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
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S.N. |
Excipient name |
Maximum dosage |
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Solid preparation |
Liquid preparation |
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1 |
Menthol |
Appropriate level as required for flavoring |
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2 |
Galacto-oligosaccharide |
Appropriate level as required for condiment |
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3 |
Fructo-oligosaccharide |
Appropriate level as required for condiment |
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4 |
Isomaltooligosaccharide |
Appropriate level as required for condiment |
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5 |
Edible sweet potato starch |
Appropriate level |
Appropriate level |
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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). |
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7 |
Citric Acid |
Appropriate level |
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8 |
Anhydrous citric acid |
Appropriate level |
Appropriate level |
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9 |
phospholipid |
Appropriate level as required for emulsifier, solubilizer |
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10 |
Concentrated soybean lecithin |
Appropriate level as required for emulsifier, solubilizer |
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11 |
Soybean lecithin powder |
Appropriate level as required for emulsifier, solubilizer |
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12 |
Appropriate level as required for emulsifier, solubilizer |
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13 |
Transparent soybean lecithin |
Appropriate level as required for emulsifier, solubilizer |
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14 |
Soybean lecithin |
Appropriate level as required for emulsifier, solubilizer |
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15 |
Octyl and decyl glycerate |
Appropriate level as required for emulsifier |
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16 |
Curcumin |
Appropriate level as required for coloring, ≤0.7g/kg |
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17 |
Fruit and vegetable powder (the specific name shall be clearly defined) |
Appropriate level as required for condiment |
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Reference:
