EU notification of China's exports of electronic cigarettes situation analysis

With the continuous tightening of global tobacco control policies and the significant improvement of public health awareness, e-cigarettes, as a substitute for traditional cigarettes, are gradually occupying an increasingly important position in the global market and showing strong growth momentum. As a global leader in the e-cigarette industry, China has more than numerous e-cigarette manufacturing and branding enterprises, more than 70% of which have exported to overseas markets as their main goal.

However, with the expansion of the e-cigarette market and the strengthening of regulation, a number of problems have gradually emerged. According to the data released by the EU Rapid Alert System for Non-Food Consumer Goods, from 2021 to 2023, the number of notifications of e-cigarettes related products reached 169, of which the notifications involving Chinese products were as high as 113, accounting for nearly 70% of the total, which emphasizes that China's e-cigarettes exported to the EU have become the "hardest hit" by notifications. This data highlights that China's e-cigarettes exported to the EU have become the "hardest hit" area.

I. Reasons for notification and hazard analysis

(i) Excessive product volume.

The EU Tobacco Products Directive (TPD) stipulates that the capacity of the cartridges or disposable cartridges in disposable e-cigarettes shall not exceed 2mL.If the capacity of the cartridges exceeds 2mL, it may lead to accidental ingestion of high doses of nicotine. Nicotine is acutely toxic at high doses, and inhalation of nicotine may cause adverse health effects such as nausea, vomiting, dizziness, rapid heartbeat, etc., and may even be life-threatening.

(ii) Excessive nicotine concentration.

The EU Tobacco Products Directive (TPD) stipulates that the nicotine concentration in e-cigarette oil should not exceed 20 mg/mL.Excessive nicotine concentration in e-cigarette oil will lead to excessive intake of nicotine. Nicotine is a highly addictive substance, and excessive intake can lead to a toxic reaction and potentially serious harm to the body. Symptoms of a toxic reaction include nausea, vomiting, headache, rapid heartbeat, elevated blood pressure, sweating, and tremors, and in severe cases may even be life-threatening. Nicotine overdose can also cause long-term damage to the nervous system, digestive system, respiratory system, etc., such as increasing the risk of cardiovascular disease and impairing respiratory health.

(iii) Product manuals.

E-cigarettes logo and product instructions are information tools that provide consumers with information on how to use the product effectively and safely. Missing or incomplete information on the logo and product instructions may prevent consumers from using the product correctly, or may lead to the use of the product by unsuitable people, jeopardizing the lives and health of consumers.

(iv) Leakage of liquid.

E-cigarettes leaking nicotine-containing liquid may be ingested by the user through skin contact or swallowing, and may also cause children to accidentally touch nicotine and ingest it through their skin, resulting in nicotine poisoning, gastrointestinal irritation, damage to the respiratory system, and other hazards.

(v) Mouthpiece dislodging.

When the design of the mouthpiece of e-cigarettes is not stable enough or it is easy to fall off during use, users may accidentally inhale it and choke on it, resulting in the risk of suffocation. This risk not only threatens the safety of adult users, but also poses a great threat to children. If children accidentally put the mouthpiece of an e-cigarette into their mouths, they may face the risk of choking because they cannot spit it out in time.

II. Analysis of notifying countries

The main countries notified by the EU on China's e-cigarette products include Ireland, Czech Republic, Bulgaria, Lithuania, Latvia, Iceland, and Malta, of which Ireland and Czech Republic are the two countries that notify the largest number of China's e-cigarette products, and the reasons for the notification are concentrated in the manuals, product capacity, and unqualified items such as nicotine concentration, etc., detailed information is shown in Table 1.

Table 1 List of e-cigarette products notified by the EU

Third, the European Union notification of China's electronic cigarettes unqualified project analysis

The European Union notified China's e-cigarettes that the unqualified items mainly include: instruction manuals, product capacity, nicotine concentration, mouthpiece shedding and liquid leakage, of which instruction manuals, product capacity and nicotine concentration are the three most notified unqualified items, detailed information is shown in Table 2.

Table 2 Analysis of unqualified items of e-cigarette products notified by EU in China

Fourth, the European Union notified the risk type analysis of China's electronic cigarettes

The risk types of our e-cigarette products notified by the EU mainly include: chemical and asphyxiation, among which chemical is the risk type with the largest number of notified batches, which is due to the failure of our e-cigarette products in terms of instruction manuals, product capacity, nicotine concentration, leakage of liquid and other items. The choking risk of our e-cigarette products is due to the fact that some e-cigarettes are accidentally inhaled when the mouthpiece falls off during use, resulting in choking. Although the notified batches of asphyxiation risk are relatively small, it is necessary for relevant manufacturers to pay enough attention to it. Detailed information is shown in Table 3.

Table 3 Analysis of unqualified items of e-cigarette products notified by the EU in China

V. Suggestions to China's export enterprises of the European Union electronic cigarettes

The EU Tobacco Products Directive (TPD) is the legislation used to regulate and monitor the manufacturing, distribution, and presentation (product design, packaging, etc.) of products and all tobacco and tobacco-related products (e.g., e-cigarette products). Starting in 2016, e-cigarettes and related products are mainly regulated by Article 20 of the TPD. In recent years, the EU regulations on e-cigarette products have become increasingly stringent, and seven major European associations have jointly even called for a ban on disposable e-cigarettes in Europe by the end of 2024. From the data of e-cigarette products notified by the EU in recent three years, the e-cigarettes notified by the EU are mainly disposable e-cigarette products. In response to the EU notification of China's e-cigarette products, China's e-cigarette exporters should attach great importance to, and actively take the following measures to improve:

1.Exporting e-cigarette products to the EU should strictly comply with the relevant EU regulations and standards to ensure product quality meets the requirements.

2. Strengthen the preparation and audit of product specifications: ensure that the contents of the specifications are informative, accurate and complete, and contain the necessary safety warning information. At the same time, increase the audit of the instructions to ensure that they meet the requirements of relevant regulations and standards.

3. Strictly control the capacity and nicotine concentration of the products, and produce them in strict accordance with the capacity and nicotine concentration standards stipulated by the European Union, to ensure that the products meet the requirements of relevant regulations and standards.

4. Optimize product design to avoid problems such as poor sealing and easy leakage. Improve and optimize the design of products that may generate choking risks to ensure that the products will not generate risks such as small parts falling off or being inhaled by mistake during use.

5. Strengthen product quality testing and monitoring, establish a perfect product quality testing system, and strictly monitor and test all aspects of the production process to ensure that product quality meets the requirements of relevant regulations and standards.