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Analysis on the Application and Approval of New Food Additives in 2023

from CIRS by

As of the end of December 2023, the National Health Commission of the People’s Republic of China (NHC) issued five announcements (No. 1 of 2023, No. 3 of 2023, No. 5 of 2023, No. 8 of 2023, and No. 10 of 2023) regarding “Three New Foods”. A total of 74 products have been approved, 33 of which are new food additives, including those with expanded scope.

CIRS Group has summarized the acceptance and approval status of new food additives in China in 2023 as follows:

Overview of new food additives accepted, issued for public comments and approved in 2023

In 2023, NHC accepted the application of 82 new food additives, including both new types and those with expanded use and scope. The China National Center for Food Safety Risk Assessment (CFSA) issued a total of 22 new food additives for public comment; moreover, HNC approved 33 new food additives, including the ones with expanded scope.

China,Food,Additive,Registration,Application

Figure 1. Overview of new food additives application in 2023

New food additives accepted by NHC in 2023 (82 types)

In 2023, NHC accepted a total of 82 new food additives, including those with expanded scope, with the acceptance codes of both domestic and imported products starting with “卫食添新申字”. Detailed information is shown in the Table below:

No.

Acceptance date

Acceptance code

Name of new food additives

1

2023.01.03

卫食添新申字(2023)第0001号

Phosphoric acid (Wet process)

2

2023.01.05

卫食添新申字(2023)第0002号

Calcium lactate

3

2023.01.05

卫食添新申字(2023)第0003号

2’-fucosyllactose, 2’-FL

4

2023.01.10

卫食添新申字(2023)第0004号

Calcium chloride

5

2023.01.10

卫食添新申字(2023)第0005号

Sodium metabisulphite

6

2023.01.10

卫食添新申字(2023)第0006号

Benzoic acid, sodium benzoate

7

2023.01.10

卫食添新申字(2023)第0007号

Sorbic acid, potassium sorbate

8

2023.01.10

卫食添新申字(2023)第0008号

Ascorbic acid

9

2023.01.10

卫食添新申字(2023)第0009号

Paprika red

10

2023.01.10

卫食添新申字(2023)第0010号

Lactic acid

11

2023.01.10

卫食添新申字(2023)第0011号

Acesulfame potassium

12

2023.01.10

卫食添新申字(2023)第0012号

Paprika oleoresin

13

2023.01.10

卫食添新申字(2023)第0013号

Sucralose

14

2023.01.10

卫食添新申字(2023)第0014号

Tartrazine

15

2023.01.10

卫食添新申字(2023)第0015号

D-isoascorbic acid (erythorbic acid) , sodium D-isoascorbate

16

2023.01.10

卫食添新申字(2023)第0016号

Disodium 5'-ribonucleotide

17

2023.01.10

卫食添新申字(2023)第0017号

Citric acid

18

2023.01.10

卫食添新申字(2023)第0018号

Dehydroacetic acid, sodium dehydroacetate

19

2023.01.10

卫食添新申字(2023)第0019号

Disodium ethylene-diamine-tetra-acetate

20

2023.01.10

卫食添新申字(2023)第0020号

Hydroxytyrosol

21

2023.01.12

卫食添新申字(2023)第0021号

Nitrous oxide

22

2023.01.28

卫食添新申字(2023)第0022号

NMN (β-Nicotinamide mononucleotide)

23

2023.01.29

卫食添新申字(2023)第0023号

Propylene glycol alginate

24

2023.02.02

卫食添新申字(2023)第0024号

D-3-hydroxybutyric acid

25

2023.02.17

卫食添新申字(2023)第0025号

Runmai improver

26

2023.02.27

卫食添新申字(2023)第0026号

Carmine cochineal

27

2023.03.03

卫食添新申字(2023)第0027号

Vitamin K2 (synthesis method)

28

2023.03.03

卫食添新申字(2023)第0028号

Cyclomaltodextin glucanotransferase

29

2023.03.06

卫食添新申字(2023)第0029号

Edible tannin

30

2023.03.06

卫食添新申字(2023)第0030号

Rebaudioside M

31

2023.03.30

卫食添新申字(2023)第0031号

Corderan gum

32

2023.04.23

卫食添新申字(2023)第0032号

D-psicose 3-epimerase

33

2023.05.04

卫食添新申字(2023)第0033号

6’-sialyllactose sodium salt, 6’-SL

34

2023.05.10

卫食添新申字(2023)第0034号

Rebaudioside M

35

2023.05.22

卫食添新申字(2023)第0035号

Xylanase

36

2023.05.25

卫食添新申字(2023)第0036号

Sodium sulfide pentahydrate

37

2023.05.31

卫食添新申字(2023)第0037号

Propylene glycol alginate

38

2023.06.02

卫食添新申字(2023)第0038号

Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)

39

2023.07.03

卫食添新申字(2023)第0039号

L-alanine

40

2023.07.04

卫食添新申字(2023)第0040号

Ramie Leaf Extract

41

2023.07.04

卫食添新申字(2023)第0041号

Stevia glycoside

42

2023.07.05

卫食添新申字(2023)第0042号

Tetrapotassium pyrophosphate

43

2023.07.06

卫食添新申字(2023)第0043号

Sucralose

44

2023.07.13

卫食添新申字(2023)第0044号

Nitric acid

45

2023.07.14

卫食添新申字(2023)第0045号

2’-fucosyllactose, 2’-FL

46

2023.07.17

卫食添新申字(2023)第0046号

6’-Sialyllactose sodium salt, 6’-SL

47

2023.07.17

卫食添新申字(2023)第0047号

3’-Sialyllactose sodium salt, 3’-SL

48

2023.08.01

卫食添新申字(2023)第0048号

Potassium sorbate

49

2023.08.11

卫食添新申字(2023)第0049号

Polyoxyethylene (20) sorbitan monooleat

50

2023.09.04

卫食添新申字(2023)第0050号

Lycopene

51

2023.09.06

卫食添新申字(2023)第0051号

(6S)-5-methyltetrahydrofolic acid, glucosamine salt

52

2023.09.06

卫食添新申字(2023)第0052号

Butylated hydroxytoluene (BHT)

53

2023.09.07

卫食添新申字(2023)第0053号

Rosemary extract

54

2023.09.15

卫食添新申字(2023)第0054号

Hydroxytyrosol

55

2023.09.18

卫食添新申字(2023)第0055号

Sanzan Gum

56

2023.09.18

卫食添新申字(2023)第0056号

Sanzan Gum

57

2023.09.18

卫食添新申字(2023)第0057号

Lactase (beta-galactosidase)

58

2023.09.19

卫食添新申字(2023)第0058号

2’-fucosyllactose, 2’-FL

59

2023.09.20

卫食添新申字(2023)第0059号

2’-fucosyllactose, 2’-FL

60

2023.09.20

卫食添新申字(2023)第0060号

Nitrous oxide

61

2023.09.20

卫食添新申字(2023)第0061号

2’-fucosyllactose, 2’-FL

62

2023.09.21

卫食添新申字(2023)第0062号

3’-Sialyllactose sodium salt, 3’-SL

63

2023.09.22

卫食添新申字(2023)第0063号

Phosphodiesterase I

64

2023.11.01

卫食添新申字(2023)第0064号

2’-fucosyllactose, 2’-FL

65

2023.11.01

卫食添新申字(2023)第0065号

2’-fucosyllactose, 2’-FL

66

2023.11.03

卫食添新申字(2023)第0066号

Glucoamylase

67

2023.11.03

卫食添新申字(2023)第0067号

Serine protease

68

2023.11.06

卫食添新申字(2023)第0068号

Tripotassium citrate

69

2023.11.08

卫食添新申字(2023)第0069号

Ascorbyl palmitate (enzymatic)

70

2023.11.13

卫食添新申字(2023)第0070号

Zinc sulfate

71

2023.11.20

卫食添新申字(2023)第0071号

Lactase (beta-galactosidase)

72

2023.11.20

卫食添新申字(2023)第0072号

Lipase

73

2023.11.20

卫食添新申字(2023)第0073号

Calcium carbonate (seaweed source)

74

2023.11.21

卫食添新申字(2023)第0074号

3-fucosyllactose, 3-FL

75

2023.11.21

卫食添新申字(2023)第0075号

Sodium sulfide pentahydrate

76

2023.11.30

卫食添新申字(2023)第0076号

2’-fucosyllactose, 2’-FL

77

2023.11.30

卫食添新申字(2023)第0077号

Cellulose

78

2023.12.08

卫食添新申字(2023)第0078号

Sanzan Gum

79

2023.12.11

卫食添新申字(2023)第0079号

Selenium-enriched yeast

80

2023.12.25

卫食添新申字(2023)第0080号

Pomelone [(8E) -undecan-6,8, 10-triene-3-ketone]

81

2023.12.25

卫食添新申字(2023)第0081号

(E)-6-Octenal

82

2023.12.29

卫食添新申字(2023)第0082号

Sanzan Gum

Note: Substances in blue have been issued a rejection decision.

New food additives that have passed the technical review and were issued for public comments in 2023 (22 types)

As of the end of December 2023, 22 new food additives have passed the technical review by the review committee of China CFSA and were issued for public comments, including 6 new food enzymes, 2 new food additives, 1 new nutrition enhancer, 10 food additives with expanded use and 3 food processing aids with expanded use.

(1) New food enzymes issued for public comments (6 types)

S.N.

Name

Source

Donor

Approval status

(As of the end of December 2023)

1

Beta-amylase

Bacillus flexus

  1. Accepted on July 7, 2023. Acceptance code: 卫食添新申字(2021)第0029号;
  2. Issued for public comments on February 10 , 2023;
  3. Officially approved on August 1, 2023 according to Notice No. 5 of 2023.

2

Lysophospholipase (lecithinase B)

Trichoderma reesei

Aspergillus nishimurae

  1. Accepted on July 15, 2022. Acceptance code: 卫食添新申字(2022)第0063号;
  2. Issued for public comments on February 10 , 2023;
  3. Officially approved on August 1, 2023 according to Notice No. 5 of 2023.

3

Serine protease

Bacillus licheniformis

Nocardiopsis prasina

  1. Accepted on May 10, 2022. Acceptance code: 卫食添新申字(2022)第0018号;
  2. Issued for public comments on April 24 , 2023;
  3. Officially approved on October 7, 2023 according to Notice No. 8 of 2023.

4

Cyclomaltodextin glucanotransferase

Anoxybacillus

caldiproteolyticus

  1. Accepted on March 3, 2023. Acceptance code: 卫食添新申字(2023)第0028号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

5

Cellulase

Penicillium oxalicum

  1. Accepted on September 14, 2022. Acceptance code: 卫食添新申字(2022)第0072号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

6

D-psicose 3-epimerase

Bacillus subtilis

Clostridium scindens ATCC35704

  1. Accepted on April 23, 2023. Acceptance code: 卫食添新申字(2023)第0032号;
  2. Issued for public comments on December 29, 2023;
  3. It has not been officially approved yet.

(2) New food additives issued for public comments (2 types)

S.N.

Name

Function

Category number

Food name/

category

Maximum levels (g/kg)

Approval status

(As of the end of December 2023)

1

Mixed tocotrienol concentrate

Antioxidant

02.01.01

Vegetable oils and fats

0.2

(counted as the total amount of tocopherol and tocotrienol)

  1. Accepted on June 21, 2019. Acceptance code: 卫食添新申字(2019)第0037号;
  2. Issued for public comments on June 26, 2023;
  3. It has not been officially approved.

2

Rebaudioside M

Sweetener

01.01.03

Modified milk

0.18

(count as steviols)

  1. Accepted on May 10, 2023. Acceptance code: 卫食添新申字(2023)第0034号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

01.02.02

Flavored fermented milk

0.2

(count as steviols)

03.01

Ice cream and iced milk

0.5

(count as steviols)

05.02.01

Gum-based candy

3.5

(count as steviols)

14.0

Beverages (except 14.01 packaged drinking water)

0.2 (count as steviols; count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.)

(3) New nutrition enhancers issued for public comments (1 type)

No.

Name

Applicable scope

Maximum levels

Production strain information

Approval status

(By the end of December 2023)

1

2’-fucosyllactose

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: Neisseria spp.

  1. Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023)第0003号;
  2. Issued for public comments on February 10, 2023;
  3. Officially approved on October 7, 2023 according to Notice No. 8 of 2023.

Source: Corynebacterium glutamate ATCC 13032;

Donor: Pseudopedobacter saltans

  1. Accepted on July 14, 2023. Acceptance code: 卫食添新申字(2023)第0045号;
  2. Issued for public comments on August 23, 2023;
  3. It has not been officially approved yet.

Source: Escherichia coli BL21(DE3);

Donor: Helicobacter pylori

  1. Accepted on September 20, 2023. Acceptance code: 卫食添新申字(2023)第0061号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

(4) Food additives with expanded scope issued for public comments (10 types)

S.N.

Name

Function

Category number

Food name/

category

Maximum levels (g/kg)

Remarks

Approval status (By the end of December 2023)

1

Calcium lactate

Stabilizer, coagulant, and acidity regulator

04.02.02.03

Pickled vegetables

10.0

-

  1. Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023)第0002号;
  2. Issued for public comments on April 24 , 2023;
  3. Officially approved on October 7, 2023 according to Notice No. 8 of 2023.

04.02.02.04

Canned vegetables

3.0

-

2

Sanzan Gum

Thickener, stabilizer and coagulant

01.01.03

Modified milk

0.5

-

  1. No acceptance information was found;
  2. Issued for public comments on February 10 , 2023;
  3. Officially approved on October 7, 2023 according to Notice No. 8 of 2023.

03.01

Ice cream and iced milk

1.5

-

14.03.03

Mixed protein drinks

0.75

Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.

14.08

Flavored drinks

0.5

01.01.03

Modified milk

0.5

-

  1. No acceptance information found;
  2. Issued for public comments on April 24 , 2023;
  3. Officially approved on October 7, 2023 according to Notice No. 8 of 2023.

14.03.03

Mixed protein drinks

0.75

Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.

14.08

Flavored drinks

0.5

3

L-alanine

Flavor enhancer

14.02.03

Fruit and vegetable juice (pulp) drinks

6.0

Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.

  1. Accepted on July 3, 2023. Acceptance code:卫食添新申字(2023)第0039号;
  2. Issued for public comments on August 23, 2023;
  3. It has not been officially approved yet.

4

Propylene glycol alginate

Thickener

06.05.02.01

Bean vermicelli, bean noodles

1.5

-

  1. Accepted on May 31, 2023. Acceptance code:卫食添新申字(2023)第0037号;
  2. Issued for public comments on August 23, 2023;
  3. It has not been officially approved yet.

06.05.02.04

Round rice ball

5

Lycopene

Colorant

08.02.01

Seasoned meat products (adding seasonings to fresh meats)

0.12

Count as lycopene

  1. Accepted on September 4, 2023. Acceptance code: 卫食添新申字(2023)第0050号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

08.02.02

Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)

0.018

08.03.05

Sausage

0.35

08.03.07. 03

Dried meat crisps

0.26

6

Polyoxyethylene (20) sorbitan monooleat

Emulsifier

16.03

Collagen casing

0.5

-

  1. Accepted on August 11, 2023. Acceptance code: 卫食添新申字(2023)第0049号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

7

Rosemary extract

Antioxidant

04.05.02

Processed nuts and seeds

0.3

-

  1. Accepted on September 7, 2023. Acceptance code: 卫食添新申字(2023)第0053号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

8

Vitamine E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)

Antioxidant

16.07

Others (Lutein Esters only)

50

-

  1. Accepted on June 2, 2023. Acceptance code: 卫食添新申字(2023)第0038号;
  2. Issued for public comments on October 26, 2023;
  3. It has not been officially approved yet.

9

Ascorbyl palmitate (enzymatic)

Antioxidant

01.03

Milk powder (including sweetened milk powder) , cream powder and its formulated products

0.2

Count as ascorbic acid in fat

  1. Accepted on November 8, 2023. Acceptance code: 卫食添新申字(2023)第0069号;
  2. Issued for public comments on December 29, 2023;
  3. It has not been officially approved yet.

07.01

Bread

0.2

14.05.01

Tea drinks

0.2

Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.

10

Sucralose

Sweetener

04.05.02.01.01

Shelled and cooked processed nuts and seeds

4.0

-

  1. Accepted on January 10, 2023. Acceptance code: 卫食添新申字(2023)第0013号;
  2. Issued for public comments on December 29, 2023;
  3. It has not been officially approved yet.

04.05.02.01.02

Unshelled and cooked processed nuts and seeds

2.0

(5) Food processing aids with expanded scope issued for public comments (3 types)

S.N.

Name

Function

Applicable scope

Approval status (By the end of December 2023)

1

Sulfuric acid

Neutralizing and removing soap

Processing technology of oil

  1. Accepted on December 19, 2022.
  2. Acceptance code: 食添新申字(2022)第0095号;
  3. Issued for public comments on February 10, 2023;
  4. Officially approved on August 1, 2023 according to Notice No. 5 of 2023.

2

Edible tannin

clarifying agent

Sugar technology

  1. Accepted on March 6, 2023. Acceptance code: 卫食添新申字(2023)第0029号;
  2. Issued for public comments on June 26, 2023;
  3. Officially approved on December 1, 2023 according to Notice No. 10 of 2023.

3

Ethyl acetate

Extracting solvent

Processing technology of tea extracts

  1. Accepted on November 11, 2022. Acceptance code: 卫食添新申字(2022)第0083号;
  2. Issued for public comments on June 26, 2023;
  3. Officially approved on December 1, 2023 according to Notice No. 10 of 2023.

Approved new food additives in 2023 (33 types)

In 2023, 33 new food additives were approved by NHC, including 18 new food additives, and 15 food additives with expanded use and scope. Notably, ascorbyl palmitate (enzymatic) was approved as both a food additive and a nutrition enhancer with expanded use. Detailed information is as follows:

(1) Approved new food enzymes (12 types)

S.N.

Name

Source

Donor

Approval status (As of the end of December 2023)

1

Aminopeptidase

Aspergillus oryzae

Aspergillus oryzae

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

2) Issued for public comments on July 1, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

2

Protease

Trichoderma reesei

Malbranchea sulfurea

1) No acceptance information found;

2) Issued for public comments on October 28, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

3

Phospholipase A2

Trichoderma reesei

Aspergillus fumigatus

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

2) Issued for public comments on October 28, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

4

Maltogenic amylase

Saccharomyces cerevisiae

Geobacillus stearothermophilus

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

2) Issued for public comments on August 6, 2021;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

5

Xylanase

Bacillus licheniformis

Bacillus licheniformis

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

2) Issued for public comments on July 1, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

6

Lactase (beta-galactosidase)

Papiliotrema

terrestris

-

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

2) Issued for public comments on October 28, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

7

Carboxypeptidase

Aspergillus oryzae

Aspergillus oryza

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

2) Issued for public comments on July 1, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

8

Deaminase

Aspergillus oryzae

-

1) Accepted on April 30, 2020. Acceptance code: 卫食添新申字(2020)第0020;

2) Issued for public comments on July 1, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

9

D-psicose 3-epimerase

Bacillus subtilis

Ruminococcus sp. CAG55

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

2) Issued for public comments on December 8, 2022;

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

10

Beta-amylase

Bacillus flexus

1) Accepted on July 7, 2021. Acceptance code: 卫食添新申字(2021)第0029号;

2) Issued for public comments on February 10, 2023;

3) Officially approved on August 1, 2023 according to No. 5 of 2023.

11

Lysophospholipase (lecithinase B)

Trichoderma reesei

Aspergillus nishimura

1) Accepted on July 15, 2022. Acceptance code: 卫食添新申字(2022)第0063号;

2) Issued for public comments on February 10, 2023.

3) Officially approved on August 1, 2023 according to No. 5 of 2023.

12

Serine proteas

Bacillus licheniformis

Nocardiopsis prasina

1) Accepted on May 10, 2022. Acceptance code: 卫食添新申字(2022)第0018号;

2) Issued for public comments on April 24, 2023;

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

Note: The quality specifications of food enzymes shall meet the requirements specified in the National Food Safety Standard - Food Additives and Enzymes (GB 1886.174).

(2) Approved new food additives (1 type)

S.N.

Name

Function

Category number

Food name/

category

Maximum levels (g/L)

Acceptance information, issuance for public comments and approval

(As of the end of December 2023)

1

Potassium Polyaspartate

Stabilizer and coagulant

15.03.01

Grape wine

0.3

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

2) Issued for public comments on October 28, 2022.

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

(3) New spice for food (1 type)

S.N.

Name

Function

Category number

Food name/

category

Maximum level (g/L)

Acceptance information, issuance for public comments and approval

(As of the end of December 2023)

1

2-Hexylpyridine

Spice for food

-

Prepared as spices food for use in various types of food (excluding food categories listed in Table B.1 of GB 2760-2014)

Appropriate level

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

2) Issued for public comments on October 28, 2022.

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

(4) New food nutrition enhancers (4 types)

S.N.

Name

Applicable scope

Use levels

Information on producing bacteria

Acceptance information, issuance for public comments and approval

(As of the end of December 2023)

1

L-Se-methylselenocysteine

The scope of use and dosage of L-Se-methylselenocysteine shall comply with the requirements for selenium as specified in the National Food Safety Standard for the Use of Food Nutrition Enhancer (GB14880)

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

2) Issued for public comments on August 19, 2022;

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

2

Magnesium lactate

The scope of use and dosage of magnesium lactate shall comply with the requirements for magnesium as specified in the National Food Safety Standard for the Use of Food Nutrition Enhancer (GB14880)

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

2) Issued for public comments on December 8, 2022;

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

3

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 K-12 DH1 MDO

Donor: Helicobacter spp.

1) Accepted on October 18, 2021, and November 3, 2021, respectively. Acceptance code: 卫食添新申字(2021)第0048号 and 卫食添新申字(2021)第0050号;

2) Issued for public comments, on April 15, 2022 and October 28, 2022, respectively;

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

Source: E. coli K-12 MG1655

Donor: Helicobacter spp.

Source: E. coli BL21(DE3)

Donor: Neisseria spp.

1) Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023)第0003号;

2) Issued for public comments on February 10, 2023.

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

4

Lacto-N-neotetraose, LNnT

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 shall not exceed 64.5 (g/kg).

Source: E. coli K-12 DH1 MDO

Donor: Neisseria spp. and Helicobacter spp.

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

2) Issued for public comments on October 28, 2022;

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

(5) Approved new food additives with expanded scope and use (7 types)

S.N.

Name

Function

Category number

Food name/category

Maximum levels

(g/kg)

Acceptance information, issuance for public comments and approval

(As of the end of December 2023)

1

Fumaric acid

Acidity regulator

08.02.02

Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)

Appropriate level

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

2) Issued for public comments on August 19, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

08.03.02

Smoked, barbecued, and roasted meats

08.03.03

Fried meats

08.03.05

Sausages

09.02.02

Frozen coating products

09.04.02

Cooked or fired aquatic products

09.04.03

Smoked, baked aquatic products

2

Sodium acetate

Acidity regulator

08.02.02

Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)

Appropriate level

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

2) Issued for public comments on August 19, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

08.03.02

Smoked, barbecued, and roasted meats

08.03.03

Fried meats

08.03.05

Sausages

09.02.02

Frozen coating products

09.04.02

Cooked or fired aquatic products

09.04.03

Smoked, baked aquatic products

3

Sodium cyclamate, calcium cyclamate

Sweetener

07.04

Fillings and surface spreading starch for bakery food (for bakery food fillings only)

2.0

Count as cyclamic acid

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

2) Issued for public comments on October 28, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

16.06

Puffed foods

0.2

4

Vitamine E

Antioxidant

06.03.02.04

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

0.2

1) No acceptance information found;

2) Issued for public comments on October 28, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

5

Ascorbyl palmitate (enzymatic)

Antioxidant

06.07

Instant rice flour products

0.2

1) No acceptance information found;

2) Issued for public comments on December 8, 2022.

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

6

Calcium lactate

Stabilizer coagulant, and acidity regulator

04.02.02.03

Pickled vegetables

10.0

1) Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023)第0002号;

2) Issued for public comments on April 24, 2023.

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

04.02.02.04

Canned vegetables

3.0

7

Sanzan Gum

Thickener, stabilizer and coagulant

01.01.03

Modified milk

0.5

1) No acceptance information found;

2) Issued for public comments on April 24, 2023.

3) Officially approved on October 7, 2023 according to No. 8 of 2023.

14.03.03

Mixed protein drinks

0.75

Count as the state of ready-to-drink, increase the usage of solid drinks according to the dilution ratio.

14.08

Flavored drinks

0.5

(6) Approved processing aids with expanded scope and use (5 types)

S.N.

Name

Function

Applicable scope

Approval status (By the end of December 2023)

1

Polydimethylsiloxane and emulsion

Defoamer

Processing technology of collagen casing

1) Acceptance code: 卫食添新申字(2018)第0018号;

2) Issued for public comments on July 1, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

2

Magnesium stearate

Lubricating agent, releasing agent, and anti-sticking agent

Tablet pressing process of effervescent tablets

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

2) Issued for public comments on July 1, 2022;

3) Officially approved on March 2, 2023 according to No. 1 of 2023.

3

Sulfuric acid

Neutralizing and removing soap

Processing technology of oil

1) Accepted on December 19, 2022. Acceptance code: 食添新申字(2022)第0095号;

2) Issued for public comments on February 10, 2023;

3) Officially approved on August 1, 2023 according to No. 5 of 2023.

4

Edible tannin

Clarifying agent

Processing technology of sugar

1) Accepted on March 6, 2023. Acceptance code: 卫食添新申字(2023)第0029号;

2) Issued for public comments on June 26, 2023;

3) Officially approved on December 1, 2023 according to No. 10 of 2023.

5

Ethyl acetate

Extraction solvent

Processing technology of tea extracts

1) Accepted on November 11, 2022. Acceptance code: 卫食添新申字(2022)第0083号;

2) Issued for public comments on June 26, 2023;

3) Officially approved on December 1, 2023 according to No. 10 of 2023.

(7) Approved food nutrition enhancers with expanded scope and use (4 types)

S.N.

Name

Category number

Food name/category

Maximum levels

Approval status

(By the end of December 2023)

1

Vitamin B1

14.04.2.01

Drinks for special uses (including sports drinks and nutritional beverages)

2 mg/kg-5 mg/kg

1) Accepted on October 31, 2022. Acceptance code: 卫食添新申字(2022)第0076号;

2) Issued for public comments on December 8, 2022;

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

2

Vitamin B2

14.04.02.01

Drinks for special uses (including sports drinks and nutritional beverages)

2 mg/kg-5 mg/kg

1) Accepted on October 31. 2022. Acceptance code: 卫食添新申字(2022)第0077号;

2) Issued for public comments on December 8, 2022.

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

3

Taurine

14.04.02.01

Drinks for special uses (including sports drinks and nutritional beverages)

0.1 g/kg-0.6 g/kg

1) Accepted on October 31. 2022. Acceptance code: 卫食添新申字(2022)第0075号;

2) Issued for public comments on December 8, 2022.

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

4

Ascorbyl palmitate (enzymatic)

As the chemical compound of Vitamin C, its scope of use and maximum levels shall comply with the provisions of GB 14880.

1) No acceptance information found;

2) Issued for public comments on December 8, 2022.

3) Officially approved on May 6, 2023 according to No. 3 of 2023.

CIRS opinion

It can be observed from the analysis above that new food enzymes still dominate, comprising the largest share at 35.29%, the majority of which are derived from genetically modified sources. However, the percentage of newly approved food additives (52.94%) this year is higher than that of food additives with expanded use (47.05%). Notably, according to Notice No. 8 of 2023, one Lacto-N-neotetraose of microbial source and three 2’-fucosyllactose of microbial sources, two types of highly anticipated HMOs, were successfully approved this year, which is expected to further enrich the infant formula market.

Compared to the first quarter of 2022, the number of substances accepted in the first quarter of this year has significantly increased, more than doubling from the same period last year, yet most of the review outcomes were unsatisfactory. This indicates that the official standards for the review of food additives have become more stringent. In the future, applicants should be well-prepared in terms of product safety and technical necessity in response to the review process. In the case of products that are not approved, companies can better organize and prepare the necessary files, and resubmit the application based on the review results.

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