China Health Food Registration QA

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skype: dk5k6c045

HLF-TW-10

What are the categories of health food in China? What is its official name?
What is the intensity of management of different categories? What is the governmental authority of health food? Website?

Evershine RD：

In China, health food is a food that claims to have specific health functions or is for the purpose of supplementing vitamins and minerals. That is, food that is suitable for consumption by specific groups of people, has the function of regulating body functions, is not for the purpose of treating diseases, and does not produce any acute, subacute or chronic harm to the human body.

The State Food and Drug Administration (NMPA) is in charge of the national health food registration and management, and is responsible for the approval of health food. The provincial, autonomous region and municipality (food) drug administrations are entrusted by the State Food and Drug Administration to be responsible for the acceptance and formal examination of the registration application materials of domestic health food, and the on-site inspection of the application for registration of health food testing and sample manufacture, Check the samples.
The inspection agency recognized by the State Food and Drug Administration is responsible for the safety toxicology test, functional test (including animal test and/or human test), functional component or iconic component test, hygiene test, stability test of registered health food Experiments, etc., undertake sample inspection and review inspection and other work.

【參考連結】

https://sppt.cfsa.net.cn:8086/db?type=2&guid=C9648171-BCB6-49B3-8287-1C7D6CE94391

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

HLF-TW-20

If a foreign company wants to sell health food in China, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

Yes. To sell health food in China, it is necessary to apply for a food business license to the National Food and Drug Administration (NMPA) in the name of a local enterprise, and the sale will be made after approval.

Food business license

Application conditions

．Have food raw material processing, food processing, sales, storage and other places suitable for the variety and quantity of the food to be operated, keep the environment of the place clean and tidy, and maintain a prescribed distance from toxic and harmful places and other pollution sources.

．Have operating equipment or facilities commensurate with the variety and quantity of food to be operated, and have corresponding disinfection, dressing, washing, lighting, lighting, ventilation, anti-corrosion, dust-proof, fly-proof, rodent-proof, insect-proof, washing and wastewater treatment, storage Garbage and waste equipment or facilities.

．There are full-time or part-time food safety managers and rules and regulations to ensure food safety.

．It has a reasonable equipment layout and technological process to prevent cross-contamination of food to be processed and directly imported food, raw materials and finished products, and prevent food from contacting toxic and unclean substances.

．Other conditions prescribed by laws and regulations.

Application information:

．Application form for food business license: Company name, social credit code (organization code, ID number), business license (subject, type), residence, business location, whether there is a peripheral warehouse, legal representative (person in charge), telephone, mobile phone, food safety management Personnel, area of use or food business area, main business format and business form, business projects, whether it is a chain operation (headquarters contact person, telephone, E-mail, address), etc.

．Duplicate of business license or other subject qualification certification documents.

．Documents such as the layout of major equipment and facilities, operation procedures and other documents that are compatible with the food business.

．Food safety self-inspection, employee health management, purchase inspection records, food safety accident handling, etc. to ensure food safety rules and regulations.

．If using automatic vending equipment to sell food, the applicant shall submit the product qualification certificate of the automatic vending equipment, the specific placement location, the operator’s name, address, contact information, and the method of publicizing the food business license.

．If the applicant entrusts another person to apply for a food business license, the agent shall submit the power of attorney and the agent’s identity certificate.

The applicant agency: the local food and drug administration at or above the county level.

http://www.gov.cn/fuwu/bm/yjj/index.htm

Food business license:

．Validity: 5 years.

．If a food business operator needs to extend the validity period of the food business license obtained in accordance with the law, it shall apply to the food and drug supervision and administration department that originally issued the license 30 working days before the expiration of the validity period of the food business license.

Note

．The local food and drug administration at or above the county level shall review the license application materials submitted by the applicant.

．The on-site inspection shall be carried out by qualified inspectors, not less than 2. The inspectors need to present valid certificates, fill in the on-site inspection form for food business licenses, and make on-site inspection records. After the applicant has verified that there is no error, the inspectors and the applicant will sign/stamp the inspection form and records. If the applicant refuses to sign or seal, the inspector shall indicate the circumstances.

．The State Food and Drug Administration is responsible for formulating the original and duplicate formats of the food business license. The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the management of the printing and issuance of food business licenses within their respective administrative regions.

．The food business license shall specify: the name of the operator, social credit code (identity number for self-employed operators), legal representative (person in charge), domicile, business premises, main business format, business items, license number, validity period, daily Supervision and management institutions, daily supervision and management personnel, complaint and reporting hotline, issuing authority, issuer, issuing date and QR code. The serial number consists of JY (the abbreviation of “operating” in Chinese Pinyin) and 14 Arabic numerals. The numbers from left to right are: 1-digit main business code, 2-digit province (autonomous region, municipality) code, 2-digit city (prefecture) code, 2-digit county (district) code, 6-digit sequence code, 1-digit check code .

．If a warehouse (including self-owned and leased) is set up outside the business premises, the specific address of the warehouse shall also be stated in the copy.

．The daily supervision and management personnel are the staff responsible for the daily supervision and management of food business activities. If the day-to-day supervision and management personnel change, they can be changed on the license by means of signature and seal.

．The local food and drug supervision and administration departments at or above the county level shall, in accordance with the responsibilities stipulated by laws and regulations, supervise and inspect the licensing items of food operators.
Routine supervision and management personnel are responsible for the supervision and inspection of the licensing items of food operators under their jurisdiction. When necessary, they shall inspect relevant food storage and logistics enterprises in accordance with the law.

【參考連結】

https://gkml.samr.gov.cn/nsjg/spjys/202011/t20201102_322851.html

http://banshi.beijing.gov.cn/pubtask/task/1/110105000000/26ef0e11-44f0-44bb-ba3a-d2ef627aa637.html?locationCode=110105000000&serverType=1001

HLF-TW-25

假如需要辦理，請問中國有專業服務公司可以協助辦理保健食品公司營業許可證？

Evershine RD：

匯佳

https://interareapsp.com/

啟冠易立財稅

https://www.yiliacc.com/

HLF-TW-30

If a foreign company wants to sell health food in China, can it assign a China company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

Yes. To sell health food in China, it is necessary to apply for a food business license to the Local food and drug supervision and administration departments at or above the county level in the name of a local enterprise, and the sale will be made after approval.

Food business license

Application conditions

．There are full-time or part-time food safety managers and rules and regulations to ensure food safety.

．Other conditions prescribed by laws and regulations.

Application information:

．Duplicate of business license or other subject qualification certification documents.

．Documents such as the layout of major equipment and facilities, operation procedures and other documents that are compatible with the food business.

．Food safety self-inspection, employee health management, purchase inspection records, food safety accident handling, etc. to ensure food safety rules and regulations.

．If the applicant entrusts another person to apply for a food business license, the agent shall submit the power of attorney and the agent’s identity certificate.

The applicant agency: the local food and drug administration at or above the county level.

http://www.gov.cn/fuwu/bm/yjj/index.htm

Food business license:

．Validity: 5 years.

Note

．The local food and drug administration at or above the county level shall review the license application materials submitted by the applicant.

．The on-site inspection shall be carried out by qualified inspectors, not less than 2. The inspectors need to present valid certificates, fill in the on-site inspection form for food business licenses, and make on-site inspection records.
After the applicant has verified that there is no error, the inspectors and the applicant will sign/stamp the inspection form and records. If the applicant refuses to sign or seal, the inspector shall indicate the circumstances.

．If a warehouse (including self-owned and leased) is set up outside the business premises, the specific address of the warehouse shall also be stated in the copy.

．The local food and drug supervision and administration departments at or above the county level shall, in accordance with the responsibilities stipulated by laws and regulations, supervise and inspect the licensing items of food operators. Routine supervision and management personnel are responsible for the supervision and inspection of the licensing items of food operators under their jurisdiction. When necessary, they shall inspect relevant food storage and logistics enterprises in accordance with the law.

Product Liability

Health food is a special food. In accordance with the food recall management measures, food producers and operators should assume the responsibility of the first responsible person for food safety in accordance with the law, establish and improve relevant management systems, collect and analyze food safety information, and comply with the law to stop unsafe food. Production and operation, recall and disposal obligations.
The State Food and Drug Administration is responsible for guiding the supervision and management of the national production and distribution, recall and disposal of unsafe food. The local food and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions.
The food and drug supervision and administration departments at or above the county level organize the establishment of a food safety expert database composed of experts in medicine, toxicology, chemistry, food, law and other related fields to provide professional support for the cessation of production, operation, recall and disposal of unsafe food.
The State Food and Drug Administration is responsible for summarizing and analyzing the information on the cessation of production, operation, recall and disposal of unsafe food across the country, and improving food safety supervision and management measures based on food safety risk factors.
Local food and drug supervision and administration departments at or above the county level are responsible for collecting, analyzing and processing information on the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions, and supervising food producers and operators to implement their main responsibilities.
If a food producer or trader finds that the food it produces and trades is unsafe food, it shall immediately stop the production and trade, and notify the relevant food producer and trader to stop production and trade and consumers to stop eating it by means of a notice or announcement, and take necessary measures. Prevention and control of food safety risks.
If the promoters of the centralized food trading market, the lessors of the food counters, and the organizers of the food fairs find that the food operated by the food operators is unsafe food, they shall take effective measures in a timely manner to ensure that the relevant operators stop operating the unsafe food. food.
If a third-party platform provider for online food trading finds that the food operated by an online food operator is unsafe food, it shall take measures such as stopping the online trading platform service in accordance with the law to ensure that the online food operator stops dealing in unsafe food.
If the unsafe food produced and operated by a food producer and business operator has not been sold to consumers and is still under the control of other producers and business operators, the food producer and business operator shall immediately recover the unsafe food and take necessary measures to eliminate risks.
There are three levels of food recalls:

． Level 1 recall: If the food has caused or may cause serious health damage or even death after consumption, the food producer should initiate the recall within 24 hours after learning of the food safety risk, and report the recall plan to the local food and drug administration at or above the county level.

． Secondary recall: General health damage has been or may be caused after consumption. Food producers should initiate a recall within 48 hours after learning of the food safety risk, and report the recall plan to the local food and drug administration at or above the county level.

． Level 3 recall: Food producers with false labels on labels and labels should initiate a recall within 72 hours of becoming aware of food safety risks, and report the recall plan to the local food and drug administration at or above the county level. Foods with defective labels and labels that will not cause health damage after consumption should be corrected by food producers and may be recalled voluntarily.

Food producers should recall unsafe food in accordance with the recall plan. Include the following:

． Name, address, legal representative, specific person in charge, contact information, etc. of the food producer

． Food name, trademark, specification, date of manufacture, batch, quantity and area of recall

． Recall reasons and harmful consequences

． Recall levels, procedures and deadlines

． The content and release method of the recall notice or announcement

． Obligations and Responsibilities of Relevant Food Producers and Operators

． Disposal measures and expenses of recalled food

． Expected effect of recall

Term

． Level 1: Food producers should complete the recall within 10 working days from the date of the announcement.

． Level 2: Food producers should complete the recall within 20 working days from the date of the announcement.

． Level 3: Food producers should complete the recall within 30 working days from the date of the announcement.

When a food operator learns of the recall of unsafe food by a food manufacturer, it should immediately take measures such as stopping the purchase and sale of unsafe food, sealing up the unsafe food, posting the recall announcement issued by the manufacturer in a conspicuous place in the business premises, and cooperating with the food manufacturer to carry out the recall. Work.
Food operators shall voluntarily recall unsafe food caused by their own reasons within the scope of their operations in accordance with the provisions of laws and regulations. Food operators should notify suppliers of recalls of unsafe food. The supplier shall promptly inform the producer.
Food producers and operators shall truthfully record the names, trademarks, specifications, production dates, batches, quantities, etc. The record keeping period shall not be less than 2 years.

【參考連結】

https://gkml.samr.gov.cn/nsjg/spjys/202011/t20201102_322851.html

http://banshi.beijing.gov.cn/pubtask/task/1/110105000000/26ef0e11-44f0-44bb-ba3a-d2ef627aa637.html?locationCode=110105000000&serverType=1001

http://big5.www.gov.cn/gate/big5/www.gov.cn/gongbao/content/2015/content_2937326.htm

HLF-TW-35

假如需要辦理指派中國公司擔任營業代理人，請問中國有專業服務公司可以協助？

Evershine RD：

中國醫藥保健品有限公司

https://www.mehecointl.com/

艾蘭得健康控股有限公司

http://www.aland.cn/

HLF-TW-40

Do foreign companies need to apply for an approval before importing health food sold to China?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? Which languages are allowed? Website?

Evershine RD：

Yes, the health food imported for the first time must be registered with the Local food and drug supervision and administration departments at or above the county level of the State Council in the name of the representative office in China or the agency entrusted in China. The health food that is supplemented with nutrients such as vitamins and minerals must complete for the record.

Health food registration

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative offices in China or by their entrusted agencies in China.
URL: http://bjspzcsp.gsxt.gov.cn:8080/bjspzc/index.jsp
Documents:

．Health food registration application form and legal responsibility commitment letter.

．A copy of the applicant’s main body registration certificate.

．Product R&D report (including R&D personnel, R&D time, R&D process, verification data above the pilot scale, demonstration report and related scientific basis for the safety, health-care function, and quality controllability of raw materials and products outside the catalogue, and a comprehensive report based on the R&D results Determined product technical requirements, etc.)

．Product formula materials (including the name and dosage of raw materials and auxiliary materials, production process, quality standards, and if necessary, the basis for the use of raw materials, the description of the parts to be used, the inspection certificate, the variety identification report, etc. should be provided in accordance with regulations.)

．Product production process materials (including the production process flow diagram and description, key process control points and descriptions.)

．Safety and health function evaluation materials (including the safety and health function test evaluation materials of raw materials and products not included in the catalogue, and human consumption evaluation materials; functional components or iconic components, hygiene, stability, strain identification, strain virulence and other test reports, as well as test reports involving doping, prohibited drug ingredients, etc.)

．Types, names, and relevant standards of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．3 minimum sales packaging samples.

．Other documents related to product registration review.

．The qualification certificate issued by the competent government department or legal service agency of the country (region) where the product is produced is the qualification certificate that the applicant for the registration is an overseas manufacturer of listed health food.

．The technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

．If the registration affairs are handled by the resident representative office of the overseas registration applicant in China, the registration certificate of the resident representative office of the foreign enterprise in China and its duplicate should be submitted; if the overseas registration applicant entrusts a domestic agency to handle the registration matters, the original notarized power of attorney should be submitted. and a duplicate of the business license of the entrusted agency.

Note

．The health function claimed by the product should have been listed in the function catalog of health food.

．The health food imported for the first time refers to the health food that is not from the same country, the same enterprise, and the same formula applied for marketing in China.

．The accepting agency will send the application materials to the review agency within 3 working days after the acceptance, and the review experts will review it, organize the inspection agency to carry out on-site inspection as needed, and organize the inspection agency to carry out review inspection, and complete the review within 60 working days , make conclusions and recommendations.

．The review agency will review the content of the application materials, and clarify the qualified terms of the product health function claim according to the sufficiency of scientific basis.

．If the review institution believes that the registration applicant needs to supplement and correct the materials, the registration applicant shall provide supplementary materials once within 3 months according to the requirements of the supplement and correction notice; after the review institution receives the supplementary materials, the review time shall be recalculated.

．If the registration applicant fails to submit supplementary materials or complete supplements and corrections within the time limit, which is insufficient to prove the product safety, health-care function and quality controllability, the review agency shall terminate the review and make a recommendation for not registration.

．If the review agency thinks it is necessary to carry out on-site inspection, it will promptly notify the inspection agency to conduct on-site inspection in accordance with the technical requirements of the product R&D report, formula, production process and other technical requirements in the application materials, and send the sealed samples of offline products to the review inspection agency for inspection. The inspection agency shall complete the on-site inspection within 30 working days from the date of receipt of the notification, and send the inspection report to the review agency.

．The time limit for overseas on-site inspection and re-inspection of health food imported for the first time shall be determined according to the actual situation of overseas manufacturers.

．The time required for on-site inspection, review inspection, and review is not included in the time limit for review and registration decisions.

．If the health food registrant transfers technology, the transferee shall re-apply for product registration under the guidance of the transferor, and the technical requirements of the product shall be consistent with the original application materials. The transferee shall submit the notarized transfer contract in addition to the registration application materials stipulated in these Measures.

．If the contents stated in the health food registration certificate and its attachments are changed, the health food registrant shall apply for the change and submit the reasons and basis for the change in writing.

．If the health food registration certificate that has been produced and sold expires and needs to be renewed, the health food registrant should apply for renewal 6 months before the expiration of the validity period.

．The registered health food raw materials have been included in the health food raw material catalog and meet the relevant technical requirements. If the health food registrant applies for a change of registration, or applies for a renewal of registration after the expiration of the period, it should follow the recordation procedure.

Record

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative office in China or an agency within China entrusted by them.
URL:http://xbjspba.gsxt.gov.cn/record_pt/index.jsp
Documents:

．Product production process materials (including production process flow diagram and description, key process control points and description.)

．Types, names, relevant standards, etc. of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．Health food filing registration form, and the legal responsibility commitment letter of the filing person for the authenticity of the submitted materials.

．A copy of the main registration certificate of the filer.

．Product technical requirements material.

．A full-item inspection report issued by a legally qualified inspection agency that meets the technical requirements of the product

．Other materials that indicate product safety and health functions.

．The certification document issued by the competent government department or legal service institution of the country (region) where the product has been produced has been on the market for more than one year, or the safety report on the overseas sales of the product and the consumption of the crowd.

．Technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

Note

．The recorded product formula, name and dosage of raw and auxiliary materials, efficacy, production process, etc. shall comply with the provisions of laws, regulations, rules, mandatory standards and technical requirements of health food raw material catalogues.

．The market supervision and administration department completes the filing of the filing information for future reference, and issues the filing number. For the registered health food, the market supervision and administration department will make a recordation certificate and publish the information in the recordation information form on its website. The format of the record number of imported health food is: Shijianbei J+4-digit era code+00+6-digit sequential number.

．For the health food that has been filed, if the filing materials need to be changed, the filing person should submit the change explanation and relevant certification documents to the original filing authority. If the filing materials meet the requirements, the market supervision and administration department shall post the changes in the change information, and keep the filing materials on file for future reference.

．The health food filing information should include the product name, the name and address of the filing person, the filing registration number, the registration date, as well as the product label, instruction manual and technical requirements.

URL:

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

Labels, manuals

All contents should be standardized and complete, comply with current regulations, technical specifications, mandatory standards, etc., and be consistent with the relevant content of the product safety and health function research and development report, and the content involving product technical requirements should be consistent with product technical requirements or conform. Includes the following:

Raw materials: List all raw materials according to formula materials. The order of each raw material is arranged in descending order according to the amount in product. Irradiated raw materials should be marked (irradiated) after the name of the raw material.
Excipients: List all excipients by formula material. The order of the excipients is arranged in descending order according to their dosage in the product. Irradiated excipients should be marked (irradiated) after the excipient name.
Content of functional ingredients or iconic ingredients: should include the name and content of the ingredients. It should be consistent with the name of the functional ingredient or the indicator of the iconic ingredient in the product technical requirements, and the minimum value of the indicator in the product technical requirements is the value indicated in the label instruction.
Applicable people: It should be a specific group of people who are safe to eat, have clear functional requirements and are suitable for this product in line with scientific basis for safety and health functions.
Unsuitable groups: specific groups that should be excluded from the scope of suitable groups, infants, pregnant women, nursing mothers and other special groups for whom the existing scientific evidence is insufficient to support the product, and specific groups that should be clearly marked in the current regulations. If it is not possible to determine the unsuitable group for the time being, it should be clearly stated that “limited to the current scientific research level, this product has not found a clear unsuitable group for the time being, and will be improved and supplemented based on the collected food safety information”.
Health function: It should be comprehensively determined through research and development and meet the relevant requirements for the management of health function claims.
Edible amount and consumption method: It should be consistent with the scientific basis of product formula compatibility and dosage, safety and health function test evaluation materials, etc.
Specifications: should be the weight or volume of the smallest preparation unit (excluding packaging materials; capsules refer to the contents; sugar-coated tablets or pills refer to the tablet core or pill core before sugar coating), which should be consistent with the product consumption and method of consumption. match. Alcoholic products should indicate the alcohol content.
Storage method: It should be comprehensively determined according to product characteristics and stability tests. If the storage method is under special conditions such as refrigeration, the specific storage conditions shall be listed.
Shelf life: It should be comprehensively determined by research and development, expressed in XX months, and if it is less than a month, it is expressed in XX days.
Precautions: It should be noted that this product cannot replace drugs. This product is not recommended for people other than suitable groups. When necessary, corresponding precautions should be added according to regulations, research and development, scientific consensus and product characteristics.
Note

．The main content of the label should be consistent with the content of the label description in the registration application materials, and the production date and production unit of the sample should be marked.

．Health food registration must provide samples with complete labels and instructions.

【參考連結】

https://www.cfe-samr.org.cn/zcfg/bjsp_134/flfg/202110/t20211008_3922.html

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

HLF-TW-45

請問在中國有哪些專業服務機構，可以協助辦理保健食品產品許可證？

Evershine RD：

瑞旭集團

https://www.cirs-group.com/foodcn

康利華

https://www.china-canny.com/

HLF-TW-50

外國公司可以用自己名義申請辦理產品許可嗎？如需要，哪個單位在管理？
需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？可允許的語文有哪些？網頁？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? Which languages are allowed? Website?

Evershine RD：

The health food imported for the first time must be registered with the Food and Drug Administration (NMPA) of the State Council in the name of the resident representative office in China or the agency authorized by the agency in China.

Health food registration

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative offices in China or by their entrusted agencies in China.
URL: http://bjspzcsp.gsxt.gov.cn:8080/bjspzc/index.jsp
Documents:

．Health food registration application form and legal responsibility commitment letter.

．A copy of the applicant’s main body registration certificate.

．Product production process materials (including the production process flow diagram and description, key process control points and descriptions.)

．Types, names, and relevant standards of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．3 minimum sales packaging samples.

．Other documents related to product registration review.

．The technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

Note

．The health function claimed by the product should have been listed in the function catalog of health food.

．The health food imported for the first time refers to the health food that is not from the same country, the same enterprise, and the same formula applied for marketing in China.

．The review agency will review the content of the application materials, and clarify the qualified terms of the product health function claim according to the sufficiency of scientific basis.

．The time limit for overseas on-site inspection and re-inspection of health food imported for the first time shall be determined according to the actual situation of overseas manufacturers.

．The time required for on-site inspection, review inspection, and review is not included in the time limit for review and registration decisions.

Record

Applicants: Overseas manufacturers of listed health food should be handled by their resident representative office in China or an agency within China entrusted by them.
URL:http://xbjspba.gsxt.gov.cn/record_pt/index.jsp
Documents:

．Product production process materials (including production process flow diagram and description, key process control points and description.)

．Types, names, relevant standards, etc. of packaging materials that directly contact health food.

．Samples of product labels and instructions; search materials that the generic name in the product name and the registered drug name are not identical.

．Health food filing registration form, and the legal responsibility commitment letter of the filing person for the authenticity of the submitted materials.

．A copy of the main registration certificate of the filer.

．Product technical requirements material.

．A full-item inspection report issued by a legally qualified inspection agency that meets the technical requirements of the product

．Other materials that indicate product safety and health functions.

．Technical regulations or standards related to health food in the country (region) of product production or international organization.

．The actual samples of the packaging, labels, and instruction manuals of the products listed in the country (region) of production.

Note

URL:

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

Labels, manuals

Raw materials: List all raw materials according to formula materials. The order of each raw material is arranged in descending order according to the amount in product. Irradiated raw materials should be marked (irradiated) after the name of the raw material.
Excipients: List all excipients by formula material. The order of the excipients is arranged in descending order according to their dosage in the product. Irradiated excipients should be marked (irradiated) after the excipient name.
Content of functional ingredients or iconic ingredients: should include the name and content of the ingredients. It should be consistent with the name of the functional ingredient or the indicator of the iconic ingredient in the product technical requirements, and the minimum value of the indicator in the product technical requirements is the value indicated in the label instruction.
Applicable people: It should be a specific group of people who are safe to eat, have clear functional requirements and are suitable for this product in line with scientific basis for safety and health functions.
Unsuitable groups: specific groups that should be excluded from the scope of suitable groups, infants, pregnant women, nursing mothers and other special groups for whom the existing scientific evidence is insufficient to support the product, and specific groups that should be clearly marked in the current regulations. If it is not possible to determine the unsuitable group for the time being, it should be clearly stated that “limited to the current scientific research level, this product has not found a clear unsuitable group for the time being, and will be improved and supplemented based on the collected food safety information”.
Health function: It should be comprehensively determined through research and development and meet the relevant requirements for the management of health function claims.
Edible amount and consumption method: It should be consistent with the scientific basis of product formula compatibility and dosage, safety and health function test evaluation materials, etc.
Specifications: should be the weight or volume of the smallest preparation unit (excluding packaging materials; capsules refer to the contents; sugar-coated tablets or pills refer to the tablet core or pill core before sugar coating), which should be consistent with the product consumption and method of consumption. match. Alcoholic products should indicate the alcohol content.
Storage method: It should be comprehensively determined according to product characteristics and stability tests. If the storage method is under special conditions such as refrigeration, the specific storage conditions shall be listed.
Shelf life: It should be comprehensively determined by research and development, expressed in XX months, and if it is less than a month, it is expressed in XX days.
Precautions: It should be noted that this product cannot replace drugs. This product is not recommended for people other than suitable groups. When necessary, corresponding precautions should be added according to regulations, research and development, scientific consensus and product characteristics.
Note

．Health food registration must provide samples with complete labels and instructions.

【參考連結】

https://www.cfe-samr.org.cn/zcfg/bjsp_134/flfg/202110/t20211008_3922.html

HLF-TW-55

請問在中國有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？

Evershine RD：

瑞旭集團

https://www.cirs-group.com/foodcn

康利華

https://www.china-canny.com/

HLF-TW-60

What documents are required when importing approved health food into China? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

Registration

Conditions of registration:

．The food safety management system of the country (region) where it is located has passed the equivalence assessment and review of the General Administration of Customs.

．Established with the approval of the competent authority of the country (region) where it is located and under its effective supervision

．Establish an effective food safety and hygiene management and protection system, legally produce and export in the country (region) where it is located, and ensure that the food exported to China complies with relevant Chinese laws and regulations and national food safety standards

．Meet the relevant inspection and quarantine requirements agreed by the General Administration of Customs and the competent authorities of the country (region) where it is located.

Registration method: The competent authority of the country (region) where the company is located shall recommend registration to the General Administration of Customs, and the competent authority of the country (region) shall review and inspect the enterprise recommended for registration. Submit the following application materials:

．Recommendation letter from the competent authority of the country (region) where you are located.

．Business list and business registration application.

．Enterprise identity documents, such as business license issued by the competent authority of the country (region) where it is located.

．A statement that the competent authority of the country (region) where the company is located recommends that the company meet the requirements of this regulation.

．The review report of the competent authority of the country (region) where the relevant enterprises are audited and inspected.

．When necessary, the General Administration of Customs may require the provision of enterprise food safety sanitation and protection system documents, such as the floor plan of the enterprise’s factory area, workshop, and cold storage, as well as process flow diagrams.

Period of validity: 5 years.
Remarks

．The application materials shall be submitted in Chinese or English. If the relevant countries (regions) and China have agreed otherwise on the registration method and application materials, the agreement shall be followed.

．The competent authority of the country (region) where it is located or the overseas manufacturer of imported food shall be responsible for the authenticity, completeness and legality of the submitted materials.

．The General Administration of Customs itself or entrusts relevant institutions to organize an evaluation team to conduct evaluation and review of the overseas production enterprises of imported food that apply for registration through written inspections, video inspections, on-site inspections, etc. and their combinations. The evaluation team consists of more than 2 evaluation reviewers.

．The overseas manufacturer of imported food and the competent authority of the country (region) where it is located shall assist in the above-mentioned evaluation and review work.

．According to the evaluation and review, the General Administration of Customs will register the overseas production enterprises of imported food that meet the requirements and give them a registration number in China, and notify the competent authority of the country (region) or the overseas production enterprise of imported food in writing; The production enterprise shall not be registered, and shall notify the competent authority of the country (region) where it is located or the overseas production enterprise of imported food in writing.

．When a registered enterprise exports food to China, it shall mark the registration number in China or the registration number approved by the competent authority of the country (region) on the inner and outer packaging of the food.

Go to the local foreign trade and economic department to obtain the “Foreign Trade Operators Registration”, and only after the recordation and registration can be qualified for foreign trade. Foreign trade operators should go to the local customs, inspection and quarantine, foreign exchange, taxation and other departments to go through the formalities required for foreign trade business within 30 days by presenting the registration form with the registration seal for recordation.
Pre-clearance documents preparation:

．Label Inspection Supervision Filing Form (Application Form)

．Original foreign language label sample picture (before and after label information)

．Original foreign language label translation (before and after label information)

．Chinese trademark design proofs (before and after label information)

．Certificate of Origin

．Chinese dealer business license, phone number

．Foreign producer company name

．Sample

Other materials required by the certificate department of the State Administration of Commodity Inspection:

．Agency contract, sales contract, invoice, packing list

．Chinese label and electronic version of the original label, translation of the original label. (or Chinese label pre-filing certificate)

．Official health certificate of the exporting country (or free sale certificate or health certificate)

．Official certificate of origin of the exporting country

．Manufacturer’s Composition Analysis Instructions

．Fumigation Certificate/Wood Free Packaging Statement

．Ocean/Air Waybill

．Documents required by other port management agencies

【參考連結】

http://www.customs.gov.cn//customs/302249/302266/302267/3625372/index.html

HLF-TW-70

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

Health food registration application materials should include product safety demonstration report, health function demonstration report, production process research report, product technical requirements research report and so on.
The requirements are as follows:

Product safety demonstration report

．Basis for the use of raw materials and excipients: According to common food (including items that can be used in common food, food additives, the same below), new food raw materials, substances that are traditionally both food and traditional Chinese medicinal materials, to be included in the catalog of health food raw materials and health food New raw materials and other categories, clarify the basis for the use of raw and auxiliary materials.

．The scientific basis for the safety of product formula compatibility and dosage: from the aspects of traditional incompatibility and modern medical pharmacology research, the scientific basis for product formula compatibility and dosage, literature basis and experimental data should be provided. Provide the basis that the variety, grade, quality, dosage and number of formula raw materials comply with relevant regulations.

．Analysis and evaluation of safety evaluation test materials: comprehensive analysis should be carried out on the safety evaluation materials and toxicology test reports of new health food raw materials involved, as well as strain identification reports and strain toxicity test reports, and product safety evaluation tests. , to evaluate product safety.

．Summary of formulas, suitable groups, unsuitable groups, consumption methods and dosages, precautions, etc.: Based on the use basis of raw and auxiliary materials, scientific basis for product formulation compatibility and dosage, safety test evaluation materials, etc., the summary formula and label instructions are drawn up. The rationality of suitable groups, unsuitable groups, consumption methods and consumption, precautions, etc.

Demonstration report on the health function of the product

．The scientific basis for the function of the main raw materials of the formula, the compatibility of the remaining raw materials: the raw materials of the product formula should have a clear purpose of use. The scientific basis for the functional effect of the main raw materials of the formula should be provided, and the compatibility necessity of the remaining raw materials should be clarified. If simple processed ordinary food is used as the raw material, sufficient domestic and foreign experimental scientific literature should be provided, and the functional components and content of the raw materials used, as well as the dose-effect relationship should be clearly defined.

．The scientific basis for product formula compatibility and dosage with health care function: the principle of product formulation, the theoretical basis and literature basis for product formula compatibility and dosage with claimed function should be provided.

．Analysis and evaluation of product health function test evaluation materials, population consumption evaluation materials, etc.: Comprehensive analysis should be carried out on product health function test evaluation materials, population consumption evaluation materials, etc., and the product health care function should be evaluated.

．A review of product formulations, suitable groups of people, unsuitable groups of people, consumption methods and consumption, etc. should be based on product formulation compatibility and dosage with scientific basis for declared functions, health function evaluation test materials, and population consumption evaluation materials, etc. Product formulation and sample label instructions should be reviewed The rationality of the raw materials, auxiliary materials, suitable groups, unsuitable groups, health care functions, edible methods and consumption, etc.

Production process research report

．The research materials related to the production process should be complete, standardized and traceable: the research process and results of the production process should be complete, and a basis should be provided to fully demonstrate the necessity, scientificity and feasibility of each process and technology used. For the first-time imported product, the research process from the small-scale process research to the large-scale production process should be provided. If the research data of the small-scale and pilot-scale production process is missing or incomplete, the production verification report of more than 10 batches of large-scale products issued by foreign manufacturers should be provided. and self-test report.

． Process research mainly includes the following contents: basis for formulation selection and specification determination, basis for selection of excipients and dosage, research report on main production process and key process parameters affecting product safety, health care function, etc., and process verification for production scale above pilot scale Reports and sample self-inspection reports, raw materials without applicable national standards, local standards, and industry standards, should provide detailed preparation process, process description and process rationality basis, and should list in detail all processing used in the process of products and raw materials The name, standard number and standard text of the adjuvant should be reviewed according to the process research and related content of the process material. The rationality of the required production process, the packaging materials that directly contact the product, and the process content involved in the quality requirements of raw and auxiliary materials.

Research on product technical requirements

．Identification method research: If the identification method of the product can be determined according to the product formula and relevant research results, it should be comprehensively and accurately explained. If microscopic identification, chromatographic identification, color reaction, etc. are used, the color photos and chromatograms provided should be able to truly reflect the identification results. If the identification item is not formulated, the reason for not being formulated shall be stated.

．Research on physical and chemical indicators: mainly include general quality control indicators (such as moisture, ash, disintegration time limit, etc.), pollutant indicators (such as lead, total arsenic, total mercury, etc.), mycotoxins indicators, as well as laws and regulations, mandatory national standards include Residues of synthetic pigments, preservatives, sweeteners, antioxidants, processing aids, etc. required in limited quantities.

．Research on functional ingredients or iconic ingredient indicators: The process and basis for the selection of product functional ingredients or iconic ingredient indicators, the formulation of indicator values, and the research on detection methods should be explained in detail, and a research report should be provided.

．Stability inspection: The registration applicant shall, in accordance with the current regulations, reasonably select and determine the stability test method and the detection method of the inspection index according to the characteristics of the sample, and carry out the stability test.

Product formulation materials

．Product formula table, including the name and dosage of raw materials and auxiliary materials.

．The dosage of raw and auxiliary materials refers to the amount of 1,000 minimum preparation units; the names of raw and auxiliary materials of products should comply with the current regulations, technical specifications, relevant national standards, etc.; Small arrangement; compound raw and auxiliary materials should provide its specific composition and dosage; essence should clarify its specific variety and quality requirements.

．Quality requirements, production process, and quality inspection certificate for raw and auxiliary materials (raw and auxiliary materials with applicable national, local, and industry-related standards are exempt from providing production processes).

．The raw materials or excipients of extracts and hydrolyzates should also provide the basis for use and the description of the parts of use.

．Animal and plant raw materials should indicate the source of species and the part of use.

．Animal raw materials should provide inspection and quarantine certificates.

．Where the laws and regulations clearly stipulate the species of animals and plants, a variety identification report issued by an authoritative institution shall also be provided.

．According to the formulation principle, if there are clear requirements for the processing of raw materials, the processing specifications of the raw materials should be indicated, such as raw, salted, honeyed, calcined, etc.

．If there are clear requirements for the purity of the raw materials, the self-inspection report of the purity of the raw materials shall be provided.

Safety and health function evaluation materials

．The samples, inspection procedures and inspection methods of the test and inspection work shall comply with the relevant regulations. Including the following contents: the qualification certificate of the food inspection agency, the safety test evaluation materials issued by the legally qualified food inspection agency, the health function test evaluation materials issued by the legally qualified food inspection agency, and the issued by the legally qualified food inspection agency Food evaluation materials (involving human consumption evaluation tests), functional ingredients or iconic ingredients, hygiene, and stability test reports of three batches of samples (if the inspection is entrusted, the entrusted unit should be a food inspection agency with legal qualifications) , the strain identification report issued by the authoritative organization, the strain virulence test report issued by the legally qualified food inspection organization, etc., and the test report of the products involving stimulants and prohibited drug ingredients issued by the legally qualified food inspection organization.

Types, names and standards of packaging materials in direct contact with products

．It should be determined based on comprehensive evaluation, such as process research and product stability test. The type, name, standard number, full text of the standard, and basis for use of packaging materials that directly contact the product should be listed.

．The original text of technical regulations and/or standards related to health food in the country (region) of product production or international organization. An explanation of the overseas manufacturer’s assurance that the health food exported to my country conforms to the provisions of relevant laws, administrative regulations and national food safety standards in my country, as well as a self-inspection report to ensure the effective operation of the production quality management system.

．If the application materials involve the submission of the certification documents of the quality management system of the product production enterprise, the certification documents issued by the competent government department of the producing country (region) or the relevant department designated by the competent government department to bear the legal responsibility shall be submitted. Indicate the name of the institution that issued the document, the name of the product, the name of the manufacturer and the date of issuance of the document.

Note

The applied product should have sufficient scientific basis for safety, health care function, and quality controllability. The registration applicant should not only provide the source, catalog and full text of the scientific basis, but also conduct research and comparison with the technical requirements of the product’s formula, process, etc., and according to the requirements of the application materials, the product safety, health care function, and quality controllable item by item. Sexuality is demonstrated and reviewed.
The source of samples for testing and research should be clear and traceable. Samples should be prepared by pilot-scale and above-scale processes, and the production workshop should establish a production quality management system that is compatible with the samples produced, and ensure the effective operation of the system. The samples of the first import registration application should be products marketed in the country (region) of production.
The submitted argumentation report or research report should provide the start and end time, location, research purpose, method, basis, process, result, conclusion, department, researcher or tester’s signature of the research. For entrusted research, the entrusted research contract and other materials should also be provided. If the functional ingredients or iconic ingredients, hygiene, and stability test reports are self-inspected by the registration applicant, the registration applicant should organize the implementation of inspection quality control, report preparation, sample and file management, etc. in accordance with regulations, and issue self-inspection reports. The test report requirements specified in this method shall be met. If the functional ingredients or iconic ingredients, hygiene, and stability test reports are commissioned by the registration applicant, the commissioned unit should be a food inspection agency with legal qualifications.
The original test records, equipment use records, pilot production records and other original materials of research or experiments should be archived by the registration applicant for future reference, and may not be submitted as application materials when applying for registration. When necessary, the review agency may organize the verification of the original data of research and development.
The same enterprise shall not use the same formula to register health food with different names.

【參考連結】

https://www.cfe-samr.org.cn/zcfg/bjsp_134/bmgz/202207/t20220729_4387.html

https://gkml.samr.gov.cn/nsjg/tssps/201906/t20190624_302696.html

HLF-TW-75

中國保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？

Evershine RD：

浙江省食品藥品檢驗研究院

http://www.zjyj.org.cn/

廣州市藥品檢驗所

http://gdidc.gd.gov.cn/

HLF-TW-77

請問在中國有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？

Evershine RD：

浙江省食品藥品檢驗研究院

http://www.zjyj.org.cn/

廣州市藥品檢驗所

http://gdidc.gd.gov.cn/

HLF-TW-80

After a foreign subsidiary imports health food and entrusts a distributor in China to sell it, does the distributor need a health food business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

To sell health food in China, it is necessary to apply for a food business license to the National Food and Drug Administration (NMPA) in the name of a local enterprise, and the sale will be made after approval.

Product Liability

Health food is a special food. In accordance with the food recall management measures, food producers and operators should assume the responsibility of the first responsible person for food safety in accordance with the law, establish and improve relevant management systems, collect and analyze food safety information, and comply with the law to stop unsafe food. Production and operation, recall and disposal obligations.
The State Food and Drug Administration is responsible for guiding the supervision and management of the national production and distribution, recall and disposal of unsafe food. The local food and drug supervision and administration departments at or above the county level shall be responsible for the supervision and administration of the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions.
The food and drug supervision and administration departments at or above the county level organize the establishment of a food safety expert database composed of experts in medicine, toxicology, chemistry, food, law and other related fields to provide professional support for the cessation of production, operation, recall and disposal of unsafe food.
The State Food and Drug Administration is responsible for summarizing and analyzing the information on the cessation of production, operation, recall and disposal of unsafe food across the country, and improving food safety supervision and management measures based on food safety risk factors.
Local food and drug supervision and administration departments at or above the county level are responsible for collecting, analyzing and processing information on the cessation of production and operation, recall and disposal of unsafe food in their respective administrative regions, and supervising food producers and operators to implement their main responsibilities.
If a food producer or trader finds that the food it produces and trades is unsafe food, it shall immediately stop the production and trade, and notify the relevant food producer and trader to stop production and trade and consumers to stop eating it by means of a notice or announcement, and take necessary measures. Prevention and control of food safety risks.
If the promoters of the centralized food trading market, the lessors of the food counters, and the organizers of the food fairs find that the food operated by the food operators is unsafe food, they shall take effective measures in a timely manner to ensure that the relevant operators stop operating the unsafe food. food.
If a third-party platform provider for online food trading finds that the food operated by an online food operator is unsafe food, it shall take measures such as stopping the online trading platform service in accordance with the law to ensure that the online food operator stops dealing in unsafe food.
If the unsafe food produced and operated by a food producer and business operator has not been sold to consumers and is still under the control of other producers and business operators, the food producer and business operator shall immediately recover the unsafe food and take necessary measures to eliminate risks.
There are three levels of food recalls:

Food producers should recall unsafe food in accordance with the recall plan. Include the following:

． Name, address, legal representative, specific person in charge, contact information, etc. of the food producer

． Food name, trademark, specification, date of manufacture, batch, quantity and area of recall

． Recall reasons and harmful consequences

． Recall levels, procedures and deadlines

． The content and release method of the recall notice or announcement

． Obligations and Responsibilities of Relevant Food Producers and Operators

． Disposal measures and expenses of recalled food

． The expected effect of recall

Term

． Level 1: Food producers should complete the recall within 10 working days from the date of the announcement.

． Level 2: Food producers should complete the recall within 20 working days from the date of the announcement.

． Level 3: Food producers should complete the recall within 30 working days from the date of the announcement.

When a food operator learns of the recall of unsafe food by a food manufacturer, it should immediately take measures such as stopping the purchase and sale of unsafe food, sealing up the unsafe food, posting the recall announcement issued by the manufacturer in a conspicuous place in the business premises, and cooperating with the food manufacturer to carry out the recall. Work.
Food operators shall voluntarily recall unsafe food caused by their own reasons within the scope of their operations in accordance with the provisions of laws and regulations. Food operators should notify suppliers of recalls of unsafe food. The supplier shall promptly inform the producer.
Food producers and operators shall truthfully record the names, trademarks, specifications, production dates, batches, quantities, etc. The record keeping period shall not be less than 2 years.

【參考連結】

https://gkml.samr.gov.cn/nsjg/spjys/202011/t20201102_322851.html

http://banshi.beijing.gov.cn/pubtask/task/1/110105000000/26ef0e11-44f0-44bb-ba3a-d2ef627aa637.html?locationCode=110105000000&serverType=1001

http://big5.www.gov.cn/gate/big5/www.gov.cn/gongbao/content/2015/content_2937326.htm

HLF-TW-85

請問在中國有哪些專精於保健食品銷售與消費權益相關法律服務的業者？

Evershine RD：

江蘇健康律師事務所

http://www.jk-lawyer.com/index.html

中倫律師事務所

https://www.zhonglun.com/

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