advanced to the domestic legislative stage after completing the EU’s internal market review procedure.
The review was conducted through the Technical Regulations Information System (TRIS), a mechanism used by the EU to examine whether draft national laws could create barriers to the free movement of goods within the single market.
According to a press release published by the Ministry of Health on September 9, the Council of Ministers has approved the preliminary draft law. 2Firsts also confirmed with Spanish government sources that the TRIS procedure has formally concluded, shifting the debate from Brussels back to Madrid.
The bill has now been submitted to the Spanish Parliament, starting with the Congress of Deputies, before moving to the Senate. If passed by both chambers without veto, the law will be enacted following the King’s sanction and publication in the Official State Gazette (BOE).
EU Concerns Overlooked
According to documents published on the TRIS platform (Notification 2025/0044/ES), Spain notified its draft decree to the European Commission on January 24, 2025, triggering objections from the Commission and seven member states — Italy, Sweden, Greece, Romania, Hungary, Czechia, and Croatia.
These objections, recorded in reasoned opinions and comments, argued that the draft could breach Article 34 of the Treaty on the Functioning of the EU, lacked proportionality, and risked creating trade barriers within the internal market.
The European Commission also raised concerns, noting that Spain’s plan to restrict unsafe e-liquid ingredients only if listed under EU chemical regulations could leave other harmful substances unregulated. In a letter to Spain’s foreign minister, DG SANTE Director-General Sandra Gallina wrote that member states should prohibit all ingredients posing health risks in nicotine-containing liquids, except nicotine itself.
According to the TRIS notification record, Spain submitted a written reply to the Commission and member states’ observations but did not adjust the main provisions of the draft.
Key Measures in the Ministry’s Release
The Ministry of Health’s September 9 press release outlined the core provisions of the draft law, including:
- Flavor ban: All e-cigarette flavors except tobacco prohibited.
- Nicotine pouches: Maximum nicotine content capped at 0.99 mg per pouch.
- Disposable e-cigarettes: Sale and supply banned, citing youth access and environmental impact.
- Smoke-free zones: Extended to bar terraces, transport stations, concerts, sports venues, playgrounds, schools, and hospitals.
- Youth restrictions: For the first time, minors prohibited not only from purchasing but also from consuming tobacco-related products.
- Advertising ban: Comprehensive ban across all media, including digital platforms and indirect promotion.
- Observatory: Re-establishment of a Tobacco Prevention Observatory to coordinate policy oversight.
- Transition period: 12 months for manufacturers to adapt products and clear existing stock of disposable e-cigarettes.
The reform is part of the 2024–2027 National Tobacco Control Plan and is presented by the government as aligned with the EU’s Beating Cancer Plan.
Industry and Market Impact
Industry groups warn that the measures could reshape Spain’s nicotine market. In interviews earlier this year, Philip Morris International said it had suspended plans to launch ZYN pouches in Spain due to regulatory uncertainty. British American Tobacco told Spanish media that a proposed €500 million investment in Barcelona was contingent on the policy outcome, and could instead be redirected to Croatia or Czechia.
Spain’s competition authority (CNMC) also raised concerns. In an April report published on its website, CNMC concluded that the measures lacked scientific justification, failed to assess less restrictive alternatives, and risked harming competition.
If implemented, the measures could reduce the vaping sector’s added value by more than 80%, with significant job losses and investment redirection, according to figures cited in 2Firsts’ Special Report on August 29.
Public Health vs. Harm Reduction
Public health advocates back the draft, framing it as a necessary step to prevent youth initiation and consistent with Europe’s cancer prevention strategies. The Ministry of Health has emphasized that regulating emerging products such as herbal inhalation devices and nicotine pouches is essential to closing policy gaps.
Harm reduction experts, however, point to Sweden’s experience. Public data from Sweden’s health authorities show smoking prevalence has fallen below 5%, largely attributed to widespread use of snus and nicotine pouches. Critics argue Spain’s approach risks undermining such alternatives, potentially pushing consumers back to cigarettes or illicit channels.
Outlook
The draft law now moves to parliamentary debate, where amendments remain possible. If the text is adopted unchanged, the European Commission retains the option of initiating infringement proceedings, while member states could challenge the measure before the European Court of Justice.
For Spain, the bill represents the strictest tobacco regulation in its history. For the EU, it is a precedent-setting case testing how far member states can go in regulating next-generation products without undermining the integrity of the single market.
Cover image: Spain’s Health Minister Mónica García | Source: Spanish Ministry of Health website
