Draft National Vape Standard Explained (Part 1): Devices and E-Liquid Rules

From the development of the global e-cigarette market, it has been steadily growing from 2014 to 2018, reaching around $16 billion by 2018. Although the Chinese e-cigarette market only accounts for about 5% of the global market and less than 0.5% of the Chinese tobacco market, the sales of e-cigarettes in China had already reached 6 billion RMB in 2018, with 10 million users.
 
The domestic e-cigarette market is booming, but there are also many issues, such as inconsistent quality and battery explosions, which are caused by a lack of regulation. To date, no safety standards or processes for e-cigarette production have been established in China.

Although the vast majority of domestic e-cigarette sellers promote "alternatives to cigarettes to help quit smoking," the lack of safety regulation means there is no basic consumer safety guarantee. Therefore, China urgently needs to establish basic consumer safety laws or mandatory standards for e-cigarettes to regulate product production processes and ensure stable quality.

The international e-cigarette market already has relevant regulatory systems. For example, in the UK, it is regulated by PHE (Public Health England); in the US, it is managed by the FDA (Food and Drug Administration), focusing primarily on hygiene and health. So who regulates e-cigarettes in China?

Let's take a look at the recent developments in e-cigarette regulation in China:

On March 12, 2014, the National Tobacco Administration sent a team to Shenzhen to investigate e-cigarettes;

On June 6, 2015, the National Tobacco Administration established the Shanghai Institute of New Tobacco Products to begin research on e-cigarettes;

On April 11, 2017, the National Tobacco Administration released industry standards for e-cigarettes, and I was one of the participants in formulating these standards;

On May 18, 2017, the National Tobacco Administration issued a notice on strengthening the regulation of tobacco monopoly, emphasizing that heated non-combustible tobacco products are considered tobacco products and are regulated by the Tobacco Administration;

On August 30, 2018, the State Administration for Market Regulation and the National Tobacco Monopoly Administration issued a notice prohibiting the sale of e-cigarettes to minors;

On January 1, 2019, the newly revised "Hangzhou Public Places Smoking Control Regulations" included e-cigarettes in the management scope;

On March 15, 2019, CCTV's 315 Gala "named" e-cigarettes;

On June 1, 2019, the new draft of the "Shenzhen Special Economic Zone Smoking Control Regulations" included e-cigarettes in the smoking control scope, and reports indicated it was passed on June 26, to be officially implemented on October 1.

From these signs, it is clear that the National Tobacco Administration has been planning for e-cigarettes for a long time.

1. Drafting Units and Structure of the National E-Cigarette Standard

The drafting units for the national e-cigarette standard are key institutions in the tobacco system researching new tobacco products, including: Shanghai Institute of New Tobacco Products, Zhengzhou Tobacco Research Institute of China National Tobacco Corporation, China Tobacco Standardization Research Center, and National Tobacco Quality Supervision and Inspection Center.

The draft structure of the national e-cigarette standard is divided into seven chapters: regulatory scope, normative reference documents, terms and definitions, technical requirements, testing methods, packaging labeling and instructions, storage and transportation.
 
Among these, Chapter 4 (Technical Requirements) and Chapter 6 (Packaging Labeling and Instructions) are mandatory, while the others are recommended. The scope of the national e-cigarette standard only applies to e-cigarettes, and heated non-combustible products are not included, as their standards are still being formulated.

The referenced documents in the national standard are mostly national food safety standards. The national e-cigarette standard defines e-cigarettes, e-cigarette liquids, e-cigarette devices, and pods in detail. For example, what we commonly call e-liquid is referred to as e-cigarette liquid here, and pods refer to the pods used in e-cigarettes; heated non-combustible products do not fall under this category.

Chapter 4 focuses on the technical requirements of the national e-cigarette standard, which are divided into three categories: e-cigarette devices, e-cigarette liquids, and e-cigarette emissions, commonly known as aerosol. The emphasis of the national e-cigarette standard is on e-cigarette liquids, which we commonly refer to as e-liquids.

2. E-Cigarette Devices
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The e-cigarette device has requirements in four aspects.

1. Mechanical and Physical Performance
 
There are requirements for sealing to prevent oil leakage. For open e-cigarettes, which are refillable, there should be maximum and minimum liquid level indicators marked on the device. Sealing tests and surface temperature tests should be conducted for free fall.

2. Electrical Performance
 
Requirements for electrical performance include input power and current deviation. The maximum input power for atomizers should not exceed 40 watts, with deviation requirements. This poses a challenge for high-wattage devices, and there are also protections against accidental activation and prolonged working time.

3. Components
 
The most important component in e-cigarette devices is the battery, which has thirteen testing requirements.

4. Chemical Performance

General requirements for the overall chemical performance of e-cigarette devices are specified. The materials used (ceramics, glass, plastics, metals, etc.) must not exceed the limit requirements. In terms of chemical performance, there are also requirements for materials that come into contact with the mouth or e-liquid. For example, if the atomizer uses a ceramic heating element, it must comply with the requirements for ceramic materials and cooking utensils in national standard 4806.4. If the shell is plastic, it must meet the requirements for plastic materials in national standard 4806.7.

3. E-Cigarette Liquids

General requirements for e-cigarette liquids, nicotine and tobacco, base liquids, e-cigarette liquid additives, quality requirements for e-cigarette liquid additives, impurity and contamination limits, and refill bottle materials.

1. Overall Requirements

E-cigarette liquids should be produced according to GB14881, which is the food safety standard.

2. Nicotine Purity

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

3. E-Cigarette Liquid Additives

The glycerin, water, and propylene glycol used in e-cigarette liquids must comply with relevant national standards. This is crucial; the e-cigarette liquid additives have specific requirements, allowing the use of 119 substances listed in Appendix B. However, these 119 substances may not be sufficient to create the many flavors currently available on the market, so the national standard for e-cigarette liquid additives is being formulated.

4. Quality Requirements for E-Cigarette Liquid Additives

If substances other than the 119 additives are used, a safety risk assessment of the physical properties of the substances must be conducted, and a third-party organization should be consulted for the assessment. Currently, it is not disclosed who will make the final determination. The safety assessment includes many aspects, and substances that should not be used in e-cigarette liquids include those claiming to be beneficial to health, increase energy, or reduce harm, as well as any substances with special functions.

5. Impurity and Contamination Limits

Limits for impurities and contaminants in e-liquids, such as specific nitrosamines in tobacco, must not exceed 50 PDM, and the total amount of 17 phthalates must not exceed 60 PDM. Limits are also set for alcohols, styrenes, carbonyl compounds, and heavy metals.

6. Refill Bottle Materials

Refill bottles, also known as e-liquid bottles, have specific requirements. The total nicotine content must not exceed 200 mg, meaning if the maximum concentration is 20 mg per milliliter, the e-liquid bottle cannot exceed 10 milliliters. If no additives are included, the size can be unlimited. The materials used for e-liquid bottles, such as glass, must comply with the requirements for glass materials in GB4806.5.