Chapter I General provisions article specification for health food registration and filing, in accordance with the People's Republic of China Law on food safety, these measures are formulated.

Article People's Republic of China domestic health food registration and record-keeping, supervision and management of the application of this approach.

Article health food registration refers to applications for food and drug supervision and management departments according to the applicant, in accordance with legal procedures, conditions and requirements on the applicant for registration of health food safety and health functions and related applications such as quality control materials for evaluation and review and decide on whether or not to grant its approval process.

Health food registration refers to health food manufacturing enterprises in accordance with legal procedures, conditions and requirements, will indicate that the product safety, health and quality control of materials submitted to the food and Drug Administration for archiving, open, for future reference.

Article fourth of health food registration and record-keeping, supervision and management should follow scientific principles, open, fair, accessible and efficient.

Fifth, the State food and Drug Administration is responsible for the administration of registration of health food, and for the first time added to the import of vitamins, minerals and other nutrients health foods for the record management, and supervise the provinces, autonomous regions and municipalities directly under the food and Drug Administration Department of health food registration and filing work.

The provinces, autonomous regions and municipalities directly under the food and Drug Administration is responsible for the health food management in the administrative area, and with the State food and Drug Administration for health food registration on-site verification work.

City and County within food and drug supervision and management is responsible for the administrative registration and filing of health supervision and management of food, take other food and drug regulatory agency commissioned work.

Sixth the State food and drug administration of administrative organization (hereinafter referred to as the Organization) is responsible for handling registration of health food materials related to imported health food registration and receive.

The provinces, autonomous regions and municipalities directly under the food and Drug Administration is responsible for receiving relevant archival materials of health food.

The State food and Drug Administration health foods review agencies (hereinafter referred to as the review bodies) responsible for organizing the health foods review, management experts for the review, and shall assume related health food for the record.

State food and Drug Administration approved inspection bodies (hereinafter referred to as inspection bodies) responsible for health food registration on-site verification.

Seventh health food registration applicant or filing shall have the appropriate expertise, familiar with the health food management law, rules and regulations and the technical requirements.

Registration of health food materials submitted by the applicant or filing should the authenticity, integrity and traceability responsibility and legal liability for the authenticity of the submitted materials.

Health food registration applicant or record shall assist the food and drug administration and registration or filing the relevant samples of on-site verification, sampling, verification and supervision work.

Eighth provincial food and drug supervision and management departments should strengthen information construction and raise the level of health food registration and record management, progressive realization of electronic registration and records.

Chapter II registration article Nineth production and imports the following products shall apply for registration of health food: (a) use outside the list of raw materials of health food materials (hereinafter referred to as catalog material) health food (b) first imported health food (belongs to the health food of vitamins, minerals and other nutrients).

Health food imports for the first time, is not the same country, the same company, the same formula applies for listing in China sales of health food products.

Tenth products claiming health benefits should have been included in the list of health food.

11th in China domestic health food registration applicant shall be registered in the legal person or other organization; imported health food registration applicant should be listed outside of the health food manufacturer.

Apply for imported health food registration, should be determined by its permanent representative offices or by the principal-agency in China.

Overseas manufacturers, refers to the product in accordance with the host country (region) listing requirements of a legal person or other organization. 12th article application health food registered should submitted following material: (a) health food registered application table, and applicants on application material authenticity is responsible for of legal responsibility commitment book; (ii) registered application people subject registration proved file copies; (three) products development report, including development people, and development time, and development process, and in the try scale above of validation data, directory outside raw materials and the products security, and health function, and quality can control sex of argument report and related science according to, And according to development results integrated determine of products technology requirements,; (four) products formula material, including raw materials and accessories of name and the dosage, and production process, and quality standard, necessary Shi also should according to provides provides raw materials using according to, and using parts of description, and test certificate ming, and varieties identification report,; (five) products production process material, including production process diagrams and the description, key process points and the description; (six) security and health function evaluation material, including directory outside raw materials and the products of security, and

Health function test evaluation material, crowd edible evaluation material; effect components or logo sex components, and health learn, and stability, and strains identification, and strains HIV force, test report, and involved doping, and prohibited drug components, detection report; (seven) directly contact health food of packaging material type, and name, and related standard,; (eight) products label, and manual sample; products name in the of general name and registered of drug name not name of retrieved material; (nine) 3 a minimum sales packaging samples;

(J) other materials related to the review of product registration. 13th article application first imports health food registered, except submitted this approach 12th article provides of material outside, also should submitted following material: (a) products producer (area) Government competent sector or legal service institutions issued of registered application human listed health food outside production manufacturers of qualification proved file; (ii) products producer (area) Government competent sector or legal service institutions issued of health food listed sales a years above of proved file,

Overseas sales or product and food safety report on the situation of the crowd and (iii) product producers (regions) or the international organizations associated with health food technical regulations or standards (iv) product in the producing country (region) of packaging, labels and instructions listed sample.

By beyond the permanent registration of the representative office of China Affairs of the applicant, shall submit the certificate of registration of resident representative offices of foreign enterprises and its photocopies; outside the authorized agent for the territory of registration an application for registration, shall submit a notarized power of Attorney original and commissioned copy of agent license.

14th article accepted institutions received application material Hou, should according to following situation respectively made processing: (a) application matters law not need made registered of, should rates told registered application people not accepted; (ii) application matters law not belongs to national food drug supervision management general terms range of, should rates made not accepted of decided, and told registered application people to about administrative organ application; (three) application material exists can spot corrections of errors of, should allows registered application people spot corrections;

(Four) application material not complete or not meet statutory form of, should spot or in 5 a days within once told registered application people need correction of all content, late not told of, since received application material of day up that for accepted; (five) application matters belongs to national food drug supervision management general terms range, application material complete, and meet statutory form, registered application people according to requirements submitted all correction application material of, should accepted registered application.

Accept or not to accept applications for registration should be stamped with the State food and Drug Administration issued administrative permission to accept special and date in written form.

15th an accepting institution shall, within 3 working days after accepting the application materials be sent to the review bodies.

Article 16th review bodies review experts should be organized to review the application materials and organize inspection bodies to carry out on-site verification according to actual needs, organizing inspection agencies to carry out verification, within 60 working days to complete the review process, and submitted to the State food and drug supervision administration of comprehensive review of conclusions and recommendations.

Special circumstances need to extend review time, agreed by the heads of review agencies, can be extended by 20 working days, extend the decision shall promptly inform the applicant in writing. 17th article review institutions should organization on application material in the of following content for review, and according to science according to of sufficient degree clear products health function claimed of qualified terms: (a) products development report of integrity, and rationality and scientific; (ii) products formula of scientific, and the products security and health function; (three) directory outside raw materials and the products of production process rationality, and feasibility and quality can control sex; (four) products technology requirements and test method of scientific and repetition sex; (five) label, and

Manual sample normative content of product names.

Article 18th review bodies can provide access to the original information in the review process.

Review body finds that the application materials are true, product safety or quality control problems exist, or does not have the claimed health benefits, shall terminate the review and put forward proposals that are not registered. Article 19th review bodies consider necessary applicant supplement materials should be told to correct everything at once.

Registration shall make correction in accordance with the notice within 3 months of the applicant's request to provide supplementary materials after the Agency received the supplementary materials for the review, review time is recalculated.

Applicant fails to submit additional information or incomplete correction, not sufficient to prove that the product of the safety, health and quality control, review agency shall terminate the review and put forward proposals that are not registered.

20th review body finds that the need for on-site verification, shall notify the inspection agencies in accordance with the application of product research and development reports, formulation, technology, and other technical requirements for on-site verification and inspection inspection line sent product samples for review.

Inspection bodies shall be completed within 30 working days after receiving the notification of the on-site verification and verification reports submitted to the review bodies.

Considers the application materials verification report is not true, cannot trace repetition or there are significant defects, review agency shall terminate the review and put forward proposals that are not registered.

21st verification bodies should be strictly in accordance with the application of the method for determination and the related instructions, on the determination method of scientific validation, reproducibility, applicability, controllability check on product quality testing, and should be entrusted to review within 60 working days from the date of inspection, verification reports to the review bodies.

Method for determination verification to the conclusion that is not scientific, not replicate, not applicable or product quality control, review agency shall terminate the review and put forward proposals that are not registered.

22nd imported health food for the first time outside the site verification and verification time according to the actual condition of foreign manufacturers.

23rd health foods review involving the testing and inspection work should be selected by the State food and Drug Administration qualified food inspection agencies.

24th review body finds that the application materials, science, security, with claimed health benefits, reasonable, viable and production quality control, technical requirements and testing methods for scientific, reasonable, it shall submit a proposal to be registered. Recommendations of the review bodies refuse to register shall be simultaneously to the applicant written notice of the intention to refuse to register. Applicant of objection to the notice shall, within 20 working days of receipt of the notification the review agencies submit written applications for review and explain the grounds for reexamination.

Review is limited to the contents of the original application and the application materials. The review authority shall accept the application for review made within 30 working days from the date of decision.

Recommendations of the change shall be rejected for registration and shall notify the applicant in writing.

25th review agencies make a comprehensive review of conclusions and recommendations, shall be submitted within 5 working days the State food and drug administration.

26th State food and drug administration shall, within 20 working days from the date of the acceptance for review procedures and conclusions reviewed the legality, regularity and integrity, and to approve the decision to register or refuse to register.

27th field verification, verification, review and register the time required is not included in the review decision within the time limit.

28th State food and Drug Administration to approve the register or refuse to register after the decision, shall, within 10 working days from the date of the decision, issued to the applicant by the receiving institution health food registration certificate or refuse to register the decision.

29th applicant to the State food and Drug Administration made the decision to refuse to register any objections, may appeal to the State food and drug administration in writing an application for administrative reconsideration or administrative proceedings to the Court.

30th article health food registration of transfer of technology, the transferee shall, under the guidance of the transferor new product registration, product technical requirements should be consistent with the original application materials. Simplified procedures for the review of review bodies in accordance with the relevant provisions.

Meet the requirements, the State food and drug administration shall provide the transferee issue new health food registration certificate, transfer and registration of health food to be cancelled.

The transferee in addition to applications for registration of material as provided herein, shall also submit a notarized contract.

31st registration of health food certificate and their content changes, as contained in the annex, shall be registered by the health food apply changes and submit a written change reasons and basis.

Registrant name change, alternation shall be applied for by the applicant after the change.

32nd has production and sales of health food registration certificate needs to extend the expiry and registration of health food shall apply 6 months before the expiry of the validity period for an extension.

Registration of health food ingredients have been included in list of raw material of health food, and in conformity with the relevant technical requirements, health food registration application to change the registered person, or expired registration of renewal, shall be in accordance with the filing procedures. 33rd article application change domestic health food registered of, except submitted health food registered change application table (including applicants on application material authenticity is responsible for of legal responsibility commitment book), and registered application people subject registration proved file copies, and health food registered certificate and annex of copies outside, also should according to following case respectively submitted material: (a) change registered people name, and address of change application, also should provides the registered people name, and address change of proved material; (ii) change products name of change application, Also should provides intends change Hou of products general name and has registered of drug name not name of retrieved material; (three) increased health food function project of change application, also should provides by increased function project of function learn test report; (four) change products specifications, and shelf life, and production process, involved products technology requirements of change application, also should provides proved change Hou products of security, and health function and quality can control sex and original registered content real equivalent of material, and

Basis and 3 batches of samples conform to the technical requirements of the product after the change project-wide inspection report (v) changes in product labels and instructions application, should also provide the prospective health food labels, brochures samples. 34th article application continued domestic health food registered of, should submitted following material: (a) health food continued registered application table, and applicants on application material authenticity is responsible for of legal responsibility commitment book; (ii) registered application people subject registration proved file copies; (three) health food registered certificate and annex of copies; (four) by provincial food drug supervision management sector verified of registered certificate validity within health food of production sales situation; (five) crowd edible situation analysis report, and

Self-examination of the production quality management system operation report and meet the technical requirements of inspection reports.

Section 35th for imported health food registration or continued registration of changes, in addition to submitted this way the materials set forth in the 33rd, 34th, 13th paragraph these measures shall be submitted (a), (b), (c), (d) and related materials of the second paragraph.

36th applications to change based on the full reasonable and will not affect the safety, health and quality control, alter registration applications to change based on inadequate, unreasonable, or proposed changes affect product safety, function and quality control of health care, refuse to change registration.

37th renewal of registration of health food safety and health functions and meet the requirements of the quality control, continue to register.

Renewal of registration of health food safety and health functions and quality control based on insufficient or no longer meets the requirements, registration within the period of validity of the certificate for production and sales, and the registrant does not submit a renewal application within the prescribed time limit, registration isn't renewed. Article 38th received continuation of health food registration application in registration of health food food and drug supervision and management departments should make a decision on whether to approve the extension before the expiry of the certificate.

Fails to make a decision is deemed granted extended registration.

39th allowed to change registration or continued registration, issue a new certificate of registration of health food, and cancellation of the original health food registration certificate.

40th article health food registration changes with continuous registration procedure is not specified, these measures can apply relevant provisions on the registration of health food.

Chapter III registration certificates administration 41st article health food registration certificate shall contain the name, Registrant's name and address and registration number, issuing date and validity periods, health features, components, or iconic elements and content, product specifications, warranty, crowd, it's not the crowds, notes.

Health food registration certificate shall specify the product labels and instructions of main content and technical requirements of the product.

Product specification should include the product name, formula, process, sensory requirement, identification, physical and chemical indicators, microbiological, composition or iconic ingredient content and methods, volume or weight difference index (NET content and allow negative deviation indicator), raw material quality and so on. The 42nd article health food registration certificate is valid for 5 years.

Change registration of health food registration certificate is valid for the original health food registration certificate is valid for the same.

Article 43rd domestic health food registration number format: country food healthy note G+4-year number + 4-bit sequence number; imported health food registration number format: country food healthy note J+4-year number + 4-bit sequence number. The 44th during the term of registration of health food, health food registration certificate is lost or damaged, health food registration to the accepting institution shall submit a written application and state the reasons.

Having reissued, in provinces, autonomous regions, municipalities directly under the food and Drug Administration posted missing statement due to damage to apply for a replacement, should be returned to the original health food registration certificate. The State food and drug administration shall, within 20 working days after accepting to be reissued.

Replacement of health food registration certificate shall mark the original approval date, and indicate "issued retrospectively".

Fourth chapter record 45th production and imported health food shall, for the record the following: (a) the raw material used has been included in the list of raw materials of health food health food; (b) added to the first import of nutrients such as vitamins, minerals, health food products.

Added to the first import of nutrients such as vitamins, minerals, health food, nutritional substances should be included in the list of raw materials of health food materials.

Article 46th domestic health food registration shall be health food production enterprise, the original registrant can record people; imported health food registration, and should be listed outside of health food manufacturers.

47th record product formulations, raw material name and dosage, efficacy, production process shall comply with the laws, rules, regulations and mandatory standards and technical requirements of the raw materials of health food directory.

48th article application health food record, except should submitted this approach 12th article subsection (four), and (five), and (six), and (seven), and (eight) items provides of material outside, also should submitted following material: (a) health food record registration form, and record people on submitted material authenticity is responsible for of legal responsibility commitment book; (ii) record people subject registration proved file copies; (three) products technology requirements material; (four) has legal qualification of test institutions issued of meet products technology requirements full project test report;

(V) other product safety and health function of the material.

Section 49th for imported health food registration, in addition to the provisions of article 48th materials, should also be submitted to the first paragraph of this article 13th (a), (b), (c), (d) and related materials of the second paragraph.

50th received food and Drug Administration for record materials, archival materials to meet the requirements of, and record does not meet the requirements, should inform the people of filing corrections-related materials. 51st food and drug supervision and management departments should complete the record information is archived for future reference, and issued the record number.

Record-keeping of health food, the food and drug supervision and management departments should make the record voucher in accordance with requirements, and will record information in the table of the information posted on its Web site.

Domestic health food registration number format: + 2 food healthy G+4, provincial code + 6-digit order number; imported health food registration form: J+4 prepared food healthy-year code of +00+6 order number. 52nd has record of health food, you need to change the archival materials, records shall be submitted to the original filing authority change the description and related documents.

Archival materials to meet the requirements, the food and Drug Administration changes should be posted on the changes in the information, archival materials archived for future reference.

53rd health food registration information shall include the product name, file name and address, registration number, registration date, and product labels, instructions, and technical requirements.

Labels and instructions of the 54th chapter fifth application for health food registration or filing, product labels, brochures samples should include the product name, ingredients, materials, components or iconic elements and content, the crowd, it's not the population, health, consumption and consumption methods, specifications, storage, shelf-life, notes and related basis and description, and so on.

The 55th health food labels and instructions of main content not related to disease prevention, treatment, and stated that "this product cannot replace drugs."

56th health food names by brand name, generic name, and property name.

Brand name refers to health foods using a legally registered trademark name or the brand name is not registered under the trademark law, to show that its product is unique, different from other similar products.

Common name, refers to the name that product characteristics such as main raw material.

Property name refers to shows that formulations or food category properties, such as the name of the product.

57th name of health food shall not contain the following: (a) false, exaggerated or absolute terms, (ii) express or imply prevention, healing words, (c) vulgar or has superstitious color words, (iv) words of human tissues and organs (v) apart from the "" symbol other than and (vi) other words that mislead the consumer.

Name of health food shall not contain names, place names, such as Hanyu Pinyin, letters and numbers, but a registered trademark as a trademark, common name contains comply with national regulations containing letters and numbers except for the raw material.

58th article general name shall not contains following content: (a) has registered of drug general name, but to raw materials name named or health food registered approved prior of except; (ii) health function name or and expressed products health function related of text; (three) easy produced misleading of raw materials shorthand name; (four) nutrients added agent products formula in the part vitamin or minerals; (five) legal regulations provides ban using of other words.

59th record health foods common name should be to regulate the material name.

60th the same enterprise may not use the same formula to register different names or filing health food cannot be registered using the same name or record different formulations of health food products.

Supervision and administration of the sixth chapter the 61st State food and Drug Administration should promptly formulate and publish a health food registration services guide and review details of applicant Declaration.

The 62nd article health food review, verification, and inspection agencies and personnel should review, verification reports, test reports issued by responsible.

Health foods review, verification, inspection agencies and personnel in accordance with the provisions of the relevant laws, regulations, rules, abide by professional ethics, in accordance with food safety standards, technical specifications and other health food products for review, verification and testing, ensuring scientific, objective and fair.

63rd in the health food registration and record management work units and individuals shall keep informed in the registration or filing of the trade secret.

It is a commercial secret, and filing an application for registration in the register or record should clearly related in content and based on the information submitted.

64th food and Drug Administration received a unit or individual reports of health food registration to receive, review, verification, inspection, examination and approval after such violations in the work, shall be verified in a timely manner.

65th involve State secrets, business secrets and food and drug supervision and Administration Department shall complete the registration or within 20 working days from the date of filing in accordance with the relevant duties published in the Web site has registration or filing of the list of health food products and related information.

66th article has following case one of of, national food drug supervision management general according to interest relationship people of requests or according to terms, can revoked health food registered certificate: (a) administrative organ staff abuse, and negligence made granted registered decided of; (ii) beyond statutory terms or violation statutory program made granted registered decided of; (three) on not has application qualification or not meet statutory conditions of registered application people granted registered of;

(D) other circumstances may revoke the registration of health food certificate according to law.

Registered person by fraud, bribery or other improper means to obtain registration of health food, the State food and Drug Administration should be rescinded. 67th article has following case one of of, national food drug supervision management General should law handle health food registered cancellation procedures: (a) health food registered validity expires, registered people not application continued or national food drug regulatory General not continued of; (ii) health food registered people application cancellation of; (three) health food registered people law terminated of; (four) health food registered law was revoked, or health food registered certificate law was revoked of; (five) according to scientific research of development,

There is evidence that health food products may present a security risk, is withdrawn in accordance with law, and (vi) cancellation of registration of health food should be provided for in laws and regulations of other cases.

68th article has following case one of of, food drug supervision management sector canceled health food record: (a) record material false of; (ii) record products production process, and products formula, exists security problem of; (three) health food production enterprise of production license was law revoked, and cancellation of; (four) record people application canceled record of; (five) law should canceled record of other case.

The seventh chapter legal liability the 69th health food registration and record-keeping violations, the food safety law and other laws and regulations have been stipulated, in accordance with its provisions.

70th applicant concealing facts or providing false information to apply for registration, the State food and Drug Administration not to accept or to refuse to register and give a warning in which the applicant may not apply again for registration within 1 year of the health food constitutes a crime, criminal responsibility shall be investigated according to law. 71st applicant by fraud, bribery or other improper means to obtain health food registration certificate by the State food and Drug Administration revoke registration of health food certificate and fines of between 10,000 yuan and 30,000 yuan.

Licensee shall not apply for register again within 3 years constitutes a crime, criminal responsibility shall be investigated according to law.

72nd under any of the following circumstances, government food and drug supervision and administration departments at or above the county level shall impose a penalty of more than 10,000 yuan to 30,000 yuan constitutes a crime, criminal responsibility shall be investigated according to law.

(A) unauthorized transfer of health food registration certificate, (ii) who forge, alter, resell, lease, lend a health food registration certificate.

73rd food and drug supervision and management departments and their staff to an applicant who does not meet the requirements for registration, or beyond the statutory authority for registration, be dealt with in accordance with the food safety law, provisions of the 144th article.

Food and drug registration review process management and staff abuse, negligence, malpractice, be dealt with in accordance with food safety laws the 145th article. Eighth chapter by-laws section 74th for imported health food registration and for imported health food registration and changes shall submit the materials in Chinese, foreign language materials are attached. Chinese translations should be notarized in notarial institutions, ensuring consistent with original content; registration standards (Chinese version), the format must conform to the quality standards of health foods in China.

Organization certificate issued shall be subject to outside producers (region) of notarization and State in which the Chinese Embassy confirmed. 75th these measures come into force on July 1, 2016. Published on April 30, 2005, the administrative measures for health food registration (trial) (formerly the national food and drug administration, 19th) repealed simultaneously.