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Analysis on Application Approval of New Food Additives in China in 2022

from CIRS by

China,Food,Analysis,New,Additive,Application,Approval

By the end of December 2022, the National Health Commission of the People's Republic of China (NHC) issued three announcements (No. 1 of 2022, No. 2 of 2022, No. 5 of 2022) in the form of "Three New Foods" with 75 products approved, including new food raw materials (novel food), new food additives and food-related products (new food contact substances). Among them, 32 kinds of new food additives (including expanded use) were approved.

According to the NHC and the China National Center for Food Safety Risk Assessment (CFSA) websites, in 2022, a total of 97 new food additives applications were accepted, and 45 new food additives (including expanded use) passed the technical evaluation and were issued for public comments.

This article provides you with detailed information about the acceptance and approval of new food additives in China in 2022.

1. List of new food additives applications in 2022 (97 types)

In 2022, a total of 97 new food additives (including expanded use) applications were accepted by the NHC. Since the acceptance code all begin with "卫食添新申字", there is no distinction between domestic and imported products.

Several applications among them were issued rejection decisions: yellow pigment was rejected on March 8, 2022 . Rebaudioside A, steviol glycosides, stevia extract, 6S-5-methyltetrahydrofolate calcium, serine protease and pyrrolidine -[1,2e] -4h-2, 4-dimethyl-1,3, 5-dithiazide were rejected on August 16, 2022. Nucleotide was rejected on September 14, 2022. Isomerized lactose (卫食添新申字(2022)0041 and 卫食添新申字(2022)0042), ammonium glycyrrhizinate were rejected on September 30, 2022 . Xylanase was rejected on October 9, 2022 . Sucralos, acesulfame potassium, mycelium extract of Cordyceps sinensis, curdlan, rock mineral selenium, gardenia yellow, riboflavin, monopotassium and tripotassium glycyrrhizinate, potassium bitartarate and vanillin (fermentation) were rejected on December 12, 2022 . L-Alanine, nisin and tomato red were rejected on January 28, 2023 .

No.

Acceptance date

Acceptance Code

Name of New Food Additives

1

2022.01.06

卫食添新申字(2022)0001

Carboxypeptidase

2

2022.01.10

卫食添新申字(2022)0002

Monascus yellow pigment

3

2022.01.30

卫食添新申字(2022)0003

Carmine cochineal

4

2022.02.11

卫食添新申字(2022)0004

Rebaudioside A

5

2022.02.11

卫食添新申字(2022)0005

Stevia glycosides

6

2022.02.11

卫食添新申字(2022)0006

Stevia extract

7

2022.02.16

卫食添新申字(2022)0007

Magnesium stearate

8

2022.03.03

卫食添新申字(2022)0008

L-alanine

9

2022.03.07

卫食添新申字(2022)0009

Xylanase

10

2022.03.07

卫食添新申字(2022)0010

Aminopeptidase

11

2022.03.08

卫食添新申字(2022)0011

L-leucine

12

2022.03.08

卫食添新申字(2022)0012

L-isoleucine

13

2022.03.08

卫食添新申字(2022)0013

L-valine

14

2022.03.21

卫食添新申字(2022)0014

6S-5-methyltetrahydrofolate calcium

15

2022.04.02

卫食添新申字(2022)0015

Maltose alpha-amylase

16

2022-04-26

卫食添新申字(2022)0016

Lactase (beta-galactosidase)

17

2022.04.28

卫食添新申字(2022)0017

Phospholipase A2

18

2022.05.10

卫食添新申字(2022)0018

Serine protease

19

2022.05.10

卫食添新申字(2022)0019

Serine protease

20

2022.05.10

卫食添新申字(2022)0020

Xylanase

21

2022.05.23

卫食添新申字(2022)0021

2-hexyl pyridine

22

2022.05.26

卫食添新申字(2022)0022

L-cystine

23

2022.05.26

卫食添新申字(2022)0023

L-cysteine hydrochloride monohydrate

24

2022.05.26

卫食添新申字(2022)0024

L-lysine acetate

25

2022.05.26

卫食添新申字(2022)0025

L-histidine

26

2022.05.26

卫食添新申字(2022)0026

L-threonine

27

2022.05.26

卫食添新申字(2022)0027

L-cysteine hydrochloride

28

2022.05.26

卫食添新申字(2022)0028

L-cysteine

29

2022.05.26

卫食添新申字(2022)0029

L-phenylalanine

30

2022.05.26

卫食添新申字(2022)0030

L-lysine hydrochloride

31

2022.05.26

卫食添新申字(2022)0031

L- histidine hydrochloride monohydrate

32

2022.05.27

卫食添新申字(2022)0032

Pyrrolidino -[1,2e] -4h-2,4-dimethyl-1,3,5-dithiazide

33

2022.06.02

卫食添新申字(2022)0033

D-psicose 3-epimerase

34

2022.06.09

卫食添新申字(2022)0034

Rock mineral selenium

35

2022.06.13

卫食添新申字(2022)0035

L-selenomethyl selenocysteine

36

2022.06.13

卫食添新申字(2022)0036

Ammonium glycyrrhizinate

37

2022.06.13

卫食添新申字(2022)0037

Acesulfame potassium

38

2022.06.20

卫食添新申字(2022)0038

Magnesium lactate

39

2022.06.28

卫食添新申字(2022)0039

Sodium acetate

40

2022.06.28

卫食添新申字(2022)0040

Fumaric acid

41

2022.07.04

卫食添新申字(2022)0041

Isomerized lactose

42

2022.07.04

卫食添新申字(2022)0042

Isomerized lactose

43

2022.07.06

卫食添新申字(2022)0043

 Nucleotide

44

2022.07.11

卫食添新申字(2022)0044

Sucralose

45

2022.07.12

卫食添新申字(2022)0045

L-serine

46

2022.07.12

卫食添新申字(2022)0046

L-Aspartic acid

47

2022.07.12

卫食添新申字(2022)0047

L(-)-Proline

48

2022.07.12

卫食添新申字(2022)0048

L-lysine-l-glutamic acid dihydrate

49

2022.07.12

卫食添新申字(2022)0049

L-citrulline

50

2022.07.12

卫食添新申字(2022)0050

L-potassium glutamate monohydrate

51

2022.07.12

卫食添新申字(2022)0051

 L-glutamic acid

52

2022.07.12

卫食添新申字(2022)0052

 L-glutamine

53

2022.07.12

卫食添新申字(2022)0053

 L-lysine-L-aspartic acid

54

2022.07.12

卫食添新申字(2022)0054

 L-ornithine hydrochloride

55

2022.07.12

卫食添新申字(2022)0055

 N-acetyl-L-cysteine

56

2022.07.12

卫食添新申字(2022)0056

 Glycine

57

2022.07.12

卫食添新申字(2022)0057

 L-lysine monohydrate

58

2022.07.12

卫食添新申字(2022)0058

L-calcium glutamate tetrahydrate

59

2022.07.12

卫食添新申字(2022)0059

L-magnesium aspartate dihydrate

60

2022.07.12

卫食添新申字(2022)0060

Sodium N-cyclohexyl sulfamate (Also called cyclamate)

61

2022.07.13

卫食添新申字(2022)0061

Potassium glycyrrhizinate

62

2022.07.13

卫食添新申字(2022)0062

Tripotassium glycyrrhizinate

63

2022.07.15

卫食添新申字(2022)0063

lysophospholipase

64

2022.07.15

卫食添新申字(2022)0064

 Potassium hydrogen tartrate

65

2022.08.12

卫食添新申字(2022)0065

vitamin E

66

2022.08.17

卫食添新申字(2022)0066

gardenia yellow

67

2022.08.17

卫食添新申字(2022)0067

Riboflavin

68

2022.08.23

卫食添新申字(2022)0068

L- lysine

69

2022.08.30

卫食添新申字(2022)0069

Curdlan

70

2022.09.02

卫食添新申字(2022)0070

Mycelial fermentation of Cordyceps sinensis

71

2022.09.05

卫食添新申字(2022)0071

Vanillin (fermentation)

72

2022.09.14

卫食添新申字(2022)0072

Cellulase

73

2022.09.29

卫食添新申字(2022)0073

Tomato red

74

2022.10.26

卫食添新申字(2022)0074

Nisin

75

2022.10.31

卫食添新申字(2022)0075

Taurine

76

2022.10.31

卫食添新申字(2022)0076

Vitamin B1

77

2022.10.31

卫食添新申字(2022)0077

Vitamin B2

78

2022.11.01

卫食添新申字(2022)0078

Serine protease

79

2022.11.01

卫食添新申字(2022)0079

beta-galactosidase

80

2022.11.04

卫食添新申字(2022)0080

L-alanine

81

2022.11.04

卫食添新申字(2022)0081

Ascorbyl palmitate (enzymatic method)

82

2022.11.04

卫食添新申字(2022)0082

Ascorbyl palmitate (enzymatic method)

83

2022.11.11

卫食添新申字(2022)0083

Ethyl acetate

84

2022.11.11

卫食添新申字(2022)0084

Dichloromethane

85

2022.11.15

卫食添新申字(2022)0085

2’-fucosyllactose

86

2022.11.16

卫食添新申字(2022)0086

beta-glucanase

87

2022.11.29

卫食添新申字(2022)0087

Apple polyphenol

88

2022.11.29

卫食添新申字(2022)0088

hydroxytyrosol

89

2022.11.29

卫食添新申字(2022)0089

Monascus red

90

2022.12.06

卫食添新申字(2022)0090

Sanzan gum

91

2022.12.06

卫食添新申字(2022)0091

Sanzan gum

92

2022.12.06

卫食添新申字(2022)0092

Sanzan gum

93

2022.12.13

卫食添新申字(2022)0093

Sanzan gum

94

2022.12.19

卫食添新申字(2022)0094

Monascus yellow pigment

95

2022.12.19

卫食添新申字(2022)0095

sulfate

96

2022.12.20

卫食添新申字(2022)0096

Carnauba wax

97

2022.12.20

卫食添新申字(2022)0097

Bees wax

2. List of new food additives issued for public comments in 2022 (45 types)

In 2022, 45 new food additives passed the technical review of the CFSA and were issued for public comments, including 13 new food enzymes, three new food processing aids (including expanded use), one new flavor for food, 16 new nutrition enhancers, four existing nutrition enhancers with expanded use, one new food additive and seven existing food additives with expanded use.

Among them, carmine cochineal, aminopeptidase, xylanase, carboxypeptidase, phospholipase A2, lactase (beta-galactosidase), and D-psicose 3-epimerase which were accepted in 2022, the other seven products applications were accepted by NHC in 2021.

2.1 List of new food enzymes (13 types)

No

Name

Source

Donor

Approval status (By the end of December 2022)

1

β-glucanase

Bacillus subtilis

Bacillus subtilis

Accepted on September 17, 2022, Acceptance number: 卫食添新申字(2021)第0040号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

2

Protease

Bacillus subtilis

Alkalihalobacillus clausii

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

3

Trehalase

Trichoderma reesei

Trichoderma reesei

Accepted on September 17, 2022, Acceptance number: 卫食添新申字(2021)第0041号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

4

Lactase

Aspergillus niger

Aspergillus oryzae

Accepted on November 9, 2022, Acceptance number: 卫食添新申字(2021)第0053号.

Passed the technical review and issued for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

5

Aminopeptidase

Aspergillus oryza

Aspergillus oryza

Accepted on March 7, 2022, Acceptance number: 卫食添新申字(2022)第0010号.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

6

Xylanase

Bacillus licheniformis

Bacillus licheniformis

Accepted on March 7, 2022, Acceptance number:卫食添新申字(2022)第0009号.

Passed the technical review and issued for public comments on July 1, 2022,

It has not been officially approved.

7

Carboxypeptidase

Aspergillus oryzae

Aspergillus oryza

Accepted on January 6, 2022, Acceptance number: 卫食添新申字(2022)第0001号.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

8

Deaminase

Aspergillus oryza

-

Accepted on April 30, 2020, Acceptance number: 卫食添新申字(2020)第0020号.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

9

Protease

Trichoderma reesei

Malbranchea sulfurea

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

10

Phospholipase A2

Trichoderma reesei

Aspergillus fumigatus

Accepted on April 28, 2022, Acceptance number: 卫食添新申字(2022)第0017号.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

11

Maltogenic amylase

Saccharomyces cerevisiae

Geobacillus stearothermophilus

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

12

Lactase(beta-galactosidase)

Papiliotrema

terrestris

-

Accepted on April 26, 2022, Acceptance number: 卫食添新申字(2022)第0016号.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

13

D-psicose 3-epimeras

Bacillus subtil

Ruminococcus sp. CAG55

Accepted on June 2, 2022, Acceptance number: 卫食添新申字(2022)第0033号.

Passed the technical review and issued for public comments on December 8, 2022.

It has not been officially approved.

Note: The quality specification of enzymes should meet the requirements of the "National Food Safety Standard, Food Additives and Enzyme" (GB 1886.174).

2.2 List of new food processing aid (one type)

No

Name

Function

Food name/category

Maximum level in grams per kilogram (g/kg)

Approval Status

(By the end of December 2022)

1

Sodium sulfide pentahydrate

Deacidizing agent, decolorizing agent, settling agent

Salt production process

0.065

Accepted on July 7, 2021, Acceptance number: 卫食添新申字(2021)第0030号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

2.3 List of existing food processing aids with expanded use (two types)

No

Name

Function

Usage scope

Approval Status

(By the end of December 2022)

1

Polydimethyl siloxane and emulsion

Antifoaming agent

Collagen casings processing technology

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

2

Magnesium stearate

Lubricant, release agent, anti-sticking agent

Effervescent tablet pressing process

Accepted on February 16, 2022, Acceptance number: 卫食添新申字(2022)第0007号.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

2.4 List of new flavor (one type)

No

Name

Function

Food name/category

Maximum level grams per liter (g/L)

Approval Status

(By the end of June 2022)

1

2-hexylpyridine

flavoring

Used in various foods after being formulated into flavors (Except for the food category in Table B1 of GB 2760-2014)

Appropriate level as required in production

Accepted on May 23, 2022, Acceptance number: 卫食添新申字(2022)第0021号.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

2.5 List of new food nutrition enhancers (16 types)

No

Name

Category number

Food name/category

Maximum level

Approval Status

(By the end of December 2022)

1

2'-

fucosyllactose

01.03.02

Modified milk powder (limited to milk powder for children)

0.7-2.4 g/L (Count as pure products. In terms of ready-to-eat state, for powdery products, the level of use should be increased by brewing time.) When mixed with Lacto-N-neotetraose, oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of 2'-

fucosyllactoseshall must not exceed 64.5 (g/kg)

Accepted on October 18, 2021, Acceptance number: 卫食添新申字(2021)第0048号, and accepted on November 3, 2021, Acceptance number: 卫食添新申字(2021)第0050号.

Passed the technical review and issued for public comments on April 15, 2022 and October 28, 2022,

It has not been officially approved.

13.01.01

Infant formula foods

13.01.02

Older infants and young children formula

13.01.03

Infant formula food for special medical purposes

2

L-alanine

  • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
  • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922.

Accepted on March 3, 2022, Acceptance number: 卫食添新申字(2022)0008.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

3

L-Arginine Hydrochloride

  • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
  • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922.

Accepted on November 16, 2021, Acceptance number: 卫食添新申字(2021)第0055号.

Passed the technical review and issued for public comments on July 1, 2022.

It has not been officially approved.

4

L-selenomethyl selenocysteine

The application range and dosage of L-Se-methyl selenocysteine are consistent with the provisions of selenium approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

Accepted on June 13, 2022, Acceptance number: 卫食添新申字(2022)第0035号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

5

L-Cysteine

  • 13.01.01 Infant formula: Execute with reference to GB 10765;
  • 13.01.02 Older infants and toddler formula (Older infants formula only): Execute with reference to GB 10766;
  • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
  • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0028号;

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

6

L-Cysteine Hydrochloride Monohydrate

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0023号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

7

L-cysteine hydrochloride

  • 13.01.01 Infant formula: Execute with reference to GB 10765;
  • 13.01.02 Older infants and toddler formula (Older infants formula only): Execute with reference to GB 10766;
  • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
  • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922.

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0027号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

8

L-Cystine

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0022号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

9

L-Histidine

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0025号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

10

L-Histidine Hydrochloride Monohydrate

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0031号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

11

L-Lysine Hydrochloride

  • 13.01.01 Infant formula: Execute with reference to GB 10765;
  • 13.01.02 Older infants and toddler formula (Older infants formula only): Execute with reference to GB 10766;
  • 13.01.03 Infant formula food for special medical purpose: Execute with reference to GB 25596;
  • 13.03 Formula foods for special medical purposes (except for the varieties involved in 13.01): Execute with reference to GB 29922

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0030号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

12

L-Lysine acetate

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0024号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

13

L-Phenylalanine

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0029号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

14

L-Threonine

Accepted on May 26, 2022, Acceptance number: 卫食添新申字(2022)第0026号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

15

Lacto-N-neotetraose

01.03.02

Modified milk powder (limited to milk powder for children)

0.2-0.6 g/L (Count as pure products – ready-to-eat state, for powdery products, the level of use should be increased by the brewing time) When mixed with 2’-FL , oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of Lacto-N-neotetraose must not exceed 64.5 g/kg

Accepted on October 18, 2021, Acceptance number: 卫食添新申字(2021)第0049号.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

13.01.01

Infant formula foods

13.01.02

Older infants and young children formula

13.01.03

Infant formula food for special medical purposes

16

Magnesium lactate

The application range and dosage of magnesium lactate are consistent with the provisions of magnesium approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

Accepted on June 20, 2022, Acceptance number: 卫食添新申字(2022)第0038号.

Passed the technical review and issued for public comments on December 8, 2022.

It has not been officially approved.

2.6 List of food nutrition enhancers with expanded use (four types)

No

Name

Category number

Food name/category

Maximum level

Approval Status

(By the end of December 2022)

1

Vitamin B1

14.04.02.01

beverages for special uses (including sports drinks and nutrient drinks.)

2 mg/kg~5 mg/kg

Accepted on October 31, 2022, Acceptance number: 卫食添新申字(2022)0076.

Passed the technical review and issued for public comments on December 8, 2022.

It has not been officially approved.

2

Vitamin B2

14.04.02.01

beverages for special uses (including sports drinks and nutrient drinks.)

2 mg/kg~5 mg/kg

Accepted on March 26, 2014, Acceptance number: 卫食添新申字(2014)第0013号;

Passed the technical review and issued for public comments on December 8, 2022,

It has not been officially approved.

3

Taurine

14.04.02.01

beverages for special uses (including sports drinks and nutrient drinks.)

0.1 g/kg~0.6 g/kg

Accepted on October 31, 2022, Acceptance number: 卫食添新申字(2022)0075.

Passed the technical review and issued for public comments on December 8, 2022,

It has not been officially approved.

4

Ascorbic palmitate (Enzymatic)

The application range and dosage of ascorbic palmitate are consistent with the provisions of vitamin C approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on December 8, 2022.

It has not been officially approved.

2.7 List of new food additive (1 type)

No

Name

Function

Category number

Food name/category

Maximum level

Approval Status

(By the end of December 2022)

1

Potassium Polyaspartate

Stabilizer and coagulator

15.03.01

Wine

0.3 g/L

Accepted on May 9, 2020, Acceptance number: 卫食添新申字(2020)第0024号.

Passed the technical review and issued for public comments on December 28, 2022.

It has not been officially approved.

2.8 List of food additives with expanded use (seven types)

No

Name

Function

Category number

Food name /category

Maximum level (g/kg)

Approval Status

(By the end of December 2022)

1

Potassium acesulfame

Sweetener

07.03

Crackers

0.6

Accepted on June 4, 2021, Acceptance number: 卫食添新申字(2021)第0022号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

2

Carmine cochineal

Colorant

08.02.01

Conditioned meat products (raw meat with added ingredients)

0.08 (Count as carminic acid)

Accepted on January 30, 2022, Acceptance number: 卫食添新申字(2022)第0003号.

Passed the technical review and issued for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

3

Fumaric acid

Acidity regulator

08.02.02 Cured meat product (brined meat, preserved pork, preserved duck, Chinese-style ham, and Chinese sausage)

08.03.02 Smoked, baked, or grilled meat

08.03.03 Fried meat

08.03.05 Meat enema

09.02.02 Frozen coated seafood product

09.04.02 Cooked or fried seafood product

09.04.03 Smoked or grilled seafood product

Appropriate level as required in production

Accepted on June 28, 2022, Acceptance number: 卫食添新申字(2022)第0040号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

4

Sodium acetate

Accepted on June 28, 2022, Acceptance number: 卫食添新申字(2022)第0039号.

Passed the technical review and issued for public comments on August 19, 2022.

It has not been officially approved.

5

Sodium N-cyclohexyl sulfamate (Also called cyclamate)

Sweetener

07.04

Fillings and topping syrups for bakeries (fillings of crackers only)

2.0 (In terms of cyclohexyl sulfamic acid)

Accepted on July 12, 2022, Acceptance number: 卫食添新申字(2022)第0060号.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

16.06

Puffed food

0.2 (In terms of cyclohexyl sulfamic acid)

6

Vitamin E

Antioxidant

06.03.02.04

Batters (e.g.  batters for fish or poultry), breaded, frying

powder

0.2

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

7

Ascorbic palmitate (Enzymatic)

Antioxidant

06.07

Instant wheat or rice product

0.2

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on October 28, 2022.

It has not been officially approved.

3. List of approved new food additives in 2022 (32 types)

In 2022, 32 types of new food additives were approved by the NHC, which includes 13 new enzymes for the food industry, one new food additive, one new processing aid, one new food nutrition enhancer, 13 existing food additives with expended use, and three processing aids with expanded use. The relevant information is as follows:

3.1 List of approved new food enzymes (13 types)

No

Name

Source

Donor

Acceptance information, public comment, and approval announcements

(By the end of December 2022)

1

Phospholipase A1

Aspergillus oryzae

Valsaria rubricosa

Accepted on March 26, 2021, Acceptance number: 卫食添新申字(2021)第0013号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

2

Maltogenic amylase

Bacillus licheniformis

Geobacillus stearothermophilus

Accepted on March 19, 2021, Acceptance number:卫食添新申字(2021)第0014号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

3

Glucose oxidase

Trichoderma reesei

Penicilliun amagasakiense

Accepted on November 10, 2020, Acceptance number: 卫食添新申字(2020)第0068号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

4

Lipase

Trichoderma reesei

Aspergillus niger var. tubingensis

Accepted on March 22, 2021, Acceptance number: 卫食添新申字(2021)第0015号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

5

β-uctofuranosidase

Aspergillus fijiensis

-

Accepted on May 26, 2020, Acceptance number: 卫食添新申字(2020)第0027号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

6

β-glucanase

Bacillus subtilis

Bacillus subtilis

Accepted on September 17, 2021, Acceptance number: 卫食添新申字(2021)第0040号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

7

Protease

Bacillus subtilis

Alkalihalobacillus clausii

Its acceptance information could not be confirmed.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

8

Trehalase

Trichoderma reesei

Trichoderma reesei

Accepted on September 17, 2021, Acceptance number: 卫食添新申字(2021)第0041号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

9

Phospholipase A1

Aspergilus niger

Talaromyces leycettanus

Accepted on July 2, 2021, Acceptance number: 卫食添新申字(2021)第0027号.

Passed the technical review and issued for public comments on December 8, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

10

Glucose oxidase

Aspergillus niger

Penicillium chrysogenum

Accepted on November 9, 2021, Acceptance number: 卫食添新申字(2021)第0052号.

Passed the technical review and issued for public comments on December 8, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

11

Lactase

Bacillus subtilis

Lactobacillus delbrueckii subsp. Bulgaricus

Accepted on March 22, 2021, Acceptance number:卫食添新申字(2021)第0016号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

12

Phytase

Aspergillus niger

Aspergillus tubingensis

Accepted on August 20, 2020, Acceptance number: 卫食添新申字(2020)第0047号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

13

Lactase

Aspergillus niger

Aspergillus oryzae

Accepted on November 9, 2021, Acceptance number: 卫食添新申字(2021)第0053号.

Passed the technical review and issued for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

Note: the quality specifications of enzyme preparations for the food industry should meet the provisions of the National Standard for Food Safety, Food Additives, and enzyme preparations for Food Industry (GB1886.174).

3.2 List of new food additives (one type)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Acceptance information, public comment, and approval announcements

(By the end of December 2022)

1

Quinoline aluminium lake

Colorant

05.03

Coatings for candy and chocolate products (only for candy)

0.3 (Count as quinoline yellow)

Accepted on June 1, 2021, Acceptance number: 卫食添新申字(2021)第0020号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

3.3 List of new food processing aids (one type)

No

Name

Function

Usage scope

Maximum level (g/kg)

Acceptance information, public comment, and approval announcements

(By the end of December 2022)

1

Sodium sulfide pentahydrate

Deacidifying agent, decolorizing agent, settling agent

Salt production process

0.065

Accepted on July 7, 2021, Acceptance number: 卫食添新申字(2021)第0030号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

3.4 List of new food nutrition enhancers (one type)

No

Name

Function

Category number

Food name/category

Maximum level (mg/kg)

Acceptance information, public comment, and approval announcements

(By the end of December 2022)

1

Inositol

Nutrition enhancer

01.03.02

Modified milk powder (limited to milk powder for children)

210 ~250

Accepted on July 8, 2021, Acceptance number: 卫食添新申字(2021)第0033号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

14.02.03

Fruit and vegetable juice (meat) beverages (including fermented products)

60 ~120

14.04.02.02

Flavored beverages

60 ~120

13.0

Special dietary food

Meet the relevant standards of special dietary food

3.5 List of food additives with expanded use (13 types)

No

Name

Function

Category number

Food Name/ Category

Maximum level (g/kg)

Acceptance information, public comment, and approval announcements

(By the end of December 2022)

1

Silicon dioxide

anticaking agent

04.04.03

Other soy products (only for soy protein powder and blended soy protein powder)

15.0

Accepted on May 27, 2021, Acceptance number: 卫食添新申字(2021)第0019号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

2

Carbon dioxide

Other

01.02.02

Flavored fermented milk

Appropriate level

Accepted on June 28, 2021, Acceptance number: 卫食添新申字(2021)0025.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

3

Turmeric

Colorant

06.03.02.04

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

0.25 (Count as curcumin)

Accepted on May 17, 2021, Acceptance number: 卫食添新申字(2021)第0018号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

4

Nisin

Preservative

04.04.01.03.02

Pot-stewed semi-dried tofu

0.5

Accepted on June 16, 2021, Acceptance number: 卫食添新申字(2021)第0024号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

5

Sucralose

Sweetener

04.04.01.05

New soy products (including puffed soy protein food and soybean meat, )

0.4

Accepted on April 12, 2021, Acceptance number: 卫食添新申字(2021)第0017号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

6

Vegetable carbon black

Colorant

01.02.02

Flavored fermented milk

5.0

Accepted on March 15, 2021, Acceptance number: 卫食添新申字(2021)第0012号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

04.01.02.05

Jam

7

Glutamine transaminase

Stabilizer and coagulant

01.02.02

Flavored fermented milk

0.3

Accepted on January 20, 2021, Acceptance number: 卫食添新申字(2021)第0005号.

Passed the technical review and issued for public comments on April 12, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

01.06.01

Unripened cheese

8

Magnesium chloride

Flavoring agent

06.07

Instant rice and flour products

Appropriate level

Accepted on September 11, 2021, Acceptance number: 卫食添新申字(2020)第0057号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

06.08

Frozen rice and flour products

12.10

Compound condiment

9

Sucralose

Sweetener

01.06.04

Processed cheese

0.2

Accepted on September 22, 2021, Acceptance number: 卫食添新申字(2021)第0043号.

Passed the technical review and issued for public comments on December 8, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

10

Lutein

Colorant

01.01.03

Modified milk

0.05

Accepted on June 29, 2021, Acceptance number: 卫食添新申字(2021)第0026号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

01.02.02

Flavored fermented milk

11

Acesulfame potassium

Sweetener

07.03

Crackers

0.6

Accepted on June 4, 2021, Acceptance number: 卫食添新申字(2021)第0022号.

Passed the technical review and issued for public comments on January 29, 2022, and officially approved on May 11, 2022, according to No. 2 of 2022.

12

Tomato red

Colorant

09.02.03

Frozen surimi and its products (including fish balls)

0.08 (Measured as Lycopene)

Accepted on September 22, 2021, Acceptance number: 卫食添新申字(2021)第0044号.

Passed the technical review and issued for public comments on December 8, 2021, and officially approved on September 7, 2022, according to No. 5 of 2022.

09.04

Cooked aquatic products (Can be directly consumed)

13

Carmine cochineal

Colorant

08.02.01

Conditioned meat products (raw meat with added ingredients)

0.08 (Count as carminic acid)

Accepted on January 30, 2022, Acceptance number: 卫食添新申字(2022)第0003号.

Passed the technical review and issued for public comments on April 15, 2022, and officially approved on September 7, 2022, according to No. 5 of 2022.

2.6 List of approved processing aids with expanded use (three types)

No

Name

Function

Usage scope

Acceptance information, public comment, and approval announcements

(By the end of December 2022)

1

White mineral oil

Release agent, lubricating agent

Processing technology of fresh yeast products (The maximum level is 0.1 g/kg)

Accepted on November 24, 2020, Acceptance number: 卫食添新申字(2020)第0070号.

Passed the technical review and issued for public comments on August 6, 2021, and officially approved on March 1, 2022, according to No. 1 of 2022.

2

Polyacrylamide

Flocculant

Salt product process

Accepted on July 17, 2020, Acceptance number: 卫食添新申字(2020)第0039号.

Passed the technical review and issued for public comments on October 21, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

3

Polydimethyl siloxane and emulsion

Defoamer

Production and processing technology of yeast-processed products (maximum usage of 0.1 g/kg, counts as polydimethylsiloxane)

Accepted on November 11, 2021, Acceptance number: 卫食添新申字(2021)第0054号.

Passed the technical review and issued for public comments on December 8, 2021, and officially approved on May 11, 2022, according to No. 2 of 2022.

Conclusion

The 2'-fucosyl lactose (2’FL) from modified E-coli was released for public comments by CFSA on April 15, 2022, which was a big step forward for the application of genetically modified microorganisms (GMM) food additives in China, and it can be expected that 2’-FL will get the approval in China soon. New food enzymes account for almost 1/3 of the food additives reviewed and approved in 2022, and most of the food enzymes are genetically modified. On December 8, 2022, the CFSA publicly solicited opinions on D-psicose-3-epimerase, whose donor bacteria were specific to the strain number.

Furthermore, it can be found that the registration period for some products is quite short. For example, it only takes about six months for glucose oxidase to receive the final approval for its acceptance by the NHC, which can be seen that if the application dossiers are well-prepared, the product can pass the technical review once and receive the final approval quickly. So, it is suggested that the applicant pays attention to the preparation of materials before submitting them to NHC.

Note: there may be omissions and errors in the data statistics process because of the change of official websites. The data in this article is for reference only, please refer to the official information published by government departments.

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