Chapter 1: General Provisions
Article 1: To standardize the acceptance of new food resource applications and ensure transparency, fairness, and impartiality in licensing, these Regulations are hereby established.
Article 2: The term "new resource food" as used in these Regulations refers to domestic and imported new resource foods approved by the Ministry of Health in accordance with the Food Hygiene Law of the People's Republic of China and the Measures for the Administration of New Resource Foods.
Article 3: The acceptance of applications for new food resources shall strictly comply with relevant regulations, including the "Administrative Measures for Health Administrative Licensing" and the "Procedures for Health Administrative Licensing of Health-Related Products."
Article 4: General Requirements for Application Materials:
(1) For initial applications for new food resource licensing, submit 1 original(s) and 4 copy/copies.
(2) Except for inspection reports and official certificates, all pages of the original application documents must be stamped with the applicant's official seal or a continuous-page stamp. For individual applicants, each page must bear the applicant's personal seal or signature, along with a copy of their ID card.
(3) Print on A4 paper, use clear distinguishing markers, arrange in the prescribed order, and bind into a booklet.
(4) Use China's legal units of measurement;
(5) Application materials must be complete and clear, and information for the same project must be consistent throughout.
(6) Foreign-language materials in the application shall be translated into standardized Chinese, and the translation
The text shall be attached before the corresponding foreign-language materials, except for ingredient names, personal names, and foreign addresses that must be in English or Latin as required by these regulations.
(7) Submission materials must be authentic and lawful. Copies shall be reproduced from originals, must be clear, and must match the originals exactly.
Chapter 2: Application Documents for License Submission
Article 5: To apply for a new food resource permit, the following materials must be submitted:
(1) Application Form for Food Safety Administrative Licensing of New Food Resources (Attachment 1);
(II) Development report and safety research report;
(3) Brief Description of Production Process and Flowchart;
(IV) Product Quality Standards;
(V) Status of domestic and international research utilization and relevant safety data;
(VI) Product Labels and Instructions;
(7) For agency declarations, a notarized power of attorney must be provided.
(8) Other materials helpful for the review.
Additionally, 1 unopened samples or 30 grams of raw material are enclosed.
Applications for new food resources for import shall also submit:
(1) Certification from relevant authorities or institutions in the country (or region) of origin confirming that the food is approved for production (or sale) there, or documentation demonstrating its traditional history of consumption in that country (or region).
(II) Authorization Letter from the Responsible Entity in China.
Article 6: For products produced via entrusted processing, in addition to the above regulations
In addition to the submitted materials, the following documents are also required:
(1) Entrusted processing agreement signed between the principal and the contractor;
(2) For imported products, submit proof of the manufacturer's quality management system or Good Manufacturing Practice (GMP) certification.
(3) Domestic products must provide a copy of the hygiene license issued to the contracted manufacturing enterprise.
Chapter 3: Specific Requirements for Submission Documents
Article 7: The content of the development report shall comply with the requirements set forth in the "Guidelines for New Food Resource Development Reports" (Attachment 2).
Article 8: The Security Research Report shall include the following content:
(I) Toxicological examination report or data;
(II) Hygiene inspection report or supporting documents;
(3) Component analysis report and testing methods or documentation;
(4) Pathogenicity, antimicrobial resistance, and toxin production test reports or data (required when submitting applications for microorganisms with no established food consumption history in China or for new microbial strains used in food processing).
(5) Provide human epidemiological data when necessary;
(vi) Other safety data that may assist the review.
Article 9: The brief description and flowchart of the production process shall include the following items:
(1) Detailed and standardized process specifications, process flow diagrams, technical parameters, and key technical requirements; names, specifications, and quality requirements for raw materials and auxiliaries used.
Specify the air cleanliness levels and zoning for production environments.
(II) Brief Description of Proposed Manufacturing Process.
Article 10: Product quality standards shall meet the following requirements:
(1) The format of quality standards shall comply with the relevant requirements of GB/T 1.1-2000 Guidelines for Standardization Work.
(2) Quality standards shall include sensory indicators, physicochemical indicators, microbial indicators, and methods for qualitative and quantitative analysis of major components.
Article 11: Product labels and instructions must comply with relevant national regulations. Additionally, when necessary, they shall include the following information: usage methods, applicable scope, target consumer groups, and recommended dosage. Warning statements indicating contraindications and safety precautions must also be provided where required.
Article 12: Domestic and international research utilization and relevant safety data shall include the following:
(I) Domestic and international approval status or market utilization.
(II) Survey data on the history of consumption and consumer demographics.
Article 13: The Power of Attorney shall comply with the following requirements:
(1) Must include the product name, the entrusted unit's name, the scope of authorization, and the date of authorization. It must be stamped with the authorizing unit's official seal or signed by the legal representative.
(II) When a single power of attorney covers multiple products, all must be declared simultaneously. Provide the original document for one product and copies for the others, along with a written explanation specifying which declaration package contains the original.
(3) The power of attorney must be notarized for authenticity.
(4) If the power of attorney is in a foreign language, it must be translated into standard Chinese, and the Chinese translation must be notarized by a notary public in China.
Article 14: The certificate issued by the relevant department or authority of the country (or region) of origin, or documentation proving the traditional history of consumption of this food in that country (or region), must meet the following requirements:
(1) Issued by the competent government authority or industry association of the country of manufacture or origin. If the original document is unavailable, a certified copy may be submitted; such copies must be verified by the issuing entity or by the Chinese embassy or consulate in the country of manufacture.
(2) Must include the product name, applicant name, and issuing entity name; be stamped with the entity's official seal or signed by the legal representative (or authorized person); and state the document date.
(3) The product name and applicant unit name specified must exactly match the declared information.
(4) When a single supporting document covers multiple products, all must be submitted together. Provide the original for one product and copies for the others, along with a written explanation specifying which product's submission package contains the original document.
(5) If supporting documents are in a foreign language, they must be translated into standard Chinese and notarized by a Chinese notary public.
(6) If proof documents cannot be submitted, the Ministry of Health may conduct an on-site inspection of the production facility.
Article 15: The content of the authorization letter from the responsible entity in China shall comply with the requirements specified in the Ministry of Health Announcement No. 2007 of Year 2.
Article 16: Submission of supplementary materials must comply with the following requirements:
(1) Submit 1 original copies of the complete supplementary materials. Each page must be stamped with the declaring unit's official seal or signed (and sealed) by the applicant, and include the date of submission.
(2) Upon receiving the "Notice of Extension for Administrative Licensing Technical Review," the applicant shall submit supplementary materials within one year. Failure to do so will be deemed as withdrawal of the application. In exceptional cases, a written explanation must be submitted.
Article 17: For new resource foods whose applications are withdrawn or not approved, the applicant may submit a written request to return the submitted power of attorney and documents certifying that the product is permitted for production and sale in the country (or region) of origin (except for original documents covering multiple products declared simultaneously), along with notarized copies.
Article 18: These regulations shall be interpreted by the Ministry of Health.
Article 19: These regulations shall take effect on the date of issuance. In the event of any inconsistency between these regulations and prior documents issued by the Ministry of Health, these regulations shall prevail.