As revealed by the notice [1] released on Jan 7, 2021, 15 substances were approved by China’s National Health Commission (NHC), including 3 new food raw materials, 5 new food additives and 7 new varieties of food related products.
3 New Food Raw Materials
Sodium hyaluronate (also called hyaluronic acid) gained much attention among the 3 new food raw materials. In 2008, sodium hyaluronate was first permitted as the raw material for health food in China. As revealed by a Frost&Sullivan survey [2], the global sales volume of sodium hyaluronate (as food ingredient) was 230 tons in 2018 and was predicted to reach 654 tons in 2023. Moreover, China is the world’s largest production and sales country of sodium hyaluronate. In 2018, the sales volume of sodium hyaluronate in China was 86% that of the global performance. With that in mind, ChemLinked believes the approval of sodium hyaluronate as food raw material is expected to prosper a promising and growing sodium hyaluronate-based food industry in the domestic market of China.
No. | Name | Recommended intake | Note |
1 | Sporocarp of Isaria cicadae Miq. (Artificial cultivation) | ≤ 3 g/day |
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2 | Sodium hyaluronate | ≤ 200 mg/day |
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3 | Lactobacillus kefiranofaciens subsp. kefiranofaciens | / |
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5 New Food Additives
New Enzyme (1)
No. | Name | Source | Donor |
1 | Beta-amylase | Bacillus licheniformis | Bacillus flexus |
Processing aid (1)
No. | Name | Function | Application scope | Note |
1 | Nitrous oxide | Propellant, foaming agent |
| Quality specification and test method of this new variety are detailed in this notice. |
Nutrition fortifier (1)
No. | Name | Food classification No. | Food category | Use amount | Note |
1 | Vitamin K2 (synthesis method) | 01.03.02 | Modified milk powder (limited to milk powder for children) | 420 μg/kg~ | Quality specification and test method of this new variety are detailed in this notice. |
Modified milk powder (limited to milk powder for the pregnant and puerpera) | 340 μg/kg~ |
Food additive with expanded scope (2)
No. | Name | Function | Food classification No. | Food category | Maximum use amount (g/kg) | Note |
1 | Gum ghatti | Emulsifier | 13.05 | Other special dietary food (food for special medical purpose designed for people over 10 years old) | 3.0 | Quality specification and test method of this new variety are detailed in this notice. |
2 | Sodium alginate | Stabilizer | 13.05 | Other special dietary food (limited to amino acid metabolize disorder formula for special medical purposes designed for people from 13 months old to 10 years old) | 1.0 | Applicable to infants from 13 to 36 months old |
As necessary | Applicable to people from 37 months old to 10 years old |
7 New Varieties of Food Related Products
New FCM (Food Contact Material) additive (1)
No. | Name | CAS No. | Application scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
1 | 1,3,5-Tris (2,2-dimethylpropanamido) benzene | 745070-61-5 | Plastic: polypropylene (PP) | 0.025 | 5 | — | — |
New FCM additive with expanded application scope (4)
No. | Name | CAS No. | Application scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
1 | C.I. Solvent Red 101; Ferric oxide; Iron oxide | 1309-37-1 | Plastic: Polycyclohexylenedimethylene terephthalate (PCT) | 0.3 | 48 (calculated as iron) | — | It should comply with the requirements of the purity of colorants regulated in GB 9685-2016 Standard for Uses of Additives in Food Contact Materials and Articles. |
2 | Magnesium hydroxide | 1309-42-8 | Plastic: polyoxymethylene (POM) | 0.07 | — | — | The maximum usage temperature of POM plastic and its products added with this substance is 121 °C. |
3 | Magnesium aluminum hydroxide carbonate (hydrate) | 11097-59-9 | Plastic: polyoxymethylene (POM) | 0.02 | — | — | The maximum usage temperature of POM plastic and its products added with this substance is 121 °C. |
4 | Polycyclooctene | 25267-51-0 | Plastic: ethylene vinyl alcohol (EVOH) | 8 | 0.05 (Cyclooctene) | — | EVOH plastic added with this substance should be used in food contact material with multi-layers yet the layer this substance applicable to should not contact food. The thickness of this layer should be not more than 100 μm. The maximum usage temperature is 121 °C. It is also not allowed to be in contact with baby food and breast milk. |
New resins (2)
No. | Name | CAS No. | Application scope | Maximum usage amount/% | Specific Migration Limit SML/(mg/kg) | Maximum Permitted Quantity QM (mg/kg) | Note |
1 | 1,3-Benzenedicarboxylic acid, polymer with dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol and 1,2- ethanediol | 35176-78-4 | Paints and coatings | 20 (calculated as paint formula) | 5 (calculated as isophthalic acid); 0.05 (2,2-Dimethyl-1,3-propanediol); 30 (calculated as ethylene glycol) | — | The maximum usage temperature of paints and coatings manufactured with this substance as raw material is 130 °C. It is not allowed to contact food whose ethanol content is higher than 20%, baby food and breast milk. |
2 | 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with decanedioic acid, 2,2- dimethyl-1,3-propanediol and 1,2- ethanediol | 51382-28-6 | Paints and coatings | 9 (calculated as paint formula) | 0.05 (2,2-Dimethyl-1,3-propanediol); 30 (calculated as ethylene glycol) | The maximum usage temperature of paints and coatings manufactured with this substance as raw material is 130 °C. It is not allowed to contact food whose ethanol content is higher than 20%, baby food and breast milk. |
For more translation service or regulatory consultation of China’s food ingredients, please contact ChemLinked.