Analysis on the Application and Approval of New Food Additives in 2024

1

2024-01-05

卫食添新申字(2024)第0001号

Marigold yellow

2

2024-01-11

卫食添新申字(2024)第0002号

2'-Fucosyllactose, 2’FL

3

2024-01-12

卫食添新申字(2024)第0003号

Lactose-N-tetraose

4

2024-01-16

卫食添新申字(2024)第0004号

L-Alanine

5

2024-01-16

卫食添新申字(2024)第0005号

2'-Fucosyllactose

6

2024-01-16

卫食添新申字(2024)第0006号

Xanthan gum

7

2024-01-17

卫食添新申字(2024)第0007号

Lipase

8

2024-01-18

卫食添新申字(2024)第0008号

Selenium-enriched yeast

9

2024-01-18

卫食添新申字(2024)第0009号

2'-Fucosyllactose, 2’FL

10

2024-01-18

卫食添新申字(2024)第0010号

Chitosan

11

2024-01-22

卫食添新申字(2024)第0011号

Anethole

12

2024-01-22

卫食添新申字(2024)第0012号

Citral

13

2024-01-22

卫食添新申字(2024)第0013号

Hydroxycitronellal

14

2024-01-23

卫食添新申字(2024)第0014号

3'-Sialyllactose sodium salt

15

2024-01-24

卫食添新申字(2024)第0015号

Xylanase

16

2024-01-24

卫食添新申字(2024)第0016号

D-Allulose-3-epimerase

17

2024-01-24

卫食添新申字(2024)第0017号

β-Alanine

18

2024-01-25

卫食添新申字(2024)第0018号

Glucose oxidase

19

2024-01-26

卫食添新申字(2024)第0019号

Polyglycerol ricinoleate

20

2024-01-30

卫食添新申字(2024)第0020号

Peroxidase

21

2024-02-06

卫食添新申字(2024)第0021号

Glucoamylase

22

2024-02-19

卫食添新申字(2024)第0022号

Rebaudioside AM (enzyme conversion method)

23

2024-02-19

卫食添新申字(2024)第0023号

Rebaudioside M (enzyme conversion method)

24

2024-03-04

卫食添新申字(2024)第0024号

Rosemary extract

25

2024-03-14

卫食添新申字(2024)第0025号

Sodium ferrous citrate

26

2024-03-18

卫食添新申字(2024)第0026号

Magnesium oxide

27

2024-03-18

卫食添新申字(2024)第0027号

4-Hydroxy-2,5-dimethyl-3(2H)-furanone

28

2024-03-19

卫食添新申字(2024)第0028号

β-Alanine

29

2024-03-20

卫食添新申字(2024)第0029号

Lactose-N-tetraose

30

2024-03-20

卫食添新申字(2024)第0030号

Lactose-N-neotetraose

31

2024-03-21

卫食添新申字(2024)第0031号

Steviol glycosides

32

2024-03-21

卫食添新申字(2024)第0032号

Serine protease

33

2024-03-22

卫食添新申字(2024)第0033号

Antarcticine (Antarctic red pigment)

34

2024-03-29

卫食添新申字(2024)第0034号

6'-Sialyllactose sodium salt

35

2024-03-29

卫食添新申字(2024)第0035号

Glucose oxidase

36

2024-03-29

卫食添新申字(2024)第0036号

Xylanase

37

2024-03-29

卫食添新申字(2024)第0037号

Catalase

38

2024-04-17

卫食添新申字(2024)第0038号

Recombinant human lactoferrin

39

2024-04-28

卫食添新申字(2024)第0039号

Fructooligosaccharides

40

2024-04-30

卫食添新申字(2024)第0040号

Steviol glycosides

41

2024-05-07

卫食添新申字(2024)第0041号

Aminopeptidase

42

2024-05-07

卫食添新申字(2024)第0042号

2'-Fucosyllactose, 2’FL

43

2024-05-10

卫食添新申字(2024)第0043号

Hydroxycitronellal

44

2024-05-10

卫食添新申字(2024)第0044号

Anethole

45

2024-05-13

卫食添新申字(2024)第0045号

Sodium cyclamate

46

2024-05-14

卫食添新申字(2024)第0046号

3-Fucosyllactose

47

2024-05-17

卫食添新申字(2024)第0047号

3'-Sialyllactose sodium salt

48

2024-05-20

卫食添新申字(2024)第0048号

Glutaminase

49

2024-05-20

卫食添新申字(2024)第0049号

2'-Fucosyllactose, 2’FL

50

2024-05-21

卫食添新申字(2024)第0050号

Lactose-N-tetraose

51

2024-05-21

卫食添新申字(2024)第0051号

Lipase

52

2024-05-21

卫食添新申字(2024)第0052号

β-Glucosidase

53

2024-05-24

卫食添新申字(2024)第0053号

Curdlan gum

54

2024-06-14

卫食添新申字(2024)第0054号

Curdlan gum

55

2024-06-18

卫食添新申字(2024)第0055号

Sucralose

56

2024-06-24

卫食添新申字(2024)第0056号

Tremella fuciformis sugar esters

57

2024-07-05

卫食添新申字(2024)第0057号

Steviol glycosides (enzyme conversion method)

58

2024-07-17

卫食添新申字(2024)第0058号

Nisin

59

2024-07-19

卫食添新申字(2024)第0059号

Hydrogen peroxide

60

2024-07-29

卫食添新申字(2024)第0060号

Sodium erythorbate

61

2024-07-30

卫食添新申字(2024)第0061号

Acesulfame potassium

62

2024-08-01

卫食添新申字(2024)第0062号

2-Methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one

63

2024-08-02

卫食添新申字(2024)第0063号

2'-Fucosyllactose, 2’FL

64

2024-08-08

卫食添新申字(2024)第0064号

Lactose-N-tetraose

65

2024-08-08

卫食添新申字(2024)第0065号

Branching enzyme

66

2024-08-08

卫食添新申字(2024)第0066号

Glucoamylase

67

2024-08-15

卫食添新申字(2024)第0067号

Lactose-N-neotetraose

68

2024-08-19

卫食添新申字(2024)第0068号

3'-Sialyllactose sodium salt

69

2024-08-20

卫食添新申字(2024)第0069号

Magnesium oxide

70

2024-08-20

卫食添新申字(2024)第0070号

L-Alanine

71

2024-08-21

卫食添新申字(2024)第0071号

Deaminase

72

2024-08-26

卫食添新申字(2024)第0072号

Isoamylase

73

2024-09-04

卫食添新申字(2024)第0073号

Propylene glycol

74

2024-09-13

卫食添新申字(2024)第0074号

Galactooligosaccharides

75

2024-09-19

卫食添新申字(2024)第0075号

Fructosyltransferase

76

2024-10-12

卫食添新申字(2024)第0076号

Deacetylated chitin (also known as Chitosan)

77

2024-10-15

卫食添新申字(2024)第0077号

2'-Fucosyllactose, 2’FL

78

2024-10-16

卫食添新申字(2024)第0078号

Curdlan gum

79

2024-10-22

卫食添新申字(2024)第0079号

Carbon dioxide

80

2024-10-22

卫食添新申字(2024)第0080号

L-Selenomethylselenocysteine

81

2024-10-24

卫食添新申字(2024)第0081号

Ascorbyl palmitate (enzymatic method)

82

2024-11-05

卫食添新申字(2024)第0082号

2'-Sialyllactose sodium salt

83

2024-11-12

卫食添新申字(2024)第0083号

6'-Sialyllactose sodium salt

84

2024-11-13

卫食添新申字(2024)第0084号

D-Allulose-3-epimerase

85

2024-11-13

卫食添新申字(2024)第0085号

3-Fucosyllactose

86

2024-11-20

卫食添新申字(2024)第0086号

2'-Fucosyllactose

87

2024-11-28

卫食添新申字(2024)第0087号

Deaminase

88

2024-12-04

卫食添新申字(2024)第0088号

2'-Fucosyllactose, 2’FL

89

2024-12-10

卫食添新申字(2024)第0089号

3-Fucosyllactose

90

2024-12-11

卫食添新申字(2024)第0090号

Lactose-N-tetraose

1

2’-fucosyllactose, 2’-FL

01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.7-2.4 g/L (count as the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with Lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source: E. coli BL21(DE3);

Donor: E. coli O126a

1) Issued for public comments on March 13, 2024;

2) Officially approved on October 7, 2023 according to No. 3 of 2024.

2

Source: E. coli K-12 GI724;

Donor: Bacteroides vulgatusa

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

Source: E. coli K-12 MG1655；

Donor: Helicobacter spp.a

Issued for public comments on May 10, 2024;

3

Source: E. coli BL21(DE3); Donor: Bacteroides fragilisa

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

Source: E. coli BL21(DE3)

Donor: Escherichia spp.a

4

Source: E. coli BL21(DE3)

Donor: Helicobacter spp.a

Issued for public comments on August 14, 2024;

Source: E. coli W;

Donor: Helicobacter spp.a

a is the donor for α-1,2-fucosyltransferase.

5

3-fucosyllactose, 3-FL

01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.25-0.9 g/L (count as the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with 2’-fucosyllactose, Lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source: E. coli BL21(DE3);

Donor: Bacteroides fragilisa

Issued for public comments on September 26, 2024;

6

3’-fucosyllactose, 3’-FL

13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.11-0.24 g/L (count as 3’-FL, the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with 2’-fucosyllactose, Lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source: E. coli W NEO3

Donor: Saccharomyces cerevisiaea, Synechocystis spb, Rhodobacter capsulatusc, Pasteurellamultocidad, Neisseria lactamicae

Issued for public comments on March 13, 2024;

Among them, a is the donor for glucosamine-6-phosphate N-acetyltransferase; b is the donor for N-acetylglucosamine-2-epimerase; c is the donor for N-acetylneuraminic acid synthase; d is the donor for cytidine-5'-monophosphate-N-acetylneuraminic acid synthase; e is the donor for α-2,3-sialyltransferase.

7

3’-fucosyllactose, 3’-FL

01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.06-0.28 g/L (count as the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with 2’-fucosyllactose, Lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source: E. coli BL21(DE3)

Donor: Campylobacter spp.a, Neisseria spp.b, Bibersteinia spp.c

Issued for public comments on October 24, 2024;

Source: E. coli W (ATCC 9637)

Donor: Saccharomyces cerevisiaea, Synechocystis spb, Rhodobacter capsulatusc, Pasteurellamultocidad, Neisseria lactamicae

Source: E. coli K-12 DH1 MDO

Donor: Campylobacter spp.a, Neisseria spp.b

a, f, j are donors for N-acetylneuraminic acid synthase; a,j are donors for UDP-N-acetylglucosamine epimerase; b, g, j are donors for CMP-N-acetylneuraminic acid synthase; c, h, i are donors for α-2,3-sialyltransferase; d is the donor for glucosamine-6-phosphate N-acetyltransferase; e is the donor for N-acetylglucosamine-2-epimerase.

8

6’-fucosyllactose, 6’-FL

13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.14-0.40 g/L (count as 6’-FL, the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with 2’-fucosyllactose, Lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source: E. coli W NEO6

Donor: Saccharomyces cerevisiaea, Synechocystis sp.b, Pasteurellamultocidac, Photobacterium damselaed, Rhodobacter capsulatuse

Issued for public comments on March 13, 2024;

a is the donor for glucosamine-6-phosphate N-acetyltransferase; b is the donor for N-acetylglucosamine-2-epimerase; c is the donor for CMP-N-acetylneuraminic acid synthase; d is the donor for α-2,6-sialyltransferase; e is the donor for N-acetylneuraminic acid synthase.

9

Lacto-N-neotetraose

01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.2-0.6 g/L (count as the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with 2’-fucosyllactose, galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of 2’-fucosyllactose shall not exceed 64.5 (g/kg).

Source:E. coli BL21 star (DE3)

Donor: Neisseria spp.a, Helicobacter spp.b

Issued for public comments on May 10, 2024;

10

source: E.coli BL21(DE3)

Donor: Neisseria spp.a, Helicobacter spp.b

Issued for public comments on October 24, 2024;

a is the donor for β-1,3-N-acetylglucosaminyltransferase;

b is the donor for β-1,4-galactosyltransferase.

11

Lacto-N-tetraose

01.03.02, modified milk powder (for children only); 13.01.01, infant formula food; 13.01.02, formula for older infants and young children; 13.01.03, infant formula food for special medical purpose

0.23-1.82 g/L (count as the state of ready to eat; for powdery products, the level of use should be increased by times of brewing);

when mixed with 2’-fucosyllactose, Lacto-N-neotetraose, galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of Lacto-N-tetraose shall not exceed 64.5 (g/kg).

source: star(DE3)E. coli BL21 star(DE3)

Donor: Neisseria spp.a, , Salmonella spp.b

Issued for public comments on June 24, 2024;

a is the donor for β-1,3-N-acetylglucosaminyltransferase; b is the donor for β-1,3-galactosyltransferase.

12

β-alanine

13.05 Other special dietary foods (excluding 13.01-13.04) (limited to sports nutrition foods)

2-4g/day

/

Issued for public comments on September 26, 2024;

13

fructo-oligosaccharide (FOS)

The scope of use and dosage of this substance shall comply with the provisions for approved FOS in the National Food Safety Standard for the Use of Food Nutritional Fortifiers (GB 14880).

/

Issued for public comments on September 26, 2024;

S.N.

Name

Function

Category number

Food name/

category

Maximum levels (g/kg)

Approval status

（As of the end of December 2024）

1

Hydroxytyrosol

Antioxidant

02.01.01

Vegetables oils and fats

0.05

1) Issued for public comments on May 10, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

2

Steviol glycosides (fermentation)

Sweetener

The scope of use and dosage of steviol glycosides (fermentation method) shall comply with the provisions of the National Food Safety Standard for the Use of Food Additives (GB2760-2024). It can be used alone or mixed with steviol glycosides and steviol glycosides (enzyme conversion method), calculated as steviol equivalent.

Issued for public comments on June 24, 2024;

The production strain information for steviol glycosides (fermentation method) is as follows:

Source: E. coli BL21(DE3)

Donors: Taxuscanadensisa, Stevia rebaudianab,Arabidopsis thalianac, Oryza sativad

a is the donor for geranylgeranyl pyrophosphate synthase;

b is the donor for pyrophosphate synthase, ent-kaurene synthase, ent-kaurene oxidase, cytochrome P450 oxidoreductase enzyme, and glycosyltransferase;

c is the donor for cytochrome monooxygenase;

d is the donor for glycosyltransferase.

3

butylated hydroxytoluene (BHT)

Antioxidant

The scope of use and dosage of butylated hydroxytoluene (BHT) shall comply with the provisions of the National Food Safety Standard for the Use of Food Additives (GB2760).

Issued for public comments on August 14, 2024;

1

D-allulose-3-epimerase

Bacillus subtilis

Ruminococcus sp. 5_1_39B_FAA

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

2

Glucoamylase

Aspergillus niger

Penicillium oxalicum

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

3

Serine protease

Fusarium venenatum

Fusarium oxysporum

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

4

Lipase

Komagataella phaffi

Aspergillus oryzae

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

5

Transglutaminase

Bacillus licheniformis

Streptomyces

mobaraensis

Issued for public comments on September 26, 2024;

6

Phosphodiesterase I

Leptographium

procerum

—

Issued for public comments on September 26, 2024;

7

Lipase

Komagataella

phaffi

Streptomyces sp.

Issued for public comments on September 26, 2024;

8

Peroxidase

Aspergillus niger

Marasmius scorodonius

Issued for public comments on October 24, 2024;

9

Xylanase

Aspergillus niger

Rasamsoniaemersonii

Issued for public comments on October 24, 2024;

1

Dichloromethane

Extraction solvent

decaffeination process of tea

≤ 2 mg/kg

1) Issued for public comments on March 13, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

1

4-Hydroxy-2,5-dimethyl-3(2H)-furanone

food spices

This applies to the food additive 4-hydroxy-2,5-dimethyl-3(2H)-furanone produced from rhamnose as the raw material. The remaining provisions comply with the National Food Safety Standard for Food Additive 4-Hydroxy-2,5-Dimethyl-3(2H)-Furanone (GB 28365).

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

2

Synthetic Anethole

food spices

It can be formulated into food flavorings for use in various food categories (excluding those listed in Table B.1 of GB 2760-2014) and used in appropriate amounts as needed for production.

Issued for public comments on September 26, 2024;

3

Hydroxycitronellal

food spices

It can be formulated into food flavorings for use in various food categories (excluding those listed in Table B.1 of GB 2760-2014) and used in appropriate amounts as needed for production.

Issued for public comments on September 26, 2024;

1

(6S)-5-methyltetrahydrofolate, glucosamine salt

13.05

Other special dietary foods, except for categories 13.01 to 13.04 (limited to nutritional supplements for pregnant and lactating women),

It shall comply with the folic acid requirements specified in the National Food Safety Standard for Nutritional Supplements for Pregnant and Lactating Women (GB 31601).

1) Issued for public comments on March 13, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

2

Sodium ferrous citrate

As a source of iron compounds, the scope of use and dosage shall comply with the provisions of the National Food Safety Standard for the Use of Food Nutrition Enhancer (GB 14880) regarding iron.

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

3

2'-fucosyllactose, 2'-FL

13.02.01

Infant cereal-based complementary foods

0.7-2.4 g/L (calculated as pure product, in ready-to-eat state; for powdery products, the level of use should be increased by times of brewing), when mixed with 2’-fucosyllactose, Lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount of these substances should not exceed 64.5 g/kg.

Issued for public comments on September 26, 2024;

13.02.02

Infant complementary feeding products

1

Polyglyceryl ricinoleate

Emulsifier

01.05.03

Pickled vegetables

10.0

-

1) Issued for public comments on March 13, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

2

Sodium cyclamate

Sweetener

01.02.02

Flavored fermented milk

0.65

Calculated as cyclohexylamine sulfonic acid

1) Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

16.07

Others (limited to konjac gel products)

1.0

3

Steviol glycosides

Sweetener

01.03.02

Formulated milk powder and formulated cream powder

0.3

calculated as steviol equivalent

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

01.06.04

Processed cheese and cheese products

0.4

04.03.02.03

Pickled edible fungi and algae

0.23

06.07

Instant rice and noodle products

0.4

4

Curdlan gum

Thickener, stabilizer and coagulant

01.05.03

Formulated cream

Used in appropriate amounts as needed for production.

-

Issued for public comments on August 14, 2024;

16.05

Starter cultures for food processing (excluding 16.04)

5

Steviol glycosides (enzymatically converted)

Sweetener

The scope of use and dosage shall comply with the provisions for approved steviol glycosides in the National Food Safety Standard for the Use of Food Additives (GB 2760-2024). It can be used alone or in combination with other steviol glycosides.

calculated as steviol equivalent

Issued for public comments on August 14, 2024;

6

Sucralose

Sweetener

04.01.02.08

preserved fruits

2.8

-

Issued for public comments on September 26, 2024;

7

Acesulfame Potassium

Sweetener

14.08

Flavored beverages

0.5

-in ready-to-eat state; for powdery products, the level of use should be increased by times of brewing

Issued for public comments on September 26, 2024;

8

Magnesium Oxide

Thickener

04.01.01.02

Surface-treated fresh fruits (limited to citrus fruits)

Used in appropriate amounts as needed for production.

-

Issued for public comments on October 24, 2024;

1

Hydrogen peroxide

Desulfurizer

Yeast-derived product processing technology

Issued for public comments on October 24, 2024;

1

2’-fucosyllactose, 2’-FL

E. coli BL21(DE3)

Helicobacter pyloria

1) Issued for public comments on October 26, 2023;

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

2

2’-fucosyllactose, 2’-FL

E. coli BL21 star (DE3)

Escherichia coli O126^a

1) Issued for public comments on March 13, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

3

2’-fucosyllactose, 2’-FL

Corynebacterium glutamicum ATCC 13032

Pseudopedobacter saltans^a

1) Issued for public comments on August 23, 2023;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

4

2’-fucosyllactose, 2’-FL

E. coli K-12 G GI724

Bacteroides vulgatus^a

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

5

2’-fucosyllactose, 2’-FL

E. coli BL21(DE3)

Bacteroides^a

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

6

2’-fucosyllactose, 2’-FL

E. coli BL21 star (DE3)

Escherichia spp.^a

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

In the above steps 1-6, ^a is the donor for α-1,2-fucosyltransferase; The usage amount, scope, and quality specifications of 2'-fucosyllactose shall comply with the requirements of the 2023 No. 8 Announcement of the National Health Commission (excluding the production strain information for 2'-fucosyllactose in Appendix C).

7

Lacto-N-neotetraose

E. coli BL21 star (DE3)

Neisseria spp.^a, Helicobacter spp.^b

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

^a is the donor for β-1,3-N-acetylglucosamine transferase, and

^b is the donor for β-1,4-galactosyltransferase.

The usage scope, amount, and quality specifications of lactose-N-neotetrose shall comply with the requirements of the 2023 No. 8 Announcement of the National Health Commission (excluding the production strain information for lactose-N-neotetrose in Appendix C).

S.N.

Name

Category No.

Food name

Applicable scope

Approval status

8

d-ribose

13.05

Other special dietary foods, excluding categories 13.01-13.04 (limited to sports nutrition foods)

1~2 g/day

1) Issued for public comments o 2021.10.21

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

1

Mixed tocotrienols concentrate

Antioxidant

02.01.01

Plant oils and fats

0.2

Calculated as total tocopherols and total tocotrienols

1. Issued for public comments on 2023.06.26
2. Officially approved on March 13, 2024 according to No. 2 of 2024.

2

Steviol glycosides (enzymatic conversion method)

sweetener

01.01.03

Formulated milk

0.18

Can be used alone or mixed with steviol glycosides, calculated as steviol equivalent.

1. Issued for public comments on 2023.10.26.
2. Officially approved on March 13, 2024 according to No. 2 of 2024.

01.02.02

Flavored fermented milk

0.2

03.01

Ice cream and ice lolly

0.5

05.02.01

Gum-based confectionery

3.5

14.0

Beverages [Excluding 14.01 Packaged drinking water, 14.02.01 Fruit and vegetable juices (Puree), and 14.02.02 Concentrated fruit and vegetable Juices (Puree)]

0.2

Can be used alone or mixed with steviol glycosides, calculated as steviol equivalent; for ready-to-drink products, the usage for corresponding solid beverages should be increased proportionally based on the dilution ratio.

The production strain information for steviol glycosides (enzymatic conversion method) is as follows:

Source: E. coli BL21 (DE3); Donors: Methylocaldum szegediense^a, Stevia rebaudiana Bertoni^b, and Solanum tuberosum^c.

^a is the donor for sucrose synthase;

^b is the donor for β-1,3-glycosyltransferase;

^c is the donor for β-1,2-glycosyltransferase.

3

Hydroxytyrosol

Antioxidant

02.01.01

Plant oils and fats

0.05

—

1) Issued for public comments on March 13, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

4

Dichloromethane

Extraction solvent

decaffeination process of tea

≤ 2 mg/kg

—

1) Issued for public comments on March 13, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

1

D-psicose 3-epimerase

Bacillus subtilis

Clostridium scindens ATCC35704

1) Issued for public comments on December 29, 2023;

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

2

Cyclodextrin glucanotransferase

Anoxybacillus

caldiproteolyticus

—

1) Issued for public comments on 2023.10.26.

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

3

Cellulase

Penicillium oxalicum

—

1) Issued for public comments on 2023.10.26.

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

4

D-psicose 3-epimerase

Bacillus subtilis

Ruminococcus sp.5_1_39B_FAA

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

5

Glucoamylase

Aspergillus niger

Penicillium oxalicum

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

6

Serine protease

Fusarium venenatum

Fusarium oxysporum

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

7

Lipase

Komagataella phaffi

Aspergillus oryza

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

S.N.

Name

Food name

Maximum level (g/L)

Remark

Acceptance information, issuance for public comments and approval

(As of the end of December 2024)

1

4-Hydroxy-2,5-dimethyl-3(2H)-furanone

Spice for food

Used in appropriate amounts in production

—

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

1

Propylene glycol alginate

Thickener

06.05.02.01

Vermicelli, noodles

1.5

—

1) Issued for public comments on Issued for public comments on 2023.08.23

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

06.05.02.04

Tapioca pearls

—

2

Polyoxyethylene (20) sorbitan monooleate (also known as Tween 80)

Emulsifier

16.03

Collagen sausage casings

0.5

—

1) Issued for public comments on Issued for public comments on 2023.10.26

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

3

Ascorbyl palmitate (enzymatic)

Antioxidant

01.03.02

Formulated milk powder and formulated cream powder

0.2

Calculated as ascorbic acid in fat

1) Issued for public comments on Issued for public comments on 2023.12.29

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

07.01

Bread

0.2

—

14.05.01

Tea beverage

0.2

For ready-to-drink products, the usage for corresponding solid beverages should be increased proportionally based on the dilution ratio.

4

Rosemary extract

Antioxidant

04.05.02

Flour pastes (e.g., drag flour pastes used for fish and poultry), breading and frying flour

0.3

—

1) Issued for public comments on Issued for public comments on 2023.10.26

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

5

Sucralose (also known as Splenda)

Sweetener

04.05.02.01.01

Instant rice flour products

4.0

—

1) Issued for public comments on Issued for public comments on 2023.12.29

2) Officially approved on March 13, 2024 according to No. 2 of 2024.

04.05.02.01.02

2.0

6

Polyglycerol polyricinoleate

Emulsifier

01.05.03

Formulated whipping cream

10.0

—

1) Issued for public comments on March 13, 2024;

2) Officially approved on August 5, 2024 according to No. 3 of 2024.

7

Sodium cyclamate

Sweetener

01.02.02

Flavored fermented milk

0.65

Calculated as cyclohexylamine sulfate

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

16.07

Others (only konjac gel products)

1.0

8

Steviol glycosides

Sweetener

01.03.02

Formulated milk powder and formulated cream powder

0.3

Calculated as steviol equivalent

1) Issued for public comments on Issued for public comments on June 24, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.

01.06.04

Processed cheese and cheese products

0.4

04.03.02.03

Pickled edible mushrooms and algae

0.23

06.07

Instant rice and noodle products

0.4

1

Sodium ferrous citrate

As a source of iron compound, the scope of use and dosage shall comply with the regulations on iron in the National Food Safety Standard for Food Nutrition enhancers (GB 14880).

1) Issued for public comments on May 10, 2024;

2) Officially approved on October 10, 2024 according to No. 5 of 2024.

2

(6S)-5-Methyl tetrahydrofolate, glucosamine salt

13.05

Other special dietary foods excluding 13.01–13.04 (only for nutritional supplements for pregnant women and lactating mothers)

Calculated as folic acid, in accordance with the regulations on folic acid in the National Food Safety Standard for Nutritional Supplements for Pregnant Women and Lactating Mothers (GB 31601).

1) Issued for public comments on March 13, 2024;

2) Officially approved on December 13, 2024 according to Notice No. 6 of 2024.