China’s largest internet buying holiday, “Singles Day”(November 11th) is just around the corner and the Administration of Quality Supervision Inspection and Quarantine (*AQSIQ) has released a new draft regulation that will have a negative impact on China’s booming Cross Border E-commerce (CBEC) business. Besides all the new licenses required for those involved in CBEC, the main take away is that China’s leaders have decided that any product that is sold to China’s consumers and is packaged/shipped within the borders of the People’s Republic of China should follow China’s regulations. This means that products being sold one by one from free trade zones or duty free shops would now be required to follow the same regulations that traditional imports follow. In the case of dietary supplements, this would mean the product would need the “blue hat” registration from China’s FDA. However, the draft law does say that international parcels would not be subject to this new regulation, so it should be OK to ship directly to consumers from country of origin, Hong Kong or Taiwan for example. See below USCHPA’s translation of the draft regulation followed by the original Chinese version:
*AQSIQ is in charge of all China’s Imports and Exports in terms of inspections, quality and food safety. They oversee China Inspection Quarantine (CIQ) departments at each port of entry.
Regulations for the Safety Supervision and Administration of Cross-Border E-commerce of Imported Food via Bonded Online Shopping
Translation Note: Cross Border E-Commerce will be referred to as “CBEC”.
Chapter I General Provisions
Article 1 [Purpose and basis] To regulate the Safety supervision and administration work of CBEC of Imported Food via Bonded Online Shopping, to ensure the safety of imported food, the Regulations are formulated in accordance with the Food Safety Law of the People’s Republic of China and its implementing regulations, the Law of the People’s Republic of China on the Entry and Exit Animal and Plant Quarantine and its implementing regulations, the Law of the People’s Republic of China on Import and Export Commodity Inspection and its implementing regulations, as well as the State Council Opinion on Fast Developing E-Commerce and Speed up Cultivation of New Economic Driving Forces (Issued by State Council,  #24), General Office of the State Council Guidance and Opinion on Promoting Healthy and Rapid Development of CBEC (Issued by General Office of the State Council,  #46), General Administration of Quality Supervision, Inspection and Quarantine Opinion on Further Play the Inspection and Quarantine Role to Promote the Development of CBEC (Issued by AQSIQ,  #202), and other laws and regulations.
Article 2 [Scope of application] The Regulations shall apply to the safety supervision and administration work and the operation of CBEC of Imported Food via Bonded Online Shopping (hereafter referred to as “Bonded Online Shopping Import”).
The “Bonded Online Shopping Import”, as mentioned in the regulations, refers to the CBEC import of regardless of whether the consumer orders are generated at the time of border entry, the imported goods declared as CBEC, no individual package based on consumers order when at the border entry, storage at special supervision area after bulk transport of the goods, CBEC operator deliver the goods to the domestic consumers in separated package based on their order.
Products entering the border via international express or mail are excluded from these Regulations.
Article 3 [Duties of operating bodies] The bonded online shopping imported food operating bodies shall comply with China’s laws and regulations in their business and operations, and ensure the bonded online shopping imported food is in line with China’s laws and regulations and food safety standards.
The bonded online shopping imported food operating bodies include: the operating companies in bonded online shopping imported food (hereafter referred to as “Operating companies”), the third-party platform companies for the trade of bonded online shopping imported food (hereafter referred to as “Third-party platform companies”), and the logistics and warehousing companies for bonded online shopping imported food (hereafter referred to as “Logistics and warehousing companies”).
Article 4 [Regulatory bodies] General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) shall be in charge of the inspection and quarantine and supervision for the bonded online shopping imported food.
Local entry-exit inspection and quarantine authorities set up by AQSIQ shall be responsible for the inspection and quarantine and supervision for the bonded online shopping imported food at their local regions.
Article 5 [Regulatory principles] Entry-exit inspection and quarantine authorities shall implement registration administration on the bonded online shopping imported food operating bodies and the imported products, conduct supervision and inspection on the operation behavior of bonded online shopping imported food, and conduct quality and safety risk supervision on the bonded online shopping imported food.
Chapter II Obligations of operating bodies
Article 6 [General obligations of operating companies] Operating companies should comply with China’s related laws and regulations on network food operation, establish and improve food safety management system, designate special personnel to be responsible for the food quality and safety, ensure the foods they sell in line with China’s relevant laws, regulations, and the requirements of national food safety standards. Those who are required by laws and regulations to apply production business license or registration should obtain food business license or registration certificate. Operating companies should get registered at the inspection and quarantine authorities in accordance with the regulations.
Operating companies should not import food via bonded online shopping as follows:
- Prohibited items by the Law of the People’s Republic of China on the Entry and Exit Animal and Plant Quarantine;
- Animal and plant derived food which has not received access permission in inspection and quarantine;
- Food prohibited from border entry by other laws and regulations or the notices of AQSIQ.
Operating companies should also ensure their bonded online shopping imported food conforming to the following requirements:
- Food being listed on the Catalogue of Registered Enterprises in Outbound Production Enterprises of Imported Food should come from the registered outbound food manufacturers.
- Health products, genetically modified food, food with no national safety standards yet, new food ingredients, and food containing new material of food ingredients, should get registration, filing, and safety assessment from relevant departments and authorities.
- Food required to receive animal and plant quarantine approval should obtain the access permission before the border entry.
Article 7 [General obligations of platform companies] Platform companies should establish and implement the administration systems of operating companies review and registration, information audit for the food sold, emergency disposal for food safety, complaint disposal, and consumer rights protection, to ensure the safety of food on their platform. Platform companies should have got registered at entry-exit inspection and quarantine authorities according to the regulations.
Platform companies should have the operating companies on the platform real-name registered, and have their responsibility for food safety management identified. For those companies which should obtain food production business license according to the law, they should be reviewed for the license.
Platform companies should establish the archive of the operating companies on the platform, review and record the information of the profile, products catalogue, brands of the operating companies, and the qualification and other information of the production and logistics companies.
Platform companies themselves being engaged in the business operation of the bonded online shopping imported food should obtain the food business license or registration certificate according to the law, and comply with the relevant measures in these Regulations.
Platform companies registered outbound should entrust legal qualified companies within borders as agents. Agent companies should take corresponding legal responsibility.
Article 8 [General obligations of logistics and warehousing companies] Logistics and warehousing companies should establish and implement the administration systems of food logistics and warehousing safety management and product traceability management. Logistics and warehousing companies should have should have got registered at entry-exit inspection and quarantine authorities according to the regulations.
Article 9 [Registration of operating bodies] CBEC operating bodies should have got registered at Registration System for Importers and Exporters of Imported Food of AQSIQ to the entry-exit inspection and quarantine authorities. Operating companies, logistics and warehousing companies could have the platform companies to get the registration for them. Operating bodies registered outbound in the bonded online shopping imported food should entrust the agents within borders to get registered on behalf of them.
Article 10 [Registration of products information] Operating companies should ensure the bonded online shopping imported food they operating comes from the legal production companies overseas, and have the production information registered at Registration System for Importers and Exporters of Imported Food of AQSIQ to the entry-exit inspection and quarantine authorities.
Article 11 [Quality and safety commitment] Operating companies should issue public commitment on the quality and safety of the products they operating in the prominent place of their own websites homepage or their homepage on the third-party platform.
Article 12 [Labels and instructions of products] The bonded online shopping imported baby formulas should have labels in Chinese, which should be printed directly on the minimum sales package before the border entry, and could not be affixed within the borders. Other bonded online shopping imported food should provide labels and instructions in Chinese. Except those foods which have special requirements in eating or storage, or contain allergen should be attached with paper Chinese labels and instructions, operating companies can choose either attaching paper Chinese labels and instructions, or providing electronic version of Chinese labels and instructions of the products through CBEC trade platforms. Both choices should be offered for consumers when they make the orders. Electronic version of information should include specific content which required by China’s laws, regulations and national food safety standards, and the names and contact information of the platform companies and operating companies.
Platform companies should publish the basic information mentioned above on their website in long term, so that the consumers can understand or search any time.
Article 13 [Self-check qualified certification] Operating companies should conduct self-check for the bonded online shopping imported food, and provide self-check qualified certification and materials when declare to the inspection and quarantine authorities. Self-check qualified certification and materials should be provided by qualified laboratory. Tests to the products imported for the first time should cover all the safety and hygiene items, which are required by the national food safety standards. Tests for the second and later times should include the middle and high risk safety and hygiene items which assessed by the entry-exit inspection and quarantine authorities.
Article 14 [Border entry declare of products] At the border entry of the bonded online shopping imported food, operating companies or their agent companies should declare to the local entry-exit inspection and quarantine authorities, and provide following materials:
- The list of products name, and relevant HS code and specifications;
- Official quarantine (hygiene) certificates required by the laws, regulations, bilateral agreements, protocols and other provisions to the original country/region.
- Self-check qualified certification and materials;
- Registration code of the operating company;
- Qualifications on registration, filing, and safety assessment of the products according to the laws.
Article 15 [Information records archive] Operating companies should establish sales record and whole-process traceability system for the bonded online shopping imported food, to truthfully record the food name, brand, specification, number, manufacturing date, manufacturing or import batch code, official certificate code, storage life, name/address/contact information of overseas production company, overseas export company, and consumers in China, and the border entry date, so to establish information archive system. The records in the information archive should all be true, and should be kept for no less than the six months after the expiring date of the product. For products with no clear expiring date, the records should be kept for no less than two years.
Platform companies should review, record, and save the content and release date of the food safety information on their platform. The information of the operating companies’ permission certificate and business license should be kept by the platform companies for no less than two years after the last business day of the operating company on the platform. The trade record and other information record should be kept for no less than six months after the product expiring date. For products with no clear expiring date, the records should be kept for no less than two years.
Platform companies should take technical measures of data backup, Recovery Console, etc, to ensure the integrity and safety of the food trade data and information on the network, and should ensure the authenticity in original data.
Article 16 [Daily check report] Platform companies should establish check system, set up special administration organizations or designate special full-time administration personnel to check the food and information sold on the platform. For those illegal activities including false information, exaggerated advertising, operation beyond approved business scope, and food quality and safety problems or any other potential security risks, the platform companies should immediately stop them, and report to the local inspection and quarantine authorities. For serious illegal acts, the platform companies should immediately stop providing network food trading platform service to them.
Article 17 [Products recall] When operating companies find the bonded online shopping imported food is not in line with China’s food safety standards or with evidence to show may endanger human health, they should stop immediately the sales and import, and recall the products have been sold according to the regulations in the Food Safety Law. Operating companies should take remedying, harmless treatment, destruction and other measures to the products recalled, and report the recall and the disposition to the entry-exit inspection and quarantine authorities.
For those foods which the entry-exit inspection and quarantine authorities announced to have quality and safety problem or have other potential safety risks, the platform companies should take measures timely to stop the sales and assist to recall, etc.
Article 18 [Cooperate with supervision and inspection] Operating companies should actively cooperate with the supervision and inspection by the inspection and quarantine authorities, and provide necessary technical support in the areas of information inquiry and data extraction.
Platform companies should obtain, process and report the food safety information in time. Platform companies should provide necessary technical support in the areas of information inquiry, data extraction and service cessation for the supervision and inspection by the entry-exit inspection and quarantine authorities.
When entry-exit inspection and quarantine authorities find any illegal activity against food safety laws and regulations on the third-party platform, and request the platform companies to take measures to stop according to law, the platform companies should cooperate.
Article 19 [Civil compensation] Consumers who buy food through platform companies and get their legitimate rights and interests harmed, they can demand compensation from platform companies. If the platform companies are unable to provide the real name, address, and valid contact information, the compensation shall be paid by the platform companies. After the platform companies pay the compensation, they reserve the recourse rights from those network operating companies.
Platform companies shall or should know the operating companies using the platform to harm the consumers’ legitimate rights and interests. If the platform companies fail in taking necessary measures or fulfilling the censor duty based on the Regulations, they would be jointly and severally liable to these operating companies based on the law.
Article 20 [Consumer rights protection] Platform companies should take measures to establish and enforce consumer dispute resolution and consumer rights protection system.
Chapter III Safety Supervision and Administration
Article 21 [Inspection and quarantine] Entry-exit inspection and quarantine authorities shall implement border entry quarantine onto the bonded online shopping imported food based on laws, to ensure the products in compliance with China’s quarantine requirements.
On the basis of risk analysis, entry-exit inspection and quarantine authorities shall conduct supervision and inspection on the quality and safety of bonded online shopping imported food in accordance with on laws and regulations on products inspection.
After supervision and inspection, when find any bonded online shopping imported food which is not in line with China’s laws and regulations and national food safety standards, entry-exit inspection and quarantine authorities shall inform promptly the operating companies about the related information, and supervise them to stop sales and recall the products.
Entry-exit inspection and quarantine authorities shall accelerate the pace of products inspection and approval on the bonded online shopping imported food by the measures of gathering declare, gathering inspection and quarantine, inspection and approval in batches, etc.
Article 22 [Special spot check] AQSIQ and Entry-exit inspection and quarantine authorities at all levels shall implement special supervision spot check plan annually on the quality and safety of bonded online shopping imported food, and publish the spot check results at regular basis.
Article 23 [Supervision and inspection] Entry-exit inspection and quarantine authorities shall supervise and inspect the registration information, record of product import and sales, product information traceability, and product recall of the operating companies and platform companies in bonded online shopping imported food.
Article 24 [Credibility records] AQSIQ shall implement credit administration on the operating bodies in bonded online shopping imported food, and establish credit records. For those operating bodies that have poor records, the efforts on the supervision, inspection and quarantine should be strengthened. For those serious circumstances, the operation of bonded online shopping imported food should be forbidden.
The Regulations shall enter into force on *** (date). AQSIQ shall be responsible for the interpretation of the Regulations. The Regulations prevails when any local regulation against these Regulations. The safety and supervision of bonded online shopping imported cosmetic products, refers to these Regulations.