The standard is a response to recent developments in the market of tobacco and related products, with a wide and diverse variety of products with differentiated characteristics emerging in Spain, with or without tobacco, with or without nicotine, with or without electronic components, and even with hybrid aspects of complex classification. These developments pose a challenge, making it necessary to provide an appropriate technical response to ensure the adequate protection of individuals who consume these new unconventional products. These products are in many cases not covered by any health regulations, whether local, national, or European, and it is, therefore, necessary to offer an urgent response to them.

The draft Royal Decree involves updating the health regulations on tobacco products and related aspects, such as their content, quality and safety requirements, or their packaging and outside packaging. This standard regulates not only the products already included in the scope of Directive 2014/40/EU, but also extends its scope to other products not regulated therein, i.e., nicotine-free electronic cigarettes, nicotine pouches, and heated herbal products, establishing a series of health-related requirements and obligations necessary for their proper control and supervision.