On December 2, the heaviest news in the e-cigarette industry was finally announced today, that is, the specific regulatory rules for e-cigarettes were officially released today.
In order to do a good job in the supervision of e-cigarettes and standardize the order of the e-cigarette market, the State Tobacco Monopoly Administration today publicly solicited opinions on the measures for the administration of e-cigarettes (Draft for comments).
With the release of the draft management measures, the detailed supervision of e-cigarettes has basically settled. Combined with the intensive policy release in recent days, let’s talk about the overall view of blue hole.
1. The nicotine content is limited to 20mg / g, which basically refers to the EU standards.
2. Fruit flavors are restricted rather than prohibited, and juvenile induced flavors are restricted, basically referring to the FDA standards.
3. Open e-cigarettes are banned and synthetic nicotine is banned.
4. The overall supervision can be summarized as consistent with the cigarette. All links need permission and approval, and unified centralized purchase platform sales is adopted.
5. The existing e-cigarette pattern will be completely broken, and the new era will enter the e-cigarette monopoly era.
6. In addition to complying with the general application regulations, the application for tobacco retail license by e-cigarette stores will be approved by regions according to the quantity.
7. At present, the national, provincial and municipal representatives of e-cigarettes will face a reshuffle. Wholesale enterprises still need to apply for wholesale licenses. At present, the conditions are unknown.
8. The end of small electronic cigarette factories in Shenzhen will benefit large factories and product quality. E-cigarettes have entered the era of scarcity.
9. The end of wechat business, collusion, disorderly price, fake goods and other modes will be illegal and conducive to the stability of the quality of circulating products.
10. E-cigarette finally came to the day when the supervision was settled. Practitioners shuffled and the industrial chain shuffled. Those who should give up decisively will leave.
The first season officially ended and a new era of e-cigarettes began.
The new regulation is conducive to the product quality circulating in the market, the sales stores are orderly and controllable, and the miasma mode is ended. On the whole, it is a major good for the industry. For specific players, the competition will start again.
New players will compete more for compliance.
The following are the full text and important interpretation notes, which only represent the views of blue hole and do not represent the views of other parties. Please forgive me if there is any misunderstanding.
The decision of the State Council on Amending the regulations for the implementation of the tobacco monopoly law of the people’s Republic of China (Guo Ling No. 750) was promulgated and implemented on November 10, 2021. In accordance with the newly revised regulations for the implementation of the tobacco monopoly law of the people’s Republic of China, the state tobacco monopoly administration has studied and drafted the measures for the administration of e-cigarettes (Draft for comments) in order to do a good job in the supervision of e-cigarettes, perform supervision duties according to law, standardize the order of e-cigarette market, ensure people’s health and safety, and promote the legalization and standardization of industrial governance, We are now seeking public opinions. Please give feedback before December 17, 2021.
Contact: Department of policies, regulations and system reform of the State Tobacco Monopoly Administration
Fax No.: 010-63606228
mail box: [email protected]
Mailing address: Department of policies, regulations and system reform, state tobacco monopoly administration, No. 55, Yuetan South Street, Xicheng District, Beijing (zip code: 100045). Please indicate “measures for the administration of electronic cigarettes for comments” on the envelope.
Interpretation: the consultation is only 15 days, which means that the regulatory rules on e-cigarettes will be fully sorted out in 2021.
Attachment: Measures for the administration of electronic cigarettes (Draft for comments)
Chapter I General Provisions
Article 1 These measures are formulated in accordance with the tobacco monopoly law of the people’s Republic of China, the law of the people’s Republic of China on the protection of minors, the regulations for the implementation of the tobacco monopoly law of the people’s Republic of China and other laws and regulations in order to strengthen the Administration of e-cigarettes and standardize the order of the e-cigarette market.
Article 2 the term “electronic cigarette” as mentioned in these Measures refers to an electronic transmission product that produces an aerosol containing nicotine (nicotine, the same below) for human suction. Electronic cigarettes include cigarette bombs, cigarette sets and products sold in combination with cigarette bombs and cigarette sets, excluding heated cigarettes that have been included in cigarette management.
Interpretation: all components are included here. The cigarette cartridge is an electronic cigarette, and the cigarette set is also an electronic cigarette, which are suitable for the management rules of electronic cigarette.
Products that do not contain nicotine or similar electronic cigarettes that are not used to transmit nicotine shall not be labeled as electronic cigarettes, and the package shall be clearly marked with “this product does not contain nicotine (nicotine)” or “this product is not used to transmit nicotine (nicotine)”.
Interpretation: nicotine products similar to 0 nicotine products or not from tobacco are not applicable to these management rules.
Article 3 These Measures shall apply to the production, operation, supervision and administration of e-cigarettes within the territory of the people’s Republic of China.
Article 4 the Department of tobacco monopoly administration under the State Council shall be in charge of the supervision and administration of e-cigarettes throughout the country and shall be responsible for formulating policies for the e-cigarette industry. The departments of tobacco monopoly administration of provinces, autonomous regions and municipalities directly under the central government shall be in charge of the supervision and administration of e-cigarettes within their respective administrative regions. For cities and counties with tobacco monopoly administrative departments, the municipal and County tobacco monopoly administrative departments shall be in charge of the supervision and administration of e-cigarettes in their respective administrative regions.
Interpretation: on the whole, the Tobacco Monopoly Bureau formulates the national management work, and the detailed management and supervision power is subdivided into provinces and urban areas, which is consistent with the management of cigarettes.
Article 5 electronic cigarette products shall meet the national standards for electronic cigarettes.
National standards for e-cigarette include specifications and technical requirements for e-cigarette, atomizer, e-cigarette liquid, e-cigarette set, e-cigarette component, cigarette cartridge, atomizer, atomizer additive, e-cigarette materials, e-cigarette release, release amount, etc.
Interpretation: the national standard has entered the comment period and will end on January 29. After the national standard is determined, there will be evidence for the quality of e-cigarettes.
Chapter II production management and quality safety
Article 6 a registration system shall be implemented for electronic cigarette products. Electronic cigarette products shall be registered with the Department of tobacco monopoly administration before they are listed and sold in China. Those who meet the conditions are allowed to register and be included in the catalogue of electronic cigarette products. Those who do not meet the conditions shall not be registered and the reasons shall be explained in writing.
Interpretation: This article shows that the listing and sales of e-cigarettes cannot be decided by e-cigarette enterprises themselves, and will be registered, which can be understood as filing.
When applying for the registration of electronic cigarette products, it shall ensure that the materials submitted are legal, true and complete.
Article 7 for electronic cigarette products that apply for registration, the Department of tobacco monopoly administration under the State Council shall organize professional institutions or relevant experts to examine their safety according to the inspection and testing reports and other application materials, and issue technical review conclusions.
Interpretation: the relevant product standards of the national standard of electronic cigarette will be used as an important basis.
Article 8 the electronic cigarette products on the market shall be consistent with the registered product information.
Article 9 the establishment of e-cigarette production enterprises, e-cigarette processing enterprises, e-cigarette brand holding enterprises and e-cigarette nicotine production enterprises must be approved by the Department of tobacco monopoly administration under the State Council, obtain the license of tobacco monopoly production enterprises, and be approved and registered by the Department of market supervision and administration. Where a license for a tobacco monopoly production enterprise is not obtained, the market supervision and administration department shall not approve the registration.
Interpretation: electronic cigarette manufacturers need double certification. The first is to obtain the production license of the tobacco department. The second is to obtain the approval of the market supervision bureau before production.
Article 10 to engage in the production of electronic cigarette products and nicotine for electronic cigarettes and obtain the license of tobacco monopoly production enterprise, the following conditions shall be met:
(1) Having funds suitable for the production of electronic cigarette products or nicotine for electronic cigarettes;
(2)Â Having fixed production and business premises, technology and equipment conditions required for the production of electronic cigarette products or nicotine for electronic cigarettes;
(3)Â Comply with the national e-cigarette industry policy requirements;
(4)Â Other conditions prescribed by the Department of tobacco monopoly administration under the State Council.
E-cigarette nicotine production enterprises also need to obtain the license of relevant national departments.
The applicant shall be responsible for the legality, authenticity and integrity of all the contents of his application materials.
Interpretation: the relevant provisions on nicotine extraction are also applicable to the license of tobacco monopoly production enterprises.
Article 11 in order to expand production capacity, e-cigarette production enterprises, e-cigarette processing enterprises and e-cigarette nicotine production enterprises must carry out capital construction or technological transformation with the approval of the competent department of tobacco monopoly administration under the State Council.
Interpretation: it is discussed one by one. As long as there is an update, it needs to be approved.
Article 12 Where an e-cigarette production enterprise, an e-cigarette processing enterprise, an e-cigarette brand holding enterprise or an e-cigarette nicotine production enterprise changes the scope of the license of a tobacco monopoly production enterprise, it shall apply to the original license issuing authority for change registration; Without approval, it is not allowed to engage in relevant production and business activities.
Interpretation: it is discussed one by one. As long as there is an update, it needs to be approved. It cannot be changed at will.
Article 13 tobacco monopoly commodities such as tobacco leaves (including reconstituted tobacco leaves and tobacco stems, the same below), redried tobacco leaves and cut tobacco used by e-cigarette production enterprises, e-cigarette processing enterprises and e-cigarette nicotine production enterprises shall be purchased from tobacco and grass enterprises with the right to operate tobacco leaves, redried tobacco leaves and cut tobacco, and shall not illegally purchase tobacco leaves, redried tobacco leaves Tobacco monopoly products such as cut tobacco and tobacco waste.
Interpretation: ensure that the nicotine used in e-cigarettes comes from enterprises with management rights, which is conducive to the control and traceability of nicotine.
Article 14 electronic cigarette products shall use registered trademarks.
The trademark logo of electronic cigarette products shall be printed by the enterprise designated by the provincial market supervision and administration department; Non designated enterprises shall not print trademarks of electronic cigarette products.
Interpretation: electronic cigarette products without trademarks cannot be listed, and need to be printed by enterprises designated by the provincial municipal supervision bureau, which will standardize the current brand chaos in the market.
Article 15 electronic cigarette products shall comply with the relevant provisions on packaging marks and warnings of electronic cigarette products.
Article 16 those engaged in the production of electronic cigarettes shall establish a product quality assurance system and be responsible for the quality and safety of the electronic cigarettes they produce or obtain registration.
Where the production of e-cigarette products is entrusted, the e-cigarette brand holding enterprise shall be responsible for the quality and safety of the e-cigarette products entrusted, and strengthen the management of the production behavior of the entrusted processing enterprise to ensure that it produces in accordance with the legal requirements.
Article 17 the Department of tobacco monopoly administration under the State Council shall establish a unified electronic cigarette product traceability system to strengthen the whole process management of electronic cigarettes.
Chapter III sales management
Article 18 an enterprise that has obtained a license for a tobacco monopoly wholesale enterprise shall be approved by the Department of tobacco monopoly administration under the State Council and may engage in the wholesale business of electronic cigarette products only after changing the scope of the license.
Interpretation: this will mainly have an impact on the current national representative, provincial representative and municipal representative. Wholesale can only be carried out with a wholesale license. The current brand agents need to re apply, but the specific conditions need to be more detailed. Moreover, wholesale licenses require higher-level approval.
Article 19 Those engaged in e-cigarette retail business shall apply to the Department of tobacco monopoly administration for a tobacco monopoly retail license or change the scope of the license according to law.
To engage in e-cigarette retail business with a tobacco monopoly retail license, the following conditions shall be met:
(1) Having funds suitable for the operation of e-cigarette retail business;
(2)Â Having a fixed business place independent of its domicile;
(3)Â Meet the requirements of reasonable layout of local e-cigarette retail outlets;
(4)Â Other conditions prescribed by the Department of tobacco monopoly administration under the State Council.
Interpretation: e-cigarette sales stores can apply for tobacco monopoly retail license or change the scope of license, but they can’t be obtained as long as they apply. We need to pay attention to the requirements for the reasonable layout of local e-cigarette retail outlets, that is, there will be no more 10 stores in a mall or more than 500 stores.
Article 20 the Department of tobacco monopoly administration under the State Council shall establish a national unified electronic cigarette trading management platform.
E-cigarette production enterprises, e-cigarette processing enterprises, e-cigarette brand holding enterprises, e-cigarette nicotine production enterprises, e-cigarette wholesale enterprises, e-cigarette retail enterprises and individuals that have obtained tobacco monopoly licenses according to law shall conduct transactions in the e-cigarette transaction management platform.
Interpretation: This is the Zhenguo generation, which can be equally understood as unified purchase and shipment. All goods in legal circulation must pass through this platform, and those not through this platform are illegal circulation. The phenomenon of random delivery of e-cigarette brands will not exist. 50000 e-cigarette products labeled by Shenzhen factory will not be directly delivered to consumers. Wechat will announce the end.
Article 21 e-cigarette production enterprises and e-cigarette brand holding enterprises that have obtained tobacco monopoly licenses according to law can only sell e-cigarette products to e-cigarette wholesale enterprises through the e-cigarette transaction management platform.
Interpretation: after the electronic cigarette brand produces goods, it shall be delivered to the transaction management platform first, and then purchased by the wholesale enterprise.
E-cigarette wholesale enterprises shall not provide e-cigarette products to units or individuals without the qualification to engage in e-cigarette retail business.
Enterprises or individuals that have obtained a tobacco monopoly and retail license and are qualified to engage in e-cigarette retail business shall purchase e-cigarette products in local e-cigarette wholesale enterprises.
Interpretation: shopkeepers should purchase goods from local wholesale enterprises, that is, these goods will not be directly related to the brand.
Article 22 before electronic cigarette products are sold on the unified electronic cigarette trading management platform, the tax base price shall be verified as required.
Interpretation: tax payment before sales is conducive to national profits and taxes.
Article 23 the supervision and administration of electronic cigarette advertising shall be governed by the provisions on tobacco advertising in relevant laws, regulations and rules.
Interpretation: this has an impact on the media and service chamber of Commerce. Advertising and display advertising are not allowed.
Article 24 no electronic cigarette product sales outlets shall be set up around ordinary primary and secondary schools, special education schools, secondary vocational schools, special schools and kindergartens. It is prohibited to sell electronic cigarette products to minors. E-cigarette operators shall set up signs in prominent places not to sell e-cigarettes to minors; If it is difficult to determine whether they are minors, they shall be required to produce their identity documents.
Article 25 it is prohibited to use vending machines to sell electronic cigarette products.
No individual, legal person or other organization shall sell e-cigarette products and nicotine for e-cigarette through the information network other than the e-cigarette transaction management platform specified in these measures.
Interpretation: the automatic cigarette vending machine was officially declared dead and wechat merchants were killed in battle.
Article 26 electronic cigarette products posted, delivered and carried in other places shall be subject to limit management and shall not exceed the limit prescribed by the relevant competent department under the State Council.
Article 27 the electronic cigarette products carried by individuals within the territory of China shall be subject to limit management and shall not exceed the limit prescribed by the relevant competent department under the State Council.
Article 28 it is prohibited to sell flavored e-cigarettes that are easy to induce minors to smoke, such as marijuana, and e-cigarettes that can add cigarette liquid by themselves.
Interpretation: seasoning is restricted, open style is restricted, and oil filling is restricted.
Chapter IV import and export trade and foreign economic and technological cooperation
Article 29 the Department of tobacco monopoly administration under the State Council shall supervise and administer the import and export trade of e-cigarettes and foreign economic and technological cooperation according to law.
Article 30 the establishment of foreign-invested e-cigarette production enterprises, e-cigarette processing enterprises, e-cigarette brand holding enterprises and e-cigarette nicotine production enterprises shall be reported to the competent department of tobacco monopoly administration under the State Council for examination and approval before they can be approved for establishment in accordance with the relevant provisions of the state.
Article 31 An enterprise holding a license for a tobacco monopoly wholesale enterprise may engage in relevant import business only after it is approved by the Department of tobacco monopoly administration under the State Council and changes the scope of the license.
Article 32 the demand for the import of electronic cigarette products and nicotine for electronic cigarettes shall be reported to the Department of tobacco monopoly administration under the State Council for examination and approval.
Imported e-cigarette products and nicotine for e-cigarette shall be sold to e-cigarette wholesale enterprises, e-cigarette production enterprises and e-cigarette processing enterprises through the e-cigarette transaction management platform specified in these measures.
Imported electronic cigarette products shall be registered in accordance with the provisions of these measures.
Article 33 electronic cigarette products imported duty-free shall be stored in the bonded warehouse designated by the customs, and shall be locked and managed jointly by the local tobacco monopoly administrative department designated by the tobacco monopoly administrative department under the State Council and the customs. The customs shall, on the basis of the duty-free import plan approved by the competent department of tobacco monopoly administration under the State Council, write off the quantity of duty-free imported electronic cigarette products in batches.
Article 34 the package of imported electronic cigarette products shall be marked with the words “exclusively operated by China National Tobacco Corporation”.
Those who operate duty-free electronic cigarette products in the customs supervision area can only retail, and the sales package shall be marked with the special marks prescribed by the competent department of tobacco monopoly administration under the State Council.
Article 35 electronic cigarette products specially for export shall be marked with the words “exclusively for export” on the package.
Article 36 enterprises that produce electronic cigarette products that are not sold in China but are only used for export shall register their products in accordance with the provisions of these measures and obtain a license for tobacco monopoly production enterprises.
Electronic cigarette products that are not sold in China and are only used for export shall comply with the laws, regulations and standards of the destination country or region; If the destination country or region has no relevant laws, regulations and standards, it shall comply with the relevant laws, regulations and standards of China.
Interpretation: there are no restrictions on overseas exports, only need to apply for the production enterprise license. Good for overseas markets.
Chapter V Supervision and inspection
Article 37 The competent department of tobacco monopoly administration shall supervise and inspect the implementation of these measures according to law, investigate and deal with cases in violation of these measures, and, together with relevant departments, investigate and deal with acts such as the production and sale of counterfeit electronic cigarette products, smuggling and smuggling, counterfeiting and shoddy.
Interpretation: there is evidence to rely on.
Article 38 When investigating and dealing with cases in violation of these measures, the Department of tobacco monopoly administration may exercise the following functions and powers:
(1)Â Interrogate the parties, suspects and witnesses of illegal cases.
(2)Â Inspect the business premises of the parties involved in the illegal case, and dispose of the illegally produced or operated electronic cigarettes and nicotine for electronic cigarettes according to law.
(3)Â Consult and copy contracts, invoices, account books, documents, records, documents, business letters and telegrams and other materials related to illegal activities.
Article 39 for individuals, legal persons and other organizations that violate these measures, the competent department of tobacco monopoly administration may take measures such as regulatory talks, circulating a notice of criticism, credit management, removing products from the catalogue of electronic cigarette products, ordering them to suspend business and carry out rectification, or even canceling their qualification to engage in the production and operation of electronic cigarettes and nicotine for electronic cigarettes according to law.
Article 40 The competent department of tobacco monopoly administration shall establish a credit management system, list dishonest enterprises, individuals or other organizations as key supervision and inspection objects, strengthen supervision, and include dishonest information into the national credit information sharing platform or publicize it in the national enterprise credit information publicity system. Market subjects involved in bad nature, serious circumstances and great social harm shall be included in the list of Joint Disciplinary objects for dishonesty.
Article 41 the supervision and inspection of the product quality of electronic cigarettes and the identification and testing of counterfeit registered trademark electronic cigarettes and fake and shoddy electronic cigarettes shall be carried out by the electronic cigarette inspection and testing institution established or designated by the Department of tobacco monopoly administration under the State Council.
Interpretation: that is, how to identify qualified products of electronic cigarette products will be carried out by designated testing institutions.
Article 42 Units and individuals who have rendered meritorious service in reporting cases of illegal production and sale of electronic cigarette products and nicotine for electronic cigarettes shall be rewarded.
Chapter VI supplementary provisions
Article 43 The term “smoke bomb” as mentioned in these Measures refers to the electronic cigarette assembly containing atomization; Cigarette sets include electronic cigarette sets and cigarette sets used for other new tobacco products. Electronic cigarette sets refer to devices that allow people to suck, suck, chew or sniff cigarette liquid by means of atomization; The products sold in combination with cigarette bombs and cigarette sets include disposable electronic cigarettes, electronic cigarette products sold in one packaging unit in accordance with relevant national standards and product registration list, etc; Atomization refers to the mixture and auxiliary substances that can be atomized into inhalable nicotine containing aerosol by electronic device in whole or in part; Smoke liquid refers to the atomization in the form of liquid.
Article 44 The term “e-cigarette brand holding enterprise” as mentioned in these Measures refers to an enterprise that has obtained the registration of e-cigarette products and is not actually engaged in production business; E-cigarette manufacturer refers to the enterprise that has obtained the registration of e-cigarette products and produces them by itself; E-cigarette processing enterprise refers to the enterprise that has not obtained the registration of e-cigarette products and is only entrusted to process e-cigarette products; Electronic cigarette nicotine production enterprises include cigarette nicotine, atomization and other production and processing enterprises.
Article 45 the tax collection and payment of e-cigarettes shall be implemented in accordance with the tax laws and regulations of the state.
Article 46 those who violate these Measures shall be punished by the Department of tobacco monopoly administration in accordance with the provisions on legal liability in the tobacco monopoly law of the people’s Republic of China, the law of the people’s Republic of China on the protection of minors, the regulations for the implementation of the tobacco monopoly law of the people’s Republic of China and other laws and regulations.
Article 47 these Measures shall be interpreted by the Department of tobacco monopoly administration under the State Council.
Article 48 these Measures shall go into effect as of the date of promulgation.
Attachment: Notes on the measures for the administration of electronic cigarettes (Draft for comments)
The decision of the State Council on Amending the regulations for the implementation of the tobacco monopoly law of the people’s Republic of China (Guo Ling No. 750, hereinafter referred to as the decision) was promulgated and implemented on November 10, 2021. In accordance with the newly revised regulations for the implementation of the tobacco monopoly law of the people’s Republic of China, in order to further strengthen the supervision of new tobacco products such as e-cigarettes, the state tobacco monopoly administration has drafted the administrative measures for e-cigarettes (Draft for comments) (hereinafter referred to as the administrative measures), which are explained as follows:
1.Drafting background and process
In recent years, due to the regulatory gap and the disorderly development of the e-cigarette industry, some products have problems such as unclear nicotine (nicotine, the same below), unknown added ingredients and cigarette oil leakage. In particular, some operators publicize and mislead consumers, induce minors to smoke, and infringe on minors’ physical and mental health. All sectors of society have strongly reflected and constantly called for strengthening supervision.
The CPC Central Committee and the State Council attached great importance to this and decided to amend the regulations for the implementation of the tobacco monopoly law of the people’s Republic of China to strengthen the supervision of new tobacco products such as e-cigarettes according to law. On November 10, the decision was officially promulgated and put into effect, making it clear that “electronic cigarettes and other new tobacco products shall be implemented with reference to the relevant provisions of these Regulations”.
In order to do a good job in the supervision of e-cigarettes, perform the supervision duties according to law, standardize the order of e-cigarette market, protect people’s health and safety, and promote the legalization and standardization of industrial governance, the State Tobacco Monopoly Bureau began to study and draft the administrative measures. Before the drafting of the management measures, expert demonstration meetings were held for many times to comprehensively demonstrate the necessity, feasibility and rationality of the preparation and issuance of the management measures, entrust a qualified third-party organization to fully investigate and evaluate the relevant situation of e-cigarettes in China and some key cities, and widely listen to the opinions and suggestions of e-cigarette enterprises. On this basis, combined with the characteristics of electronic cigarette products and market development, and absorbing international regulatory experience, the management measures have been formed.
2. Main contents of management measures
The administrative measures has six chapters and 48 articles. The main contents are: clarify the definition and supervision object of e-cigarette. Strengthen the production management of e-cigarettes, and establish the quality and safety assurance system of e-cigarettes and the traceability system of e-cigarettes. Market entities engaged in the production, wholesale and retail of e-cigarettes shall obtain the license issued by the competent administrative department of tobacco monopoly accordingly. Establish a national unified e-cigarette trading management platform to manage the trading of e-cigarette products and e-cigarette nicotine. Electronic cigarette products shall comply with the national standards for electronic cigarettes and the relevant provisions on packaging marks and warnings, and use registered trademarks according to law. The relevant provisions on tobacco advertising shall apply to electronic cigarette advertising. The Department of tobacco monopoly administration under the State Council shall supervise and administer the import and export trade of e-cigarettes and foreign economic and technological cooperation according to law. The tax collection and payment of e-cigarettes shall be implemented in accordance with the national tax laws and regulations.
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