- Application feasibility analysis
- Application for new food raw material/novel food
- Testing services (safety assessment reports)
- Other customized consulting and compliance services
Definition of New Food Raw Material/Novel Food in China
New food raw material/novel food refers to the following items that are not traditionally consumed in China:
- Animals, plants, and microorganisms；
- Components isolated from animals, plants, and microorganisms；
- Food components with altered original structures；
- Other newly developed food ingredients
Here, "traditional consumption habits" refer to a history of more than 30 years of production and operation of a certain food as standardized or non-standardized packaged food within a provincial jurisdiction, and it is not included in the "Pharmacopoeia of the People's Republic of China."
At the same time, new food raw material/novel food must have the characteristics of food ingredients, meet the required nutritional requirements, be non-toxic, harmless, and not pose any acute, subacute, chronic, or other potential risks to human health.
Regulatory Requirements of New Food Raw Material/Novel Food in China
According to the "Food Safety Law of the People's Republic of China," new food raw material/novel food need to be approved by the the National Health Commission（NHC） before they can be used in food production.
Exclusions from the Scope of New Food Raw Material/Novel Food Application in China
- Lack of characteristics of food ingredients
- Already listed in the national food safety standards "Standard for the Use of Food Additives" (GB2760) and "Standard for the Use of Food Nutritional Enhancers" (GB14880)
- Decisions made by the NHC not to grant administrative permits
Other cases that do not comply with relevant laws, regulations, and requirements for new food ingredient management. For example, the 2009 Announcement No. 14 of the former Ministry of Health stated that only items limited to health food ingredients are no longer included in the scope of acceptance and review of new resource food administrative permits. Also, it includes national first-class protected animals and plants, second-class protected wild animals and plants, and other substances prohibited for use in food.
Documents Required for New Food Raw Material/Novel Food Application in China
- Application form
- Research report on new food raw material/novel food development
- Safety assessment report
- Production process
- Relevant standards (including safety requirements, quality specifications, testing methods, etc.) followed
- Labels and instructions
- Research and utilization information and relevant safety assessment data from domestic and foreign sources
- Declaration of authorization (provided when applying through an agent)
- Other materials helpful for the evaluation process
Additionally, one unopened minimum package sample or 30 grams of raw material should be provided.
For the import of new food ingredients (new resource food), in addition to the above-mentioned materials, the following should also be submitted:
- Proof of permission for the product to be produced or sold in the exporting country (region) issued by relevant departments or organizations.
- Proof of examination or certification of the production enterprise by relevant institutions or organizations in the country (region) where the imported new food ingredient manufacturer is located.
One original and four copies of the application materials are required. The application materials should be complete, clear, and consistent in content. Foreign language materials should be translated into standard Chinese. Literature materials can provide Chinese abstracts, and the translated text should be attached before the corresponding foreign language materials.
Testing Items for New Food Raw Material/Novel Food Application in China (Safety Assessment Report)
- Ingredient analysis report: including full ingredient analysis, detection results, and methods for possible harmful components.
- Hygienic examination report: detection results and methods for pollutants and microorganisms in three representative samples.
- Toxicological evaluation report (the toxicological data required may vary depending on different situations).
- Microbial resistance test report and toxin-producing capability test report (only applicable to microbial new food ingredients).
- Safety assessment opinion: conducted based on the principles and methods of hazard factor identification, hazard characteristics description, exposure assessment, and hazard description.
Related Regulations and Supporting Documents for New Food Raw Material/Novel Food Application in China
- Food Safety Law of the People's Republic of China
- Measures for the Safety Assessment and Management of New Food Raw Material/Novel Food
- Regulations on the Declaration and Acceptance of New Food Raw Material/Novel Food
- Procedures for the Safety Assessment of New Food Raw Material/Novel Food