Federal Public Service Health, Food Chain Safety and Environment

3 MAY 2024. - Royal Decree amending The Royal Decree of October 28, 2016, concerning the manufacturing and marketing of electronic cigarettes.

Report to the king, 

Sire,
To all present and future, Our Greetings.
Brussels, May 3, 2024.
FILIP
By the King:
The Minister of Health, 
F. VANDENBROUCKE

This draft Royal Decree amends the Royal Decree of October 28, 2016, concerning the manufacturing and marketing of electronic cigarettes. The proposed amendments concern composition and labeling.

Regarding composition, Article 4 has been amended to introduce a ban on the marketing of fully disposable electronic cigarettes. The full justification for this has been explained in a notification report addressed to the EU Commission in accordance with the procedure of Article 24, paragraph 3, of Directive 2014/40/EU of April 3, 2014, on the approximation of the laws, regulations, and administrative provisions of the Member States concerning the manufacture, presentation, and sale of tobacco and related products. Moreover, the ban on the Belgian trade of disposable e-cigarettes aligns with the 2022-2028 inter-federal strategy for a smoke-free generation. The primary objective is to reduce the prevalence of smokers and counteract the significant popularity of tobacco and similar products among young people and young adults.

Regarding labeling (Article 5), several modifications have been made to correct certain errors. Additionally, it has been added that the package insert must contain information on smoking cessation, in accordance with sheet 6.5 of the aforementioned inter-federal strategy.

Article-by-article commentary

Article 1. Article 4 is amended to introduce a ban on the marketing of fully disposable electronic cigarettes.

Article 2. Article 5 is amended to:

-Add a provision 8° to paragraph 9 to introduce a package insert with information on smoking cessation 

-Correct an error in paragraph 15.

Article 3. Article 3 corrects a spelling error in the German wording of the health warning.

Article 4. Article 4 concerns the entry into force of the decree.

Article 5. Article 5 concerns the authority of the Minister.

MAY 3, 2024 - Royal Decree amending the Royal Decree of October 28, 2016, concerning the manufacturing and marketing of electronic cigarettes

FILIP, King of the Belgians,

Having regard to the Act of January 24, 1977, on the protection of users' health in terms of foodstuffs and other products, Article 6, § 1, a), as amended by the Act of March 22, 1989, and Article 10, first paragraph, replaced by the Act of February 9, 1994; Having regard to the Royal Decree of October 28, 2016, concerning the manufacturing and marketing of electronic cigarettes; Having regard to the notifications to the European Commission, on December 9, 2022, and November 8, 2023, pursuant to Article 5, paragraph 1, of Directive 2015/1535/EU of the European Parliament and the Council of September 9, 2015, on an information procedure regarding standards and technical regulations and rules concerning information society services; Having regard to the notifications to the European Commission on December 9, 2022, and September 19, 2023, and the implementing decision of the European Commission of March 18, 2024, pursuant to Article 24, paragraph 3, of Directive 2014/40/EU of the European Parliament and the Council of April 3, 2014, on the approximation of the laws, regulations, and administrative provisions of the Member States concerning the manufacture, presentation, and sale of tobacco and related products, and repealing Directive 2001/37/EC; Having regard to the opinions of the Inspector of Finance, given on February 2, 2024, and February 28, 2024; Having regard to the agreement of the Secretary of State for Budget, dated March 26, 2024; Having regard to the request for an opinion from the Council of State, pursuant to Article 84, § 1, first paragraph, 2°, of the laws on the Council of State, coordinated on January 12, 1973; Considering that the request for an opinion was registered on April 22, 2024, on the roll of the Legislative Section of the Council of State under number 76.195/3; Having regard to the decision of the Legislative Section of April 23, 2024, to not issue an opinion within the requested timeframe, pursuant to Article 84, § 5, of the laws on the Council of State, coordinated on January 12, 1973; Considering the 2022-2028 inter-federal strategy for a smoke-free generation of December 14, 2022; Considering the objective to reduce the prevalence of tobacco product use, including e-cigarettes; Considering the explosive influx of disposable electronic cigarettes into the Belgian and European markets; Considering that disposable electronic cigarettes are neither marketed, promoted, nor used as a smoking cessation aid and have no place or added value in Belgian smoking cessation policy; Considering that disposable electronic cigarettes pose clear health risks and significant environmental burdens; Considering that these products are popular among young people without smoking cessation intentions and are primarily marketed to them; Considering that a disproportionately high number of regulatory violations have been observed in the field regarding disposable electronic cigarettes;

On the proposal of the Minister of Health,

We have decided and We decree:

Article 1. In Article 4 of the Royal Decree of October 28, 2016, concerning the manufacturing and marketing of electronic cigarettes, replaced by the Royal Decree of November 7, 2022, the following amendments are made: 1° In paragraph 1, the provision under 2° is repealed; 2° A paragraph 1/1 is inserted, stating: " § 1/1. It is prohibited to market electronic cigarettes in the form of a fully disposable product. A fully disposable product is defined as a product pre-filled with liquid and not refillable."

Article 2. In Article 5 of the same decree, replaced by the Royal Decree of November 7, 2022, the following amendments are made: 1° Paragraph 9 is supplemented with the provision under 8°, stating: "8° Information on smoking cessation." 2° In paragraph 15, the number "13" is replaced by the number "12."

Article 3. In Article 6/1, § 3, of the same decree, inserted by the Royal Decree of November 7, 2022, the word "Ire>" is replaced by the word "Ihre."

Article 4. Article 1 enters into force on January 1, 2025.

Article 5. The Minister responsible for Health is charged with the execution of this decree.