China-Available Excipients for Health Food Filing (2021 version)
Published by
State Administration for Market Regulation (SAMR)
Compiled by
CIRS
Entries Included
150+
Date Issued
2021-02-20
Last Update Time
2021-02-20

Introduction:

According to the regulations on health food, the use of excipients in filing health food should comply with the "Regulations on the Available Excipients and Their Use for Health Food Filing Products (2021 version)". This directory contains information on 197 types of excipients available for filing products.

 

How to search in the directory:

Information on the name, relevant standards, and maximum usage can be found by entering the name of each excipient.

 

Notes:

1. The use of food flavour in solid and liquid preparation of health food filing products shall comply with relevant national standards and regulations, and its composition shall be included in Appendix A of GB 2760 or GB 30616, and the amount can be used with no limitation other than GMP.

2. The use of coating premix and coating agent (used in gelatin candy) shall comply with the relevant national standards and regulations, and its composition shall be included in GB 2760 or the current Chinese Pharmacopoeia, and the amount can be used with no limitation other than GMP.

3. The excipients used in preparing encapsulated and microencapsulated raw material shall comply with the relevant national standards and regulations, and their composition shall be included in GB 2760. It is allowed to use the excipients included in this regulation and the amount shall meet the corresponding requirements.

 

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lSAMR Health Food (Dietary Supplement) Registration/Filing in China

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