China finalizes e-cigarette regulations for licensing and review

Since we reported in December 2021 on some important developments in China’s e-cigarette regulations (including the draft national e-cigarette standard) as well as in March 2022 on the finalized management rules for e-cigarettes, China State Tobacco Monopoly Administration (STMA), also known as China National Tobacco Corporation (CNTC), has not only issued the national electronic cigarette standard GB 41700-2022, but also issued other regulations detailing the procedure and requirements for licensing, technical review, etc. weeks, we will publish a series of articles summarizing these new regulations. This article will first focus on GB 41700-2022.

It should be noted that, according to the e-cigarette management rules, e-cigarettes intended for export only are not necessarily required to comply with GB 41700-2022; rather, they must comply with the laws, regulations and standards of the country of destination. When the destination country does not have relevant laws or standards, e-cigarettes only for export must comply with Chinese laws and standards, which we believe will include GB 41700-2022.

GB 41700-2022 was published on April 8, 2022 and will come into force on October 1, 2022. As we previously reported, the first draft standard was notified to the World Trade Organization (WTO) in 2019. At that time, China had not officially placed e-cigarettes under the state tobacco monopoly. Later, in November 2021, around the same time as the amended implementing regulations for the Tobacco Monopoly Law (which places e-cigarettes under the tobacco monopoly in China) and the draft rules management, STMA has published a new draft standard on e-cigarettes for comment. In March 2022, STMA again amended the draft standard for a further round of public comment. The current GB 41700-2022 is largely consistent with the March 2022 draft and its structure is as follows:

  • Article 1 – Scope

  • Section 2 – Referenced Standards

  • Section 3 – Terms and definitions

  • Section 4 – Design and raw material requirements

  • Article 5 – Technical requirements

  • Section 6 – Test Methods

  • Section 7 – Labeling and Directions for Use

  • Appendix A – Additives Approved for Use in Electronic Atomization and Maximum Use Levels

  • Annexes B to F – Methods of determination, etc.

We summarize the main requirements below.

Definitions

“Electronic cigarette” is defined as an electronic delivery system used to generate aerosols for human smoking, excluding roll-up cigarettes. It is noted that, in the 2021 project, the electronic cigarette is used to generate aerosols “containing nicotine”. The Chinese government explained that the deletion of the term “containing nicotine” here is to include electronic cigarettes that do not contain nicotine in the definition of electronic cigarettes. At the same time, the current standard also adds that electronic atomization materials must contain nicotine, which, as explained by the Chinese government, prohibits the sale of electronic cigarettes that do not contain nicotine.[1] These changes and the accompanying government explanation are important, as they seem to suggest that e-cigarettes without nicotine are also regulated as e-cigarettes in China and are banned from sale.

“Electronic atomization materials” means the mixture and auxiliary substances which can be partially or fully atomized by the electronic device into absorbable aerosols. E-liquids are e-atomization materials in a liquid state. In keeping with industry practice, we’ll use the term “e-liquids” for the rest of the article.

Nicotine in e-liquids

As required by previous versions, the standard states that e-liquids must contain nicotine, and that nicotine must be extracted from tobacco, with a purity of at least 99%. The standard further requires that the concentration of nicotine in e-liquids does not exceed 20 mg/g and that the total nicotine content does not exceed 200 mg. On the other hand, the emission of nicotine per puff should not exceed 0.2 mg.

Additives in e-liquids

The standard requires that additives permitted for use in e-liquids and maximum use levels must follow Schedule A, which lists 101 substances. In the 2021 draft, this list is part of Schedule B and contains 122 substances. The standard also provides that the use of other additives must evaluate their toxicological characteristics and the risks for the safety of use, and confirm that such use will not increase the risks for the health of the user. The scope of the evaluation includes, but is not limited to, food safety, absorption safety, and safety under conditions of use. As a result of this provision, it appears that the use of additives not listed in Annex A is possible, but it is not entirely clear how the assessment should be carried out. In the meantime, it is prohibited to use the following substances as additives: a) substances that are carcinogenic, mutagenic, genotoxic or toxic to the respiratory system; b) additives and stimulants related to energy and vitality; (c) substances which may give the consumer the erroneous impression that they are beneficial to health or that they reduce harmful effects; and (d) substances solely for coloring purposes.

Restricted substances

Like the two previous versions, the current standard also imposes restrictions on “e-cigarette materials”, i.e. materials, excluding e-liquids, used for the manufacture of e-cigarettes. However, while the previous two versions generally require materials in contact with the mouth, e-liquids and e-cigarette emissions meet the requirements for materials in contact with food. The current standard more specifically requires these materials to comply with GB 4806.1 (General Safety Standard) as well as material standards from GB 4806.3 to GB 4806.11. These material standards cover specific food contact materials including plastics, paper, metal, etc. This may lead to compliance issues if, in the future, China releases new material standards, such as those for composite materials, adhesives, etc.

On the other hand, for materials that are not in contact with the mouth, e-liquids or e-cigarette emissions, previous drafts and the current standard seem to take different approaches. In the 2021 draft, these materials are required to meet the limits on regulated substances in electrical and electronic products and provide a list of exceptions in Appendix A. In the March 2022 draft, Appendix A is replaced by the positive list of additives. (see above), and it is only generally required that these materials comply with the standards and regulations applicable to electrical and electronic products. The current standard also removes the original Annex A, but more specifically requires that these materials must meet the limits on substances restricted in homogeneous materials in GB/T 26572. In the current GB/T 26572-2011 standard , the standard on “requirements for concentration limits for certain restricted substances in electrical and electronic products”, the limits on restricted substances in homogeneous materials are: lead, mercury, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers (not to exceed 0.1%) and cadmium (not to exceed 0.01%).

The flavours

As part of the design requirements, the standard requires that e-liquids are not permitted to induce minors and are not permitted to have the product exhibit any characteristic flavors other than tobacco. This wording is not in the 2021 draft but appears to have been added for consistency with the business rules, which contain the same requirement. This can lead to uncertainty in practice, especially when various flavoring substances are permitted additives in Annex A.

The standard contains various other requirements, for example, the e-cigarette device and the cartridge must have a closed structure preventing “artificial filling”, which essentially prohibits refillable e-cigarettes. The standard also provides specifications for levels of impurities in e-liquids and carbonyl compounds in emissions.


FOOTNOTES

[1] See Answers to Questions Related to the Management Rules for Electronic Cigarettes and the National Standard on Electronic Cigarettes, STMA, April 15, 2022, available at: https://www.samr.gov.cn/xw/mtjj/202204/t20220414_341287. html

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