Spain has banned characterising flavours, including menthol, in heated tobacco products, and further requires these products to contain health warning labels, in line with regulations for boxed cigarettes and roll-your-own tobacco. These provisions are stipulated in Royal Decree 47/2024 of 16 January 2024, which modifies Royal Decree 579/2017, of 9 June 2017. The new Royal Decree regulates certain aspects related to the manufacture, presentation and marketing of tobacco products and related products, effective 17 April 2024. Specifically, the Decree made the following modifications:

• Article 3—added a definition of “heated tobacco product”: a novel tobacco product that is heated to produce an emission containing nicotine and other chemicals, which is then inhaled by users, and which, depending on its characteristics, is a smokeless tobacco product or a smoking tobacco product;
• Article 5—introduces a ban on heated tobacco products with a characteristic aroma, that contain flavourings in their components or any other technical characteristic that allows modifying the smell or taste of tobacco products or intensifying the smoke of heated tobacco products;
• Article 17—introduces labelling requirements for heated tobacco products, including the information message and the colour photographs, which form part of the combined health warnings referred to in Article 16.

These changes are required of the 27 European Union (EU) Member States based on an amendment to the European Tobacco Products Directive (2014/40/EU), which withdraws certain exemptions applicable to heated tobacco products, per Commission Delegated Directive (EU) 2022/2100 of 29 June 2022.

This amendment is a result of a Commission Report of 15 June 2022, which indicated a substantial change of circumstances, as defined in Article 2.28 of Directive 2014/40/EU. These changes of circumstances included an increase in the volume of sales of heated tobacco products by at least ten percent in at least five Member States and the volume of sales at retail exceeded two and five percent of the total sales of tobacco products at the EU level.

For more information, please contact Susana Verdejo Fernández, WHO FCTC focal point in Spain (sverdejo@sanidad.gob.es)

(Pictured: WHO FCTC delegates from Spain at the Tenth session of the Conference of the Parties (COP10) to the WHO FCTC, Panama City, Panama, 5 to 10 February 2024 © WHO / FCTC / Ana Alveo)