On 17 February 2016, China Food and Drug Administration (CFDA) released the Health Food Raw Materials Directory (the first batch) –Nutrition Supplement Raw Materials Directory. In order to further regulate the management of health food filing and in accordance with requirements of Measures for the Management of Health Food Registration and Filing, CFDA organized to draft the Name List of Excipients available for Health Food Filing (the first batch) (Chinese version download) and the Name List of Health Food Filing Excipients Need Further Argument (Chinese version download). The two documents cover the technical requirements for health food excipients.
These two documents were released on 30 May 2016 and are now open for public comments. Enterprises can come up with their opinions and send them to the CFDA before 11 June 2016.
I Specific Contents:
These two drafts specified the variety of the excipients available for health food filing, relevant standards for reference, the maximum usage of excipients in each dosage and the usage basis. Details can be found in the following table:
Quantities of excipients
155 (the first batch for public comment) and other 137 (still need further argument)
Standards of excipients for reference
national Standards, Chinese pharmacopoeia, industrial standards, announcements released by Ministry of Health or National Health and Family Planning Commission and others
Main dosage forms of health food in need of filing
Oral liquid, hard capsule, soft capsule, drop, particle/ powder, tablet and soft sweets
Basis for the maximum usage of the excipients
1. Unit of maximum usage of excipients is g/kg which means the permillage that the mass of excipients shares the total mass.
2. Basis for the maximum usage is GB2760-2014 and Chinese pharmacopoeia
3. The maximum usage of one excipient in soft sweets, tablets, hard capsule, soft capsule and drops shall be subject to the limit of candy regulated by GB2760-2014; the maximum usage of one excipient in oral liquid shall be subject to the limit of beverage regulated by GB2760-2014; the maximum usage of one excipient in solid drink, particle and powder shall be subject to the limit of solid drink regulated by GB2760-2014.
1. If the excipients of health food do not comply with requirements of Name List of Excipients Available for Health Food Filing, this health food is not available for filing;
2. Concentrated fruit and vegetable juices (such as apple juice, orange juice, lemon juice, pineapple juice, blueberry juice, litchi juice, peach juice and vegetable juice), fruit powder, acerola cherry powder and acerola cherry extracts are all contained in the Name List of Health Food Excipients Need Further Argument. These excipients are controversial and still need further discussion to decide whether these excipients are available for health food filing. If enterprises have any opinion on this issue, they can submit their suggestions to CFDA or they can also send their opinions to CIRS, and CIRS will help enterprises to submit their opinions.
3. Materials such as amino acid, dietary fiber, unsaturated fatty acid, saturated fatty acid, iodine, soy isolate protein, DHA, dried full cream milk, dried full cream goat milk powder, goat milk powder are not included in the two name lists, as a result, the above mentioned materials cannot be added into health food for filing as excipients.