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With reference to Q&As regarding China health food registration published by China Center for Food Evaluation (subordinated to State Administration for Market Regulation) these days, ChemLinked collects the questions that our clients most concern and the following are the details:
Q1 What are the registration requirements for health food whose raw material is nucleic acid?
For health food produced with nucleic acid as raw material and corresponding coordinated substances, when applying for the registration, the particularity of application materials should be noted:
The information regarding name, sources, and content of specific components of nucleic acid used in the product shall be provided in the document of formula and its basis.
A test report on the purity of nucleic acid raw materials issued by a qualified inspection institution shall be provided.
The only function can this kind of product declare is the immune enhancement.
Patients with gout shall be indicated as "unsuitable people".
Q2 How many functions can a health food product declare?
The "Administrative Measures for Registration and Filing of Health Foods (2020 Revision)" does not specify how many health functions a product can declare. The applicant can determine the name and number of health functions according to the product formula and basis. When applying for two or more functions for a product, it is necessary to explain the correlation between the functions on a scientific basis. It is also necessary to pay attention to the consistency between the suitable people and the unsuitable people of the product, and do not contradict each other. Generally speaking, the more functions a product has, the fewer people it is suitable for.
Q3 What kind of reference documentation are acceptable when register/file a health food product?
The following reference documentation are regarded acceptable:
1. Scientific research papers officially published in domestic core professional journals or international professional journals;
2. Description of Chinese traditional herbal classics;
3. Literature analysis and evaluation report;
4. International standards, national standards, risk assessment and statistical information officially issued by internationally recognized food hygiene authorities or organizations, or Chinese authorities or relevant departments.
Q4 For health food targeting at children, pregnant women, nursing mothers and other special groups, what are the requirements for animal function and toxicology experiments?
First, the food safety and health function of the product must be supported by sufficient scientific theory, literature and experimental basis. Second, the registration inspection shall comply with the current relevant provisions, and fully consider the particularity, scientificity and rationality of the test items, trial feeding population and dose design. Third, the necessary safety toxicology test and hygiene test shall be completed before human feeding test if it is required. A written certificate shall be issued and the ethical review approval document of the ethics committee of the test institution shall be obtained. The samples that fail to pass the safety toxicology test and hygiene test shall not proceed human feeding test.
Q5 What are the new key points in the registration evaluation of health food?
1. For the registration of a new product, the followings need to be submitted and reviewed:
The name and address of the enterprise submitting application.
Reason for re-registration (if the previous application for product registration has been withdrawn).
Application form for registration inspection, and preparation instructions for amorphous samples issued by the registration inspection institution.
Registration inspection report.
Product technical requirements.
Relevant information of gelatin and gelatin hollow capsules (if applicable)
2. For registration renewal:
Analysis report on population consumption.
Product technical requirements.
Relevant information of gelatin and gelatin hollow capsules (if applicable).
Test report on efficacy ingredients or functional components, hygiene and stability.
3. For registration change:
The alteration item.
Product technical requirements.
Relevant information of gelatin and gelatin hollow capsules (if applicable).
Microbial indicator.
Test report on efficacy ingredients or functional components, hygiene and stability.
Process material and inspection report (if applicable).
Methodological validation data and test report (if applicable).
4. For technology transfer:
Product technical requirements.
Relevant information of gelatin and gelatin hollow capsules (if applicable).
Test report on efficacy ingredients or functional components, hygiene and stability.
Inspection report.
Other questions involved:
What are the requirements for raw materials of toxicity test?
How to choose the proper test method for the content of functional components in health food with probiotics?
What are the requirements for test substance during functional evaluation test?
What are the guidelines for stability test of health food?
What are the labeling requirements for health food with different raw materials in terms of unsuitable people and precautions?
…
For further information of the Q&A collection, please contact ChemLinked.
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