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Analysis on Application Approval of China New Food Additives in 2021

from CIRS by

Updated on 20 Jan. 2022

China,Food,Additive,Approval,Registration

In 2021, the National Health Commission of the People's Republic of China (NHC) issued five announcements (No.9, 2020; No.2, 2021; No.5, 2021; No.6, 2021; No.9, 2021) for the approval of new food additives, with 35 new food additives (including expanded use) approved.

Besides, from websites of NHC and China National Center for Food Safety Risk Assessment (CFSA), in 2021, a total of 63 new food additives applications were accepted, and 49 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 2021 as following.

1. List of new food additives application acceptance in 2021 (63 products)

In 2021, a total of 63 new food additives (including expanded use) applications were accepted by NHC. The acceptance numbers are all shown as "卫食添新申字", and no distinction between domestic and imported products.

Some new products, especially those that applied in the first half of the year have passed the technical review by CFSA and were issued for public comments. Besides, a few new products were officially approved in 2021.

No

Acceptance Date

Acceptance Code

Name of New Food Additives

1

2021-01-08

卫食添新申字(2021)第0001号

Glutaminase

2

2021-01-08

卫食添新申字(2021)第0002号

Advantame

3

2021-01-11

卫食添新申字(2021)第0003号

Beta-glucanase

4

2021-01-20

卫食添新申字(2021)第0004号

Curdlan

5

2021-01-20

卫食添新申字(2021)第0005号

Glutamine transaminase

6

2021-01-25

卫食添新申字(2021)第0006号

Vegetable carbon black

7

2021-01-25

卫食添新申字(2021)第0007号

Sucralose

8

2021-03-03

卫食添新申字(2021)第0008号

Chili oleoresin

9

2021-03-03

卫食添新申字(2021)第0009号

Paprika red

10

2021-03-03

卫食添新申字(2021)第0010号

Paprika red

11

2021-03-08

卫食添新申字(2021)第0011号

Potassium sorbate

12

2021-03-15

卫食添新申字(2021)第0012号

Vegetable carbon black

13

2021-03-18

卫食添新申字(2021)第0013号

Plant-derived recombinant human lactoferrin

14

2021-03-19

卫食添新申字(2021)第0014号

Maltogenic amylase

15

2021-03-22

卫食添新申字(2021)第0015号

Lipase

16

2021-03-22

卫食添新申字(2021)第0016号

Lactases

17

2021-03-26

卫食添新申字(2021)第0013号

Phospholipase A1

18

2021-04-12

卫食添新申字(2021)第0017号

Sucralose

19

2021-05-17

卫食添新申字(2021)第0018号

Turmeric

20

2021-05-27

卫食添新申字(2021)第0019号

Silicon dioxide

21

2021-06-01

卫食添新申字(2021)第0020号

Quinoline yellow aluminum lake

22

2021-06-02

卫食添新申字(2021)第0021号

Pulullan

23

2021-06-04

卫食添新申字(2021)第0022号

Potassium acesulfame

24

2021-06-04

卫食添新申字(2021)第0023号

Potassium acesulfame

25

2021-06-16

卫食添新申字(2021)第0024号

Nisin

26

2021-06-28

卫食添新申字(2021)第0025号

Carbon dioxide

27

2021-06-29

卫食添新申字(2021)第0026号

Lutein

28

2021-07-02

卫食添新申字(2021)第0027号

Phospholipase A1

29

2021-07-02

卫食添新申字(2021)第0028号

2'-Fucosyllactose(2'-FL)

(synthetic)

30

2021-07-07

卫食添新申字(2021)第0029号

β-Amylase

31

2021-07-07

卫食添新申字(2021)第0030号

Sodium sulfide pentahydrate

32

2021-07-07

卫食添新申字(2021)第0031号

Pyrrolidinyl-[1,2e]-4H -2,4-dimethyl-1,3,5-dithiazine

33

2021-07-07

卫食添新申字(2021)第0032号

Glutaminase

34

2021-07-08

卫食添新申字(2021)第0033号

lnositol (Cyclohexanehexol)

35

2021-07-12

卫食添新申字(2021)第0034号

D-ribose

36

2021-08-10

卫食添新申字(2021)第0035号

Polyoxyethylene(20) Sorbitan Monooleate(Polysorbate 80)

37

2021-08-23

卫食添新申字(2021)第0036号

Urea

38

2021-08-27

卫食添新申字(2021)第0037号

Protease

39

2021-09-06

卫食添新申字(2021)第0038号

Monascus color

40

2021-09-17

卫食添新申字(2021)第0039号

Protease

41

2021-09-17

卫食添新申字(2021)第0040号

β-glucanase

42

2021-09-17

卫食添新申字(2021)第0041号

Trehalase

43

2021-09-17

卫食添新申字(2021)第0042号

Vitamin K(Vitamin K2)

44

2021-09-22

卫食添新申字(2021)第0043号

Sucralose

45

2021-09-22

卫食添新申字(2021)第0044号

Tomato red

46

2021-09-29

卫食添新申字(2021)第0045号

6S-5-methyltetrahydrofolate calcium

47

2021-10-08

卫食添新申字(2021)第0046号

Tea polyphenol palmitate

48

2021-10-13

卫食添新申字(2021)第0047号

Silicone modified polyether

49

2021-10-18

卫食添新申字(2021)第0048号

2'-Fucosyllactose(2'-FL)

50

2021-10-18

卫食添新申字(2021)第0049号

Lacto-N-Neotetraose

51

2021-11-03

卫食添新申字(2021)第0050号

2'-Fucosyllactose(2'-FL)

52

2021-11-03

卫食添新申字(2021)第0051号

N-acetylneuraminic acid

53

2021-11-09

卫食添新申字(2021)第0052号

Glycose Oxidase

54

2021-11-09

卫食添新申字(2021)第0053号

Lactase

55

2021-11-11

卫食添新申字(2021)第0054号

Polydimethyl siloxane

56

2021-11-16

卫食添新申字(2021)第0055号

L-Arginine Hydrochloride

57

2021-11-16

卫食添新申字(2021)第0056号

L-Arginine- aspartic acid

58

2021-11-16

卫食添新申字(2021)第0057号

L-Arginine

59

2021-11-18

卫食添新申字(2021)第0058号

Vegetable carbon black

60

2021-11-18

卫食添新申字(2021)第0059号

L-Alanine

61

2021-12-15

卫食添新申字(2021)第0060号

Turmeric

62

2021-12-29

卫食添新申字(2021)第0061号

Caffeine

63

2021-12-30

卫食添新申字(2021)第0062号

Curdlan

2. List of new food additives which passed the technical review and were issued for public comments in 2021 (49 products)

In 2021, 49 of new food additives passed the technical review of CFSA and were issued for public comments. These include 3 new nutrition enhancers, 1 new food flavor, 1 new food additive, 21 new enzymes and 23 existing food additives with expended use (including 1 nutrition enhancer, 4 processing aids and 18 food additives).

1) List of new food nutrition enhancers (3 products)

No

Name

Category number

Food name/category

Maximum level

Approval Status

(As of the end of 2021)

1

2′-Fucosyllactose (synthetic)

01.03.02

Modified milk powder (limited to milk powder for children)

1.2 g/L

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

Passed the technical review and issued public comments on 21st October, 2021

2

D-ribose

13.05

Other special dietary foods except 13.01~13.04 (only for sports nutrition foods)

≤33 g/kg

14.04.02.01

beverages for special uses (only for sports drinks)

≤8.0 g/kg

(Count as the state of ready to drink)

3

lnositol (Cyclohexanehexol)

01.03.02

Modified milk powder (limited to milk powder for children)

210 mg/kg~250 mg/kg

14.02.03

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

60 mg/kg~120 mg/kg

14.04.02.02

Flavored drink

60 mg/kg~120 mg/kg

13.0

Foods for special dietary uses

Refer to relevant standards for special dietary foods

2) List of new flavor (1 type)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(As of the end of 2021)

1

Thaumatin

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

Passed the technical review and issued public comments on 12th April, 2021;

22th October,2021, officially approved by Announcement No.9 of 2021.

3) List of new food enzymes (21 products)

No

Name

Source

Donor

Approval Status

(As of the end of 2021)

1

4-α-glucanotransferase

Aeribacillus pallidus

Passed the technical review and issued public comments on 18th February,2021;

26th July,2021, officially approved by Announcement No.6 of 2021.

2

Alpha-amylase

Aspergillus niger

Rhizomucor pusillus

3

Polygalacturonase

Trichoderma reesei

Aspergillus tubingensis

4

Pectin esterase

Trichoderma reesei

Aspergillus tubingensis

5

Phosphoinositide Phospholipase C

Bacillus licheniformis

Pseudomonas sp.

6

Phospholipase C

Bacillus licheniformis

Bacillus thuringiensis

7

Xylanase

Trichoderma reesei

Thermopolyspora flexuosa

8

Glucoamylase

Aspergillus niger

Gloeophyllum trabeum

9

Lipase

Trichoderma reesei

Fusarium oxysporum

10

Protease

Anoxybacillus caldiproteolyticus

Passed the technical review and issued public comments on 12th April,2021

22th October,2021, officially approved by Announcement No.9 of 2021.

11

Glutaminase

Bacillus licheniformis

Bacillus licheniformis

12

Xylanase

Trichoderma reesei

Aspergillus niger var. tubingensis

13

Phospholipase A1

Aspergillus oryzae

Valsaria rubricosa

Passed the technical review and issued public comments on 6th August,2021

14

Maltogenic amylase

Bacillus licheniformis

Geobacillus stearothermophilus

15

Glucose oxidase

Trichoderma reesei

Penicillium amagasakiense

16

Lipase

Trichoderma reesei

Aspergillus niger var. tubingensis

17

β-fructofuranosidase

Aspergillus fijiensis

Passed the technical review and issued public comments on 21st October, 2021

18

Lactase

Bacillus subtilis

Lactobacillus delbrueckii subsp. bulgaricus

19

Phytase

Aspergillus niger

Aspergillus tubingensis

20

Phospholipase A1

Aspergillus niger

Talaromyces leycettanus

Passed the technical review and issued public comments on 8th December,2021

21

Glucose oxidase

Aspergillus niger

Penicillium

chrysogenum

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

4) List of new food additive (1 type)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(As of the end of 2021)

1

Quinoline yellow aluminum lake

Colorant

05.03

Coatings for candy and chocolate products(only for candy)

0.3

(Measured as quinoline yellow)

Passed the technical review and issued public comments on 21st October, 2021

5) List of food nutrition enhancer with expanded scope (1 type)

No

Name

Category number

Food name/category

Maximum level

Approval Status

(As of the end of 2021)

1

Vitamin K (Vitamin K2)

01.03.02

Modified milk powder(Milk powder for children, pregnant and puerpera are excluded)

340 μg/kg ~680 μg/kg

Passed the technical review and issued public comments on 21st October, 2021

13.03

Formula foods for special medical purposes (excepted for those mentioned in 13.01)

Refer to the regulation of vitamin K1 in GB 29922

6) List of processing aids with expanded scope (4 products)

No

Name

Function

Usage scope

Approval Status

(As of the end of 2021)

1

White oil (liquid paraffin)

Release agent, lubricating agent

Processing technology of fresh yeast products(The maximum level is 1.5g /kg)

Passed the technical review and issued public comments on 28th May,2021

2

White mineral oil(liquid paraffin)

Release agent, lubricating agent

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

Passed the technical review and issued public comments on 6th August,2021

3

Polyacrylamide

Flocculating agents

Processing technology of salt

Passed the technical review and issued public comments on 21st October, 2021

4

Polydimethyl siloxane

Antifoaming agents

Yeast processing products production and processing technology

(The maximum level is 0.1 g /kg, measured as polydimethyl siloxane)

Passed the technical review and issued public comments on 8th December,2021

7) List of food additives with expanded scope (18 products)

No

Name

Function

Category number

Food name/ category

Maximum level

(g/kg)

Approval Status

(As of the end of 2021)

1

Sucralose

Sweetener

08.03.01

Sauced meat products

0.35

Passed the technical review and issued public comments on

18th February,2021

2

Advantame

Sweetener

14.04

Carbonated drinks

0.006

Passed the technical review and issued public comments on 12th April,2021;

Except for No.3, other products were officially approved by Announcement No. 9 of 2021 (22nd October,2021)

3

Glutamine transaminase

Stabilizer and coagulator

01.02.02

Flavored fermented milk

0.3

01.06.01

Unripened cheese

4

Curdlan

Stabilizer,coagulator and thickener

08.02.01

Conditioned meat products (raw meat with added ingredients)

Appropriate level as required in production

14.06.03

instant coffee

16.03

collagen casing

5

Paprika red

Colorant

08.02.01

Conditioned meat products (raw meat with added ingredients)

Appropriate level as required in production

6

Sucrose fatty acid esters

Emulsifier

01.05.01

Light cream

2.5

7

Paprika red

Colorant

16.07

Other (only for Konjac gel processing)

Appropriate level as required in production

Passed the technical review and issued public comments on 28th May,2021;

22nd October,2021, officially approved by Announcement No. 9 of 2021

8

Chili oleoresin

Flavor enhancer, colorant

16.07

Other (only for Konjac gel processing)

Appropriate level as required in production

9

Silicon dioxide

Anti-caking agent

04.04.03

Other soy products (only for soy protein powder or modulated soy protein powder)

15.0

Passed the technical review and issued public comments on 6th August,2021

10

Carbon dioxide

Other

01.02.02

Flavored fermented milk

Appropriate level as required in production

11

Turmeric

Colorant

06.03.02.04

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

0.25(Measured as curcumin)

12

Nisin

Preservative

04.04.01.03.02

Pot-stewed semi-dried tofu

0.5

13

Sucralose

Sweetener

04.04.01.05

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

0.4

14

Vegetable carbon black

Colorant

01.02.02

Flavored fermented milk

5.0

04.01.02.05

Jam

15

Magnesium chloride

Flavoring agent

06.07

Instant rice and flour products

Appropriate level as required in production

Passed the technical review and issued public comments on 21st October,2021

6.08

Frozen rice and flour products

12.10

Compound condiment

16

Lutein

Colorant

01.01.03

Modified milk

0.05

01.02.02

Flavored fermented milk

17

Tomato red

Colorant

09.02.03

Frozen surimi and its products (including fish balls, etc.)

0.08(Measured as Lycopene)

Passed the technical review and issued public comments on 8th December,2021

09.04

Cooked aquatic products (Can be directly consumed)

18

Sucralose

Sweetener

01.06.04

Processed cheese

0.2

3. List of approved new food additives in 2021(35 products)

In 2021, 35 new food additives were approved by NHC, which include 1 new food nutrition enhancer, 1 new processing aid, 1 new food flavor, 18 new food enzymes, 14 existing food additives with expanded scope(including 1 existing food nutrition enhancer and 2 existing processing aids)

Due to applications for the same product is accepted more frequently and the lack of clear information on the scope of use, the information on some approved products is missing. CIRS summarized relevant information below:

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

No

Name

Category number

Food Name/ category

Maximum level (g/kg)

1

Vitamin K2

(Synthetic method)

01.03.02

Modified milk powder(limited to milk powder for children)

420 μg/kg–750 μg/kg

Modified milk powder (limited to milk powder for pregnant and puerpera)

340 μg/kg–680 μg/kg

2) List of approved new processing aid (1 type)

No

Name

Function

Usage scope

1

Nitrous oxide

Propellant, Foaming agent

01.05 Processing of cream (light cream) and similar products;

02.02 Processing of water-oily fat emulsified products (vegetable milk only);

Processing of fat emulsified products other than 02.02, including mixed or flavored fat emulsified products (vegetable cream only)

3) List of new flavor (1 type)

No

Name

Function

Category number

Food name/category

Maximum level (g/kg)

1

Thaumatin

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

4) List of approved new food enzymes (18 products)

No

Name

Source

Donor

1

Beta-amylase

Bacillus licheniformis

Bacillus flexus

2

Alpha-amylase

Bacillus licheniformis

Cytophaga sp.

3

Protease

Bacillus subtilis

Thermus Aquaticus

4

Lactase

Bacillus subtilis

Bifidobacterium bifidum

5

Protease

Bacillus subtilis

Bacillus amyloliquefaciens

6

Phosphoinositide phospholipase C

Pseudomonas fluorescens

Microorganisms encoding the phosphoinositolipase C gene isolated from soil

7

4-α-glucanotransferase

Aeribacillus pallidus

8

α-amylase

Aspergillus niger

Rhizomucor pusillus

9

Polygalacturonase

Trichoderma reesei

Aspergillus tubingensis

10

Pectinesterase

Trichoderma reesei

Aspergillus tubingensis

11

Phosphoinositide Phospholipase C

Bacillus licheniformis

Pseudomonas sp.

12

Phospholipase C

Bacillus licheniformis

Bacillus thuringiensis

13

Xylanas

Trichoderma reesei

Thermopolyspora flexuosa

14

Glucoamylase

Aspergillus niger

Gloeophyllum trabeum

15

Lipase

Trichoderma reesei

Fusarium oxysporum

16

Protease

Anoxybacillus caldiproteolyticus

17

Glutaminase

Bacillus licheniformis

Bacillus licheniformis

18

Xylanase

Trichoderma reesei

Aspergillus niger var. tubingensis

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

5) List of approved food nutrition enhancers with expanded scope (1 type)

No

Name

Category number

Food Name/ category

Maximum level (g/kg)

1

6S-5-methyltetrahydrofolate calcium

13.05

Other special dietary foods except 13.01~13.04 (only for nutritional supplements for pregnant, lactating women and sports nutrition foods)

The usage should comply with the relevant requirements in GB 31601-2015 and GB24154-2015

6) List of approved food additives with expanded scope (11 products)

No

Name

Function

Category number

Food Name/ category

Maximum level (g/kg)

1

Gum ghatti

Emulsifier

13.05

Other food for special dietary use (only for foods for special medical purpose of for people over 10 years old)

3.0

2

Sodium alginate

(SA)

Stabilizer

13.05

Other food for special dietary use (only for foods for special medical purpose of 13 months -10 years old)

1.0

(Products suitable for children aged 13-36months)

Appropriate level as required in production

(Products

suitable for people aged 37 months to 10 years)

3

Silicon dioxide

Anti-caking agentt

04.04.03

Other soy products

(only for bean curd powder)

15.0

4

Tomato red

Colorant

05.02.02

Other candy except for Gum-based candy

0.25

12.10.02

Semi-solid blended condiment

0.125

5

Curdlan

Thickener

04.01.02.05

Jam

Appropriate level as required in production

04.04.01.05

New bean curd product (puffed soy protein food, soybean meat, etc.)

06.05.02.04

Starch-based snack

16.07

Other

(only for Konjac gel product)

6

Tamarind polysaccharide gum

thickener

04.01.02.05

Jam

5.0

04.01.02.08.05

Fruitcake

20.0

14.02.03

Fruit/vegetable juice (puree) beverage

3.0

(Count as the state of ready to drink, for solid beverage, the level of use should be increased by times of dilution)

7

Advantame

Sweetener

14.04

Carbonated beverage

0.006(Count as the state of ready to drink)

8

Curdlan

Stabilizer, coagulator and thickener

08.02.01

Conditioning meat products (raw meat with conditioning materials)

Appropriate level as required in production

14.06.03

Instant coffee

16.03

Collagen casings

9

Paprika red

Colorant

08.02.01

Conditioning meat products (raw meat with conditioning materials)

Appropriate level as required in production

16.07

Other food (only for product of Konjac gel)

Appropriate level as required in production

10

Chili oleoresin

Flavor enhancer, colorant

16.07

Other food (only for product of Konjac gel)

Appropriate level as required in production

11

Sucrose fatty acid esters

Emulsifier

01.05.01

Cream

2.5

7)List of approved processing aids with expanded scope (2 products)

No

Name

Function

Usage scope

1

Butane

propellant

Processing technology of spray release oil for bakery food

2

Phosphoric acid(wet-process)

Nutrients for refining, degumming and fermentation

Oil processing technology, fermentation technology

Summary

There are three main stages of applying for a new food additive: Firstly, NHC accepts the application. Secondly, CFSA runs a technical review and issue public comments. Finally, if everything goes well, NHC will approve the application. Generally, it will take approximately 1 year to apply for a new food additive. While if the application is about expending usage scope, the timeline may be shorter.

Compared with 2020, the number of products accepted in 2021 decreased by 10, and products issued for public comments increased by 22, of which new food enzymes accounted for 53.1%. Meanwhile, based on the analysis on the application approval of new food additives in 2020&2021, it can be seen that the new varieties are mainly enzymes and nutrition enhancers, the number of products with expanded scope are still large. This also reflects the rapid growth on these two kinds of products with the rapid development of bioengineering technology and technological innovation industry.

In the past, the NHC only accepted the applications for new food enzymes derived from genetically modified microorganism, but at the beginning of 2021, they allowed the application of new varieties of genetically modified microorganism food additives (GMM food additive). This means that enterprises can currently submit applications for additives or enzymes products produced through genetically modified technology. Up to now, many products have submitted the application and are waiting for technical review. If you have any needs or questions about the GMM food additive, please contact us at service@cirs-group.com.

Note: There may be omissions and errors in the data statistics process because of the change of the official website. The data in this article is for reference only. Please refer to the official information published by the government.