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From Belgium to the European Union: Impact and Compliance Suggestions of Belgium's Electronic Cigarette Regulations
Author.
LCS
Source:
Post time:
2025-07-21
background
On April 24th, the Federal Overheidsdienst Volksgezondheid, Veilighid van de Voeds elketen en Leefmilieu, Dienst Inspectie Consumpitiegoederen, under the Belgian Federal Ministry of Public Health, Food Supply Chain Safety and Environmental Public Services, issued guidance on electronic cigarettes by mail in accordance with the Royal Decree of October 28, 2016, which mainly translated from the Tobacco Product Directive (TPD) of the European Union, Article 20 of Directive 2014/40/EU. (Informative) new regulations.
Core content of the new regulations
Clarify the boundaries between liquid storage containers/cartridges and refill containers for electronic cigarettes, and prohibit the design of multiple cartridges with attractive features.
The new regulations have been confirmed through communication with the European Commission to have legitimacy and authority at the EU level, and may affect the regulatory policies of the entire EU.
The specific points covered by the new regulations are as follows:
1、 Refine the definition of liquid storage containers/cartridges and replenishment containers for electronic cigarettes
Liquid reservoirs that remain attached, or that can remain attached to an electronic cigarette during its use by the consumer are to be considered as cartridges whose volume cannot exceed 2 ml. In other words, no system can allow the refill bottle to remain attached to the electronic cigarette during its consumption by the consumer.
Reference translation:
A liquid container that remains connected or can remain connected to an electronic cigarette during use should be considered as a cartridge, and its capacity should not exceed 2 milliliters. In other words, no system can allow the refill container to remain connected when consumers use electronic cigarettes.
explain:
This supplementary explanation is based on the definition of electronic cigarettes (which states that the cartridge - whether refillable or not - can be a component of an electronic cigarette, but the oil bottle is not). In other words, storage containers that can be used in conjunction with electronic cigarettes (including from a design perspective) should meet the 2mL limit; A refilling container is a separate product from the definition of an electronic cigarette, used only for refilling and cannot be used as a component of an electronic cigarette. After refilling, it should be disconnected - if it is designed to be connected to the electronic cigarette during use or can be connected, it will change the identity of the product from an "independent" refilling container to a liquid storage container for the electronic cigarette, thereby causing compliance issues.
2、 Prohibit attractive features
The services of the FPS Public Health also specify that electronic cigarettes with multiple 2 ml tanks, or that can be loaded by several cartridges or allow the storage of multiple cartridges, are now considered to be electronic cigarettes with an attractive feature. This is prohibited based on Article 4 § 2 of the aforementioned Royal Decree of October 28, 2016, which states that “it is prohibited to market electronic cigarettes with attractive features not useful for the operation of the device”.
Reference translation:
The service department of FPS Public Health Department also explicitly stated that electronic cigarettes with multiple 2ml e-liquid storage compartments, or the ability to upload multiple cartridges (editor's note: the device can integrate multiple cartridges and can be used simultaneously with more than one cartridge), or electronic cigarettes that allow the carrying of multiple cartridges (editor's note: the device can integrate multiple cartridges, but only one can be used at a time), are now considered to have attractive characteristics. According to Article 4, Paragraph 2 of the Royal Decree of October 28, 2016, this is prohibited, which states that "the sale of electronic cigarettes with attractive features that are useless for their device operation is prohibited".
explain:
Although Belgium's national level explanation of multi smoke bombs starts from the "attractive characteristics", it directly explains from the definition with Spain, and the Czech Republic and Malta believe that this design carries the risk of accidental consumption of a high dose of nicotine, both of which reject the design of multi smoke bombs (refer to tweet: inventory of electronic cigarette related content in EU safety gates).
Background and significance of communication with the European Commission
The decision of Belgian FPS to further explain the product definition is based on communication with the services of the European Commission. That is to say, these decisions were approved by the European Commission, which also reflects the Commission's position. This not only provides legitimacy and authority for the new regulations in Belgium, but also provides direction for the European Commission to ensure consistency in the implementation of the Tobacco Products Directive among member states (including the results of this communication with Belgium), and to avoid regulatory loopholes or market distortions in the future.
Based on the EU political system framework and the inherent requirements of the single market, it can be inferred that this new regulation not only affects the local market in Belgium, but may also have a profound impact on the unity of EU legislation and policies of other member states.
The impact on EU legislation
Although EU member states are responsible for enforcing EU laws domestically, the European Commission plays a crucial role in ensuring that these laws are uniformly and correctly enforced throughout the EU through its supervisory and enforcement powers.
The new regulations in Belgium may prompt a re examination of the regulatory framework for electronic cigarettes at the EU level, and may even push for further refinement of legislation related to electronic cigarettes at the EU level. Currently, TPD is considered to have ambiguous applicability on new products such as attached supplementary containers. The case of Belgium also highlights the challenge of technological innovation to existing regulations, which will prompt DG SANTE or other departments to initiate technical assessments to explore the need for updating directives or issuing technical standards. For example, clarify the criteria for distinguishing between "liquid storage containers/cartridges" and "supplementary containers" for electronic cigarettes, and establish more specific prohibitions on the design of multiple cartridges. This will help unify market rules - although it may cause industry resistance, especially from manufacturers who want to preserve design flexibility.
Policy predictions from other member countries
Overall, there are objective differences in market maturity, consumer habits, and industry pressures among member countries, as well as differences in their understanding of the tax dependence on tobacco/e-liquid substitution compensation and the use of electronic cigarettes as a substitute for traditional tobacco harm reduction. Regulatory enforcement efforts and speed may also vary. However, improving the rules of the single market and reducing compliance costs in cross-border trade are the core of the work of the European Commission, especially the Directorate General for Internal Market, Industry, Entrepreneurship and SMEs. Under the binding force of EU law and the coordinating role of the Commission, especially if the EU issues supplementary guidelines, it is expected that most member states will gradually adopt similar interpretations in the next 1-2 years.
Suggestions for stakeholders
As the world's largest producer of electronic cigarettes, China faces both challenges and opportunities brought about by Belgium's new regulations and potential EU policy changes. Suggestions for all stakeholders:
1) Adjust product design: Launch research and development in a timely manner to design electronic cigarette liquid storage containers/cartridges that meet the 2mL limit, as well as separable 10mL replenishment containers that meet the requirements. Ensure that the product is detached from the electronic cigarette after filling to avoid being classified as an electronic cigarette storage container/cartridge. Especially, modular design can be developed to adapt to the regulatory requirements of different member countries.
2) Value compliance: closely monitor updates to the EU Common Entry Gate (EU-CEG) to ensure that product notification documents accurately reflect new regulatory requirements.
3) Strengthen inventory management: Work with members of the EU supply chain to accelerate the clearance of existing 10mL connected replenishment containers during the transition period permitted by Belgium (until December 31, 2025- Belgium provides a transition period for products that do not comply with the new regulations, after which the Belgian Consumer Goods Inspection Agency will take all necessary measures to remove "illegal" products). Meanwhile, avoid mass production of products that do not comply with the new regulations.
4) Participate in policy lobbying and adjust market strategies: Through industry associations or EU agents, engage in dialogue with EU and member state regulatory agencies to strive for more flexible transition arrangements. Increase market investment in member countries with relatively loose regulations, such as Eastern Europe, as a short-term buffer.
5) Long term plan: Invest in the research and development of low nicotine or nicotine free products to cater to the public health trends in the European Union. Explore cooperation with local enterprises in the European Union to enhance market adaptability and brand trust.
summarize
The new regulations for electronic cigarettes in Belgium have strengthened the strict implementation of TPD through communication with the European Commission, which may promote the refinement of legislation at the EU level and encourage other member states to adopt similar interpretations. However, considering the different levels of development among member countries, the follow-up speed of different member countries may vary due to market factors. Chinese e-cigarette manufacturers should quickly adjust product design, optimize inventory management, and respond to regulatory tightening in the EU market through a combination of compliance and lobbying. Closely monitoring the follow-up actions of the European Commission will be the key to seizing market opportunities.
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