Tobacco products and electronic cigarettes' legislation violations - observational study in 31 European countries, 2005-2022.

Background: European Union (EU) law regulates the manufacture, presentation, and sale of tobacco and related products in all member states. This study examined whether legislation non-compliant tobacco products and electronic cigarettes were available for sale in the European market.

Methods: We queried the EU Rapid Information System for dangerous non-food products, covering 28 current and former EU member states and 3 associated countries, also known as Rapex, for non-compliant tobacco and related products reported between 2005 and 2022.

Findings: During the operation of the Rapex system, 183 violations were reported (six on tobacco, three on traditional cigarettes, and 174 on e-cigarettes). Insufficient product safety information was found in 86% of the reports on e-cigarettes and 74% of the refills. Violations regarding the volume of the liquid container were observed in 26% of the e-cigarette reports and 20% of the refill reports. Approximately 15% of the reported e-cigarettes and 17% of refill liquids exceeded permissible nicotine levels. More serious standard violations were recorded for refills than for e-cigarettes. Approximately one-third of Rapex system countries submitted no notifications.

Interpretation: E-cigarettes were the most frequently reported items in the European market of tobacco and non-tobacco nicotine products. The most common concerns were inadequate product safety information, incorrect liquid container volume, and excessive nicotine concentration. Identifying the most recognized legal infringements did not require laboratory tests and was based only on packaging and the manufacturer's declaration analysis. Further studies are necessary to corroborate whether products available in countries where no violations have been reported meet EU safety standards.