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China Approves 3 New Food Raw Materials, 5 New Food Additives and 7 New Varieties of Food Related Products

Sodium hyaluronate was approved as the new food raw material. 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.

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 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

  • Unsuitable for infants, the pregnant/lactating women and people who are allergic to edible fungi.

  • The safety indicators and test method of beauverin are specified in the notice.

2

Sodium hyaluronate

≤ 200 mg/day

  • Unsuitable for infants, the pregnant and lactating women.

  • Maximum use limit: dairy (0.2 g/kg), liquid beverage no more than 50 mL (2.0 g/kg), liquid beverage 51-500 mL (0.20 g/kg), alcoholic drink (1.0 g/kg), etc.

  • Quality requirements and safety indicators are detailed in the notice.

3

Lactobacillus kefiranofaciens subsp. kefiranofaciens

/

  • Approved as edible fungus.

  • Not applicable to the production of baby food.

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

  • 01.05 Processing of cream (light cream) and similar products; 

  • 02.02 Processing of water-oily fat emulsified products (liquid non-dairy cream only);

  • Processing of fat emulsified products other than 02.02, including mixed or flavored fat emulsified products (non-dairy whipping cream only)

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~
750 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~
680 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.

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