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China,Food,Health Food,Filing,Excipient,Registration

On 4 June, 2019, State Administration for Market Regulation (SAMR) issued a Notice on the Supplement List of Available Excipients for Heath Food Filing (1) for public comments. Opinions and advice shall be given before 30 June, 2019.

The drafted Supplement List includes 3 aspects:

Newly added excipients: including 17 new excipients such as soybean lecithin, curcumin, fruit and vegetable powder, etc.
Supplement product standards for current excipients: add more suitable standards for current 24 kinds of excipients, such as D-mannitol, titanium dioxide, maltodextrin.
Update the Chinese Pharmacopoeia version in current excipient list.

Among them, the most striking part is the 17 newly added excipients. When they are officially approved, enterprises can get more choices for the production of filing products. Please refer to below table for more detailed information.

17 newly added excipients and their maximum dosage

S.N.	Excipient name	Maximum dosage
S.N.	Excipient name	Solid preparation	Liquid preparation
1	Menthol	Appropriate level as required for flavoring
1	Menthol	Appropriate level as required for flavoring
2	Galacto-oligosaccharide	Appropriate level as required for condiment


3	Fructo-oligosaccharide	Appropriate level as required for condiment
4	Isomaltooligosaccharide	Appropriate level as required for condiment
5	Edible sweet potato starch	Appropriate level	Appropriate level
6	Magnesium carbonate	It is unavailable for products supplementing Mg or products targeted for 1-3 years old; Other products: ≤0.8g per day (count as Mg).
6	Magnesium carbonate
7	Citric Acid	Appropriate level	Appropriate level
8	Anhydrous citric acid	Appropriate level	Appropriate level
9	phospholipid	Appropriate level as required for emulsifier, solubilizer
10	Concentrated soybean lecithin	Appropriate level as required for emulsifier, solubilizer
11	Soybean lecithin powder	Appropriate level as required for emulsifier, solubilizer
12	Fractionated soybean lecithin	Appropriate level as required for emulsifier, solubilizer
13	Transparent soybean lecithin	Appropriate level as required for emulsifier, solubilizer
14	Soybean lecithin	Appropriate level as required for emulsifier, solubilizer
15	Octyl and decyl glycerate	Appropriate level as required for emulsifier
16	Curcumin	Appropriate level as required for coloring, ≤0.7g/kg
17	Fruit and vegetable powder (the specific name shall be clearly defined)	Appropriate level as required for condiment

Reference:

SAMR Notice

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SAMR Issued a Draft on 17 New Excipients for Health Food Filing