Notice of the State Tobacco Monopoly Administration on the revision and issuance of the implementation rules for the technical review of electronic cigarette products and policy interpretation
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Notice of the State Tobacco Monopoly Administration on the revision and issuance of the implementation rules for the technical review of electronic cigarette products and policy interpretation
On August 20, the State Tobacco Monopoly Administration issued the "Revised Implementation Rules for Technical Review of Electronic Cigarette Products", aiming to further standardize the technical review management of electronic cigarette products and improve the level of supervision. The rules cover the scope of application, application conditions, review process, etc. of technical review to ensure the legality and safety of the electronic cigarette market.
[Two Supremes Reprinted from the State Tobacco Monopoly Administration] On August 20, the official website of the State Tobacco Monopoly Administration issued a notice on the "Revised and Issued Implementation Rules for Technical Review of Electronic Cigarette Products" and the implementation rules.
The following is the original content:
Policy Interpretation of the "Implementation Rules for Technical Review of Electronic Cigarette Products"
In order to further standardize the technical review management of electronic cigarette products and improve the level of electronic cigarette supervision, the State Tobacco Monopoly Administration revised and issued the "Implementation Rules for Technical Review of Electronic Cigarette Products".
This revision has strengthened the coordination and connection with relevant laws and regulations, and optimized and improved the relevant requirements for the technical review of electronic cigarette products. The revised "Implementation Rules for Technical Review of Electronic Cigarette Products" mainly includes general provisions, application, technical review and annexes, a total of four chapters and 26 articles. The main contents are: First, the scope of application of technical review and the management functions of each management subject are clarified; second, the basic conditions for technical review application are clarified, including the conditions of the applicant, the conditions for applying for e-cigarette products, and the materials required for the application; third, the main process, working methods and related requirements of technical review are clarified.
Notice of the State Tobacco Monopoly Administration on the revision and issuance of the implementation rules for the technical review of e-cigarette products
National Tobacco Law [2024] No. 120
All provincial tobacco monopoly bureaus, Zhengzhou Tobacco Research Institute of China National Tobacco Corporation, Shanghai New Tobacco Products Research Institute Co., Ltd., and all relevant units:
In order to further implement the "E-cigarette Management Measures" (Announcement No. 1 of the State Tobacco Monopoly Administration in 2022) and standardize the technical review of e-cigarette products, the revised "E-cigarette Product Technical Review Implementation Rules" are now issued to you, please follow them carefully.
... Article 3 The electronic cigarette products referred to in these rules include cigarette cartridges, cigarette utensils, disposable electronic cigarettes, and electronic cigarette products sold in a packaging unit in accordance with relevant national standards.
Article 4 The tobacco monopoly administrative department of the State Council is responsible for the formulation, release, and adjustment of the technical review management system, as well as the supervision and management of the implementation of technical review.
The provincial tobacco monopoly administrative department is responsible for the acceptance of applications for technical review of electronic cigarette products within its administrative area, as well as the supervision and management of the implementation of technical review.
The technical review work shall be implemented by professional institutions organized by the tobacco monopoly administrative department of the State Council (hereinafter referred to as technical review institutions).
Chapter II Application
Article 5 The applicant for technical review of electronic cigarette products (hereinafter referred to as the applicant) shall submit a technical review application to the provincial tobacco monopoly administrative department where the enterprise is located through the electronic cigarette product technical review management system (hereinafter referred to as the management system).
Article 6 The applicant shall meet the following conditions:
(1) Have corporate legal person status;
(2) Be the trademark owner of the electronic cigarette product applied for;
(3) Comply with the requirements of the national electronic cigarette industry policy;
(4) The existing marketable specifications and quantities should meet the relevant requirements of the national unified electronic cigarette transaction management platform;
(5) Other conditions stipulated by the tobacco monopoly administrative department of the State Council.
If the trademark owner is a foreign enterprise, it shall entrust its institution or agent established in the country to apply to the provincial tobacco monopoly administrative department of the jurisdiction.
If the application is handled for a foreign brand holding enterprise, it shall meet the conditions of the first, third and fifth items of the preceding paragraph.
Article 7 The applicant shall make a commitment to the legality, authenticity, completeness and traceability of the submitted materials.
Article 8 Electronic cigarette products applying for technical review shall meet the following conditions:
(i) Comply with the mandatory national standard of "Electronic Cigarettes";
(ii) Use a trademark approved and registered in China;
(iii) Comply with the relevant provisions on the packaging and warnings of electronic cigarette products;
(iv) Other conditions stipulated by the tobacco monopoly administrative department of the State Council.
Electronic cigarette products sold in a packaging unit, the cigarette cartridges and cigarette devices contained therein and their matching combinations shall all be products that have passed the technical review.
Article 9 To apply for technical review of electronic cigarette products, the following materials shall be submitted:
(i) Basic information of the product;
(ii) Trademark registration certificate of the product;
(iii) Product packaging and appearance design drawings;
(iv) Draft of product manual;
(v) Product description report;
(vi) Product formula and raw material report;
(vii) Key production process description related to safety;
(viii) Product inspection and testing report and other necessary inspection and testing reports;
(ix) Product safety assessment or demonstration report;
(x) Letter of commitment of the applicant that the application materials are responsible for the authenticity of the application materials;
(xi) Application for physical samples;
(xii) Other relevant materials.
For electronic cigarette products sold in one packaging unit, only the materials (i) to (iv) and (xi) specified in the preceding paragraph need to be submitted.
In addition to the materials specified in the preceding paragraph, imported electronic cigarette products shall also provide certification materials for the country (region) where they are located to obtain approval for production or sales.
Article 10 The provincial tobacco monopoly administrative department shall organize and complete the review of the completeness and standardization of the online submitted materials within 8 working days after receiving the application. If the conditions are met, a notice of mailing paper materials and physical samples shall be issued.
Article 11 After receiving the mailing notice, the applicant shall submit the technical review paper materials and physical samples consistent with the application materials to the provincial tobacco monopoly administrative department by mail.
Chapter III Technical Review
Article 12 The technical review work shall adhere to the principles of science, fairness and efficiency.
Article 13 The technical review mainly includes the following aspects:
(I) The completeness and rationality of product description, formula and raw material report;
(II) The validity and applicability of relevant inspection and testing reports;
(III) The scientificity, reliability and sufficiency of product safety assessment and demonstration;
(IV) The rationality, feasibility and controllability of product quality and safety assurance;
(V) The conformity of product flavor;
(VI) Other contents that require technical review.
Article 14 The technical review institution shall establish an expert database composed of experts in relevant professional fields.
Article 15 The technical review institution shall be responsible for conducting a formal review of the application materials, and after passing the preliminary review, it shall put forward review opinions. According to the needs of the review work, it shall select personnel from the expert database to form a review expert group, and make technical review conclusions in the form of a meeting.
Article 16 The technical review institution shall complete the technical review within 60 working days after the formal review is passed.
Article 17 During the technical review process, the technical review institution may carry out relevant review inspections, on-site inspections, or require the applicant to further supplement relevant evidence materials according to actual needs.
The time required for review inspections, on-site inspections, and supplementary evidence materials shall not be counted within the review time limit.
Article 18 The tobacco monopoly administrative department of the State Council shall include products that have passed the technical review into the transaction management platform and implement dynamic management.
Article 19 If the registration information of an enterprise changes, or the main body of the enterprise changes due to legal reasons, it shall promptly apply to the original acceptance department for change.
If the product design (including appearance, structure, formula, raw materials, etc.) changes, it is necessary to reapply for technical review.
Article 20 The information of the electronic cigarette products sold on the market shall be consistent with that of the products that have passed the technical review.
Article 21 In the following circumstances, the tobacco monopoly administrative department shall not accept the technical review application submitted by the applicant:
(a) The business license is revoked by the market supervision and management department, or the business entity of the enterprise is terminated according to law;
(b) The qualification of domestic sales production and operation of electronic cigarettes is cancelled or suspended by the tobacco monopoly administrative department;
(c) The production is entrusted to an enterprise that has not obtained the tobacco monopoly production enterprise license;
(d) False information is submitted when applying, or the technical review is passed by improper means;
(e) The tobacco monopoly administrative department or other state organs have filed a case for investigation and the case has not been closed for suspected illegal operation of electronic cigarette related businesses;
(f) Other circumstances that violate laws, regulations and rules.
Chapter IV Supplementary Provisions
Article 22 Electronic cigarette related manufacturers shall establish a sound quality and safety assurance system for exported electronic cigarette products and ensure that it operates effectively.
Article 23 Where the staff of the tobacco monopoly administrative department and the technical review agency neglect their duties, abuse their power, or engage in favoritism and fraud during the technical review and management process, they shall be punished according to law; if they are suspected of committing a crime, they shall be transferred to the relevant departments for handling according to law.
Article 24 Without the consent of the applicant, the staff of the tobacco monopoly administrative department and the technical review agency shall not disclose the commercial secrets, undisclosed information or sensitive business information submitted by the applicant, except where otherwise provided by law or involving national security or major social public interests.
Article 25 The State Council tobacco monopoly administrative department shall be responsible for interpreting these rules.
Article 26 These rules shall come into force on the date of publication. The "Implementation Rules for Technical Review of Electronic Cigarette Products" in the document "Notice of the State Tobacco Monopoly Administration on Issuing Four Documents, including Several Policy Measures (Trial) to Promote the Legalization and Standardization of the Electronic Cigarette Industry" (Guoyanban [2022] No. 43) issued on April 15, 2022 is hereby repealed at the same time.
