According to the "Regulations on the Administration of E-cigarettes" (Announcement No. 1 of 2022 by the State Tobacco Monopoly Administration), the State Tobacco Monopoly Administration has revised the "Implementation Rules for the Technical Review of E-cigarette Products" issued on April 15, 2022, in light of the current status of e-cigarette product technology evaluation. The "Draft for Soliciting Comments on the Implementation Rules for the Technical Review of E-cigarette Products" and the revision explanations are now made public for the solicitation of public opinions.
Organizations or individuals can submit comments from April 26 to May 9, 2024 by sending an email to wangyuning@tobacco.gov.cn. Please indicate "Public Consultation on the Implementation Rules for the Technical Review of e-cigarette Products" in the email subject line.
Revised Explanation of the Draft Implementation Rules for the Technical Review of E-cigarette Products
In order to further implement the "Management Measures for e-cigarettes" (Notice No. 1 of 2022 by the State Tobacco Monopoly Administration) and regulate the technical evaluation and management of e-cigarette products, the State Tobacco Monopoly Administration has revised and improved the "Implementation Rules for the Technical Evaluation of e-cigarette Products" based on the current situation of technical evaluation and management of e-cigarette products, forming the "Draft Implementation Rules for the Technical Evaluation of e-cigarette Products (for soliciting opinions)". The relevant situation is explained as follows:
1. Revision Background
In order to standardize the technical evaluation of e-cigarette products, on April 15, 2022, the State Tobacco Monopoly Administration released the "Implementation Rules for the Technical Evaluation of E-cigarette Products" in the form of a supporting document to the "Regulations on the Management of E-cigarettes". The "Rules" stipulate the principles, content, process, and requirements of the technical evaluation work. The "Rules" have played a good guiding role in the technical evaluation of e-cigarette products, and can adapt well to the needs of the evaluation work, ensuring that the technical evaluation work is carried out in an orderly manner. As the technical evaluation work continues to deepen, some content in the current "Rules" does not fully align with the actual work. In light of this, the State Tobacco Monopoly Administration has been continuously refining and improving the content of the "Rules" based on the latest e-cigarette technical evaluation situation, forming the "Draft for the Implementation Rules for the Technical Evaluation of E-cigarette Products (Consultation Draft)".
2. Main Content
The "draft for soliciting opinions" is divided into four chapters with a total of 25 articles. The main revisions in this update compared to the previous regulations include:
- According to the scope of application of e-cigarette product technical reviews, the relevant provisions for exporting e-cigarette products have been removed based on the needs of the technical review work.
- The requirements for applicants to submit materials and their integrity obligations have been refined to make them more clear and comprehensive. For example, Article 7 states that applicants must commit to the legality, truthfulness, completeness, and traceability of the materials they submit.
- New management requirements have been added, such as adding Article 21, paragraph 5, which states that if a company is under investigation for suspected illegal operation of e-cigarette-related businesses by the tobacco monopoly administrative authority or other national agencies, and the case has not been closed, the tobacco monopoly administrative authority will not accept the technical review application submitted by that applicant.
Draft Regulations on the Technical Review of E-cigarette Products (Soliciting Opinions)
Chapter 1: Introduction
The first article is to standardize the technical review and management of e-cigarette products, protect the rights and interests of consumers, and according to the "People's Republic of China Tobacco Monopoly Law," "Implementation Regulations of the People's Republic of China Tobacco Monopoly Law," and the "Regulations on the Management of E-cigarettes" (State Tobacco Monopoly Administration Announcement No. 1 of 2022) and other laws, regulations, and normative documents, this detailed rules are formulated.
The second regulation states that e-cigarette products sold within the territory of the People's Republic of China must undergo technical evaluation. E-cigarette products that have not passed the technical evaluation are prohibited from being marketed and sold.
Article 3: The e-cigarette products referred to in these regulations include pods, vaporizers, disposable e-cigarettes, and e-cigarette products sold in a single packaging unit according to relevant national standards.
Article 4: The administrative department for the state tobacco monopoly under the State Council is responsible for the development, publication, and adjustment of the technical evaluation management system, as well as the supervision and management of the implementation of technical evaluations.
The provincial tobacco monopoly administrative supervisory department is responsible for accepting applications for technical evaluation of e-cigarette products within its jurisdiction, as well as overseeing the implementation of technical evaluations.
The technical review work is carried out by the administrative authority of the State Council for the tobacco monopoly, which organizes specialized institutions (referred to as technical review agencies) to implement it.
Chapter 2: Application
Article 5 Applicants for e-cigarette product technology review (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 e-cigarette product technology review management system (hereinafter referred to as the management system).
Article 6 Applicants must meet the following conditions:
- Possessing corporate legal status.
- As the trademark holder for the applied e-cigarette product.
- In line with national policies for the e-cigarette industry.
- Other conditions specified by the State Council's tobacco monopoly administrative department.
If the trademark holder is a foreign enterprise, they should appoint an agency or agent established in China to apply to the local provincial tobacco monopoly administration department.
For overseas brand holding companies applying, they must meet the conditions stated in the first, third, and fourth paragraphs above.
Article 7 The applicant shall commit to the legality, truthfulness, completeness, and traceability of the materials submitted.
Article 8 E-cigarette products applying for technical evaluation must meet the following conditions:
- In compliance with mandatory national standards for e-cigarettes.
- Using trademarks registered and approved in China.
- Comply with regulations regarding e-cigarette product packaging labeling and warning messages.
- Other conditions stipulated by the administrative authority in charge of tobacco monopoly under the State Council.
E-cigarette products sold within a packaging unit should contain pods and smoking utensils that are all products that have passed technical reviews.
Article 9 For the application of electronic cigarette product technical review, the following materials shall be submitted:
(1) Basic information of the product;
(2) Trademark registration certificate of the product;
(3) Packaging and exterior design drawings of the product;
(4) Sample draft of the product manual;
(5) Product description report;
(6) Product formula and raw material report;
(7) Key production process descriptions related to safety;
(8) Product inspection and testing reports and other necessary inspection and testing reports;
(9) Product safety assessment or justification report;
(10) Commitment letter from the applicant regarding the authenticity of the application materials;
(11) Samples of the product;
(12) Other relevant materials.
For electronic cigarette products sold in one packaging unit, only the materials specified in items (1) to (4) and (11) of the preceding paragraph shall be submitted.
In addition to the materials specified in the preceding paragraph, imported electronic cigarette products shall also provide proof of authorization for production or sale in the country (region) of origin.
Article 10 The provincial tobacco monopoly administrative department shall organize and complete the review of the completeness and standardization of the materials submitted online within 8 working days from the date of receipt of the application. If the conditions are met, a notice shall be issued for mailing the paper materials and samples.
Article 11 After receiving the mailing notice, the applicant shall submit technical evaluation paper materials and 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:
(1) Completeness and rationality of product description, formula, and raw material reports;
(2) Validity and applicability of relevant inspection and testing reports;
(3) Scientific, reliable, and sufficient safety assessment and justification of the product;
(4) Rationality, feasibility, and controllability of product quality and safety assurance;
(5) Compliance of product flavor;
(6) Other contents requiring technical review.
Article 14 The technical review organization shall establish a pool of experts composed of professionals in relevant fields.
Article 15 The technical review organization shall be responsible for formal examination of the application materials, conduct preliminary review after qualification, propose review opinions, and select personnel from the pool of experts to form a review expert group to make technical review conclusions in the form of meetings according to the needs of the review work.
Article 16 The technical review organization shall complete the technical review within 60 working days after the formal examination is qualified.
Article 17 During the technical review process, the technical review organization may conduct relevant re-examination, on-site inspections, or request the applicant to further supplement relevant evidence materials as needed.
The time required for re-examination, on-site inspections, and supplementary evidence materials shall not be counted in the review time limit.
Article 18 The State Council's tobacco monopoly administrative department shall include products that have passed the technical review in the trading management platform and implement dynamic management.
Article 19 If there are changes in the registration information of an enterprise, or if the legal subject of the enterprise changes due to statutory reasons, the enterprise shall apply for changes to the original acceptance department in a timely manner.
If there are changes in the product design (including appearance, structure, formula, raw materials, etc.), re-application for technical review is required.
Article 20 The electronic cigarette products listed for sale shall be consistent with the information of the products that have passed the technical review.
Article 21 The tobacco monopoly administrative department shall not accept the technical review application submitted by an applicant in the following situations:
(1) The business license has been revoked by the market supervision and management department, or the enterprise's business subject has been terminated in accordance with the law;
(2) The qualification for the production and operation of electronic cigarettes for domestic sales has been cancelled or suspended by the tobacco monopoly administrative department;
(3) Entrusting enterprises without a tobacco monopoly production enterprise license to produce;
(4) Submitting false materials during the application process, or passing the technical review by improper means;
(5) Under investigation for suspected illegal operation of electronic cigarette-related businesses or other reasons by the tobacco monopoly administrative department or other state organs, and the case has not yet been closed;
(6) Other circumstances in violation of laws, regulations, and rules.
Chapter IV Supplementary Provisions
Article 22 The staff of the tobacco monopoly administrative department and the technical review organization shall be punished according to law for acts of dereliction of duty, abuse of power, and favoritism in the technical review and management process; if suspected of committing a crime, they shall be transferred to relevant departments for handling according to law.
Article 23 Without the consent of the applicant, the staff of the tobacco monopoly administrative department and the technical review organization shall not disclose the business secrets, undisclosed information, or confidential commercial information submitted by the applicant, except as otherwise provided by law or involving national security and major public interests.
Article 24 These detailed rules shall be interpreted by the State Council's tobacco monopoly administrative department.
Article 25 These detailed rules shall come into force on ××, ××, 2024. The "Implementation Rules for Technical Review of Electronic Cigarette Products" promulgated on April 15, 2022, shall be simultaneously repealed.
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