Spain’s plans to ban all nicotine pouches and most vapes have hit a significant roadblock, with six fellow European Union member states lodging formal objections to the proposed legislation.
According to documents seen by El Confidencial, Italy, Sweden, Greece, the Czech Republic, Hungary, and Romania have all issued reasoned opinions on the Spanish proposal. This effectively triggers a standstill period of at least three months, during which the Spanish government must address the concerns raised by these member states.
Failure to provide satisfactory explanations or modify the draft legislation could significantly delay or even derail its implementation.
The objections centre on concerns that the Spanish regulations run counter to EU’s internal market rules.
While the specific details of each country’s reasoned opinion remain largely confidential, Sweden has publicly stated its opposition to the proposed limits on nicotine pouches. In a press release, the Swedish government argued that the proposed nicotine limit of 0.99mg per pouch is disproportionate, and that Spain has failed to justify why less intrusive measures would not suffice to achieve the intended health objectives.
Spain’s government is also facing opposition from the country’s competition authority, the CMC, which has demanded more scientific evidence before it will clear the proposal.
The Spanish proposal submitted to the TRIS (Technical Regulations Information System), a mechanism for ensuring transparency and compatibility of technical regulations within the EU, includes several key measures. These include a ban on flavorings in electronic cigarettes, both with and without nicotine, and severe nicotine caps on pouches that in practice constitutes a ban on the entire category.
The decree also proposes a reduction in the maximum nicotine concentration allowed in e-liquids, lowering it from a previous draft of 20mg/ml to 15mg/ml.
The number of objections from other EU Member States is unusual: last year only 3.3% of the 765 notified draft regulations received reasoned opinions, and none received as many as six.
The Spanish Ministry of Health now has until July 28th to respond to the concerns raised by the dissenting countries. They can either argue that the contested aspects of the decree do not unduly impact the internal market or opt to revise the legislation to address the specific objections.
