The Ministry of Health submits the Draft Royal Decree updating the regulations on tobacco and related products to a public hearing.

The Ministry of Health has published a draft Royal Decree updating the regulations on tobacco and related products. This initiative is part of the Comprehensive Plan for the Prevention and Control of Smoking 2024-2027 and focuses on aspects such as product content, quality and safety requirements, and outer packaging. The aim is to improve public health protection through stricter regulation adapted to the current market reality.

Currently, there is a wide variety of products in our country with different characteristics: with or without tobacco, with or without nicotine, with or without electronic components, and even with hybrid aspects that make it difficult to categorise them. This diversity represents a challenge and requires an appropriate technical response to ensure the protection of the health of people who consume these new products.

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Health regulates nicotine bags and vapers with and without nicotine, including restrictions on flavourings

Objectives

The project is part of the Comprehensive Plan for the Prevention and Control of Smoking 2024-2027 and aims to meet the following objectives:

• Preventing the initiation of tobacco use: focuses on denormalising the use of tobacco and related products, reinforcing compliance with current legislation.
• Adapt to new market realities: regulates new products such as nicotine pouches and herbal products that were not covered by previous regulations.
• Respond to the Sustainable Development Goals (SDGs): contribute to the goal of reducing premature mortality from non-communicable diseases.
• Harmonise Spanish legislation with European legislation: aligns with the European Code Against Cancer and the European Plan to Combat Cancer.
• Improve the information available to citizens: introduce changes to labelling so that consumers are better informed about the characteristics and risks of products.

Proposed measures

To achieve these objectives, the draft introduces several amendments to Royal Decree 579/2017, which regulates the manufacture, presentation and marketing of tobacco and related products. These amendments include:

• Generic packaging: A uniform appearance is made mandatory for cigarettes and rolling tobacco, eliminating design elements and attractive colours that may encourage consumption.

• Non-nicotine e-cigarettes are regulated: labelling requirements are established, such as the inclusion of a list of ingredients, health warnings (‘Consuming this product is harmful to your health’) and an information leaflet with information on use, storage, contraindications, possible adverse effects, etc.
• Restriction of flavourings: the use of flavourings in e-cigarettes is limited, allowing only tobacco flavourings to avoid artificial flavours appealing to young people.
• Regulation of new products: two new product categories are introduced; nicotine pouches and heated herbal products, establishing safety, labelling and marketing requirements.
• Modification of labelling: tobacco and related product labelling is updated to improve the information available to consumers, including clearer and more comprehensive health warnings.

Transition period for manufacturers and marketers

The draft Royal Decree establishes two deadlines in its single transitional provision: manufacturers have 10 months to adapt to the new labelling, packaging and manufacturing rules, while retailers have 12 months to sell the products they still have in stock under the previous rules.