Chinese e-cigarette manufacturers must provide information on their production process and quality management, among other requirements, to obtain a manufacturing license required by China’s new e-cigarette regulations.
China’s State Tobacco Monopoly Administration (STMA) published a rule explaining how e-cigarette companies can obtain the manufacturer license required by the new e-cigarette regulations. This law applies not only to companies who make e-cigarettes for the Chinese domestic market, but also to those that make e-cigarettes only for export.
Companies will need an e-cigarette manufacturing license for products that are divided into three categories – e-cigarette products, such as cartridges, devices, and cartridges and devices for combined sales; e-atomization materials (e-liquids); and e-cigarette-use nicotine.
In the application form the applicant must select a product type from the categories mentioned above and specify whether the manufacturing of the product is for domestic sales or for export. It is worth noting that while it is possible to select multiple products, it is not permitted to choose across categories in the same application. So, an applicant cannot select both the cartridge and the e-liquids in a single application, but it is permissible to select both the cartridge for domestic sales and the device for export in the same application as they are in the same category.
Also, the term "device" encompasses not just e-cigarettes, but also "heated cigarettes," or heat-not-burn (HNB) products. While HNBs are regulated as traditional cigarettes rather than e-cigarettes in China, the manufacture of an HNB device in China, whether for domestic or international sales, is subject to the same manufacturer license regulations as e-cigarettes. In the manufacturer license application form there is a separate product category for HNB devices.
In addition to the application form, applicants must also submit:
- investor information form;
- business license;
- proof of suitable funds, production and sales information, including the balance sheet, income statement, cash flow statement, and production and sales statistics for the past three years;
- material related to the required technology and equipment which includes
- ownership certificate or lease agreement for the production site;
- description of the surrounding environment of the production site, infrastructure, investment scale;
- production process and quality management material including
- list of main production equipment and testing instruments
- production capacity measurement report and explanatory materials (including factory’s general floor plan, process equipment layout, worker number, labor productivity, flow of process, process/line capacity, effective operation rate, etc.)
- main quality control points and control measures (separate descriptions of the production process, work-in-process, and products)
- product quality testing (including testing parameters, testing systems, etc.)
- production process and relevant standards
- power of attorney (when applicable)
- other material, including:
- documentation for trademark registration in China
- for the production of e-liquids: license for operating dangerous chemicals, material explaining the sources of “e-cigarette use nicotine” used in the past three years, including the total amount of e-cigarette use nicotine purchased (kg), the purchase batch, the name of the supplier, purchase time, purchase quantity (kg), source information (importing country/domestic production), purity information (mass fraction percentage)
- applicants for export must submit material explaining the export business and the scale of export, including the customs declaration forms for the past three years
Manufacturers that have registered with STMA before November 10, 2021, and have completed e-cigarette manufacturer information reporting in December 2021 must apply before September 30, 2022. Other applicants can apply only after September 30, 2022.
Review of the manufacturer license application is 20 working days, which can be extended by 10 working days. However, the time for any additional hearings or testing that may be needed is not included within the time limit.