New Food Ingredients Management Measures

Article 1: To strengthen supervision and management of new food resources, ensure consumer health, and in accordance with the "Food Hygiene Law of the People's Republic of China" (hereinafter referred to as the "Food Hygiene Law"), these Measures are hereby formulated.

 

Article 2: The new food resources specified in these Measures include:

(1) Animals, plants, and microorganisms not traditionally consumed in China;

(II) Food ingredients derived from animals, plants, or microorganisms that lack a history of consumption in China;

(3) New microbial strains used in food processing.

(4) Food ingredients whose composition or structure has changed due to the adoption of new production processes.

 

Article 3: New food resources shall comply with the provisions of the Food Hygiene Law and relevant regulations, rules, and standards. They must not pose any acute, subacute, chronic, or other potential health risks to humans.

 

Article 4: The State encourages scientific research and development on new food resources.

 

Article 5: The Ministry of Health oversees the supervision and administration of food safety for new food resources nationwide. Local health administrative departments at or above the county level are responsible for such supervision and administration within their respective jurisdictions.

Chapter 2: Application for New Food Resources

Article 6: Units or individuals producing or using new resource foods shall submit their products to the Ministry of Health for approval prior to their first market launch.

 

Article 7: Applicants for new food resources shall submit the following materials to the Ministry of Health:

(I) Application Form for Food Safety Administrative Licensing of New Food Resources;

(2) Development report and safety research report;

(III) Brief Description of Production Process and Flowchart;

(4) Product Quality Standards

(5) Overview of domestic and international research utilization and relevant safety data;

(6) Product labels and instructions;

(7) Other materials that facilitate the review.

 

Additionally, include 1 unopened product samples or 30 grams of raw materials. For applications to import new resource foods, submit either a certificate issued by the relevant authority or institution in the country (or region) of production authorizing its production (or sale), or documentation proving its traditional history of food consumption in that country (or region).

Chapter 3: Safety Evaluation and Approval

Article 8: The Ministry of Health shall establish a food safety evaluation system for new resources. The evaluation shall be based on risk assessment and the principle of substantial equivalence. The Ministry of Health shall formulate and promulgate regulations, technical specifications, and standards for the safety evaluation of new resource foods.

 

Article 9: The Expert Evaluation Committee for New Food Resources of the Ministry of Health (hereinafter referred to as the Evaluation Committee) is responsible for assessing the safety of new food resources. The Committee comprises experts in food hygiene, toxicology, nutrition, microbiology, processing technology, and chemistry.

 

Article 10. The Evaluation Committee shall conduct safety assessments based on the following information and data: for new food resources, source, traditional consumption history, production process, quality standards, major components and their contents, estimated intake, intended use and scope of application, and toxicology; for microbial products, biological characteristics of the strain, genetic stability, pathogenicity or virulence, and other relevant scientific data.

 

Article 11: After accepting an application for a new food resource, the Ministry of Health shall require the applicant to provide supplementary materials during technical review. For cases requiring validation testing, the Evaluation Committee shall determine the test items, batches, methods, and accredited laboratories for safety validation, as well as whether on-site inspections and sample sealing are necessary, and notify the applicant accordingly. Safety validation tests shall generally be conducted at laboratories designated by the Ministry of Health. On-site inspections and sample sealing shall be organized and implemented by the provincial health administrative department.

 

Article 12: The Ministry of Health shall conduct an administrative review based on the technical assessment conclusions and on-site inspection results from the Evaluation Committee, and decide whether to approve the product as a new resource food. If, during the review process, it is determined that the declared product is a conventional food, the applicant shall be notified and the approval process shall be terminated.

 

Article 13: The specific procedures for approving new food resources shall be conducted in accordance with relevant regulations, including the "Administrative Measures for Health Administrative Licensing" and the "Procedures for Health Administrative Licensing of Health-Related Products."

 

Article 14: The Ministry of Health shall announce approved new resource foods via a list. Depending on the characteristics of each new food, the announcement generally includes the name (including Latin name), species, source, biological characteristics, processing method, main components, edible parts, usage levels, scope of use, target consumers, consumption amounts, and quality standards. For microorganism-based foods, the strain number shall also be announced.

 

Article 15: The Ministry of Health shall periodically publish the list of new resource foods converted to ordinary foods based on their usage.

 

Article 16: The Ministry of Health may convene an evaluation committee to reassess a newly approved food resource under any of the following circumstances:

(I) Where changes occur in the understanding of the safety for consumption or nutritional value of an approved novel food due to advancements in science and technology;
(2) Doubts regarding the food safety or nutritional quality of new food resources;

(3) Supervision and monitoring of new food resources. If a product fails re-evaluation, the Ministry of Health may issue an announcement prohibiting its production, operation, and use.

Chapter 4: Production and Operations Management

Article 17: Food production and business enterprises shall ensure the food safety of new resource foods produced, operated, or used. New resource foods that do not meet the requirements stipulated in Article 2 of this Law and have not been approved and announced by the Ministry of Health as new resource foods shall not be produced, operated, or used as food or food ingredients. Article 18: Enterprises producing new resource foods must comply with relevant laws, regulations, technical specifications, and requirements. Such enterprises shall apply for a sanitary license from the provincial health administrative department and may commence production only after obtaining the license. Article 19: Before producing or using new resource foods, food production enterprises shall verify against the Ministry of Health's announcements to ensure that the product is either an officially announced new resource food or has substantial equivalence to one. Article 20: Enterprises producing new resource foods or using them to manufacture other food products shall establish a system for collecting and reporting information on food safety. They must submit annual reports on new resource food safety to the local health administrative department. If any food safety issues are identified, they must be reported to the local health administrative department immediately. Article 21: The labeling of new resource foods and food products containing new resource foods shall comply with relevant national regulations. The names of new resource foods displayed on labels must match those specified in the Ministry of Health's announcements. Article 22: In the production and operation of new resource foods, no claims or implications regarding therapeutic effects or specific health benefits shall be made.

Chapter 5: Health Supervision

Article 23: Health administrative departments of people's governments at or above the county level shall conduct spot checks and daily health supervision on the production, distribution, and use of new resource foods in accordance with the Food Hygiene Law and relevant regulations.

 

Article 24: Health administrative departments of local people's governments at or above the county level shall regularly inspect and report on the collection and reporting status of new food resource safety information, and promptly report such safety information within their jurisdiction to higher-level health administrative departments. Provincial health administrative departments shall investigate, verify, and handle reported safety information, then promptly submit reports to the Ministry of Health. The Ministry of Health shall timely analyze new food resource safety information and make it public. Enterprises engaged in production, operation, or use of new food resources shall cooperate with health administrative departments in investigating and addressing food safety issues. If an enterprise conceals food safety information, the health administrative department may issue a public reprimand.

 

Article 25: Any entity that produces or processes new resource foods without approval from the Ministry of Health, or uses unapproved new resource foods as raw materials for food production, shall be punished by the health administrative department of the local people's government at or above the county level in accordance with Article 42 of the Food Hygiene Law.

Chapter 6 Supplementary Provisions

Article 26: Definitions Hazard Assessment: A scientific evaluation of the likelihood of adverse health effects from consuming food containing hazardous substances, comprising four steps: hazard identification, hazard characterization, exposure assessment, and risk characterization. Substantial Equivalence: A new resource food is considered substantially equivalent to a traditional food, food ingredient, or an already approved new resource food if it is comparable in species, source, biological characteristics, main components, edible parts, usage levels, application scope, and target population. When the processing methods and quality standards are also essentially consistent, it may be deemed equally safe and thus possess substantial equivalence.

 

Article 27: Management of genetically modified foods and food additives shall be in accordance with relevant national regulations.