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The Chinese health food industry is currently in a period of transition. The government has instituted a series of radical reforms and legislative changes that will affect the health food industry significantly.
1. Combination of registration and filing system
The current blanket registration policy that applies to all varieties of health foods will be refined to include specific registration types and combined of registration and filing for different varieties of health foods.
Mandatory registration applied to: health foods using new raw materials and health foods imported for the first time
Filing applied to: nutrient supplements (vitamin and minerals).
Other kinds of health foods except the ones required for registration
2. The Testing Verification and Reexamination Agency Can Now be Chosen
Testing and reexamination are required for health food registration. Before the revision of the Food Safety Law, the agency for registration testing could be chosen by enterprises, however, the testing verification and reexamination agency was designated by CFDA.
The new Food Safety Law stipulates that the reexamination agency can be selected from the list of accredited reexamination agencies, which has been published by relevant authorities.
3. Health food testing procedures will be optimized
Registration testing and testing reexamination will be carried out simultaneously under new optimized testing procedures. Theoretically, the registration period will be shortened to 65 days after the procedure is optimized (15 days for field inspection, and 50 days for reexamination).
Registration procedure for health food (Comparison between current policy and optimized policy) | ||
Step and subject | Item | Timeframe |
Step 1: Applicant | Applying for sampling to provincial food and drug administration authority before the registration, and the samples will be used for registration testing (testing for the first time) |
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Step 2: Provincial food and drug administration authority | Field sampling and sample sealing After optimization: field inspection, sampling and designating reexamination agency of the fifth step will be conducted at the same time. |
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Step 3: Registration testing agency | Issuing testing report for the qualified samples After optimization: reexamination of the sixth step will be carried out at the same time, which will be conducted by different testing agencies. | Hygiene inspection + stability test: 120 days |
Step 4. Applicant | Formal application, and submission of registration application form, the report for the registration testing, and the sealed samples After optimization: the reports for the registration testing and reexamination will be submitted at the same time. | Toxicology test + function test: 150-330 days |
Step 5: Provincial food and drug administration authority | Inspecting trial production site, sampling (for reexamination), and designating reexamination agencies after acceptance of registration application After optimization: it will be conducted at the same time as Step 2. | 15 days |
Step 6: Reexamination agency | Carrying out reexamination After optimization: it will be conducted at the same time as Step 3. | 50 days |
Step 7: CFDA | Organizing review meeting | 85 days |
Carrying out expert evaluation | 150 days | |
Administrative examination and approval | 60 days | |
This article is jointly contributed by senior regulatory specialist Spring He from REACH24H Consulting Group and Rachel Shen from Chemlinked Team.
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