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Inventory of electronic cigarette related content in EU security gates

Author.

LCS

Source:

Post time:

2025-07-21

The EU Safety Gate is a core tool for coordinating market supervision among member states of the EU, used to quickly report and respond to products in the market that may endanger consumer health and safety. It is a rapid warning system used by the EU for non food product safety monitoring. Its main functions include:

·Information sharing: Member States, the European Commission, and relevant agencies exchange real-time information on hazardous products through the system, including product descriptions, risk types, and measures taken.

·Quick response: Promote member states to take prompt action, such as recalling, banning, or destroying hazardous products.

·Cross border collaboration: Ensuring consistency within the EU internal market and preventing the movement of hazardous products between member states.

·Public transparency: providing consumers with information on dangerous products and enhancing market trust.

Explanation 1: RAPEX (Rapid Alert System for Non Food Products) is the predecessor of safety doors. RAPEX was officially established in 2004 in accordance with the EU's General Product Safety Directive (2001/95/EC), with the aim of promoting information sharing among member states regarding hazardous products. Its origin can be traced back to the non food consumer product safety information exchange mechanism in the 1990s. In 2010, the system was upgraded and renamed as Safety Gate, expanding its coverage to all non food products and further improving its functionality. In 2020, the European Union optimized Safety Gate through digital reform, improving information transparency and system efficiency.

To achieve the above goals, the Directorate General for Justice and Consumers of the European Commission issues weekly alert reports.

The warning and regulatory trends related to electronic cigarettes should be of concern to all stakeholders

1、 The risk of accidental consumption of a high dose of nicotine is the most important reason why products are regulated.

2、 The number of notifications showed an upward trend in 2023 and 2024, and remained at a high level at the beginning of 2025, indicating that regulatory efforts continue to strengthen.

3、 Czech Republic, as the EU member state with the highest number of warning submissions (accounting for over 60%), shows that its market supervision is enthusiastic and active. The country of origin with the highest proportion is China (over 80%), followed closely by Poland and the Czech Republic, accounting for 8% and 5% respectively. The main mandatory measures are withdrawal, accounting for nearly half, while other measures include import rejected, recall, stop of sales or ban, and destruction.

Explanation 2: Withdrawal refers to taking measures or preventing circulation in the supply chain.

Explanation 3: Recall refers to any action taken by the end user.

4、 Disposable electronic cigarettes are a heavily regulated area

Disposable electronic cigarettes account for 75% of the mandatory product types in the past, due to their product characteristics including:

1) There is a risk of excessive nicotine intake, with specific reasons including

a) The amount of e-liquid in the unit packaging exceeds the standard (not meeting the maximum oil tank capacity (2ml) requirement - the e-liquid volume of electronic cigarettes has increased from 4.8-13ml in 2022 to 21-36ml in 2025, indicating that some manufacturers may not comply with the 2mL limit due to market demand, which may lead to stricter enforcement in the future), and

b) Nicotine concentration exceeding the limit (although there are clear legal requirements, it is common for disposable electronic cigarette packaging information to be insufficient, such as unclear or inaccurate labeling of actual nicotine content, and random testing showing a high probability of not meeting the maximum nicotine content limit of 20mg/ml - Safety Gate statistics show a significant increase in cases of nicotine concentration exceeding the limit (20-50mg/ml) - although this may be related to consumers' demand for high-intensity products - this will lead regulatory agencies to strengthen concentration testing)

2) The lifecycle is short, and its waste can pose environmental risks. Health and the environment are inseparable, and environmental pollution harms public health. The microplastics and chemicals released from discarded disposable electronic cigarettes can contaminate soil, waterways, and the food chain, posing a threat to humans. In addition, the disposal of lithium batteries also carries the risk of combustion or explosion

3) Young people are at high risk of becoming infected and addicted.

a) The relatively lower price and low threshold of disposable electronic cigarettes increase the risk of encouraging young people and non-smokers to try electronic cigarettes for the first time;

b) Fancy design makes it popular among young people and leads to misunderstandings about related risks;

c) It is available for sale at various sales outlets and online, and is easy to obtain.

d) Diversified flavors (such as "strawberry mango" and "blueberry ice") have become key factors in attracting consumers, but they may also mask the risk of high nicotine content and increase the potential danger of misuse by teenagers.

5、 Risks of emerging chemical substances: The use of new chemical substances, such as hexahydrocannabinol (HHC) and other psychotoxic substances, may pose health risks if they fall into the hands of children. This increases regulatory complexity.

6、 Cross border e-commerce challenges: Many products are sold through online platforms such as vapeseurope.com and Amazon, making it more difficult to regulate cross-border e-commerce. This may promote the EU to improve the responsibility mechanism for e-commerce platforms.

7、 The concern for child safety is intensifying: the problem of missing child resistance is frequent, and future regulations may require stricter packaging design.

There are also two details worth paying attention to,

1、 The hidden danger in the design of automatic oiling equipment with 2mL smoke bombs and 10mL refilling oil bottles.

The use of oil bottles combined with equipment is not accepted by the European Union (especially when there is automatic refilling) due to the risk of accidental ingestion of high doses of nicotine.

According to the Hungarian Health Risk Report, a 2mL nicotine cartridge with a nicotine concentration of 20mg/mL has a nicotine intake equivalent to 1-2 packs of traditional cigarettes. To control the risk of excessive intake, the EU TPD limits the capacity of nicotine cartridges to 2mL. If the device adopts a "2+10 design" (i.e. 2mL cartridges paired with 10mL automatic refilling oil bottles), consumers may accidentally overdose due to a lack of nicotine intake feedback, posing a health risk. In 2024, Malta submitted a warning case indicating that such designs are considered high-risk by EU member states (see Figure 1: Example of Malta's warning products).

 

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2、 The multi smoke bomb design was rejected.
Although Spain has clarified the requirement and details of 2mL in Article 28 of the Royal Decree RD 579/2017 on the conversion of TPD at the national level, namely
 
 
 


Reference Chinese translation:
According to Article 28 of Royal Decree 579/2017, the total amount of liquid or volume contained in a DSLN (pre filled, storage tank or cartridge) shall not exceed 2 milliliters. That is to say, the equipment shall not contain more than one storage tank or storage device, and the total liquid capacity of a single or multiple storage devices shall not exceed 2 milliliters per use. This includes any additional liquid storage containers in the equipment.

Spain's understanding of the 2mL limit on TPD provides a reference for other member countries.

In addition, the latest Safety Gate warning case confirms this "understanding" and provides support for a "unified understanding" or "unified understanding" at the EU level. The four in one design product warning case submitted by Czech Republic in Figure 2 and the four in one design product warning case submitted by Malta in Figure 3 were both withdrawn due to a total liquid capacity exceeding 2mL.

 
 

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summarize

The European Union, as a political entity with both federal and confederation characteristics, has always regarded the single market as one of its goals and great achievements. Several legislative and institutional practices are fulfilling their responsibilities to achieve this goal. All stakeholders should attach importance to compliance (such as strengthening packaging design, proactively disclosing nicotine content, optimizing supply chain traceability), and support consumer education to enhance public awareness of the risks of electronic cigarettes, keep up with trends, and help enterprises achieve sustainable development. In the future, the EU may further restrict disposable electronic cigarettes, implement taste bans, and increase requirements for zero nicotine or non nicotine electronic cigarettes, which need to be prepared in advance.

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