National Law Review (August 7, 2019):
China has taken a major step toward permitting the sale of regulated e-cigarettes by publishing a draft national standard (GB) on “electronic cigarettes.” The Standard was notified to the World Trade Organization (WTO) on May 1, 2019. …
… The comprehensive new Standard consists of the following seven chapters:
- Reference standards
- Terms and definitions
- Technical requirements
- Testing methods
- Packaging, labeling and instruction manual
- Storage and transportation
The Standard also contains sixteen appendices, including those on the methods for the determination of various substances in the e-liquid, sample labels of e-cigarette device and e-liquid, etc. Particularly, Appendix B provides a positive list of 119 additives that are permitted for use in e-liquid. The use of non-listed additives will be subject to prior safety assessment, with considerations on the edible safety, inhalation safety, stability, addiction, etc. of a substance. We expect that more details about the safety assessment on non-listed substances will be provided in separate regulations. Certain additives also are explicitly prohibited from being used in e-liquid, such as substances purely for coloring purposes, carcinogenic, mutagenic, reproductive toxic and respiratory toxic substances, 2,3-butanedione, etc.
Other notable technical requirements under the draft Standard include:
For e-cigarette device:
§ Mechanic and physical performance, such as sealing, maximum surface temperature, etc.;
§ Electrical performance, such as input/output power, batteries, etc.; and
§ Chemical performance; for example, materials used for components in contact with the mouth or e-liquid must comply with the corresponding food packaging standards of China, such as GB 4806.7 on plastics articles, GB 9685 on food packaging additives, etc.
§ Purity and concentration limits for nicotine;
§ Requirements for base liquid, including glycerin, propylene glycol and water;
§ Limits for impurities and contaminants; and
§ Requirements for material in contact with e-liquid; they must comply with the corresponding food packaging standards.
§ Stability of aerosol and nicotine emissions; and
§ Limits for carbonyl compounds and heavy metals.
The new Chinese Standard on e-cigarettes will be published by the State Administration for Market Regulation (SAMR) and the Standardization Administration of China (SAC), but the agency responsible for drafting and maintaining the Standard is the State Tobacco Monopoly Administration. It is unclear when this Standard will be finalized and published; Chinese authorities may release the Standard later this year. Nevertheless, the new Standard will have a significant impact on the regulatory landscape of the manufacturing, sales and import of e-cigarette products in China. Industry should be mindful of its development and make sure that the e-cigarette products manufactured or imported in China entirely comply with the detailed requirements under the new Standard.
(Chemical Watch, August 13, 2019):
China publishes first draft of e-cigarette standard
Country looks to regulate device components and additives
The standard provides a positive list of 119 additives that can be used in e-liquids in English and Chinese with Cas numbers, where available. But it does not impose a maximum use limit on these, which it says can be used “according to production needs”. Additives must also comply with the national standard GB 9685, which governs additives in FCMs and products.
It also sets out the methods for determining the presence, as well as the specific concentration limits for, impurities or pollutants found in e-liquids. These focus on:
- propionaldehyde; and
And it includes methods for determining the release of certain chemicals in e-cigarette emissions.
While governmental bodies are responsible for publishing the standard, it was proposed, managed and drafted by the State Tobacco Monopoly Administration. The Administration and the China National Tobacco Corporation are collectively known as China Tobacco, which drafts all legislation on tobacco.
The proposed date for entry into force is six months after the proposed date for adoption, which is yet to be determined.