The National Tobacco Monopoly Administration plans to amend certain regulatory policy documents for electronic cigarettes

The National Tobacco Monopoly Administration is publicly soliciting opinions on the "Notice on Modifying Certain E-Cigarette Regulatory Policy Documents (Draft for Comments)." Notice on Modifying Certain E-Cigarette Regulatory Policy Documents (Draft for Comments) In order to implement the restrictive industrial policy requirements for e-cigarettes and enhance the systematic, holistic, and coordinated nature of the e-cigarette regulatory policy system, the National Tobacco Monopoly Administration has decided to modify certain provisions of seven e-cigarette regulatory policy documents. The relevant matters are notified as follows. Modifications to the "Several Policy Measures for Promoting the Legal and Standardized Development of the E-Cigarette Industry (Trial)" (Guo Yan Ban [2022] No. 43) (1) The first article is modified to read: "The e-cigarette industry is legally included in regulation, with a scientifically reasonable industrial layout, stable and orderly market operation, more efficient resource allocation, achieving total management under dynamic balance of supply and demand, implementing national tobacco control requirements, effectively ensuring public health and safety, and guiding the development of the e-cigarette industry onto a legal and standardized track." (2) The eleventh article is modified to read: "To achieve a balance of supply and demand in the e-cigarette market, total management of e-cigarette related production enterprises will be conducted, with production capacity and scale determined in accordance with laws and regulations. The State Council's tobacco monopoly administrative department will comprehensively consider factors such as tobacco control, determined production capacity, market demand, enterprise orders, and legal compliance, categorizing and determining the annual production scale, which will serve as the upper limit for the corresponding product category's production and transaction volume for the natural year. Provincial tobacco monopoly administrative departments will organize e-cigarette wholesale enterprises within their administrative regions to carry out business activities within the annual sales target for the province (region, city)." (3) The first paragraph of the fourteenth article is modified to read: "In consideration of domestic sales and export needs, the annual production and sales scale of domestic e-cigarette nicotine will be determined scientifically and reasonably. The State Council's tobacco monopoly administrative department will calculate the annual usage based on determined production capacity and scale, coordinating the yield rates of raw materials such as tobacco leaves (including reconstituted tobacco leaves and tobacco stems), re-dried tobacco leaves, and tobacco cuttings (including dust and granules), and will issue purchase and sales plans for tobacco monopoly products such as tobacco leaves (including reconstituted tobacco leaves and tobacco stems), re-dried tobacco leaves, and tobacco cuttings (including dust and granules)." Modifications to the "Fixed Asset Investment Management Rules for E-Cigarettes" (Guo Yan Fa [2024] No. 104) (1) The fourth article, first paragraph, fourth item is modified to read: "(4) Fixed asset investment behaviors such as on-site technological transformation (including the purchase of production equipment), capacity integration and restructuring, relocation, and restoration of construction implemented by licensed production enterprises;" (2) The sixth article is modified to read: "In the circumstances described in the fourth article, first paragraph, fourth item of these rules, if no new production capacity for e-cigarette products and raw materials is added, e-cigarette enterprises shall, prior to the occurrence of the investment behavior, refer to the application report requirements in the seventh article and the capacity report requirements in the eighteenth article of these rules, and submit the production and operation situation, production equipment and capacity utilization, main content and investment amount of the proposed investment project, and a commitment letter not to expand capacity, through the local tobacco monopoly administrative department, step by step to the State Council's tobacco monopoly administrative department for record. The project implementation process will be supervised by the local tobacco monopoly administrative department, and after the project is completed, the project construction situation will be reported step by step to the State Council's tobacco monopoly administrative department through the local tobacco monopoly administrative department." (3) Modify the second item of the second paragraph of Article 7 to read: “(2) Basic information about the proposed investment project, including project location, project content, newly formed production capacity, total investment scale, etc.” (4) Modify the second item of the fourth item of the second paragraph of Article 7 to read: “2. The actual production and sales volume of the enterprise in the past 36 months, along with relevant supporting materials. Among them, export sales should provide transaction contracts and customs declaration documents;” and modify the third item to read: “3. Opinions issued by the provincial tobacco monopoly administrative authority regarding the enterprise's compliance with tobacco monopoly management laws and regulations and the review opinions on the project application report.” (5) Modify the third item of Article 10 to read: “(3) The actual production volume of the electronic cigarette enterprise in the past 12 months has not reached 85% of the production capacity reported to the State Council's tobacco monopoly administrative authority in the most recent report, and the actual production volume in the past 36 months has not reached 85% of the production capacity approved by the State Council's tobacco monopoly administrative authority.” III. Amend the "Implementation Rules for Technical Review of Electronic Cigarette Products" (Guo Yan Fa [2024] No. 120) (1) Add an item as the third item of the first paragraph of Article 6: “(3) Enterprises holding domestic sales brands that have legally obtained electronic cigarette production enterprise licenses;” (2) Modify the fourth item of the first paragraph of Article 6 to read: “(4) Comply with national electronic cigarette industry policy requirements and management regulations regarding production capacity and production scale;” (3) Modify the third paragraph of Article 6 to read: “For applications submitted by foreign brand-holding enterprises, the conditions of the first, fourth, and sixth items of the previous paragraph must be met.” (4) Modify the third item of the first paragraph of Article 8 to read: “(3) Comply with relevant regulations on the naming, packaging labeling, and warnings of electronic cigarette products;” (5) Modify the third item of Article 21 to read: “(3) Delegating major production processes to enterprises that have not obtained tobacco monopoly production enterprise licenses or engaging in production or commissioned production business that does not comply with approved production capacity and approved production scale;” (6) Add an item as the fifth item of Article 21: “(5) Violating the naming regulations for electronic cigarette products;” IV. Amend the "Traceability Management Rules for Electronic Cigarette Products" (Guo Yan Ban [2022] No. 43) (1) Modify Article 9 to read: “Electronic cigarette production enterprises (including product production, processing, brand-holding enterprises, etc., hereinafter the same) and electronic cigarette wholesale enterprises should use the electronic cigarette traceability platform to apply for, upload, query, and scrap electronic cigarette product QR codes.” (2) Modify Article 14 to read: “Electronic cigarette production enterprises and electronic cigarette wholesale enterprises should establish and improve supporting systems and necessary facilities for implementing traceability management, and apply for and use electronic cigarette product QR codes within the scope approved by the State Council's tobacco monopoly administrative authority, approved production capacity (excluding brand-holding enterprises), and approved production scale.” (3) Modify the first paragraph of Article 15 to change “electronic cigarette production enterprises” to “electronic cigarette product production enterprises and brand-holding enterprises that have obtained domestic sales electronic cigarette license qualifications.” (4) Modify the third item of the first paragraph of Article 15 to read: “(3) Transaction contracts with electronic cigarette wholesale enterprises, and for commissioned production, also need transaction contracts with electronic cigarette processing enterprises.” (5) Article 17 is amended to read: "E-cigarette manufacturing enterprises shall label the QR code on the outer packaging of e-cigarette products in accordance with relevant requirements, and the information of the QR code shall be consistent with the actual information of the e-cigarette products. The QR codes unused by e-cigarette manufacturing enterprises in previous years shall be carried over for use in the current year. QR codes that are no longer used shall apply for scrapping, and the total number of QR codes used (including carried over) throughout the year shall not exceed the approved production capacity (excluding brand-holding enterprises) and the approved production scale." Amend the "Regulations on the Management of E-cigarette Import and Export Trade and Foreign Economic and Technological Cooperation" (Guo Yan Fa [2022] No. 125) (1) The first paragraph of Article 11 is amended to read: "E-cigarette manufacturing enterprises (including product manufacturing, processing, brand-holding enterprises, etc.), aerosol production enterprises, and nicotine production enterprises for e-cigarettes (hereinafter referred to as e-cigarette related production enterprises) shall produce and operate e-cigarette products and raw materials for export within the approved licensing scope, approved production capacity (excluding brand-holding enterprises), and approved export production scale." (2) The second paragraph of Article 11 is amended to read: "For overseas orders that exceed the approved export production scale, enterprises may organize relevant production and sales only after fulfilling the relevant procedures on the e-cigarette trading management platform and obtaining approval in accordance with the relevant regulations of the State Tobacco Monopoly Administration." Amend the "Regulations on the Establishment, Division, Merger, and Revocation Management of E-cigarette Related Production Enterprises" (Guo Yan Ban [2022] No. 104) (1) The second paragraph of Article 22 is amended to read: "After the division or merger of e-cigarette related production enterprises, they shall reapply for the tobacco monopoly production enterprise license. For fixed asset investments, approved production capacity, and approved production scale related to e-cigarettes, the relevant regulations of the State Council's tobacco monopoly administrative department shall apply." Amend the "Integrated Government Service Platform Electronic Certificate Tobacco Monopoly Production Enterprise License Part 2: E-cigarettes" (Guo Yan Ban Zong [2024] No. 25) (1) Change "production scale" in 5.1, 7.1.1, and 7.2 to "approved production capacity." (2) Amend 5.5.3 to read: "5.5.3 Approved Production Capacity "Chinese Name: Approved Production Capacity; "English Name: approved production capacity; "Short Name: HDCN; "Description: Information on the approved production capacity of enterprises holding the tobacco monopoly production enterprise license (e-cigarettes) for the annual production and operation of nicotine, aerosol, and e-cigarette products; "Value Type and Format: C..1000; "Value Range: Free text, approved and managed by the State Tobacco Monopoly Administration according to the total management requirements for the dynamic balance of supply and demand of e-cigarettes; "Constraint Conditions: Mandatory; "Value Example: Nicotine for e-cigarettes not exceeding 1.0 tons/year" In addition, make corresponding adjustments to the article numbers, punctuation marks, etc., in the relevant documents. This notice shall take effect from the date of issuance. "Several Policy Measures for Promoting the Legal and Standardized Development of the E-cigarette Industry (Trial)" "Regulations on Fixed Asset Investment Management of E-cigarettes" "Implementation Rules for Technical Review of E-cigarette Products" "Traceability Management Rules for E-cigarette Products" "Regulations on the Management of E-cigarette Import and Export Trade and Foreign Economic and Technological Cooperation" "Regulations on the Establishment, Division, Merger, and Revocation Management of E-cigarette Related Production Enterprises" "Integrated Government Service Platform Electronic Certificate Tobacco Monopoly Production Enterprise License Part 2: E-cigarettes" shall be amended accordingly in accordance with this notice, and the order of the articles shall be adjusted accordingly Reissued