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Analysis on Application Approval of New Food Additives in the First Half of 2022

from CIRS by

China,Food,Additive,Approval,New,CFSA

At the end of June, the National Health Commission of the People's Republic of China (NHC) issued two announcements (No. 1 of 2022, No. 2 of 2022) in the form of "three new food" with a total of 68 kinds of products approved, including new food raw materials (novel food), new food additives and food-related products (new food contact substances). Among them, 29 kinds of new food additives (including expanded use) were approved.

Besides, from websites of NHC and China National Center for Food Safety Risk Assessment (CFSA), in the first half of 2022, a total of 37 new food additives applications were accepted, and 8 new food additives (including expanded use) passed the technical evaluation and were issued for public comments.

CIRS Group will take you to the detailed information about the acceptance and approval of new food additives in China in the first half of 2022 as following.

1. List of new food additives application in the first half of 2022 (37 types)

In the first half of 2022, a total of 37 new food additives (including expanded use) applications were accepted by NHC. The acceptance code all begin with "卫食添新申字", and there is no distinction between domestic and imported products.

Among them, monascus yellow pigment (卫食添新申字(2022)第0002号) was not granted the administrative license on March 8, 2022.

No.

Acceptance date

Acceptance Code

Name of New Food Additives

1

2022.01.06

卫食添新申字(2022)第0001号

Carboxypeptidase

2

2022.01.10

卫食添新申字(2022)第0002号

Monascus yellow pigment

3

2022.01.30

卫食添新申字(2022)第0003号

Carmine cochineal

4

2022.02.11

卫食添新申字(2022)第0004号

Rebaudioside A

5

2022.02.11

卫食添新申字(2022)第0005号

Stevia glycosides

6

2022.02.11

卫食添新申字(2022)第0006号

Stevia extract

7

2022.02.16

卫食添新申字(2022)第0007号

Magnesium stearate

8

2022.03.03

卫食添新申字(2022)第0008号

L-alanine

9

2022.03.07

卫食添新申字(2022)第0009号

Xylanase

10

2022.03.07

卫食添新申字(2022)第0010号

Aminopeptidase

11

2022.03.08

卫食添新申字(2022)第0011号

L-leucine

12

2022.03.08

卫食添新申字(2022)第0012号

L-isoleucine

13

2022.03.08

卫食添新申字(2022)第0013号

L-valine

14

2022.03.21

卫食添新申字(2022)第0014号

6S-5-methyltetrahydrofolate calcium

15

2022.04.02

卫食添新申字(2022)第0015号

Maltose alpha-amylase

16

2022-04-26

卫食添新申字(2022)第0016号

Lactase (beta-galactosidase)

17

2022.04.28

卫食添新申字(2022)第0017号

Phospholipase A2

18

2022.05.10

卫食添新申字(2022)第0018号

Serine protease

19

2022.05.10

卫食添新申字(2022)第0019号

Serine protease

20

2022.05.10

卫食添新申字(2022)第0020号

Xylanase

21

2022.05.23

卫食添新申字(2022)第0021号

2-hexyl pyridine

22

2022.05.26

卫食添新申字(2022)第0022号

L-cystine

23

2022.05.26

卫食添新申字(2022)第0023号

L-cysteine hydrochloride monohydrate

24

2022.05.26

卫食添新申字(2022)第0024号

L-lysine acetate

25

2022.05.26

卫食添新申字(2022)第0025号

L-histidine

26

2022.05.26

卫食添新申字(2022)第0026号

L-threonine

27

2022.05.26

卫食添新申字(2022)第0027号

L-cysteine hydrochloride

28

2022.05.26

卫食添新申字(2022)第0028号

L-cysteine

29

2022.05.26

卫食添新申字(2022)第0029号

L-phenylalanine

30

2022.05.26

卫食添新申字(2022)第0030号

L-lysine hydrochloride

31

2022.05.26

卫食添新申字(2022)第0031号

L- histidine hydrochloride monohydrate

32

2022.05.27

卫食添新申字(2022)第0032号

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

33

2022.06.02

卫食添新申字(2022)第0033号

D-psicose 3-epimerase

34

2022.06.09

卫食添新申字(2022)第0034号

Rock mineral selenium

35

2022.06.13

卫食添新申字(2022)第0035号

L-selenomethyl selenocysteine

36

2022.06.13

卫食添新申字(2022)第0036号

Ammonium glycyrrhizinate

37

2022.06.13

卫食添新申字(2022)第0037号

Acesulfame potassium

2. List of new food additives passed the technical review and were issued for public comments in the first half of 2022 (8 types)

In the first half of 2022, 8 new food additives passed the technical review of CFSA and were issued for public comments, including 4 new food enzymes, 1 new food processing aid, 1 new nutrition enhancer and 2 existing food additives with expanded use. Among them, except carmine cochineal (which was accepted in 2022), the other 7 products applications were accepted by NHC in 2021.

2.1 List of new food enzymes (4 types)

No

Name

Source

Donor

Approval status (By the end of June 2022)

1

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 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

Accepted on September 17, 2021, Acceptance number: 卫食添新申字(2021)第0039号;

Passed the technical review and issued 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, 2021, Acceptance number: 卫食添新申字(2021)第0041号;

Passed the technical review and issued 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, 2021, Acceptance number: 卫食添新申字(2021)第0053号;

Passed the technical review and issued public comments on April 15, 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, Enzymes" (GB 1886.174).

2.2 List of new food processing aid (1 type)

No

Name

Function

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 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 public comments on January 29, 2022, and officially approved on May 11, 2022 according to No. 2 of 2022.

2.3 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 2022)

1

2'-fucosyllactose

01.03.02

Modified milk powder (limited to milk powder for children)

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

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, for the combined release;

Passed the technical review and issued public comments on April 15, 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 purpose

2.4 List of food additives with expanded scope (2 types)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(By the end of June 2022)

1

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 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 public comments on April 15, 2022.

It has not been officially approved.

3. List of approved new food additives in the first half of 2022 (29 types)

In the first half of 2022, 29 types of new food additives were approved by NHC, which include 12 new enzymes for food industry, 1 new food additive, 1 new processing aid, 1 new food nutrition enhancer, 11 existing food additives with expended use and 3 processing aids with expended use.

The relevant information is as follows:

3.1 List of approved new food enzymes (12 types)

No

Name

Source

Donor

Acceptance information, public comment and approval announcements

(By the end of June 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 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 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 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 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 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

Accepted on September 17, 2021, Acceptance number: 卫食添新申字(2021)第0039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.

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 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 public comments on October 21, 2021, and officially approved on May 11, 2022 according to No. 2 of 2022.

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

3.2 List of new food additive (1 type)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 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 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 aid (1 type)

No

Name

Function

Usage scope

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 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 (1 type)

No

Name

Function

Category number

Food name/category

Maximum level (mg/kg)

Acceptance information, public comment and approval announcements

(By the end of June 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 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, etc.)

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 (11 types)

No

Name

Function

Category number

Food Name/ category

Maximum level (g/kg)

Acceptance information, public comment and approval announcements

(By the end of June 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 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)第0025号;

Passed the technical review and issued 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

Batter (Such as batter containing fish and poultry), coating flour, powder used for food frying

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 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 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 (puffed soy protein food, soybean meat, etc.)

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 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 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 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, 2020, Acceptance number: 卫食添新申字(2020)第0057号;

Passed the technical review and issued 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

Remanufacturing 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 public comments on October 21, 2021, and officially approved on May 11, 2022 according to No. 2 of 2022.

01.02.02

Flavoured 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.

3.6 List of approved processing aids with expanded scope (3 types)

No

Name

Function

Usage scope

Acceptance information, public comment and approval announcements

(By the end of June 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 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 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, count 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

Through above analysis, new food enzyme accounted for the largest proportion in the first half of 2022, which accounting for 41.38% of the approved products and 50.0% of the products issued for public comments, most of which were genetically modified sources. At the same time, the 2'-fucosyl lactose (2’FL) from modified E-coli was released for public comments by CFSA on April 15, 2022, which is a big step forward for the application of GMM food additives in China, and it can be expected that 2’-FL will get the approval in China soon. In order to help enterprises understand the registration of new GMM food additives in China, CIRS Group will hold a webinar in July 2022: How to Register Genetically Modified Microorganism (GMM) Food Additive in China?

On the other hand, it can be found that the registration period of some products is quite short. For example, it only takes about 6 months for glucose oxidase to get the final approval from its acceptance by NHC, which can be seen that if the application dossiers are well-prepared, the product could have the chance to pass the technical review at one time and get the final approval quickly. The applicant shall pay 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.

If you have any needs or questions, please contact us at service@cirs-group.com.

Further Information

Analysis on Application Approval of China New Food Additives in 2021

Analysis on Application Approval of New Food Additives in the First Half of 2021

NHC New Food Additive Registration in China