Procedures for Safety Evaluation of New Food Resources

Article 1: To standardize the safety evaluation of new food resources and protect consumer health, this protocol is established in accordance with the Ministry of Health's "Measures for the Administration of New Food Resources."

Article 2: This regulation specifies the principles, content, and requirements for safety assessment of new food resources.

Article 3: Safety assessment of new food resources shall be conducted using risk assessment and the principle of substantial equivalence.

Article 4: Safety evaluation of new food resources includes review and assessment of application materials, on-site inspection and evaluation of production facilities, safety evaluation after human consumption, and re-evaluation of safety.

Article 5: The review and evaluation of application materials for new food resources involve a comprehensive assessment of the new food resource's characteristics, historical consumption, production processes, quality standards, major components and their contents, scope of use, dosage levels, recommended intake, target populations, microbiological safety, toxicology data, relevant domestic and international safety literature, and comparative analysis with similar food ingredients.

Article 6: Evaluation of Characteristics of New Food Resources: For animals and plants, information shall include source, edible parts, biological characteristics, and variety identification. For microorganisms, information shall include source, taxonomic status, strain identification, and biological characteristics. For food ingredients isolated from animals, plants, or microorganisms, information shall include source, physicochemical properties, and chemical structures of major components. The sources and biological characteristics of animals, plants, and microorganisms must be clearly defined. The physicochemical properties and chemical structures of major components in food ingredients isolated from these sources must be clearly identified, and the structure must not indicate toxic effects.

Article 7: Evaluation of Historical Consumption. Historical consumption data constitute the most valuable human evidence for safety assessment, encompassing domestic and international consumption records (including consumer demographics, intake levels, duration of use, and adverse reaction reports), as well as approval status in other countries and market utilization. For new resource foods, there must be no recorded history of significant adverse reactions in humans.

Article 8: Evaluation of Production Process – Key aspects include raw material handling, extraction, concentration, drying, sterilization, and other processes, along with data on critical technical parameters and processing conditions. The production process must be safe and reasonable. All raw materials, additives, and processing aids used during production must comply with relevant Chinese food standards and regulations.

Article 9: Evaluation of Quality Standards. Key aspects include sensory indicators, active ingredient content, physicochemical parameters, and microbial limits. The formulation of quality standards must comply with national principles and regulations for standard development. The standards shall specify raw materials, their sources, and quality attributes, and include qualitative and quantitative testing methods for key components.

Article 10: Evaluation of Ingredient Composition and Content: The ingredient composition and content must be clearly stated, including major nutrients and potential harmful ingredients. At expected intake levels, the content of each ingredient must not adversely affect health.

Article 11: Evaluation of Scope and Usage Quantity: The purpose of the new resource food is clearly defined, and its scope and quantity of use are well-supported.

Article 12 Evaluation of Recommended Intake and Suitable Population: The basis for the population recommended intake is sufficient, and the unsuitable population is clearly defined. When evaluating whether the recommended intake is reasonable, total intake levels from all dietary sources should be considered.

Article 13: Evaluation of Microbiological Tests. Microbiology is a key indicator for assessing the safety of new food resources. The microbiological tests must include reports from three recent representative batches covering physicochemical parameters (e.g., lead, arsenic, mercury) and microbial indicators (e.g., bacteria, molds, yeast). All tested parameters must comply with the quality standards specified in the application.

Article 14: Evaluation of Domestic and International Safety Literature. Safety literature is a critical reference for assessing the safety of new food resources, including safety assessments by international organizations and other countries, as well as publicly available research studies on safety.

Article 15: Safety Evaluation of Toxicology Studies. Toxicology studies are a prerequisite for assessing product safety. Based on the food's history of safe consumption domestically and internationally, as well as its approval status across various countries, different toxicology tests shall be conducted by comprehensively analyzing characteristics such as the food's source, composition, target consumer groups, and intake levels. At potential human intake levels, new resource foods must not cause acute, chronic, or other potential health hazards.
(1) For food ingredients derived from animals or plants that have no history of human consumption domestically or internationally, as well as those isolated from such sources and their microorganisms, or produced via novel processes that alter original components or structures, the following evaluations are required in principle: acute oral toxicity studies, three mutagenicity tests (Ames test, mouse bone marrow micronucleus test, and either mouse sperm deformity test or testicular chromosome aberration test), 90-day oral toxicity study, teratogenicity and reproductive toxicity studies, chronic toxicity and carcinogenicity studies, and metabolic studies.
(II) For food raw materials derived from animals or plants, or their microorganisms, that have a history of consumption only in specific foreign countries or limited domestic regions, as well as those produced via new processes resulting in altered original components or structures, the following toxicological evaluations are generally required: acute oral toxicity tests, three mutagenicity tests, 90-day oral toxicity tests, teratogenicity tests, and reproductive toxicity tests. However, if existing literature and compositional analysis indicate no toxic effects and there is evidence of long-term consumption by a large population without adverse effects for new food resources, the evaluation may be limited to acute oral toxicity tests, three mutagenicity tests, 90-day oral toxicity tests, and teratogenicity tests.
(3) For food ingredients that have been widely approved for use in multiple countries, including those derived from animals, plants, and microorganisms, as well as those produced via novel processes that result in changes to original composition or structure, acute oral toxicity testing, three mutagenicity tests, and a 30-day oral toxicity study shall be conducted, based on the submission of safety evaluation data.
(4) Microorganisms with no history of human consumption domestically or internationally and intended for direct human consumption shall be evaluated for acute oral toxicity/pathogenicity tests, three mutagenicity tests, a 90-day oral toxicity test, and teratogenicity tests.
and reproductive toxicity studies. For microorganisms with a history of consumption only in select foreign countries or specific regions within China, acute oral toxicity/pathogenicity studies, three mutagenicity tests, and a 90-day oral toxicity study shall be conducted. For microorganisms approved for use in multiple countries, acute oral toxicity/pathogenicity studies and two mutagenicity tests are sufficient.
Food-grade microorganisms with no prior use history domestically or internationally must undergo acute oral toxicity/pathogenicity testing, three mutagenicity tests, and a 90-day oral toxicity study. Food-grade microorganisms with use history in only个别 countries abroad or limited regions within the country must undergo acute oral toxicity/pathogenicity testing and three mutagenicity tests. Food-grade microorganisms approved for use in multiple countries may undergo only acute oral toxicity/pathogenicity testing.
Bacteria submitted as new food resources must undergo antimicrobial resistance testing. Microorganisms proposed as new food resources should be tested for toxin production capability based on whether they belong to toxigenic genera. Toxicology testing for macrofungi shall follow the requirements for plant-based new food resources.
(5) Based on potential hazards of the new food resource, conduct additional toxicological testing using sensitive tests or endpoints as needed, or validate and supplement existing toxicological studies per the assessment conclusions of the New Food Resource Evaluation Committee.
(6) Toxicological testing methods and criteria for result evaluation shall be conducted in accordance with the current national standard GB5193 "Procedures and Methods for Toxicological Evaluation of Food Safety." For toxicity or pathogenicity tests involving microorganisms, relevant regulations may be referenced.
(7) For new food resources, a toxicology study report conducted by a GLP-compliant laboratory abroad may be submitted. Based on the evaluation conclusions of the New Food Resource Assessment Committee, this report may serve to verify or supplement toxicology data.

Article 16: On-site inspections and evaluations are key tools for assessing the development of new food resources and verifying whether production processes align with submitted documentation. The scope of on-site inspections includes the qualifications of the manufacturing facility.
Certificates, production process, environmental conditions of the production facility, production records (including raw material sources and charging logs), product quality control procedures and technical documentation, as well as consistency with the approved submission materials.

Article 17: After the launch of new food resources, an information monitoring and reporting system for population safety shall be established. The system shall focus on collecting adverse reaction data following consumption by the public to conduct post-market safety evaluations, thereby further confirming the safety of new food resources for human consumption.

Article 18: As scientific and technological advances, improved testing capabilities, evolving safety assessment standards and requirements, and market supervision needs emerge, new resource foods shall undergo re-evaluation. This re-evaluation shall cover the target consumer groups, recommended intake levels, compositional makeup, microbiological safety, toxicological data, and post-consumption safety information for these foods.

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.
(VI) Foreign-language materials in the application documents shall be translated into standard Chinese, and the translations shall be attached prior to the corresponding foreign-language materials. This requirement does not apply to ingredient names, personal names, or foreign addresses that are required to be in English or Latin under 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 documents required above, the following materials must also be submitted:
(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; and classification of air cleanliness levels and zones in the production environment.
(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.