China Tobacco Administrator's Notice on E-Cig Quality Assurance Systems
Disclaimer: This notice is translated from the Notice issued by the China State Tobacco Monopoly Administration (STMA) on July 20, 2023. The translation is provided for reference only. The Chinese original text is the only authoritative source of information.
To promote the governance, rule of law, and standardization of the electronic cigarette industry, and effectively prevent the risks associated with the export of electronic cigarettes, the "Guidelines for Promoting the Building of Quality Assurance Systems for Exported Electronic Cigarette Products" (hereinafter referred to as the "Guidelines") has been formulated in accordance with the "Tobacco Monopoly Law of the People's Republic of China," the "Implementation Regulations of the Tobacco Monopoly Law of the People's Republic of China," and the "Administrative Measures for Electronic Cigarettes" and other laws, regulations, rules, and normative documents.
The "Guidelines" consist of eighteen articles, with the main content as follows:
- Clarify that enterprises are the main responsible entities for the building of quality assurance management systems for exported electronic cigarette products.
- Specify the main content for the building of quality assurance management systems for exported electronic cigarette products, including quality and safety standards, streamlining production processes, allocation of production resources, the establishment of sound systems, standardization of product packaging, traceability of logistics and transportation, and export declaration and registration requirements.
- Specify the requirements for the building of quality assurance management systems for exported electronic cigarette products.
The Document is as follows:
State Tobacco Administration Document  No. 112
To all provincial-level tobacco monopoly bureaus:
The "Guidelines for Promoting the Building of Quality Assurance Systems for Exported Electronic Cigarette Products" is hereby issued to you for careful implementation.
Office of the State Tobacco Monopoly Administration
July 18, 2023
Guidelines for Promoting the Building of Quality Assurance Systems for Exported Electronic Cigarette Products
Article 1: In order to promote the development of the electronic cigarette industry in a lawful and standardized manner, effectively prevent the risks associated with the export of electronic cigarettes, and encourage electronic cigarette-related enterprises (hereinafter referred to as "enterprises") to actively establish quality assurance systems for exported electronic cigarette products, these guidelines are formulated in accordance with the "Tobacco Monopoly Law of the People's Republic of China," the "Implementation Regulations of the Tobacco Monopoly Law of the People's Republic of China," and the "Administrative Measures for Electronic Cigarettes" (Announcement No. 1 of the State Tobacco Administration in 2022) and other laws, regulations, rules, and normative documents.
Article 2: The building of quality assurance systems for exported electronic cigarette products should be guided by Xi Jinping's Thought on Socialism with Chinese Characteristics for a New Era, adhere to the principles of prioritizing safety, prevention as the primary approach, risk control, and comprehensive control throughout the process. Based on the actual situation of the enterprises, actively align with international advanced technology, rules, and standards, focus on improving product quality, and ensure the safety of products, thereby raising the overall quality and safety level of exported electronic cigarette products.
Article 3: Enterprises are fully responsible for the quality and safety of their exported electronic cigarette products, and they shall conduct their production and business activities in accordance with laws and regulations, subject to supervision and management.
Article 4: Enterprises shall ensure that their export products comply with the legal requirements and standards of the destination country (region). If there are no relevant legal requirements and standards in the destination country (region), they shall comply with the relevant legal requirements and standards of China.
Article 5: Enterprises shall establish a comprehensive quality assurance management system that covers all elements, processes, and data, ensure the effective operation of the system, and ensure that the procurement of raw materials, production processes, storage, transportation, and other aspects of exported electronic cigarettes continuously comply with relevant laws, regulations, and quality safety requirements. Enterprises that meet the conditions are encouraged to participate in relevant quality system qualifications certification.
Article 6: Enterprises should define quality and safety standards for exported electronic cigarette products, develop testing procedures for raw materials, semi-finished products, and finished products, implement quality and safety testing, and generate testing reports or certificates.
Article 7: Enterprises should systematically streamline production processes to ensure the sustainable and stable production of products that meet the quality and safety standards defined by the enterprises. They should enhance business operation training to ensure that employees can follow the processes correctly.
Article 8: Enterprises should ensure that the production resources they produce or entrust for processing meet the relevant requirements, including:
- Personnel with appropriate qualifications who have received training.
- Safe workshops and spaces.
- Appropriate equipment and maintenance support.
- Qualified raw materials and packaging materials.
- Qualified storage and transportation conditions.
- Other necessary production resources.
Article 9: Enterprises should establish supplier evaluation systems, incoming inspection record systems, production record file systems, factory inspection record systems, entrusted processing product inspection record systems, product traceability systems, and non-conforming product disposal systems. The relevant records should be authentic and effective, and the retention period should not be less than 6 months after the expiration of the product shelf life.
Article 10: The boxes and packaging of exported electronic cigarette products should be labeled with the tobacco monopoly production enterprise license number, product name, production batch number, and production date. In the case of exported electronic cigarette products that are entrusted for processing, the boxes and packaging should also be labeled with the tobacco monopoly production enterprise license number of the entrusted electronic cigarette production enterprise.
Article 11: The domestic and international logistics transportation of exported electronic cigarette products should comply with relevant safety requirements to ensure full traceability throughout the process.
Article 12: When exporting electronic cigarette products, enterprises shall truthfully declare to the customs in accordance with the law and shall record relevant information in the national unified electronic cigarette trading management platform within 30 days after the export declaration.
Article 13: If there are quality and safety issues with exported electronic cigarette products that have caused or may cause harm to human health, the enterprise shall immediately cease the production of related products, take corresponding measures to prevent and reduce harm, and report to the local tobacco monopoly bureau.
Article 14: If the quality and safety issues of exported electronic cigarette products are reported by international organizations or foreign government agencies, the enterprise shall immediately report to the local tobacco monopoly bureau, and the relevant enterprise shall accept the verification and handling conducted by the tobacco monopoly bureau in accordance with the law.
Article 15: The State Tobacco Monopoly Administration will establish a quality traceability system for exported electronic cigarette products, improve the credit supervision of enterprise quality and safety, and realize the informatization, networking, and intelligence of the quality and safety supervision of exported electronic cigarette products. Provincial-level tobacco monopoly bureaus should strengthen joint supervision in collaboration with customs, market supervision, taxation, and other departments.
Article 16: Exported electronic cigarette products refer to electronic cigarette products produced by enterprises that are not sold within China and are solely for export. The building of quality assurance systems for the nicotine and aerosol quality of exported electronic cigarettes shall refer to these guidelines.
Article 17: These guidelines are interpreted by the State Tobacco Monopoly Administration.
Article 18: These guidelines shall be implemented from the date of issuance.
Original public release:
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