Detailed Guide to China's Mandatory National E-Cigarette Standard

On July 12, 2019, the launch conference for the Guangdong Electronic Cigarette Shared Laboratory was successfully held in Shenzhen.

At the conference, Director Xue, one of the main technical experts of the shared laboratory and a veteran in the tobacco industry, provided a detailed interpretation of the "Mandatory National Standard for Electronic Cigarettes" that is currently under review.

(The following content is organized based on the conference.)
 

There are several points that electronic cigarette manufacturers should pay special attention to.

First, the national standard mainly regulates electronic cigarette devices, e-liquids, and emissions. Notably, the national standard redefines what we commonly refer to as e-liquid as "e-liquid". Moreover, e-liquid is a key focus of the national standard.

Second, there are four requirements for electronic cigarette devices, including: mechanical and physical performance, electrical performance, components, and chemical performance.

It is worth noting that the regulations require that the liquid storage tank of the device must indicate minimum and maximum scales, power, current, and maximum input power of the atomizer (not exceeding 40W), along with deviation requirements, which poses a challenge for high-output devices. Additionally, there must be labeling for protection mechanisms against accidental activation and prolonged operation of the electronic cigarette.

Third, the national standard proposes 13 testing requirements for electronic cigarette batteries (see the official release of the national standard for details).
 

These mainly include testing the overall chemical performance of electronic cigarette devices, including limits on six substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers) and material requirements for components that come into contact with the mouth or e-liquid.

Fourth, the national standard has seven requirements for e-liquids, which are: general requirements, nicotine and tobacco, base liquids, e-liquid additives, quality requirements for e-liquid additives, limits on impurities and contaminants, and materials for refill bottles.

E-liquids must be produced according to food safety standards, with strict requirements for nicotine purity, glycerin, and water.

The nicotine purity used in e-liquids should not be lower than 99%, and the tobacco used to extract nicotine should not be moldy. The nicotine concentration in e-liquids should not exceed 20 mg per milliliter, which is 2%, while the commonly used concentration is 3%-5%.

It is particularly important to note that e-liquid additives can only use the 119 additives specified by the national standard, meaning that future e-liquids cannot be made with various flavors according to personal preferences, which also implies that there will no longer be such a wide variety of pod flavors in the electronic cigarette market. Additives outside the scope of the national standard require manufacturers to seek third-party verification of their safety before use, but the national standard does not specify which institutions to approach for verification or who will approve it.
 

Additionally, e-liquids must not contain substances that claim to be beneficial to health, enhance energy, or reduce harm.

Fifth, the total nicotine content in refill bottles must not exceed 200 mg, meaning that if the maximum concentration is 20 mg per milliliter, the e-liquid bottle cannot exceed 10 milliliters. If not added, it can be infinitely large. The materials used for e-liquid bottles, such as glass, must comply with the requirements for glass materials in GB4806.5.

Sixth, technical requirements for electronic cigarette emissions

The relative deviation of each test result for aerosol collection from the average value must not exceed 25%; the nicotine release amount must also not exceed a relative deviation of 25% from the average value.

Seventh, electronic cigarette devices and e-liquids will be uniformly packaged according to the national standard, and the instructions will also be uniformly formulated according to the national standard.

Eighth, currently, there are three possible policies for regulating electronic cigarettes in China.

A. Similar to traditional cigarettes, control will be implemented, and private enterprises will not be allowed to enter. B. A more open approach, where simple reporting is sufficient for operation. C. A licensing (registration, permit) system, where only licensed companies can operate.

Based on the current situation, the likelihood of adopting the second policy is relatively high. #p#分页标题#e#

Impact of the national standard on the electronic cigarette industry

1. Significant improvement in product quality 2. Corresponding increase in product costs 3. Extension of product launch time 4. Continuous improvement in R&D levels 5. Increasing demand for testing equipment, which will promote the continuous development of testing technology.

Since all personnel involved in standard formulation come from the tobacco bureau, the future of electronic cigarettes in China should be under the unified management of the National Tobacco Bureau.

Additionally, this regulation only applies to vapor electronic cigarettes, and heated non-combustion tobacco is not included in this scope; regulations for heated non-combustion tobacco are currently being formulated.

So will vapor electronic cigarettes shine brightly in the Chinese market, or will they face numerous challenges? Let's wait and see.