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

1

2024-01-05

衛食添新申字(2024)第0001號

Marigold yellow

2

2024-01-11

衛食添新申字(2024)第0002號

2'-Fucosyllactose, 2’FL

3

2024-01-12

衛食添新申字(2024)第0003號

Lactose-N-tetraose

4

2024-01-16

衛食添新申字(2024)第0004號

L-Alanine

5

2024-01-16

衛食添新申字(2024)第0005號

2'-Fucosyllactose

6

2024-01-16

衛食添新申字(2024)第0006號

Xanthan gum

7

2024-01-17

衛食添新申字(2024)第0007號

Lipase

8

2024-01-18

衛食添新申字(2024)第0008號

Selenium-enriched yeast

9

2024-01-18

衛食添新申字(2024)第0009號

2'-Fucosyllactose, 2’FL

10

2024-01-18

衛食添新申字(2024)第0010號

Chitosan

11

2024-01-22

衛食添新申字(2024)第0011號

Anethole

12

2024-01-22

衛食添新申字(2024)第0012號

Citral

13

2024-01-22

衛食添新申字(2024)第0013號

Hydroxycitronellal

14

2024-01-23

衛食添新申字(2024)第0014號

3'-Sialyllactose sodium salt

15

2024-01-24

衛食添新申字(2024)第0015號

Xylanase

16

2024-01-24

衛食添新申字(2024)第0016號

D-Allulose-3-epimerase

17

2024-01-24

衛食添新申字(2024)第0017號

β-Alanine

18

2024-01-25

衛食添新申字(2024)第0018號

Glucose oxidase

19

2024-01-26

衛食添新申字(2024)第0019號

Polyglycerol ricinoleate

20

2024-01-30

衛食添新申字(2024)第0020號

Peroxidase

21

2024-02-06

衛食添新申字(2024)第0021號

Glucoamylase

22

2024-02-19

衛食添新申字(2024)第0022號

Rebaudioside AM (enzyme conversion method)

23

2024-02-19

衛食添新申字(2024)第0023號

Rebaudioside M (enzyme conversion method)

24

2024-03-04

衛食添新申字(2024)第0024號

Rosemary extract

25

2024-03-14

衛食添新申字(2024)第0025號

Sodium ferrous citrate

26

2024-03-18

衛食添新申字(2024)第0026號

Magnesium oxide

27

2024-03-18

衛食添新申字(2024)第0027號

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

28

2024-03-19

衛食添新申字(2024)第0028號

β-Alanine

29

2024-03-20

衛食添新申字(2024)第0029號

Lactose-N-tetraose

30

2024-03-20

衛食添新申字(2024)第0030號

Lactose-N-neotetraose

31

2024-03-21

衛食添新申字(2024)第0031號

Steviol glycosides

32

2024-03-21

衛食添新申字(2024)第0032號

Serine protease

33

2024-03-22

衛食添新申字(2024)第0033號

Antarcticine (Antarctic red pigment)

34

2024-03-29

衛食添新申字(2024)第0034號

6'-Sialyllactose sodium salt

35

2024-03-29

衛食添新申字(2024)第0035號

Glucose oxidase

36

2024-03-29

衛食添新申字(2024)第0036號

Xylanase

37

2024-03-29

衛食添新申字(2024)第0037號

Catalase

38

2024-04-17

衛食添新申字(2024)第0038號

Recombinant human lactoferrin

39

2024-04-28

衛食添新申字(2024)第0039號

Fructooligosaccharides

40

2024-04-30

衛食添新申字(2024)第0040號

Steviol glycosides

41

2024-05-07

衛食添新申字(2024)第0041號

Aminopeptidase

42

2024-05-07

衛食添新申字(2024)第0042號

2'-Fucosyllactose, 2’FL

43

2024-05-10

衛食添新申字(2024)第0043號

Hydroxycitronellal

44

2024-05-10

衛食添新申字(2024)第0044號

Anethole

45

2024-05-13

衛食添新申字(2024)第0045號

Sodium cyclamate

46

2024-05-14

衛食添新申字(2024)第0046號

3-Fucosyllactose

47

2024-05-17

衛食添新申字(2024)第0047號

3'-Sialyllactose sodium salt

48

2024-05-20

衛食添新申字(2024)第0048號

Glutaminase

49

2024-05-20

衛食添新申字(2024)第0049號

2'-Fucosyllactose, 2’FL

50

2024-05-21

衛食添新申字(2024)第0050號

Lactose-N-tetraose

51

2024-05-21

衛食添新申字(2024)第0051號

Lipase

52

2024-05-21

衛食添新申字(2024)第0052號

β-Glucosidase

53

2024-05-24

衛食添新申字(2024)第0053號

Curdlan gum

54

2024-06-14

衛食添新申字(2024)第0054號

Curdlan gum

55

2024-06-18

衛食添新申字(2024)第0055號

Sucralose

56

2024-06-24

衛食添新申字(2024)第0056號

Tremella fuciformis sugar esters

57

2024-07-05

衛食添新申字(2024)第0057號

Steviol glycosides (enzyme conversion method)

58

2024-07-17

衛食添新申字(2024)第0058號

Nisin

59

2024-07-19

衛食添新申字(2024)第0059號

Hydrogen peroxide

60

2024-07-29

衛食添新申字(2024)第0060號

Sodium erythorbate

61

2024-07-30

衛食添新申字(2024)第0061號

Acesulfame potassium

62

2024-08-01

衛食添新申字(2024)第0062號

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

63

2024-08-02

衛食添新申字(2024)第0063號

2'-Fucosyllactose, 2’FL

64

2024-08-08

衛食添新申字(2024)第0064號

Lactose-N-tetraose

65

2024-08-08

衛食添新申字(2024)第0065號

Branching enzyme

66

2024-08-08

衛食添新申字(2024)第0066號

Glucoamylase

67

2024-08-15

衛食添新申字(2024)第0067號

Lactose-N-neotetraose

68

2024-08-19

衛食添新申字(2024)第0068號

3'-Sialyllactose sodium salt

69

2024-08-20

衛食添新申字(2024)第0069號

Magnesium oxide

70

2024-08-20

衛食添新申字(2024)第0070號

L-Alanine

71

2024-08-21

衛食添新申字(2024)第0071號

Deaminase

72

2024-08-26

衛食添新申字(2024)第0072號

Isoamylase

73

2024-09-04

衛食添新申字(2024)第0073號

Propylene glycol

74

2024-09-13

衛食添新申字(2024)第0074號

Galactooligosaccharides

75

2024-09-19

衛食添新申字(2024)第0075號

Fructosyltransferase

76

2024-10-12

衛食添新申字(2024)第0076號

Deacetylated chitin (also known as Chitosan)

77

2024-10-15

衛食添新申字(2024)第0077號

2'-Fucosyllactose, 2’FL

78

2024-10-16

衛食添新申字(2024)第0078號

Curdlan gum

79

2024-10-22

衛食添新申字(2024)第0079號

Carbon dioxide

80

2024-10-22

衛食添新申字(2024)第0080號

L-Selenomethylselenocysteine

81

2024-10-24

衛食添新申字(2024)第0081號

Ascorbyl palmitate (enzymatic method)

82

2024-11-05

衛食添新申字(2024)第0082號

2'-Sialyllactose sodium salt

83

2024-11-12

衛食添新申字(2024)第0083號

6'-Sialyllactose sodium salt

84

2024-11-13

衛食添新申字(2024)第0084號

D-Allulose-3-epimerase

85

2024-11-13

衛食添新申字(2024)第0085號

3-Fucosyllactose

86

2024-11-20

衛食添新申字(2024)第0086號

2'-Fucosyllactose

87

2024-11-28

衛食添新申字(2024)第0087號

Deaminase

88

2024-12-04

衛食添新申字(2024)第0088號

2'-Fucosyllactose, 2’FL

89

2024-12-10

衛食添新申字(2024)第0089號

3-Fucosyllactose

90

2024-12-11

衛食添新申字(2024)第0090號

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.