By Timothy S. Donahue
Top Takeaways:
- Higher limit: Spain is reportedly considering a 4 mg-per-pouch nicotine cap, up from the 0.99 mg limit in its original proposal.
- Flavor ban remains: The latest draft is said to retain restrictions effectively limiting nicotine pouches to tobacco flavor.
- Not final: The revised text is reportedly before Spain’s Council of State and has not yet been formally approved.
Spain may be giving nicotine pouches a little more room, but not much.
Spain has reportedly increased its proposed nicotine limit for nicotine pouches from 0.99 mg to 4 mg per pouch as the government moves closer to finalizing sweeping new restrictions on tobacco and nicotine products.
Industry sources say the latest version of the Royal Decree amending Royal Decree 579/2017 has been submitted to Spain’s Council of State (Consejo de Estado) for review and now includes the higher 4 mg limit.
Nicotine Insider has not independently confirmed the 4 mg provision in a publicly available government version of the latest text.
The reported change would mark a significant retreat from the Health Ministry’s original proposal, which would prohibit the sale, distribution, or free supply of nicotine pouches containing more than 0.99 mg of nicotine per pouch. That draft also prohibited flavoring ingredients other than those that produce tobacco aromas or flavors.
The 4 mg figure is particularly notable because Spain previously considered that exact limit when defending its proposal to the European Union.
In an official response submitted through the European Commission’s Technical Regulation Information System, Spain discussed 4 mg as one of the regulatory alternatives considered. The government noted that 4 mg aligns with higher-dose nicotine replacement products authorized in Spain and with the nicotine pouch limit adopted by Latvia. Spain nevertheless defended its decision to set the proposed limit at 0.99 mg per pouch.
If confirmed, the latest revision would represent a fourfold increase over the limit Spain originally proposed.
The reported 4 mg cap would still exclude much of the existing Spanish nicotine pouch market. Industry representatives say that products with 4 mg or less account for only a small share of current sales.
The latest text is also said to retain restrictions on flavors that would effectively limit nicotine pouches to tobacco flavors.
The original Royal Decree goes well beyond nicotine pouches. It would also impose new requirements on e-cigarettes, both nicotine-containing and nicotine-free, restrict flavors in vaping products, and introduce additional rules governing tobacco and related products. Spain notified the European Commission of the measure in January 2025, prompting objections and comments from several EU member states and industry groups.
Industry sources expect the Royal Decree to receive final approval as early as October, though November or December is also possible. A 12-month transition period is also reportedly planned before the new requirements take effect.
