On 12 January, 2017, China Food and Drug Administration (CFDA) finally released the Health Food Raw Materials Directory (the first batch)-Nutrition Supplement Raw Materials Directory (CN version free download). Meanwhile, Directory of Health Function Available to Claim for Health Food (the first batch)- Directory of Health Function for Nutrition Supplement (CN version free download) was also attached in the Notice. It takes about one year for CFDA to finalize and publish the formal Health Food Raw Materials Directory since the first Draft Health Food Raw Materials Directory was released for publish comments on 17 February, 2016 and takes more than half year since the Revised Draft was published on 2 June, 2016.
China Health Food Raw Materials Directory (the first batch)
Compared with the Revised Draft Health Food Raw Materials Directory, the format and content of Health Food Raw Materials Directory (the first batch) was changed a little, herein taking one Nutrient- Calcium as an example as following:
Name of Raw Material | Daily Intake | Function | ||||||
Nutrient | Name of the Compound | Standard Basis | Application Scope | Functional component | Suitable Crowds | Min | Max | |
Calcium | Calcium carbonate | GB1886.214 | All people | Ca (Calculation in Ca, mg) | 1-3 | 120 | 500 | Supply Calcium |
Calcium acetate | GB15572 | people aged more than 4 years old | 4-6 | 150 | 700 | |||
Calcium Chloride | GB1886.45 | All people | 7-10 | 200 | 800 | |||
Calcium citrate | GB17203 | All people | 11-13 | 250 | 1000 | |||
Calcium Gluconate | GB15571 | All people | ||||||
Calcium Lactate | GB1886.21 | people aged more than 4 years old | 14-17 | 200 | 800 | |||
Calcium monophosphate | GB1886.3 | All people | Adult | 200 | 1000 | |||
Calcium phosphate monobasic | GB25559 | people aged more than 4 years old | pregnant woman | 200 | 800 | |||
Calcium phosphates | GB25558 | All people | ||||||
Calcium sulfate | GB1886.6 | All people | wet nurse | 200 | 1000 | |||
L - calcium lactate | GB25555 | All people | ||||||
Calcium glycerophosphate | Chinese Pharmacopoeia | people aged more than 4 years old |
Directory of Health Function Available to Claim for Health Food (the first batch)
As the first batch of health function directory is only for nutrition supplement, therefore, for the moment, there is only one health function-supplying vitamin, mineral in the first batch below:
Health Function | Notes |
Supplying Vitamin, Mineral | Including supplying: Calcium, magnesium, potassium, manganese, iron, zinc, selenium, copper, vitamin A, vitamin D, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, folic acid, biotin, choline, vitamin C, vitamin K, pantothenic acid, vitamin E |
With the releasing of these two Directories, health food filing policy will come into force soon. For more information about registering or filing a health food in China, please kindly click here.
If you would like to get the English versions of these two Directories, please do not hesitate to contact us at service@cirs-group.com.
Regulation reference:
http://www.sda.gov.cn/WS01/CL0087/168507.html