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

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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

 

Solid preparation

Liquid preparation

 

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).



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