February 27, 2016
Order of China Food and Drug Administration
No. 22
The Provisions on Health Food Registration and notification Administration were reviewed and passed during the administrative meeting of China Food and Drug Administration on February 4, 2016, and are now released and will become effective from July 1, 2016.
Bi Jingquan, Director
February 26, 2016
Provisions on Health Food Registration and notification Administration
Chapter 1. General
Article 1. The provisions are established in accordance with the Law on Food Safety of the People’s Republic of China to standardize health food registration and notification.
Article 2. The regulations are applicable to health food registration and notification as well as the supervision and administration in the People’s Republic of China.
Article 3. Health food registration refers to the review and approval process in which the food and drug administration authority reviews the application of the registration applicant by complying with the legal procedures, conditions and requirements to carry out systematic assessment and review of the relevant application documents to determine the safety, health functions and quality controllability for health food being registered, and finally making a decision whether to approve the registration.
Health food notification refers to the process in which the health food manufacturer complies with the legal procedures, conditions and requirements to provide documents showing the product safety, health functions and quality controllability to the food and drug administration authority for notification, release, and search.
Article 4. Health food registration and notification as well as the supervision and administration should be performed according to scientific, open, fair, convenient, and effective principles.
Article 5. China Food and Drug Administration is responsible for health food registration and administration as well as the notification administration for health foods imported for the first time and belonging to nutritious substance groups such as vitamin supplements or minerals, as well as guiding and supervising the relevant work for health food registration and notification under the responsibility of the food and drug administration authority of provinces, autonomous regions and direct municipalities.
The food and drug administration authority of provinces, autonomous regions and direct municipalities is responsible for the notification administration of health foods in their own administrative region, and gives support to the relevant work such as on-site inspection for health food registration to China Food and Drug Administration.
The food and drug administration authority of municipal and county level is responsible for the supervision and administration of health food registration and notification in their own administrative region, and completes other work entrusted by the food and drug administration authority of the superior level.
Article 6. The administrative accepting organization of China Food and Drug Administration (hereinafter called the accepting organization) is responsible for accepting health food registration and receiving the notification documents for the relevant imported health foods.
The food and drug administration authority of provinces, autonomous regions and direct municipalities is responsible for accepting the notification documents for the relevant health foods.
The review organization for health foods of China Food and Drug Administration (hereinafter called the review organization) is responsible for organizing health foods review, managing review experts, and the relevant notification work for health foods in accordance with the relevant laws and regulations.
The audit and inspection organization of China Food and Drug Administration (hereinafter called the inspection organization) is responsible for on-site inspection work for health food registration.
Article 7. The health food registration applicant or notifier should have the relevant professional knowledge and be familiar with the relevant laws, regulations, rules and technical requirements for health food registration administration.
The health food registration applicant or notifier should be responsible for the authenticity, integrity and traceability of the provided documents, and should bear legal liabilities for the authenticity of the submitted documents.
The health food registration applicant or notifier should give support to the food and drug administration authority to carry out work such as on-site inspection, sampling, review inspection and supervision related to registration or notification.
Article 8. The food and drug administration authority above provincial level should strengthen information establishment, improve the information level of the health food registration and notification administration, and gradually implement electronic registration and notification.
Chapter 2. Registration
Article 9. In case of production and import of the following products, health food registration should be applied:
(1) Health food in which ingredients not listed in the Health Food Ingredients List (hereinafter called non-listed ingredients) is used;
(2) Health food imported for the first time (except health foods belonging to nutritious substance groups such as vitamin supplements or minerals).
Health food imported for the first time refers to health food not produced in the same country, by the same manufacturer or with the same formula, and has an application to be released in the market in China.
Article 10. The health functional claim for products should be listed in the health food functional claims list.
Article 11. The registration applicant of domestic health food should be the legal person or other organization legally registered in China; and the registration applicant of imported health food should be the foreign manufacturer of health food released in the market.
Where registration of imported health food is applied for, the application should be made by its representative office in China or the entrusted agent in China.
Foreign manufacturer refers to the legal person or other organization for which the product meets the requirements for release in the market in that country (region).
Article 12. When applying for health food registration, the following documents should be provided:
(1) The application form for health food registration, and the legal certification of the applicant regarding the authenticity of the application documents;
(2) A copy of the registration certificate of the entity of the registration applicant;
(3) Report on product R&D, including the developers, development time, development course, validation data of pilot tests and above, reasoning report and relevant scientific basis for the safety, health function and quality controllability of non-listed ingredients and products, as well as the product technical requirements comprehensively determined in accordance with the R&D results;
(4) Product formulation documents, including the name and quantity of use of ingredients and excipients, production process, specification, and when necessary, providing the basis for use of ingredients, instructions for the location of use, conforming certificate in inspection, report on type appraisal, etc.;
(5) Product production process document, including production process chart and instructions, and the key process control points and instructions;
(6) Safety and health function assessment documents, including the safety and health function test and assessment document for non-listed ingredients and products, and the assessment document for human use; the report on test of functional ingredients or nominal ingredients, hygienics, stability, bacteria identification, bacteria toxicity, etc., as well as the report on test of ingredients of stimulant and illicit drugs;
(7) The type, name, relevant standards, etc. of packing material in direct contact with the health food;
(8) Draft of product label and instructions for use; and research documents which show that the generic name in the product name is not the same as the name of any registered drug;
(9) 3 samples of the smallest packaged retail product;
(10) Other documents related to product registration review.
Article 13. When applying for registration of health food imported for the first time, in addition to documents specified in Article 12 in the Provisions, the following documents should also be provided:
(1) The qualification certificate of the registration applicant as a foreign manufacturer of the health food to be released in the market, which is issued by the competent governmental authority or legal service organization in the product production country (region);
(2) A certificate issued by the competent governmental authority or legal service organization in the product production country (region) showing that the health food has been sold in the market for over one year, or a report on safety in foreign sales of the product and human use;
(3) Product production country (region) or international organization technical regulations or standards related to the health food;
(4) Actual sample of the packing, label and instructions for use for the product released in the market in the production country (region).
Where the registration is carried out by a permanent representative office of the foreign registration applicant in China, the Certificate of Registration of Permanent Representative Office of Foreign Enterprise and its copy should be provided; and where the registration is carried out by a domestic agent as entrusted by the foreign registration applicant, the original of the notarized power of attorney and the copy of the business license of the entrusted agent should be provided.
Article 14. When the accepting organization receives the application documents, it should handle the case in accordance with the following situations:
(1) Where the applied item is not required to be registered in accordance with the relevant laws and regulations, the registration applicant should be notified promptly that the application is not accepted;
(2) Where the applied item does not fall into the scope of responsibility of China Food and Drug Administration, the determination not to accept the application should be made in a timely fashion, and the registration applicant should be notified to apply to the relevant administrative authority;
(3) Where any application document has any error which can be corrected on site, the registration applicant should be allowed to correct it on site;
(4) Where the application documents are not complete or do not comply with the legal form, the registration applicant should be notified on site or within 5 working days at one time for all the contents required to be added and/or corrected, and where the registration application is not notified upon expiry, the application is accepted from the date of receiving the application documents;
(5) Where the applied item falls into the scope of responsibility of China Food and Drug Administration and the application documents are complete and comply with the legal form, and the registration applicant complies with the requirements to provide all the added and/or corrected application documents, the registration application should be accepted.
Regardless of whether the registration application is accepted or not, a dated written certificate affixed with the special seal for administrative permit of China Food and Drug Administration should be issued.
Article 15. The accepting organization should send the application documents to the review organization within 3 working days after receiving them.
Article 16. The review organization should organize review experts to review the application documents; organize the review organization to carry out on-site review based on actual needs; organize the inspection organization to carry out review inspection; complete the review work within 60 working days; and send comprehensive review conclusions and proposals to China Food and Drug Administration.
Where the time for review is required to be extended in special situations, the time can be extended for 20 working days upon the approval of the responsible person of the review organization. The decision to extend the time should be notified in writing to the applicant in a timely manner.
Article 17. The review organization should organize review for the following contents in the application documents, and clarify the defined words claiming health functions in accordance with the level of adequacy of scientific basis:
(1) The completeness, rationality and scientific level of the product R&D report;
(2) The scientific level of the product formulation, and the safety and health functions of the product;
(3) The rationality, feasibility and quality controllability of the production processes for non-listed ingredients and products;
(4) The scientific level and repeatability of product technical requirements and inspection methods;
(5) The main contents in the draft of the label and instructions for use as well as the standardization of the product name;
Article 18. The review organization can access and review the source documents in the process of review.
Where the review organization considers that any application document is not true, or the product has a safety or quality controllability issue, or does not have the claimed health function, it should terminate the review and give a proposal for denial of registration.
Article 19. Where the review organization considers that the registration applicant must add and/or correct any document, all the contents to be added and/or corrected should be notified at the same time. The registration applicant should provide the documents to be added and/or corrected within 3 months on one occasion in accordance with the addition and correction notice; and when the review organization receives the documents added and/or corrected, the review time is recalculated.
Where the registration applicant fails to provide the documents that need to be added or fails to complete the correction upon expiry and it is not sufficient to prove the product safety, health function and quality controllability, the review organization should terminate the review and give a proposal for denial of registration.
Article 20. Where the review organization requires an on-site inspection, it should promptly notify the inspection organization to comply with the technical requirements in the product R&D report, formulation, production process, etc. in the application documents to carry out on-site inspection, and send sealed samples of the product from the production line to the review inspection organization for inspection.
The inspection organization should complete the on-site inspection within 30 working days from receiving the notice, and send the inspection report to the review organization.
Where it is considered in the inspection report that any application document is not true, there is no traceability and repeatability or there is any major defect, the review organization should terminate the review and give a proposal for denial of registration.
Article 21. The review inspection organization should strictly follow the test method and the relevant instructions in the application documents to carry out operations, and validate the science, repeatability and suitability of the test method, and carry out review inspection for the product quality controllability, and should complete the review inspection within 60 working days from receiving the entrustment, and send the review inspection report to the review organization.
Where it is considered in the review inspection conclusion that the test method is not scientific, cannot be repeated or is not suitable or the product quality cannot be controlled, the review organization should terminate the review and give a proposal for denial of registration.
Article 22. The time limit for foreign on-site review and review inspection for health foods imported for the first time is determined in accordance with the actual situations of the foreign manufacturer.
Article 23. The test and inspection work involved in health food review should be done by a qualified food inspection organization selected by China Food and Drug Administration.
Article 24. Where the review organization considers that the application documents are true, the product is scientific and safe and has the claimed health function, the production process is reasonable and feasible and the quality is controllable, and the technical requirements and inspection method are scientific and reasonable, it should give a proposal for approval of registration.
Where the review organization gives a proposal for denial of registration, it should at the same time give a written notice to the registration applicant for denial of registration. Where the registration applicant has any objection to the notice, it should provide a written review application to the review organization within 20 working days from receiving the notice and state the reason for review. The contents in the review should be only limited to the original applied items and application documents.
The review organization should make a decision on review within 30 working days from accepting the review application. Where the proposal for denial of registration is changed, the registration applicant should be notified in writing.
Article 25. When the review organization makes the comprehensive review conclusion and proposal, it should provide them within 5 working days to China Food and Drug Administration.
Article 26. China Food and Drug Administration should carry out review for the legality, standardization and completeness of the review process and conclusion within 20 working days from the date of accepting, and make a decision to approve or not approve the registration.
Article 27. The time required for on-site inspection, review inspection and recheck is not included in the time limit to make the review and registration decision.
Article 28. When China Food and Drug Administration makes a decision to approve or not approve the registration, the accepting organization should issue a health food registration certificate or a decision not to approve the registration to the registration applicant within 10 working days of making a decision.
Article 29. Where the registration applicant has any objection to the decision not to approve the registration made by China Food and Drug Administration, it can provide a written administrative review application to China Food and Drug Administration or make administrative procedures to the People’s Court.
Article 30. Where the health food registrant transfers any technology, the transferee should make product registration application again with the guidance of the transferor, and the product technical requirements, etc. should be consistent with those in the previous application documents.
The review organization should simplify the review processes in accordance with the relevant regulations. Where the requirements are met, China Food and Drug Administration should issue a new health food registration certificate to the transferee and cancel the health food registration of the transferor.
In addition to the registration application documents specified in the Provisions, the transferee should also provide the notarized transfer contract.
Article 31. Where any content in the health food registration certificate or its attachment is changed, the health food registrant should apply for change and provide the reason and basis for change in writing.
Where the name of the registrant is changed, an application for change should be made by the registration applicant after the change.
Article 32. Where the registration certificate for health food which has been produced and sold expires and renewal is needed, the health food registrant should apply for renewal 6 months prior to expiry.
Where the registered health food ingredient is listed in the Health Food Ingredients List and complies with the relevant technical requirements and the health food registrant makes an application to change the registration, or an application is made for renewal of registration upon expiry, the notification procedures should be followed.
Article 33. Where an application is made to change the registration of domestic health food, in addition to the health food registration change application form (including the legal certification of the applicant regarding the authenticity of the application documents), the copy of the registration certificate of the entity of the registration applicant, and the copy of the health food registration certificate and its attachment, documents should also be submitted in accordance with the following situations:
(1) For application to change the name and/or address of the registrant, the certificate of change of the name and/or address of the registrant should also be provided;
(2) For application to change the product name, the research document showing that the generic name of the product to be changed is not the same as the name of any registered drug should also be provided;
(3) For application to add any function of the health food, the report on function test of the added function should also be provided;
(4) For application to change the product technical requirements involving the product specification, shelf life, production process, etc., documents and basis proving that the product safety, health function and quality controllability after change are materially the same as those in the previous registration as well as the report on test of all the items meeting the product technical requirements with samples from 3 lots after the change should also be provided;
(5) For application to change the product label and/or the instructions for use, the sample of draft of the health food label and/or instructions for use should also be provided.
Article 34. Where an application is made to renew the registration of domestic health food, the following documents should be provided:
(1) The application form for renewal of health food registration, and the legal certification of the applicant regarding authenticity of the application documents;
(2) Copy of the registration certificate of the entity of the registration applicant;
(3) Copy of the health food registration certificate and its attachment;
(4) The production and sales of the health food within the valid period of the registration certificate verified by the food and drug administration authority of provincial level;
(5) Analysis report on use in populations, self-check report on the production quality management system as well as the inspection report complying with the product technical requirements.
Article 35. Where an application is made to change the registration or renew the registration of imported health food, in addition to the documents specified in Article 33 and 34, respectively, in the Provisions, the relevant documents specified in Items (1), (2), (3) and (4) in Clause 1 and in Clause 2 in Article 13 in the Provisions should also be provided.
Article 36. Where the reason and basis for the change application are adequate and reasonable and the product safety, health function and quality controllability are not influenced, the change of registration is approved; and where the reason and basis for change application is not adequate and not reasonable, or any item planned to be changed has influence on the product safety, health function and quality controllability, the change of registration is not approved.
Article 37. Where the safety, health function and quality controllability of the health food for which an application is made to renew the registration comply with the requirements, the renewal of registration is approved.
Where the safety, health function and quality controllability of the health food for which an application is made to renew the registration have no sufficient basis or do not meet the requirements any longer, no production or sales are carried out in the valid period of the registration certificate, or the registrant does not make an application for renewal in the specified period, the renewal of registration is not approved.
Article 38. The food and drug administration authority receiving the application to renew the registration of health food should make a decision to approve the renewal or not prior to the expiry of the health food registration certificate. Where no decision is made upon expiry, it is deemed that the renewal of registration is approved.
Article 39. Where the registration change or renewal is approved, a new health food registration certificate is issued, and at the same time the previous health food registration certificate is canceled.
Article 40. Where there are no provisions for the registration change and registration renewal procedures for health food, the relevant provisions for health food registration in the Provisions can be used.
Chapter 3. Registration certificate administration
Article 41. In the health food registration certificate, the product name, name and address of the registrant, Registration No., date of issue and valid period, health function, functional ingredient or nominal ingredient and content, product specification, shelf life, suitable population, unsuitable population, and precautions should be stated.
The main contents of the product label and instructions for use and product technical requirements, etc., should be stated in the attachment to the health food registration certificate.
The product technical requirements should include the product name, formulation, production process, sensory requirements, identification, physical and chemical indexes, microorganism indexes, content and test method of functional ingredients or nominal ingredients, difference index of packed content or weight (index of allowable negative deviation from net weight), quality requirements of ingredients and excipients, etc.
Article 42. The health food registration certificate is valid for 5 years. The valid period of health food registration certificate with change of registration is the same as that of the previous health food registration certificate.
Article 43. The format of the registration number for domestic health food is State Food Health Registration G + 4-digit year code + 4-digit serial number; and the format of the registration number for imported health food is State Food Health Registration J + 4-digit year code + 4-digit serial number.
Article 44. Where the health food registration certificate is lost or damaged in the valid period of the health food registration, the health food registrant should make a written application to the accepting organization for re-issue and state the reason. Where an application is made for re-issue if lost, a missing declaration should be released on the website of the food and drug administration authority above province level; and where an application is made for re-issue if damaged, the original of the health food registration certificate should be returned.
China Food and Drug Administration should re-issue the certificate within 20 working days after accepting the application. In the re-issued health food registration certificate, the original date of approval should be stated, and “Re-issue” should be stated.
Chapter 4. Notification
Article 45. Where the following health foods are produced and/or imported, they shall be notified in accordance with the relevant laws and regulations:
(I) Health food in which the ingredient used is listed in the Health Food Ingredients List;
(2) Health food that belongs to nutritious substances such as vitamin supplements and mineral substances and is imported for the first time.
For health food belonging to nutritious substances such as vitamin supplements and mineral substances and is imported for the first time, the nutritious substance should be one listed in the Health Food Ingredients List.
Article 46. The notifier of domestic health food should be the health food manufacturer, and the original registrant can be the notifier; and the notifier of imported health food should be the foreign manufacturer of the health food released in the market.
Article 47. The notified product formulation, name and quantity of use of ingredient and excipient, function, production process, etc. should comply with the provisions in the relevant laws, regulations, rules, mandatory standards as well as the technical requirements in the ingredients list of health food.
Article 48. When applying for notification of health food, in addition to the documents specified in Clause (4), (5), (6), (7) and (8) in Article 12 in the Provisions, the following documents should also be provided:
(1) Form for notification registration of health food, and the legal certification of the notifier regarding the authenticity of the provided documents;
(2) Copy of the registration certificate of the entity of the notifier;
(3) documents for technical requirements of the product;
(4) Report of testing for all items complying with the product technical requirements issued by an inspection organization with legal qualifications;
(5) Other documents showing the safety and health functions of the product.
Article 49. When applying for notification of imported health food, in addition to the relevant documents specified in Article 48 in the Provisions, the relevant documents specified in Item (1), (2), (3) and (4) in Clause 1 and in Clause 2 in Article 13 in the Provisions should also be submitted.
Article 50. Where the food and drug administration authority receives the documents for notification and the documents for notification comply with the relevant requirements, on site archiving is carried out; and where any document does not comply with the requirements, the notifier should be notified at one time to add and/or correct the relevant document.
Article 51. The food and drug administration authority should complete the archiving and search work for the notification information and issue the notification number. For notified health food, the food and drug administration authority should comply with the relevant required format to make the notification voucher, and release the information in the notification information form on its website.
The format of notification number for domestic health food is State Food Health notification G + 4-digit year code + 2-digit administrative region code + 6-digit serial number; and the format of notification number for imported health food is State Food Health notification J + 4-digit year code + 00 + 6-digit serial number.
Article 52. Where change of any notified document is required for notified health food, the notifier should provide the statement for the change and the relevant certificates to the original notified authority. Where the documents for notification meet the relevant requirements, the food and drug administration authority should register the change in the information for change, and file the notification documents.
Article 53. The notification information of health food should include the product name, name and address of the notifier, the notification registration number, the date of registration as well as the product label and instructions for use and the technical requirements.
Chapter 5. Label and instructions for use
Article 54. Where an application is made for health food registration or notification, the draft of the product label and instructions for use should include the product name, ingredients, excipients, functional ingredients or nominal ingredients and contents, suitable population, unsuitable population, health functions, quantity of use and method of use, specifications, storage method, shelf life, precautions as well as the relevant establishment basis and instructions.
Article 55. The main contents on the label and in the instructions for use of health food must not involve disease prevention or treatment function, and must declare, “This product cannot be used as a replacement for prescription drugs”.
Article 56. The name of health food consists of the trademark name, generic name and property name.
Trademark name refers to the trademark name of health food registered in accordance with the relevant laws and regulations or unregistered trademark name complying with the provisions in the Law on Trademark, which is used to show that the product is proprietary and can differentiate the product from other similar products.
Generic name refers to the name showing the features of the product such as the main ingredient.
Property name refers to the name of the product showing the preparation or category of the food.
Article 57. The name of the health food must not contain any of the following contents:
(1) False, exaggerated or absolute wording;
(2) Express or implied word for disease prevention or treatment function;
(3) Vulgar or superstitious wording;
(4) Names of human body parts and organs;
(5) Symbols except “”.
(6) Other words misleading consumers.
The name of health food must not contain the name of people, places, Chinese spelling, letters and numbers, etc., except registered trademark as the trademark name and generic name containing ingredient name with letter and/or number complying with the provisions of the State.
Article 58. Generic name must not contain any of the following contents:
(1) Generic name of registered drug, except those named in the name of ingredient or which is first approved for registration of health food;
(2) Name of health function or word related to describing the health function of the product;
(3) Abbreviation of ingredient which is easily misleading;
(4) Some vitamins or mineral substances in the formulation of nutrient supplement product.
(5) Other words prohibited for use in accordance with the relevant laws and regulations.
Article 59. The generic name to notify health food should be named with the standardized name of the ingredient.
Article 60. The same manufacturer must not use the same formulation to register or notify health foods of different names, and must not use the same name to register or notify health foods of different formulations.
Chapter 6. Supervision and Administration
Article 61. China Food and Drug Administration should promptly establish and release guidelines for registration application of health food and the review rules, to facilitate application for the registration applicant.
Article 62. Organizations and personnel responsible for health food review, audit, and inspection should be responsible for the issued review opinion, audit report, and inspection report.
Organizations and personnel for health food review, audit and inspection should comply with the provisions in the relevant laws, regulations and rules, follow the code of conduct, and follow the food safety standards and technical specifications to carry out review, audit and inspection for health foods, and ensure that the relevant work is scientific, objective and fair.
Article 63. Organizations and individuals participating in administration of health food registration and notification should keep the confidentiality of business secrets received in the process of registration or notification.
In case of business secret, the registration applicant and notifier should state the relevant content and basis in the provided documents when applying for registration or notification.
Article 64. When the food and drug administration authority receives report on violation of the relevant laws and regulations in health food registration accepting, review, audit, inspection, approval, etc. from any relevant organization or individual, it should promptly carry out verification and management.
Article 65. Except State secrets or business secrets, the food and drug administration authority should release the registered or notified health foods list and the relevant information on the website according to the relevant responsibilities within 20 working days from completion of registration or notification.
Article 66. In case of one of the following situations, China Food and Drug Administration can revoke the health food registration certificate in accordance with the request of the interested party or in accordance with its rights and obligations:
(1) The registration approval is obtained by personnel in an administrative authority through malpractice or negligence;
(2) The registration approval is determined by exceeding the legal rights and obligations or in violation of any legal procedure;
(3) The registration is approved for any registration applicant who does not have the application qualifications or does not comply with the legal conditions;
(4) Any other situation in which the health food registration certificate can be cancelled in accordance with the relevant laws and regulations.
Where the registrant obtains the heath food registration in improper manner such as cheating or bribe, China Food and Drug Administration should revoke such registration.
Article 67. In case of one of the following situations, China Food and Drug Administration should handle formalities to cancel the health food registration in accordance with the relevant laws and regulations:
(1) Upon expiry of the health food registration, the registrant does not apply for renewal or China Food and Drug Administration does not approve the renewal;
(2) The health food registrant applies for cancellation;
(3) The health food registrant terminates it in accordance with the relevant laws and regulations;
(4) The health food registration is cancelled in accordance with the relevant laws and regulations, or the health food registration certificate is revoked in accordance with the relevant laws and regulations;
(5) According to scientific research and development, there is evidence showing that the health food may have a potential safety problem, and the health food registration is revoked;
(6) Any other situation in which the health food registration should be canceled as specified in the relevant laws and regulations.
Article 68. In case of one of the following situations, the food and drug administration authority will revoke the health food notification:
(1) Any notification document is false;
(2) The production process, product formulation, etc. of the notified product has any safety issue;
(3) The production permit of the health food manufacturer is revoked or canceled in accordance with the relevant laws and regulations;
(4) The notifier applies to cancel the notification;
(5) Any other situation in which the notification should be cancelled in accordance with the relevant laws and regulations.
Chapter 7. Legal Liabilities
Article 69. As for any illegal action in health food registration and notification, where there is provision in the relevant laws and regulations such as the law on food safety, such provision governs.
Article 70. Where the registration applicant hides any true information or provides any false documents to apply for registration, China Food and Drug Administration will not accept the application or will not register it, and will give a warning; and the applicant is not allowed to reapply for food product registration within 1 year. If these actions are criminal, the applicant will be held criminally responsible.
Article 71. Where the registration applicant obtains the health food registration certificate with improper manner such as cheating or bribe, China Food and Drug Administration will revoke the health food registration certificate, and penalize with a fine greater than RMB 10,000 and less than RMB 30,000. The licensee is not allowed to re-apply for registration within 3 years; and where crime is involved, the criminal liabilities will be borne in accordance with the relevant laws and regulations.
Article 72. In case of one of the following situations, a penalty fine greater than RMB 10,000 and less than RMB 30,000 will be issued by the food and drug administration authority of the People’s Government above county level; and where crime is involved, the criminal liabilities will be borne in accordance with the relevant laws and regulations.
(1) Unauthorized transfer of health food registration certificate;
(2) Forge, alter, sell, lease, or lend any health food registration certificate.
Article 73. Where any food and drug administration authority and any of its personnel approve the registration for unqualified applicant, or approve the registration beyond the legal rights and obligations, the provisions in Article 144 in the Law on Food Safety shall govern.
In the process of registration review, where any food and drug administration authority and any of its personnel misuse any right and obligation or have negligence or malpractice, the provisions in Article 145 in the Law on Food Safety shall govern.
Chapter 8. Supplementary Provisions
Article 74. When applying for registration of health food imported for the first time or handling notification and change of imported health food, documents in Chinese should be provided, and documents in foreign languages should be attached. The Chinese translation should be notarized by a domestic notary public to ensure that it is consistent with the original contents; and the product specifications (Chinese version) for registration application must comply with the format of the specifications for health food in China. Certificates issued by foreign organizations should be notarized by a notary public in the production country (region) and confirmed by the embassy or consulate of China in the country.
Article 75. The Provisions are effective from July 1, 2016. The Health Food Registration and Notification Administration Provisions (draft) released on April 30, 2005 (formerly Order No. 19 of China Food and Drug Administration) is cancelled at the same time.
