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Analysis on the Approval Status of New Food Additives in the First Half of 2023

from CIRS by

As of the end of June 2023, the National Health Commission of the People’s Republic of China (NHC) issued two announcements (No. 1 of 2023,No. 3 of 2023) in which a total of42products were approved. 22 of them were new food additives (including those for expanded use).

CIRS Group will introduce more detailed information about the acceptance and approval of new food additives in China in the first half of 2023 as following:

Overview of the approval status of new food additives in the first half of 2023

China,Food,Additive,New,Registration,Approval

Figure 1. Overview of new food additives approval status in the first half of 2023

List of new food additives accepted in the first half of 2023 (38 types)

In the first half of 2023, NHC had accepted 38 new food additives applications (including those for expanded use). Detailed information is shown in the table:

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

3,4-Dihydroxypheny lethanol

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-hydroxybutyrate

25

2023-02-17

卫食添新申字(2023)第0025号

Moistening wheat 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

Curdlan

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)

Note: Substances in blue were rejected.

List of new food additives issued for public comments in the first half of 2023 (11 types)

In the first half of 2023, 11 new food additives have passed the technical review of CFSA and were issued for public comments. Detailed information is as follows.

1) List of new food enzymes (3 types)

No.

Name

Source

Donor

Approval status

(By the end of June 2023)

1

beta-amylase

Bacillus flexus

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

2) It has not been officially approved.

2

Lysophospholipase (lecithinase B)

Trichoderma reesei

Aspergillus nishimurae

1) Accepted on July 15, 2023. Acceptance code: 卫食添新申字(2022) No. 0063;

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

3) It has not been officially approved.

3

Serine protease

Bacillus licheniformis

Nocardiopsis prasina

1) Accepted on May 10, 2022. Acceptance code: Acceptance code: 卫食添新申字(2022) No.0018;

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

3) It has not been officially approved.

2) List of new food additives (1 type)

No.

Name

Function

Category number

Food name/

category

Maximum level (g/kg)

Approval status

(By the end of June 2023)

1

Mixed tocotrienol concentrate

Antioxidant

02.01.01

Vegetables 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) No. 0037;

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

3) It has not been officially approved.

3) List of new food nutrition enhancer (1 type)

No.

Name

Category number

Food name/category

Maximum level (g/L)

Approval status

(By the end of June 2023)

1

2'-fucosyllactose

01.03.02

Modified milk powder (limited to milk powder for children)

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), oligo-galactose, oligofructose, polyfructose and raffinose, the total amount of 2'-fucosyllactose shall must not exceed 64.5 (g/kg).

1) Accepted on January 5, 2023. Acceptance code: 卫食添新申字(2023) No. 003;

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

3) It has not been officially approved.

13.01.01

Infant formula foods

13.01.02

Formula for older infants and young children

13.01.03

Infant formula food for special medical purpose

Source: E. coli BL21(DE3); Donor: Neisseria spp.

4) List of food additives for expanded scope (3 types)

No.

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Note

Approval status

(By the end of June 2023)

1

Sanzan Gum

Thickener, stabilizer and coagulant

01.01.03

Modified milk

0.5

-

1)No acceptance information found;

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

3)It has not been officially approved.

03.01

Ice cream and ice 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

2

Calcium lactate

Stabilizer and coagulant, 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) No. 0002;

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

3)It has not been officially approved.

04.02.02.04

Canned vegetable

3.0

-

3

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) It has not been officially approved.

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

5) List of new food processing aid with expanded scope (3 types)

No.

Name

Function

Usage scope

Approval status

(By the end of June 2023)

1

Sulfuric acid

Neutralizing and removing soap

Processing technology of oil

1) Accepted on December 19, 2022. Acceptance code: 食添新申字(2022) No.0095;

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

3) It has not been officially approved.

2

Edible tannin

Clarifying agent

Processing technology of sugar

1) Accepted on March 6, 2023. Acceptance code: 卫食添新申字(2023) No.0029;

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

3) It has not been officially approved.

3

Ethyl acetate

Extracting solvent

Processing technology of tea extract

1) Accepted on November 11, 2022. Acceptance code: 卫食添新申字(2022) No.0083;

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

3) It has not been officially approved.

List of new food additives approved in the first half of 2023 (22 types)

In the first half of 2023, a total of 22 new food additives were approved by NHC, including 12 new food additives and 10 food additives for expanded scope and use. Detailed information is as follows:

1) List of approved new food enzymes (9 types)

No.

Name

Source

Donor

Approval status

(By the end of June 2023)

1

Aminopeptidase

Aspergillus oryzae

Aspergillus oryzae

1) Accepted on March 7, 2022. Acceptance code: 卫食添新申字(2022) No. 0010;

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) No. 0017;

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) No. 0014

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) No. 0009;

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-alactosidase)

Papiliotrema

terrestris

-

1) Accepted on April 26, 2022. Acceptance code: 卫食添新申字(2022) No. 0016;

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) No. 0001;

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) No. 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) No. 0033;

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

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

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

2) List of approved new food additives (1 type)

No.

Name

Function

Category number

Food name/category

Maximum level(g/L)

Approval Status

(By the end of June 2023)

1

Potassium Polyaspartate

Stabilizer and coagulator

15.03.01

Grape wine

0.3

1) Accepted on May 9, 2020. Acceptance code: 卫食添新申字(2020) No. 0024;

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

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

3) List of new food flavor substance (1 type)

No.

Name

Function

Category number

Food name/category

Maximum level

Approval Status

(By the end of June 2023)

1

2-Hexylpyridine

Food flavor substance

-

Formulated into food flavors for all types of food (except food category 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) No. 0021;

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

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

4) List of new food nutrition enhancer (1 type)

No.

Name

Dosage and scope of use

Approval Status

(By the end of June 2023)

1

L-Se-methylselenocysteine

The scope of use and dosage of L-Se-methylselenocysteine shall compy with the provisions of selenium approved in GB14880 "National Food Safety Standard for the Use of Food Nutrition Enhancer".

1) Accepted on June 13, 2022.Acceptance code: 卫食添新申字(2022) No. 0035;

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

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

5) List of approved new food additives with expanded scope and use (5 types)

No.

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 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) No. 0040;

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, baked, or grilled meat

08.03.03

Fried meats

08.03.05

Sausage

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) No. 0039;

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, baked, or grilled meat

08.03.03

Fried meats

08.03.05

Sausage

09.02.02

Frozen coating products

09.04.02

Cooked or fired aquatic products

09.04.03

Smoked, baked aquatic products

3

Sodium cyclamate

Sweetener

07.04

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

2.0 (count as cyclohexyl sulfamic acid

1)Accepted on July 12, 2022. Acceptance code: 卫食添新申字(2022) No. 0060;

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 food

0.2 (count as cyclohexyl sulfamic acid

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) List of approved processing aids with expanded scope and use (2 types)

No.

Name

Function

Usage scope

Approval Status

(By the end of June 2023)

1

polydimethylsiloxane and emulsion

Defoamer

Production and processing technology of collagen casings

1) Acceptance code: 卫食添新申字(2018) No. 0018;

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) No. 0007;

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

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

7) List of approved food nutrition enhancer with expanded scope and use (4 types)

No.

Name

Category number

Food name/category

Maximum level

Approval Status

(By the end of June 2023)

1

Vitamin B1

14.04.2.01

Drinks for special uses (including sports drinks and nutrient drinks)

2 mg/kg~5 mg/kg

1) Accepted on October 31, 2022. Acceptance code: 卫食添新申字(2022) No. 0076;

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

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

2

Vitamin B2

14.04.02.01

Drinks for special uses (including sports drinks and nutrient drinks)

2 mg/kg~5 mg/kg

1) Accepted on October 31. 2022. Acceptance code: 卫食添新申字(2022) No. 0077;

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 nutrient drinks)

0.1 g/kg~0.6 g/kg

1) Accepted on October 31. 2022. Acceptance number: 卫食添新申字(2022) No. 0075;

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 source of Vitamin C, its scope of use and dosage is consistent with the provisions in GB14880.

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.

Conclusion

Based on the statistics above, in the first half of 2023, new food enzymes, most which are from genetically modified sources, accounted for the largest proportion, with 39.1% approved and 27.2% issued for public comments. On May 6, NHC issued Announcement No.3 of 2023, clearly stipulating the strain number of D-psicose 3-epimerase donor strain for the first time. It shows that the official requirements for food enzymes have become more rigorous, and that enterprises’ R&D results are better protected.

In the first quarter of 2023, a large number of products were accepted by the NHC, twice as many as those accepted in the same period last year. However, most of the review results were unsatisfactory, this is because the requirements for food additives review became more stringent. In the future, food enterprises should make adequate preparations in the product safety and the necessity of technologies applied in products, to better cope with the review. Even if the products were rejected by the NHC, related enterprises may still rearrange their application materials by reference to the technical review results provided by the expert committee and submit their application for a second time.

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